General aspects of Brazilian Pharmaceutical Fields : Market, Industries, Regulatory Issues and how to enter in the Brazilian Market

1. Brazilian Pharmaceu/cal Field Figures
By Ladina Consul.ng - Brazil

2. Socio-demographics & GDP
Population projection in July 16, 2015 (IBGE):
2

3. 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

4. Annual average exchange rate
BRL/USD
4

5. Key Macroeconomic Indicators
5

6. Retail Market Analysis
By Ladina Consul.ng - Brazil

7. Brazilian Pharmaceutical Market
7

8. Top 25 companies
8

9. 9
2014 – Total Sales Market

10. 10
Retail Sector Sales

11. Brazilian Pharmaceutical Market
11

12. Brazilian Pharmaceutical Market
Per product type
12

13. 13

14. Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture 2013,pg 5
Brazilian Market Pharma – Units Sold
14

15. 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

16. Business Environment
16

17. Healthcare Provision
17

18. Pricing and Reimbursement
18

19. Regulatory Environment
19

20. Pharmaceutical Business Environment
20

21. Pharmaceutical Business Environment
.
21

22. Pharmaceutical Business Environment
ANALYSIS OF REBATES AND DISCOUNTS
22

23. New Competitive Scenario :
Main Pressures Of Pharmaceutical
Industry in Brazil
By Ladina Consul.ng - Brazil

24. 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

25. Market Prognosis Scenario 2015-2019: Pricing and Reimbursement
CMED : Camara de Regulação de Mercado de
Medicamentos (Pharmaceutical Market Regulatory Agency-
Pricing Commission)
25

26. 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

27. Generic prices
27

28. Price increases
28

29. Public sector prices
29

30. Influence of Tax to choice best place
to implement t Business
30

31. Oncology
By Ladina Consul.ng - Brazil

32. Market Studies
Selected Oncology Molecules
By Ladina Consul.ng - Brazil

33. 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

34. 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

35. 20mg
48%
10mg
37%
40mg
13%
80mg
2%
Share by strength, in units
35

36. 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

37. Average discount per player
Ranking in values
37

38. 30.278
25.156
2014 2015
Units
27.890
18.305
2014 2015
USD (million)
-34%
38

39. Regulatory Path
for Registering imported
products in Brazil
By Ladina Consul.ng - Brazil

40. Introduction
40

41. Ways to Register in Brazil
41

42. Timelines for subsidiary opening 1
42

43. Comparison between scenarios 1 and 2
43

44. Timelines for registration 1
PE : Pharmaceutical Equivalence
BE : Bioquivalence
COA: Certificate of Analysis
44

45. Timelines for registration 2
45

46. 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

47. Required documents for GMPc Application
47

48. Basic Requirements to Sell API in Brazil 1
48

49. Basic Requirements to Sell API in Brazil 2
List of APIs that must have GMPc of the manufacturing facility and registration
at ANVISA.
49

50. Basic Requirements to Sell API in Brazil 3
50

51. General Regulatory Notes 1
51

52. Public Market (Governament)
Oncologies Products – Tenders/ Sell
2014 :
By Ladina Consul.ng - Brazil

53. List : Product / Presentation / Quantities / Supplier and Values
53

54. Thank you.
54
Mobil : +55 19 991614172