Impact of China on the Pharmaceutical Industry – Thematic Research

Pages: 117 Published: October 01, 2021 Report Code: GDHCHT282

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Over recent years, driven by regulatory reforms and national strategic initiatives to support healthcare innovation, the Chinese pharma industry has shifted away from a focus on generics and towards R&D of innovative treatments. More domestic companies are now investing in drug discovery and development in areas of IO and regenerative medicine. Where previously, drugs to address healthcare gaps were in-licensed from big pharma or biotech, more domestic companies are now out-licensing their innovative products to major companies. The Chinese government has also sought to make the market more accessible to international drug companies and has implemented many regulatory changes to allow for faster drug approvals and clearer guidelines. China’s pharma industry has been transformed as a result and is the second largest globally after the US. According to the China Statistical Yearbook, it was valued at $72.1B in 2012 and grew to $149.8B in 2019. It is expected to reach $468.2B by 2029 at a compound annual growth rate (CAGR) of 12.1%. Other factors driving the growth of the Chinese pharma market include its rapidly aging population, increased prevalence of chronic conditions, and the expansion of social health insurance.

Scope

This report provides an assessment of the major industry, regulatory, macroeconomic, and technology trends shaping the Chinese pharma industry. It provides detailed analysis of deals, clinical trials, marketed and pipeline products, and contract manufacturing. It also provides an overview of key regulatory and market access information, market drivers and barriers, and key players in the Chinese pharma sector.

Key Highlights

China has the second largest pharma market in the world behind the US. The government has identified biopharma as a key industry for economic development. Recent regulatory reforms and national strategic initiatives are shifting focus from generics and towards R&D innovation. The Chinese government has implemented many regulatory changes to allow for faster drug approvals and clearer guidelines, and to attract international companies. This includes accepting data from non-Chinese clinical trials and the establishment of four accelerated approval pathways. In addition, its 10-year Made in China 2025 initiative is intended to strengthen innovation, develop an efficient domestic supply chain, and transform China into a manufacturing superpower.

China is a leader in generics manufacturing, with approximately 90% of currently marketed products in the country generic. The China biosimilars market, while currently limited, will likely see significant growth over the next few years as there are over 100 biosimilars currently in development. China aims to continue to lead in the generics space but China’s recent incentives for domestic innovation are shifting the emphasis from generic to innovative drugs. Factors driving the growth of the biosimilars market include the establishment of a biosimilars pathway in 2105, changes made to reduce costs and barriers for companies performing R&D, increased reimbursement of biologics, as well as a greater acceptance of non-originator brands.

China is an emerging player in the regenerative medicine research space, with over 320 cell and gene therapies in the pipeline. The main factors driving this sector are well-defined regulations on quality, well-developed infrastructure for conducting biomedical clinical trials, and government–industry collaborations focusing on innovation. However, the international scientific community has raised concerns about the quality and availability of data behind some regional advanced therapy approvals. Therefore, advances in regenerative medicines in China might not extend to other regions if ethical or efficacy standards are not met.

Increased domestic development of immuno-oncology (IO) drugs in China is expected to compete with geographic expansion of global IO developers to China over the next few years. There are almost 400 pipeline IO drugs in development in China, 90% of which are being developed by Chinese companies. R&D of domestically developed immune checkpoint inhibitors has been a particular focus of the Chinese government. In addition, the majority of IO (and regenerative medicine) drugs are CAR-T cell therapies. While there is significant focus on IO and regenerative medicine development, there are few API biologic facilities in China to manufacture these products, when compared to API chemical manufacturing capabilities.

China is a global leader in API chemical manufacturing and has the largest number of API chemical manufacturing facilities in the world. However, manufacturing scandals, the ongoing US trade war, and COVID-19 supply chain disruptions could negatively impact its position in this area. Concerns over China’s history of manufacturing contamination scandals, including API, could damage the country’s reputation abroad, at the critical time when the government is striving to promote the industry on a global scale. President Biden has flagged the US’ dependence on China as a national security threat based on supply chain issues that occurred during the COVID-19 pandemic and highlighted plans to move pharma manufacturing from China to the US. However, the pharma industry has largely been wary of these plans, and it remains unlikely that any significant changes will be made to API supply from China.

China is a leader in many emerging technologies such as artificial intelligence (AI), 5G, and 3D printing, all of which have the potential to transform the pharma industry and the wider healthcare industry. China is poised to become a leader in emerging technologies in pharma based on the foothold it has in many of these areas. There are several examples of companies utilizing AI, 3D printing, and 5G in drug R&D and manufacturing, which will lead to more efficient and cost-effective pharma smart processes.

Reasons to Buy

See what trends are shaping the Chinese pharma market and driving innovation, including key government policies and strategic initiatives.

See how emerging areas such as immuno-oncology, regenerative medicine, and biosimilars are developing.

Get an analysis of China's strong manufacturing and outsourcing sector, including plans to further strengthen these capabilities.

See how emerging technologies such as 5G, artificial intelligence, and 3D printing are set to drive pharma innovation in China.

Table of Contents

Table of Contents

Abbreviations

Related Reports

Executive Summary

• Key Findings

Introduction

• National Strategic Plans and Regulatory Reforms Are Driving Growth and Transformation of the Chinese Pharma Market

• Big Pharma Is Investing in China with Deals and Investment in R&D Centers

• Overview of Disease Prevalence in China

• Forecast Diagnosed Prevalence of Top Indications in China

• Key Influencer Twitter Chat Related to China

Trends

• The China Pharma Market Is Dominated By Generics

• The Biosimilars Market Is Set to Expand

• China Is Striving to Build Its Regenerative Medicine Sector

• China Is Also Building Its Immuno-Oncology Footprint

• China Has Strong Manufacturing and Outsourcing Capabilities

• Plans to Boost Manufacturing in West China

• Made in China 2025 Aims to Drive Further Manufacturing in China

• Drug Pricing Reforms to Increase Access to Innovative Drugs

• Medical Tourism Is Developing in China

• US-China Relations

• Shedding the Pharma Industry’s Poor Reputation in China

• Healthy China 2030 Aims to Improve the Overall Health of the Chinese Population

• Regulatory Reforms to Attract Overseas Companies

• China Is a Global Leader in 5G

• China’s Emerging 3D Printing Industry

Value Chain

Market Analysis

• China Pharma Market Expected to See Major Growth by 2029

• The Number of Pharma Deals in China Has Increased Since 2017

• Funding and Strategic Alliances Are Leading Deal Types in China

• Acquisitions Lead M&A Activity in China

• Top 10 M&A Deals 2018–2021: Chinese Companies

• Top 10 M&A Deals 2018–2021: International Companies

• Licensing Agreements and Oncology Dominate Strategic Partnerships

• Examples of Strategic Partnerships 2018–2021: Chinese Companies

• Examples of Strategic Partnerships 2018–2021: International Companies

• Financing Focuses on Biologics in Oncology across China

• Top Funding Deals 2018–2021: Chinese Entities

• Examples of Emerging Technology Deals 2018–2021

• China Pharma Market Jobs Analysis

Clinical Trials

• The Number of Clinical Trials in China Has Risen Over the Past Decade

• The Majority of Trials in China Are Early Phase

• Oncology Indications Dominate Clinical Trials in China

• The Majority of Clinical Trials in China Are Run by Chinese Entities

• Top 10 Clinical Trials Sites in China by Historical Volume

• Top 10 Clinical Trial Investigators in China by Historical Volume

• Top 10 Trials in China by Completed Enrollment Since 2019Marketed Products

• Most Marketed Drugs in China Are Developed by Chinese Companies

• Generics Have the Largest Share of Marketed Drugs in China

• China’s Position in the Global Generics Manufacturing Market

• Leading Generics Manufacturers in China

• Majority of Marketed Drugs Are for Bacterial Infections

• The Majority of Biologics Are Used to Treat Infectious Disease

• Most Companies Marketing Biologics in China Are Chinese

• Examples of China-Made Biologics (Innovator, Vaccines, etc.)

• Currently Approved COVID-19 Vaccines in China

• China Leads in Number of COVID-19 Vaccinations

• The Majority of Marketed Biosimilars Are Developed in China

• Examples of Marketed Biosimilars in China

• Many Marketed IO Drugs Are from International Companies

• Examples of Immuno-oncology Drugs from Chinese Companies

Pipeline Products

• Majority of Pipeline Drugs Are Developed by Chinese Companies

• Majority of Pipeline Drugs Are in Phase II or Lower, and Most Are Innovator Biologics

• Oncology Overwhelmingly Drives the Drug Pipeline in China

• Most Innovator Biologics and Biosimilars Are Also in the Oncology Space

• Examples of Late-Stage Pipeline Biologics in China

• Examples of Late-Stage Pipeline Biosimilars in China

• Regenerative Medicine Is a Rapidly Growing Sector in China

• Most Pipeline Regenerative Medicines Are in Early Stages of Development by Chinese Research Institutes

• The Highest Number of Regenerative Medicine Clinical Trials That Started in 2020 Were in China

• However, Phase II and Phase III Trials Have Been Impacted By A Gene-Editing Scandal

• Examples of Regenerative Medicines in China

• Domestic Companies Are Developing the Vast Majority of Novel Pipeline Immuno-oncology Drugs in China

• Majority of Pipeline Drugs Are in Phase II or Lower, and Most Are CAR-T Cell Therapies

• Examples of Late-Stage Pipeline Immuno-oncology Drugs

• Pipeline COVID-19 Vaccines and Treatments in China

• Examples of Pipeline COVID-19 Vaccines and Treatments

Contract Manufacturing in China

• Companies with Different Contacting Manufacturing Facilities in China

• China Is a Global Leader in API Chemical Manufacturing

• Outsourcing Deals for Biologic Manufacturing Are Increasing in China

• WuXi Has the Most CDMO Facilities and Has Forged the Most Outsourcing Deals in China

• West China Is Noticeably Lacking CDMO Facilities

• Examples of Contract Manufacturing Deals – Biosimilars/Biologics

• Examples of Contract Manufacturing Deals – Gene and Cell Therapy

• Examples of Contract Manufacturing Deals – COVID-19

Regulatory and Market Access

• Drug Approval Process in China

• Regulatory Reforms in China

• Regulation of Drugs in China

• Market Access for Drugs in China

Market Drivers and Barriers

• Market Drivers in China

• Market Barriers in China

Companies

Appendix

• Bibliography

• Key Themes Impacting the Pharmaceutical Industry

• Our Thematic Research Methodology

• About the Authors

• Contact Us

• Disclaimer

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