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India Pharma 2015
Unlocking the Potential of the
Indian Pharmaceuticals Market
Pharmaceuticals & Medical
Products Practice
India Pharma 2015
Unlocking the Potential of the
Indian Pharmaceuticals Market
Gautam Kumra
Palash Mitra
Chandrika Pasricha
Executive Summary
As pharmaceuticals companies scan for new growth opportunities over the next
decade, they have realised that some of the most promising are to be found in
the world’s emerging economies. In recent times, the pharmaceuticals industry
has shown high interest in India due to its sustained economic growth, healthcare
reforms and patent-related legislation.
Following a series of reforms beginning in the early 1990s, India has enjoyed
over a decade of strong growth and a rise in the spending power of its citizens.
Real average household income in India has roughly doubled over the past two
decades. In the meantime, disease patterns in India have undergone a shift.
Increasingly stressful lifestyles have led to significant increases in the incidence
of chronic diseases. While government interventions have brought some acute
ailments under control, a sizeable part of the population remains susceptible to
a wide range of acute diseases.
Driven by increasing affordability, shifting disease patterns and modest healthcare
reforms, the total consumer spending on healthcare products and services in the
country grew at a compounded annual rate of 14 per cent from 2000 to 2005. The
pharmaceuticals industry, which accounts for 15 to 20 per cent of total healthcare
spend, grew at a compounded annual rate of 9 per cent during this period.
Spending on healthcare will continue to be robust. According to a recently
published report by the McKinsey Global Institute, The ‘Bird of Gold’: The Rise of
India’s Consumer Markets, spending on healthcare will witness the highest growth
rate among all spending categories over the next two decades. Healthcare grew
from 4 per cent of average household income in 1995 to 7 per cent in 2005, and
is expected to grow to 13 per cent by 2025.
9
This view of the healthcare sector has resulted in growing interest among
business leaders and policy makers in the pharmaceuticals industry. Yet much
remains unknown about the long-term potential and evolution of the Indian
pharmaceuticals market. How is the market likely to grow? To what extent
will increasing incomes and spending power drive this growth? What role will
health insurance and medical infrastructure play? How is the spending on
pharmaceutical products likely to differ between urban and rural regions? What
share of the market is likely to be captured by patent-protected products? What
are the implications for domestic players, multinational companies and policy
makers?
In response to these questions, McKinsey & Company’s Pharmaceuticals &
Medical Products Practice launched a year-long research project to study the
future of the Indian pharmaceuticals market. We built a demand model that
projects the market potential based on the impact of five fundamental growth
drivers: income demographics, medical infrastructure build-up, health insurance
penetration, incidence of diseases and likely competitive intensity. Using the
output from this model, we distributed the market forecast across therapy and
geographic segments. In addition, we built a model that translates several supply
factors into estimates of the share of patent-protected products by 2015. Finally,
we complemented the results of the modelling with on-the-ground insights from
an extensive field study.
Our analysis shows that if the Indian economy continues on its current high
growth path, then the Indian pharmaceuticals market will undergo a major
transformation in the next decade. The market will triple to US$20 billion by
2015 and move into the world’s top-10 pharmaceuticals markets. The absolute
growth of US$14 billion will be next to the growth potential of the US and China,
and in the same league as the growth in Japan, Canada and the UK. While
the therapy mix will gradually move in favour of specialty and super-specialty
therapies, mass therapies1
such as anti-infective and gastro-intestinal drugs
will continue to comprise half of the market by 2015. Generics will continue to
dominate, while patent-protected products are likely to constitute 10 per cent of
the market within this timeframe. Leveraging the strong distribution infrastructure
in the Tier 1 markets,2
i.e., metros, Class I and Class IA towns, these markets
1	 We define specialty therapies as those where products are prescribed primarily by specialist
physicians and consulting physicians; super-specialty therapies as those where specialist and
super-specialist physicians account for 80 per cent of prescriptions; and mass therapies as
those where products are prescribed mainly by general practitioners.
2	 We define Tier 1 markets as metros (population 1 million), Class I towns (0.5 million to 1
million) and Class 1A towns (0.1 million to 0.5 million). Tier 2 markets are the remaining urban
markets (Class II, III and IV towns) and rural areas.
10
11
will account for half of the growth potential. Tier 2 markets, i.e., remaining urban
markets and rural areas, will grow in importance and account for the remaining
half. These changes in the market will have important implications for Indian
companies, multinational firms and policy makers.
We briefly outline these findings below. Readers interested in the detailed results
and analysis should see the main chapters of the report, while those interested
in our methodology and assumptions are directed to the appendices.
INDIAN PHARMACEUTICALS MARKET WILL TRIPLE OVER THE NEXT DECADE
Six trends will influence the growth of the Indian pharmaceuticals market over
the next decade: doubling of disposable incomes and the number of middle-class
households, expansion of medical infrastructure, greater penetration of health
insurance, rising prevalence of chronic diseases, adoption of product patents,
and aggressive market penetration driven by the relatively smaller companies.
We believe that from a market size of US$6.3 billion3
in 2005, the Indian
pharmaceuticals market will grow to about US$20 billion4
by 2015. This implies
a compounded annual growth rate of 12.3 per cent. This growth will be materially
higher than the annual growth rate of 9 per cent witnessed during 2000 to
2005.
In terms of scale, the Indian pharmaceutical market is ranked 14th in the world.
By 2015, it will rank among the top 10 in the world, overtaking Brazil, Mexico,
South Korea and Turkey (Exhibit 1). More importantly, the incremental market
growth of US$14 billion over the next decade is likely to be the third largest
among all markets. The US and China are expected to add US$200 billion and
US$23 billion respectively. India, Japan, Canada and the UK are expected to be
the next in line, with growth expectations in the range of US$13–14 billion during
this timeframe (Exhibit 2).
3	 This estimate includes all retail sales of pharmaceutical products and institutional sales at
ex-manufacturer prices (source: IMS World Review and IMS Midas).
4	 This projection is at ex-manufacturer prices and is based on a Re-$ exchange rate of Rs. 45 per
US$.
12
Exhibit 2Exhibit 2
BY ABSOLUTE GROWTH, INDIA WILL BE AMONG THE TOP 5 MARKETS
GLOBALLY DURING 2005 TO 2015
Source: IMS World Review; analyst projections; McKinsey India Pharmaceutical Demand Model
Incremental growth (2005–2015)
US$ billion
13
7
11
12
14
14
14
23
196US
China
Japan
Germany
France
UK
Canada
India
Brazil
Exhibit 1
Exhibit 1
INDIA IS PROJECTED TO BE THE 10th LARGEST MARKET BY 2015
Top 14 pharmaceuticals markets, 2005
US$ billion
Top 14 pharmaceuticals markets, 2015
6
7
8
9
10
13
13
14
19
20
31
32
68
248
15
15
19
20
20
25
25
25
32
38
38
46
82
444
UK
Italy
France
Japan
Germany
Canada
US
Spain
India
Turkey
South Korea
Brazil
Mexico
China
Germany
China
UK
Spain
Italy
Turkey
South Korea
Mexico
Brazil
India
Canada
US
Japan
France
Source: IMS World Review; analyst projections; McKinsey India Pharmaceutical Demand Model
6
5
3
2
4
8
1
7
14
13
12
11
10
9
6
5
3
2
4
8
1
7
14
13
12
11
10
9
13
Underpinning the market projection of US$20 billion is the assumption that
the growth drivers will change significantly by 2015. Real GDP will grow at the
compounded annual rate of 7.3 per cent.5
Per capita disposable income will rise
from US$463 in 2005 to US$765 in 2015. Twenty-seven million households
currently in the low-income category6
will move up. The middle-income category
will witness the steepest rise, with the addition of 59 million households. Driven
largely through private investments, the number of hospital beds and physicians
in the country is expected to double by 2015 (i.e., additional 2 million hospital
beds and 0.4 million physicians). Corporate hospital chains will play a leading
role in transforming the quality of secondary and tertiary care. Health insurance
penetration is expected to double by 2015 to cover 220 million people.
Traditional premium-based insurers will drive nearly 90 per cent of this growth in
health insurance coverage. Patent infrastructure will scale up to enable up to 30
approvals annually and an average approval timeframe of two years.
A close examination of the growth drivers indicates that rising disposable
incomes and an upward shift in income demographics will be the dominant
growth factor and will account for nearly 40 per cent of the projected market
growth. Improvements in medical infrastructure come next, accounting for 20
per cent. Greater health insurance penetration will account for nearly 15 per cent
of the growth. A gradual shift in disease profile will account for another 10 per
cent of the growth. Finally, population growth and other factors will make up the
remaining 15 per cent (Exhibit 3).
If the underlying growth drivers move more rapidly than envisaged in the base-
case scenario, then the compounded annual growth rate could reach 14 per
cent. In this scenario, the momentum will be steeper in medical infrastructure
build-up, health insurance penetration and patent approvals, enabling the market
to reach a size of US$24 billion by 2015. Conversely, if progress is slower than
anticipated, then the market could remain limited to US$16 billion. This would
imply a compounded annual growth rate of 10 per cent, no different from the
growth rate observed over the past six years (Exhibit 4).
5	 Our forecast of GDP is the same as that in the study conducted by the McKinsey Global
Institute on the rise of the Indian consumer market. This estimate is derived from a
macroeconomic model developed by Oxford Economics.
6	 We define low-income households as having annual income < Rs. 0.9 lakh and middle-income
households as having annual income between Rs. 0.9 lakh and 5 lakh
14
Beyond scale, the high potential of the Indian market is underpinned by attractive
industry dynamics as compared to other generics markets (Exhibit 5). India’s is
primarily a branded generics market. The influence of physicians remains high,
allowing fair competition on the basis of product quality and scientific detailing.
Exhibit 4Exhibit 4
INDIAN PHARMA MARKET IS LIKELY TO TRIPLE BY 2015
Size of Indian pharmaceuticals market*
US$ billion
* Including Institutional sales
Source: McKinsey India Pharmaceutical Demand Model
2005
16
20
24
‘Slowing
momentum’
‘Maintaining
strong
growth’
‘Aggressive
market
expansion’
2015
6.3
CAGR
9.8%
CAGR
12.3%
CAGR
14.2%
Base case
Exhibit 3Exhibit 3
AFFORDABILITY AND MEDICAL INFRASTRUCTURE WILL
DRIVE 75% OF DEMAND GROWTH
US$ billion
Source: McKinsey India Pharmaceutical Demand Model
~14
6.3
~20
2005 2015 Growth
between
2005-15
~45
Sources of growth
Per cent
Market growth, 2005-2015
40
Income
growth
20
Medical
infrastructure
15Insurance
penetration
10
Increase in
prevalence
15
Others
15
This picture is markedly different from other important generics markets. For
example, the US and UK are pure generics markets with balance of power
entirely in favour of the trade. Markets such as Germany, France and Mexico
have a strong share of branded generics. However, the influence of individual
pharmacies and retail chains is on the rise.
MASS THERAPIES WILL REMAIN IMPORTANT DESPITE A SHIFT TOWARDS
SPECIALTY THERAPIES
The relative importance of mass and specialty therapies is an important aspect
of market evolution. During 2004 to 2006, the share of specialty and super-
specialty products has inched up from 35.2 to 35.9 per cent. We expect this
trend to gain momentum. By 2015, we expect specialty and super-specialty
therapies to account for 45 per cent of the market.
The growing prevalence of lifestyle disorders will spur the growth in specialty and
super-specialty therapies (Exhibit 6). Most notable among these ailments will be
those under the broad umbrella of ‘metabolic disorders’. India is already home
to the largest diabetic population in the world. The prevalence of diabetes will
rise from 2.8 per cent in 2005 to 3.7 per cent in 2015; coronary heart disease
Exhibit 5Exhibit 5
MOST MARKETS ARE MOVING TOWARDS TRADE-DRIVEN
PURE GENERICS
Source: McKinsey analysis
Pure INN
(e.g.,
Omeprazol)
Product
brand
(e.g., Losec)
INN+
(e.g.,
Omeprazol
Ratiopharm)
Type of
product
branding
Physician Trade
Key influencer
Individual pharmacy
Poland
France
Germany
UK
Russia
US
Italy
Hungary
India
China
Mexico
16
1
7	 Our definition of poverty is different from that of the Indian government, it is based on caloric
intake and is set at 2,400 calories per capita per day for rural areas and 2,100 calories for
urban areas. The government’s definition corresponds to an income of approximately Rs. 330
to Rs. 450 (US$7 to US$10) per capita per month.
from 3.3 to 4.9 per cent; and obesity from 1.3 to 2.7 per cent. The population
of patients suffering from hypertension will grow by another 50 million cases
over the next decade. Prominent among the therapeutic areas that will grow as
a result of the increase in lifestyle disorders are cardiovascular, neuropsychiatry
and oncology.
Despite this shift in disease profile, the growth opportunity in mass therapies
will remain significant for two reasons. First, the gap between prevalence and
treatment rates remains high in a range of diseases spanning anti-infective,
gastro-intestinal, respiratory and pain management therapies. While a fifth of the
population exhibits some degree of anaemia, only 25 per cent receive treatment.
Similarly, for anti-peptic disorders and diarrhoea, the treatment levels languish at
30 per cent. Second, nearly 140 million people will move above the poverty line7
during the next decade (Exhibit 7), which should increase the spending on basic
healthcare and the consumption of mass therapy drugs for acute ailments. Over
the past few years, several smaller players have spotted the opportunity in mass
therapies and grown strongly by driving market penetration to a new level.
Exhibit 6Exhibit 6
RAPID GROWTH IN PREVALENCE OF SEVERAL CHRONIC
DISEASES
Source: NCMH background papers, 2005; Central Bureau of Health Intelligence; WHO; Decision Resources;
McKinsey analysis
Prevalence rates of key chronic diseases in India
0.18
1.30
2.50
2.80
3.31
0.20
2.702.70
3.70
4.91
Coronary heart
disease
Diabetes Asthma Obesity Cancer
India (2005)
India (2015)
Number
of patients
(million)
36 62 31 46 27 34 14 34 2.0 2.5
Per cent of population
17
This projected change in the therapy mix is similar to what has been witnessed in
other developing markets. In China for example, the share of mass therapies has
declined from 60 per cent in 1999 to 54 per cent in 2006. This implies a shift of
6 percentage points in favour of specialty therapies in a seven-year timeframe.
This experience is quite similar to our projected shift for the Indian market of 10
percentage points in a decade.
Neither specialty nor mass therapies can be ignored during the next decade. The
rising prevalence of one and low treatment levels of the other make both areas
of concern.
GENERICS TO DOMINATE WITH SHARE OF PATENTED PRODUCTS RISING TO
A SIZEABLE 10 PER CENT
Generics products will continue to dominate the Indian market. Over the next few
years, the patent laws will provide an impetus to the launch of patent-protected
products. Such products have the potential to capture up to a 10 per cent share
of the total market by 2015, implying a market size of US$2 billion. This segment
is likely to grow strongly beyond 2010, by which time we expect patent-related
infrastructure to be in place and the regulatory issues to have been finalised.
Exhibit 7Exhibit 7
140 MILLION INDIANS WILL MOVE ABOVE THE POVERTY
LINE IN THE NEXT DECADE
Globals (>1,000)
Strivers (500–1,000)
Seekers (200–500)
Aspirers (90–200)
Deprived (<90)
Population in each income bracket
Millions of people
Household income brackets
INR thousand (2000)
Source: The ‘Bird of Gold’: The Rise of India’s Consumer Market, May 2007, McKinsey Global Institute
1985 1995 2005E 2015F 2025F
1,000
1,400
200
400
600
800
18
The positive outlook for generics products is due to several factors. First, the
current pipeline of generics products that are either undergoing new process
development or have been recently launched is strong. In addition, domestic
players have the opportunity to develop new combinations and formulations of
products that are already in the market. Second, and more importantly, generics
players continue to have a wide range of options for new generics launches
from the basket of pre-1995 products. The total number of such products is
more than 200, and with the inclusion of combinations and formulation changes,
the list is likely to get much longer. Third, it is likely that a proportion of post-
1995 molecules will not get full patent protection due to the relatively narrower
definition of patentability in the Indian Patent Act. Finally, the sales and marketing
infrastructure of domestic companies has grown substantially over the past
decade and is well positioned to maintain the market dominance of generics
products.
Patentability and data exclusivity will be key determinants of the future of patented
products. Patentability is lower in India than in other markets such as Brazil
and Russia. Indian patent law does not allow for the automatic patentability of
different forms such as salts, esters, ethers, polymorphs and isomers. These
decisions are taken case-by-case on the basis of arbitration. Similarly, patents
granted are not automatically extendable to new indications. The government’s
stance on data exclusivity is another factor of great importance. This policy issue
is currently under the consideration of the government. One of the options being
considered is to implement data protection after a transition period.
The experience of other developing markets underscores the importance of
regulatory support and the interest levels of multinational firms. In Brazil, driven
by the market dominance of multinational companies, patented products have
captured a 15 per cent share of the market within 10 years of patent protection.
This was despite reasonably high product prices (i.e., 60 to 70 per cent of US
price levels) and a primarily self-pay market mechanism. In China, the share of
patented products has gone up to 5 per cent after five years of patent protection.
High interest levels of multinational companies as well as government support
in patent implementation have been the main drivers. In contrast, the share of
patented products in Poland has remained below 5 per cent despite a decade
of patent protection. Inadequate regulatory support is behind this outcome—
patented products have failed to make it to the reimbursement list (Exhibit 8).
19
We have based the estimate for patent-protected products on four factors: global
product pipeline, share of the pipeline introduced in India, time gap between
the global and India launches, and likely commercial success of the products
launched. The base-case estimate of a US$2 billion market size in 2015 assumes
that, during 2010 to 2015, 35 to 40 new molecules will be launched globally
every year, and 75 per cent of these will be introduced in the Indian market within
a year of global launch.
If the multinational pharmaceuticals companies lower their emphasis on the
Indian market, then the market for patented products could be significantly lower
than the base-case estimate of US$2 billion. This segment could then be limited
to a 5 to 6 per cent share of the market and a size of US$0.8–1 billion by
2015 (Exhibit 9). The government’s stand on the issue of data exclusivity, the
outcome of the initial spate of arbitrations on patentability and the progress in
patent infrastructure build-up will play important roles in shaping the outlook of
multinational companies towards the Indian market opportunity.
We expect the market for patented products to be concentrated in five
therapeutic areas: neuropsychiatry, oncology, anti-infective, gastro-intestinal and
cardiovascular. By 2015, we expect these five therapies to contribute 60 to 70
per cent of total patented product launches (Exhibit 10).
Exhibit 8
Exhibit 8
China
• 25-30%
share;
increasing
MNC interest
• Rapidly expanding
insurance coverage
(+20% of urban)
• Small, but increasing
number of patented
products in
reimbursement list
• Major revisions in
patent law in year
2000 to conform to
WTO
• Active efforts by
government to
crack down on
infringement
5% share
in 4-5 years
Poland
• 75-80% share
(including
European Gx
players)
• Co-pay (~60% by
patient)
• Very few patented
products in
reimbursement list –
additions very infrequent
• Patent Law and
implementation
broadly in line with
that in more
developed markets
<5% after
10-12 years
DEVELOPING COUNTRIES HAVE SEEN VARYING LEVELS
OF SUCCESS OF PATENTED DRUGS
Source: Secondary research; expert interviews; McKinsey research
MNC presence
Reimbursement
regime
Regulatory/
government support
Brazil
• 65-70% share
of MNCs
• 8 MNCs in
top 10
• More than 90% self
pay
• Patent law and
implementation
broadly in line with
that in more
developed markets
Share of
patented drugs
14–15% share
of patented
products
in 10 years
20
Exhibit 10Exhibit 10
GLOBAL PIPELINE FOR PATENTED PRODUCTS IS
CONCENTRATED IN FIVE TAs
Share of global pipeline by therapeutic areas*
Per cent
* Excluding pre-clinical
Source: Pharmaprojects; McKinsey analysis
29
7
10
10
17
27
Cardiovascular
Gastro-intestinal
Anti-infective
Central nervous
system
Others Anti-cancer
Exhibit 9
Exhibit 9
10% OF THE INDIAN MARKET IS LIKELY TO BE PATENT
PROTECTED BY 2015
Share of
market
Per cent
Number of
molecules
launched by
2015
Number of
molecules
>US$ 15 millionScenario
‘Aggressive
market
expansion’
‘Maintaining
strong
growth’
‘Slowing
momentum’
12-15
10-12
7-8
Size of pharmaceuticals market
US$ billion
3.0-3.5
2.0-2.5
0.8-1.0
300
150
65
100+
~40
20
Source: McKinsey India Patent Share Model
Base case
21
Tier 2 MARKETS WILL REGISTER HIGH GROWTH BUT TIER 1 MARKETS
will REMAIN IMPORTANT
Growth in the Indian pharmaceuticals market will be well distributed across urban
and rural demand centres. Currently, Tier 1 markets account for nearly 60 per
cent of the market. Tier 2 markets account for the remaining 40 per cent. The
significant share of Tier 2 markets can be credited to a large extent to the strong
wholesale distribution system.
Nearly 45 per cent of market growth in the next decade will take place in Tier
2 markets. Rural markets alone will account for 27 per cent, with the Class II,
III and IV towns accounting for the remaining 18 per cent. By 2015, the share
of Tier 2 markets will grow marginally to 44 per cent, implying a market size of
US$8.8 billion (Exhibit 11).
A strong shift in income demographics underpins the growth potential of the Tier
2 markets. By 2015, these markets will add 46 million households with high
and medium levels of affordability. This compares favourably with Tier 1 markets,
which will add 19 million households with similar affordability levels.
According to the McKinsey Global Institute’s report, rural areas are expected to
account for a third of the country’s consumption growth in the next two decades.
Our conclusion that rural markets will account for 27 per cent of the growth in
pharmaceuticals is in line with the projected consumption increase in rural India.
Exhibit 11Exhibit 11
RURAL AND TIER 2 MARKETS WILL CONTRIBUTE ALMOST
HALF OF PHARMACEUTICALS GROWTH TILL 2015
Note: Metro: >1 million population, Class I towns: 0.1-1 mn, Class II-IV: 5k- 0.1 mn, Rural: less than 5K
Source: McKinsey India Pharmaceutical Demand Model
24
20
27
29
2015
Rural
Class II-IV
(Tier 2)
Class I/IA
Metros
100% = US$20 billion
Market by geographic tiers,
2015 Absolute demand growth
Per cent US$ billion (2005-2015)
Contribution
to total growth
Per cent
4.1
3.2
2.7
3.6 27
18
25
30
22
The rising importance of Tier 2 markets has an important implication for
pharmaceutical companies. Sales infrastructure deployed in Tier 2 markets does
not match the current revenue share or the future market potential of these
markets. In an average mass products sales division, only 20 to 30 per cent
of the sales force is deployed in Tier 2 markets. The number is even lower for
specialty products divisions. Sales force coverage and deployment needs to rise
in these markets to capture the market potential.
While Tier 2 markets will show strong growth,Tier 1 markets will remain important,
driven by four factors. First, affordability will rise significantly in these markets
due to higher disposable incomes. Second, the prevalence of lifestyle-related
ailments is likely to be much higher than in the Tier 2 markets. Third, there
is an opportunity to further intensify coverage of GPs, particularly for specialty
therapies. Finally, these markets will witness the steepest rise in the standards
of healthcare infrastructure.
IMPORTANT IMPLICATIONS FOR INDUSTRY AND POLICY MAKERS
The upcoming changes in the Indian pharmaceuticals market will create major
opportunities for Indian and multinational companies alike. Mass therapy and
specialty therapy in Tier 1 markets is expected to reach US$5.7 million and US
$5.5 million respectively. Mass and specialty therapies in Tier 2 markets are
expected to grow to US$8.8 billion. Biological products are expected to reach
US$1.4 billion and institutional sales to reach US$4.1 billion.
However, for pharmaceutical companies, the call for decisive action is not a
matter of choice, contingent on whether they want to address a new growth
opportunity. It is a matter of necessity borne out by the need to withstand
competitive pressure and maintain market standing. A closer examination of the
shifts in industry dynamics illustrates this point.
Over the past five years, the relative performance of the large domestic
companies, the mid-sized and small domestic companies and the multinational
firms has changed. On the back of enterprise and innovative sales and marketing
models, the mid-sized and small domestic companies have outperformed the
market in terms of growth. During this timeframe, the large domestic companies
have managed to grow with the market. The multinationals appear to have lost
some momentum and market share since 2000.
23
Going forward, the large domestic companies will face strong competition on both
sides. On one hand, smaller players can mai ntain their trajectory if they continue
to pioneer market creation. On the other, multinational firms can gain share
through the launch of patented products depending on the level of regulatory and
infrastructural support. In such a competitive scenario, top-tier domestic players
will find it a challenge to maintain or improve their market share performance.
Hence the priorities are likely to differ for the three groups of industry players.
For leading domestic companies, the case for action is underpinned by the
need to counter the threat to their market leadership. For mid-sized and small
domestic players, the challenge lies in replicating past success and coping with
increasing scale and complexity. For multinational firms, the imperative is to
build businesses of scale in the new patent regime and be relevant in this high
growth market.
Another change expected is the rising influence of retail. Organised retail
currently constitutes less than 1 per cent of the pharmaceuticals market. This
share is expected to grow, resulting in a shift in influence from physicians and
manufacturers to the retail trade. Organised retail accounts for 30 to 40 per cent
of all retail sales in countries such as Brazil, Mexico and Russia (Exhibit 12).
While it will take time to reach such levels in India, pharmaceutical companies
will do well to recognise this trend and prepare for the implications.
Exhibit 12
Exhibit 12
LARGE SHARE OF PHARMACY CHAINS IN OTHER BRANDED
GENERICS MARKETS
~30
~35
~36
~50
Pharmacy chain share
of total retail sales
Per cent
China
Russia
Mexico
Brazil
Key drivers of penetration
• High pharma industry growth attracting investments by large
international chains (e.g., Watson, Mannings)
• Expansion by existing players to exhaust govt quota of
drugstore licenses in few large cities
• Vertical integration by large wholesalers
• Industry consolidation (large players buying out small
independent pharmacies)
• Rapid growth in higher margin unbranded and private label
generics (partly driven by govt efforts on INN prescription)
• Recent entry by large US chains (Walgreens and Krogers)
• Rapid growth in higher margin unbranded generics and
‘similars’ (driven by active government efforts to increase
consumer awareness about generics and encourage generic
substitution)
Major chains
(Number of stores)
• Lao Bai Xing (80)
• Nepstar (1,100)
• Chengda Fang
Yuan (540)
• 36.6 (980)
• Dr. Stoletov (n/a)
• Farmacia Similaris
(3,700)
• Pargue Meros
(260)
• Pacheco (240)
Source: Secondary research; expert interviews; McKinsey research
24
The combination of market opportunities and the likely changes in industry
structure have different implications for domestic players and multinational
companies. While their strategies must take into account these implications,
policy makers will need to provide the appropriate incentives to encourage
access and innovation.
Significant implications for Indian players
Indian companies will need to pursue differentiated strategies, sustain product
access, drive market creation and strengthen sales and marketing capabilities.
Shift focus from market share capture to market creation.1.	 Traditional
product markets today are well covered and growth opportunities are medium
or low. Coverage of specialist physicians for specialty therapies such as anti-
depressants is a case in point. Further intensifying coverage of psychiatrists
in Tier 1 markets can lead to only mediocre growth. Higher growth can come
from expanding to CPs and GPs in Tier 1 markets. In India, the share of
CPs and GPs in anti-depressant prescriptions is much lower than that of
their counterparts in developed markets such as the US, indicating untapped
opportunity.
Adopt new and differentiated business models.2.	 With the ongoing changes
in market opportunities, competitive scenario and disease profiles, a
homogenous business model is unlikely to work. For example, the sales
infrastructure needed and expected financial returns are likely to differ
significantly across Tier 1 and Tier 2 markets. Hence, domestic companies
will do well to vary their approach in terms of products, pricing, physician
coverage, selling approach and infrastructure, and financial expectations.
Sustain product access.3.	 For local players over 200 pre-1995 products will
be the primary source of product access. In addition, incremental innovation
through fixed-dose combinations will be important. Finally, in-licensing will
provide a meaningful opportunity and the basket could include as much
as one-third of all globally launched products. Companies with high quality
sales coverage, strong marketing capabilities and a reputation for fair selling
practices will emerge as the preferred partners for product in-licensing.
Strengthen sales and marketing capabilities.4.	 To withstand competition and
create genuine differentiation in the market place, domestic companies will
need to upgrade their sales and marketing capabilities. These capabilities
will need to encompass new product development and launch, brand lifecycle
25
management, marketing spend effectiveness and sales force effectiveness.
As companies attempt to create newer markets and adopt different business
models, these capabilities will become more specialised.
Multinationals need to align aspirations and business model
To build a business of meaningful scale, multinational companies will need to
clarify aspirations, customise their business models and invest in the country
organisation.
Clarify aspirations for the India business.1.	 Multinational companies can focus
on high-end specialised segments and be niche players. At the other end of
the spectrum, they could aspire to be market leaders by introducing a full
portfolio of products, extending presence to generics and indigenising their
business model. The aspiration will have implications for business model,
organisation and resourcing, and hence needs to be clarified upfront.
Customise the strategy and business model.2.	 Multinational companies can
follow one of four business models (Exhibit 13). Each can serve a specific level
of market presence and revenue aspiration. If the aspiration is to be among
the leading players in the market, then the approach needs to be indigenised.
GlaxoSmithKline’s approach towards the Indian market is a case in point.
In contrast, leading in a specialised therapy or a niche segment is likely to
provide higher profitability, but is unlikely to lead to a top-15 position.
Exhibit 13
Exhibit 13
MNCs HAVE TRADITIONALLY ADOPTED ONE OF FOUR MODELS
IN INDIA
Source: IMS; secondary research; McKinsey analysis
Broad
Narrow
Low Medium High
Level of aspiration from India business
Level of
indigenisation
• Product
portfolio
• Sales model
• Pricing
• Supply
chain
Market
leadership
Therapy
leadership
Global
mirroring
Build on
legacy
• Therapy
domination
through
strong
prescriber
and patient
relationships
• Therapies and
products mirror
global portfolio
• Portfolio of legacy
mass-market products
• Very few product
launches in India
• Extensive
product
portfolio
exploring all
opportunities
in market
• Localised
approach
in product
portfolio,
distribution
and sourcing
26
Invest in the local organisation.3.	 The experience of multinational companies
across sectors in India clearly indicates that a strong local team with local
market experience is key to success. However, this in itself may not be
sufficient. For multinational companies with significant aspirations for the
market, the corporate organisation and senior leaders need to visibly support
and champion the India business.
Policy makers will need to encourage access and innovation
Access to affordable healthcare will remain a key imperative for the government. It
also has the responsibility of encouraging product as well as process innovation.
Emphasise access through health insurance.1.	 The government should play
two roles in this area. First, it needs to encourage private health insurers
through regulatory reform (i.e., reducing the minimum capital requirement
levels) and help build consumer awareness of the need for health coverage.
The second role is more direct and involves providing a minimum level of
cover to a large section of the deprived in both rural and urban areas. Several
options are being debated, the most recent being one that combines health
cover and social security benefits for the unorganised sector. We believe that
such efforts will be required to provide the majority of the population with
basic access to healthcare.
Ensure smooth implementation of patent law.2.	 The patent infrastructure in
the country has been appreciably upgraded over the past two years to support
the new law, with the addition of patent examiners, decentralisation of the filing
process and digitisation of records. These are all important achievements
during the initial years. It will be critical though to maintain this momentum
and ensure a speedy and effective approvals process. Another important
question is that of data exclusivity. Most developing nations, including the
other BRIC countries, have adopted some form of data exclusivity. The matter
is now being examined by the government. It should be settled in a time-bound
manner to provide clarity to the industry.
Support capability building in R&D.3.	 Although it is recognised as a strong
source of R&D talent, India faces strong competition from several countries
in Asia, Eastern Europe and Latin America. Beyond the existing financial
benefits, the government will need to encourage capability building in R&D.
The measures adopted by the Singapore government in the biotechnology
sector are a pointer. Aspiring to make biotechnology investments reach 3
per cent of the country’s GDP, the Singapore government is providing tax
incentives, but also supporting industry in forging links with companies in
the US and Europe for training and secondment. Securing linkages between
27
industry and academia is another important role that the government needs
to play.
Continued emphasis on improving public health resources and infrastructure.4.	
The low treatment rates for diseases such as respiratory infections and
diarrhoea highlight the need to further build awareness of public health
issues such as sanitation and access to healthcare support. In order to
step up disease prevention, the government should consider private-public
partnerships and undertake human resource reform to attract professionals
in public health by creating career tracks and incentives.
Adopt a broader view of healthcare costs.5.	 Drug pricing is an important
issue and is on the agenda of most governments. However, drugs account
for 15 to 20 per cent of healthcare expenditure. Moreover, driven by intense
competition, drug prices in India are already among the lowest in the world.
In such a situation, the government will need to take a holistic view of
healthcare costs and pursue a broader set of initiatives to ensure access
and affordability. Ensuring some form of health coverage for a large part of
the population is a critical step. Other examples include introducing some
form of reimbursement control, ensuring higher patient co-pays for lifestyle
diseases, making preferential tenders and improving the economics of public
hospitals (Exhibit 14).
Exhibit 14
Exhibit 14
MEASURES UNDERTAKEN BY COUNTRIES TO IMPROVE
HEALTHCARE ACCESS AND REDUCE COSTS
Source: Secondary research ; McKinsey research
Description ExamplesMeasures
Public health
insurance
• Provision of healthcare – either health
insurance or tax-financed
• All large European countries,
Japan, Korea, New Zealand
• China – urban (BMI)
1
Reimbursement
control
• Control of reimbursement list through
exemption from government
reimbursement scheme or higher co-pays
• UK, Spain, Germany, France,
Poland, New Zealand, China2
Preferential tenders
• Nationwide tenders for drug purchase
by all community pharmacies or by public
hospitals
• New Zealand, NHS (UK)
3
Improved hospital
economics
• Use of treatment protocols, and other
reforms to improve cost economics of
public hospitals
• DRG system in Germany to
reduce LOS in hospitals4
Fixed trade margins
• Fixed retailer margins on drugs to
discourage dispensing of higher priced
brands
• Germany, UK
5
High patient co-pay
for lifestyle drugs
• Low/zero reimbursement for OTC
or lifestyle drugs
• Germany, UK, Spain, France,
Poland6
28
* * *
We would like to emphasise that the overall outcome we have described depends
on three preconditions. First, that India maintains a relatively high rate of
long-term growth, in the range of 7 to 8 per cent a year. That in turn depends
crucially on the government continuing to pursue a pro-reform, pro-growth
economic agenda. Second, the public and private sectors continue to invest in
the development of healthcare-related hard and soft infrastructure and creating
a thriving labour market. Third, the government adopts a regulatory stance on
pricing and implementation of patent legislation that encourages industry growth.
A slowdown in these areas could dampen growth and put the opportunities we
have described at risk. Quite importantly, it will disrupt the industry’s social role
in providing wide access to affordable life-enhancing drugs.
India’s pharmaceuticals market has grown at a reasonable pace during the past
decade. The market has the potential to transform itself over the next 10 years
and play a crucial role in countering the growing burden of disease. Sustained,
progressive and collaborative efforts by the government and the pharmaceuticals
industry hold the key to achieving India’s full potential.

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Indian Pharma Market 2015

  • 1. India Pharma 2015 Unlocking the Potential of the Indian Pharmaceuticals Market Pharmaceuticals & Medical Products Practice
  • 2.
  • 3. India Pharma 2015 Unlocking the Potential of the Indian Pharmaceuticals Market Gautam Kumra Palash Mitra Chandrika Pasricha
  • 4. Executive Summary As pharmaceuticals companies scan for new growth opportunities over the next decade, they have realised that some of the most promising are to be found in the world’s emerging economies. In recent times, the pharmaceuticals industry has shown high interest in India due to its sustained economic growth, healthcare reforms and patent-related legislation. Following a series of reforms beginning in the early 1990s, India has enjoyed over a decade of strong growth and a rise in the spending power of its citizens. Real average household income in India has roughly doubled over the past two decades. In the meantime, disease patterns in India have undergone a shift. Increasingly stressful lifestyles have led to significant increases in the incidence of chronic diseases. While government interventions have brought some acute ailments under control, a sizeable part of the population remains susceptible to a wide range of acute diseases. Driven by increasing affordability, shifting disease patterns and modest healthcare reforms, the total consumer spending on healthcare products and services in the country grew at a compounded annual rate of 14 per cent from 2000 to 2005. The pharmaceuticals industry, which accounts for 15 to 20 per cent of total healthcare spend, grew at a compounded annual rate of 9 per cent during this period. Spending on healthcare will continue to be robust. According to a recently published report by the McKinsey Global Institute, The ‘Bird of Gold’: The Rise of India’s Consumer Markets, spending on healthcare will witness the highest growth rate among all spending categories over the next two decades. Healthcare grew from 4 per cent of average household income in 1995 to 7 per cent in 2005, and is expected to grow to 13 per cent by 2025. 9
  • 5. This view of the healthcare sector has resulted in growing interest among business leaders and policy makers in the pharmaceuticals industry. Yet much remains unknown about the long-term potential and evolution of the Indian pharmaceuticals market. How is the market likely to grow? To what extent will increasing incomes and spending power drive this growth? What role will health insurance and medical infrastructure play? How is the spending on pharmaceutical products likely to differ between urban and rural regions? What share of the market is likely to be captured by patent-protected products? What are the implications for domestic players, multinational companies and policy makers? In response to these questions, McKinsey & Company’s Pharmaceuticals & Medical Products Practice launched a year-long research project to study the future of the Indian pharmaceuticals market. We built a demand model that projects the market potential based on the impact of five fundamental growth drivers: income demographics, medical infrastructure build-up, health insurance penetration, incidence of diseases and likely competitive intensity. Using the output from this model, we distributed the market forecast across therapy and geographic segments. In addition, we built a model that translates several supply factors into estimates of the share of patent-protected products by 2015. Finally, we complemented the results of the modelling with on-the-ground insights from an extensive field study. Our analysis shows that if the Indian economy continues on its current high growth path, then the Indian pharmaceuticals market will undergo a major transformation in the next decade. The market will triple to US$20 billion by 2015 and move into the world’s top-10 pharmaceuticals markets. The absolute growth of US$14 billion will be next to the growth potential of the US and China, and in the same league as the growth in Japan, Canada and the UK. While the therapy mix will gradually move in favour of specialty and super-specialty therapies, mass therapies1 such as anti-infective and gastro-intestinal drugs will continue to comprise half of the market by 2015. Generics will continue to dominate, while patent-protected products are likely to constitute 10 per cent of the market within this timeframe. Leveraging the strong distribution infrastructure in the Tier 1 markets,2 i.e., metros, Class I and Class IA towns, these markets 1 We define specialty therapies as those where products are prescribed primarily by specialist physicians and consulting physicians; super-specialty therapies as those where specialist and super-specialist physicians account for 80 per cent of prescriptions; and mass therapies as those where products are prescribed mainly by general practitioners. 2 We define Tier 1 markets as metros (population 1 million), Class I towns (0.5 million to 1 million) and Class 1A towns (0.1 million to 0.5 million). Tier 2 markets are the remaining urban markets (Class II, III and IV towns) and rural areas. 10
  • 6. 11 will account for half of the growth potential. Tier 2 markets, i.e., remaining urban markets and rural areas, will grow in importance and account for the remaining half. These changes in the market will have important implications for Indian companies, multinational firms and policy makers. We briefly outline these findings below. Readers interested in the detailed results and analysis should see the main chapters of the report, while those interested in our methodology and assumptions are directed to the appendices. INDIAN PHARMACEUTICALS MARKET WILL TRIPLE OVER THE NEXT DECADE Six trends will influence the growth of the Indian pharmaceuticals market over the next decade: doubling of disposable incomes and the number of middle-class households, expansion of medical infrastructure, greater penetration of health insurance, rising prevalence of chronic diseases, adoption of product patents, and aggressive market penetration driven by the relatively smaller companies. We believe that from a market size of US$6.3 billion3 in 2005, the Indian pharmaceuticals market will grow to about US$20 billion4 by 2015. This implies a compounded annual growth rate of 12.3 per cent. This growth will be materially higher than the annual growth rate of 9 per cent witnessed during 2000 to 2005. In terms of scale, the Indian pharmaceutical market is ranked 14th in the world. By 2015, it will rank among the top 10 in the world, overtaking Brazil, Mexico, South Korea and Turkey (Exhibit 1). More importantly, the incremental market growth of US$14 billion over the next decade is likely to be the third largest among all markets. The US and China are expected to add US$200 billion and US$23 billion respectively. India, Japan, Canada and the UK are expected to be the next in line, with growth expectations in the range of US$13–14 billion during this timeframe (Exhibit 2). 3 This estimate includes all retail sales of pharmaceutical products and institutional sales at ex-manufacturer prices (source: IMS World Review and IMS Midas). 4 This projection is at ex-manufacturer prices and is based on a Re-$ exchange rate of Rs. 45 per US$.
  • 7. 12 Exhibit 2Exhibit 2 BY ABSOLUTE GROWTH, INDIA WILL BE AMONG THE TOP 5 MARKETS GLOBALLY DURING 2005 TO 2015 Source: IMS World Review; analyst projections; McKinsey India Pharmaceutical Demand Model Incremental growth (2005–2015) US$ billion 13 7 11 12 14 14 14 23 196US China Japan Germany France UK Canada India Brazil Exhibit 1 Exhibit 1 INDIA IS PROJECTED TO BE THE 10th LARGEST MARKET BY 2015 Top 14 pharmaceuticals markets, 2005 US$ billion Top 14 pharmaceuticals markets, 2015 6 7 8 9 10 13 13 14 19 20 31 32 68 248 15 15 19 20 20 25 25 25 32 38 38 46 82 444 UK Italy France Japan Germany Canada US Spain India Turkey South Korea Brazil Mexico China Germany China UK Spain Italy Turkey South Korea Mexico Brazil India Canada US Japan France Source: IMS World Review; analyst projections; McKinsey India Pharmaceutical Demand Model 6 5 3 2 4 8 1 7 14 13 12 11 10 9 6 5 3 2 4 8 1 7 14 13 12 11 10 9
  • 8. 13 Underpinning the market projection of US$20 billion is the assumption that the growth drivers will change significantly by 2015. Real GDP will grow at the compounded annual rate of 7.3 per cent.5 Per capita disposable income will rise from US$463 in 2005 to US$765 in 2015. Twenty-seven million households currently in the low-income category6 will move up. The middle-income category will witness the steepest rise, with the addition of 59 million households. Driven largely through private investments, the number of hospital beds and physicians in the country is expected to double by 2015 (i.e., additional 2 million hospital beds and 0.4 million physicians). Corporate hospital chains will play a leading role in transforming the quality of secondary and tertiary care. Health insurance penetration is expected to double by 2015 to cover 220 million people. Traditional premium-based insurers will drive nearly 90 per cent of this growth in health insurance coverage. Patent infrastructure will scale up to enable up to 30 approvals annually and an average approval timeframe of two years. A close examination of the growth drivers indicates that rising disposable incomes and an upward shift in income demographics will be the dominant growth factor and will account for nearly 40 per cent of the projected market growth. Improvements in medical infrastructure come next, accounting for 20 per cent. Greater health insurance penetration will account for nearly 15 per cent of the growth. A gradual shift in disease profile will account for another 10 per cent of the growth. Finally, population growth and other factors will make up the remaining 15 per cent (Exhibit 3). If the underlying growth drivers move more rapidly than envisaged in the base- case scenario, then the compounded annual growth rate could reach 14 per cent. In this scenario, the momentum will be steeper in medical infrastructure build-up, health insurance penetration and patent approvals, enabling the market to reach a size of US$24 billion by 2015. Conversely, if progress is slower than anticipated, then the market could remain limited to US$16 billion. This would imply a compounded annual growth rate of 10 per cent, no different from the growth rate observed over the past six years (Exhibit 4). 5 Our forecast of GDP is the same as that in the study conducted by the McKinsey Global Institute on the rise of the Indian consumer market. This estimate is derived from a macroeconomic model developed by Oxford Economics. 6 We define low-income households as having annual income < Rs. 0.9 lakh and middle-income households as having annual income between Rs. 0.9 lakh and 5 lakh
  • 9. 14 Beyond scale, the high potential of the Indian market is underpinned by attractive industry dynamics as compared to other generics markets (Exhibit 5). India’s is primarily a branded generics market. The influence of physicians remains high, allowing fair competition on the basis of product quality and scientific detailing. Exhibit 4Exhibit 4 INDIAN PHARMA MARKET IS LIKELY TO TRIPLE BY 2015 Size of Indian pharmaceuticals market* US$ billion * Including Institutional sales Source: McKinsey India Pharmaceutical Demand Model 2005 16 20 24 ‘Slowing momentum’ ‘Maintaining strong growth’ ‘Aggressive market expansion’ 2015 6.3 CAGR 9.8% CAGR 12.3% CAGR 14.2% Base case Exhibit 3Exhibit 3 AFFORDABILITY AND MEDICAL INFRASTRUCTURE WILL DRIVE 75% OF DEMAND GROWTH US$ billion Source: McKinsey India Pharmaceutical Demand Model ~14 6.3 ~20 2005 2015 Growth between 2005-15 ~45 Sources of growth Per cent Market growth, 2005-2015 40 Income growth 20 Medical infrastructure 15Insurance penetration 10 Increase in prevalence 15 Others
  • 10. 15 This picture is markedly different from other important generics markets. For example, the US and UK are pure generics markets with balance of power entirely in favour of the trade. Markets such as Germany, France and Mexico have a strong share of branded generics. However, the influence of individual pharmacies and retail chains is on the rise. MASS THERAPIES WILL REMAIN IMPORTANT DESPITE A SHIFT TOWARDS SPECIALTY THERAPIES The relative importance of mass and specialty therapies is an important aspect of market evolution. During 2004 to 2006, the share of specialty and super- specialty products has inched up from 35.2 to 35.9 per cent. We expect this trend to gain momentum. By 2015, we expect specialty and super-specialty therapies to account for 45 per cent of the market. The growing prevalence of lifestyle disorders will spur the growth in specialty and super-specialty therapies (Exhibit 6). Most notable among these ailments will be those under the broad umbrella of ‘metabolic disorders’. India is already home to the largest diabetic population in the world. The prevalence of diabetes will rise from 2.8 per cent in 2005 to 3.7 per cent in 2015; coronary heart disease Exhibit 5Exhibit 5 MOST MARKETS ARE MOVING TOWARDS TRADE-DRIVEN PURE GENERICS Source: McKinsey analysis Pure INN (e.g., Omeprazol) Product brand (e.g., Losec) INN+ (e.g., Omeprazol Ratiopharm) Type of product branding Physician Trade Key influencer Individual pharmacy Poland France Germany UK Russia US Italy Hungary India China Mexico
  • 11. 16 1 7 Our definition of poverty is different from that of the Indian government, it is based on caloric intake and is set at 2,400 calories per capita per day for rural areas and 2,100 calories for urban areas. The government’s definition corresponds to an income of approximately Rs. 330 to Rs. 450 (US$7 to US$10) per capita per month. from 3.3 to 4.9 per cent; and obesity from 1.3 to 2.7 per cent. The population of patients suffering from hypertension will grow by another 50 million cases over the next decade. Prominent among the therapeutic areas that will grow as a result of the increase in lifestyle disorders are cardiovascular, neuropsychiatry and oncology. Despite this shift in disease profile, the growth opportunity in mass therapies will remain significant for two reasons. First, the gap between prevalence and treatment rates remains high in a range of diseases spanning anti-infective, gastro-intestinal, respiratory and pain management therapies. While a fifth of the population exhibits some degree of anaemia, only 25 per cent receive treatment. Similarly, for anti-peptic disorders and diarrhoea, the treatment levels languish at 30 per cent. Second, nearly 140 million people will move above the poverty line7 during the next decade (Exhibit 7), which should increase the spending on basic healthcare and the consumption of mass therapy drugs for acute ailments. Over the past few years, several smaller players have spotted the opportunity in mass therapies and grown strongly by driving market penetration to a new level. Exhibit 6Exhibit 6 RAPID GROWTH IN PREVALENCE OF SEVERAL CHRONIC DISEASES Source: NCMH background papers, 2005; Central Bureau of Health Intelligence; WHO; Decision Resources; McKinsey analysis Prevalence rates of key chronic diseases in India 0.18 1.30 2.50 2.80 3.31 0.20 2.702.70 3.70 4.91 Coronary heart disease Diabetes Asthma Obesity Cancer India (2005) India (2015) Number of patients (million) 36 62 31 46 27 34 14 34 2.0 2.5 Per cent of population
  • 12. 17 This projected change in the therapy mix is similar to what has been witnessed in other developing markets. In China for example, the share of mass therapies has declined from 60 per cent in 1999 to 54 per cent in 2006. This implies a shift of 6 percentage points in favour of specialty therapies in a seven-year timeframe. This experience is quite similar to our projected shift for the Indian market of 10 percentage points in a decade. Neither specialty nor mass therapies can be ignored during the next decade. The rising prevalence of one and low treatment levels of the other make both areas of concern. GENERICS TO DOMINATE WITH SHARE OF PATENTED PRODUCTS RISING TO A SIZEABLE 10 PER CENT Generics products will continue to dominate the Indian market. Over the next few years, the patent laws will provide an impetus to the launch of patent-protected products. Such products have the potential to capture up to a 10 per cent share of the total market by 2015, implying a market size of US$2 billion. This segment is likely to grow strongly beyond 2010, by which time we expect patent-related infrastructure to be in place and the regulatory issues to have been finalised. Exhibit 7Exhibit 7 140 MILLION INDIANS WILL MOVE ABOVE THE POVERTY LINE IN THE NEXT DECADE Globals (>1,000) Strivers (500–1,000) Seekers (200–500) Aspirers (90–200) Deprived (<90) Population in each income bracket Millions of people Household income brackets INR thousand (2000) Source: The ‘Bird of Gold’: The Rise of India’s Consumer Market, May 2007, McKinsey Global Institute 1985 1995 2005E 2015F 2025F 1,000 1,400 200 400 600 800
  • 13. 18 The positive outlook for generics products is due to several factors. First, the current pipeline of generics products that are either undergoing new process development or have been recently launched is strong. In addition, domestic players have the opportunity to develop new combinations and formulations of products that are already in the market. Second, and more importantly, generics players continue to have a wide range of options for new generics launches from the basket of pre-1995 products. The total number of such products is more than 200, and with the inclusion of combinations and formulation changes, the list is likely to get much longer. Third, it is likely that a proportion of post- 1995 molecules will not get full patent protection due to the relatively narrower definition of patentability in the Indian Patent Act. Finally, the sales and marketing infrastructure of domestic companies has grown substantially over the past decade and is well positioned to maintain the market dominance of generics products. Patentability and data exclusivity will be key determinants of the future of patented products. Patentability is lower in India than in other markets such as Brazil and Russia. Indian patent law does not allow for the automatic patentability of different forms such as salts, esters, ethers, polymorphs and isomers. These decisions are taken case-by-case on the basis of arbitration. Similarly, patents granted are not automatically extendable to new indications. The government’s stance on data exclusivity is another factor of great importance. This policy issue is currently under the consideration of the government. One of the options being considered is to implement data protection after a transition period. The experience of other developing markets underscores the importance of regulatory support and the interest levels of multinational firms. In Brazil, driven by the market dominance of multinational companies, patented products have captured a 15 per cent share of the market within 10 years of patent protection. This was despite reasonably high product prices (i.e., 60 to 70 per cent of US price levels) and a primarily self-pay market mechanism. In China, the share of patented products has gone up to 5 per cent after five years of patent protection. High interest levels of multinational companies as well as government support in patent implementation have been the main drivers. In contrast, the share of patented products in Poland has remained below 5 per cent despite a decade of patent protection. Inadequate regulatory support is behind this outcome— patented products have failed to make it to the reimbursement list (Exhibit 8).
  • 14. 19 We have based the estimate for patent-protected products on four factors: global product pipeline, share of the pipeline introduced in India, time gap between the global and India launches, and likely commercial success of the products launched. The base-case estimate of a US$2 billion market size in 2015 assumes that, during 2010 to 2015, 35 to 40 new molecules will be launched globally every year, and 75 per cent of these will be introduced in the Indian market within a year of global launch. If the multinational pharmaceuticals companies lower their emphasis on the Indian market, then the market for patented products could be significantly lower than the base-case estimate of US$2 billion. This segment could then be limited to a 5 to 6 per cent share of the market and a size of US$0.8–1 billion by 2015 (Exhibit 9). The government’s stand on the issue of data exclusivity, the outcome of the initial spate of arbitrations on patentability and the progress in patent infrastructure build-up will play important roles in shaping the outlook of multinational companies towards the Indian market opportunity. We expect the market for patented products to be concentrated in five therapeutic areas: neuropsychiatry, oncology, anti-infective, gastro-intestinal and cardiovascular. By 2015, we expect these five therapies to contribute 60 to 70 per cent of total patented product launches (Exhibit 10). Exhibit 8 Exhibit 8 China • 25-30% share; increasing MNC interest • Rapidly expanding insurance coverage (+20% of urban) • Small, but increasing number of patented products in reimbursement list • Major revisions in patent law in year 2000 to conform to WTO • Active efforts by government to crack down on infringement 5% share in 4-5 years Poland • 75-80% share (including European Gx players) • Co-pay (~60% by patient) • Very few patented products in reimbursement list – additions very infrequent • Patent Law and implementation broadly in line with that in more developed markets <5% after 10-12 years DEVELOPING COUNTRIES HAVE SEEN VARYING LEVELS OF SUCCESS OF PATENTED DRUGS Source: Secondary research; expert interviews; McKinsey research MNC presence Reimbursement regime Regulatory/ government support Brazil • 65-70% share of MNCs • 8 MNCs in top 10 • More than 90% self pay • Patent law and implementation broadly in line with that in more developed markets Share of patented drugs 14–15% share of patented products in 10 years
  • 15. 20 Exhibit 10Exhibit 10 GLOBAL PIPELINE FOR PATENTED PRODUCTS IS CONCENTRATED IN FIVE TAs Share of global pipeline by therapeutic areas* Per cent * Excluding pre-clinical Source: Pharmaprojects; McKinsey analysis 29 7 10 10 17 27 Cardiovascular Gastro-intestinal Anti-infective Central nervous system Others Anti-cancer Exhibit 9 Exhibit 9 10% OF THE INDIAN MARKET IS LIKELY TO BE PATENT PROTECTED BY 2015 Share of market Per cent Number of molecules launched by 2015 Number of molecules >US$ 15 millionScenario ‘Aggressive market expansion’ ‘Maintaining strong growth’ ‘Slowing momentum’ 12-15 10-12 7-8 Size of pharmaceuticals market US$ billion 3.0-3.5 2.0-2.5 0.8-1.0 300 150 65 100+ ~40 20 Source: McKinsey India Patent Share Model Base case
  • 16. 21 Tier 2 MARKETS WILL REGISTER HIGH GROWTH BUT TIER 1 MARKETS will REMAIN IMPORTANT Growth in the Indian pharmaceuticals market will be well distributed across urban and rural demand centres. Currently, Tier 1 markets account for nearly 60 per cent of the market. Tier 2 markets account for the remaining 40 per cent. The significant share of Tier 2 markets can be credited to a large extent to the strong wholesale distribution system. Nearly 45 per cent of market growth in the next decade will take place in Tier 2 markets. Rural markets alone will account for 27 per cent, with the Class II, III and IV towns accounting for the remaining 18 per cent. By 2015, the share of Tier 2 markets will grow marginally to 44 per cent, implying a market size of US$8.8 billion (Exhibit 11). A strong shift in income demographics underpins the growth potential of the Tier 2 markets. By 2015, these markets will add 46 million households with high and medium levels of affordability. This compares favourably with Tier 1 markets, which will add 19 million households with similar affordability levels. According to the McKinsey Global Institute’s report, rural areas are expected to account for a third of the country’s consumption growth in the next two decades. Our conclusion that rural markets will account for 27 per cent of the growth in pharmaceuticals is in line with the projected consumption increase in rural India. Exhibit 11Exhibit 11 RURAL AND TIER 2 MARKETS WILL CONTRIBUTE ALMOST HALF OF PHARMACEUTICALS GROWTH TILL 2015 Note: Metro: >1 million population, Class I towns: 0.1-1 mn, Class II-IV: 5k- 0.1 mn, Rural: less than 5K Source: McKinsey India Pharmaceutical Demand Model 24 20 27 29 2015 Rural Class II-IV (Tier 2) Class I/IA Metros 100% = US$20 billion Market by geographic tiers, 2015 Absolute demand growth Per cent US$ billion (2005-2015) Contribution to total growth Per cent 4.1 3.2 2.7 3.6 27 18 25 30
  • 17. 22 The rising importance of Tier 2 markets has an important implication for pharmaceutical companies. Sales infrastructure deployed in Tier 2 markets does not match the current revenue share or the future market potential of these markets. In an average mass products sales division, only 20 to 30 per cent of the sales force is deployed in Tier 2 markets. The number is even lower for specialty products divisions. Sales force coverage and deployment needs to rise in these markets to capture the market potential. While Tier 2 markets will show strong growth,Tier 1 markets will remain important, driven by four factors. First, affordability will rise significantly in these markets due to higher disposable incomes. Second, the prevalence of lifestyle-related ailments is likely to be much higher than in the Tier 2 markets. Third, there is an opportunity to further intensify coverage of GPs, particularly for specialty therapies. Finally, these markets will witness the steepest rise in the standards of healthcare infrastructure. IMPORTANT IMPLICATIONS FOR INDUSTRY AND POLICY MAKERS The upcoming changes in the Indian pharmaceuticals market will create major opportunities for Indian and multinational companies alike. Mass therapy and specialty therapy in Tier 1 markets is expected to reach US$5.7 million and US $5.5 million respectively. Mass and specialty therapies in Tier 2 markets are expected to grow to US$8.8 billion. Biological products are expected to reach US$1.4 billion and institutional sales to reach US$4.1 billion. However, for pharmaceutical companies, the call for decisive action is not a matter of choice, contingent on whether they want to address a new growth opportunity. It is a matter of necessity borne out by the need to withstand competitive pressure and maintain market standing. A closer examination of the shifts in industry dynamics illustrates this point. Over the past five years, the relative performance of the large domestic companies, the mid-sized and small domestic companies and the multinational firms has changed. On the back of enterprise and innovative sales and marketing models, the mid-sized and small domestic companies have outperformed the market in terms of growth. During this timeframe, the large domestic companies have managed to grow with the market. The multinationals appear to have lost some momentum and market share since 2000.
  • 18. 23 Going forward, the large domestic companies will face strong competition on both sides. On one hand, smaller players can mai ntain their trajectory if they continue to pioneer market creation. On the other, multinational firms can gain share through the launch of patented products depending on the level of regulatory and infrastructural support. In such a competitive scenario, top-tier domestic players will find it a challenge to maintain or improve their market share performance. Hence the priorities are likely to differ for the three groups of industry players. For leading domestic companies, the case for action is underpinned by the need to counter the threat to their market leadership. For mid-sized and small domestic players, the challenge lies in replicating past success and coping with increasing scale and complexity. For multinational firms, the imperative is to build businesses of scale in the new patent regime and be relevant in this high growth market. Another change expected is the rising influence of retail. Organised retail currently constitutes less than 1 per cent of the pharmaceuticals market. This share is expected to grow, resulting in a shift in influence from physicians and manufacturers to the retail trade. Organised retail accounts for 30 to 40 per cent of all retail sales in countries such as Brazil, Mexico and Russia (Exhibit 12). While it will take time to reach such levels in India, pharmaceutical companies will do well to recognise this trend and prepare for the implications. Exhibit 12 Exhibit 12 LARGE SHARE OF PHARMACY CHAINS IN OTHER BRANDED GENERICS MARKETS ~30 ~35 ~36 ~50 Pharmacy chain share of total retail sales Per cent China Russia Mexico Brazil Key drivers of penetration • High pharma industry growth attracting investments by large international chains (e.g., Watson, Mannings) • Expansion by existing players to exhaust govt quota of drugstore licenses in few large cities • Vertical integration by large wholesalers • Industry consolidation (large players buying out small independent pharmacies) • Rapid growth in higher margin unbranded and private label generics (partly driven by govt efforts on INN prescription) • Recent entry by large US chains (Walgreens and Krogers) • Rapid growth in higher margin unbranded generics and ‘similars’ (driven by active government efforts to increase consumer awareness about generics and encourage generic substitution) Major chains (Number of stores) • Lao Bai Xing (80) • Nepstar (1,100) • Chengda Fang Yuan (540) • 36.6 (980) • Dr. Stoletov (n/a) • Farmacia Similaris (3,700) • Pargue Meros (260) • Pacheco (240) Source: Secondary research; expert interviews; McKinsey research
  • 19. 24 The combination of market opportunities and the likely changes in industry structure have different implications for domestic players and multinational companies. While their strategies must take into account these implications, policy makers will need to provide the appropriate incentives to encourage access and innovation. Significant implications for Indian players Indian companies will need to pursue differentiated strategies, sustain product access, drive market creation and strengthen sales and marketing capabilities. Shift focus from market share capture to market creation.1. Traditional product markets today are well covered and growth opportunities are medium or low. Coverage of specialist physicians for specialty therapies such as anti- depressants is a case in point. Further intensifying coverage of psychiatrists in Tier 1 markets can lead to only mediocre growth. Higher growth can come from expanding to CPs and GPs in Tier 1 markets. In India, the share of CPs and GPs in anti-depressant prescriptions is much lower than that of their counterparts in developed markets such as the US, indicating untapped opportunity. Adopt new and differentiated business models.2. With the ongoing changes in market opportunities, competitive scenario and disease profiles, a homogenous business model is unlikely to work. For example, the sales infrastructure needed and expected financial returns are likely to differ significantly across Tier 1 and Tier 2 markets. Hence, domestic companies will do well to vary their approach in terms of products, pricing, physician coverage, selling approach and infrastructure, and financial expectations. Sustain product access.3. For local players over 200 pre-1995 products will be the primary source of product access. In addition, incremental innovation through fixed-dose combinations will be important. Finally, in-licensing will provide a meaningful opportunity and the basket could include as much as one-third of all globally launched products. Companies with high quality sales coverage, strong marketing capabilities and a reputation for fair selling practices will emerge as the preferred partners for product in-licensing. Strengthen sales and marketing capabilities.4. To withstand competition and create genuine differentiation in the market place, domestic companies will need to upgrade their sales and marketing capabilities. These capabilities will need to encompass new product development and launch, brand lifecycle
  • 20. 25 management, marketing spend effectiveness and sales force effectiveness. As companies attempt to create newer markets and adopt different business models, these capabilities will become more specialised. Multinationals need to align aspirations and business model To build a business of meaningful scale, multinational companies will need to clarify aspirations, customise their business models and invest in the country organisation. Clarify aspirations for the India business.1. Multinational companies can focus on high-end specialised segments and be niche players. At the other end of the spectrum, they could aspire to be market leaders by introducing a full portfolio of products, extending presence to generics and indigenising their business model. The aspiration will have implications for business model, organisation and resourcing, and hence needs to be clarified upfront. Customise the strategy and business model.2. Multinational companies can follow one of four business models (Exhibit 13). Each can serve a specific level of market presence and revenue aspiration. If the aspiration is to be among the leading players in the market, then the approach needs to be indigenised. GlaxoSmithKline’s approach towards the Indian market is a case in point. In contrast, leading in a specialised therapy or a niche segment is likely to provide higher profitability, but is unlikely to lead to a top-15 position. Exhibit 13 Exhibit 13 MNCs HAVE TRADITIONALLY ADOPTED ONE OF FOUR MODELS IN INDIA Source: IMS; secondary research; McKinsey analysis Broad Narrow Low Medium High Level of aspiration from India business Level of indigenisation • Product portfolio • Sales model • Pricing • Supply chain Market leadership Therapy leadership Global mirroring Build on legacy • Therapy domination through strong prescriber and patient relationships • Therapies and products mirror global portfolio • Portfolio of legacy mass-market products • Very few product launches in India • Extensive product portfolio exploring all opportunities in market • Localised approach in product portfolio, distribution and sourcing
  • 21. 26 Invest in the local organisation.3. The experience of multinational companies across sectors in India clearly indicates that a strong local team with local market experience is key to success. However, this in itself may not be sufficient. For multinational companies with significant aspirations for the market, the corporate organisation and senior leaders need to visibly support and champion the India business. Policy makers will need to encourage access and innovation Access to affordable healthcare will remain a key imperative for the government. It also has the responsibility of encouraging product as well as process innovation. Emphasise access through health insurance.1. The government should play two roles in this area. First, it needs to encourage private health insurers through regulatory reform (i.e., reducing the minimum capital requirement levels) and help build consumer awareness of the need for health coverage. The second role is more direct and involves providing a minimum level of cover to a large section of the deprived in both rural and urban areas. Several options are being debated, the most recent being one that combines health cover and social security benefits for the unorganised sector. We believe that such efforts will be required to provide the majority of the population with basic access to healthcare. Ensure smooth implementation of patent law.2. The patent infrastructure in the country has been appreciably upgraded over the past two years to support the new law, with the addition of patent examiners, decentralisation of the filing process and digitisation of records. These are all important achievements during the initial years. It will be critical though to maintain this momentum and ensure a speedy and effective approvals process. Another important question is that of data exclusivity. Most developing nations, including the other BRIC countries, have adopted some form of data exclusivity. The matter is now being examined by the government. It should be settled in a time-bound manner to provide clarity to the industry. Support capability building in R&D.3. Although it is recognised as a strong source of R&D talent, India faces strong competition from several countries in Asia, Eastern Europe and Latin America. Beyond the existing financial benefits, the government will need to encourage capability building in R&D. The measures adopted by the Singapore government in the biotechnology sector are a pointer. Aspiring to make biotechnology investments reach 3 per cent of the country’s GDP, the Singapore government is providing tax incentives, but also supporting industry in forging links with companies in the US and Europe for training and secondment. Securing linkages between
  • 22. 27 industry and academia is another important role that the government needs to play. Continued emphasis on improving public health resources and infrastructure.4. The low treatment rates for diseases such as respiratory infections and diarrhoea highlight the need to further build awareness of public health issues such as sanitation and access to healthcare support. In order to step up disease prevention, the government should consider private-public partnerships and undertake human resource reform to attract professionals in public health by creating career tracks and incentives. Adopt a broader view of healthcare costs.5. Drug pricing is an important issue and is on the agenda of most governments. However, drugs account for 15 to 20 per cent of healthcare expenditure. Moreover, driven by intense competition, drug prices in India are already among the lowest in the world. In such a situation, the government will need to take a holistic view of healthcare costs and pursue a broader set of initiatives to ensure access and affordability. Ensuring some form of health coverage for a large part of the population is a critical step. Other examples include introducing some form of reimbursement control, ensuring higher patient co-pays for lifestyle diseases, making preferential tenders and improving the economics of public hospitals (Exhibit 14). Exhibit 14 Exhibit 14 MEASURES UNDERTAKEN BY COUNTRIES TO IMPROVE HEALTHCARE ACCESS AND REDUCE COSTS Source: Secondary research ; McKinsey research Description ExamplesMeasures Public health insurance • Provision of healthcare – either health insurance or tax-financed • All large European countries, Japan, Korea, New Zealand • China – urban (BMI) 1 Reimbursement control • Control of reimbursement list through exemption from government reimbursement scheme or higher co-pays • UK, Spain, Germany, France, Poland, New Zealand, China2 Preferential tenders • Nationwide tenders for drug purchase by all community pharmacies or by public hospitals • New Zealand, NHS (UK) 3 Improved hospital economics • Use of treatment protocols, and other reforms to improve cost economics of public hospitals • DRG system in Germany to reduce LOS in hospitals4 Fixed trade margins • Fixed retailer margins on drugs to discourage dispensing of higher priced brands • Germany, UK 5 High patient co-pay for lifestyle drugs • Low/zero reimbursement for OTC or lifestyle drugs • Germany, UK, Spain, France, Poland6
  • 23. 28 * * * We would like to emphasise that the overall outcome we have described depends on three preconditions. First, that India maintains a relatively high rate of long-term growth, in the range of 7 to 8 per cent a year. That in turn depends crucially on the government continuing to pursue a pro-reform, pro-growth economic agenda. Second, the public and private sectors continue to invest in the development of healthcare-related hard and soft infrastructure and creating a thriving labour market. Third, the government adopts a regulatory stance on pricing and implementation of patent legislation that encourages industry growth. A slowdown in these areas could dampen growth and put the opportunities we have described at risk. Quite importantly, it will disrupt the industry’s social role in providing wide access to affordable life-enhancing drugs. India’s pharmaceuticals market has grown at a reasonable pace during the past decade. The market has the potential to transform itself over the next 10 years and play a crucial role in countering the growing burden of disease. Sustained, progressive and collaborative efforts by the government and the pharmaceuticals industry hold the key to achieving India’s full potential.