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China Biopharmaceutical Contract Manufacturing Market, 2020-2030

Research and Markets

Dublin, June 29, 2020 (GLOBE NEWSWIRE) -- The "China Biopharmaceutical Contract Manufacturing Market, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

This 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.

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)
  • [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.

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.

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.

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

Key Topics Covered

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Biopharmaceuticals
3.3. Manufacturing of Biopharmaceuticals
3.3.1. Types of Expression Systems Used
3.3.1.1. Bacterial Expression Systems
3.3.1.2. Yeast Expression Systems
3.3.1.3. Insect Expression Systems
3.3.1.4. Plant Expression Systems
3.3.1.5. Mammalian Expression Systems
3.3.1.6. Fungal Expression Systems
3.3.2. Processing Steps
3.3.2.1. Upstream Processing
3.3.2.2. Downstream Processing
3.4. Overview of Contract Manufacturing
3.4.1. Contract Manufacturing Scenario in China
3.5. Need for Outsourcing in the Biopharmaceutical Industry
3.5.1. Regulatory Considerations while Outsourcing Biopharmaceutical Manufacturing to China
3.6. Commonly Outsourced Operations in the Biopharmaceutical Industry
3.7. Basic Guidelines for Selecting a CMO Partner
3.8. Advantages of Outsourcing Manufacturing Services
3.8.1. Advantages of Selecting a China-Based Contract Manufacturer
3.9. Risks and Challenges Associated with Biopharmaceutical Contract Manufacturing
3.9.1. Challenges Specific to China-based Contract Manufacturers

4. CASE STUDY: COMPARISON OF SMALL MOLECULES AND LARGE MOLECULES
4.1. Chapter Overview
4.2. Small Molecule and Large Molecule Drugs / Therapies
4.2.1. Comparison of Key Characteristics
4.2.2. Comparison of Manufacturing Processes
4.2.3. Comparison of Key Manuafcturing Challenges

5. COMPETITIVE LANDSCAPE
5.1. Chapter Overview
5.2. Chinese Biopharmaceutical Contract Manufacturers: Overall Market Landscape
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Company Size
5.2.3. Analysis by Scale of Operation
5.2.4. Analysis by Location of Headquarters
5.2.5. Analysis by Location of Manufacturing Fcailities
5.2.6. Analysis by Type of Product
5.2.7. Analysis by Types of Services Offered
5.2.8. Analysis by Type of Biologic
5.2.9. Analysis by Expression System Used
5.2.10. Analysis by Type of Bioreactor Used
5.2.11. Analysis by Mode of Operation of Bioreactor
5.2.12. Analysis by Packaging Form Used
5.2.13. Analysis by Regulatory Accreditations / Certifications

6. COMPANY PROFILES
6.1 Chapter Overview
6.2 ChemPartner Biologics
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Manufacturing Facilities and Capabilities
6.2.4. Recent Developments and Future Outlook
6.3. JHL Biotech
6.4. JOINN Biologics
6.5. MabPlex
6.6. Mycenax Biotech
6.7. WuXi AppTec

7. PARTNERSHIPS
7.1 Chapter Overview
7.2. Partnership Models
7.3. Chinese Biopharmaceutical Contract Manufacturers: Recent Partnerships
7.3.1. Analysis by Year of Partnership
7.3.2. Analysis by Partnership Model
7.3.3. Analysis by Scale of Operation
7.3.4. Analysis by Type of Biologic
7.3.5. Analysis by Focus Area
7.3.6. Analysis by Target Indication
7.3.7. Most Active Players: Geographical Distribution by Number of Partnerships
7.3.8. Intercontinental and Intracontinental Agreements

8. RECENT EXPANSIONS
8.1. Chapter Overview
8.2. Chinese Biopharmaceutical Contract Manufacturers: Recent Expansions
8.2.1. Analysis by Year of Expansion
8.2.2. Analysis by Type of Expansion
8.2.3. Analysis by Scale of Operation
8.2.4. Analysis by Type of Biologic
8.2.5. Analysis by Location of Expansion Project
8.2.6. Analysis by Region

9. CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3 Clinical Trial Analysis: Biologic Drugs
9.3.1. Analysis by Trial Registration Year
9.3.2. Analysis by Trial Phase
9.3.3. Analysis by Trial Recruitment Status
9.3.4. Geographical Analysis by Number of Clinical Trials
9.3.5. Geographical Analysis by Enrolled Patient Population
9.3.6. Analysis by Type of Sponsor / Collaborator
9.3.7. Most Active Players: Analysis by Number of Registered Trials

10. REGIONAL CAPABILITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Northern China
10.4. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Eastern China
10.5. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Southern China

11. CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Methodology
11.3. Chinese Biopharmaceutical Contract Manufactures: Installed Capacity
11.3.1. Analysis by Company Size
11.3.2. Analysis by Scale of Operation
11.3.3. Analysis by Location of Manufacturing Facility
11.3.4. Analysis by Expression System Used
11.4. Concluding Remarks

12. BIG PHARMA BIOPHARMACEUTICAL MANUFACTURING INITIATIVES IN CHINA
12.1. Chapter Overview
12.2. Scope and Methodology
12.3. List of Biopharmaceutical R&D and Manufacturing Initiatives of Big Pharma Players in China
12.3.1. Analysis by Number of Initiatives
12.3.2. Analysis by Year of Initiative
12.3.3. Analysis by Type of Initiative
12.4. Competitive Benchmarking of Big Pharma Players
12.4.1. Harvey Ball Analysis: Big Pharma Investment Summary

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
13.1. Chapter Overview
13.2. Assumptions and Key Parameters
13.3. Chines Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
13.4. Conclusion

14. MARKET SIZING AND OPPORTUNITY ANALYSIS
14.1. Chapter Overview
14.2. Key Assumptions and Forecast Methodology
14.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030
14.3.1. Biopharmaceutical Contract Manufacturing Market in China for APIs, 2020-2030
14.3.2. Biopharmaceutical Contract Manufacturing Market in China for FDFs, 2020-2030
14.4. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Expression System Used
14.4.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Mammalian Systems
14.4.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Microbial Systems
14.4.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Other Expression Systems
14.5. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Scale of Operation
14.5.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Preclinical / Clinical Scale Operations
14.5.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Commercial Operations
14.6. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Distribution by Size of Manufacturers
14.6.1. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Small Companies
14.6.2. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Mid-sized Companies
14.6.3. Biopharmaceutical Contract Manufacturing Market in China, 2020-2030: Share of Large / Very Large Companies

15. SWOT ANALYSIS
15.1. Chapter Overview
15.2. Strengths
15.3. Weaknesses
15.4. Opportunities
15.5. Threats
15.6. Comparison of SWOT Factors
15.7. Concluding Remarks

16. FUTURE OF THE CHINA BIOPHARMACEUTICAL CMO MARKET
16.1. Chapter Overview
16.2. Outsourcing Activities Anticipated to Increase in Future
16.3. Shift from One-time Contracts to Strategic Partnerships
16.4. Adoption of Innovative Technologies
16.4.1. Single Use Bioreactors
16.4.2. Novel Bioprocessing Techniques
16.4.3. Bioprocess Automation
16.5. Growing Popularity of the Quality by Design Principle in Bioprocessing
16.6. Increasing Focus on Niche Therapeutic Areas
16.7. Biosimilars Market to Contribute to Contract Service Revenues
16.8. Capability and Facility Expansions to Establish One Stop Shop Expertise
16.9. Increase in Financial In-flow and Outsourcing Budgets
16.10. Challenges Faced by Sponsors and Service Providers
16.10.1. Concerns Associated with Single Use Systems
16.10.2. Issues Related to Capacity Fluctuations
16.11. Concluding Remarks

17. INTERVIEW TRANSCRIPTS

18. APPENDIX 1: TABULATED DATA

Companies Mentioned

  • 3SBio
  • ABL Bio
  • AC Immune
  • Adagene
  • Adimmune
  • Almirall
  • Alvotech
  • Amaran Biotechnology
  • AmbioPharm
  • Amicus Therapeutics
  • AMW
  • Applied Biological Materials
  • Aravive Biologics
  • Arch Biopartners
  • Arcus Biosciences
  • AstraZeneca
  • Asymchem Laboratories
  • AutekBio
  • Bayer
  • BeiGene
  • Berkeley Lights
  • Bioasis Technologies
  • BioMarin Pharmaceutical
  • BJ Bioscience
  • Boehringer Ingelheim BioXcellence
  • Boyalife
  • Brii Biosciences
  • CANbridge Pharmaceuticals
  • Canton Biologics
  • Beijing CC-Pharming
  • Celltrion
  • Changchun High & New Technology Industry
  • ChemPartner
  • Chime Biologics
  • China Regenerative Medicine International
  • Chinese Academy of Medical Sciences
  • Chinese Peptide
  • Chinese General Hospital
  • CMAB Biopharma
  • CPC Scientific
  • CSBio
  • EirGenix
  • Eli Lilly
  • Encure Biopharma
  • EOC Pharma
  • Etinpro
  • Fapon Biopharma
  • Fuda Cancer Hospital
  • GE Healthcare
  • GeneMedicine
  • GeneQuantum Healthcare
  • GenScript
  • GlaxoSmithKline
  • GreenPak Biotech
  • Harbour BioMed
  • Henlius Biotech
  • Hile Bio-Technology
  • Hong Kong Institute of Biotechnology
  • Hummingbird Bioscience
  • Hybio Pharmaceutical
  • iBio
  • I-Mab Biopharma
  • Immune Pharmaceuticals
  • IncoCell Tianjin
  • Inhibrx
  • IQVIA
  • JHL Biotech
  • Jiangsu Provincial Center for Disease Control and Prevention
  • JOINN Biologics
  • Kanda BioTech
  • Levena Biopharma
  • Lonza
  • MabPlex
  • Mab-Venture Biopharma
  • MedImmune
  • Merck Millipore
  • Mycenax Biotech
  • Nan Fung Group
  • National Taiwan University Hospital
  • Navrogen
  • NBE-Therapeutics
  • Novartis
  • NovoCodex Biopharmaceuticals
  • Oxford BioTherapeutics
  • PaizaBio
  • Pall Corporation
  • Peking Union Medical College Hospital
  • Pfizer
  • Phanes Therapeutics
  • Pharmadule Morimatsu
  • Qilu Pharmaceutical
  • Regulus Therapeutics
  • Roche
  • Samsung Bioepis
  • Sandoz
  • Sanofi
  • ScinoPharm
  • Shanghai Jiao Tong University
  • Shenzhen Geno-immune Medical Institute
  • Shenzhen JYMed Technology
  • Stellar Biotechnologies
  • Sun Yat-sen University
  • Suzhou Kintor Pharmaceuticals
  • Taiwan Liposome Company
  • Taron Solutions
  • Therapure Biopharma
  • Thermo Fisher Scientific
  • ThermoGenesis
  • Thousand Oaks Biopharmaceuticals
  • Tsinghua University Innovation Center for Immune Therapy
  • UNC Lineberger Comprehensive Cancer Center
  • Vectron Biosolutions
  • Verseau Therapeutics
  • Vir Biotechnology
  • WuXi AppTec
  • WuXi Biologics
  • Yunfeng Capital
  • Zai Lab
  • Zhejiang Hisun Pharmaceutical
  • Zhejiang Teruisi Pharmaceutical

For more information about this report visit https://www.researchandmarkets.com/r/7gp78w

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