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China's pharmaceutical R&D industry started late, with insufficient technical capacity and fewer investment at the initial stage of development. However, it has achieved rapid development in recent years and has great room for improvement. In 2017, China invested approximately US $13.2 billion in medical R&D, accounting for 8.9 percent of the total global medical R&D investment in the same period. With the improvement of Chinese drug firms’ R&D strength and the strengthening of government control of generic drugs, such as development of the generic consistency evaluation, the clinical trial data of audits and inspections, etc., the Chinese pharmaceutical R&D spending will continue to increase. China's pharmaceutical R&D spending is expected to reach US $29.2 billion in 2021, accounting for the total amount of the global pharmaceutical R&D spending will rise to 18.3%.
The global market for drug development services reached about US $71.7 billion in 2017.At a time when the cost of developing new drugs is high and generic competition is fierce around the world, pharmaceutical companies are increasingly inclined to outsource drug development to speed up the development of new drugs. The global market for drug development services is expected to grow to US $102.8 billion by 2021.
Compared with the global pharmaceutical development service market, the volume of China's pharmaceutical development service market is small, but the growth is fast. In 2017, China's drug development services market size reached approximately US $9.2 billion, and is expected to increase by 2021 to $27.8 billion.
CDMO market is developing rapidly in recent years, it is a highly fragmented industry, full of market competition. The world's leading CDMO company mainly include catalent, patheon, Lonza, BI, Jubilant, top CDMO enterprises currently accounts for the overall market share of about 18%.
In recent years, along with the great progress of China and India in talent cultivation, pharmaceutical technology research, especially in China, which has complete infrastructure, adequate raw material supply and significant operating cost advantage, these areas gradually become the CDMO emerging markets. Currently the CDMO business is transforming from developed markets to emerging markets, the CDMO market share of Europe and the United State has decreased from 75% in 2010 to 67% at present. Countries such as China and India has improved their market share from 10% to 15% at present, with China's market share accounted for about 8%.
Similar to the international market competition, China’s CDMO overall market concentration is low at present, part of the CDMO players with comprehensive competitiveness such as Asymchem, STA Pharmaceutical, WuXi Biologics and Porton Fine Chemicals etc., has higher market share., but there is still no absolute leading enterprises.
Table of Contents
1. Overview of Contract Development & Manufacturing Organization
1.2 Mainstream Technologies
1.2.1 Asymmetric synthesis
1.2.2 Cryogenic reaction
1.2.3 Enzymic catalytic reaction
1.2.4 High temperature and high pressure reaction
1.2.5 Crystallization technologies
1.2.6 High activity laboratory
1.3 Industry Chain
2.1 Snapshot of Policies
2.2 Chinese Pharmaceutical Marketing Authorisation Holder System (MAH)
3. Background of CDMO Industry
3.1 Development of Global Pharmaceuticals Industry
The global pharmaceutical industry has huge market space，with stable future growth
Europe and the United States remain the world's largest pharmaceutical market
China's future global market share will gradually increase
Drivers of Global Pharmaceuticals Industry
3.2 Why CDMO？-Reasons for the rise
The R&D cost of new drugs continues to rise while the success rate decreases year by year
Biotech companies are on the rise
Strong returns on patented drugs and pressure on patent expiry have prompted drug companies to step up R&D of new drugs
Chemical drugs remains dominate, the number of micromolecule new drugs is on the rise
3.3 Trends of global pharmaceutical market
The importance of emerging markets are increasing
The share of patented innovative drugs will continue to increase
Innovative biotechnology r&d companies continue to develop
Micromolecule chemical drugs will remain a key area of R&D for some time to come
3.4 Trends of China pharmaceutical market
The popularity of generic drugs has declined and new drugs R&D are on the rise
The pharmaceutical industry has become more innovative and small biotech companies have sprung up
4 CDMO Market
4.1 Entire Pharmaceutical Outsourcing Market
4.2 CRO Market
4.3 CDMO market
4.4 Market Landscape
4.5 Review of CDMO M&A
6 CDMO Players in China
6.1 Asymchem Laboratories (Tianjin) Co., Ltd.
6.2 WuXi Biologics (Cayman) Inc.
6.3 STA Pharmaceutical Co. Ltd.
6.4 Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
6.5 3SBio Inc.
6.5.4 CDMO for antibody drugs
6.6 Porton Fine Chemicals Ltd.
6.7 Lianhe Chemical Technology Co., Ltd.
6.7.2 CDMO Business
6.8 Laviana Pharma Co., Ltd.
6.9 Pharmaron Beijing Co., Ltd.
6.9.3 CDMO Business
6.10 PharmaResources (Shanghai) Co., Ltd.
6.10.2 CDMO Business
6.11 Shanghai ChemPartner Co., Ltd.
6.11.2 CDMO Business
7 Industry Development Trends
7.1 Integrated Industry Chain
Porton Fine Chemicals Ltd.-Expanding CDMO business to upstream CRO business
STA Pharmaceutical Co. Ltd. - Expanding CDMO business to downstream pharmaceutics
7.2 Bio-pharmaceutical CDMO-Main battlefield in the future
List of Charts
Service links of CDMO in pharmaceutical production & research process
Service content of CDMO in pharmaceutical production & research process
Value chain of CDMO Industry
CDMO business models
Policies of China CRO&CDMO Industry, 2010-2017
Global Pharmaceuticals Industry Market Sizez by Segment, 2012-2021E
Global Pharmaceuticals Industry Market Sizez by Region, 2012-2021E
China Pharmaceuticals Industry Market Sizez by Segment, 2012-2021E
The total cost of health care in China，2011-2017
Total global health care costs，2011-2015
The scale of venture capital in China and the global pharmaceutical sector，2013-2016
The average cost of a new drug from development to approval
Cumulative success rate from phase I to phase III of new drug development
The number of drugs at each stage of development, 2016/2017
The number of global biotech IPOs and the amount raised，2011-2015
Number of CDE class I chemical new drugs application, 2013-2017
Number of CDE class I biological new drugs application, 2013-2017
Overview of some IND declaration companies in China
Average NAS sales in the United States after the drug was marketed，1996-2015
Global pipeline for drug development，2001-2017
The number of new drugs approved by FDA, 2001-2017
Number of global micromolecule new drugs under different R&D stages, 2012-2017
Number of micromolecule new drug projects access next stage, 2012-2017
Pineline share of biological and non-biological drugs under R&D, 1995-2017
Global and China pharmaceutical R&D investment, 2012-2021E
Global CRO +CDMO market size, 2012-2021E
China CRO +CDMO market size, 2012-2021E
Global CRO market size, 2012-2021E
China CRO market size, 2012-2021E
Global CDMO market size, 2012-2021E
China CDMO market size, 2012-2021E
Market share of global TOP5 CDMO enterprises, 2017
Regional market share of global CDMO industry, 2017
Global CDMO market relative cost comparison by region
Revenue CAGR of some Global DCMO enterprises, 2013-2017
Market share of Chinese CDMO enterprises, 2017
Revenue CAGR of some Chinese DCMO enterprises, 2013-2017
Capacity of global CMO companies, 2017
Top 2017 CDMO M&A Headlines
Major CDMO market M&A, 2014-2017
Ownership Structure of ASYMCHEM
Business scope of ASYMCHEM
Core technology of ASYMCHEM
R&D investment of ASYMCHEM, 2013-2017
Organization structure of ASYMCHEM Pharmaceutical Science and Technology Institute
Domestic revenue share of ASYMCHEM, 2011-2017
Facilities of ASYMCHEM
Capacity of ASYMCHEM
Revenue structure of ASYMCHEM (by product), 2013-2017
Reserve projects of ASYMCHEM (by product), 2013-2017
Innovative drugs in ASYMCHEM’s commercial projects
Penem antibiotics capacity of Tianjin Asymchem Pharmaceuticals Co., Ltd.
Expansion plan of ASYMCHEM
Capacity addition plan of WuXi Biologics
Backlog increased to US$476mn, with additional US$1.0bn in potential milestones
There has been a constant inflow of projects and customers in the last few months
WuXi Biologics recorded a significant increase in project numbers
Ownership structure of STA Pharmaceutical
Revenue Structure of STA Pharmaceutical (by product), 2012-2017
CDMO business model of STA Pharmaceutical
Production and Sales of Jiuzhou Pharmaceutical’s CDMO business, 2015-2017
CDMO projects of Jiuzhou Pharmaceutical till 2017
History and key milestones of 3SBio Inc.
Key Therapeutic Areas & Capability Focus of 3SBio Inc.
R&D center structure of 3SBio Inc.
R&D platform of 3SBio Inc.
R&D process of 3SBio Inc.
Manufacturing bases of 3SBio Inc.
key information for each production line of 3SBio’s CDMO platform
New drug R&D services of 3SBio’s CDMO platform
CDMO capabilities of 3SBio
Services of Porton by drug life cycle
CDMO revenue of Porton, 2013-2017
Pilot-Scale & Commercial-Scale Manufacture sites of Porton
Pre-production products of Porton’s bio-pharmaceutical CDMO project
Top5 clients of Laviana Pharma, 2015-2017
Ownership structure of Pharmaron
Strucure of Pharmaron’s R&D department
CDMO capacity of Pharmaron, 2015-2017
Services of Pharmaron’s CRO&CDMO business platform
Revenue and gross margin of Pharmaron’s CDMO business, 2015-2017
Number of clients and projects of Pharmaron’s CDMO business, 2015-2017
Ownership structure of PharmaResources
TOP5 Clients of PharmaResources, 2015-2017
CDMO Revenue of PharmaResources, 2015-2017
Classificaiton of Shanghai ChemPartner’s CDMO business
CDMO revenue and gross margin of Shanghai ChemPartner, 2015-2017
Business chain expand of Porton Fine Chemicals Ltd.
Business chain expand of STA Pharmaceutical Co. Ltd.
Bio-pharmaceutical share in global new drugs under R&D, 2012-2017
Competitive landscape of global bio-pharmaceutical market, 2017
Revenue of Samsung Biologics (by business), 2014-2017
Capacity of Samsung Biologics, 2013-2018E (‘0000 litre)
Capacity of Samsung Biologics by plant
Utilisation rate forecasts by each plant of Samsung Biologics, 2014-2022E