Table of Content

Chapter 1: Introduction: Brief History Of China Biopharma Service Industry
Service and Business Model of a Biologics CMO
Business model of CDMOs
Biologics CDMOs Have High Barrier for Entry in China
Strong Growth Provides CMO Opportunities
History of China’s Biologics CMOs and Policy Impacts
History of China’s Biologics CMO
Chapter 2: Legal Framework of MAH, Government Subsidy Program And Implications
Introduction of MAH-related guidelines in Drug Administration Law (2019)
Current Status of MAH in China
Issues in MAH Implementation
Issues with Current Regulatory Framework
Government Subsidy Programs Related to MAH
Impact of MAH and Subsidy Programs on CDMOs
Chapter 3: Innovation in China Biopharma And Outsourcing of Commercial Scale Bioprocessing Domestic Developers Prefer In-house Manufacturing
Innovative Products More Likely Outsourced
Domestic Developers Progress in Innovation
Diversification Taking Place, but Pathway Remains Crowded
Biobetter vs. First-In-Class mAbs: A Major Trend
Company Pipelines and Capacity Needs for Chinese CMOs
Domestic CMO Capacity Needs in 5 Years
CMO Commercial Scale Bioprocessing Trends in China
CMO expanding capacity to reduce production costs
Chinese CMO Cost Reduction Efforts
More Commercial Scale CMO Bioprocessing Coming
Developers Becoming CMOs
Chapter 4: Who Uses China-Based Biologics CMOs
Using China-based CMOs for Western Markets
Case Studies
a. WuXi Biologics – TaiMed
b. WuXi Biologics – Shanghai Hile Biopharmaceutical
c. WuXi Biologics – Amicus
Overseas Clients Targeting China Markets
Case Studies
a. JHL Biotech – Sanofi
b. WuXi Biologics – AC Immune SA
Domestic CMO Clients Targeting Western
Case Studies
a. MabPlex – Encure Biopharma
b. WuXi Biologics – Ambrx – ZMC
Domestic Clients Targeting Domestic Markets
Case Studies
a. ShellBio – Lunan Pharma
b. Tobio Pharm – Zelgen Biopharma
How Domestic Clients Make ?Make vs. Buy’ Decisions
Key Attributes in Selection of CMO
Chapter 5: China-Based Biologics CMOs
Idle Capacity Issue
Hiring Challenges Today
Summary of the China Biologics CMO Landscape
Categorization of China CMOs
Trends Among China Biologics CMOs
Overall Conclusion
Chapter 6: Domestic Biologics CMOs vs. MNC Biologics CDMOs
Strengths of Domestic Biologic CDMOs vs. MNC Biologics CDMOs
Weaknesses of China Biologics CDMOs vs. MNC Biologics CDMOs
Opportunities and Threats for China Biologics CDMOs
Strength, Weakness, and Threats of MNC CMOs
AppendIx I: Biopharmaceutical-Devoted CDMOs
AppendIx II: Companies With Biologics Development and CMO Operations
AppendIx III: Developer Companies Also CMOs



List of Figures


Fig 1: Growth of China Biologics and Percentages of Each Category
Fig 2: CAGR and Market Size of the China Biologics in General Biopharmaceuticals and Monoclonal Antibodies
Fig 3: China Biologics Manufacturing Geographic Distribution by Chinese Province/Region
Fig 4: Investment Financing Amount and Number of Investment Cases from 2010- 2018
Fig 5: Ratio of biopharmaceutical investment for each subsector (2019)
Fig 6: China’s Monoclonal Antibody Manufacturers and Number of INDs/year
Fig 7: Cost Comparison Between Single use and Stainless Steel Technology
Fig 8: Plant facility Time-To-Ready Comparison Between Single Use Technology and Stainless Steel Technology
Fig 9: China Bioprocessing Manufacturing Costs Distribution
Fig 10: Market share of the Analytical Instruments (Assays) in China
Fig 11: Influencing Factors of The Cost for Upstream Bioprocess
Fig 12: China’s Distribution Channels of Bioprocess Equipment and Consumables
Fig 13: Sample Organization Chart of Distributor Management Execution Team
Fig 14: Distributors Management System Framework
Fig 15: Distributors’ Value Chain
Fig 16: Distribution Structure of Vendor in Case 1
Fig 17: Framework of the Distribution Channel Management
Fig 18: Relationship Between Number of End Users and the Sales Cost
Fig 19: Distribution Extension and Breadth
Fig 20: Influencing Factors of the Distribution Extension
Fig 21: Power Shift Diagram in The Distribution Chain

 

List of Tables


Table 1 Number of Follow-on Biopharmaceuticals in the Pipeline by Countries Where Involved Companies Have Their Headquarters*
Table 2 Some of the NMPA Approved Biologics and The Relevant Processing Bioreactors
Table 3 Partial List of mAbs in NRDL and Price Reduction
Table 4 Merits of Different Distribution & Sales Model
Table 5 End User Perspectives of Evaluation Indicators for Suppliers
Table 6 Evaluation Indicators for Suppliers/Vendors to Select Chinese Distributors
Table 7 Existing Distributor Annual Performance Indicators
Table 8A Active Bioprocessing-related Distributors in China
Table 8B Life Sciences and Equipment-related Active Distributors in China
Table 9 Some Concerns When Considering Chinese Distributors