China Biopharmaceutical Contract Manufacturing Market, 2020 - 2030
China represents nearly 18% of the global population. Studies indicate that the Chinese pharmaceutical market is the second largest in terms of annual pharmaceutical revenues, and is estimated to generate more than 10% of the global sales. Till date, over 25 biologics and biosimilar products have been approved in China. In addition, close to 1,000 clinical trials, investigating a variety of biologics and biosimilars for treating a diverse range of diseases, are presently underway in this region. The growing pipeline, coupled to an increasing demand for biopharmaceuticals, has compelled industry stakeholders to enlist the help of capable contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). Due to benefits, such as low labor costs, access to a large indigenous consumer base and a relatively less stringent regulatory environment, several players have demonstrated the preference to partner with contract service providers based in China.
The biopharmaceutical contract manufacturing market in China presently features a mix of large, mid-sized and small players, some of which offer end-to-end solutions, ranging from development and clinical trial services to commercial manufacturing and regulatory consulting. Additionally, in order to attract more foreign clients and stay ahead within a competitive environment, Chinese CMOs are actively expanding their manufacturing related capabilities and capacities. This has led to the establishment of several partnerships and strategic acquisitions.
The novel Coronavirus outbreak in China has resulted in immediate disruptions / slow-down in global pharma / biopharma supply chains. In the short-term, it is anticipated to substantially impact the global contract manufacturing market, specifically those countries that have opted to lockdown. However, in the longer term, we remain bullish on the industry’s growth prospects as we expect biopharma companies to resume normal operations after the COVID-19 pandemic is put under control.
SCOPE OF THE REPORT
The “China Biopharmaceutical Contract Manufacturing Market, 2020-2030” report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of biopharmaceuticals in China. The study also features a detailed analysis of key drivers and trends related to this evolving domain. Amongst other elements, the report includes:
A detailed review of the overall landscape of companies offering contract manufacturing services for biopharmaceuticals in China, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number of manufacturing facilities, as well as location of these facilities, type of business segment, type of manufacturing service(s) offered (process development and characterization, method validation and testing, analytical development, stability studies, quality assurance and control, scale-up, downstream processing, regulatory support, data analytics and reporting, and others), type of biologic(s) manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), type of expression system(s) used (mammalian, microbial and others), type of bioreactor(s) used (single-use bioreactors and stainless steel bioreactors) and its mode of operation (batch, fed-batch and perfusion), type of packaging, and affiliations to regulatory accreditations and certifications (if any).
An analysis of the various partnerships pertaining to biopharmaceutical manufacturing in China, which have been established since 2016, based on several parameters, such as the year of partnership, type of partnership model adopted, scale of operation, type of biologic, focus area of the deal, target indication, most active players (in terms of number of partnerships signed), and geography.
An analysis of the various expansion initiatives undertaken by contract manufacturers in China, in order to augment their capabilities, over the period 2016-2020 (till February), taking into consideration several relevant parameters, such as year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion and new facility), scale of operation of manufacturing facility, type of biologic and location of manufacturing facility.
A clinical trial analysis of completed and active studies related to biopharmaceuticals that have been / are being / are likely to be conducted in China, based on trial registration year, trial phase, trial recruitment status, type of sponsor / collaborator, geography and number of patients enrolled.
An estimate of the overall, installed capacity for manufacturing biopharmaceuticals, based on data reported by industry stakeholders in the public domain; it highlights the distribution of available biopharmaceutical production capacity on the basis of company size (small, mid-sized, large and very large firms), scale of operation (preclinical, clinical and commercial), key geographical regions (China, Hong-Kong, Taiwan) and expression system used.
A review of recent initiatives undertaken by big pharma players in China for the manufacturing of biopharmaceuticals, highlighting trends across various parameters, such as number of initiatives, year of initiative, and benchmark analysis of big pharma players.
A qualitative analysis, highlighting the various factors that need to be taken into consideration by drug / therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing and packaging of biopharmaceutical products. Each profile features an overview of the company, its financial performance (if available), information on its service portfolio, details related to manufacturing capabilities and facilities, recent developments (partnerships and expansions), and an informed future outlook.
A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field. It also includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.
One of the key objectives of the report was to estimate the existing market size and the future growth potential within the biopharmaceutical contract manufacturing market in China. Based on various parameters, such as projected growth of the overall biopharmaceutical market in China, cost of goods sold, and direct manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] type of product (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems used (mammalian, microbial and others), [C] scale of operation (preclinical, clinical and commercial), and [D] company size (small, mid-sized and large / very large). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
Birgit Schwab, Senior Manager Strategic Marketing, Rentschler Biotechnologie
Jeffrey Hung, Chief Commercial Officer, Vigene Biosciences
Stephen Taylor, Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
News releases from company websites
Government policy documents
Industry analysts’ views
While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the biopharmaceutical contract manufacturing market in China and its likely evolution in the short-mid-term and long term.
Chapter 3 provides a general introduction to biopharmaceuticals and biopharmaceutical manufacturing processes. It also includes information on the various expression systems used for the development of different types of biotherapeutic products. The chapter features a brief overview of the contract manufacturing scenario in China and includes a detailed discussion on the need for outsourcing within the biopharmaceutical industry. Further, we have presented a list of commonly outsourced biomanufacturing activities. The chapter concludes with a discussion on the advantages and challenges that are currently associated with this market.
Chapter 4 is a case study comparing the key characteristics of large and small molecule drugs, along with information on the steps involved in their respective manufacturing processes.
Chapter 5 provides an overview of the China biopharmaceutical contract manufacturing landscape. It includes information on close to 40 CMOs that are currently active in this domain. In addition, it features an in-depth analysis of the market, based on a number of parameters, such
such as year of establishment, company size, scale of operation, location of headquarters, number of manufacturing facilities, as well as location of these facilities, type of business segment, type of manufacturing service(s) offered, type of biologic(s) manufactured, type of expression system(s) used, type of bioreactor(s) used, and its mode of operation, type of packaging and affiliations to regulatory accreditations and certifications.
Chapter 6 features detailed profiles of key industry players that offer various contract manufacturing services at different scales of operation. Each profile features a brief overview of the company, information on its service portfolio, details related to its manufacturing capabilities and facilities, and an informed future outlook.
Chapter 7 features an elaborate analysis of the various partnerships and collaborations that have been inked amongst players in this domain, in the time period 2016-2020 (till February). It provides a brief description on the various types of partnership model (which include manufacturing agreements, mergers / acquisitions, product development agreements, service alliances, and others) that have been adopted by stakeholders in this domain. Further, it includes analyses based on the year of agreement, partnership model, scale of operation, type of biologic, focus area of the deal, target indication and most active players. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.
Chapter 8 presents detailed analysis on the various expansion initiatives undertaken by contract manufacturers in China, in order to augment their capabilities, over the period 2016-2020(till February). It includes information on expansions carried out for increasing existing capabilities, as well as those intended for setting-up of new facilities by manufacturers engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion, and new facility), scale of operation of manufacturing facility, type of biologic, location of manufacturing facility.
Chapter 9 presents a detailed clinical trial analysis of completed and active related to biopharmaceuticals, highlighting prevalent trends across several relevant parameters, such as trial registration year, phase of development, type of biologic, current trial recruitment status, study focus area, key therapeutic areas (in terms of number of trials undertaken / conducted), enrolled patient population and trial location, and leading industry and non-industry players (in terms of number of trials undertaken / conducted).
Chapter 10 provides an overview of various recent developments that have been undertaken in different provinces namely, northern China, eastern China, southern China. Thus, depicting the emerging strength of the contract peptide manufacturers in different regions.
Chapter 11 features an analysis of the overall, installed capacity for manufacturing biopharmaceutical therapeutics / drugs in China based on data reported by industry stakeholders in the public domain; it highlights the distribution of available biopharmaceutical production capacity on the basis of company size (small, mid-sized, large and very large firms), scale of operation (preclinical, clinical and commercial), key geographical regions (China, Hong-Kong, Taiwan) and expression system used.
Chapter 12 highlights the recent initiatives undertaken by big pharma players in China for the manufacturing of biopharmaceuticals, highlighting trends across various parameters, such as number of initiatives, year of initiative, and benchmark analysis of big pharma players.
Chapter 13 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by biopharmaceutical therapeutics / drug developers while deciding whether to manufacture their respective products in-house or engage the services of CMOs.
Chapter 14 presents a detailed market forecast analysis, highlighting the likely growth of the China biologics manufacturing market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs)), [B] types of expression systems (mammalian, microbial and others), [C] scale of operation (preclinical, clinical and commercial), and [D] size of the company (small-sized, mid-sized and large / very large).
Chapter 15 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of contract manufacturing market in China, under a SWOT framework.
Chapter 16 highlights the emerging trends and potential market drivers for China biopharmaceutical contract manufacturers. It highlights the various opportunities associated with the growing biopharmaceutical drugs / therapies pipeline, increase in outsourcing of aseptic manufacturing operations, adoption of innovative technologies and increasing opportunities in China, which are likely to impact the evolution of the market in the coming years.
Chapter 17 is a collection of survey interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interview held with Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie), Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences) and Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies).
Chapter 18 is an appendix that contains tabulated data and numbers for all the figures provided in the report.
Chapter 19 is an appendix that provides the list of companies and organizations mentioned in the report.
LIST OF COMPANIES / LIST OF COMPANIES AND ORGANIZATIONS
The following companies / institutes / government bodies and organizations have been mentioned in this report.
2. ABL Bio
3. AC Immune
8. Amaran Biotechnology
10. Amicus Therapeutics
12. Applied Biological Materials
13. Aravive Biologics
14. Arch Biopartners
15. Arcus Biosciences
17. Asymchem Laboratories
21. Berkeley Lights
22. Bioasis Technologies
23. BioMarin Pharmaceutical
24. BJ Bioscience
25. Boehringer Ingelheim BioXcellence
27. Brii Biosciences
28. CANbridge Pharmaceuticals
29. Canton Biologics
30. Beijing CC-Pharming
32. Changchun High & New Technology Industry
34. Chime Biologics
35. China Regenerative Medicine International
36. Chinese Academy of Medical Sciences
37. Chinese Peptide
38. Chinese General Hospital
39. CMAB Biopharma
40. CPC Scientific
43. Eli Lilly
44. Encure Biopharma
45. EOC Pharma
47. Fapon Biopharma
48. Fuda Cancer Hospital
49. GE Healthcare
51. GeneQuantum Healthcare
54. GreenPak Biotech
55. Harbour BioMed
56. Henlius Biotech
57. Hile Bio-Technology
58. Hong Kong Institute of Biotechnology
59. Hummingbird Bioscience
60. Hybio Pharmaceutical
62. I-Mab Biopharma
63. Immune Pharmaceuticals
64. IncoCell Tianjin
67. JHL Biotech
68. Jiangsu Provincial Center for Disease Control and Prevention
69. JOINN Biologics
70. Kanda BioTech
71. Levena Biopharma
74. Mab-Venture Biopharma
76. Merck Millipore
77. Mycenax Biotech
78. Nan Fung Group
79. National Taiwan University Hospital
83. NovoCodex Biopharmaceuticals
84. Oxford BioTherapeutics
86. Pall Corporation
87. Peking Union Medical College Hospital
89. Phanes Therapeutics
90. Pharmadule Morimatsu
91. Qilu Pharmaceutical
92. Regulus Therapeutics
94. Samsung Bioepis
98. Shanghai Jiao Tong University
99. Shenzhen Geno-immune Medical Institute
100. Shenzhen JYMed Technology
101. Stellar Biotechnologies
102. Sun Yat-sen University
103. Suzhou Kintor Pharmaceuticals
104. Taiwan Liposome Company
105. Taron Solutions
106. Therapure Biopharma
107. Thermo Fisher Scientific
109. Thousand Oaks Biopharmaceuticals
110. Tsinghua University Innovation Center for Immune Therapy
111. UNC Lineberger Comprehensive Cancer Center
112. Vectron Biosolutions
113. Verseau Therapeutics
114. Vir Biotechnology
115. WuXi AppTec
116. WuXi Biologics
117. Yunfeng Capital
118. Zai Lab
119. Zhejiang Hisun Pharmaceutical
120. Zhejiang Teruisi Pharmaceutical
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