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Add to CartOncology Biosimilars Market
By Drug Class;
mAb (Monoclonal Antibodies), G-CSF, Hematopoietic Agents and OthersBy Type of Cancer;
Lung Cancer, Breast Cancer, Prostate Cancer, Stomach Cancer, Cervical Cancer, Blood Cancer, Brain Cancer and OthersBy Distribution Channel;
Hospital Pharmacies, Retail Pharmacies and Online PharmaciesBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa and Latin America - Report Timeline (2021 - 2031)Oncology Biosimilar Market Overview
Oncology Biosimilar Market (USD Million)
Oncology Biosimilar Market was valued at USD 5,107.57 million in the year 2024. The size of this market is expected to increase to USD 61,846.01 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 42.8%.
Oncology Biosimilars Market
*Market size in USD million
CAGR 42.8 %
| Study Period | 2025 - 2031 |
|---|---|
| Base Year | 2024 |
| CAGR (%) | 42.8 % |
| Market Size (2024) | USD 5,107.57 Million |
| Market Size (2031) | USD 61,846.01 Million |
| Market Concentration | Low |
| Report Pages | 304 |
Major Players
- Amgen Inc.
- Pfizer Inc.
- Celltrion Inc.
- Biocon Ltd.
- Mylan N.V.
- Teva Pharmaceutical Industries Ltd.
- Samsung Bioepis Co., Ltd.
- Sandoz International GmbH
- Merck & Co., Inc.
- Dr. Reddy's Laboratories Ltd.
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Oncology Biosimilars Market
Fragmented - Highly competitive market without dominant players
The Oncology Biosimilars Market is witnessing rapid growth as healthcare providers turn to cost-efficient treatments for cancer management. More than 45% of oncology prescriptions now feature biosimilars, reflecting their growing clinical trust. By ensuring effective and affordable solutions, these therapies are improving accessibility while reducing the financial strain of cancer treatments.
Advancements in Cancer Therapeutics
Continuous progress in biologic drug innovation has driven biosimilar adoption across breast, lung, and colorectal cancers. Nearly 52% of these therapies mimic monoclonal antibodies, offering precision and consistency in treatment outcomes. This innovation is positioning biosimilars as vital contributors to advancing oncology care.
Growing Research and Regulatory Support
Close to 57% of oncology-focused research initiatives now invest in biosimilar development, underlining their importance. Regulatory approvals from the FDA and EMA are accelerating market adoption. Strong emphasis on equivalence and interchangeability is improving confidence, integrating biosimilars seamlessly into cancer treatment pathways.
Affordability Accelerating Demand
The rising expense of oncology treatments has boosted reliance on biosimilars. Around 48% of treatment facilities have adopted them to optimize cost efficiency while safeguarding treatment standards. Their economic advantage is broadening patient access to advanced therapies, enhancing the overall reach of modern cancer care.
Positive Market Prospects
The Oncology Biosimilars Market is set for significant growth as manufacturing innovations, delivery platforms, and trial designs continue to advance. Approximately 50% of pipeline biosimilars are designed to expand accessibility and boost therapeutic outcomes. Strengthening adoption and clinical trust will solidify biosimilars’ role in cost-effective oncology treatment.
Oncology Biosimilars Market Key Takeaways
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The oncology biosimilars market is projected to expand at a CAGR of 8.6% during the 2025 to 2030 forecast period.
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Rising incidence of cancer cases and increasing focus on cost-effective biologic therapies are driving market growth.
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Monoclonal antibody biosimilars such as trastuzumab and bevacizumab are witnessing strong market adoption.
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Expanding approvals from regulatory authorities and support for biosimilar substitution policies are boosting accessibility.
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Europe currently leads the market, followed by North America and Asia-Pacific, due to increasing oncology drug utilization.
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Growing investment in biologic manufacturing facilities and clinical trials is strengthening supply chain capacity.
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Key market participants including Amgen Inc., Pfizer Inc., and Samsung Bioepis are focusing on strategic collaborations and expanded biosimilar portfolios.
Oncology Biosimilar Market Recent Developments
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In June 2025, a leading pharmaceutical company signed a global licensing and manufacturing agreement to co-develop a biosimilar version of a leading immunotherapy drug, expanding accessibility in the Oncology Biosimilars Market.
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In January 2025, updated regulatory guidance enabled faster approval pathways for oncology biosimilars, accelerating affordability and adoption in the Oncology Biosimilars Market.
Oncology Biosimilars Market Segment Analysis
In this report, the Oncology Biosimilars Market has been segmented by Drug Class, Type of Cancer, Distribution Channel, and Geography.
Oncology Biosimilars Market, Segmentation by Drug Class
The Drug Class segmentation defines the therapeutic categories that shape the commercial landscape of oncology biosimilars. Each class contributes uniquely to patient access, treatment affordability, and competitive market dynamics. Increasing approvals of monoclonal antibodies (mAb) and hematopoietic agents are driving rapid adoption in oncology settings, supported by rising healthcare expenditure and patent expiries of branded biologics.
mAb (Monoclonal Antibodies)
The monoclonal antibodies segment dominates the oncology biosimilars market owing to its strong efficacy in targeting specific tumor antigens and reducing systemic toxicity. With biosimilars for agents like trastuzumab and bevacizumab achieving over 40% market penetration, this segment continues to expand through price competitiveness and global regulatory approvals.
G-CSF
The G-CSF segment (granulocyte-colony stimulating factor) plays a key role in managing chemotherapy-induced neutropenia. Widespread adoption in oncology support care, coupled with increasing hospital demand for cost-effective biosimilars such as filgrastim and pegfilgrastim, sustains strong market performance across developed and emerging economies.
Hematopoietic Agents
The hematopoietic agents segment contributes significantly by facilitating red blood cell production and enhancing patient recovery post-chemotherapy. The segment’s growth is driven by rising incidences of anemia and bone marrow suppression among cancer patients, with biosimilars offering improved affordability and therapeutic equivalence.
Others
The others segment includes biosimilars beyond the major classes, addressing niche oncology indications. These products target diverse cytokines, growth factors, and therapeutic enzymes, reflecting ongoing innovation and diversification within the biosimilar landscape.
Oncology Biosimilars Market, Segmentation by Type of Cancer
The Type of Cancer segmentation reveals how biosimilars are deployed across multiple oncology indications. Increasing cancer prevalence, coupled with the economic burden of biologics, drives accelerated substitution by biosimilars. The focus remains on cost efficiency and improving treatment accessibility across both solid and hematologic malignancies.
Lung Cancer
The lung cancer segment represents one of the largest applications for oncology biosimilars, supported by rising global cases and broad therapeutic coverage. Biosimilars of monoclonal antibodies targeting EGFR and PD-L1 pathways are gaining traction due to reimbursement support and clinical comparability to reference drugs.
Breast Cancer
The breast cancer segment remains pivotal, driven by biosimilar approvals for trastuzumab, which have achieved substantial market penetration across Europe and North America. Pharmaceutical partnerships and expanded oncology pipeline developments further enhance growth prospects in this area.
Prostate Cancer
The prostate cancer segment is growing steadily, with biosimilars addressing hormonal and supportive therapy needs. Advances in androgen deprivation therapy biosimilars and their cost-effectiveness compared to branded counterparts strengthen uptake across hospitals and specialty clinics.
Stomach Cancer
The stomach cancer segment benefits from the development of monoclonal antibody biosimilars targeting HER2 and VEGF pathways. Increasing adoption in Asia Pacific and expanding treatment guidelines contribute to accelerated biosimilar acceptance in this domain.
Cervical Cancer
The cervical cancer segment showcases emerging potential for biosimilars as healthcare systems prioritize affordable biological therapies. Strategic collaborations between regional biopharma companies and global distributors are expected to expand market accessibility across developing regions.
Blood Cancer
The blood cancer segment includes applications for leukemia and lymphoma biosimilars, focusing on hematopoietic and G-CSF agents. Rapid regulatory clearances and improved clinical outcomes reinforce this segment’s importance within supportive oncology treatment frameworks.
Brain Cancer
The brain cancer segment remains niche but shows potential with biosimilars enhancing treatment affordability for glioblastoma and related malignancies. Clinical validation studies and ongoing biopharmaceutical partnerships continue to expand the therapeutic portfolio in neuro-oncology biosimilars.
Others
The others segment captures applications across multiple rare cancer types, reflecting ongoing R&D investments and lifecycle management strategies by leading biopharma players to extend biosimilar coverage.
Oncology Biosimilars Market, Segmentation by Distribution Channel
The Distribution Channel segmentation highlights how oncology biosimilars reach end-users through structured networks. The balance between hospital-based distribution and emerging online pharmacy models defines the competitive landscape. Digital transformation and healthcare access programs are expected to reshape channel strategies globally.
Hospital Pharmacies
The hospital pharmacies segment leads the market, serving as the primary distribution hub for oncology biosimilars. Hospitals account for over 60% of biosimilar prescriptions due to direct patient care integration, robust procurement frameworks, and specialized oncology administration infrastructure.
Retail Pharmacies
The retail pharmacies segment is expanding as awareness and acceptance of biosimilars increase among patients and clinicians. Enhanced accessibility and government-driven pricing regulations are improving patient adherence and market penetration within this channel.
Online Pharmacies
The online pharmacies segment demonstrates rapid growth driven by digital healthcare adoption and e-commerce expansion. Rising comfort with telemedicine and home delivery of biologics under medical supervision is creating new opportunities for biosimilar suppliers and distributors.
Oncology Biosimilars Market, Segmentation by Geography
In this report, the Oncology Biosimilars Market has been segmented by Geography into five regions: North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Regions and Countries Analyzed in this Report
North America
North America dominates the oncology biosimilars market, driven by strong regulatory support from the FDA and widespread physician acceptance. The U.S. leads with significant penetration in monoclonal antibody biosimilars, while Canada continues to expand its adoption through cost-containment initiatives.
Europe
Europe remains the most mature biosimilars market, accounting for over 45% of global revenue. Countries like Germany, France, and the U.K. demonstrate high adoption rates due to robust healthcare systems, price control frameworks, and centralized procurement policies under the European Medicines Agency (EMA).
Asia Pacific
Asia Pacific is the fastest-growing region, supported by rapid biosimilar approvals and local manufacturing in China, India, and South Korea. Increasing investments in oncology R&D, cost-effective production, and expanding patient populations are key growth catalysts in this region.
Middle East and Africa
The Middle East and Africa region is witnessing gradual expansion with growing awareness about biosimilar oncology therapies and partnerships between global pharmaceutical companies and regional distributors. Government healthcare reforms continue to strengthen biosimilar penetration.
Latin America
Latin America shows consistent growth driven by increasing acceptance in markets such as Brazil and Mexico. Local production initiatives, supportive regulations, and expanding access to affordable cancer treatment options enhance the regional outlook.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Oncology Biosimilar Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Cost-effectiveness
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Expanding oncology drug market - The global oncology biosimilar market is experiencing significant expansion, driven by the growing demand for oncology drugs worldwide. With cancer prevalence on the rise and an increasing number of patients requiring treatment, there is a pressing need for cost-effective therapies. Biosimilars, which are highly similar versions of already approved biological drugs, offer a promising solution by providing more affordable alternatives to expensive biologics.
One of the primary drivers of the expanding oncology biosimilar market is the expiration of patents on several blockbuster biologics used in cancer treatment. As these patents expire, it opens the door for biosimilar manufacturers to enter the market and offer more competitively priced options. Additionally, healthcare systems and providers are under pressure to contain costs, making biosimilars an attractive choice due to their potential for cost savings without compromising on efficacy or safety.
Regulatory agencies worldwide are increasingly establishing clear pathways for the approval of biosimilars, streamlining the process and fostering confidence among both healthcare professionals and patients. This regulatory support is essential for encouraging investment in biosimilar development and driving market growth. As a result, pharmaceutical companies are investing heavily in research and development of oncology biosimilars, aiming to capitalize on this expanding market opportunity.
Restraints
- Regulatory hurdles
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Complex manufacturing processes - The global oncology biosimilar market is witnessing significant growth, largely fueled by the increasing prevalence of cancer worldwide and the need for more affordable treatment options. Biosimilars, which are highly similar versions of already approved biologic medicines, offer a promising avenue for reducing the economic burden of cancer treatment. However, their manufacturing processes are notably complex, presenting both challenges and opportunities for companies operating in this space.
The production of oncology biosimilars entails intricate processes involving the cultivation of living cells to produce therapeutic proteins. Unlike small molecule drugs, which can be chemically synthesized, biosimilars are derived from living organisms, necessitating careful control over cell cultures and purification methods to ensure consistency and safety. These manufacturing complexities often require substantial investments in specialized infrastructure and expertise, posing barriers to entry for smaller companies.
Achieving similarity to the reference biologic is crucial for regulatory approval and market acceptance. The manufacturing process must replicate the structure, efficacy, and safety profile of the originator product to a high degree of similarity. This necessitates sophisticated analytical techniques and extensive comparability studies to demonstrate equivalence in terms of molecular structure, biological activity, and clinical outcomes. Regulatory agencies, such as the FDA and EMA, have established stringent guidelines to ensure the quality, safety, and efficacy of biosimilars, adding another layer of complexity to the manufacturing process.
Opportunities
- Increasing demand for cancer treatment
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Emerging markets potential - The global oncology biosimilar market is witnessing a surge, driven primarily by the potential in emerging markets. Emerging markets, including countries in Asia, Latin America, and parts of Africa, are experiencing a growing demand for affordable cancer treatments. Biosimilars offer a cost-effective alternative to expensive biologic drugs, making them particularly attractive in regions where access to healthcare resources is limited and affordability is a significant concern.
One key factor driving the growth of oncology biosimilars in emerging markets is the increasing prevalence of cancer. As these regions undergo demographic and lifestyle changes, the incidence of cancer is on the rise. This, coupled with improving healthcare infrastructure and awareness, is driving the demand for effective yet affordable cancer treatments. Biosimilars, with their comparable efficacy and lower costs, are well-positioned to address this demand and improve access to essential cancer care.
Regulatory reforms and initiatives aimed at promoting biosimilar adoption are further fueling market growth in emerging economies. Governments in these regions are implementing policies to expedite the approval process for biosimilars, reduce barriers to entry, and encourage competition in the market. Additionally, partnerships between local pharmaceutical companies and global biotech firms are facilitating technology transfer and enhancing the production capabilities of biosimilars in these markets.
Oncology Biosimilars Market Competitive Landscape Analysis
Oncology Biosimilars Market is witnessing robust growth driven by increasing prevalence of cancer, rising adoption of cost-effective biologics, and favorable regulatory frameworks. Leading pharmaceutical companies are engaging in strategic partnerships and collaboration to expand biosimilar portfolios and global presence. Focus on technological advancements such as recombinant DNA technology, monoclonal antibodies, and immuno-oncology applications is driving adoption, with utilization rates reaching 42% across key oncology centers.
Market Structure and Concentration
The market exhibits moderate concentration, with top oncology biosimilar manufacturers controlling over 60% of total sales. Strategic merger and acquisition activities strengthen portfolios and regional presence. Smaller players focus on niche cancer therapies and specialty biosimilars to capture growth, while established companies invest in technological advancements to sustain competitive expansion and maintain market leadership.
Brand and Channel Strategies
Companies enhance brand visibility through collaborations with hospitals, oncology clinics, and distributors. Strategic partnerships facilitate broader adoption, achieving 38% coverage in high-demand regions. Focused strategies on product efficacy, affordability, and clinical support drive consistent growth and strengthen long-term healthcare relationships.
Innovation Drivers and Technological Advancements
Continuous innovation in biosimilar development, manufacturing processes, and clinical trial designs fuels market development. Companies invest in technological advancements to improve safety, efficacy, and regulatory compliance. Collaborative partnerships in R&D result in over 45% of biosimilars incorporating advanced protein engineering, formulation improvements, and targeted therapy applications, promoting sustainable expansion.
Regional Momentum and Expansion
North America and Europe lead adoption with utilization rates above 50%, while Asia-Pacific is emerging as a high-growth region. Companies pursue expansion through regional partnerships, hospital collaborations, and government incentives. Implementation of technological advancements ensures broader patient access and improved oncology treatment outcomes.
Future Outlook
The Oncology Biosimilars Market is projected for sustained growth driven by rising cancer prevalence, cost-effective therapeutic adoption, and technological innovations. Strategic partnerships and continuous innovation are expected to push adoption rates beyond 65%. Companies focusing on collaborative strategies and advanced biosimilar solutions will shape the market’s future expansion and competitive landscape.
Key players in Oncology Biosimilar Market include:
- Sandoz International GmbH
- Pfizer Inc.
- Celltrion Inc.
- Biocon Biologics
- Amgen Inc.
- Samsung Bioepis
- Coherus BioSciences
- Dr. Reddy’s Laboratories
- Teva Pharmaceutical Industries Ltd.
- BIOCAD
- Lilly (Eli Lilly)
- Intas Pharmaceuticals
- Apotex Inc.
- Zydus Cadila
- Hetero Drugs
In this report, the profile of each market player provides following information:
- Market Share Analysis
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Drug Class
- Market Snapshot, By Type of Cancer
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Region
- Oncology Biosimilar Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Cost-effectiveness
- Expanding oncology drug market
- Restraints
- Regulatory hurdles
- Complex manufacturing processes
- Opportunities
- Increasing demand for cancer treatment
- Emerging markets potential
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Oncology Biosimilars Market, By Drug Class, 2021 - 2031 (USD Million)
- mAb (Monoclonal Antibodies)
- G-CSF
- Hematopoietic Agents
- Others
- Oncology Biosimilars Market, By Type of Cancer, 2021 - 2031 (USD Million)
- Lung Cancer
- Breast Cancer
- Prostate Cancer
- Stomach Cancer
- Cervical Cancer
- Blood Cancer
- Brain Cancer
- Others
- Oncology Biosimilars Market, By Distribution Channel, 2021 - 2031 (USD Million)
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
- Oncology Biosimilars Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Oncology Biosimilars Market, By Drug Class, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Sandoz International GmbH
- Pfizer Inc.
- Celltrion Inc.
- Biocon Biologics
- Amgen Inc.
- Samsung Bioepis
- Coherus BioSciences
- Dr. Reddy’s Laboratories
- Teva Pharmaceutical Industries Ltd.
- BIOCAD
- Lilly (Eli Lilly)
- Intas Pharmaceuticals
- Apotex Inc.
- Zydus Cadila
- Hetero Drugs
- Company Profiles
- Analyst Views
- Future Outlook of the Market