Global and China Monoclonal Antibody Industry Report, 2014-2019

Global and China Monoclonal Antibody Industry Report, 2014-2019

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-? 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).
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


Companies Mentioned
Roche Pharmaceuticals
Johnson & Johnson
Merck
Novartis
AbbVie
Amgen
Shanghai Lansheng States Kin Pharmaceutical Co., Ltd.
Shanghai CP Guojian Pharmaceutical Co., Ltd.
Shanghai Zhangjiang Biotech Co., Ltd.
Shanghai CP GuoJian Biotech Academy
Shanghai Guosheng Pharmaceutical Co., Ltd.
Beijing Biotech Pharmaceutical Co., Ltd.
Chengdu Huasun Group Co., Ltd.
Chengdu Huasun Biotech Co., Ltd.
Shanghai Medipharm Biotech Co., Ltd.
Zhejiang Hisun Pharmaceutical Co., Ltd.
Yunnan Walvax Biotechnology Co., Ltd.
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Beijing SL Pharmaceutical Co., Ltd.
Shenzhen Main Luck Pharmaceuticals Inc.
Huahai Pharmaceutical Co., Ltd.
Livzon Pharmaceutical Group Inc.
Hualan Biological Engineering Co., Ltd.