Table Of Contents
OVERVIEW
Catalyst
Summary
EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor insight into the Chinese vaccines market
Related reports
MARKET OVERVIEW
Key findings
Historic development
Current market situation
In 2009, the Chinese vaccine market was valued at $700m–1,520m, growing at a CAGR of around 15%
More than 1 billion doses of human vaccines were registered and approved by the National Institutes of Food and Drug Control in 2010
According to WHO estimates, 200 million doses of the five main vaccines are distributed in China per year
Regulatory process for vaccines
It takes at least 2 years for an imported vaccine to be approved and launched in China
Domestic vaccine manufacturers have advantages in the approval process with the central and local authorities
The central government has put vaccine development at the heart of its biological products development strategy
New SFDA guidance emphasizes quality and safety as key considerations for vaccine manufacturing
Vaccination recommendations
Vaccines are grouped into two categories in China
Vaccine pricing
Different pricing mechanisms apply to category 1 and category 2 vaccines in China
Prices of category 1 vaccines can fluctuate depending on medical needs
Vaccines from multinational companies enjoy higher prices in China
Local governments have conducted a series of price cuts on Category 2 vaccines
Vaccine reimbursement
NIP vaccines are fully paid for by the government
The human rabies vaccine was the only category 2 vaccine listed on the 2009 version of the NRDL
Vaccine distribution and access
Under new regulations, the number of vaccine distribution sites increased from 143 to more than 700
Vaccination coverage
Official statistics suggest that vaccination coverage is very high in China
In reality, the vaccination coverage for migrant populations and newborns in rural less developed regions is much lower than claimed in the official statistics
KEY COMPANIES ACTIVE IN THE CHINESE VACCINES MARKET
Key findings
Industry overview
More than 50 vaccine manufacturers are registered with the SFDA, with an annual output of more than 1 billion doses
Multinational corporations
GlaxoSmithKline
Sanofi Pasteur
Merck & Co., Novartis, and Pfizer
Local vaccine players
China National Biotec Group
Sinovac
STRATEGIC RECOMMENDATIONS FOR MARKET ACCESS
Key findings
Key future target indications
SWOT analysis of China as a target market for vaccines
Drivers and resistors
Drivers
Resistors
Best strategy for market penetration
BIBLIOGRAPHY
Journal articles
Websites
Datamonitor reports
APPENDIX
Contributing experts
Conferences attended
Report methodology
LIST OF TABLES
Table: Development of the Chinese vaccine industry, 1919–2011
Table: Approved volume of category 1 and category 2 vaccines in China, by type of manufacturer (000s of doses), 2008–10
Table: China: estimated number of vaccine doses distributed for key indications, 20 10
Table: Regulations for the vaccines industry in China, 1982–2011
Table: Examples of category 1 and category 2 vaccines, 2011
Table: Vaccine recommendations and reimbursement status in China, 2011
Table: China: vaccination coverage in different regions
Table: SFDA-registered vaccine manufacturers, 2011
Table: Total number of vaccine doses produced by key multinational vaccine manufacturers’ registered with and approved by the China National Institutes for Food and Drug Control , 2010
Table: GlaxoSmithKline: marketed vaccines in mainland China, 2011
Table: GlaxoSmithKline: pipeline vaccines in mainland China, 2011
Table: Sanofi Pasteur: marketed vaccines in mainland China, 2011
Table: Merck & Co., Novartis, and Pfizer: marketed vaccines in China, 2010
Table: Key local vaccine manufacturers in China, 20 11
Table: China National Biotec Group : human vaccine portfolio, 2011
Table: China National Biotec Group : key vaccine deals and alliances, 2011
Table: Sinovac’s sales breakdown, by product class ($m), 2011
Table: Sinovac markets eight vaccines in mainland China, 2011
Table: Sinovac: pipeline products in mainland China, 2011
Table: Sinovac: key vaccine deals and alliances, 20 11
Table: SWOT analysis of China as vaccine market, 20 11
Table: Summary of the drivers and resistors that will impact the human vaccine market in China, 2011
Table: Main demographic indicators of the two recent nationwide censuses in China, 2005 and 2011
Table: Recent deals and alliances in the Chinese vaccine market , 2009– 11
Table: Vaccines listed on the immunization program of Shanghai municipality, 2011
Table: Number of multinational vaccines listed on the immunization program of Shanghai municipality, 2011
LIST OF FIGURES
Figure: Timeline: key events affecting the Chinese vaccine industry, 1919–2011
Figure: Volume share of state-owned, privately owned, and foreign companies in the category 1 and category 2 vaccine markets in China, 2010
Figure: China: application and approval procedures for imported vaccine, 2011
Figure: SFDA key initiatives in the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines, 2010
Figure: Vaccination schedule in China, 2011
Figure: China: three ways of drug pricing in China, 2010
Figure: Average vaccine prices in China, by type of company, 2009
Figure: Distribution of category 1 and category 2 vaccines in China, 2011
Figure: Vaccination coverage in China, 2006–10
Figure: The five key multinational vaccine players operating in China, 2011
Figure: Number of approved doses of multinational vaccine manufacturers, 2008–10
Figure: Volume share of the approved vaccine doses by the five multinational vaccine manufacturers in China, 2010
Figure: GlaxoSmithKline’s main vaccine operations in China, 2011
Figure: Sanofi Pasteur’s main vaccine operations in China, 2011
Figure: A brief history of China National Biotec Group
Figure: China National Biotec Group: organizational structure and geographic presence, 2011
Figure: A brief history of Sinovac Biotech , 2011
Figure: Sinovac : geographic presence in China , 2011
Figure: Key future target vaccine indications in China, 20 11
Figure: China: population indicators from 1950 to 2050
Figure: The Shanxi vaccine scandal, 2007–10