Global Oncology Biosimilar Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Disease Indication;
Breast Cancer, Colorectal Cancer, Blood Cancer, Neutropenia Cancer, Non-Small Cell Lung Cancer, and Others.By Drug Type;
mAb, Immunomodulators, Hematopoietic Agents, G-CSF, and Others.By Distribution Channel;
Retail Pharmacies, Hospital Pharmacy, and Online Pharmacy.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Oncology Biosimilar Market (USD Million), 2021 - 2031
In the year 2024, the Global Oncology Biosimilar Market was valued at USD 5,107.57 million. 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%.
The global oncology biosimilar market has been steadily expanding, driven by the increasing demand for cost-effective alternatives to expensive biologic drugs used in cancer treatment. Biosimilars offer a promising avenue to alleviate the economic burden of cancer care while maintaining therapeutic efficacy. With the expiration of patents for several blockbuster biologics, including monoclonal antibodies and therapeutic proteins, pharmaceutical companies are seizing the opportunity to develop biosimilar versions. This trend has fueled competition in the oncology market, resulting in greater accessibility to life-saving treatments for patients worldwide.
In recent years, regulatory agencies such as the FDA and EMA have established robust frameworks for the approval of biosimilars, ensuring rigorous testing to demonstrate similarity in terms of efficacy, safety, and quality compared to their reference biologics. This regulatory clarity has instilled confidence among healthcare providers and patients, further propelling the adoption of oncology biosimilars. Moreover, favorable reimbursement policies and incentives offered by governments and healthcare organizations have incentivized the utilization of biosimilars, driving down treatment costs and widening patient access to innovative cancer therapies.
The oncology biosimilar landscape is witnessing dynamic shifts, with several key players strategically investing in research and development to expand their biosimilar portfolios. Collaborations and partnerships between pharmaceutical companies and biotechnology firms are becoming increasingly common, leveraging complementary expertise to accelerate biosimilar development and commercialization. Additionally, advancements in bioprocessing technologies and manufacturing capabilities have enhanced the scalability and efficiency of biosimilar production, further driving down costs and increasing market competitiveness.
Global Oncology Biosimilar Market Recent Developments
- In May 2022, Amneal Pharmaceuticals, Inc. received United States Food and Drug Administration ("FDA") approval for a Biologics License Application ("BLA") for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.
- In September 2021, Samsung Bioepis and Biogen announced that the Food and Drug Administration (FDA) had approved BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ was the first ophthalmology biosimilar approved in the United States.
Segment Analysis
The Global Oncology Biosimilar Market is segmented by disease indication, with key segments including breast cancer, colorectal cancer, blood cancer, neutropenia cancer, non-small cell lung cancer (NSCLC), and others. Breast cancer is one of the leading indications in the oncology biosimilar market, as the development of biosimilars targeting HER2-positive breast cancer continues to grow. Biosimilars in this segment provide more affordable alternatives to branded monoclonal antibodies (mAb) such as trastuzumab, which has transformed the treatment of breast cancer. Colorectal cancer also represents a significant portion of the market, with biosimilars to monoclonal antibodies like bevacizumab being utilized to target vascular endothelial growth factor (VEGF), crucial in tumor growth. Blood cancers, such as lymphoma and leukemia, are also an important focus, where biosimilars of rituximab and other monoclonal antibodies provide cost-effective solutions for patients undergoing treatment for hematologic malignancies. Other disease indications, including neutropenia cancer and NSCLC, are experiencing increased biosimilar adoption as these cancers often require long-term treatment regimens, and biosimilars help manage the high cost of therapies.
The drug type segmentation in the oncology biosimilars market includes monoclonal antibodies (mAb), immunomodulators, hematopoietic agents, granulocyte colony-stimulating factor (G-CSF), and others. Monoclonal antibodies are the most prominent drug type in oncology biosimilars, with drugs like trastuzumab, rituximab, and bevacizumab being frequently replicated to offer affordable options for cancer treatment. These biosimilars are critical in reducing the high costs associated with oncology treatments while maintaining efficacy and safety profiles similar to the originators. Immunomodulators, which enhance the body's immune response to fight cancer, are another growing category, with biosimilars like pembrolizumab offering alternatives in immuno-oncology. Hematopoietic agents and G-CSF are also important in cancer treatment, primarily used to stimulate the production of white blood cells in patients undergoing chemotherapy, making them essential in managing treatment-related side effects. The others category includes additional biologics that have been replicated for oncology indications, such as fusion proteins and cytokines, expanding the range of biosimilars available to treat various cancer types.
The distribution channel for oncology biosimilars is also diverse, including retail pharmacies, hospital pharmacies, and online pharmacies. Retail pharmacies serve as a key access point for patients needing oncology biosimilars, particularly those with ongoing treatment regimens for cancer. These pharmacies help bridge the gap in providing affordable biosimilars to the general population. Hospital pharmacies, however, play a pivotal role in the distribution of oncology biosimilars due to their direct involvement in the administration of cancer treatments, often in conjunction with inpatient care. They are critical in ensuring that patients have access to the most suitable biosimilar drugs tailored to their specific needs. Online pharmacies are becoming increasingly important as more patients seek convenient ways to access oncology medications from home. E-commerce platforms allow for easy ordering of cancer treatments, often at competitive prices, with delivery options that ensure timely access to medications, especially in regions with limited access to physical retail or hospital pharmacies. The growth of these distribution channels will continue to make oncology biosimilars more accessible, thus promoting wider adoption and improving affordability for cancer patients globally.
Global Oncology Biosimilar Segment Analysis
In this report, the Global Oncology Biosimilar Market has been segmented by Disease Indication, Drug Type, Distribution Channel, and Geography.
Global Oncology Biosimilar Market, Segmentation by Disease Indication
The Global Oncology Biosimilar Market has been segmented by Disease Indication into Breast Cancer, Colorectal Cancer, Blood Cancer, Neutropenia Cancer, Non-Small Cell Lung Cancer, and Others.
The Global Oncology Biosimilar Market is witnessing significant growth, primarily driven by increasing incidences of various types of cancers worldwide. The market has been segmented by test type to cater to the diverse needs of patients and healthcare providers. Among these segments, breast cancer holds a prominent share due to its high prevalence and the urgent need for effective treatment options. Colorectal cancer follows closely behind, reflecting the growing awareness and screening initiatives aimed at early detection and management.
Blood cancer, including leukemia, lymphoma, and myeloma, represents another crucial segment in the oncology biosimilar market. With advancements in medical research and treatment modalities, there's a rising demand for biosimilars targeting these malignancies. Additionally, biosimilars for neutropenia cancer, characterized by abnormally low levels of neutrophils in the blood, are gaining traction owing to their potential in improving patient outcomes and reducing healthcare costs.
Non-small cell lung cancer (NSCLC), one of the most prevalent types of lung cancer, also commands a significant share in the oncology biosimilar market. As the understanding of the molecular mechanisms underlying NSCLC improves, there's a growing emphasis on personalized treatment approaches, driving the development and adoption of biosimilars tailored to specific patient subgroups.
Global Oncology Biosimilar Market, Segmentation by Drug Type
The Global Oncology Biosimilar Market has been segmented by Drug Type into mAb, Immunomodulators, Hematopoietic Agents, G-CSF, and Others.
The Global Oncology Biosimilar Market has witnessed significant growth in recent years, primarily due to the rising prevalence of cancer worldwide and the increasing demand for cost-effective treatment options. One of the key factors driving market expansion is the emergence of biosimilars, which offer comparable efficacy to biologics at lower costs. These biosimilars are particularly crucial in oncology, where biologics play a vital role in cancer treatment but often come with hefty price tags, limiting accessibility for many patients.
The market segmentation based on drug type reflects the diverse range of biosimilars available for oncology treatments. Monoclonal antibodies (mAbs) constitute a significant segment, as they are widely used in targeted cancer therapies, offering personalized treatment options for patients. Immunomodulators, another important category, encompass drugs that modulate the immune system's response to cancer, enhancing the body's ability to fight the disease. Hematopoietic agents, including biosimilars for erythropoietin and thrombopoietin, are essential for managing anemia and thrombocytopenia in cancer patients undergoing chemotherapy.
Granulocyte colony-stimulating factors (G-CSF) are critical in managing chemotherapy-induced neutropenia, reducing the risk of infections in cancer patients. This segment represents a significant portion of the oncology biosimilar market, driven by the need to improve patient outcomes and reduce healthcare costs.
Global Oncology Biosimilar Market, Segmentation by Distribution Channel
The Global Oncology Biosimilar Market has been segmented by Distribution Channel into Retail Pharmacies, Hospital Pharmacy, and Online Pharmacy.
The Global Oncology Biosimilar Market, characterized by its segmented distribution channels, reflects a growing trend in healthcare accessibility and affordability. Retail pharmacies play a pivotal role in providing convenient access to biosimilar drugs for cancer treatment. Patients benefit from the proximity of these pharmacies, facilitating ease of procurement and medication adherence. Additionally, the expertise of pharmacists in guiding patients through treatment regimens enhances overall healthcare outcomes.
Hospital pharmacies constitute another significant distribution channel for oncology biosimilars. These facilities often serve as the primary point of care for cancer patients, where healthcare professionals closely monitor treatment responses and manage side effects. Through hospital pharmacies, physicians can efficiently integrate biosimilars into treatment protocols, ensuring patients receive cost-effective yet clinically equivalent alternatives to originator biologics. The institutional setting also fosters interdisciplinary collaboration, optimizing patient care and treatment outcomes.
Online pharmacies emerge as a convenient avenue for patients to access oncology biosimilars, particularly for those in remote or underserved regions. The digital platform offers a wide range of products and facilitates comparative pricing, empowering patients to make informed decisions about their treatment options. Moreover, online pharmacies provide a discreet and efficient means of obtaining medications, catering to the diverse needs of cancer patients and their caregivers. However, regulatory oversight and quality assurance remain critical considerations to ensure the safety and efficacy of biosimilar products in the online marketplace.
Global Oncology Biosimilar Market, Segmentation by Geography
In this report, the Global Oncology Biosimilar Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Oncology Biosimilar Market Share (%), by Geographical Region, 2024
In 2023, the global oncology biosimilar market exhibited a notable distribution across various geographical regions, with distinct market shares reflecting regional dynamics. North America emerged as a dominant player, boasting a substantial market share. This can be attributed to factors such as advanced healthcare infrastructure, favorable regulatory frameworks, and high adoption rates of biosimilars in cancer treatment. Additionally, robust research and development activities in the region contributed to the availability of a diverse portfolio of oncology biosimilars, further driving market growth.
Europe also commanded a significant share of the global oncology biosimilar market in 2023. The region's well-established healthcare systems, coupled with initiatives promoting the use of biosimilars to curb healthcare costs, propelled market expansion. Moreover, the presence of key market players and strategic collaborations fostered the development and commercialization of biosimilars, catering to the increasing demand for affordable cancer treatment options in the region.
Asia Pacific emerged as a rapidly growing market for oncology biosimilars, characterized by increasing investments in healthcare infrastructure and rising awareness about biosimilar therapies. Countries like India and China, with their large patient populations and expanding pharmaceutical sectors, played pivotal roles in driving market growth. Moreover, initiatives by governments and healthcare organizations to enhance access to affordable cancer care further fueled the demand for oncology biosimilars in the region, contributing to its notable market share in 2023.
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.
Competitive Landscape Analysis
Key players in Global Oncology Biosimilar Market include :
- 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.
In this report, the profile of each market player provides following information:
- 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 Disease Indication
- Market Snapshot, By Drug Type
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Region
- Global 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
- Global Oncology Biosimilar Market, By Disease Indication, 2021 - 2031 (USD Million)
- Breast Cancer
- Colorectal Cancer
- Blood Cancer
- Neutropenia Cancer
- Non-Small Cell Lung Cancer
- Others
- Global Oncology Biosimilar Market, By Drug Type, 2021 - 2031 (USD Million)
- mAb
- Immunomodulators
- Hematopoietic Agents
- G-CSF
- Others
- Global Oncology Biosimilar Market, By Distribution Channel, 2021 - 2031 (USD Million)
- Retail Pharmacies
- Hospital Pharmacy
- Online Pharmacy
- Global Oncology Biosimilar 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
- Global Oncology Biosimilar Market, By Disease Indication, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- 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.
- Company Profiles
- Analyst Views
- Future Outlook of the Market