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Inside the numbers
According to BioPlan's recently released Top 1000 Global Biopharmaceutical Manufacturing Index, China holds 8.5% of the global concentration of capacity and employment, India 8.0%, and Japan and other Asian countries 9.2%; these areas are growing more rapidly in biomanufacturing capacity than the global average. Asia-Pacific has one of the largest concentration of global biopharmaceutical manufacturing capacity (2). Asia's combined share of 25.7% of global concentration of capacity and employment virtually matches Europe's share at 26.2% and is gaining on North America's share of 37.5%. These results show that the biopharmaceutical industry is becoming increasingly international in scope and is beginning to move away from its exclusively US and European focus as larger manufacturers locate in emerging markets to support regional markets and provide backup manufacturing for products in major markets. The BioPlan study suggests that biopharmaceutical research and development, both for biosimilars and innovative products, is increasing in China, India, Russia, and select emerging markets (2).
Also, many large Chinese and Indian companies are developing commercial-scale biopharmaceutical manufacturing facilities to serve domestic and regional needs. This trend is evident in vaccine manufacturing. An important development occurred earlier this year in March, when the World Health Organization (WHO) reported that China's State Food and Drug Administration was shown to comply with international standards for vaccine regulation. With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for WHO prequalification of specific products. Prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety, and efficacy, is a prerequisite for manufacturers to supply to countries through UN procuring agencies (3).
Along with biopharmaceutical manufacturing growth in Asia comes opportunity for vendors, such as providers of equipment and consumables. The BioPlan study shows that more than half of respondents specifically sell to India and China, and 38.7% of all vendors sell in other Asian markets (2).
Eric Langer is president of BioPlan Associates, tel. 301.921.5979, firstname.lastname@example.org
1. BioPlan Associates, 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations (Rockville, MD), April 2011.
2. BioPlan Associates, Top 1000 Global Biopharmaceutical Facilities Index, www.top1000bio.com/index.asp, accessed June 20, 2011.
3. WHO, "China's State Food and Drug Administration Gets WHO Approval for Vaccine Regulatory System" Press Release, Mar. 1, 2011.