China Monoclonal Antibody Industry Report, 2010-2011
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China has been engaging in the R&D of monoclonal antibody industry for a long time, but still lags far behind the European and American countries in terms of industrialization. In 2010, the market scale of monoclonal antibody drugs in China was no more than around USD340million, while the global sales in the same period hit USD44billion.

Restricted by high technical threshold and the need of huge capital, only a few Chinese enterprises can realize industrialized production of monoclonal antibody drugs. Presently, there are around 10 monoclonal antibody drug manufacturers that have carried clinical trials in China, but only some including Shanghai CP Guojian Pharmaceutical, Beijing Biotech Pharmaceutical Company, Chengdu Huasun Group and Shanghai Meien Biotechnology have launched their products into the market. As of May 2011, a total of 17 monoclonal antibody drugs were approved by SFDA and rolled out into the market, among which, nearly 60% were the imported products.

Monoclonal Antibody Drugs Approved for being Launched in Chinese Market as of 2011
201107002.gif
Source: SFDA; ResearchInChina

Currently, the monoclonal antibody product with the highest value of drug use is Roche’s Rituximab which was introduced to China in 2000, and its market shares in the first three quarters of 2009 reached 36.6%. Another leading monoclonal antibody drug of Roche, Trastuzumab accessed into Chinese market late, but its market share keeps rising in the recent years, and it swept a 22.7% market share in the first three quarters of 2009. In addition, Merck’s monoclonal antibody drug Cetuximab gets used for curing colorectal cancer, and the market shares of this drug got to 22.2%.

The monoclonal antibody market is mainly dominated by the imports, but China’s monoclonal antibody drug sales grows significantly as Shanghai CP Guojian Pharmaceutical and Biotech Pharma have launched its own humanized products with price superiority. For instance, Biotech Pharma’s Nimotuzumab, rolled out into the market only in two years, obtained the sale of over RMB100 million in the second year after being launched in the market.
 
Since monoclonal antibody drugs are supported by national policies, Chinese pharmaceutical companies such as Fosun Pharma, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Hisun Pharmaceutical, SL Pharmaceutical, Kanghong Pharmaceutical, Shenzhen Accord Pharmaceutical, Livzon Pharmaceutical Group, etc are also planning to make more projections into the R&D of monoclonal products. In July of 2010, Fosun Pharma announced in Shanghai its joint funding with the international pharmaceutical corporation Chemo to build up the monoclonal antibody drug project, with the total investments approximating RMB500 million as estimated. Livzon Pharmaceutical plans to associate with its shareholder JoinCare to make joint funding for establishing a monoclonal antibody bio-technology company.
1. Overview of Monoclonal Antibody Industry
1.1 Definition
1.2 Classification
1.3 Technological Development

2. Development Environment 
2.1 International Environment
2.2 Policy Environment
2.3 Industry Environment

3. China’s Monoclonal Antibody Industry Market
3.1 Status Quo
3.2 Market Size
3.3 Supply & Demand
3.4 Competition Pattern
3.5 Prospects
3.5.1 Huge Development Space 
3.5.2 Development Trend of Monoclonal Antibody Drugs: All Humanized Antibody
3.5.3 Expanding Indications of Available Monoclonal Antibody Drugs 
3.5.4 Active R&D 

4. Market Segments in China
4.1 Rituxan
4.2 Herceptin
4.3 Erbitux
4.4 Nimotuzumab
4.5 Etanercept

5. Key Manufacturers Worldwide 
5.1 Roche
5.1.1 Profile
5.1.2 Business in China
5.1.3 Genentech
5.2 Johnson & Johnson
5.2.1 Profile 
5.2.2 Monoclonal Antibody Business
5.2.3 Development Outlook 
5.2.4 Business in China
5.3 Merck
5.3.1 Profile
5.3.2 Monoclonal Antibody Business
5.3.3 Business in China
5.4 Novartis
5.4.1 Profile
5.4.2 Monoclonal Antibody Business
5.4.3 Business in China
5.5 Abbott
5.5.1 Profile
5.5.2 Monoclonal Antibody Business
5.5.3 Business in China

6. Key Manufacturers in China
6.1 Shanghai Lansheng States Kin Pharmaceutical Co., Ltd.
6.1.1 Profile
6.1.2 Shanghai CP Guojian Pharmaceutical Co., Ltd.
6.2 Biotech Pharmaceutical Co., Ltd. (BPL)
6.2.1 Profile 
6.2.2 Competitive Edge
6.2.3 Prospects
6.3 Chengdu Huasun Group Inc., Ltd.   
6.3.1 Profile
6.3.2 Operation
6.3.3 Products
6.4 Shanghai Meien Biotechnology Co., Ltd.
6.4.1 Profile
6.4.2 Products
6.5 Shanghai Asia United Antibody Medical Co., Ltd
6.5.1 Profile
6.5.2 Products
6.6 Zhejiang Hisun Pharmaceutical Co., Ltd.
6.6.1 Profile 
6.6.2 Operation
6.6.3 Prospects 
6.7 Shenzhen Main Luck Pharmaceuticals Inc. 
6.8 Beijing Mabworks Biotech Co., Ltd.
6.8.1 Profile 
6.8.2 Antibody Application Products
6.8.3 Antibody Products amid R&D
6.9 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. 
6.9.1 Profile 
6.9.2 Operation
6.9.3 Development 
Applications and Proportions of Monoclonal Antibody in Recent Years
Development Process and Major Events of Monoclonal Antibody
Sales of Monoclonal Antibody Drugs in the World, 2007-2010 
M&A Events Related to Monoclonal Antibody of Biological Product Enterprises Worldwide, As of 2011 
Availability Time of the World's Leading Monoclonal Antibody Drugs and their Sales in 2010  
Innovation Funds for Bio-Industry from the 9th to the 12th Five-Year Plan Periods in China  
Policies Related to Biotechnology Drugs 
Total Industrial Sales and Growth Rate of Biological & Biochemical Products in China, 2008- 2010   
Industrial Bases of Monoclonal Antibody Drugs in China, 2010 
Monoclonal Antibody Drugs Approved for Marketing in China, As of 2011
Sales of Antibody Drugs in China, 2008-2010  
The Purchasing Amount of Main Monoclonal Antibody Drugs in the Typical Hospitals of China’s 22 Cities, 2009 
Causes of Death of Chinese Residents, 2008
Incidence of Malignant Tumor in China, 1993-2008 
Consumption Value Shares of Monoclonal Antibody Drugs, Q1-Q3 2009 
Proportions of Monoclonal Antibody Drugs in Bio-Pharmaceuticals in China and the World, 2008-2010
China's Leading Monoclonal Antibody Drugs under Research, As of 2010
Listed Companies Invested in Monoclonal Antibody Industry in China, 2009-2010
Sales of Rituximab in Sample Hospitals, 2003, 2008 and 2009  
The Purchasing Amount of Rituximab in Typical Hospitals of China’s 3 Major Cities, 2009
Sales and Growth of Trastuzumab (Herceptin) in the World, 2006-2010  
The Purchasing Amount of Trastuzumab in Typical Hospitals of China’s 3 Major Cities, 2009
The Purchasing Amount of Cetuximab in Typical Hospitals of China’s 3 Major Cities, 2009
Sales of Nimotuzumab in China, 2008-2010 
Sales of Etanercept in China, 2006-2010 
The Purchasing Amount of Etanercept in Typical Hospitals of China’s 3 Major Cities, 2009
Revenue and Operating Profit of Roche, 2008-2010 
Major M&A Cases of Roche, 1990-2010
Roche Investment in China
Sales of Major Monoclonal Antibody Products of Genentech in the World, 2007-2010 
Net Sales and Operating Profit of Johnson & Johnson, 2008-2010 
Sales of Infliximab Worldwide, 2007-2010 
Monoclonal Antibody Products of Johnson & Johnson
Sales and Net Revenue of Merck, 2008-2010 
Net Sales and Net Revenue of Novartis, 2008-2010 
Development Process of Pharmaceutical Business of Novartis in China
Net Sales of Abbott, 2007-2010  
Sales of Humira Worldwide, 2007-2010 
Product Line of Major Monoclonal Antibody under Research of Shanghai Lansheng States Kin Pharmaceutical 
Operating Income and Net Income of Shanghai CP Guojian Pharmaceutical, 2008-2010 
Monoclonal Antibody Product Series under Research of Shanghai CP Guojian Pharmaceutical 
Under-research Monoclonal Antibody Projects of BPL
Operating Income and Total Profit of Chengdu Huasun Group, 2007-2010 
Sales and Sales Volume of Metuximab in China, 2007-2010
Liver Cancer Incidence and Death Cases in China and the World, 2000 & 2010 
Operating Income and Gross Margin of Zhejiang Hisun Pharmaceutical, 2001-2010 
Operating Income Structure of Zhejiang Hisun Pharmaceutical by Product, 2010  
Application Antibody Products of Beijing Mabworks Biotech
Under-research Antibody Projects of Beijing Mabworks Biotech
Operating Income and Total Profit of Shanghai Fosun Pharmaceutical (Group), 2008-2010 

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