Oncology Biosimilars Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Drug Class (Monoclonal Antibodies, G-CSF, Hematopoietic Agents, Others), By Type of Cancer (Breast Cancer, Lung Cancer, Stomach Cancer, Prostate Cancer, Cervical Cancer, Blood Cancer, Brain Cancer, Others), By Distribution Channel (Retail Pharmacies, Hospital Pharmacies, Online Pharmacies), By Region and Competition, 2020-2030F

Market Overview

The Global Oncology Biosimilars Market, valued at USD 4.54 Billion in 2024, is projected to experience a CAGR of 6.94% to reach USD 6.79 Billion by 2030. Oncology biosimilars are biological products demonstrably highly similar to an approved original oncology biological product, exhibiting no clinically meaningful differences regarding safety, purity, and potency. The market's expansion is fundamentally driven by the increasing global incidence of various cancer types and the impending patent expiration of numerous blockbuster oncology biologics, which creates opportunities for lower-cost alternatives. Furthermore, robust government initiatives and healthcare policies actively promoting biosimilar adoption contribute significantly to market acceleration by fostering greater access and affordability for cancer treatments.

However, a significant challenge impeding broader market expansion remains the substantial investment and complex scientific expertise required for biosimilar development and manufacturing processes. This inherent complexity, coupled with the necessity for extensive regulatory validation, often prolongs market entry. Despite these hurdles, the economic benefits are notable; according to the Association for Accessible Medicines, in 2023, biosimilars generated $12.6 billion in savings within the healthcare system, underscoring their critical role in cost containment.

Key Market Drivers

The increasing global incidence of cancer serves as a primary catalyst for the oncology biosimilars market, generating substantial demand for effective yet affordable treatment solutions. As the worldwide cancer burden rises, healthcare systems are compelled to seek cost-efficient therapeutic alternatives to manage growing patient populations and control expenditures. This rising prevalence directly drives the necessity for accessible oncology therapies, with biosimilars playing a pivotal role in expanding treatment access. According to the World Health Organization and the International Agency for Research on Cancer (IARC), in their February 2024 news release, approximately 20 million new cancer cases were estimated globally in 2022. This escalating patient volume underlines the critical need for biosimilars to ensure sustainable and equitable cancer care.

Concurrently, the expiration of key biologic drug patents represents another fundamental driver, unlocking significant market opportunities for oncology biosimilars. This development intensifies competition among manufacturers, typically resulting in lower drug prices and enhanced treatment affordability. Improved pricing directly contributes to broader patient access, especially in areas previously constrained by the high cost of originator biologics. According to The Center for Biosimilars, in December 2023, nearly 20 oncology biologics' patents were anticipated to expire by 2024, creating considerable scope for biosimilar entry. This robust pipeline is further supported by a facilitating regulatory environment; for example, as of April 2025, the FDA had approved 74 biosimilars across various therapeutic areas, including oncology, signifying sustained momentum in biosimilar integration. These factors collectively reinforce the growing influence of biosimilars in reshaping global oncology care.

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Key Market Challenges

A significant challenge impeding the broader expansion of the Global Oncology Biosimilars Market is the substantial investment and intricate scientific expertise required for biosimilar development and manufacturing processes, alongside the necessity for extensive regulatory validation. This inherent complexity and considerable financial outlay directly deter potential manufacturers and prolong the market entry of oncology biosimilar products. The development pathway demands rigorous analytical characterization, preclinical evaluation, and clinical trials to establish biosimilarity to the original biologic, which is both capital-intensive and time-consuming.

This challenging development environment limits the number of pharmaceutical companies capable of undertaking such programs, especially for complex oncology biologics. Consequently, many reference products, even after patent expiration, do not face biosimilar competition. According to the Association for Accessible Medicines, in 2023, more than 80 percent of brand biologics eligible for competition did not have biosimilars in development. This considerable gap in biosimilar pipeline development directly hampers market growth by delaying the availability of lower-cost alternatives, thus extending the market exclusivity of original biologics and constraining overall market competition and patient access.

Key Market Trends

The growing acceptance and trust in clinical settings significantly influences the global oncology biosimilars market by fostering greater confidence among healthcare professionals and patients. This increased assurance directly translates into higher adoption rates for biosimilar treatments. According to the Association for Accessible Medicines, biosimilar medicines generated $20.2 billion in savings in 2024 alone, highlighting their crucial economic value which underpins broader acceptance. Furthermore, a survey conducted on behalf of the Alliance for Safe Biologic Medicines in August 2024, revealed that 88% of physicians agree switching studies enhance their confidence in the safety of transitioning patients from an originator medicine to an interchangeable biosimilar. This robust physician confidence is paramount for overcoming historical skepticism and driving market penetration.

The expansion into complex and high-value oncology biologics represents another pivotal trend, signifying the industry’s progression beyond simpler molecules to address a wider array of cancers with biosimilar alternatives. This strategic shift is crucial for maximizing patient access and reducing treatment costs for advanced therapies. For example, the European Medicines Agency approved a record 28 biosimilars in 2024, with oncology consistently remaining the dominant therapeutic area, indicating sustained focus and investment in this complex segment. Moreover, in the first quarter of 2025, the FDA and EMA approved seven biosimilars, many of which were for new oncology agents or expanded indications for existing biologics, demonstrating the continuous progress in developing biosimilars for more intricate cancer treatments.

Segmental Insights

The Global Oncology Biosimilars Market is experiencing significant expansion, with Lung Cancer identified as the fastest-growing segment. This rapid growth is primarily driven by the increasing global prevalence of non-small cell lung cancer (NSCLC), creating an urgent demand for effective and affordable treatment options. The introduction of new biosimilar versions of established biologics, such as bevacizumab, specifically targeting NSCLC treatments, further fuels this momentum. Additionally, ongoing research and clinical trials dedicated to lung cancer therapies, coupled with accelerated approvals from regulatory bodies like the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enhance market acceptance and adoption of these cost-effective alternatives.

Regional Insights

North America emerges as the leading region in the global oncology biosimilars market, primarily attributable to its robust regulatory framework and sophisticated healthcare infrastructure. The U. S. Food and Drug Administration (FDA) plays a crucial role by actively streamlining approval pathways under the Biologics Price Competition and Innovation Act, thereby enhancing scientific and regulatory clarity for biosimilar development and market entry. Concurrently, Health Canada’s stringent oversight and provincial biosimilar switching policies further encourage adoption, ensuring cost savings and improved patient access to critical oncology treatments. This conducive environment, combined with high clinician confidence and advanced healthcare facilities, facilitates widespread acceptance and effective integration of oncology biosimilars across the region.

Recent Developments

• In August 2025, Pfizer announced a substantial investment of $120 million dedicated to expanding its biosimilars manufacturing facility located in North Carolina. This capital allocation is specifically purposed to enhance the large-scale production capabilities for oncology and immunology biosimilars. The expansion endeavors to reinforce the reliability and efficiency of the supply chain for these vital therapeutic agents within the U.S. market. By augmenting its manufacturing capacity, Pfizer is strategically positioning itself to address the increasing demand for cost-effective oncology biosimilars and solidify its competitive presence in this evolving global sector.

• In April 2025, Biocon Biologics, a subsidiary of Biocon Ltd, received U.S. Food and Drug Administration (FDA) approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Roche’s Avastin. This approval significantly expands Biocon Biologics’ oncology portfolio in the United States, building upon its existing biosimilars such as OGIVRI (trastuzumab-dkst) and FULPHILA (pegfilgrastim-jmdb). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor, indicated for treating various cancers including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, and primary peritoneal cancers. The drug functions by restricting the blood supply to tumors.

• In February 2025, Amgen provided an update on its biosimilars business, signaling robust future growth driven by upcoming product launches and pipeline advancements. The company anticipated releasing results from a Phase 3 trial for its biosimilar version of Bristol Myers Squibb’s cancer immunotherapy, Opdivo, during the second quarter. Furthermore, Amgen confirmed its active development of biosimilar versions of Merck’s Keytruda, a leading cancer therapy. This strategic emphasis on high-value oncology targets underscores Amgen’s ongoing efforts to enhance its position and offering within the global oncology biosimilars market.

• In January 2025, Sandoz articulated its strategic roadmap, confirming plans for several biosimilar launches in the year that significantly influence the global oncology biosimilars market. The company planned U.S. and European launches for Wyost®/Jubbonti® (denosumab), indicated for bone-related cancer complications, among other uses. Additionally, Sandoz announced that biosimilars for major oncology assets like pembrolizumab and nivolumab entered late-stage clinical trials in 2024. This strategic expansion aims to capitalize on forthcoming patent expirations, reinforcing Sandoz's dedication to providing accessible biologic treatment options for patients.

Key Market Players

• Teva Pharmaceuticals Industries Ltd.
• STADA Arzneimittel AG
• Shanghai Henlius Biotech, Inc.
• Sandoz Group AG
• Samsung Bioepis NL B.V.
• Pfizer Inc.
• Ligand Pharmaceuticals Inc.
• Mylan Inc.
• Innovent Biologics (USA), Inc.
• Celltrion Inc.

Report Scope:

In this report, the Global Oncology Biosimilars Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Oncology Biosimilars Market, By Drug Class:

o   Monoclonal Antibodies

o   G-CSF

o   Hematopoietic Agents

o   Others

• Oncology Biosimilars Market, By Type of Cancer:

o   Breast Cancer

o   Lung Cancer

o   Stomach Cancer

o   Prostate Cancer

o   Cervical Cancer

o   Blood Cancer

o   Brain Cancer

o   Others

• Oncology Biosimilars Market, By Distribution Channel:

o   Retail Pharmacies

o   Hospital Pharmacies

o   Online Pharmacies

• Oncology Biosimilars Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Oncology Biosimilars Market.

Available Customizations:

Global Oncology Biosimilars Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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