"How big is it? How fast is it growing?" companies ask. The answers vary by industry segment.
In 1989 China developed and marketed its first genetically engineered drug, recombinant human interferon alpha 1b. This was considered to be the official launch of China's modern biopharmaceutical industry. Since then, China's biopharmaceutical revenue has grown phenomenally—from RMB 1.8 billion (~$230 million) in 1990 to RMB 30.31 million (~$3.88 billion) in 2005. Although these numbers are still small compared with the size of the biotech industry in the West (Amgen's 2005 revenue was $12.4 billion, and is growing at 18%), this growth is greater than 16-fold. Venture capitalists are optimistic about the opportunity this represents, especially considering the country's 1.3 billion population.
China has developed and commercialized 30 biotech drugs and 150 more biopharmaceutical products are in the pipeline. Over the next five years, 40 new "Class 1" innovative biopharmaceuticals are expected to complete clinical trials and enter the market. "Class 1" refers to innovative biological products that have never been marketed in any country before, according to China's State Food and Drug Administration (SFDA).
The Chinese biopharmaceutical industry is beginning to establish itself as a research-driven, domestic, market-oriented industry. Meanwhile, China is also emerging as a global outsourcing hub for many overseas biopharmaceutical companies, especially those in the United States and Europe.
However, as companies continue to grow their business in China, a number of issues need to be resolved, including biogenerics versus innovative discoveries, intellectual property protection, quality and regulatory oversight, access to venture capital, and enterprise management.
BIOGENERIC MANUFACTURING PROVIDES THE FOUNDATION
Based on the enormous domestic need for biologics, public health policy in China established biogeneric manufacturing as a cornerstone of China's biopharmaceutical industry. As the Western world argued about the definition and legality of biogenerics, the Chinese industry quietly thrived, driven by a relatively liberal regulatory environment and a huge domestic market demand.