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Global and China Monoclonal Antibody Industry Report, 2014-2019
Publication Date Oct 2014
Product Type Report
Pages 136
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Despite world-wide economic downturn and great changes in exchange rate, benefiting from robust market demand, global monoclonal antibody market size exceeded USD 80 billion in 2013, still one of biotech drugs with the fastest CAGR in recent years.

Global blockbuster monoclonal antibody agents are still concentrated in Roche (Genentech), Amgen, AbbVie (Abbott), Johnson & Johnson, Novartis, etc. In 2013, the top 10 best-selling monoclonal antibody agents (Humira, Remicade, Enbrel, Rituxa, Avastin, Herceptin, Lucents, Synagis, Prolia/Xgeva and Erbitux, in order) mostly came from these companies mentioned above. Global sales of these ten monoclonal antibody agents totaled about USD 58.1 billion in 2013, and are predicted to amount to USD 64.1 billion in 2014.

These companies construct mature monoclonal antibody R&D platform, have unparalleled technical advantages in a series of processes including the selection of target gene, genetic sequencing, construction of monoclonal antibody structure and industrialized production, and are well-capitalized (R&D costs of these companies accounted for 15%-20% of revenue during the same period.). It is expected that they will keep a leading position in global monoclonal antibody market over the next five to ten years.

In Sept. 2014, Opdivo (nivolumab) of Bristol-Myers Squibb was accepted for priority review by FDA and EMA. The indication of the drug is unresectable or metastatic melanoma. In the same month, KEYTRUDA (pembrolizumab) under Merck became the first FDA-approved Anti-PD-1 therapy, which can be used for advanced melanoma.

In Apr. 2014, Janssen under Johnson & Johnson announced the FDA had approved SYLVANT (siltuximab) for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Lilly's CYRAMZA (ramucirumab) became first FDA-approved treatment for with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior chemotherapy.

The Chinese monoclonal antibody market developed rapidly in recent years, with market size recording a CAGR of 38.9% during 2010-2013. There are nine domestic monoclonal antibody agents introduced to the market, such as Shanghai CP Guojian Pharmaceutical’s Nimotuzuma and Biotech Pharm’s recombinant humanized anti-CD25 monoclonal antibody. However, the market is dominated by imported agents like Rituximab, Trastuzumab, Infliximab and Bevacizumab, which account for more than 70%.

However, in Aug. 2014, Hisun Pharm received notice from SFDA on applying for production field inspection for Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein, which is expected to be introduced to the market by the end of 2014. Then supply capacity of domestic monoclonal antibody agents will be further enhanced.

With advancement of monoclonal antibody technology, incoming expiry date for patents of some blockbuster monoclonal antibody agents and bright future for monoclonal antibody, Livzon Pharmaceutical Group, Walvax Biotechnology, Hualan Biological Engineering, Shanghai Fosun Pharmaceutical and other companies invested heavily to enter monoclonal antibody market, and multiple products have entered stage of pre-preclinical or clinical research.

In Sept. 2014, Hualan Biological Engineering submitted clinical applications for its three monoclonal antibody generic drugs, namely, trastuzumab, bevacizumab and rituximab; In Aug. 2014, Walvax Biotechnology’s recombinant anti-tumor necrosis factor-α fully human monoclonal antibody injection obtained clinical trial permission issued by Korean Food and Drug Administration (KFDA); In Apr. 2014, Shanghai Fosun Pharmaceutical formally received clinical trial permission approved and issued by CFDA for recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection (rituximab monoclonal antibody genetic drug).

Table of Contents

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 Competitive Landscape
2.4 Development Prospect and Prediction
2.4.1 Market Size
2.4.2 Competitive Landscape
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/Infilixma
3.3.5 Bevacizumab
3.3.6 Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein
3.4 Competitive Landscape
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 Advantages
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
5.11 Livzon Pharmaceutical Group Inc.
5.11.1 Profile
5.11.2 Monoclonal Antibody Business
5.12 Hualan Biological Engineering Co., Ltd.
5.12.1 Profile
5.12.2 Monoclonal Antibody Business

6 Summary and Forecast
6.1 Comparison between Domestic and Foreign Companies
6.2 Market Forecast

List of Selected Charts

Composition of Monoclonal Antibody Agents Worldwide by Type, 2013
Technological Level of Monoclonal Antibody Agents in Developed Countries of Europe and America
Targets of Some Monoclonal Antibody Agents Approved for Marketing by FDA by Sept. 2014
R&D Fields of Therapeutic Antibody around the Globe, 2004 & 2013
Sales of Monoclonal Antibody Agents Worldwide, 2009-2014
M&A Events Related to Monoclonal Antibody Worldwide by Sept. 2014
Time to Market and Annual Sales of Major Monoclonal Antibody Agents around the Globe, 2011-2014
R&D Investment of Major Biopharmaceutical Companies Worldwide, 2009-2014
Expiration Date of Major Monoclonal Antibody Patents Worldwide
Competitive Analysis of Enbrel on American and Canadian Markets
Research on New Indications of Some Monoclonal Antibody Products in the World, 2013-2014
Several Cooperative Projects of Monoclonal Antibody Enterprises around the Globe, 2012-2014
Monoclonal Antibody Agents Approved for Marketing in China by Sept. 2014
Progress of Research on Some Monoclonal Antibody Agents in China, 2014
Technological Level Comparison of Monoclonal Antibody Agents at Home and Abroad
Sales of Monoclonal Antibody Agents in China, 2010-2014
Purchase Amount of Major Monoclonal Antibody Agents in Typical Hospitals of 22 Cities in China, 2009-2013
Purchase Amount of Rituximab in Sample Hospitals of China and YoY Growth, 2008-2013
Purchase Amount of Rituximab in Typical Hospitals of Three Major Cities in China, 2009-2013
Purchase Amount of Trastuzumab in Sample Hospitals of China, 2009-2013
Purchase Amount of Trastuzumab in Typical Hospitals of Three Major Cities in China, 2009-2013
Purchase Amount of Cetuximab in Sample Hospitals of China, 2009-2013
Purchase Amount of Cetuximab/Erbitux in Typical Hospitals of Three Major Cities in China, 2009-2013
Purchase Amount of Nimotuzumab in Hospitals of Three Major Cities in China, 2010-2013
Purchase Amount of Bevacizumab/Avastin in Typical Hospitals in China, 2011-2013
Purchase Amount of Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein in Sample Hospitals of China and YoY Growth, 2009-2013
Purchase Amount of Recombinant Human Tumor Necrosis Factor Receptor Type II - Antibody Fusion Protein in Hospitals of Three Major Cities in China, 2010-2013
Price Comparison of Yisaipu, Qiangke and Enbrel in 2014H1
Death Causes Composition of Rural Residents in China, 2012
Death Causes Composition of Urban Residents in China, 2012
Monoclonal Antibody Products Covered by Local Medical Insurance in China, 2014
Some Clinical Monoclonal Antibody Products in China by Sept. 2014
Some Listed Companies and Projects Investing in Monoclonal Antibody Industry in China, 2010-2014
Major M&A Cases of Roche, 1990-2014
Revenue and Net Income of Roche, 2008-2014
Revenue Breakdown of Roche (by Business), 2010-2014
Pharmaceutical and Diagnostic Revenue Breakdown of Roche (by Application), 2012-2013
Pharmaceutical and Diagnostic Revenue Breakdown of Roche (by Application), 2014H1
Roche’s Revenue Breakdown and Percentage (by Region), 2012-2013
Pharmaceutical and Diagnostic Revenue Breakdown Roche (by Region), 2013
Pharmaceutical and Diagnostic Revenue Breakdown Roche (by Region), 2014H1
R & D Costs of Roche (by Business), 2011-2014
Some Products Approved for Marketing of Roche by the End of 2013
Global Sales of Major Monoclonal Antibody Products of Roche (Genentech), 2010-2013
Sales of Roche’s Monoclonal Antibody Products (by Region), 2011-2014
Some Products being Developed of Roche by Jul. 24, 2014
Roche’s Pharmaceutical Sales and YoY Growth in China, 2010-2014
Roche’s Diagnostic Sales and YoY Growth in China, 2010-2014
Roche’s Main Subsidiaries in China
Sales of Roche’s Rituximab/Rituxan in China, 2009-2013
Sales of Roche’s Herceptin/Trastuzumab in China, 2009-2013
Sales of Bevacizumab/Avastin in China, 2011-2013
Total Revenue and Net Income of Johnson & Johnson, 2009-2014
Total Revenue Breakdown of Johnson & Johnson (by Product), 2009-2014
Total Revenue Structure of Johnson & Johnson (by Product), 2009-2014
Pharmaceutical Revenue Breakdown of Johnson & Johnson (by Product), 2011-2013
R&D Costs and % of Total Revenue of Johnson & Johnson, 2009-2014
Monoclonal Antibody Products of Johnson & Johnson
Global Monoclonal Antibody Sales of Johnson & Johnson, 2009-2014
Johnson & Johnson’s Enterprises in China and Main Products
China’s Import Value of Infliximab, 2010-2013
Revenue and Net Income of Merck, 2009-2014
Revenue Breakdown of Merck (by Product), 2011-2013
R&D Costs and % of Total Revenue of Merck, 2009-2014
Progress of Merck’s Research Projects by Jul. 2014
Sales of Infliximab/Remicade of Merck, 2011-2014
Revenue and Operating Income of Novartis, 2009-2014
Revenue Breakdown of Novartis (by Business), 2010-2014
Revenue Breakdown of Novartis (by Region), 2011-2014
R&D Costs and % of Total Revenue of Novartis, 2009-2014
Novartis’ Monoclonal Antibody Products and Their Sales, 2011-2014
Novartis’ Subsidiaries in China
Purchase Amount of Basiliximab in Typical Hospitals of 22 Cities in China, 2010-2013
Sales of Lucentis in China, 2012-2013
Main Sales Regions and Indications of HUMIRA
Revenue Breakdown of Abbvie (by Product or Region), 2011-2013
R&D Costs and % of Total Revenue of Abbvie (by Quarter), 2013-2014
R&D Costs of Abbvie, 2009-2014
Abbvie’s Monoclonal Antibody Products and Their Sales, 2012-2014
Global Adalimumab Sales, 2007-2014
Global Synagis Sales of Abbvie, 2012-2014
Purchase Amount of Adalimumab in Typical Hospitals of 22 Cities in China, 2010-2013
Revenue and Net Income of Amgen, 2009-2014
Revenue Breakdown of Amgen (by Product), 2009-2014
Revenue Breakdown of Amgen (by Region), 2009-2014
R&D Costs and % of Total Revenue of Amgen, 2008-2014
Amgen’s Products Being Developed by Jun. 2014
Amgen’s Market-oriented Monoclonal Antibody Products by Jun. 2014
Revenue of Amgen’s Monoclonal Antibody Products Sold, 2009-2014
Revenue Breakdown of Amgen ENBREL (by Region), 2009-2014
ENBEL’s Patent Term
Similar Competitive Products of ENBEL
Revenue Breakdown of Panitumumab (by Region), 2009-2014
Panitumumab’s Patent Term
Similar Competitive Products of Panitumumab
Revenue Breakdown of Amgen’s Denosumab (by Region), 2010-2014
Denosumab’s Patent Term
Similar Competitive Products of Denosumab
Revenue and Net Income of Shanghai CP Guojian, 2008-2010
Some Monoclonal Antibody Products Being Developed of Shanghai CP Guojian, by Oct. 2014
Some Monoclonal Antibody Products Being Developed of Shanghai Zhangjiang Biotech
Monoclonal Antibody Research Projects of Beijing Biotech Pharmaceutical
Revenue and Operating Income of Chengdu Huasun Group, 2009-2014
Revenue and Net Income of Chengdu Huasun Biotech, 2007-2013
Revenue and Operating Income of Zhejiang Hisun Pharmaceutical, 2009-2014
Industrial Layout of Yunnan Walvax Biotechnology
Revenue and Operating Income of Yunnan Walvax Biotechnology, 2009-2014
Monoclonal Antibody Technical Indicators of Shanghai Fengmao
R&D Progress of 5 Categories of Monoclonal Antibody Generic Drugs of Shanghai Fengmao by Sept. 2014
Monoclonal Antibody Products Being Developed and Progress of Genor Biopharma
Revenue and Operating Income of Shanghai Fosun Pharmaceutical, 2008-2013
Revenue and Operating Income of Beijing SL Pharmaceutical, 2009-2014
Revenue and Operating Income of Huahai Pharmaceutical, 2009-2014
Revenue and Operating Income of Livzon Pharmaceutical Group, 2009-2014
Revenue and Operating Income of Hualan Biological Engineering, 2009-2014
Investment of Some Domestic and Foreign Enterprises in Monoclonal Antibody Field in Recent Years
Global Monoclonal Antibody Market Size and YoY Growth, 2013-2019E
Sales and Patent Expiration of Global Top Six Monoclonal Antibody Agents
Chinese Monoclonal Antibody Market Size and Its Share in the Global Market, 2013-2019E

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