Developing Country Vaccine
Industry and Global Vaccine Needs
ADVAC 2015
Dr. Suresh Jadhav Executive Director
Serum Institute of India Limited
Maharashtra, India, 411028
11 May 2015
Outline Immunization landscape
Vaccine Industry: DCVMN Overview
Role of DCVM
- UN Supplies
- Global Vaccination Coverage
-Vaccine Affordability
- Global Health Threats
Global unmet needs and The way forward
Global Vaccine Market
Source: Kaddar, WHO Presentation 2014
Global Vaccine supply
• Comprise 25 leading international companies.
• Majority of revenue stake owned by Big 5 Pharma.
• Represents research-based pharmaceutical and biotech companies.
• Generates 80-85 % of total revenue in global vaccine market.
• Contributes 12-15 % in volumes to global vaccine requirement.
Formed in Year 2000.
Year -2014. 39 members in 15 countries
representing Latin America, Middle East,
Africa, and the Asia-Pacific region.
WHO prequalified production facilities.
High volume low cost business models
In 2013, Emerging vaccine
manufacturers catered to 50 % of
procurement volumes and 50 % by value
of UNICEF shares.
Largely kept prices of traditional
vaccines affordable in-spite of declining
interest of Big Pharma in EPI vaccines.
Jadhav et al 2014, CMI.
Developing countries: Vaccine Industry
Supplies vaccines to 80 % of population: However shares less than
20% of global market in value
Increase in production capacities and potential to undertake or
partner for newer vaccines development
Business models based on access to emerging economies and
markets, UN market and Private sector in Low and Middle income
countries
Growth drivers: Large population, Unmet vaccination needs and low vaccination rates, Increasing governments focus on prevention/childhood rates
Future growth Expectations: Combination vaccines, -Influenza, -Traveller vaccines, Neglected Tropical diseases, pneumococcal and rotavirus, HPV vaccines
DCVMN
DCVMN: Formed in
Year 2000
Year 2014: 39
members in 15
countries. 12 members are
WHO prequalified.
Jadhav et al 2014, CMI.
COUNTRY VACCINE MANUFACTURER
ARGENTINA National Administration Of Laboratories And Institute Of
Health Anlis "Dr.Carlos G. Malbran
BANGLADESH Incepta Vaccine limited
BRAZIL Bio-Manguinhos / Fiocruz
Instituto Butantan
CHINA Beijing Minhai Biotechnology Co., Ltd.
Changchun BCHT Biotechnology Co.
China National Biotech Corporation
Hualan Bio
Liaoning ChengDa Biotechnology Co., Ltd,
Sinergium Biotech
Sinovac
TiantanBio
Walvax Biotechnology Co., Ltd
Xiamen Innovax Biotech Co.,Ltd
CUBA Finlay Institute
The Center for Genetic Engineering and
Biotechnology
EGYPT Vacsera
Jadhav et al 2014, CMI.
COUNTRY VACCINE MANUFACTURER
INDIA Bharat Biotech International Limited
Cadilla Pharmaceuticals
Biological E Ltd.
Haffkine Bio-Pharmaceutical Corporation Ltd.
Indian Immunologicals Ltd
Panacea Biotec Limited
Serum Institute of India Ltd.
INDONESIA Bio Farma
IRAN Razi Vaccine & Serum Research Institute
Pasteur Institute of Iran
KOREA Greencross Corporation
EuBiologics Co., Ltd.
LG Life Sciences
SK Chemicals
MEXICO Birmax
SOUTH AFRICA Biovac
TAIWAN The National Institute of Infectious Diseases and Vaccinology
THAILAND BioNet-Asia Co., Ltd.
Queen Saovabha Memorial Institute
The Government Pharmaceutical Organization,
VIETNAM Institute of Vaccines and Medical Biologicals,
Vabiotech
WHO Prequalified Vaccines & DCVMN Name of DCVMN Member WHO Prequalified Vaccines
1. Bio Farma / Indonesia TT, DT, Td, DTwP, Hep B, DTwP-Hep B,
Measles, mOPV, bOPV, tOPV
2. Biological-E / India TT, DTwP-Hep B-Hib, JE
3. Bio-Manguinhos / Fiocruz / Brazil YF, Men. A + C
4. The Center for Genetic Engineering and
Biotechnology / Cuba
Hep B, Hib
5. Chengdu Institute/ China JE
6. Green Cross Corpn. / Korea Seasonal and Influenza A (H1N1) - Pandemic
Influenza vaccines.
7. The Government Pharmaceutical
Organization / Thailand
Measles
8. Haffkine Institute/Mumbai mOPV, bOPV, tOPV
9. The Pasteur Institute, Dakar YF
10. Serum Institute of India TT, DT, Td, DTwP, Hep B, BCG, Hib,
Measles, Rubella, MR, MMR, Meningococal
conjugate vaccine against serotype A, H1N1
Pandemic Influ., bOPV, tOPV, DTwP-Hep B,
DTwP-Hib, DTwP-Hep B-Hib
11. LG Life Sciences/South Korea Hep-B, DTwP-Hep B-Hib
12 Panacea Biotech, India DTwP-Hep B-Hib
Global distribution of deaths among
children under five (2013)
6.6 million children died in 2013
More than half due to conditions that could be prevented or treated with access to simple, affordable interventions
Global Disease Burden of Vaccine-
Preventable Deaths (< 5 years)
Pertussis 13%
Hib* 13%
Measles 8%
Tetanus 4%
Pneumo diseases
* 32%
Rotavirus* 30%
Lancet, 2010 Jun 5; 375(9730): 1969-87.
Estimated 1.5 million
deaths in children
preventable through
routine vaccination
*WHO estimates
Global Vaccination Coverage-2013
Global Vaccine Action Plan
(GVAP)
Framework to prevent millions of deaths by 2020 through more equitable access to existing vaccines for people in all communities
Endorsed at 2012 World Health Assembly
Developed by Decade of Vaccines (DoV) Collaboration
Challenges in Meeting Global Needs
Limited resources
Competing health priorities
Poor management of health systems
Inadequate monitoring and supervision
Political instability
Priority needs to be given to strengthening routine vaccination globally.
Rapid growth in Emerging Economy
producers (DCVMs).
From Year 2008 to Year 2013: GAVI funded vaccines from DCVMN was above 50 %. Jadhav et al 2014, CMI.
Emergence of DCVMs
UNICEF publication, 2014
Vaccine Supplies to UNICEF
In Year 2012-14, the contributions of DC manufacturers to UNICEF supplies were
maintained around 54 %. Jadhav et al 2014, CMI.
DC Vaccine Industry Contributions
SAGE presentation 2014
In Year 2013: This coverage increased to 84 %.
Measles vaccine
Global coverage of children by their second birthday with one dose of measles
-containing vaccine in 2013: 84% SAGE presentation 2014
Hepatitis B Vaccine
Global coverage with three doses of hepatitis B vaccine is estimated at 79 % in year 2013. (WHO data; 2014)
Polio eradication
Year 2014: SEARO certified polio-free (27 March)
•No type 3 virus globally for 16 months
•Most countries on track to stop type 1
SAGE presentation 2014
SAGE presentation 2014
Hib Vaccine
Global coverage with three doses of Hib vaccine is estimated at 45 % in 2013
(WHO estimates, 2013)
Pentavalent vaccine and UNICEF
Supplies
Vaccine Pricing and Affordability
Year 1974: EPI program was launched.
Year 1999: Total cost of full course of EPI vaccine averaged USD
1.37
Year 2000: Adding two priority vaccines-Hepatitis B and Hib to EPI
vaccines increased the cost to USD10.
Year 2011: The expansion of EPI Program have raised the price of
purchasing the full course of vaccine in GAVI country to 38.80 USD.
(Price does not include programmatic or cost associated with vaccine
wastage).
Price of vaccine became a significant issue for immunization
stakeholders in Year 2011, when GAVI faced a US $ 3.7 billion
financial shortfall for its 2011-2015 programme implementation.
In Past 5 Years: WHO is recommending high unit cost products such
as pneumococcal conjugate vaccine and rotavirus vaccine for global
use in infants and HPV vaccines for adolescents.
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
Pricing and DCVMN
Crucell GSK DCVMN (SII/BE)
Presentation Single
dose
Two dose
lyophilized
Single
dose
-liquid
Two dose
lyo
Ten dose
liquid
Country of
manufacture
Republic
of Korea
Belgium India India India
2011 price
per dose
$2.80-
3.20
$2.95 $2.25-2.50 $2.25 $1.19-
2.11
DCVMN supplied Pentavalent vaccines, mainstay of GAVI Purchase at prices
almost 40 % less than Crucell, a European company.
GAVI’s support for pentavalent vaccine has averted 474,000 future deaths. source: WHO Department of Immunisation, Vaccines and Biologicals’ estimates and projections, November 2010
2011 Price Per dose of DTP-Hep-B-Hib (Pentavalent)
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
Poliomyelitis (Polio)
Launch of Global Polio Eradication Initiative has led to 99% drop in cases since 1988
3 countries remain polio-endemic: Afghanistan, Nigeria, Pakistan (vs 125 in 1988)
Polio Eradication and Endgame Strategic Plan 2013–2018 – aims to eradicate disease by 2018
One of major challenge in end game strategy will be vaccine supplies.
Supply of IPV and DCVM Existing price from developed country vaccine manufacturer (Big
Pharma): 4.50 Euros/dose.
EVM* Price: 2.50 Euros/dose till year 2013.
Year 2013 DCVM price: 1.25 Euro/dose in single dose container.
0.90 Euro/dose in multidose container for immediate use. Future
pricing may reduce to 0.60 Euros/dose in multidose vial.
Year 2014: 10 dose vial cost EUR 0.75 per dose from Big Pharma.
* Pricing from IPV producer in Europe acquired by Indian Vaccine Manufacturer
DCVMN and Global Pandemic threats
WHO Global Action Plan for Pandemic Influenza (GAP). -This represent an leading
example wherein pandemic
threats led to capacity building.
-New manufacturers have been
established in developing
countries, which brings hopes to
more adequate production
capacity and equitable access in
case of a future pandemic.
- By 2015, production capacity
of more than 1 billion doses is
expected by DC manufacturers.
DCVM and Global Health Threats Meningitis
Vaccine Project Successful example of Global Partnerships
MenAfric Vac: Impact
MVP and NIBSC presentation
DCVMN and Access to New Vaccines
Vaccine 2010, 28, 2115-21.
Vaccines DCVMN manufacturer Country Comments
Pneumococcal
Conjugate
BioManguinhos/GSK
Chengdu Institute/PATH SII, India/PATH Finlay Institute
Brazil
China India Cuba
Under development
Rotavirus Serum Institute of India
-Instituto Butantan -China National Biotech Group
-Biological Evans
India
Brazil China India
Phase-3
Phase-2 Under development Under development
Meningococcal
vaccines Includes
polysaccharide and
conjugate vaccines
Biological Evans
China National Biotech Group Finlay
Serum Institute of India Ltd
Panacea Biotech BioManguinhos
India
China Cuba India
India Brazil
Under development
Japanese
encephalitis vaccine
Vabiotech
Bharat Biotech Indian Immunologicals
Panacea Biotech
Vietnam
India India India
Under development
Phase 3 Under development Under development
Seasonal and
Pandemic Influenza
Vaccines
(also includes vaccines
with oil in water
adjuvants
-Vabiotech
-GPO - IVAC
- Butantan
- Chinese National Biotech Grp - Birmax
- BioManguinhos
Vietnam
Thailand Vietnam
Brazil
China Mexico
Brazil
Under development
Phase III Under development Phase I/II (new adjuvant)
Under development Under development
Under development
DCVMN and Access to New Vaccines
Vaccines DCVMN manufacturer Country Comments
Malaria vaccine Bharat Biotech India Under development
Typhoid Vaccine Finlay Institute Cuba Under development
Dengue Vaccine Biological Evans
Bio-anguinhos/Bionet
India
Brazil
Under development
Yellow fever ANLIS Argentina Phase III
Hepatitis A Bio-manguinhos Brazil Under development
Leishmaniases Bio-manguinhos Brazil Under development
Leptospirosis Bio-manguinhos Brazil Under development
HPV Vaccine Serum Institiute
CCGEB Innovax
Indian Immunologicals
India
Cuba China India
Under development
Chikungaya Indian immunologicals India Under development
Anthrax vaccine Panacea Biotech India Phase III
DCVMN and Pneumococcal Vaccines
Year 2000: PCV 7: CDC Purchase price was USD 44.25/dose.
Year 2009; PCV 13 CDC Purchase price was at 71.04 USD per dose.
Following deliberation in Year 2007, access to PCV 7 and 13 was supported by AMC with initial target price of USD 2.00 per dose. Finally the price was locked in with tail price of 3.50 USD/dose.
No competition from low cost producers as on date. However, some DCVMN members are expected to enter this segment of vaccines by Year 2016.
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
DCVMN and Rotavirus Vaccines
Year 2006: USD 15.00 for full course; PAHO supplies
Year 2011: Big Pharma manufacturers reduced the price in range of 5.00 to 10.00 USD per course following sales of 30 million doses.
Two DCVMN members are expected to have vaccine by Year 2015. One of member have announced its plan to launch this vaccine at USD 1.00 per dose.
The Right Shot: Extending the reach of Affordable and Adaptable Vaccines. www. Msfaccess.org; April 2012
Human papillomavirus (HPV)
Most common viral infection of the reproductive tract (> 100 types)
Can cause cervical cancer, other types of cancer, and genital warts
> 85% of cervical cancer deaths are in low- and middle-income countries
HPV vaccine introduced in 45 countries by end of 2012
HPV Vaccines and GAVI
36
Summary
DCVM have moved from dependency to self sufficiency and has finally emerged as global suppliers for affordable vaccines.
DCVM look forward to supplies and markets in developed world:
- Will have to overcome challenges and would need partnerships/collaborations with scientific community and Big Pharma to address issues of access, IP.
-Support from international agencies/foundations in terms of funding and advocacy.
The Facts
1 in 5 children do not have access to
life-saving immunizations
Vaccines
prevent
2 to 3
million deaths
annually
around
the world $20 can fully
vaccinate a
child against
pneumonia,
diarrhea, polio
and measles
Over 22 million infants remain
unimmunized in the world each
year
Thank You
We have to choose between a global market driven only by calculations of short-term profit,
Or
one which has a human face — Kofi Annan
We at DCVMN believe in second option
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