CCM Data & Primary Intelligence
Future of Red Biotechnology in China
The First Edition
Prepared by:
Guangzhou CCM Information Science & Technology Co., Ltd. Guangzhou, P. R. China
April 2010
Copyright by Guangzhou CCM Information Science & Technology Co., Ltd. (P. R. China) Any publication, distribution or copying of the content in this report is prohibited. Website: http://www.cnchemicals.com Tel: +86-20-3761 6606 Fax: +86-20-3761 6968 Email: econtact@cnchemicals.com
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CCM Data & Primary Intelligence Description: Red biotechnology (RB) refers to the biotechnology applied in pharmaceutical production and it has become the most important part in biotechnology industry. About 60% of achievements in biotechnology in the world are applied in production of bio-pharmaceuticals. At present, RB products mainly include gene recombinant drugs, blood products, vaccines, diagnostic reagents, etc. What is the current production situation of different RB products in China? Driven by its substantial environmental or economic benefits, China’s RB industry has witnessed fast development and has played an increasingly important role in Chinese economic growth. However, the overall development of China’s RB industry remains in growth stage, and still has an enormous gap compared with developed countries. What is the future trend of Chinese RB industry development? What are the relevant supporting policies on Chinese RB industry? What have been the popular cutting-edge technologies in China in recent years? Where are the investment opportunities and what is the investment mode in China? What is covered in this report? - Overview of China’s red biotechnology; - Detailed analysis of each sub-categories of red biotechnologies in China: gene recombinant drugs, blood products, vaccines, diagnostic reagent, etc., in terms of market data, major players, technical suppliers, technologies or R&D situations; - Future prospects of each category of red biotechnologies, with key influencing factors and commercial opportunities - Profiles of major players and research institutes - Related policies and regulations What benefits will you get? - Gain a clear understanding about the industry landscape and latest developments in R&D, production, technology advancement and future trends in China’s red ⎫biotechnology; - Keep informed of the precise development situation of key RB products with basic data and latest info; - Gain reasonable and constructive suggestions on market opportunities in China’s RB fields; - Figure out, current trend and future growth prospect of red biotechnology in China; - Know more about how innovative players and research groups are carrying out innovation, collaboration and achieving commercial success in China.
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CCM Data & Primary Intelligence Main content: No.
Content Executive summary Methodology & sources I Overview of red biotechnology in China Introduction to red biotechnology Role of red biotechnology in medicine industry Overview of red biotechnology development II Development environment of red biotechnology in China II-1 Macro economic environment II-2 Policy environment II-3 Medicine industry development II-4 Venture capital III Market segments of red biotechnology industry in China III-1 Gene recombinant drugs ErythropoietinďźˆEPO III-1.1 III-1.2 Insulin III-1.3 G-CSF III-1.4 Rh-GH III-1.5 Interferon III-1.6 Anti-tumor monoclonal antibody III-2 Blood products III-3 Human vaccines III-4 Diagnostic reagent III-4.1 Diagnostic reagent history in China III-4.2 Current production situation in China III-4.3 Producers information of Chinese diagnostic reagent III-4.3.1 Biochemical diagnostic reagent III-4.3.2 Immunodiagnostic reagent III-4.3.3 Molecular diagnostic reagent III-4.3.3.1 PCR reagent III-4.3.3.2 Biochips III-4.4 Forecast III-5 Other red biotechnology based drugs III-5.1 Antibiotic III-5.1.1 Current antibiotic production in China III-5.1.2 Penicillin production technology III-5.1.3 Waste treatment technology III-6 Forecast on supply & demand to the next 5~10 years III-6.1 Forecast on gene recombinant market during 2010~2020 III-6.1.1 Supply of gene recombinant drugs during 2000~2020 III-6.1.2 Demand for gene recombinant drugs during 2009~2020 III-6.1.3 Difference between demand and supply during 2009~2020 Website: http://www.cnchemicals.com Tel: +86-20-3761 6606
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CCM Data & Primary Intelligence III-6.2 III-6.2.1 III-6.2.2 III-6.2.3 III-6.3 III-6.3.1 III-6.3.2 III-6.3.3 III-6.4 III-6.4.1 III-6.4.2 III-6.4.3 IV IV-1 IV-2 IV-3 IV-4 V V-1 V-2 V-3 V-3.1 V-3.2 V-3.3 V-3.4 V-3.5 V-3.6 V-3.7 V-4 VI VI-1 VI-2 VI-2.1 VI-2.2
VI-2.3 VI-2.4 VI-2.5 VI-2.6
Forecast on blood product market during 2010~2020 Supply of blood products during 2005~2020 Demand for blood products during 2009~2020 Difference between demand and supply during 2009~2020 Forecast on human vaccine market during 2010~2020 Supply of human vaccines during 2005~2020 Demand for human vaccines during 2009~2020 Difference between demand and supply during 2009~2020 Forecast on diagnostic reagent market during 2010~2020 Supply of diagnostic reagents during 2005~2020 Demand for diagnostic reagents during 2009~2020 Difference between demand and supply during 2009~2020 Cutting edge technology development in China Stem cell treatment Monoclonal antibody Diagnostic reagent Vaccine Geographical distribution of China’s red biotechnology industry Regional distribution Introduction to RB industrial clusters Overview of major RB industrial bases Changsha Natioanl Biomedical Industrial Base Zhangjiang National Biomedical Industrial Base Zhongguancun National Biomedical Industrial Base Shenzhen National Biological Industry Base Changchun National Biological Industry Base Guangzhou National Biological Industry Base Shijiazhuang National Biological Industry Base Forecast on national biological industry base in the next 5~10 years Analysis of main Chinese companies in red biotechnology Choice of main Chinese companies in red biotechnology industry Analysis on main Chinese companies in red biotechnology industry Company engaged in biotech drugs - Shanghai FOSUN Pharmaceutical (GROUP) Co., Ltd. Companies engaged in blood products - Shanghai RAAS Blood Products Co., Ltd. - Hualan Biological Engineering, Inc.. Company engaged in vaccine - Beijing Tiantan Biological Products Co., Ltd. Company engaged in bio-engineering drugs - Beijing SL Pharmaceutical Co., Ltd. Company engaged in antibiotics - Shandong Lukang Pharmaceutical Co., Ltd. Company engaged in diagnostic reagents
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CCM Data & Primary Intelligence VII VII-1 VII-1.1 VII-1.2 VII-1.3 VII-1.4 VII-2 VII-3 VII-3.1 VII-3.2 VII-3.3 VIII VIII-1 VIII-1.1 VIII-1.2 VIII-2 VIII-2.1 VIII-2.2 VIII-2.3 IX IX-1 IX-1.1 IX-1.2 IX-1.3 IX-1.4 IX-2
- Shanghai Kehua Bio-Engineering Co., Ltd. Main foreign involvement in China’s red biotechnology Foreign companies in China GlaxoSmithKline (China) Co., Ltd. Pfizer (China) Co., Ltd. Novartis (China) Co., Ltd. Sanofi Pasteur (China) Co., Ltd. Comparison of foreign companies and Chinese companies Forecast on foreign involvement in China in next 5~10 years Forecast on Novartis expansion in China Forecast on GSK expansion in China Forecast on Sanofi-aventis expansion in China Analysis of investment in the next 5 years Investment opportunities in biopharmaceutical industry Solid foundation of bio-pharmaceutical investment Investment hotspots in China Risk analysis of the investment in China’s red biotechnology Risk from international environment Risk from domestic environment Estimation of bio-pharmaceutical investment risk in the next 5 years Profiles of key players in China Companies Gene recombinant drugs Blood products Vaccine Diagnostic reagent Research institutes
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Executive summary: After about thirty years’ development, China has scored great achievement in red biotechnology (RB). More and more pharmaceuticals are produced by biotechnology. The increasing use of red biotechnology in pharmaceutical production have generated both economic and environmental benefits. Bio-pharmaceuticals are capturing relatively small market share, with its output value accounting for around XX% of China’s medicine industry in 2008. However, bio-pharmaceuticals have great development potential and the growth rate of its output value was higher than that of chemical medicines and Chinese medicines, with CAGR of XX% in 2004-2009. In 2009, China’s industrial output value of RB products was around USDXX million, up XX% over previous year.
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CCM Data & Primary Intelligence - Major bio-pharmaceutical products in China Gene recombinant drugs In China, the first recombinant DNA protein drug,α-interferon, was produced by Shenzhen Kexin Biotech Co., Ltd. Up to XX genetically engineered drugs had been developed in China, and the total market value reached USDXX billion. EPO, interferon, CSF, growth hormone and insulin are the main gene recombinant drugs in China. With requirements for high-level production technology, there are only a few growth hormone manufacturers in China. But there are more than XX manufacturers in China for other products like EPO, interferon and CSF and the competition has been relatively intense. Blood products After more than ten years’ development, currently China's blood products have been closed to or reached the international level. Blood products include more than 20 kinds of products, such as human albumin, immunoglobulin, coagulation factor, etc. In China, comprehensive utilization rate of plasma has been low and main blood products in China are human albumin at present. Human vaccines Currently, China is the largest vaccine producer in the world, with the most vaccine manufacturing enterprises. Lost of the enterprises are private ones. At present, there are around XX human vaccine manufacturers in China. They can produce about XX species of vaccines to prevent XX species of infectious diseases. In recent years, China’s human vaccines output has been more than XX million doses. Diagnostic reagent Diagnostic reagent can be mainly divided into three categories, biochemical diagnostic reagent, immunodiagnostic reagent and molecular diagnostic reagent. Chinese diagnostic reagents industry has been so thriving. Its output value increased from
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CCM Data & Primary Intelligence USDXX million in 2005 to USDXX million in 2009, with CAGR XX% during this period. - Production technology At present, stem cell treatment, monoclonal antibody, diagnostic reagent and vaccine are the four most important research areas of red biotechnology in China. In recent years, many Chinese bio-pharmaceutical companies have swarmed to use the foreign technologies once their patens expired, to chase the immediate profits. These companies always copy each other’s technologies. Without self-innovation, Chinese bio-pharmaceutical industry still lags behind foreign countries. Some Chinese bio-pharmaceutical companies have realized these problems and started searching ways for development of domestic bio-pharmaceutical industry. The most popular way is bio-pharmaceutical manufacturer cooperating with biotechnology companies to reduce risk and investment. The manufacturers outsource the R&D of new products, so they can focus more on their products’ sales and promotion. - China’s red biotechnology industry distribution Owing to the late start-up, bio-pharmaceutical enterprises, most of which are small-scale, are scattered throughout the country. There are relatively more bio-pharmaceutical enterprises distributed in Yangtze River Delta region, the Pearl River Delta Region, North China, Central and Western regions. Total output value of top 4 production provinces, including Shandong, Jilin, Jiangsu and Henan, reached USDXX million in 2008, accounting for XX% of the national total.
Character of CCM' Report: The aim of this report is to provide powerful assistance to the strategy group and the management team in making correct decision as how to penetrate the ever-increasing China market and how to catch the maximum commercial opportunities. The report is formulated independently by CCM’s professional market researchers, based on the first-hand and primary data which are analyzed by scientific methodology, confirmed with both manufacturers/end users/traders and legal authorities, and presented in a logic way. Sample pages：
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I Overview of red biotechnology in China - Introduction to red biotechnology Biotechnology has developed fast in the past decades around the world. It mainly includes pharmaceutical
biotechnology
(red
biotechnology),
industrial
biotechnology
(white
biotechnology), agricultural biotechnology (green biotechnology), marine biotechnology, etc. ……………… - Role of red biotechnology in medicine industry Compared with the entire pharmaceutical industry and other sub-industries, such as chemical medicines and Chinese medicine, bio-pharmaceutical accounts for very small proportion. Its output value constituted only around XX% of the total of China’s medicine industry in 2008. However, its development potential is very great. Its output value growth rate was higher than that of chemical medicines and Chinese medicines, with CAGR of XX% in 2004-2009. In 2009, RB products industrial output value was around USDXX million, up XX% year on year in 2008. …………….. ¾
Manufacturers
Though demand for human albumin exceeds supply, the facts that lack of raw materials and their price increase, as well as increasing mergers and acquisition, force some blood product manufacturers to suspend their human albumin production and the number of active ones decreased during 2004-2007. In recent two years, there have been XX active human albumin producers in China. Production scale of most of them are small and only several manufacturers have plasma processing capacity over XXt/a. ………………. Table III-2-1 Some major human albumin manufacturers in China, 2010 No.
Company
Plasma processing cap. (tonne)
1
Hualan Biological Engineering Inc.
XX
2
Shandong Taibang Biological Products Co. Ltd.
XX
3
Chengdu Rongsheng Pharmaceuticals Co., Ltd.
XX
4
Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.
XX
5
Shanghai RAAS Blood Products Co., Ltd.
XX
6
Shanghai Institute of Biological Products
XX
7
Guiyang Qianfeng Biological Products Co., Ltd.
XX
Source: CCM International
Some blood products manufacturers have been listed in China, such as Hualan Biological,
Shanghai RAAS, Tiantan Biological, etc. In 2008, the sales income of Hualan Biological and Shanghai RAAS were USDXX million and USDXX million respectively. And Hualan Biological’s sales income increased to USDXX million in 2009. …………….. Chinese producers are generally small-scale compared with foreign enterprises. Few of them can achieve annual sales for diagnostic reagent of more than or close to USDXX million. Less than XX producers can obtain annual diagnostic reagent sales of more than USDXX million. The average profit rate has been low due to the price war induced by cutthroat competition and copying the technology from each other, etc. Average profit rate has decreased from XX%-XX% to XX%-XX% in the past 5 years. Table III-4.3.1 Major diagnostic reagent producers in China, 2008 Type of No.
Company
Abbreviation
Output value, Product
Company
USD million Biochemical diagnostic reagent,
Shanghai Kehua Bio-engineering Co.,
Shanghai
Ltd.
Kehua
1
A share listed
Immunodiagnostic reagent,
XX
Molecular diagnostic reagent Da An gene Co., Ltd. of Sun Yat-Sen 2
Immunodiagnostic reagent, Da An gene
University
Molecular diagnostic reagent XX
Biosino Bio-technology and science 3
XX
A share listed
Biosino
H share listed
Biochemical diagnostic reagent
InTec Products, Inc.
InTec
American owned
Immunodiagnostic reagent
Shanghai Fosun Pharmaceutical
Shanghai A share listed
Biochemical diagnostic reagent
inc. 4 5 Group Co., Ltd.
Fosun
Sino-American Biotechnology
Sino-American
6
XX
Immunodiagnostic reagent,
XX
American owned Company
Biotechnology
Molecular diagnostic reagent Biochemical diagnostic reagent,
7
XX
Livzon Pharmaceutical Group Inc.
Livzon
A share listed
XX
Immunodiagnostic reagent, Molecular diagnostic reagent
8
Shenzhen PG Bioengineering Co., Ltd
Source: CCM International
Shenzhen PG
Germany owned
Molecular diagnostic reagent
XX