Asia-Pacific Biosimilars Market Outlook, 2030

The Asia Pacific region, comprising countries such as China, India, Japan, South Korea, Australia, and Southeast Asian nations, plays an increasingly pivotal role in the global biosimilars market due to its growing manufacturing capabilities, improving regulatory frameworks, and expanding patient base. While Asia-Pacific is the quickest-growing market for biosimilars due to low production costs, skilled and cheap labor availability, slender regulations laid down by governments, there are, however, high for manufacturing and sophistication, and the prevalence on the market of economically priced generic drugs, which has come forward as some of the biosimilars market's main constraints.

In addition to Japan and South Korea, several other countries in Asia Pacific are also working to promote the use of biosimilars. India, for example, has a growing biosimilar industry and has become a major supplier of biosimilars to other countries. The country's government has also taken steps to promote the use of biosimilars, such as introducing guidelines for biosimilar development and providing incentives to manufacturers. Governments across the region have recognized the importance of biotechnology in healthcare and economic growth, providing incentives for R&D and manufacturing. For example, China’s “Made in China 2025” initiative emphasizes biosimilars as a strategic industry, encouraging domestic innovation and production.

Similarly, India’s biosimilar industry benefits from government policies aimed at enhancing biotech exports and quality standards. Certification processes such as approvals from regulatory bodies like Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), China’s National Medical Products Administration (NMPA), India’s Central Drugs Standard Control Organization (CDSCO), and the ASEAN harmonized guidelines are critical to ensuring product safety and efficacy.

According to the research report "Asia Pacific Biosimilars Market Outlook, 2030," the Asia Pacific Biosimilars market is anticipated to grow at more than 19.34% CAGR from 2025 to 2030. The biosimilars market in Asia Pacific is a dynamic and rapidly evolving industry, with several key players leading the way. Some of the major companies operating in this space include Celltrion, Samsung Bioepis, Dr. Reddy's Laboratories, Biocon, and Shanghai Henlius Biotech. These companies have been instrumental in developing and commercializing biosimilars in the region, and are expected to continue driving innovation and growth in the coming years.

Japan is another country that has been actively promoting the use of biosimilars. The country's regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), has been working to streamline the approval process for biosimilars, making it easier for manufacturers to get their products approved. In February 2019, China’s first official biosimilar was approved. The rituximab biosimilar HLX01 was developed by Shanghai Henlius Biopharmaceutical for the treatment of Non-Hodgkin’s Lymphoma (NHL). Three more biosimilars were approved in China in 2019, and seven biosimilars were approved in 2020, at an increase of 75% between 2019 and 2020.

A bevacizumab biosimilar by Luye Pharma Group Ltd was approved in May 2021 for non-small cell lung cancer, and an infliximab biosimilar by Mabpharm Ltd was approved in July 2021 for ankylosing spondylitis. Consumer preferences in the region have also shifted decisively towards biosimilars, influenced by factors such as affordability, improved healthcare coverage, and increased confidence in biosimilar efficacy and safety.

Patients and physicians, particularly in countries with limited healthcare budgets, view biosimilars as viable and effective alternatives to expensive original biologics, enabling broader patient access to critical treatments for conditions like cancer, rheumatoid arthritis, and diabetes. Additionally, awareness campaigns and educational initiatives by governments and industry stakeholders have played a vital role in dispelling misconceptions around biosimilars, fostering greater acceptance and uptake.

Market Drivers

Large Patient Population and Rising Demand for Affordable Biologics: The Asia-Pacific region, home to more than half of the world’s population, has a high and growing burden of chronic diseases such as cancer, diabetes, and autoimmune disorders. The increasing incidence of these conditions has created a strong demand for biologic treatments. However, the high cost of originator biologics makes them inaccessible to much of the population. This has made biosimilars a highly attractive solution, offering more affordable yet effective alternatives. Countries like India and China are leveraging biosimilars to expand access to treatment, reduce healthcare costs, and meet the growing needs of underserved patient populations.

Government Initiatives and Local Manufacturing Support: Governments across the Asia-Pacific region are actively supporting the development and use of biosimilars through favorable policies, investment in domestic biotech infrastructure, and regulatory reforms. Countries like India, South Korea, and China have developed national biosimilar guidelines aligned with WHO standards and are promoting local manufacturing capabilities to ensure supply chain resilience. For example, South Korea has become a global hub for biosimilar development, with companies like Celltrion and Samsung Bioepis leading innovation. These initiatives not only boost domestic industry growth but also position these countries as major exporters of biosimilars globally.

Market Challenges

• Regulatory Inconsistencies Across Countries: Unlike the European Union, the Asia-Pacific region lacks a unified regulatory framework for biosimilars. While countries like Japan, South Korea, and Australia have well-defined guidelines, others are still developing or refining their regulatory pathways. This regulatory fragmentation poses a challenge for companies looking to launch biosimilars across multiple markets. It increases time-to-market, compliance costs, and the need to conduct country-specific trials or dossier adjustments, making market expansion more complex and less efficient.
• Limited Awareness and Trust Among Physicians and Patients: Despite increasing regulatory approvals, physician and patient awareness of biosimilars remains limited in several Asia-Pacific markets. Concerns about biosimilar safety, efficacy, and interchangeability persist, particularly in countries with less exposure to global clinical data or post-marketing surveillance systems. Educational efforts and real-world evidence are often lacking or fragmented, making it harder for healthcare professionals to confidently prescribe biosimilars. This skepticism can slow uptake and limit the potential impact of biosimilars in markets that would otherwise benefit significantly from cost-effective treatment options.

Market Trends

• Growing Role of Regional and Global Partnerships: There is a strong trend toward strategic alliances between local biotech firms and multinational pharmaceutical companies. These partnerships help combine local market knowledge and cost-effective manufacturing with global expertise in regulatory navigation and commercialization. For instance, Indian companies like Biocon have partnered with Mylan (now part of Viatris) to bring biosimilars to global markets. Such collaborations are accelerating biosimilar development, increasing exports from Asia-Pacific, and enhancing competitiveness on the global stage.
• Expansion of Biosimilar Exports and Global Footprint: Asia-Pacific manufacturers are not only serving domestic markets but also increasingly targeting international markets, especially in Europe, Latin America, and emerging economies. Countries like South Korea and India are exporting biosimilars approved by stringent regulators such as the EMA and WHO prequalification programs. This trend is transforming the region from a consumer of biosimilars into a global supplier, supported by cost advantages, improving quality standards, and growing international credibility.

The moderate growth of insulin products in the Asia Pacific biosimilars industry is primarily driven by increasing diabetes prevalence coupled with efforts to reduce healthcare costs through biosimilar adoption.

The Asia Pacific biosimilars industry is witnessing moderate growth in insulin products due to a confluence of rising diabetes rates and the push for affordable treatment options across emerging economies. Countries such as India, China, Indonesia, and the Philippines are grappling with a rapidly growing diabetic population, a result of urbanization, sedentary lifestyles, and dietary changes. This escalating burden places immense pressure on national healthcare systems, making cost-effective alternatives like biosimilar insulin increasingly attractive.

Biosimilar insulins, which are clinically similar to original biologics but offered at lower costs, are seen as a strategic solution to improve patient access without overstretching public health budgets. Governments and healthcare authorities across the region are therefore gradually embracing biosimilars through updated regulatory pathways, pricing reforms, and public procurement initiatives. India and China, in particular, have made significant strides by supporting domestic biosimilar manufacturers and encouraging local production to reduce dependence on multinational pharmaceutical companies. However, the growth remains moderate rather than exponential due to several barriers.

Regulatory frameworks, though evolving, remain inconsistent and sometimes unclear across the Asia Pacific, leading to delays in product approvals and market entry. Furthermore, physician and patient confidence in biosimilar insulin remains mixed, as concerns over efficacy and safety persist, particularly in markets where biosimilar literacy is low. Unlike traditional generics, biosimilars require extensive clinical validation and pharmacovigilance, which demands greater investment and technical expertise, posing a challenge for smaller local players.

Oncology products are leading in the Asia Pacific biosimilars industry due to the high cost burden of cancer treatment and increasing demand for affordable biologic therapies in a region with a rapidly growing cancer population.

Oncology biosimilars are at the forefront of the Asia Pacific biosimilars industry primarily because of the urgent need to address the growing cancer burden across the region, paired with the prohibitively high costs of original biologic treatments. Asia Pacific is experiencing a sharp rise in cancer incidence due to aging populations, urban lifestyles, environmental risk factors, and improved diagnostic capabilities. Countries such as China, India, Japan, South Korea, and several Southeast Asian nations have seen an increasing number of cancer patients, which has placed unprecedented pressure on healthcare systems to provide effective and sustainable treatments.

Biologic drugs, such as monoclonal antibodies used in cancer therapies (e.g., trastuzumab, rituximab, bevacizumab), are highly effective but extremely expensive, limiting access for a large portion of the population. This has created a strong market incentive for biosimilars that offer clinically comparable efficacy and safety at a significantly reduced cost. Governments across Asia Pacific are actively promoting the adoption of oncology biosimilars to enhance accessibility and reduce healthcare expenditures. Countries like India and South Korea have well-established biosimilar regulatory frameworks that facilitate quicker approvals and encourage local production.

China has also accelerated its biosimilars pathway through regulatory reforms, including the 2019 National Reimbursement Drug List (NRDL) expansion, which incentivized the uptake of oncology biosimilars. Public hospitals and national insurance schemes are increasingly favoring biosimilars in tenders and procurement policies, further boosting their presence in oncology treatment protocols.

Contract Research and Manufacturing Services (CRAMS) manufacturers are the fastest-growing segment in the Asia Pacific biosimilars industry due to rising outsourcing demand from global pharmaceutical companies seeking cost-efficient.

The rapid growth of Contract Research and Manufacturing Services (CRAMS) manufacturers in the Asia Pacific biosimilars industry is being driven by a significant shift in the global pharmaceutical landscape, where companies are increasingly outsourcing research, development, and manufacturing operations to reduce costs and accelerate time-to-market. Asia Pacific, particularly countries like India, China, South Korea, and Singapore, has emerged as a preferred hub for biosimilar outsourcing due to its combination of advanced scientific infrastructure, skilled workforce, and cost-efficient operations.

These countries offer substantial advantages in biologics manufacturing, including state-of-the-art facilities that comply with international regulatory standards (e.g., US FDA, EMA), growing investment in biopharmaceutical R&D, and favorable government policies promoting biotech innovation and exports. Global biopharma companies, facing rising costs and competitive pressures in Western markets, are turning to Asia Pacific CRAMS providers to leverage their capabilities in analytical development, process optimization, clinical trials, and large-scale biologic production.

This trend is especially pronounced in the biosimilars sector, where cost control is critical to compete with established biologics while ensuring high quality and regulatory compliance. In response, many CRAMS manufacturers in Asia are expanding their service portfolios from basic manufacturing to include full-service offerings - spanning from preclinical studies to commercial-scale production - thus becoming integral partners in the global biosimilars supply chain.

The region’s CRAMS industry is further fueled by the increasing presence of multinational collaborations, technology transfers, and investments from both local governments and foreign firms. India and China, for example, have launched initiatives to support biotech hubs and biomanufacturing parks that streamline regulatory approval and infrastructure development.

China is leading the Asia Pacific biosimilars industry due to its rapidly expanding biotech ecosystem, strong government support, growing domestic demand for affordable biologics, and increasing regulatory alignment with global standards.

China’s leadership in the Asia Pacific biosimilars industry is driven by an extraordinary combination of market dynamics, governmental initiatives, and industry evolution that collectively position it as a dominant force in the region. The Chinese government has played a pivotal role in this transformation by implementing strategic policies, funding innovation, and streamlining regulatory pathways to foster the growth of biosimilars and biologics.

Notably, China’s National Medical Products Administration (NMPA) has increasingly aligned its biosimilar regulatory framework with international standards, simplifying the approval process while ensuring safety and efficacy, thereby boosting the confidence of both domestic and foreign pharmaceutical companies. This regulatory modernization has accelerated the entry of biosimilars into the Chinese market, allowing companies to compete with branded biologics and meet the urgent demand for more cost-effective therapies. Furthermore, China’s vast and aging population presents a rapidly growing patient base with increasing incidences of chronic diseases such as cancer, autoimmune disorders, and diabetes - conditions often treated with biologics.

However, the high cost of originator biologics has traditionally limited accessibility, creating a strong and expanding market for affordable biosimilars. This demand incentivizes domestic manufacturers to ramp up production and innovation, leveraging cost advantages like lower labor costs, advanced manufacturing capabilities, and economies of scale.

Additionally, Chinese biopharma companies are increasingly investing in advanced technologies, such as cell line development, process optimization, and biosimilar characterization, improving product quality and international competitiveness. The government’s “Made in China 2025” initiative and other industrial policies further emphasize biopharmaceutical innovation as a key strategic sector, encouraging collaborations between research institutions, universities, and the private sector.

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

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.