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.
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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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.
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The report includes the following content:
·
Status quo, market size, competition pattern and
development forecast of the global monoclonal antibody industry.
·
Status quo, market size, competition pattern and
development forecast of China monoclonal antibody industry.
·
Operation, monoclonal antibody business, development
in China and R & D of six global and 10 Chinese monoclonal antibody
companies.
Table of Contents
1 Overview of Monoclonal Antibody Industry
1.1 Definition
1.2 Classification
1.3 Technological Development
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
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
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
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
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
6.1 Comparison between Domestic and Foreign Companies
6.2 Market Forecast
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