BrazilianPharmaceu/calFieldFiguresByLadinaConsul.ng-Brazil
Socio-demographics & GDP
Population projection in July 16, 2015 (IBGE):
2
Number of pharmacies and physicians
184pharmaciesper1000physicians
37pharmaciesper100kpopula/on
2.272 11.541
61.056
Independent Chains (Franchise) Chains
Independent Pharmacies
Numberofphysicians:406.872
NumberofPoS(pharmacies):74.869
CFM(FederalCouncilofMedicine)3
Annual average exchange rate BRL/USD
4
Key Macroeconomic Indicators
5
RetailMarketAnalysisByLadinaConsul.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 ByLadinaConsul.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
OncologyByLadinaConsul.ng-Brazil
Market Studies Selected Oncology Molecules
ByLadinaConsul.ng-Brazil
Selected molecules
Selec.oncriteriaThese10moleculeswereselectedbythefollowingcriteria:• HighersalesinUSD• BeGergrowthtrend• Fewerplayers• BeGeraverageprice
33
2.373
3.5194.096
4.663
5.595
2011 2012 2013 2014 2015
Units (000)
+48%
140.400141.867
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%
Numberof
Players:
12
34
20mg48%
10mg37%
40mg13%
80mg2%
Sharebystrength,inunits
35
Sharebyproducttype
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
BRANDEDGENERIC NON-BRANDEDGENERIC 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
BRANDEDGENERIC NON-BRANDEDGENERIC ORIGINAL
UNITS
USD
36
Averagediscountperplayer
Rankinginvalues
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
ByLadinaConsul.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 :
ByLadinaConsul.ng-Brazil
List : Product / Presentation / Quantities / Supplier and Values
53
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