The rise of a national biopharmaceutical industry in ... · The rise of a national...
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The rise of a national biopharmaceutical industry in Brazil:
Consolidation, Trends and Challenges.
Non-profit association of eleven brazilian pharmaceutical companies focused on
innovation and development of new products through international standards andhigh-quality research.
GRUPO FARMABRASIL
Upgrading theManagement and Pro-innovation Legal Framework
Increasing accessto medicines
through increasingNational supply
I N N O V A T I O N
GRUPO FARMA BRASIL STRATEGIC GOALS
Consolidation of the National Pharmaceutical
Industry based on the existing portfolio and new Products.
Rise and consolidation of a Brazilian Pharmaceutical Industry
31 3439
13
15
18
2012 2013 2014
Brazilian Pharmaceutical Market (R$ billions)
Non-Retail
Varejo
(31%)
(31%)
(69%)(69%)
50
56
44
(30%)
(70%)
*9%
Source: PMB March 2014, NRC March 2014; (PMB – PPP and NRC – bidding price).
*Growth rate used: CAGR.
Retail and non-retail market
BRAZILIAN PHARMACEUTICAL MARKET
Retail
GLOBAL RANKING
Change in ranking over 5 years Source: IMS World Review 2014
Rank 2008 Index
1 United States 100
2 Japan 27
3 China 14
4 France 13
5 Germany 8
6 Italy 7
7 Canada 7
8 UK 7
9 Spain 5
10 Brazil 4
11 Mexico 4
12 Australia 3
13 Russia 3
14 South Korea 3
15 Turkey 3
16 India 3
17 Greece 2
18 Netherlands 2
19 Poland 2
20 Belgium 2
4
2
1
1
12
1
8
1
4
4
2
4
Rank 2018 Index
1 United States 100
2 China 45
3 Japan 29
4 Brazil 13
5 Germany 10
6 France 8
7 Italy 7
8 UK 7
9 Canada 7
10 Russia 7
11 India 6
12 Spain 5
13 Mexico 4
14 South Korea 4
15 Australia 4
16 Venezuela 4
17 Turkey 3
18 Poland 2
19 Saudi Arabia 2
20 Argentina 2
2
1
1
1
1
2
1
1
1
1
2
1
Rank 2013 Index
1 United States 100
2 China 29
3 Japan 29
4 Germany 13
5 France 11
6 Brazil 9
7 Italy 8
8 UK 7
9 Canada 7
10 Spain 6
11 Russia 6
12 India 5
13 Mexico 4
14 Australia 4
15 South Korea 4
16 Turkey 3
17 Venezuela 2
18 Poland 2
19 Argentina 2
20 Belgium 2
1
1
1
1
4
2
1
2
4
2
4
1
1
4
1
8
1
24.0427.00
28.50 29.0831.82
0.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
2007 2008 2009 2010 2011
Billions
Source: IBGE – Annual Survey of Industry from 2007 to 2011
P.S.: 2011 is the last data publicly available.
Growth (CAGR)
5,77%
BRAZILIAN PHARMACEUTICAL INDUSTRIAL PRODUCTION
GROSS VALUE OF PRODUCTION
Creation, maintenance and expansion of supporting policies
BUILDING AN INDUSTRY
Creation ofAnvisa
GenericDrug Law
Patent Law
36% of national
production of medicines
53% of national
production of genericdrugs
The share of brazilian companies in the ranking of thetop tem corporations went from 4,7% in 1998 to25,11% in 2013, growing nearly 435%.
15 years
New level of the brazilian industry
BRAZILIAN RETAIL RANKING
Market Share in Brazilian Retail Market
CorporationMarket Share
CorporationMarket Share
1998 2013
Novartis 6,30% GRUP SANOFI 9,18%
Roche 5.5% EMS CORP 7,81%Bristol Meyers Squibb 5.4% HYPERMARCAS 7,50%
Hoechst Marion Roussel 5.2% ACHÉ 5,66%
ACHÉ 4.7% NOVARTIS CORP 5,36%
Janssen Cilag 3.7% PFIZER CORP 4,55%
Boehringer lng. 3.7% EUROFARMA 4,14%Glaxo Wellcome 3.5% BAYER CORP. 3,61%
Scheding Plough 3.2% GLAXOSMITHKLINE 3,16%
Eli Lilly 3,00% TAKEDA PHARMA CORP 3,13%
Demais empresas 55.5% Demais empresas 45,90%
Source: Callegari (2000) for 1998 and IMS Health for 2013
* Data considering PPP.
Reference, similar and generic drugs, fitoterapeutical and biological medicines,
biossimilars, and API.Portfolio:
40 thousand direct jobs and around 150 thousand indirect jobs
Jobs:
R$ 6 billion in the last 5 yearsInvestment in new factories and new
facilities:
Bionovis, Orygen Biotecnologia, Cristália Biotec, Libbs Biotec (factory 2014-2016: R$ 2 billion)
and Hebron Biotec
Investment in Biotechnology:
GRUPO FARMABRASIL TODAY
0.79%
2.39%
6.00%
0.40%0.72%
1.11% 1.27%1.01%
1.39%
0.00%
1.00%
2.00%
3.00%
4.00%
5.00%
6.00%
7.00%
Brazil Pharmachemicaland
pharmaceuticalproducts
GrupoFarmabrasil
Mining andquarrying
Manufacturingindustry
Chemicals Computerequipment and
peripherals
Machinery,appliances and
electricalequipment
Cars, buses andtrucks
% of net income invested in R&D
Source: IBGE, Diretoria de Pesquisas, Coordenação de Indústria, Pesquisa de Inovação Tecnológica 2011.
GRUPO FARMABRASIL
PINTEC (2011): 458 companies from
pharmaceuticalsector
Clinical Trials in progress by one associate of Grupo FarmaBrasil
Source: Libbs
GRUPO FARMABRASIL
95 3691010
1804
3815
6056
2008 2009 2010 2011 2012 2013
Number of patients involved in clinical trials sponsored by Libbs
Expansion to American Continent
FOUNDATIONS FOR THE FUTURE
Eurofarma Colômbia/Fábrica MSD
Eurofarma Peru
Eurofarma Chile
Cristália/IMA
Eurofarma Argentina
Eurofarma Uruguai
Hebron USA
Brace Farma (EMS)
*Biolab has begun its internationalization to USA.
Hebron Del Peru
Eurofarma Bolívia
Eurofarma Centro-América
Exports from Grupo FarmaBrasil to the World
FOUNDATIONS FOR THE FUTURE
New Path and Trends
Growth (CAGR)
9,08%
Biotechnology Conventional
Source: EvaluatePharma World Preview 2014
0
200
400
600
800
1000
1200
490 533 573 581 593 624 600 589 606 632 660 690 717 746 774
79 94 108 116127 141
152165
181 197215 233
252272 291
Conventional Biotechnology
Growth of Biologic market
GLOBAL PHARMACEUTICAL MARKET IN US$ BILLIONS
Forecast to 2020: US$ 291
billion (27% share in total
sales).
Growth (CAGR)
3,09%
Biotechnology
New Path
New Skills
Manufacturing Plants
(biologics)
Biosimilars
New Biologics
Synthetic drugs
Continued path
Accumulated experience
and skills New Molecules
2013
Incremental Innovation
Certified GMP manufacturing
facility
Generic Drugs
2003
Paths drawn by BNDES
VISION OF THE FUTURE OF BRAZILIAN PHARMACEUTIRCAL INDUSTRY
Source: Pedro Palmeira/BNDES
Source: IBGE – Annual Survey of Industry; Sistema Alice (MDIC).
The population ageing stimulates the rise of the demand in the
health sector in Brazil
Changes in the epidemiological
profile
Prevalence of chronicand neurodegenerative
diseases
Increase in the per capita
HealthcareSpending
Demographic changes: new opportunities
POPULATION AGEING
Population Aging in Brazil
Fonte: IBGE
Healthcare Spending by Age Group (US$/Capita)
Fonte: IBGE
Years
>80 Years
70–79 Years
60–69 Years
50–59 Years
40–49 Years
30–39 Years
20–29 Years
10–19 Years
0–9 Years
25 15 5 5 15 25 15 5 5 15 25
Men Women Men Women
Life Expectation will Increase to 72 years (2006) to 76 years (2020)
Expanding access to medicines will increase procurement ofbiotech medicines.
Units X R$ sales
PUBLIC PROCUREMENTWITH BIOTECHNOLOGY DRUGS
3.70%
96.30%
Units
Biopharmaceuticals Pharmaceuticals
31.97%
68.03%
Reais(R$)
Biopharmaceuticals Pharmaceuticals
Public Procurement of medicines - Ministry of Health: 2010
LIBBS BIOTECNOLOGIA
BIONOVIS
HEBRONBIOTECNOLOGIA
CRISTÁLIABIOTECNOLOGIA
ORYGEN BIOTECNOLOGIA
Response of brazilian industry to national health needs
GRUPO FARMABRASIL AND THE BIOTECHNOLOGY
PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS)
GRUPO FARMABRASIL IN THE PDP PROGRAM
36 Partnerships for developing and
producing Biologic Drugs
25 biologic drugs including second
and third-generation biologic drugs
Currently procurement of these drugs
is around R$ 1,8 billion
Savings of R$ 225
millions/year
cancer
rheumatoid arthritis
diabetes
surgical tissue adhesive
growth hormone
allergy vaccine
Source: Brazilian Ministry of Health
Deficit reduction on trade balance of US$
900 millions
PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS)
GRUPO FARMABRASIL IN THE PDP PROGRAM
Data of june/2014
0 5 10 15 20 25 30 35 40
Outras Empresas
Aché
Cristália
Bionovis
Orygen
Libbs
Eurofarma
EMS
Supera
PDPs – Biologic and Synthetic Drugs (GFB)
Synthetics Biologics
* Baxter, Biocad, Biocen, Biomm, Blanver, Apotex, Bristol, Boehringer, Chemo, Chron Epigen, GSK,
Ideen, IGL Group, Indar, Laborvida, Injerflex, Lupim, Lifemed, Microbiológica, MSD, Novartis, NPA, NT
Pharma, Pfizer, PharmaPraxis, Roche, Sanofi, UCB Pharma.
PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS)
GRUPO FARMABRASIL IN THE PDP PROGRAM
58%
42%
Partneships
Grupo FarmaBrasil Other partners
Data of june/2014
Challenges
TRAINNING HUMAN RESOURCES
CHALLENGES TO BIOTECH DEVELOPMENT IN BRAZIL
Need of training future biotech factory
operators;
Human Resources are scarce in some
intermediate stages of the drug
development process, such as preclinical
studies, scaling up and manufacturing pilot
batches;
Need of adapting biotechnology graduation
programs to meet industrial needs.
PUBLIC HEALTH EXPENDITURE
CHALLENGES TO BIOTECH DEVELOPMENT IN BRAZIL
Public Health Expenditure/PublicHealth Expenditure in Brazil*
Populations/Brazilianpopulation (2011)
USA 10,87 1,58Switzerland 9,96 0,04
France 6,24 0,33Germany 6,12 0,40Ireland 6,09 0,02Japan 5,03 0,64
United Kingdom 4,98 0,32Spain 3,81 0,24
South Korea 1,84 0,25Brazil 1,00 1,00Russia 0,76 0,72China 0,24 6,80
Some countries have 40% of Brazilian population but spend sixtimes more than what Brazil spends.
Source: World Bank
* Average of 2004 to 2012.
PUBLIC HEALTH EXPENDITURE
CHALLENGES TO BIOTECH DEVELOPMENT IN BRAZIL
0
1
2
3
4
5
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Health Expenditure GDP (R$ Trillion)
7% 7,1% 8,2% 8,5% 8,5% 8,3% 8,8% 9% 8,9% 9%
Growth rate 14,44%
Public Health Expenditure x GDP (Brail)
IMPROVING REGULATION FOR BIOTECH DRUGS
CHALLENGES TO BIOTECH DEVELOPMENT IN BRAZIL
Open the opportunity for the companies to discuss their Plans for developing
biotech drugs with the regulatory agency, ANVISA, assuring more legal and
regulatory certainty to the undergoing investments.
Regulate “Good manufacturing practices (GMP)”, specifically to biological
drugs.
Elaborate Guidelines for Registration and Post registration of biological
drugs.
ACCESS AND BENEFIT SHARING IN BIODIVERSITY
CHALLENGES TO BIOTECH DEVELOPMENT IN BRAZIL
Brasil – highest biodiversity
Efforts of conservation and sustainable use
Opportunity (innovation and income generation)
Manufacture fitoterapeutical
drugs
ACCESS AND BENEFIT SHARING IN BIODIVERSITY
CHALLENGES TO BIOTECH DEVELOPMENT IN BRAZIL
Reviewing the legal framework for ABS (Access and Benefit Sharing)
Priorities
Have better knowledge about biodiversity in order to protect it
Incentivate research, develpment and Innovation (access)
Enhance Traditional Knowledge
Promote bioindustry and productivity of manufacture sector
System debureaucratization
Make benefit sharing effective
Focus on biopiracy
Reginaldo ArcuriExecutive President
Adriana Diaferia Executive Vice President
+55 61 3224-2003
SBS, Quadra 02, Bloco E, nº 12, 15º andar, Salas nº 1501 e 1502,
Edifício Prime Business Convenience, CEP 70.070-120 - Brasília/DF
THANK YOU