China Biologics Contract Manufacturing Market: Industry Trends and Global Forecasts - Distribution by Type of Product, Expression System Used, Scale of Operation, Company Size and Type of Biologic
CHINA BIOLOGICS CONTRACT MANUFACTURING MARKET: OVERVIEW
As per Roots Analysis, the global China biologics contract manufacturing market valued at USD 0.8 billion in the current year is anticipated to grow at a CAGR of 13% during the forecast period.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Product
APIs
FDFs
Expression System Used
Mammalian Systems
Microbial Systems
Other Expression Systems
Scale of Operation
Preclinical / Clinical Scale Operations
Commercial Operations
Company Size
Small Companies
Mid-sized Companies
Large / Very Large Companies
Type of Biologic
Antibodies
Vaccines
Other Biologics
CHINA BIOLOGICS CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS
Biologics represent one of the fastest growing segments of the pharmaceutical industry. This can
be attributed to the rapid pace of innovation in this field, driven by the need for effective and personalized pharmacological interventions. Notably, China which was the epicenter of the COVID-19 pandemic, is the world's second largest pharmaceutical market and accounts for nearly 20% of the global output of APIs. Further, with over 25 biologics and biosimilar products approved till date and close to 1,000 clinical trials being conducted to investigate a variety of biologics and biosimilars, the biologics contract manufacturing market in China is growing at a healthy pace. Apart from this, several benefits, such as lower manufacturing costs, enhanced reimbursement policies, availability of cheap and skilled labor and a supportive regulatory landscape, has facilitated China in becoming an attractive choice for various stakeholders engaged in the biologics contract manufacturing market.
It is worth noting that most of the contract service providers engaged in this domain have profound experience in niche and emerging areas. In addition, the innate expertise and availability of required capabilities, as well as infrastructure, enables such service providers to effectively fulfil the requirements of their clients, while eliminating costly oversights and reducing chances of product failure.
CHINA BIOLOGICS CONTRACT MANUFACTURING MARKET: KEY INSIGHTS
The report delves into the current state of the China biologics contract manufacturing market and identifies potential growth opportunities within industry. Some key findings from the report include:
Over 35 CMOs / CDMOs in China claim to offer a variety of services related to development and manufacturing of a wide range of biotherapeutic products.
Several players provide one-stop solutions and are capable of operating at various scales; the landscape includes a mix of both established players and new entrants.
At present, only a handful of firms claim to have capabilities for the manufacturing of novel biologics.
In order to tap the increasing opportunity for biologics in Asia-Pacific, China has emerged a preferred choice for CMOs.
To cater to the evolving needs of clients / sponsors, CMOs have established facilities across different regions of China; Eastern China, with the maximum number of sites, has emerged as a manufacturing hub.
With over 80 deals inked in past five years, there has been a surge in the partnership activity within this domain; majority of these collaborations were signed for the development and manufacturing of antibody-based products.
The number of partnerships signed within this domain has increased at a CAGR of 21% in the past few years.
More than 60% of the reported deals were inked in relation to clinical stage molecules.
Big pharma players have also made significant investments in this region, including establishing new facilities, expanding existing R&D centers and growing manufacturing facilities, focused on biotherapeutics.
Pfizer invested USD 350 million to establish a new state-of-art global biotechnology center in Hangzhou, China for the production of high quality biosimilars to meet both local and international demand.
Merck partnered with GenScript to establish a plasmid and viral vector manufacturing platform in order to expediate development and commercialization of cell and gene therapies in Chinese and global market.
We expect global biopharmaceutical developers to continue to outsource their manufacturing operations to China in the long term; the CMO industry in the region is likely to grow at an annualized rate of ~13%, till 2030.
Example Players in the China Biologics Contract Manufacturing Market
ChemPartner Biologics
JHL Biotech
JOINN Biologics
MabPlex
Mycenax Biotech
WuXi AppTec
CHINA BIOLOGICS CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE
Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the China biologics contract manufacturing market, focusing on key market segments, including [A] type of product, [B] expression system used, [C] scale of operation, [D] company size and [E] type of biologic.
Market Landscape: A comprehensive evaluation of companies offering contract manufacturing services for biopharmaceuticals in China, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] scale of operation, [D] location of headquarters, [E] number of manufacturing facilities, [F] location of facilities, [G] type of business segment, [H] type of manufacturing service(s) offered, [I] type of biologic(s) manufactured, [J] type of expression system(s) used, [K] type of bioreactor(s) used, [L] mode of operation, [M] type of packaging and [N] affiliations to regulatory accreditations and certifications.
Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the biopharmaceutical manufacturing market in China, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] scale of operation, [D] type of biologic, [E] focus area of the deal, [F] target indication, [G] most active players (in terms of number of partnerships signed) and [H] geography.
Recent Expansions: A comprehensive evaluation of expansion initiatives undertaken by contract manufacturers in China, based on several relevant parameters, such as [A] year of expansion, [B] type of expansion, [C] scale of operation of manufacturing facility, [D] type of biologic and [E] location of manufacturing facility.
Clinical Trial Analysis: An insightful analysis of clinical trials related to biopharmaceuticals conducted in China, based on several parameters, such as [A] trial registration year, [B] trial phase, [C] trial recruitment status, [D] type of sponsor / collaborator, [E] geography and [F] number of patients enrolled.
Capacity Analysis: A detailed analysis of installed capacity for manufacturing biopharmaceuticals in China, based on several parameters, such as [A] company size, [B] scale of operation, [C] key geographical regions and [D] expression system used.
Big Pharma Initiatives: A comprehensive analysis of the recent initiatives undertaken by big pharma players in China for the manufacturing of biopharmaceuticals, based on various relevant parameters, such as [A] number of initiatives, [B] year of initiative and [C] benchmark analysis of big pharma players.
Make Versus Buy Decision Making Framework: A detailed qualitative analysis, focusing on the various factors that need to be considered by drug / therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
Company Profiles: In-depth profiles of the companies that have a diverse range of capabilities for the development, manufacturing and packaging of biopharmaceutical products, focusing on [A] overview of the company, [B] financial information (if available), [C] service portfolio, [D] details related to manufacturing capabilities and facilities and [E] recent developments and an informed future outlook.
Case Study: A detailed comparison of the important characteristics of large and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
SWOT Analysis: An analysis of industry affiliated trends, opportunities and challenges, which are likely to impact the evolution of China biologics contract manufacturing market; it includes a Harvey ball analysis, assessing the relative impact of each SWOT parameter on industry dynamics.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading companies in this market?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?
REASONS TO BUY THIS REPORT
The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
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TABLE OF CONTENTS
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.2.1. Research Assumptions
1.2.2. Project Methodology
1.2.3. Forecast Methodology
1.2.4. Robust Quality Control
1.2.5. Key Considerations
1.2.5.1. Demographics
1.2.5.2. Economic Factors
1.2.5.3. Government Regulations
1.2.5.4. Supply Chain
1.2.5.5. COVID Impact / Related Factors
1.2.5.6. Market Access
1.2.5.7. Healthcare Policies
1.2.5.8. Industry Consolidation
1.3 Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Biopharmaceuticals
3.3. Manufacturing 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. Biopharmaceutical Outsourcing in China: Regulatory Scenario
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. Benefits of Engaging Chinese Contract Service Providers
3.9. Risks and Challenges Associated with Biopharmaceutical Contract Manufacturing
3.9.1. Challenges Associated with Engaging Chinese Contract Service Providers
3.10. Future Perspective
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 Manufacturing-Related 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 Facilities
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
6.2.2.1. Cell Line Development
6.2.2.2. Process Development
6.2.2.3. Formulation Development
6.2.2.4. Aseptic Filling and Freeze Drying
6.2.2.5. Drug Developability and Manuafcturing Study
6.2.2.6. Container Extractables and Leachables Study
6.2.2.7. Analytical Development and Testing
6.2.3. Manufacturing Facilities and Capabilities
6.2.4. Recent Developments and Future Outlook
6.3. JHL Biotech
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.2.1. Cell Line and Process Development
6.3.2.2. Analytical and Formulation Development
6.3.2.3. cGMP Manufacturing
6.3.2.4. Quality Systems
6.3.2.5. Regulatory Support
6.3.2.6. Project Management Services
6.3.3. Manufacturing Facilities and Capabilities
6.3.4. Recent Developments and Future Outlook
6.4. JOINN Biologics
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.2.1. Development Services
6.4.2.2. Manufacturing Services
6.4.2.3. Fill / Finish Services
6.4.2.4. Quality Assurance and Quality Control
6.4.3. Manufacturing Facilities and Capabilities
6.4.4. Recent Developments and Future Outlook
6.5 MabPlex
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.2.1. Development Services
6.5.2.2. GMP Manufacturing Services
6.5.3. Manufacturing Facilities and Capabilities
6.5.4. Recent Developments and Future Outlook
6.6. Mycenax Biotech
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.2.1. Cell Development Services
6.6.2.2. Process Development Services
6.6.2.3. Analytical and Quality Control
6.6.2.4. GMP Manuafacturing Services
6.6.3. Manufacturing Facilities and Capabilities
6.6.4. Recent Developments and Future Outlook
6.7. WuXi AppTec
6.7.1. Company Overview
6.7.2. Financial Information
6.7.3. Service Portfolio
6.7.3.1. Discovery Sciences
6.7.3.2. Development Services
6.7.3.3. Testing Services
6.7.3.4. Clinical Manufacturing Services
6.7.3.5. Commercial Manufacturing Services
6.7.3.6. Fill / Finish Operations
6.7.4. Manufacturing Facilities and Capabilities
6.7.5. Recent Developments and Future Outlook
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 Type of Partnership
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 Therapeutic Area
7.3.7. Most Active Players: Analysis by Number of Partnerships
7.3.8. Geographical Analysis
7.3.8.1. Geographical Distribution by Number of Partnerships
7.3.8.2. 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 Capacity of Expanded Facility
8.2.7. Most Active Players: Analysis by Number of Expansions
8.2.8. 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 Status
9.3.4. Geographical Analysis by Number of Clinical Trials
9.3.5. Geographical Analysis by Enrolled Patient Population
9.3.6. Analysis of Enrolled Patient Population by Trial Registration Year
9.3.7. Analysis of Enrolled Patient Population by Trial Phase
9.3.8. Analysi by Type of Sponsor / Collaborator
9.3.9. Most Active Players: Analysis by Number of Registered Trials
9.3.10. Analysis by Clinical Trial Center
10. REGIONAL CAPABILITY ANALYSIS
10.1. Chapter Overview
10.2. Assumptions and Key Parameters
10.3. Overall Landscape of Chinese Biopharmaceuticals Contract Manufacturers
10.4. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Northern China
10.5. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Eastern China
10.6. Regional Capability Analysis: Biopharmaceuticals Contract Manufacturers in Central China
10.7. 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 Expression System Used
11.3.4. Analysis by Location of Manufacturing Facility
11.3.5. Analysis by Company Size and Location of Manufacturing Facility
11.3.6. Analysis by Scale of Operation and Location of Manufacturing Facility
11.4. Concluding Remarks
12. BIG PHARMA BIOPHARMACEUTICAL MANUFACTURING INITIATIVES IN CHINA
12.1. Chapter Overview
12.2. List of Biopharmaceutical R&D and Manufacturing Initiatives of Big Pharma Players in China
12.2.1. Analysis by Number of Initiatives
12.2.2. Analysis by Year of Initiative
12.2.3. Analysis by Company and Year of Initiative
12.2.4. Analysis by Type of Initiative
12.2.5. Analysis by Type of Biologic
12.3. Competitive Benchmarking of Big Pharmaceutical Players
12.3.1. Harvey Ball Analysis: Big Pharma Investment Summary
12.3.2. Geographical Analysis by Investment Made
13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
13.1. Chapter Overview
13.2. Assumptions and Key Parameters
13.3. Chinese Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
13.3.1. Scenario 1
13.3.2. Scenario 2
13.3.3. Scenario 3
13.3.4. Scenario 4
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, Till 2035
14.3.1. Biopharmaceutical Contract Manufacturing Market in China for APIs, Till 2035
14.3.2. Biopharmaceutical Contract Manufacturing Market in China for FDFs, Till 2035
14.4. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Distribution by Expression System Used
14.4.1. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Mammalian Systems
14.4.2. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Microbial Systems
14.4.3. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Other Expression Systems
14.5. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Distribution by Scale of Operation
14.5.1. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Preclinical / Clinical Scale Operations
14.5.2. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Commercial Operations
14.6. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Distribution by Company Size
14.6.1. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Small Companies
14.6.2. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Mid-sized Companies
14.6.3. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Large and Very Large Companies
14.7. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Distribution by Type of Biologic
14.7.1. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Antibodies
14.7.2. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Vaccines
14.7.3. Biopharmaceutical Contract Manufacturing Market in China, Till 2035: Share of Other Biologics
15 COVID-19 Impact on China Biopharmaceutical CMO Market
15.1. Chapter Overview
15.2. Current Opinions and Recuperative Initiatives of Key Players
15.2.1. WuXi AppTec
15.2.2. Boehringer Ingelheim
15.2.3. GE Healthcare
15.2.4. Lonza
15.2.5. AmbioPharm
15.2.6. Impact on China Biopharmaceutical Contract Manufacturing Market
16. SWOT ANALYSIS
16.1. Chapter Overview
16.2. Strengths
16.3. Weaknesses
16.4. Opportunities
16.5. Threats
16.6. Comparison of SWOT Factors
16.7. Concluding Remarks
17. FUTURE OF THE CHINA BIOPHARMACEUTICAL CMO MARKET
17.1. Chapter Overview
17.2. Outsourcing Activities Anticipated to Increase in Future
17.3. Shift from One-time Contracts to Strategic Partnerships
17.4. Adoption of Innovative Technologies
17.4.1. Single Use Bioreactors
17.4.2. Novel Bioprocessing Techniques
17.4.3. Bioprocess Automation
17.5. Growing Popularity of the Quality by Design Principle in Bioprocessing
17.6. Increasing Focus on Niche Therapeutic Areas
17.7. Biosimilars Market to Contribute to Contract Service Revenues
17.8. Capability and Facility Expansions to Establish One Stop Shop Expertise
17.9. Increase in Financial In-flow and Outsourcing Budgets
17.10. Challenges Faced by Sponsors and Service Providers
17.10.1. Concerns Associated with Single Use Systems
17.10.2. Issues Related to Capacity Fluctuations
17.11. Concluding Remarks
18. INTERVIEW TRANSCRIPTS
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANISTIONS