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Research Report on Global and China Monoclonal Antibody Industry, 2013-2017

August 2013 | 50 pages | ID: R5C090EE893EN
China Research and Intelligence Co., Ltd.

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Antibody drugs are usually generated from monoclonal antibody through genetic engineering, with the advantages of strong targeting, few side effects, etc. With rather promising application prospect in clinic treatment, antibody drugs are mainly applied in curing diseases like tumour, immune system and so on. In terms of the global market, antibody drugs account for over 40% of the entire biotech drug market and the market share still keeps increasing. Antibody drugs have become one of the most important parts of biotech drugs and monoclonal antibody drugs are even star products of antibody drugs. Among the top 10 best-selling drugs in 2012, six of them were monoclonal antibody drugs with each annual sales value exceeding USD 5 billion.

In recent years, the market scale of monoclonal antibody drugs increased rapidly. In 2012, the global sales value of monoclonal antibody preparation exceeded USD 50 billion. Among that, Roche (plus Genentech) was the leading monoclonal antibody enterprises, which possessed seven products sold in the market including Avastin, Herceptin, Rituximab, etc. In 2012, its sales value of monoclonal antibody products reached USD 20 billion. Mono-antibody drugs will become the main force promoting the development of biological drugs in the next few years.

In recent years, China bio-pharmaceuticals industry develops rapidly, but antibody drugs lag far behind the average international level with sales value being less than 3% of biological drug share. At present, China antibody drug market is still in the initial stage. However, with Shanghai CITIC National Health Pharmaceutical Co., Ltd. and Biotech Pharmaceutical Co., Ltd. releasing humanization products, product types of domestic antibody drugs will enter the upgrading stage. Although domestic full humanization products have not been released, humanization products and full humanization products will become the domestic trend of monoclonal antibody products in the future.

Monoclonal antibody still belongs to high-end products in China market, which mainly depends on import. In 2012, the market scale of monoclonal antibody was only over CNY 2 billion, which accounted for less than 1% of the global market share but the growth rate was rather high. Roche is the largest winner in China monoclonal antibody market with the market shares of its Rituximab and Trastuzumab being the largest. Merck and Novartis also occupy rather large market shares. Take Rituximab and Trastuzumab that were produced and sold by Roche at an earlier time for instance, their sales values in sample hospitals were only CNY 17.70 million and CNY 2.70 million respectively in 2003, which increased to CNY 590 million and CNY 530 million in 2011. In 2012, the sales value of Etanercept produced by China native enterprises exceeded CNY 400 million, with net profit approximating CNY 200 million and profit margin far exceeding that of other biological drugs. Currently, China domestic monoclonal antibody drugs are still in the initial stage and only nine kinds of drugs have been sold in the market. Most drug varieties that are in clinical study or have been sold are complete copies of products sold overseas with rather low production level and small scale, which restricts the domestic development of monoclonal antibody drugs. Facing huge market space, many pharmaceutical enterprises have already entered monoclonal antibody drug field, such as Shanghai CITIC National Health Pharmaceutical Co., Ltd., Zhejang Hisun Pharmaceutical Co., Ltd., Livzon Pharmaceutical Group Inc., Shanghai Fosun Pharmaceutical (Group) Co., Ltd., etc.

Since 2011, Chinese government has issued many documents to support the development of biological drugs. In January 2012, China MIIT issued the "12th Five-Year Plan" Development Plan of Medical Industry; in July 2012, Chinese State Council released the "12th Five-Year Plan" Development Plan of National Strategic Emerging Industries; in January 2013, Chinese State Council launched the 12th Five-Year Plan on Biology Industry Development. In terms of listed enterprises, the " industrialization of annually producing 3.2 million injections of Anbainuo" of Zhejang Hisun Pharmaceutical Co., Ltd. has already been listed in the special fund plan of emerging industry development, getting CNY 40 million subsidy from the government.

Monoclonal antibody market develops rapidly in recent years with constant introduction of new varieties, so the market share of each drug is also changing constantly. CRI predicts that new varieties will constantly come to market and the market structure will be further adjusted in the next few years. Monoclonal antibody products will be more widely applied in clinic and the influence on cancer treatment and the markets of related fields will become increasingly obvious. CRI predicts that the annual market scale of China monoclonal antibody market will exceed CNY 10 billion by 2017.

Through this report, readers can acquire the following information:
  • Supply and Demand of Monoclonal Antibody Drugs in China
  • Research and Development of Monoclonal Antibody Drugs in China
  • Major Monoclonal Antibody Enterprises in China Market
  • Popular Products in China Monoclonal Antibody Market
  • Forecast on China Monoclonal Antibody Market
The Following Enterprises and People are Recommended to Purchase This Report:
  • Biopharmaceutical Manufacturing Enterprises
  • Biopharmaceutical Trading Enterprises
  • Medical Institutions
  • Investors and Research Institutes Concerned About Biopharmaceutical Industry

1.1 Definition
1.2 Classification
1.3 Preparation Process of Monoclonal Antibody
1.4 Development Course of Monoclonal Antibody
  1.4.1 Rapid Development of Monoclonal Antibody Drugs
  1.4.2 Future Development Direction
1.5 Characteristics of Monoclonal Antibody Drugs
  1.5.1 Major Clinical Application
  1.5.2 Advantages of Monoclonal Antibody Drugs
1.6 Problems of Monoclonal Antibody Drugs
  1.6.1 Safety
  1.6.2 Cost


2.1 Rapid Development of Global Monoclonal Antibody Market
2.2 High Market Concentration Rate
2.3 Development Trend


3.1 Market Overview
  3.1.1 Imported Products
  3.1.2 Monoclonal Antibody Products Produced by China Native Enterprises
  3.1.3 Market Scale of Monoclonal Antibody in China.
3.2 Monoclonal Antibody Products Under Research and Development in China
3.3 Opportunities of Monoclonal Antibody Enterprises in China
  3.3.1 Huge Market Potential
  3.3.2 Several Expired Patents
  3.3.3 Products Expected to Be Exported
3.4 Problems of Monoclonal Antibody Enterprises in China
  3.4.1 Barriers of Technology and Funds
  3.4.2 Poor Competitiveness of China Native Enterprises
  3.4.3 Few Varieties of Products on the Market and Follow-up Products


4.1 Shanghai Lansheng National Health Pharmaceutical Co., Ltd.
  4.1.1 Shanghai CITIC National Health Pharmaceutical Co., Ltd.
  4.1.2 Shanghai Zhangjiang Biotechnology Co., Ltd.
4.2 Baitai Biological Pharmaceutical Co., Ltd.
4.3 Chengdu Huasun Biotechnology Co., Ltd.
4.4 Zhejang Hisun Pharmaceutical Co., Ltd.
4.5 Shenzhen Accord Pharmaceutical Co., Ltd.


5.1 Forecast on Market Scale
  5.1.1 Antitumor
  5.1.2 Immune System Treatment
  5.1.3 Anti-inflammation
5.2 Recommendation on Development of China Monoclonal Antibody Market
  5.2.1 Seizing Opportunities
  5.2.2 Technology Innovation
  5.2.3 Reducing Costs


Chart Global Development Course of Monoclonal Antibody
Chart Forecast on Market Scale of Global Monoclonal Antibody, 2008-2017
Chart Market Scale of China Monoclonal Antibody, 2007-2012
Chart Catalogue of Imported Monoclonal Antibody Products in China Market
Chart Catalogue of Domestic Monoclonal Antibody Products in China
Chart Some Monoclonal Antibody Products Under R&D in China
Chart Major Monoclonal Antibody Products with Patents Expired in the Next Decade
Chart Forecast on Market Scale of Monoclonal Antibody in China, 2013-2017

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