Global and China Monoclonal Antibody Industry Report, 2013
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In recent years, the monoclonal antibody market around the globe has witnessed substantial growth, and the CAGR of market scale during 1997-2011 has reached 44% approximately. It is predicted that the global monoclonal antibody market scale will reach USD78 billion in 2012. Meanwhile, monoclonal antibody is also a key major source of blockbuster drugs. In 2011, the sales of six monoclonal antibody agents as Infliximab (Johnson & Johnson), Etanercept (Amgen), Bevacizumab (Roche), Rituximab (Roche), Adalimumab (Abbvie) and Trastuzumab (Roche) reached above USD5 billion around the globe, approximating 60% of global monoclonal antibody market.

Due to the features as high technical threshold, large capital demand and high rate of return, the international pharmaceutical giants (including Roche, Johnson & Johnson, Abbvie, Amgen, Novartis, etc.) are still accelerating the research and industrialization of monoclonal antibody agents through M&A or cooperation on the basis of existing monoclonal antibody products. For example, in April 2012, Amgen and AstraZeneca announced that they would jointly develop and sell the 5 monoclonal antibody agents of Amgen under research, namely, AMG827, AMG139, AMG181, AMG557 and AMG157.

Although the monoclonal antibody has witnessed rapid development, and the market scale is expected to share 8%-10% of world’s total in 2012, the market in China is still mainly occupied by imported products. As of the end of 2012, the number of imported monoclonal antibody products approved by SFDA amounted to 11, while that of domestic-made products only reached 8; the number of imported monoclonal antibody agents approved for clinical tests in China amounted to 27, while the figure of domestic products only hit 20, mainly imitating the overseas original drugs.

At present, the imported products as Rituximab, Trastuzumab, Cetuximab, Infliximab and Bevacizumab have contributed 70%-75% of monoclonal antibody market in China; the rest market is shared by the home-made drugs as Yisaipu?(Recombinant Human TNF Receptor-Ig Fusion Protein)and Xenopax? (Recombinant Humanized Anti-CD25 Monoclonal Antibody)of CPGJ, and Nimotuzomab of Biotech Pharma. Besides, several imported monoclonal antibody agents have accessed some local medical insurance systems. For example, Remicade?(Infliximab), which is used to treat rheumatoid, has accessed 11 local medical insurances, Simulect? (Bevacizumab, used in anti-transplant rejection) has accessed 10 local medical insurances, and Rituxan? (Rituximab, used to treat tumors) has accessed 9 local medical insurances. Meanwhile, since it may take 3-5 years for the domestic-made monoclonal antibody agents to achieve large scale and industrialized marketing, the imported markets will still embrace expectable development in future.

In view of the optimistic market prospect, advancement of monoclonal antibody technologies, support of favorable policies and the upcoming patent expiration of several key monoclonal antibody agents, multiple local enterprises as Hisun Pharmaceutical, Fosun Pharmaceutical, Walvax Biotechnology and SL Pharmaceutical are now marching into the monoclonal antibody market by huge capitals successively.

As of December 2012, the first monoclonal antibody generic drug (generic drug of enbrel) – Anbainuo? of Hisun Pharmaceutical was under phase III clinical supplementary test, and is expected to be approved by the end of 2013. The commercialized capacity will be 3.2 million pieces per year; furthermore, Enbrel has been tested in Brazil, etc., and is expected to achieve export.

In July 2012, the environmental impact assessment concerning phase I of new medicine pilot test base project (monoclonal antibody agents) of Fosun Pharmaceutical was publicized. According to the notice, the pilot scale of the project will be 130kg/a (equal to 1.3 million pcs/a of Rituximab), and the construction content involves raw material storage, pilot workshop, quality inspection, administration building and supporting public auxiliary facilities.

In April 2012, Walvax Biotechnology announced to jointly sign Cooperation Framework Agreement with Shanghai Fengmao Biotechnology, Shanghai Winlord Industries & Trading, and natural persons Wang Xiaofei and Kong Haiyan, planning to invest in Shanghai Fengmao in future four years, and research and industrialize Rituximab, Bevacizumab, Adalimumab, Panitumumab, Denosumab and long-acting EPO; in August, the company invested RMB246 million to establish the fully-owned subsidiary Shanghai Walvax, so as to promote the industrialization of the above six blockbuster bio-similar products. Nevertheless, according to the public information, the monoclonal antibody generic drugs of Walvax Biotechnology cannot be marketed until 2017 (Rituximab and Panitumumab as planned), and the commodity volume is expected to be 12kg/a, sharing 10% of planned capacity.

Global and China Monoclonal Antibody Industry Report, 2013 of ResearchInChina mainly involves the following contents:

?Development status, market scale, competitive pattern and development forecast, etc. of monoclonal antibody industry around the globe;
?Development status, market scale, competitive pattern and development forecast, etc. of monoclonal antibody industry in China;
?Operation, monoclonal antibody business, development in China, R&D status, etc. of 6 monoclonal antibody enterprises around the globe and 10 enterprises in China.

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

2. Development of Global Monoclonal Antibody Industry
2.1 Development Situation
2.2 Market Scale
2.3 Competitive Pattern
2.4 Development Prospect and Forecast
2.4.1 Market Scale Forecast
2.4.2 Competitive Pattern Forecast
2.4.3 R&D Tendency Prediction

3. Monoclonal Antibody Industry in China
3.1 Development Situation
3.2 Market Scale
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 TNF Receptor-Ig Fusion Protein for Injection
3.4 Competitive Pattern
3.5 Development Prospect

4. Key Enterprises of Monoclonal Antibody Agents Overseas 
4.1 Roche Pharmaceuticals
4.1.1 Profile
4.1.2 Operation
4.1.3 R&D and Investment
4.1.4 Monoclonal Antibody Business (Genentech)
4.1.5 Business in China
4.2 Johnson & Johnson
4.2.1 Profile
4.2.2 Operation
4.2.3 R&D and Investment
4.2.4 Monoclonal Antibody Business
4.2.5 Business in China
4.3 Merck
4.3.1 Profile
4.3.2 Operation
4.3.3 R&D and Investment
4.3.4 Monoclonal Antibody Business
4.3.5 Business in China
4.4 NVS
4.4.1 Profile
4.4.2 Operation
4.4.3 R&D and Investment
4.4.4 Monoclonal Antibody Business
4.4.5 Business in China
4.5 AbbVie (Abbott)
4.5.1 Profile
4.5.2 Operation
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 R&D and Investment
4.6.4 Monoclonal Antibody Business
4.6.5 Business in China

5. Key Enterprises of Monoclonal Antibody Agents in China
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 Shanghai Yalian Antibody Pharmaceutical Co., Ltd.
5.5.1 Profile
5.5.2 Monoclonal Antibody Business
5.6 Zhejiang Hisun Pharmaceutical Co., Ltd.
5.6.1 Profile
5.6.2 Monoclonal Antibody Business
5.7 Yunnan Walvax Biotechnology Co., Ltd.
5.7.1 Profile
5.7.2 Monoclonal Antibody Business
5.8 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
5.8.1 Profile
5.8.2 Monoclonal Antibody Business
5.9 Beijing SL Pharmaceutical Co., Ltd.
5.9.1 Profile
5.9.2 Monoclonal Antibody Business
5.10 Shenzhen Main Luck Pharmaceuticals Inc.
5.10.1 Profile
5.10.2 Monoclonal Antibody Business
Composition of Monoclonal Antibody Agents Worldwide by Type, 2011
Technological Level of Monoclonal Antibody Agents in Developed Countries of Europe and America
Target Spots of Monoclonal Antibody Agents Approved by FDA by May 2012
R&D Fields of Therapeutic Antibody around the Globe, 2004 and 2011
Number of Monoclonal Antibody Agents (Including Clinical) Approved by FDA by May 2012
Sales of Monoclonal Antibody Agents Worldwide, 2009-2012
M&A Events Related to Monoclonal Antibody Worldwide (As of 2011)
Time to Market and Annual Sales of Major Monoclonal Antibody Agents around the Globe, 2010-2011
R&D Investment of Major Biopharmaceutical Companies Worldwide, 2009-2011
Expiration Date of Major Monoclonal Antibody Patents Worldwide
Competitive Analysis of Enbrel on American and Canadian Market
Several Cooperative Projects of Monoclonal Antibody Enterprises around the Globe, 2011-2012
Monoclonal Antibody Industrial Bases in China
Monoclonal Antibody Agents Approved in China (As of December 2012)
Technological Level Comparison of Monoclonal Antibody Agents at Home and Abroad
Sales of Monoclonal Antibody Agents in China, 2010-2012
Purchase Amount of Major Monoclonal Antibody Agents in Typical Hospitals of 22 Cities in China, 2009-2011
Purchase Amount of Rituximab in Sample Hospitals of China and YoY Growth, 2008-2011
Purchase Amount of Rituximab in Typical Hospitals of Three Major Cities in China, 2009-2011
Purchase Amount of Trastuzumab in Sample Hospitals of China, 2010-2011
Purchase Amount of Trastuzumab in Typical Hospitals of Three Major Cities in China, 2009-2011
Purchase Amount of Cetuximab in Sample Hospitals of China, 2010-2011
Sales Condition of Cetuximab/Erbitux? in China, 2009-2011
Purchase Amount of Nimotuzumab in Hospitals of Three Major Cities in China, 2010-2011
Purchase Amount of Recombinant Human TNF Receptor-Ig Fusion Protein in Sample Hospitals of China and YoY Growth, 2009-2011
Purchase Amount of Recombinant Human TNF Receptor-Ig Fusion Protein in Hospitals of Three Major Cities in China, 2010-2011
Price Comparison of Yisaipu?, Qiangke? and Enbrel? 
Death Causes Composition of Rural Residents in China, 2010
Monoclonal Antibody Products Accessing Local Medical Insurance in China
Several Monoclonal Antibody Products under Research in China(As of the end of 2011)
Listed Companies Investing in Monoclonal Antibody Industry in China, 2009-2012
Major M&A Cases of Roche, 1990-2010
Revenue and Operating Income of Roche, 2008-2012
Revenue of Roche by Business, 2010-2012
Revenue of Roche’s Pharmaceutical Business by Application, 2010-2011
Revenue of Roche by Region, 2010-2011
Revenue of Roche’s Pharmaceutical Business by Region, 2010-2012
R&D Investment of Roche by Business and % in Revenue, 2011
Sales of Roche’s (Genentech) Major Monoclonal Antibody Products Worldwide, 2010-2011
Sales of Roche’s Monoclonal Antibody Products by Region, 2010-2011
Investment of Roche in China
Sales Condition of Roche’s Rituximab in China, 2009-2011
Sales Condition of Roche’s Trastuzumab in China, 2009-2011
Revenue and Net Income of Johnson & Johnson, 2008-2011
Revenue Structure of Johnson & Johnson by Product, 2011
R&D Investment of Johnson & Johnson and % in Revenue, 2009-2011
Monoclonal Antibody Products of Johnson & Johnson
Sales of Johnson & Johnson’s Infliximab Worldwide, 2009-2011
Enterprises in China and Major Products of Johnson & Johnson
Import Value of Infliximab in China, 2010-2011
Revenue and Net Income of Merck, 2008-2011
Revenue of Merck by Product, Q3 2011 and Q3 2012
R&D Investment of Merck and % in Revenue, 2009-2011
Sales Condition of Cetuximab/Erbitux in China, 2009-2011
Revenue and Net Income of Novartis, 2008-2012
Revenue Structure of Novartis by Business, 2011
R&D Investment of Novartis and % in Revenue, 2009-2011
Novartis’ Monoclonal Antibody Products and Sales, 2011
Development History of Novartis’ Pharmaceutical Business in China
Revenue of AbbVie by Product or Region, 2009-2011
R&D Investment of AbbVie, 2009-2011
Monoclonal Antibody Products and Sales of AbbVie, 2011
Global Sales of Adalimumab, 2007-2011
Revenue and Net Income of Amgen, 2008-2012
Revenue of Amgen by Product, 2009-2011
Revenue of Amgen by Region, 2009-2011
R&D Investment of Amgen and % in Revenue, 2008-2011
Product Lines of Amgen by the end of 2011
Marketized Monoclonal Antibody Products of Amgen (As of February 2012)
Revenue of Amgen’s Monoclonal Antibody Products for Sale, 2009-2011
Status Quo of Amgen’s Several Monoclonal Antibody Products under Research(As of February 2012)
Revenue of Amgen’s Enbrel by Region, 2009-2011
Patent Term of Enbrel
Revenue of Panitumumab by Region, 2009-2011
Patent Term of Panitumumab
Revenue of Amgen’s Denosumab by Region, 2010-2011
Revenue and Net Income of CP Guojian, 2008-2010
Several Monoclonal Antibody Products of CP Guojian under Research (As of June 2012)
Several Monoclonal Antibody Products of Zhangjiang Biotech under Research
Several Monoclonal Antibody Products of Biotech Pharmaceutical under Research
Revenue and Total Profit of Huasun Group, 2007-2010
Revenue of Huasun Biotech, 2007-2011
Revenue and Profit of Hisun Pharmaceutical, 2008-2012 
Revenue and Profit of Walvax Biotechnology, 2007-2012
Monoclonal Antibody Technical Indicators of Shanghai Fengmao
R&D Progress of Shanghai Fengmao’s Five Monoclonal Antibody Generic Drugs (As of August 2012)
Revenue and Total Profit of Fosun Pharmaceutical, 2008-2012
Revenue and Operating Income of SL Pharmaceutical, 2007-2012 

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