Growth of Biopharmaceutical Contract Manufacturing Organizations in China: An In-depth Study of Emerging Opportunities
BioPlan Associates’ report on the China Contract Manufacturing Organizations (CMOs) industry cover regional industry developments, regulatory and legal changes, and reviews China’s major CMO and CDMO companies with facility information, company ownership, background, management and facility capacity and history. This study is based on in-depth research, using public secondary and primary information resources. This is an on-going project that will be updated in the future to provide trends information, and relevant new in-depth insights into the rapidly growing and changing Chinese biologics industry.
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
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
