Global and China Monoclonal Antibody Industry Report, 2013-2017
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Currently, monoclonal antibody agents have been successfully used in the treatment of tumors, cancers and other serious diseases as a heavyweight in the biopharmaceutical industry. In 2009-2012, the market size of monoclonal antibody agents grew at a CAGR of 13%, far higher than the overall growth rate of biopharmaceuticals in the same period. Thanks to robust market demand, approval of new products and new indications as well as launch of monoclonal antibody generic drugs, the global monoclonal antibody market size will ascend by more than 12% in 2013-2017, hitting USD141 billion in 2017.

Driven by enhanced economic level, expanded scope of medical insurance reimbursement, as well as lower prices incurred by intensified competition, Chinese monoclonal antibody market is expected to continue to grow significantly. In 2013-2017, Chinese monoclonal antibody market will grow at 35%, sharing 2.15% of the global monoclonal antibody market in 2017 (0.98% in 2012).

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The global monoclonal antibody industry is still dominated by European and American companies, especially, important monoclonal antibody products are mainly produced by Roche (Genentech), Amgen, AbbVie (Abbott), Johnson & Johnson and other companies. In 2012, the global best-selling Infliximab (Johnson & Johnson), Etanercept (Amgen), Bevacizumab (Roche), Rituximab (Roche), Adalimumab (AbbVie) and Trastuzumab (Roche) stemmed from the above four companies. The global sales (including the sales of third parties) of these six monoclonal antibody agents totaled USD45 billion, accounting for 57.7% of the global.

Propelled by the optimistic market prospect, advancement of monoclonal antibody technologies and the upcoming patent expiration of several key monoclonal antibody agents, the research and industrialization of monoclonal antibody agents has become a global investment highlight, wherein the future market competition will be evident.

In September 2013, the Infliximab generic drug - Inflectra developed by South Korea Celltrion and the U.S. Hospira jointly was launched upon the approval of the EU EMA. In November 2013, the Trastuzumab generic drug developed by the U.S. Mylan and India Biocon together was available in the market under the permit of Drug Controller General Of India. Mylan will sell the product tagged with the brand name Hertraz in India in early 2014.

In addition, India Biocon's first anti-CD6 Alzumab (Itolizumab) for the treatment of chronic plaque psoriasis was approved to be sold in India in August 2013.

In recent years, China monoclonal antibody industry has been developing fast with the market size CAGR of 44.6% in 2010-2012. More than 100 companies have been involved in monoclonal antibody agents, and 10 ones of them have conducted clinical applications. The Chinese market is dominated by Rituximab, Trastuzumab, Infliximab, Bevacizumab and other imported products, all of which occupied 70-75% market share totally in 2012.

However, by virtue of price and geographical advantages, the competitiveness of Chinese local monoclonal antibody products has been gradually improved, such as the competition between Nimotuzumab and Cetuximab. The market share of Merck's Cetuximab in China shrinks and was excluded from top 200 drugs purchased by Chinese typical urban hospitals of 22 cities in 2012 with the value of RMB130 million (down 16.35% year on year).

Meanwhile, the R & D of monoclonal antibody has also made progress. The Adalimumab generic drug developed by Huahai Pharmaceutical and American Oncobiologics jointly was ratified by the EU EMA and the U.S. FDA in December 2013 and the clinical trial Phase I was implemented. The Trastuzumab generic drug of Genor Biopharma was granted with Australian Clinical Preliminary Summary Report Phase I in August 2012 and SFDA's clinical trial approval in July 2013.

The report includes the following content:

20120114.gifStatus quo, market size, competition pattern and development forecast of the global monoclonal antibody industry;
20120114.gif Status quo, market size, competition pattern and development forecast of China monoclonal antibody industry;
20120114.gif Operation, monoclonal antibody business, development in China and R & D of six global and 10 Chinese monoclonal antibody companies.

1 Overview of Monoclonal Antibody Industry
1.1 Definition
1.2 Classification
1.3 Technological Development

2 Overview of Global Monoclonal Antibody Industry 
2.1 Status Quo 
2.2 Market Size 
2.3 Competition Pattern 
2.4 Development Prospect and Prediction
2.4.1 Market Size 
2.4.2 Competition Pattern 
2.4.3 R & D Trend 

3 Chinese Monoclonal Antibody Market 
3.1 Status Quo 
3.2 Market Size 
3.3 Market Segments
3.3.1 Rituximab/Rituxan
3.3.2 Trastuzumab/Herceptin
3.3.3 Cetuximab/Erbitux
3.3.4 Nimotuzumab/Infilixmab
3.3.5 Bevacizumab
3.3.6 Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein
3.4 Competition Pattern 
3.5 Development Prospect 

4 Key Foreign Monoclonal Antibody Agent Enterprises
4.1 Roche Pharmaceuticals
4.1.1 Profile
4.1.2 Operation 
4.1.3 Revenue Structure 
4.1.4 R & D and Investment
4.1.5 Monoclonal Antibody Business (Genentech) 
4.1.6 Business in China 
4.2 Johnson & Johnson 
4.2.1 Profile
4.2.2 Operation 
4.2.3 Revenue Structure 
4.2.4 R & D and Investment
4.2.5 Monoclonal Antibody Business 
4.2.6 Business in China 
4.3 Merck 
4.3.1 Profile
4.3.2 Operation 
4.3.3 Revenue Structure 
4.3.4 R & D and Investment
4.3.5 Monoclonal Antibody Business 
4.3.6 Business in China 
4.4 Novartis  
4.4.1 Profile
4.4.2 Operation 
4.4.3 Revenue Structure 
4.4.4 R & D and Investment
4.4.5 Monoclonal Antibody Business 
4.4.6 Business in China 
4.5 AbbVie
4.5.1 Profile
4.5.2 Revenue Structure 
4.5.3 R & D and Investment 
4.5.4 Monoclonal Antibody Business 
4.5.5 Business in China 
4.6 Amgen 
4.6.1 Profile
4.6.2 Operation 
4.6.3 Revenue Structure 
4.6.4 R & D and Investment
4.6.5 Monoclonal Antibody Business 
4.6.6 Business in China 

5 Key Chinese Monoclonal Antibody Agent Enterprises
5.1 Shanghai Lansheng States Kin Pharmaceutical Co., Ltd. 
5.1.1 Profile
5.1.2 Shanghai CP Guojian Pharmaceutical Co., Ltd.
5.1.3 Shanghai Zhangjiang Biotech Co., Ltd. 
5.1.4 Shanghai CP GuoJian Biotech Academy
5.1.5 Shanghai Guosheng Pharmaceutical Co., Ltd. 
5.2 Beijing Biotech Pharmaceutical Co., Ltd.
5.2.1 Profile
5.2.2 Competitive Edges
5.2.3 Development Prospect 
5.3 Chengdu Huasun Group Co., Ltd.
5.3.1 Profile
5.3.2 Chengdu Huasun Biotech Co., Ltd.
5.4 Shanghai Medipharm Biotech Co., Ltd.
5.4.1 Profile
5.4.2 Monoclonal Antibody Business 
5.5 Zhejiang Hisun Pharmaceutical Co., Ltd.
5.5.1 Profile
5.5.2 Monoclonal Antibody Business 
5.6 Yunnan Walvax Biotechnology Co., Ltd.
5.6.1 Profile
5.6.2 Monoclonal Antibody Business 
5.7 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
5.7.1 Profile
5.7.2 Monoclonal Antibody Business 
5.8 Beijing SL Pharmaceutical Co., Ltd.
5.8.1 Profile
5.8.2 Monoclonal Antibody Business 
5.9 Shenzhen Main Luck Pharmaceuticals Inc.
5.9.1 Profile
5.9.2 Monoclonal Antibody Business 
5.10 Huahai Pharmaceutical Co., Ltd.
5.10.1 Profile
5.10.2 Monoclonal Antibody Business 

6 Summary and Forecast
6.1 Comparison between Domestic and Foreign Companies
6.2 Market Forecast
Composition of Monoclonal Antibody Agents Worldwide by Type, 2011
Technological Level of Monoclonal Antibody Agents in Developed Countries of Europe and America
Targets of Some Monoclonal Antibody Agents Approved by FDA by Oct 2013
R&D Fields of Therapeutic Antibody around the Globe, 2004 and 2011
Sales of Monoclonal Antibody Agents Worldwide, 2009-2013
M&A Events Related to Monoclonal Antibody Worldwide by Oct 2013
Time to Market and Annual Sales of Major Monoclonal Antibody Agents around the Globe, 2011-2012
R&D Investment of Major Biopharmaceutical Companies Worldwide, 2009-2012
Expiration Date of Major Monoclonal Antibody Patents Worldwide
Competitive Analysis of Enbrel on American and Canadian Market
Research on New Indications of Some Monoclonal Antibody Products in the World, 2013
Several Cooperative Projects of Monoclonal Antibody Enterprises around the Globe, 2012-2013
Monoclonal Antibody Agents Approved in China by Oct 2013
Technological Level Comparison of Monoclonal Antibody Agents at Home and Abroad
Sales of Monoclonal Antibody Agents in China, 2010-2013
Purchase Amount of Major Monoclonal Antibody Agents in Typical Hospitals of 22 Cities in China, 2009-2012
Purchase Amount of Rituximab in Sample Hospitals of China and YoY Growth, 2008-2012
Purchase Amount of Rituximab in Typical Hospitals of Three Major Cities in China, 2009-2012
Purchase Amount of Trastuzumab in Sample Hospitals of China, 2010-2012
Purchase Amount of Trastuzumab in Typical Hospitals of Three Major Cities in China, 2009-2012
Purchase Amount of Cetuximab in Sample Hospitals of China, 2009-2012
Purchase Amount of Cetuximab/Erbitux in Typical Hospitals of Three Major Cities in China, 2009-2012
Purchase Amount of Nimotuzumab in Hospitals of Three Major Cities in China, 2010-2012
Purchase Amount of Bevacizumab/Avastin in Typical Hospitals in China, 2011-2012 
Purchase Amount of Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein in Sample Hospitals of China and YoY Growth, 2009-2012
Purchase Amount of Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein in Hospitals of Three Major Cities in China, 2010-2012
Price Comparison of Yisaipu, Qiangke and Enbrel
Death Causes Composition of Rural Residents in China, 2010
Monoclonal Antibody Products Covered by Local Medical Insurance in China by Oct 2013
Some Clinical Monoclonal Antibody Products in China by Oct 2013
Some Listed Companies and Projects Investing in Monoclonal Antibody Industry in China, 2010-2013
Major M&A Cases of Roche, 1990-2013
Revenue and Operating Income of Roche, 2008-2013
Revenue of Roche by Business, 2010-2013
Roche’s Pharmaceutical and Diagnostic Revenue Breakdown (by Application), 2012
Roche’s Sales Revenue Breakdown and Percentage (by Region), 2012-2013
Roche’s Sales Revenue Breakdown and Percentage in Seven Emerging Countries, 2012-2013
Roche’s R & D Investment (by Business), 2011-2013 
Global Sales of Major Monoclonal Antibody Products of Roche (Genentech), 2010-2013
Sales Revenue of Roche’s Monoclonal Antibody Products (by Region), 2011-2012
Roche’s Research Progress, by Jun 2013 
Roche’s Pharmaceutical Sales and YoY Growth in China, 2010-2013
Roche’s Diagnostic Sales and YoY Growth in China, 2010-2013
Roche’s Main Subsidiaries in China
Marketing of Roche’s Rituximab / Rituxan in China, 2009-2012
Marketing of Roche’s Herceptin / Trastuzumab in China, 2009-2012
Pharmaceutical Revenue of Johnson & Johnson (by Product), 2010-2012
R&D Investment and % of Total Revenue of Johnson & Johnson, 2009-2013
Monoclonal Antibody Products of Johnson & Johnson
Global Monoclonal Antibody Sales of Johnson & Johnson, 2010-2012 
Johnson & Johnson’s Enterprises in China and Main Products
China’s Import Value of Infliximab, 2010-2012
Merck’s Sales Revenue and Net Income, 2008-2013 
Merck’s Revenue (by Product), 2010-2012 
Merck’s Revenue (by Product), 2012-2013
R&D Investment and % of Total Revenue of Merck, 2009-2013 
Progress of Merck’s Research Projects, by Oct 2013
Marketing of Cetuximab / Erbitux in China, 2009-2012
Novartis’ Sales Revenue and Operating Income, 2009-2013 
Novartis’ Revenue (by Business), 2010-2012
Novartis’ Revenue (by Region), 2010-2012
R&D Investment and % of Total Revenue of Novartis, 2009-2012 
Monoclonal Antibody Products and Sales Revenue of Novartis, 2011-2012
Novartis’ Subsidiaries in China
Purchase Amount of Basiliximab in Typical Hospitals of 22 Cities in China, 2010-2012
Abbvie’s Revenue (by Region), 2010-2013 
Abbvie’s Revenue (by Product or Region), 2009-2013 
Abbvie’s R & D Investment, 2009-2012 
Abbvie’s Monoclonal Antibody Products and Sales Revenue, 2012
Global Adalimumab Sales, 2007-2013 
Purchase Amount of Adalimumab in Typical Hospitals of 22 Cities in China, 2010-2012
Amgen’s Revenue and Net Income, 2008-2013 
Amgen’s Revenue (by Product), 2009-2013 
Amgen’s Revenue (by Region), 2009-2012 
R&D Investment and % of Total Revenue of Amgen, 2008-2012
Amgen’s In-research Products and Progress, by Feb 2013
Amgen’s Market-oriented Monoclonal Antibody Products, by Feb 2013
Revenue of Amgen’s Monoclonal Antibody Products, 2009-2012
Revenue of Amgen ENBREL (by Region), 2009-2012
ENBEL’s Patent Term 
Panitumumab Revenue (by Region), 2009-2011 
Panitumumab’s Patent Term
Amgen’s Denosumab Revenue (by Region), 2010-2012 
Denosumab’s Patent Term
Revenue and Net Income of Shanghai CP Guojian, 2008-2010
Some In-research Monoclonal Antibody Products of Shanghai CP Guojian, by Jun 2012
Some In-research Monoclonal Antibody Products of Shanghai Zhangjiang Biotech 
Monoclonal Antibody Research Projects of Beijing Biotech Pharmaceutical 
Revenue and Operating Income of Chengdu Huasun Group, 2007-2010
Revenue of Chengdu Huasun Biotech, 2008-2013 
Revenue and Operating Income of Zhejiang Hisun Pharmaceutical, 2008-2013
Revenue and Profit of Yunnan Walvax Biotechnology, 2008-2013
Monoclonal Antibody Technical Indicators of Shanghai Fengmao
R & D Progress of 5 Categories of Monoclonal Antibody Generic Drugs of Shanghai Fengmao, by Aug 2012
In-research Monoclonal Antibody Products and Progress of Genor Biopharma
Revenue and Operating Income of Shanghai Fosun Pharmaceutical, 2008-2013
Revenue and Operating Income of Beijing SL Pharmaceutical, 2008-2013
Revenue and Operating Income of Huahai Pharmaceutical, 2008-2013
Investment of Some Domestic and Foreign Enterprises in Monoclonal Antibody Field in Recent Years
Global Monoclonal Antibody Market Size and YoY Growth, 2012-2017E
Sales and Patent Expiration of Global Top Six Monoclonal Antibody Agents 
Chinese Monoclonal Antibody Market Size and Its Share in the Global Market, 2012-2017E

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