Global and China Monoclonal Antibody Industry Report, 2019-2025
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Global monoclonal antibody market can be presented as follows:

1. Monoclonal antibody drug market booms and is highly concentrated with the approvals for such drugs.
Monoclonal antibody drugs have been maturing from a research target to an improved technology, from clinical research to commercialization over the past three decades. In recent years, the number of monoclonal antibody drugs approved for launch proliferated, with 78 approved and available on the market as of May 2018.

In 2017, 7 of 10 best-selling drugs worldwide were monoclonal antibody drugs, the fastest growing segment in global bio-pharmaceutical market. In Merck’s case, the sales of its Keytruda which was launched in 2014, hit RMB7.171 billion in 2018 alone.

Global monoclonal antibody market has been expanding over the recent years, with its size posting USD115.2 billion in 2018, a year-on-year increase of 11%. As of April 2019, there have been 182 monoclonal antibody drugs undergoing Phase III clinical trials worldwide. It is expected that many a monoclonal antibody drug will be approved and rolled out into the market in the forthcoming years, favoring a ballooning market size to USD240.2 billion in 2025.

The world’s monoclonal antibody market is now almost carved up by Roche, Johnson & Johnson, Merck, Novartis, AbbVie and Amgen. In 2018, the global top eight monoclonal antibody drugs by sales, collectively USD64,052 million, were HuMiRA, Herceptin, Avastin, Keytruda, Rituxan, Remicade, Stelara and ENBREL?, with a combined 55.6% share in global market.

2. The Chinese monoclonal antibody market has a rosy prospect but players compete with each other fiercely.
As of April 2019, the National Medical Products Administration (NMPA) of China has approved the roll-out of 33 antibody drugs (including fusion protein), including 21 imported and 12 homemade products, far lower than the volume approved by the US Food and Drug Administration (FDA). China has quickened its pace of approving monoclonal antibody drugs led by Opdivo and Keytruda, and projects to list them into its medical insurance drugs catalogue, giving impetus to the expansion of the market in the country.

China’s monoclonal antibody market developed by leaps and bounds between 2013 and 2017 at a CAGR of 15.6%, and would be worth RMB14.2 billion in 2018, 20.3% higher than in the previous year. The monoclonal antibody market size in China will grow up to RMB120.7 billion in 2025 as more new such drugs and biosimilar drugs are approved and launched.

In China, most monoclonal antibody drugs are at the clinical research stage, the majority of which are biosimilar products. Among those on the market, Sintilimab from Innovent Biologics and Toripalimab from Shanghai Junshi Biosciences are two new monoclonal antibody drugs, and HLX01 developed by Shanghai Henlius Biotech is China’s first biosmilar. Other monoclonal antibody developers include Biotech Pharma, Chengdu Taihe Health Technology Group, Zhejiang Hisun Pharmaceutical, Genor Biopharma, Beijing Shuanglu Pharmaceutical, Zhejiang Huahai Pharmaceutical, Livzon Pharmaceutical Group, Mabpharm, Hualan Biological Engineering and Anhui Anke Biotechnology (Group) Co., Ltd..

Companies like Innovent Biologics, Shanghai Junshi Biosciences and Shanghai Henlius Biotech that stay ahead of others in drug approval for launch, will have an edge over their peers in the market. But several players’ application for production and Phase III clinical trials by a number of companies which will then release their products under approval, means that competition between local firms and their foreign counterparts, between reference listed drugs (RLD) and biosimilars, will remain tough in the Chinese monoclonal antibody market.

3. As star monoclonal antibody drug patents expire, generic drugs will shock the market.
In the next five years, as the duration of star monoclonal antibody drug patents draws to an end, biosimilar market will be the battlefield of numerous pharmaceutical companies. Generic drugs for four monoclonal antibody drugs have been approved and become available on the market in European Union and the United States, signaling their squeeze of RLD in the market.


4. Monoclonal antibodies with PD-1 and PD-L1 as targets spring up.
The editorial board of the New England Journal of Medicine indicates that the PD-1 monoclonal antibody is the best anticancer performer over the past thirty years. Following the approval and release of Opdiva and Keytruda, two PD-1 targeted monoclonal antibodies in 2014, PD-1/PD-L1 monoclonal antibody drugs like Tecentriq, Bavencio, Imfinzi and Libtayo have also been brought to market.

Sales of Opdivo and Keytruda have been on the rise since their launch, especially the later with sales of USD7,171 million in 2018, nearly doubling the figure in the previous year. Global PD-1/PD-L1 monoclonal antibody market size reached as much as USD13.9 billion in 2018, and will expectedly surge to a staggering USD57.4 billion in 2025. 

The report highlights the following:
20120114.gifGlobal monoclonal antibody industry (status quo, market size, market structure, competitive landscape and development prospects);
20120114.gifChina’s monoclonal antibody industry (status quo, market size, market segments, competitive pattern and development outlook);
20120114.gifSix foreign and nineteen Chinese monoclonal antibody companies (profile, operation and monoclonal antibody business).

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 Market Structure
2.4 Competition Pattern
2.5 Development Prospect and Prediction
2.5.1 New Monoclonal Antibody Drugs Will Be Approved and Available on the Market Successively
2.5.2 Patents for Star Monoclonal Antibody Drugs Expire and Generic Drugs Hit the Market
2.5.3 Monoclonal Antibody Taking PD-1 and PD-L1 as the Targets Is a Rising Star

3. Chinese Monoclonal Antibody Market
3.1 Status Quo
3.2 Market Size
3.3 Market Segments
3.3.1 Rituximab (Mabthera)
3.3.2 Bevacizumab (Avastin)
3.3.3 Trastuzumab (Herceptin)
3.3.4 Adalimumab (Humira)
3.3.5 Omalizumab
3.3.6 Cetuximab
3.3.7 Infliximab
3.4 Competition Pattern
3.5 Development Prospect
3.5.1 Good Prospects of Monoclonal Antibody Market
3.5.2 Rapid Expansion of PD-1 & PD-L1 Market
3.5.3 Vigorous Development of Monoclonal Antibody Biosimilar Drug Market

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 & Co Inc.
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 Operation
4.5.3 Revenue Structure
4.5.4 R&D and Investment
4.5.5 Monoclonal Antibody Business
4.5.6 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 BIOTECH Pharmaceutical Co., Ltd. 
5.1.1 Profile
5.1.2 R&D and Production
5.1.3 Monoclonal Antibody Business
5.2 Chengdu Taihe Health Technology Group Inc.,Ltd.
5.2.1 Profile
5.2.2 Operation
5.2.3 Monoclonal Antibody Business
5.3 Shanghai Medipharm Biotech Co.,Ltd.
5.3.1 Profile
5.3.2 Monoclonal Antibody Business
5.4 Zhejiang Hisun Pharmaceutical Co., Ltd.
5.4.1 Profile
5.4.2 Operation
5.4.3 R&D
5.4.4 Monoclonal Antibody Business
5.5 Yunnan Walvax Biotechnology Co, Ltd.
5.5.1 Profile
5.5.2 Operation
5.5.3 R & D
5.5.4 Monoclonal Antibody Business
5.6 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
5.6.1 Profile
5.6.2 Operation
5.6.3 R & D and Investment
5.6.4 Monoclonal Antibody Business
5.7 Beijing SL Pharmaceutical Co., Ltd.
5.7.1 Profile
5.7.2 Operation
5.7.3 Monoclonal Antibody Business
5.8 Zhejiang Huahai Pharmaceutical Co.,Ltd.
5.8.1 Profile
5.8.2 Operation
5.8.3 Monoclonal Antibody Business
5.9 Livzon Pharmaceutical Group Inc.
5.9.1 Profile
5.9.2 Operation
5.9.3 R & D
5.9.4 Monoclonal Antibody Business
5.10 Mabpharm Limited
5.10.1 Profile
5.10.2 Monoclonal Antibody Business
5.11 Hualan Biological Engineering Inc.
5.11.1 Profile
5.11.2 Operation
5.11.3 R & D
5.11.4 Monoclonal Antibody Business
5.12 Anhui Anke Biotechnology (Group) Co., Ltd.
5.12.1 Profile
5.12.2 Operation
5.12.3 Monoclonal Antibody Business
5.13 Innovent Biologics, Inc.
5.13.1 Profile
5.13.2 Operation
5.13.3 Monoclonal Antibody Business
5.14 Shanghai Junshi Biosciences Co., Ltd.
5.14.1 Profile
5.14.2 Operation
5.14.3 Monoclonal Antibody Business
5.15 Hengrui Medicine Co., Ltd.
5.15.1 Profile
5.15.2 Operation
5.15.3 Monoclonal Antibody Business
5.16 Changchun High and New Technology Industries (Group) Inc.
5.16.1 Profile
5.16.2 Operation
5.16.3 Monoclonal Antibody Business
5.17 Guilin Sanjin Pharmaceutical Co., Ltd.
5.17.1 Profile
5.17.2 Operation
5.17.3 Monoclonal Antibody Business
5.18 Shenzhen Main Luck Pharmaceuticals Inc.
5.18.1 Profile
5.18.2 Monoclonal Antibody Business
5.19 3SBio Group
5.19.1 Profile
5.19.2 Operation
5.19.3 Monoclonal Antibody Business
Composition of Monoclonal Antibodies Worldwide by Type, 2018
Targets of Some Monoclonal Antibodies Approved by FDA by May. 2018
Number of Global Approvals for Monoclonal Antibodies, 1986-2018
World’s Top 10 Drugs by Sales, 2017
Sales Structure of Global Biological Drug Market (by Type), 2017
Keytruda Monoclonal Antibody Sales of Merck, 2014-2018
Global Monoclonal Antibody Market Size, 213-2025
Global Monoclonal Antibody Market Structure (by Therapeutic Field), 2017
Global Monoclonal Antibody Market Structure (by Therapeutic Field), 2018
Shares for Global Incidences with Cancer and Deaths, 2018
Shares for Incidence with Various Kinds of Cancer Worldwide, 2018
Shares for Male Incidence with Various Kinds of Cancer Worldwide, 2018
Shares for Female Incidence with Various Kinds of Cancer Worldwide, 2018
Shares for Incidences and Deaths by Regions Worldwide, 2018
Shares for Male Incidences and Deaths by Regions Worldwide, 2018
Shares for Female Incidences and Deaths by Regions Worldwide, 2018
Sales Revenue of Major Monoclonal Antibodies Worldwide, 2012-2018 (USD mln)
R&D Input of World-renowned Monoclonal Antibody Manufacturers, 2011-2018
Global Distribution of Clinical Research Phases for Monoclonal Antibody Drugs as of April 11, 2019
Expiry Dates for Major Monoclonal Antibodies Worldwide
PD-1/PD-L1 Targeted Monoclonal Antibody Drugs Approved by FDA as of October 2018
Mechanism of PD-1 Antibody
Immuno-Oncology PD-1 and PD-L1 Inhibitor Uptake in the United States
Opdivo and Keytruda Sales, 2014-2018
Global PD-1/PD-L1Monoclonal Antibody Market Size, 2014-2025E
Monoclonal Antibodies Approved for Marketing in China by April 2019
Some Monoclonal Antibody Products Covered by National and Regional Medical Insurance in China, by the end of 2018
R&D Progress of Main Monoclonal Antibody-like Biosimilars That Have Entered Phase III Clinical Trials in China, by H1 2018
Chinese Monoclonal Antibody Market Size, 2013-2025E
Cancer Incidence in China, 2013-2018
Price Comparison between Monoclonal Antibodies with and without Price Negotiations in China
Approval on Indications of Rituximab (FDA)
Rituximab R&D Progress in China, by Oct 2018
Chinese Rituximab Market Size, 2013-2025E
Chinese Bevacizumab Market Size, 2013-2025E
Bevacizumab R&D Progress in China, by Oct 2018
Chinese Trastuzumab Market Size, 2013-2025E
Trastuzumab Similimum R&D Progress in China, by H1 2018
Chinese Adalimumab Market Size, 2013-2025E
Adalimumab R&D Progress in China, by Oct 2018
Chinese Omalizumab Market Size, 2018-2025E
Chinese Cetuximab Market Size, 2013-2025E
Chinese Infliximab Market Size, 2013-2025E
R&D Progress of Main Monoclonal Antibody Companies in China
Year 2017 Availability of 55 Oncology Medicines First Launched Globally 2012-2016
Chinese PD-1/PDL-1Monoclonal Antibody Market Size, 2018-2025E
R&D Progress of Monoclonal Antibody Targeting PD-1 in China, by Oct 2018
R&D Progress of Monoclonal Antibody Targeting PD-L1 in China, by Oct 2018
Definitions of Biosimilars between China and Other International Organizations
Comparison between Duration of Biosimilar Patent Protection in China, Europe and America
Drug Registration Process in China and the United States
Major M&A Cases of Roche, 1990-2019
Roche’s Global Presence
Revenue and Net Income of Roche, 2008-2018
Roche’s Revenue (by Product), 2014-2018
Roche’s Revenue (by Region), 2014-2018
R & D Costs of Roche (by Business), 2011-2018
Global Sales of Major Monoclonal Antibody Products of Roche (Genentech), 2010-2018
Roche’s Mabthera/Rituxan Sales (by Region), 2011-2018
Roche’s Avastin Sales (by Region), 2011-2018
Roche’s Herceptin Sales (by Region), 2011-2018
Roche’s Perjeta Sales (by Region), 2012-2018
Roche’s Actemra/RoActemra Sales (by Region), 2011-2018
Roche’s Kadcyla Sales (by Region), 2013-2018
Roche’s Revenue in China (by Product), 2010-2018
Roche’s Main Subsidiaries in China, 2018
Johnson & Johnson’s Operating Results, 2010-2018
Johnson & Johnson’s Revenue (by Division), 2009-2018
Sales of Johnson & Johnson’s Main Pharmaceutical Products (by Region), 2013-2018
R&D Costs and % of Total Revenue of Johnson & Johnson, 2009-2018
Monoclonal Antibody Products of Johnson & Johnson
Monoclonal Antibody Sales of Johnson & Johnson, 2009-2018
Johnson & Johnson’s Enterprises in China and Main Products
Merck’s Operating Results, 2013-2018
Merck’s Revenue (by Product), 2013-2018
Merck’s Revenue (by Region), 2013-2018
R&D Costs and % of Total Revenue of Merck, 2009-2018
Merck’s R&D Pipeline, as of Feb 22, 2019
Sales of Monoclonal Antibodies of Merck, 2011-2018
Merck’s Revenue in China, 2016-2018
Revenue and Operating Income of Novartis, 2009-2018
Novartis’ Revenue (by Division), 2015-2018
Novartis’ Revenue Structure (by Division), 2015-2018
R&D Costs and % of Total Revenue of Novartis, 2009-2018
Novartis’ Monoclonal Antibodies
Novartis’ Monoclonal Antibody Revenue (by Product), 2013-2018
Novartis’ Development Course in China
AbbVie’s Operating Results, 2014-2018
Main Sales Regions and Indications of HUMIRA
AbbVie’s Revenue (by Product), 2013-2018
AbbVie’s Revenue (by Region), 2013-2018
R&D Costs and % of AbbVie’s Total Revenue, 2013-2018
AbbVie’s Monoclonal Antibody Revenue (by Product), 2013-2018
Amgen’s Products Being Developed by Jun. 2019
Revenue of Amgen’s Monoclonal Antibody Products Sold, 2009-2018
Revenue of Amgen ENBREL (by Region), 2009-2018
ENBEL’s Patent Term
Similar Competitive Products of ENBEL
Revenue of Amgen Panitumumab (by Region), 2009-2018
Panitumumab’s Patent Term
Revenue of Amgen Denosumab (by Region), 2010-2018
Denosumab’s Patent Term
Similar Competitive Products of Denosumab
Erenumab-aooe’s Patent Term
Similar Competitive Products of Erenumab-aooe
Revenue Breakdown of Amgen Blinatumomab (by Region), 2015-2018
Blinatumomab’s Patent Term
Revenue Breakdown of Amgen Evolocumab (by Region), 2014-2018
Evolocumab’s Patent Term
Revenue and Net Income of Chengdu Taihe Health Technology, 2014-2018
Revenue and Net Income of Chengdu Huasun Biotech, 2013-2018
Key Partners of Zhejiang Hisun Pharmaceutical
Revenue and Net Income of Zhejiang Hisun Pharmaceutical, 2012-2018
R&D Costs and % of Total Revenue of Zhejiang Hisun Pharmaceutical, 2013-2018
R&D Costs of Some Projects and % of Total Revenue of Zhejiang Hisun Pharmaceutical, 2017
Monoclonal Antibody R&D Progress of Zhejiang Hisun Pharmaceutical, by H1 2018
Business Territory of Yunnan Walvax Biotechnology
Revenue and Net Income of Yunnan Walvax Biotechnology, 2012-2018
R&D Costs and % of Total Revenue of Yunnan Walvax Biotechnology, 2013-2018
Progress of Yunnan Walvax Biotechnologys’ Major Fundraising Projects, by H1 2018
Product Registration and Application of Yunnan Walvax Biotechnology, by H1 2018
Monoclonal Antibody R&D Progress of Genor Biopharma, by H1 2018
Revenue and Net Income of Shanghai Fosun Pharmaceutical, 2013-2018
R&D Costs and % of Total Revenue of Shanghai Fosun Pharmaceutical, 2013-2018
Monoclonal Antibody R&D Progress of Henlius, by the end of 2018
Rituximab Similimum R&D History of Henlius
Total Revenue, Net Income and R&D Investment of Henlius, 2016-2018
Revenue and Net Income of Beijing SL Pharmaceutical, 2012-2018 
Revenue and Net Income of Huahai Pharmaceutical, 2012-2018
Monoclonal Antibody Products Being Developed and Progress of Huahai Pharmaceutical, by the end of 2017
Revenue and Net Income of Livzon Pharmaceutical Group, 2012-2018
R&D Costs and % of Total Revenue of Livzon Pharmaceutical Group, 2013-2018
Purposes of Funds Raised by Non-public Offering of Livzon Pharmaceutical Group, 2016
Monoclonal Antibody R&D Progress of Livzon Pharmaceutical Group, by the end of 2018
Monoclonal Antibody Drugs Being Developed and Progress of Mabpharm, by March 2019
Revenue and Net Income of Hualan Biological Engineering, 2013-2018
R&D Costs and % of Total Revenue of Hualan Biological Engineering, 2013-2018
Revenue and Net Income of Hualan Genetic Engineering, 2015-2018 
Revenue and Net Income of Anhui Anke Biotechnology, 2012-2018
Monoclonal Antibody R&D Progress of Anhui Anke Biotechnology, by March 2019
Purposes of Funds Raised by Non-public Offering of Anhui Anke Biotechnology, 2018
Revenue and Net Income of Innovent Biologics, 2017-2018
Main Product Development of Innovent Biologics, by the end of 2018
Revenue and Net Income of Shanghai Junshi Biosciences, 2016-2018
Monoclonal Antibody R&D Progress of Shanghai Junshi Biosciences, 2018
Global Layout of Shanghai Junshi Biosciences
Toripalimab of Shanghai Junshi Biosciences
Revenue and Net Income of Hengrui Medicine, 2015-2018
Revenue Structure of Hengrui Medicine (by Product), 2017-2018
Monoclonal Antibody R&D of Hengrui Medicine, 2018
Revenue and Net Income of Changchun High and New Technology Industries (Group), 2015-2018
Revenue of Changchun High and New Technology Industries (Group) (by Product), 2017-2018
GenSci’s Operation, 2017-2018
Operation of Changchun BCHT Biotechnology, 2017-2018
Technical Roadmap of Trinomab Natural Human Monoclonal Antibody
Revenue and Net Income of Guilin Sanjin Pharmaceutical, 2015-2018
Operation of Dragonboat Biopharmaceutical, 2017-2018
Revenue and Net Income of 3SBio Group, 2015-2018
Monoclonal Antibody R&D Progress of 3SBio Group, by the end of 2017

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The human vaccine industry presented the following main characteristics in 2016 in China: 1. Lot release volume of human vaccines declined.Affected by the illegal vaccine case in Mar 2016 in Shandong...

China Independent Clinical Laboratory Industry Report, 2016-2020

Owing to a large population base, uneven distribution of medical resources among regions, aging population, and continuous advance of health care reform, the Chinese independent clinical laboratory ma...

China Human Vaccine Industry Report, 2016-2020

Amid the unsafe domestic vaccine events, China’s human vaccine lot release volume in 2015 fell by 17.9% year on year to only 650 million doses,touching a 5-year low. Moreover, with the improvements in...

China Animal Vaccine Industry Report, 2016-2020

Animal vaccine is a kind of biological agent that enables inoculated animals to produce active immunity for disease prevention. In recent years, European and American animal vaccine markets have seen ...

China Blood Product Industry Report, 2016-2019

Recombinant blood products have developed for many years in foreign countries, but China’s blood products are still proteins extracted from human blood. Thus, reserves and control of plasma resources ...

China Contract Research Organization (CRO) Industry Report, 2015-2018

In recent years, China's contract research organization (CRO) industry has developed rapidly, with the market size rising from RMB8.5 billion in 2007 to RMB42.6 billion in 2014, registering a CAGR of ...

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