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Brazilian	Pharmaceu/cal	Field	Figures	
By	Ladina	Consul.ng	-	Brazil
Socio-demographics & GDP
Population projection in July 16, 2015 (IBGE):
2
Number of pharmacies and physicians
184	pharmacies	per	1000	physicians	
37	pharmacies	per	100k	popula/on	
2.272
11.541
61.056
Independent
Chains
(Franchise)
Chains
Independent
Pharmacies
Number	of		physicians:	406.872	
Number	of		PoS	(pharmacies):	74.869	
CFM	(Federal	Council	of		Medicine)	3
Annual average exchange rate
BRL/USD
4
Key Macroeconomic Indicators
5
Retail	Market	Analysis	
By	Ladina	Consul.ng	-	Brazil
Brazilian Pharmaceutical Market
7
Top 25 companies
8
9
2014 – Total Sales Market
10
Retail Sector Sales
Brazilian Pharmaceutical Market
11
Brazilian Pharmaceutical Market
Per product type
12
13
Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture 2013,pg 5
Brazilian Market Pharma – Units Sold
14
Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture 2013,pg 7
Brazilian Market Pharma – Commercial Deficit – Participation of
Importation in the market $ Br Reais
15
Business Environment
16
Healthcare Provision
17
Pricing and Reimbursement
18
Regulatory Environment
19
Pharmaceutical Business Environment
20
Pharmaceutical Business Environment
.
21
Pharmaceutical Business Environment
ANALYSIS OF REBATES AND DISCOUNTS
22
New Competitive Scenario :
Main Pressures Of Pharmaceutical
Industry in Brazil
By	Ladina	Consul.ng	-	Brazil
Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture- 2013
Industry
Competition
Strengthening
retail and
institutional
paying
Regulatory
Changes
Shortage
molecules
patent to
expire
Pharmaceutical
Industry
Pressure on
Prices
New Competitive Scenario :
Main Pressures Of Pharmaceutical Industry in Brazil
24
Market Prognosis Scenario 2015-2019: Pricing and Reimbursement
CMED : Camara de Regulação de Mercado de
Medicamentos (Pharmaceutical Market Regulatory Agency-
Pricing Commission)
25
Mechanisms applied by CMED and the information that applicants must
include in pricing dossiers are determined by the classification of a new
drug into one of six categories:
CMED : Camara de Regulação de Mercado de
Medicamentos (Pharmaceutical Market Regulatory Agency-
Pricing Commission)
26
Generic prices
27
Price increases
28
Public sector prices
29
Influence of Tax to choice best place
to implement t Business
30
Oncology	
By	Ladina	Consul.ng	-	Brazil
Market Studies
Selected Oncology Molecules
By	Ladina	Consul.ng	-	Brazil
Selected molecules
Selec.on	criteria	
	
These	10	molecules	were	selected	by	the	following	criteria	:	
•  Higher	sales	in	USD	
•  BeGer	growth	trend	
•  Fewer	players	
•  BeGer	average	price		
33
2.373	
3.519	
4.096	
4.663	
5.595	
2011	 2012	 2013	 2014	 2015	
Units (000)
+48%	
140.400	
141.867	
146.851	
156.106	
160.424	
2011	 2012	 2013	 2014	 2015	
USD (000)
73.743	
112.602	
133.011	
153.681	
181.328	
2011	 2012	 2013	 2014	 2015	
Tabs (000)
+16%	 +14%	 +20%	 +1%	 +4%	 +6%	 +3%	 +53%	 +18%	 +16%	 +18%	
CAGR
+24%	
CAGR
+3%	
CAGR
+25%	
Number	of	
Players:	
12	
34
20mg	
48%	
10mg	
37%	
40mg	
13%	
80mg	
2%	
Share	by	strength,	in	units	
35
Share	by	product	type	
5,4%	 8,8%	 7,2%	 7,1%	 10,8%	
32,2%	
61,3%	 66,1%	 67,3%	 68,4%	
62,5%	
30,0%	 26,8%	 25,6%	 20,8%	
2011	 2012	 2013	 2014	 2015	
BRANDED	GENERIC	 NON-BRANDED	GENERIC	 ORIGINAL	
3,0%	 6,3%	 5,2%	 4,6%	 6,4%	
23,8%	
48,3%	 53,8%	 54,7%	 56,2%	
73,1%	
45,4%	 41,0%	 40,7%	 37,4%	
2011	 2012	 2013	 2014	 2015	
BRANDED	GENERIC	 NON-BRANDED	GENERIC	 ORIGINAL	
UNITS	USD	
36
Average	discount	per	player		
Ranking	in	values	
37
30.278	
25.156	
2014	 2015	
Units
27.890	
18.305	
2014	 2015	
USD (million)
-34%	
38
Regulatory Path
for Registering imported
products in Brazil
By	Ladina	Consul.ng	-	Brazil
Introduction
40
Ways to Register in Brazil
41
Timelines for subsidiary opening 1
42
Comparison between scenarios 1 and 2
43
Timelines for registration 1
PE : Pharmaceutical Equivalence
BE : Bioquivalence
COA: Certificate of Analysis
44
Timelines for registration 2
45
Check list for registration of Imported Finished Products ( Generic and
Branded Generic) 1
BMRs : Batch Manufacturing Record
RLD : Reference Listed Drug
CRO : Certified Research Organization
46
Required documents for GMPc Application
47
Basic Requirements to Sell API in Brazil 1
48
Basic Requirements to Sell API in Brazil 2
List of APIs that must have GMPc of the manufacturing facility and registration
at ANVISA.
49
Basic Requirements to Sell API in Brazil 3
50
General Regulatory Notes 1
51
Public Market (Governament)
Oncologies Products – Tenders/ Sell
2014 :
By	Ladina	Consul.ng	-	Brazil
List : Product / Presentation / Quantities / Supplier and Values
53
Thank	you.	
54
Mobil : +55 19 991614172

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