Beruflich Dokumente
Kultur Dokumente
Naveen Kumar
Flow of Presentation
Introduction
VACCINES
A vaccine is any preparation intended to
produce immunity to a disease by stimulating the production of antibodies. Vaccines include, for example, suspensions of killed or attenuated microorganisms, or products or derivatives of microorganisms.- WHO.
Vaccines vs Pharmaceuticals
Vaccines Pharmaceuticals
Regulatory
Focus on prevention not patients, but healthy subjects Key role for the government agencies Very low acceptance of side effects
Focus on treatment patient is generally sick Key role for healthcare players Acceptance of side effects varies by severity of disease
Manufacturing
High manufacturing and supply chain complexity (Cold Chain Management, complex biological processes)
Medium manufacturing and supply chain complexity (Easier to handle chemical synthesis in most cases)
Marketing/ Sales
Small Major sales through government Very few generic products (Due to manufacturing complexity)
Massive sales force commitment Sales through physician as prescriber Increasing generic threat
Storage problems Due to less financial incentive from govt. to manufacturers insufficient doses Demand uncertainty Manufacturing interruptions - required to maintain cGMP standards so high product rejection rate - supply can be impacted
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Vaccine
Discount in `(A-B)
2066 365
1446 280
620 85
Tripacel
Okavax
1211
1468
762
986
449
482
58.9
48.9
Avaxim 80
TetractHib ActHib 10
952
504 426
665
305 251
287
199 175
43.2
65.2 69.7
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combination vaccines in clinical development Five major playersGlaxoSmithKline, Merck, Sanofi-Aventis, Pfizer and Novartis Vaccines approved by FDA in 2010 : Provenge, Prevnar 13, and Menveo
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Vaccine segments
Adolescents
Adults
Elderly
14
20
15 24 26
28
10
5
18
0
2007
15
2008
2009
2010
Major markets
Country US Sales, 2008 ($ mn) 4741 Market share 2008(%) 42.7
Germany
Japan France Italy Spain UK
1755
911 835 303 198 176
15.8
8.2 7.5 2.7 1.8 1.6
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Novartis
SP-MSD
2.9
1.2
17
Others 21%
GSK 23%
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Top vaccines
Brand name Prevnar(13) Company Pfizer Sales($ billion) 2010 3.6
Fluarix
Fluzone Gardasil IPOL
GSK
SAP Merck SAP
1.85
1.75 1.35 1.33
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Corixa
PowderMed
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GSK
Pfizer
$300 mn
$230 mn $214 mn
May 2005
Oct 2006 Nov 2007
2010
2015(F)
Sales (millions)
$67791
$64532
$9338
$7212
$17983
$17430
EPS
$2.23
$3.00
Top product
Lipitor ($10773)
Prevnar($5624)
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Source: Forbes
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in the range of 10-13% over the next 10 years to reach a size of between US$1.4 billion and US$1.8 billion by 2020 India produces about 40-70% of the WHO demand for DPT and BCG, and almost 90% of the demand for measles The largest vaccine producer in India is the Serum Institute of India, it is the worlds largest producer of measles and DPT vaccines
Export, 179
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Major players
MNCs
GSK Sanofi Pasteur Novartis Wyeth Merck
Local manufacturers
Serum institute of
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Rotavirus vaccine
Rotavirus vaccine Cadi-05 Malaria vaccine H1N1 influenza (Swine flu) vaccine Conjugated typhoid vaccine
Bharat Biotech
Shantha Biotechnics Cadila Bharat Biotech Bharat Biotech, Panacea Biotech, SII Bharat Biotech
Phase 3
Phase 2 Phase 3 Phase 1 Phase 2/3 Phase 3
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Increase exports
Vaccines
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Source: PwC
medical needs Contingency planning for pandemic infections Growing income in the developing world markets Threat from bioterrorism Potential for therapeutic vaccines Continued interest and investment from major pharma players Education and awareness about disease prevention Participation by government in terms if improving PSUs and investment
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Funding
High maintenance Slow regulatory approval Dependence on government
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Strengths
Prevent disease Vaccines are widely available and programs
Competition
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Weaknesses
Vaccine Research and Development is
Lengthy and Expensive Less awareness Vaccine Manufacturing : High cost High maintenance products Regulatory approvals Funding to new enterprises
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Opportunities
Vaccines for Diseases Currently Without a
Vaccine Improved Vaccines for Partially VaccinePreventable Diseases Global recognition of the benefits of immunization Combination vaccines way ahead
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Threats
Only strong players so intense competition
government procurement to push volumes Gestation period is long Ageing of their product basket Vaccine Distribution Networks The Anti-Vaccine Movement
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Future vaccines
Vaccine Estimated annual burden of disease 10,000-20,000 deaths 500,000 severe cases At risk population
Dengue
2.5 billion people are at risk, with a strong trend upwards 2 billion people in endemic regions children under 5 Endemic regions including Africa, Asia and S. America. Individuals infected with Multidrug resistant TB
Malaria
1.1 to 2.7 million deaths, 300-500 million cases 1.6 million deaths; 8 million cases
Tuberculosis
HIV/AIDS
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Almost 3 million deaths; 38- High risk groups Continent 42 million cases of Africa
And more
Diabetes
Cancer
Smoking Obesity Asthma Allergy HTN
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Adjuvants
Substances that helps vaccine to produce a stronger immune response
Faster response
Conjugate vaccines
Conjugation of sugar molecules present on bacteria to a strong immunogenic carrier protein Can stimulate cell mediated long lasting memory
Broad immunity
Adjuvant and conjugate vaccines may help to increase vaccine efficacy in the elderly population
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DNA vaccine
Advantages Technique
Injection of DNA encoding the antigen Involves transfection of DNA plasmid containing antigen coded gene into target cells which results in immune response
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Conclusion
Vaccine industry has been proved to be one of the fastest growing
the increasing awareness for vaccine-preventable diseases, adults and the elderly are coming into focus as an attractive target population for future vaccine development
Advancement in the molecular biology and vaccine delivery systems
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