China Biosimilars Market Analysis Report 2022 to 2030

China Biosimilars Market Analysis

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China's biosimilar market size was valued at $1.54 Bn in 2022 and is estimated to expand at a CAGR of 23.7% from 2022 to 2030 and will reach $8.46 Bn in 2030. The market is segmented by product type and indication type. The China biosimilar market will grow as the Chinese biosimilar market is driven by its cost-effective manufacturing capabilities. The key market players are Bio-Thera Solutions (CHN), Innovent Biologics (CHN), Shanghai Henlius Biotech (CHN), MabSpace Biosciences Co. (CHN), and others.

ID: IN10CNPH026 CATEGORY: Pharmaceuticals GEOGRAPHY: China AUTHOR: Chandani Patel

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China Biosimilars Market Executive Summary

China's biosimilar market size was valued at $1.54 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 23.7% from 2022 to 2030 and will reach $8.46 Bn in 2030. Between 2018 and 2021, 13 new biosimilars were licensed in China, bringing the total number of approved biosimilars in the nation to 20. This is a considerable increase over the previous three years. With China's significant biosimilar pipeline, this trend looks destined to continue. China has a substantial generic business even though it offers generic versions of practically all drugs. Yet, biosimilar drugs make up just 0.002% of all commercially available drugs.

China's market for biosimilars is tiny and lags behind markets in nations like Japan and South Korea in the Asia-Pacific (APAC) region. Presently, Japan has 26 approved biosimilars, compared to South Korea's 18 authorized biosimilars. Until the most current boom, which began in 2019, there were no authorized biosimilars available in China.

To support China's biosimilar industry, the country's regulatory agency, the National Medical Products Administration, established new rules and regulations (NMPA). The NMPA issued the first rules for a recognized biosimilar pathway within China in 2015, ten years after the EU created the first-ever regulatory pathway for biosimilars in 2006 and nearly six years after South Korea and Japan put their own frameworks in place in 2009. This new regulatory strategy provided standardized standards for the development and assessment of biosimilars as well as specified criteria for preclinical R&D, clinical trials, and manufacturing.

This is encouraging the development of biosimilars in China, along with the growing cost of biological drugs. In February 2019, China's first official biosimilar obtained clearance. The rituximab biosimilar HLX01 was developed by Shanghai Henlius Biopharmaceutical to treat non-lymphoma (NHL). As a result, China's bisimilar market will expand in the years to come.

China biosimilar market report 2022 to 2030

Market Dynamics

Market Growth Drivers

China continues to approve new biosimilars; for instance, in 2020, seven new biosimilars received approval, a 75% increase from the previous year, when just three more biosimilars did. Two biosimilar products were previously approved by China in H1 2021. Infliximab and bevacizumab biosimilars from Mabpharm Ltd. and Luye Pharma Group Ltd., respectively, were authorized in 2021 for the treatment of non-small cell lung cancer and ankylosing spondylitis. With roughly 100 biosimilars in development and 11 biosimilar medications presently awaiting NMPA certification, the rise in Chinese biosimilars will definitely continue in the future.

The present surge in biosimilars has reportedly allowed China to overcome South Korea and move up to second position behind Japan, becoming one of the top markets for biosimilars in just three years, according to a number of approvals. It is projected that China's biosimilar markets would reach new heights as a result of the recent regulatory changes made by the NMPA and the country's strong biosimilar pipeline.

Market Restraints

Many patent-related problems, such as patent litigation and the impossibility to produce biosimilars until the patent on the reference product has expired, are faced by biosimilar producers in China. This may reduce the number of products on the market and postpone the introduction of biosimilars.

Despite China's well-established regulatory framework for biosimilars, businesses nevertheless face significant challenges. For instance, the regulatory process may be drawn out and unpredictable, and the nuances of the regulatory system may not be totally clear.

Competitive Landscape

Key Players

Bio-Thera Solutions, Ltd. (CHN)
Innovent Biologics, Inc. (CHN)
Shanghai Henlius Biotech, Inc. (CHN)
MabSpace Biosciences Co., Ltd. (CHN)
Shenzhen Mellow Hope Pharm Industrial Co., Ltd. (CHN)
Jiangsu Hengrui Medicine Co., Ltd. (CHN)
Qilu Pharmaceutical Co., Ltd. (CHN)
Gan & Lee Pharmaceuticals Co., Ltd. (CHN)
Fosun Pharma (Shanghai) Co., Ltd. (CHN)
Chengdu Kanghong Biotech Co., Ltd. (CHN)
Pfizer Inc. (USA)
Amgen Inc. (USA)
Roche Holding AG (Switzerland)
Merck & Co., Inc. (USA)
Sanofi S.A. (France)
Novartis International AG (Switzerland)
Eli Lilly and Company (USA)
AbbVie Inc. (USA)
AstraZeneca plc (UK)
GlaxoSmithKline plc (UK)

Recent Developments

In 2021, Johnson & Johnson and Biological E Ltd. formed a cooperation for the development and marketing of a COVID-19 vaccine in China. While not a biosimilar, this collaboration demonstrates China's rising interest in biologics and vaccines.

In order to introduce a biosimilar form of adalimumab in Brazil, Biocon Biologics formed a cooperation with Libbs Farmaceutica in 2021.

Healthcare Policies and Regulatory Landscape

The Chinese Center for Drug Evaluation released its first and last biosimilars guidance in 2015, delivering a strong signal to all industry players regarding the future of biosimilars in China. The suggestions outline the key ideas for the study, development, and evaluation of biosimilars. In order to be equivalent to the original drug in terms of quality, safety, and efficacy, a biosimilar drug must have the exact same amino acid sequence.

A revolutionary biological medication that has a patent protecting it is from China. Even if it has received CDNA approval, it must be licensed by the China National Drug Administration (CNDA) throughout the time of the biosimilars' comparative clinical trials and cannot be a different biosimilar. Both the European Union and the United States share the same definitions of biosimilars. A biosimilar is a biological product that is essentially the same as and does not significantly differ clinically from a reference product that has already been authorized by the FDA in the United States.

In terms of structure, biological activity, effectiveness, safety, and immunogenicity profile, a biosimilar is a biological medication that is very similar to another biological treatment that has already been approved in the EU and is referred to as "reference medicine."

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

China Biosimilars Market Segmentation

By Product

The monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, enoxaparin sodium, glucagon, and calcitonin are among the product categories that make up the biosimilars market. Monoclonal antibodies held a sizable portion of the market in 2020. The market is being driven by elements including the widespread use of monoclonal antibodies in the treatment of autoimmune diseases, cancer, and osteoporosis, as well as the affordability of such treatments.

Monoclonal Antibodies
- Infliximab
- Trastuzumab
- Rituximab
- Adalimumab
- Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
Insulin
Granulocyte Colony-Stimulating Factor
Erythropoietin
Recombinant Human Growth Hormone
Etanercept
Follitropin
Teriparatide
Interferons
Enoxaparin Sodium
Glucagon
Calcitonin

By Indication

The biosimilars market is divided into oncology, autoimmune and inflammatory diseases, chronic illnesses, blood disorders, growth hormone insufficiency, infectious diseases, and other indications based on the indication (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). The market's largest sector in 2020 will be oncology. This market is expanding as a result of elements like the reduced cost of biosimilars compared to novel biologics and the increased incidence and prevalence of cancer.

Oncology
Inflammatory & Autoimmune Disorders
Chronic Diseases
Blood Disorders
Growth Hormone Deficiency
Infectious Diseases
Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

Methodology for Database Creation

Our database offers a comprehensive list of healthcare centers, meticulously curated to provide detailed information on a wide range of specialties and services. It includes top-tier hospitals, clinics, and diagnostic facilities across 30 countries and 24 specialties, ensuring users can find the healthcare services they need.

Additionally, we provide a comprehensive list of Key Opinion Leaders (KOLs) based on your requirements. Our curated list captures various crucial aspects of the KOLs, offering more than just general information. Whether you're looking to boost brand awareness, drive engagement, or launch a new product, our extensive list of KOLs ensures you have the right experts by your side. Covering 30 countries and 36 specialties, our database guarantees access to the best KOLs in the healthcare industry, supporting strategic decisions and enhancing your initiatives.

How Do We Get It?

Our database is created and maintained through a combination of secondary and primary research methodologies.

1. Secondary Research

With many years of experience in the healthcare field, we have our own rich proprietary data from various past projects. This historical data serves as the foundation for our database. Our continuous process of gathering data involves:

Analyzing historical proprietary data collected from multiple projects.
Regularly updating our existing data sets with new findings and trends.
Ensuring data consistency and accuracy through rigorous validation processes.

With extensive experience in the field, we have developed a proprietary GenAI-based technology that is uniquely tailored to our organization. This advanced technology enables us to scan a wide array of relevant information sources across the internet. Our data-gathering process includes:

Searching through academic conferences, published research, citations, and social media platforms
Collecting and compiling diverse data to build a comprehensive and detailed database
Continuously updating our database with new information to ensure its relevance and accuracy

2. Primary Research

To complement and validate our secondary data, we engage in primary research through local tie-ups and partnerships. This process involves:

Collaborating with local healthcare providers, hospitals, and clinics to gather real-time data.
Conducting surveys, interviews, and field studies to collect fresh data directly from the source.
Continuously refreshing our database to ensure that the information remains current and reliable.
Validating secondary data through cross-referencing with primary data to ensure accuracy and relevance.

Combining Secondary and Primary Research

By integrating both secondary and primary research methodologies, we ensure that our database is comprehensive, accurate, and up-to-date. The combined process involves:

Merging historical data from secondary research with real-time data from primary research.
Conducting thorough data validation and cleansing to remove inconsistencies and errors.
Organizing data into a structured format that is easily accessible and usable for various applications.
Continuously monitoring and updating the database to reflect the latest developments and trends in the healthcare field.

Through this meticulous process, we create a final database tailored to each region and domain within the healthcare industry. This approach ensures that our clients receive reliable and relevant data, empowering them to make informed decisions and drive innovation in their respective fields.