India and China's biogeneric and vaccine strengths
Today many biotechnology analysts are pointing to China and India as becoming strategically important for biotechnology growth and investment. For the forseeable future the strength of Indian and Chinese biotechnology will be confined to the area of generics and vaccines where they have already established some strengths.
According to a report by KPMG Indian firms accounted for 22 per cent of the global generics market in 2006. The Indian and Chinese strength in the generics market could prove important at a time when many biotechnology drugs and products are coming off patent. During the period 2002 to 2004 20 biotechnology drugs lost their patent and in 2005 the patents of 13 US biotechnology products expired. IMS Health estimated that some $16 billion worth of annual drug sales were expected to go off-patent in 2007, down from $23 billion in 2006. Regulation of the biogenerics industry is still in its infancy and the European and American biogenerics industry is still relative small, which also opens up opportunities for Indian and Chinese companies in this space.
There are currently more than 400 biogeneric manufacturers in China geared towards developing and manufacturing generic biopharmaceuticals (recombinant products, such as interferon series, colony-stimulating series, erthyopoietin, insulin, growth hormone, interleukin-2; and various vaccines, blood products, antibodies and diagnostic products) according to the analysts Eliza Yibing Zhou and Eric Eric Langer writing in International BioPharm. By 2006 these companies had marketed 361 recombinant biogenerics (including therapeutics and vaccines). Intitally intended for the domestic population these drugs are now also going abroad. In 2005 China exported $478 million of these drugs to foreign countries, an increase of 54% from 2004.
Private Chinese companies active in the biogenerics space include nine biopharmaceutical generic companies: Guangxi Beisheng Pharmaceuticals, based in Beihai City; Shenzhen Kexing Biotech, founded in Shenzhen Science and Industry Park in 1989); Beijing SL Pharmaceutical; Hangzhou Jiuyuan Gene Engineering; Tianjin Hualida Biotechnology, started in 1992, now partially owned by Teva Pharmaceuticals; Xiamen Amoytop Biotech, established in 1996; Shenyang Sunshine Pharma, established in 1993; and Anhui Anke Biotechnology, based in Hefei National New and High Technology Industries Development Zone; Hualan Biological Engineering, initiated in 1992 and located in Xinxiang; six biotechnology companies: Beijing Tri-Prime Genetic Engineering, one of China's first biotechnology companies, established in 1992; Changchun ChangSheng Gene, founded in 1994 and located in High & New Technology Development Zone of Changchun City; Changchun GeneScience Pharmaceuticals, created by a former Genentech researcher in 1997 based in Changchun High-Tech Development Zone; Sinovac Biotech, also known as Beijing Kexing Bioproducts, based in Beijing; Beijing Tiantan Biological Products Corporation, listed on the Shanghai Stock Exchange; and NCPC Genetech Biotechnology, a joint venture between North China Pharmaceutical Group Corporation and Maui Biotechnology Development Company; and three state sponsored pharmaceutical companies under the umbrella of the China National Biotec Corporation: Changchun Institute of Biological Products, founded in 1935; Shanghai Institute of Biological Products, founded in 1949 and Chengdu Rongsheng Pharmaceuticals; and Wuhan Institute of Biological Products, established in 1950.
In India the following companies active in the biogenerics space include: Serum Institute of India established in 1961 and Reliance Life Sciences founded in 2001 by The Reliance Group, the largest private sector company in India (oil, gas, refining, petrochemicals and textiles); biopharmaceutical generic companies: Dr Reddy's Laboratories, established in 1984; Ranbaxy Laboratories, the tenth largest generics pharmaceutical company in the world; Wockhardt, with headquarters in Mumbai and established in the 1960s; Natco Pharma, started 1981 and based in Hyderabad; Panacea Biotech, established in 1984; Zenotech Laboratories; Intas Biopharma, based in Ahmedabad; and a number of biotechnology companies such as India's top biotechnology comapny Biocon, established in 1978; Shantha Biotech of Hyderabad, established 1993; Bharat Biotech of Hyderabad; and BV Biocorp, the biotech drug research division of Pune-based poultry major Venkateswara Hatcheries group.
China and India could make inroads into the biotechnology vaccine market following the acceptance of biogenerics by the EC and the USA. Both countries have a growing presence in the field, particularly in vaccines. An article in Genetic Engineering News reported that the Indian vaccine market grew 18.64% in the years 2003-2004, accounting for 47% of the total biopharma segment with sales of US$253 million. Dominant players in India include Shantha Biotechnics; Serum Institute of India; Bharat Biotech; Baharat Serums and Vaccines; Biological E; Indian Immunologicals and Panacea Biotech. According to the analyst Eliza Yibing Zhou from BioPlan Associates China is the largest vaccine manufacturing country in the world today, who attributes its fast growth to the outbreak of SARS in 2003, avian flu and the spread of hepatits B in China. Currently China has more than 30 vaccine manufacturers who have the ability to make 41 vaccines to prevent 26 viral diseases and is producing eight of the world's top ten genetically engineered drugs or vaccines. Chinese companies active in this space include many of those involved in biogenerics such as Sinovac Biotech; Beijing Tiantan Biological Products Co Ltd ; Shenzhen Neptunus Interlong Biotech; and others such as Changchun BCHT Pharma; Anhui Biochem Pharma and Changchun Changsheng Life Sciences Ltd.
How far China and India will be able to push their strengths in the biogenerics and vaccine market and penetrate the European and American markets in the future will be greatly dependent on the degree to which they adhere to international standards of good manufacturing and clinical standards. Concerns about corruption in the Chinese State Food and Drug Administration and a growing number of counterfeit drugs being shipped from China will not reassure the wider world in the near future about the safety of biogenerics and vaccines being developed in places like China and India. In March 2007 Peter Pitts the President of the American Center for Medicine in the Public Interest and a former Associate Commissioner of the Food and Drug Administration reported that US customs agents intercepted more than 50 shipments of counterfeit Tamiflu, the antiviral drug being stockpiled in anticipation of a bird flu pandemic. The packages were written in Chinese and none of the drugs had any of Tamiflu's active ingredients.
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