Report Description Table of Contents Oncology Biosimilars Market Size The Oncology Biosimilars Market size was valued at USD 6.8 billion in 2024 and is projected to reach around USD 21.1 billion by 2030, expanding at a CAGR of 20.3%, the growth is driven by the rising cancer prevalence, increasing demand for cost-effective biologic therapies, and the patent expiration of blockbuster oncology biologics. Oncology Biosimilars Market Dynamics: Market Drivers Increasing Cancer Prevalence Cancer is a major global health concern and the second leading cause of death in the US. The WHO’s cancer agency, the International Agency for Research on Cancer (IARC) estimated that there were more than 9.7 Mn cancer deaths and 20 Mn new cancer cases in 2022 globally. Lung cancer was the most frequently diagnosed cancer worldwide, with approximately 2.5 Mn new cases. It accounted for 12.4% of all new cancer cases followed by breast cancer in women (11.6%) & colorectal cancer (9.6%). Around 35 Mn new cancer cases are predicted in 2050, projecting a 77% increase from 2022. In 2025, the US is projected to have approximately 2.04 Mn new cancer diagnoses and 0.62 Mn cancer deaths. Cancer accounts for a substantial share of overall health care expenses in the U.S. In 2015, approximately $183 Bn was spent on cancer-related health care, and this figure is expected to rise by 34%, reaching $246 Bn by 2030. Biosimilars play a significant role in reducing the cost of cancer treatments & improving patient access to essential therapies. Cost Efficiency of Biosimilars The significant expense of cancer treatments imposes a heavy strain on the healthcare system. In recent years, growing awareness of the cost-saving potential of biosimilars has led to increased clinical adoption and market availability, with several oncology-related biosimilars now accessible. In 2023, cost savings from biosimilars surged by over 30%, reaching $12.4 billion. Since their launch, these medications have collectively saved $36 billion. Biosimilars are projected to be as much as 35% cheaper than their branded counterparts, potentially contributing to a $100 billion reduction in U.S. drug costs between 2020 and 2024. Developing and securing approval for a biosimilar is significantly more cost-effective compared to a reference biologic, typically ranging from $100 million to $250 million, whereas creating a new prescription medicine can cost around $2.6 billion. As of April 2025, there are 25 FDA approved oncology biosimilars which include bevacizumab, trastuzumab, rituximab and others. Market Opportunities The pharmaceutical industry is undergoing a pivotal transformation as a wave of biologic drug patent expirations reshapes the market for biosimilars. Many blockbuster biologics used in oncology (like Herceptin, Avastin, and Rituxan) have lost or are losing patent protection in major markets like the US and Europe. By 2030, 69 biologic medicines will lose exclusivity, creating a $31.8 billion market opportunity. Key contenders include Perjeta (pertuzumab) & Yervoy (ipilimumab), both pivotal in treating metastatic breast cancer and non-small cell lung cancer. Additionally, checkpoint inhibitors like nivolumab (Opdivo) & pembrolizumab (Keytruda) are expected to see biosimilar alternatives by 2028. Over the next decade, the expiration of patents & other intellectual property rights held by biological innovators will create opportunities for oncology biosimilars to enter the market. Market Restraints The development of biosimilars involves a comprehensive evaluation process, including analytical assessments, functional studies, nonclinical investigations, and clinical trials. Both the European Medicines Agency (EMA) & the FDA have rigorous approval standards. Countries in regions such as the Middle East & North Africa frequently adhere to EMA or FDA regulatory standards while also implementing distinct local frameworks. This dual approach contributes to variations in biosimilar approval & regulatory alignment, leading to greater discrepancies across markets. A key hurdle in biosimilar adoption is obtaining FDA interchangeability approval. While an FDA-approved biosimilar can be used to treat its intended condition, an additional regulatory designation is required for it to be considered interchangeable with its reference biologic. These differing regulatory approaches influence market penetration & healthcare cost optimization, shaping biosimilar adoption dynamics across regions. Oncology Biosimilars Market: Competitive Landscape The biosimilar market is set to evolve into three distinct categories- emerging, established and smaller players. Leading companies like Samsung Bioepis, Sandoz and Amgen are expanding their portfolios with biosimilars targeting high-value drugs such as Opdivo & Keytruda. Meanwhile, emerging players like Biocad, Mabxience (Insud Pharma), Innovent Biologics & Luye Pharm are making strides with late-stage biosimilars for oncology indications. Additionally, smaller firms like Shanghai Henlius Biotech & Prestige Biopharma are entering the market, focusing on less competitive segments. To navigate this shifting landscape, manufacturers of reference product must assess incoming biosimilar competition, strategize launches for next-generation and monitor patent dynamics. U.S. Oncology Biosimilar Pipeline - (As of April 1, 2025) Molecule Reference Product Biosimilars Status Rituximab Rituxan® (Genentech Inc.) MabionCD20 Rituximab In clinical trials In clinical trials Trastuzumab Herceptin® (Genentech Inc.) TX05 HD201 Trastuzumab AP063 Pending FDA approval In clinical trials In clinical trials In clinical trials Bevacizumab Avastin® (Genentech Inc.) FKB238 Aybintio® HD204 TRS003 Bambevi® Pending FDA approval In clinical trials In clinical trials In clinical trials In clinical trials Pertuzumab Perjeta® (Genentech Inc.) HLX11 PERT-IJS EG1206A In clinical trials In clinical trials In clinical trials Nivolumab Opdivo® (Bristol-Myers Squibb Co.) ABP 206 In clinical trials Pembrolizumab Keytruda® (Merck & Co., Inc.) GME751 SB27 ABP 234 BAT3306 CT-P51 In clinical trials In clinical trials In clinical trials In clinical trials In clinical trials Oncology Biosimilars Market: Recent Developments On April 14, 2025, Accord BioPharma, Inc., the U.S. specialty arm of Intas Pharmaceuticals, announced the completion of Intas' acquisition of UDENYCA® (pegfilgrastim-cbqv) from Coherus BioSciences, Inc. As a biosimilar to Neulasta® (pegfilgrastim), UDENYCA enhances the company's FDA-approved portfolio, strengthens its presence in oncology, and accelerates its growth in the biosimilar market. On April 10, 2025, Biocon Biologics Ltd announced that the U.S. FDA had granted approval for Jobevne™ (bevacizumab-nwgd), a biosimilar of Bevacizumab intended for intravenous administration. JOBEVNE, a recombinant humanized monoclonal antibody, is designed to treat multiple types of cancer and serves as a biosimilar to the reference product Avastin® (bevacizumab). On March 26, 2025, Fresenius announced FDA approval of its Biologics License Application (BLA) for denosumab biosimilars Conexxence® and Bomyntra®, developed by Fresenius Kabi. These biosimilars are authorized for all indications of their reference products, Prolia® and Xgeva®. Additionally, Fresenius Kabi has reached a Global Settlement with Amgen regarding its denosumab biosimilars. On April 26, 2024, Shanghai Henlius Biotech, Inc. announced FDA approval for HERCESSI™ (HLX02, trastuzumab-strf), a biosimilar to Herceptin®, through its business partner Accord BioPharma Inc. The monoclonal antibody biosimilar is approved in the U.S. for treating HER2-overexpressing breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma. Previously approved in China and the EU, HLX02 strengthens Henlius' global biosimilar presence. Oncology Biosimilars Market Segmentation: A Comprehensive Overview By Indication Lung Cancer Breast Cancer Colorectal Cancer Blood Cancer Cervical Cancer Others By Drug Class Monoclonal Antibodies Hematopoietic Agents Granulocyte Colony-Stimulating Factor By Route of Administration Subcutaneous Intravenous Others By Distribution Channel Online Pharmacy Hospital Pharmacy Retail Pharmacy Others By Region North America Asia-Pacific Europe Latin America Middle East Africa Regional Analysis – Oncology Biosimilars Market The oncology biosimilars market is experiencing varied growth across different regions, influenced by factors such as regulatory environments, healthcare infrastructure & pricing dynamics. North America, particularly the U.S., is witnessing steady growth due to the high prevalence of cancer and increasing healthcare cost pressures. Although biosimilar adoption was initially slow due to physician hesitancy, initiatives like the FDA’s Biosimilars Action Plan and recent patent expirations of major oncology biologics are accelerating market uptake. In 2020, Pfizer became the first company to launch three monoclonal antibody (mAb) biosimilar treatments for oncology (ZIRABEV™, RUXIENCE™ & TRAZIMERA™) to the U.S. market. Europe leads the global market in biosimilar adoption, driven by robust regulatory support from the European Medicines Agency (EMA), well-established reimbursement frameworks & strong physician confidence. Countries like Germany, the UK & France have seamlessly integrated oncology biosimilars into clinical practice, making Europe a mature and highly competitive market. By the end of December 2024, a total of 109 biosimilars are approved for use in Europe. Asia-Pacific is the fastest-growing region, propelled by a large cancer patient population, supportive government policies, and increasing local biosimilar manufacturing, especially in countries like China, India & South Korea. The cost-sensitive nature of the market, along with improving access to healthcare, is contributing to rapid adoption. In Latin America, growth is supported by rising cancer incidence & governmental efforts to expand access to affordable biologic treatments. However, challenges such as regulatory complexity and economic instability in some countries limit faster adoption. Brazil & Mexico remain key markets in the region. Meanwhile, the Middle East and Africa show emerging potential. Increasing awareness of biosimilars and governmental focus on reducing cancer treatment costs are positive indicators. However, limited infrastructure and regulatory delays mean that market growth here is still at a relatively early stage. Key Players in the Oncology Biosimilars Market Novartis AG Pfizer Amgen Samsung Bioepis Viatris Celltrion Biocon GSK (GlaxoSmithKline) Roche Sanofi Oncology Biosimilars Market Report Coverage Report Attribute Details Forecast Period 2024 – 2032 Market Size Value in 2024 USD 6.8 Billion Revenue Forecast in 2030 USD 21.1 Billion Overall Growth Rate CAGR of 20.3% (2024 – 2030) Base Year for Estimation 2023 Historical Data 2017 – 2021 Unit USD Million, CAGR (2024 – 2030) Segmentation By Indication, By Drug Class, By Route of Administration, By Distribution Channel, By Geography By Indication Lung Cancer, Breast Cancer, Colorectal Cancer, Blood Cancer, Cervical Cancer, Others By Drug Class Monoclonal Antibodies, Hematopoietic Agents, Granulocyte Colony-Stimulating Factor By Route of Administration Subcutaneous, Intravenous, Others By Distribution Channel Online Pharmacy, Hospital Pharmacy, Retail Pharmacy, Others By Region North America, Europe, Asia-Pacific, Latin America, Middle East & Africa Country Scope U.S., Germany, China, Japan, India, Brazil, UK, etc. Market Drivers Growing cancer prevalence, cost-effectiveness of biosimilars, regulatory approvals Pricing and Purchase Options Customization available upon request Frequently Asked Question About This Report How Big is the Oncology Biosimilars Market? The Global Oncology Biosimilars Market size was valued at USD 6.8 Bn in 2024 & is projected to reach around USD 21.1 billion by 2030, expanding at a CAGR of 20.3% What are the Key Factors Driving the Growth of the Oncology Biosimilars Market? Rising cancer prevalence, increasing demand for cost-effective biologic therapies, and the patent expiration of blockbuster oncology biologics are key drivers of the oncology biosimilars market. Who are the Major Players in the Oncology Biosimilars Market? Major players include Novartis AG, Pfizer, Amgen, Samsung Bioepis, Viatris, Celltrion, Biocon, etc. Which Region Held the Largest Oncology Biosimilars Market Share? North America held the largest market share in 2024. Source- https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services https://www.fightcancer.org/sites/default/files/National%20Documents/Costs-of-Cancer-2020-10222020.pdf https://www.rand.org/news/press/2022/01/10.html https://accessiblemeds.org/wp-content/uploads/2025/01/AAM-2024-Generic-Biosimilar-Medicines-Savings-Report.pdf https://www.centerforbiosimilars.com/view/improving-biosimilar-access-through-global-regulatory-convergence https://www.centerforbiosimilars.com/view/the-next-frontier-oncology-biosimilars-in-2025-and-beyond Table of Contents Executive Summary • Market Overview • Market Attractiveness by Indication, Drug Class, Route of Administration, Distribution Channel, and Region • Strategic Insights from Key Executives (CXO Perspective) • Historical Market Size and Future Projections (2022–2032) • Summary of Market Segmentation by Indication, Drug Class, Route of Administration, Distribution Channel, and Region Market Share Analysis • Leading Players by Revenue and Market Share • Market Share Analysis by Indication, Drug Class, and Route of Administration Investment Opportunities in the Oncology Biosimilars Market • Key Developments and Innovations • Mergers, Acquisitions, and Strategic Partnerships • High-Growth Segments for Investment Market Introduction • Definition and Scope of the Study • Market Structure and Key Findings • Overview of Top Investment Pockets Research Methodology • Research Process Overview • Primary and Secondary Research Approaches • Market Size Estimation and Forecasting Techniques Market Dynamics • Key Market Drivers • Challenges and Restraints Impacting Growth • Emerging Opportunities for Stakeholders • Impact of Macroeconomic and Technological Factors • COVID-19 and Post-Pandemic Analysis Global Oncology Biosimilars Market Analysis • Historical Market Size and Volume (2022–2032) • Market Size and Volume Forecasts (2024–2032) • Market Analysis by Indication: o Lung Cancer o Breast Cancer o Colorectal Cancer o Blood Cancer o Cervical Cancer o Others • Market Analysis by Drug Class: o Monoclonal Antibodies o Hematopoietic Agents o Granulocyte Colony-Stimulating Factor • Market Analysis by Route of Administration: o Subcutaneous o Intravenous o Others • Market Analysis by Distribution Channel: o Online Pharmacy o Hospital Pharmacy o Retail Pharmacy o Others • Market Analysis by Region: o North America o Asia-Pacific o Europe o Latin America o Middle East & Africa North America Oncology Biosimilars Market Analysis • Historical Market Size and Volume (2022–2032) • Market Size and Volume Forecasts (2024–2032) • Market Analysis by Indication • Market Analysis by Drug Class • Market Analysis by Route of Administration • Market Analysis by Distribution Channel • Country-Level Breakdown: o United States o Canada o Mexico Asia-Pacific Oncology Biosimilars Market Analysis • Historical Market Size and Volume (2022–2032) • Market Size and Volume Forecasts (2024–2032) • Market Analysis by Indication • Market Analysis by Drug Class • Market Analysis by Route of Administration • Market Analysis by Distribution Channel • Country-Level Breakdown: o China o India o Japan o South Korea o Rest of Asia-Pacific Europe Oncology Biosimilars Market Analysis • Historical Market Size and Volume (2022–2032) • Market Size and Volume Forecasts (2024–2032) • Market Analysis by Indication • Market Analysis by Drug Class • Market Analysis by Route of Administration • Market Analysis by Distribution Channel • Country-Level Breakdown: o Germany o United Kingdom o France o Italy o Spain o Rest of Europe Latin America Oncology Biosimilars Market Analysis • Historical Market Size and Volume (2022–2032) • Market Size and Volume Forecasts (2024–2032) • Market Analysis by Indication • Market Analysis by Drug Class • Market Analysis by Route of Administration • Market Analysis by Distribution Channel • Country-Level Breakdown: o Brazil o Argentina o Rest of Latin America Middle East & Africa Oncology Biosimilars Market Analysis • Historical Market Size and Volume (2022–2032) • Market Size and Volume Forecasts (2024–2032) • Market Analysis by Indication • Market Analysis by Drug Class • Market Analysis by Route of Administration • Market Analysis by Distribution Channel • Country-Level Breakdown: o GCC Countries o South Africa o Rest of Middle East & Africa Key Players and Competitive Analysis • Novartis AG – Leading Provider of Oncology Biosimilars • Pfizer – Innovator in Cancer Treatment Biosimilars • Amgen – Key Player in Oncology Biosimilar Drug Development • Samsung Bioepis – Prominent Developer of Oncology Biosimilars • Viatris – Leading Supplier of Biosimilars in Oncology • Celltrion – Global Leader in Biopharmaceuticals and Oncology Biosimilars • Biocon – Expanding Portfolio in Oncology Biosimilars • GSK (GlaxoSmithKline) – Significant Presence in Oncology Biosimilars • Roche – Key Player in Biosimilars for Oncology Applications • Sanofi – Innovating in Oncology Biosimilars for Cancer Treatment Appendix • Abbreviations and Terminologies Used in the Report • References and Sources List of Tables • Market Size by Indication, Drug Class, Route of Administration, Distribution Channel, and Region (2024–2032) • Regional Market Breakdown by Indication, Drug Class, and Distribution Channel (2024–2032) List of Figures • Market Dynamics: Drivers, Restraints, Opportunities, and Challenges • Regional Market Snapshot for Key Regions • Competitive Landscape and Market Share Analysis • Growth Strategies Adopted by Key Players • Market Share by Indication, Drug Class, and Distribution Channel (2024 vs. 2032)