Biosimilar Market Report: Trends, Forecast and Competitive Analysis to 2031

Biosimilar Market Trends and Forecast

The future of the global biosimilar market looks promising with opportunities in the oncology, blood disorder, growth hormonal deficiency, rheumatoid arthritis, and chronic & autoimmune disorder markets. The global biosimilar market is expected to grow with a CAGR of 15.9% from 2025 to 2031. The major drivers for this market are the increasing demand for affordable biologics, the rising prevalence of chronic diseases, and the growing acceptance of biosimilar therapies.

• Lucintel forecasts that, within the product category, recombinant non-glycosylated protein is expected to witness higher growth over the forecast period.
• Within the application category, chronic & autoimmune disorder is expected to witness the highest growth.
• In terms of region, North America is expected to witness the highest growth over the forecast period.

Gain valuable insights for your business decisions with our comprehensive 150+ page report. Sample figures with some insights are shown below.

Emerging Trends in the Biosimilar Market

The biosimilar industry is experiencing a transformative phase marked by technological innovation, regulatory evolution, and competitive pricing strategies. As healthcare systems worldwide seek affordable biologic alternatives, biosimilar adoption continues to accelerate. The expansion of manufacturing capacity, digital transformation, and growing physician acceptance are reshaping the competitive landscape. Partnerships between global and local players are enabling market access and innovation. The following five key trends highlight how the biosimilar market is evolving to meet changing healthcare demands.

• Expansion of Oncology Biosimilars: Biosimilars targeting oncology drugs are driving the next growth wave, offering cost-effective alternatives for cancer treatment and improving patient access. With patent expirations of major biologics such as Herceptin and Avastin, oncology biosimilars are expanding globally, significantly reducing treatment costs and broadening therapeutic options.
• Advancement in Manufacturing Technologies: Improved cell-line development, process optimization, and advanced analytics are enhancing biosimilar quality and consistency. The adoption of single-use bioreactors and continuous manufacturing is lowering production costs and improving scalability.
• Regulatory Harmonization Across Regions: Global regulatory agencies are increasingly aligning approval processes, reducing time-to-market for biosimilars. Streamlined guidelines from the FDA, EMA, and NMPA are supporting faster global commercialization and higher confidence among healthcare providers.
• Growing Interchangeability and Substitution Policies: Governments and healthcare regulators are promoting policies that support biosimilar substitution to enhance affordability. Expanded interchangeability designations are expected to boost market share and patient access significantly.
• Increased Strategic Collaborations and Partnerships: Pharmaceutical companies are forming alliances to share development costs, expand distribution networks, and access global markets. Collaborations between biotech startups and established firms are fostering innovation and accelerating biosimilar launches.

These emerging trends are reshaping the biosimilar market by driving innovation, lowering costs, and expanding patient access worldwide. As technology and regulatory systems continue to evolve, the biosimilar sector is poised to become a central pillar of cost-effective biologic healthcare.

Recent Developments in the Biosimilar Market

The biosimilar market is witnessing accelerated development driven by innovation, regulatory clarity, and expanding product portfolios. Major pharmaceutical companies are investing in advanced biologic manufacturing, while emerging players are leveraging biosimilar pipelines to enter high-value therapeutic segments. The following developments highlight the dynamic progression of this industry.

• Regulatory Advancements: Streamlined biosimilar approval pathways by agencies like the FDA, EMA, and PMDA are enhancing global product accessibility and confidence in biosimilar safety and efficacy.
• Increased Market Competition: The entry of multiple biosimilars for top-selling biologics has intensified competition, leading to price reductions and broader patient access.
• Investment in R&D: Companies are increasing investments in biosimilar development pipelines, focusing on complex biologics such as monoclonal antibodies.
• Technological Integration: The use of AI and advanced analytics in biosimilar development is optimizing production processes and reducing development timelines.
• Expansion in Emerging Markets: Growing biosimilar adoption in Asia-Pacific and Latin America is driving global revenue growth through strategic collaborations and localized production.

These developments are fostering a more competitive and accessible biosimilar landscape, empowering healthcare systems to deliver effective biologic therapies at reduced costs.

Strategic Growth Opportunities in the Biosimilar Market

As biosimilar continue to mature, their applications across therapeutic areas offer significant growth potential. With rising global healthcare expenditure, demand for cost-efficient biologics is expanding across key therapeutic domains. The following areas represent major growth opportunities by application.

• Oncology: The oncology segment presents the largest opportunity due to high treatment costs and the growing availability of biosimilar monoclonal antibodies.
• Autoimmune Disorders: Biosimilars targeting autoimmune diseases such as rheumatoid arthritis and psoriasis are gaining traction as affordable alternatives.
• Diabetes Management: Insulin biosimilars are helping reduce the economic burden of diabetes care while improving treatment accessibility.
• Ophthalmology: Biosimilars for eye disorders such as macular degeneration are expanding due to rising demand for anti-VEGF biologics.
• Infectious Diseases: The use of biosimilars in managing infectious diseases is growing as health systems seek cost-effective biologic therapies.

These application-driven growth opportunities are broadening biosimilar adoption across healthcare sectors, enhancing affordability, and improving treatment access worldwide.

Biosimilar Market Driver and Challenges

The biosimilar market is influenced by technological, economic, and regulatory factors that shape its development and adoption. Continuous innovation, increasing cost pressures, and evolving healthcare systems are creating both opportunities and challenges.

The factors responsible for driving the biosimilar market include:

1. Patent Expirations of Biologics: The expiration of major biologic patents opens the market for biosimilar competition, reducing treatment costs and expanding access.

2. Rising Demand for Affordable Healthcare: Growing patient demand for cost-effective therapies drives biosimilar adoption across therapeutic areas.

3. Regulatory Support and Policy Reforms: Governments worldwide are implementing favorable policies and clear guidelines to encourage biosimilar approvals.

4. Technological Advancements in Biomanufacturing: Innovations in biologics production enhance efficiency, quality, and scalability.

5. Growing Physician and Patient Acceptance: Increasing education and awareness are improving biosimilar trust and utilization rates.

Challenges in the biosimilar market are:

1. Complex Manufacturing Processes: Biosimilar development remains technologically demanding, requiring advanced infrastructure and high-quality control.

2. Regulatory Variability Across Markets: Differences in approval standards create delays and increase costs for global manufacturers.

3. Pricing Pressure and Market Competition: Intense price competition limits profit margins and challenges sustainability for smaller players.

The interplay of these drivers and challenges is shaping a dynamic and competitive biosimilar market. Continuous innovation, regulatory alignment, and global collaboration will be critical to sustaining growth and ensuring broader access to affordable biologics.

List of Biosimilar Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies biosimilar companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the biosimilar companies profiled in this report include-

• Amgen
• F Hoffman-La Roche
• Sandoz International
• Dr. Reddy’s Laboratories
• Teva Pharmaceutical Industries
• Pfizer
• Samsung Biopis
• Biocon
• Viatris
• Celltrion Healthcare

Biosimilar Market by Segment

The study includes a forecast for the global biosimilar market by product, application, and region.

Biosimilar Market by Product [Value from 2019 to 2031]:

• Recombinant Non-glycosylated Proteins
• Recombinant Glycosylated Proteins

Biosimilar Market by Application [Value from 2019 to 2031]:

• Oncology
• Blood Disorders
• Growth Hormonal Deficiency
• Rheumatoid Arthritis
• Chronic & Autoimmune Disorders
• Others

Biosimilar Market by Region [Value from 2019 to 2031]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Biosimilar Market

The global biosimilar market has witnessed rapid growth driven by rising healthcare costs, patent expirations of biologics, and the increasing demand for affordable therapeutic alternatives. Biosimilars have gained strong acceptance as they offer comparable safety and efficacy to originator biologics at lower prices. Regulatory advancements, supportive government policies, and investments from major pharmaceutical players are fueling innovation across key markets. The United States, China, Germany, India, and Japan have emerged as major contributors to biosimilar development, each advancing through distinct regulatory frameworks, manufacturing capabilities, and market adoption strategies aimed at improving healthcare accessibility and affordability.

• United States: The US biosimilar market continues to expand following the FDA’s clear regulatory pathway and increasing payer acceptance. Recent approvals of biosimilars for oncology, immunology, and diabetes therapies have driven market penetration. Price competition has intensified as multiple biosimilars for blockbuster biologics such as Humira and Avastin enter the market. Improved physician awareness and hospital formulary inclusions are accelerating adoption. Additionally, policy initiatives to enhance interchangeability and pharmacy-level substitution are supporting sustainable growth in the US biosimilar ecosystem.
• China: China has emerged as one of the fastest-growing biosimilar markets due to strong government support and rising domestic manufacturing capabilities. The National Medical Products Administration (NMPA) has streamlined approval processes, encouraging innovation among local biopharma firms. Increased investments in research and development, coupled with rising demand for affordable biologics, are propelling growth. The country’s focus on developing biosimilars for oncology and autoimmune diseases positions it as a competitive player globally. Favorable reimbursement policies and strategic partnerships with multinational companies further enhance China’s biosimilar expansion.
• Germany: Germany remains a key driver of the European biosimilar market, supported by robust healthcare infrastructure and favorable regulatory alignment under the European Medicines Agency (EMA). High physician confidence in biosimilars, along with strong uptake in therapeutic areas such as oncology and rheumatology, is contributing to steady growth. Recent initiatives encouraging automatic substitution at the pharmacy level have boosted market accessibility. Furthermore, competitive tendering processes and cost-containment measures have made Germany an attractive market for biosimilar manufacturers.
• India: India continues to strengthen its position as a global biosimilar manufacturing hub. The country’s cost-effective production capabilities and supportive regulatory reforms have enabled rapid product launches. Indian pharmaceutical companies are expanding into international markets through strategic alliances and biosimilar exports. The focus on R&D innovation, coupled with strong domestic demand for affordable biologics, is fueling market growth. Government initiatives under the “Make in India” program and the establishment of biopharma clusters are promoting sustainable biosimilar development across the country.
• Japan: Japan’s biosimilar market is growing steadily, supported by government policies aimed at reducing healthcare costs and improving access to biologic treatments. The Pharmaceuticals and Medical Devices Agency (PMDA) has provided a well-defined regulatory framework for biosimilars. Key therapeutic areas, including oncology, diabetes, and autoimmune disorders, are driving demand. Local manufacturers are collaborating with global players to enhance product development and distribution. Increasing physician awareness and inclusion of biosimilars in national reimbursement programs are further strengthening Japan’s biosimilar ecosystem.

Features of the Global Biosimilar Market

Market Size Estimates: Biosimilar market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.

Segmentation Analysis: Biosimilar market size by product, application, and region in terms of value ($B).

Regional Analysis: Biosimilar market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different products, applications, and regions for the biosimilar market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the biosimilar market.

Analysis of competitive intensity of the industry based on Porter’s Five Forces model.

This report answers following 11 key questions:

Q.1. What are some of the most promising, high-growth opportunities for the biosimilar market by product (recombinant non-glycosylated proteins and recombinant glycosylated proteins), application (oncology, blood disorders, growth hormonal deficiency, rheumatoid arthritis, chronic & autoimmune disorders, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?

Q.2. Which segments will grow at a faster pace and why?

Q.3. Which region will grow at a faster pace and why?

Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?

Q.5. What are the business risks and competitive threats in this market?

Q.6. What are the emerging trends in this market and the reasons behind them?

Q.7. What are some of the changing demands of customers in the market?

Q.8. What are the new developments in the market? Which companies are leading these developments?

Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?

Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?

Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

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