China Biosimilars Market Research Report, 2030

Biosimilars have played a significant role in alleviating healthcare burdens and enhancing patient access to high-quality biologic-based pharmaceutical therapies. The World Health Organization (WHO), as well as various national governments and regulatory agencies, have established corresponding regulations and guidelines to encourage the development of biosimilars. China, as a populous nation with a substantial demand for biologic therapies, has made substantial investments in the research and development (R&D) of a number of biosimilars, making it the global leader in terms of the number of biosimilar varieties developed and the companies involved. China is emerging as a global biotech leader, attracting significant investment and partnerships from multinational pharmaceutical companies. Its innovative therapies and biosimilars are gaining international traction, reshaping the industry despite ongoing challenges. In 2024, China solidified its position as a global hub for biotech innovation, drawing significant attention and investment from multinational pharmaceutical companies. By early 2022, over 60 pharmaceutical companies were involved in the development of copy biological products. As of September 2023, major international pharmaceutical companies in biosimilar development, including Amgen, Celltrion, Mylan, and Samsung Bioepis, have submitted 17 applications for biosimilars in China. These applications largely target antibody-based biosimilars such as adalimumab, bevacizumab, rituximab, and trastuzumab. According to the research report, “China Biosimilars Market Research Report, 2030” published by Actual Market Research, the China Biosimilars market is projected to grow with 18.84% CAGR by 2025-30. 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. 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."

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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. 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. Monoclonal antibodies (mAbs) are at the forefront of China's biosimilars industry, driven by a confluence of escalating healthcare demands, robust policy support, and a burgeoning domestic biopharmaceutical sector. These therapeutic proteins, which target specific antigens to treat complex diseases like cancer and autoimmune disorders, have become pivotal in modern medicine. In China, the mAbs market is experiencing rapid growth, with projections indicating a substantial increase in market value by 2025. The surge in mAbs' prominence is largely attributed to the rising incidence of chronic diseases, particularly various cancers, within the Chinese population. As the population ages and lifestyle-related health issues become more prevalent, the demand for targeted therapies has escalated. Monoclonal antibodies offer precision in treatment, minimizing damage to healthy cells and enhancing therapeutic efficacy. This has led to their widespread adoption in oncology and immunology. China's regulatory landscape has significantly bolstered the development and approval of mAb biosimilars. The National Medical Products Administration (NMPA) has streamlined approval processes, facilitating faster market entry for biosimilars. This regulatory support is complemented by the inclusion of mAb biosimilars in the National Reimbursement Drug List (NRDL), making them more accessible to patients. Domestically, Chinese biopharmaceutical companies have made significant strides in mAb biosimilar development. Companies like Henlius Biopharmaceuticals and Innovent Biologics have introduced biosimilars for treatments such as trastuzumab and adalimumab, respectively. These developments not only cater to the domestic market but also position China as a competitive player in the global biosimilars arena. Oncology is leading the biosimilars industry in China due to several interrelated factors that reflect both the country's shifting disease burden and strategic healthcare priorities. China faces a rising incidence of cancer, driven by an aging population, urbanization, lifestyle changes, and environmental factors, which has created an urgent demand for effective and affordable cancer therapies. Biosimilars, especially those targeting oncology, offer a cost-effective alternative to expensive originator biologics, making cutting-edge cancer treatments more accessible across diverse socioeconomic groups. Additionally, the Chinese government has implemented strong policies to encourage the development and adoption of biosimilars within oncology, including streamlined regulatory pathways by the National Medical Products Administration (NMPA) and the inclusion of key biosimilar oncology drugs in the National Reimbursement Drug List (NRDL), significantly improving patient access. Domestic biopharmaceutical companies have invested heavily in research and development of biosimilar oncology products, such as trastuzumab and rituximab, driven by both the large domestic market potential and ambitions to compete globally.

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Nikita Jabrela

Business Development Manager

In-house manufacturers are leading the biosimilars industry in China due to a combination of strategic, economic, and regulatory factors that favor vertical integration and domestic control over the biosimilar production process. Chinese biopharmaceutical companies have recognized the critical importance of maintaining end-to-end control over research, development, and manufacturing to ensure high quality, reduce production costs, and accelerate time-to-market key competitive advantages in the rapidly evolving biosimilars sector. The government’s strong support for local pharmaceutical manufacturing through policies under initiatives like “Made in China 2025” and the National Medical Products Administration’s emphasis on stringent quality standards have encouraged companies to invest heavily in state-of-the-art manufacturing facilities within the country. This approach not only mitigates supply chain risks associated with reliance on external contract manufacturers but also enhances proprietary technology development and intellectual property protection, which are crucial in biosimilar innovation. Additionally, in-house manufacturing enables greater flexibility and responsiveness to market demand fluctuations, regulatory changes, and customization of production processes specific to complex biologics. Many leading Chinese biosimilar developers, such as Innovent Biologics and Henlius, have built robust manufacturing capabilities that support their pipeline of monoclonal antibodies and other biologics, reinforcing their leadership in the domestic and increasingly global markets. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

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By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.