Oncology Biosimilars Market Size & Growth Report to 2030

Key Findings:

• The market is experiencing a significant CAGR of ~ 22% by 2030 and market size was valued at ~ US$ 4 Bn in 2023
• By drug class, the monoclonal antibodies segment dominated the global market in the benchmark year 2023
• Geographically, the Europe is accounted to hold the largest revenue share of around 1/3 market share in the benchmark year 2023

The global oncology biosimilars market size was valued at around USD 4 billion in 2023 and projected to grow at a robust CAGR of around 22% during the forecast period from 2024 to 2030. The oncology biosimilars market is experiencing substantial growth, driven by the increasing prevalence of cancer and the patent expirations of several biologic cancer treatments. With biologic therapies becoming a standard in cancer treatment, the introduction of biosimilars offers a cost-effective alternative. This market is expanding as patients and healthcare providers seek affordable solutions, especially in regions with rising cancer cases. The global market is projected to grow at a robust CAGR through 2030, with significant adoption in the U.S. and Europe, where the demand for high-quality, cost-efficient treatments is rising​.

Key segments of the market include monoclonal antibodies, granulocyte colony-stimulating factors, and blood cancer biosimilars, which are expected to see rapid growth. The most common routes of administration for oncology biosimilars are intravenous and subcutaneous, with hospitals being the primary end-users of these therapies. North America remains the largest market due to a well-established healthcare infrastructure, though the Asia-Pacific region is anticipated to witness the highest growth, thanks to an expanding healthcare sector and an increasing number of biosimilar manufacturers.

Market Snapshot:

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Market Drivers:

The global oncology biosimilars market is primarily driven by the increasing prevalence of cancer globally, with more patients seeking effective yet affordable treatment options. As cancer becomes more common, the demand for biologic therapies—specifically monoclonal antibodies and other biologics—has surged. However, these treatments can be expensive, and the growing shift toward biosimilars offers a more cost-effective alternative, allowing more patients to access treatment. In addition, the patent expirations of key biologic cancer drugs are opening up opportunities for biosimilar manufacturers to introduce generic versions, contributing to the market’s expansion. Governments in various regions, especially in the U.S. and Europe, are actively promoting the adoption of biosimilars as part of healthcare cost-containment strategies​.

Additionally, the market benefits from advancements in biosimilar manufacturing and regulatory support, with several countries streamlining approval processes for biosimilars to encourage their use. The regulatory frameworks established by bodies like the FDA and EMA have provided confidence in the safety and efficacy of biosimilars, thus facilitating broader market acceptance. Furthermore, the increasing availability of biosimilars in emerging markets, such as Asia-Pacific, is expected to further accelerate growth, as these regions face a rising cancer burden and seek affordable treatment options. Combined with continued research and development efforts to expand the range of biosimilar oncology treatments, these factors are fueling strong market growth​.

Market Trends:

Increasing Demand for Affordable Cancer Treatments: Cancer therapies are among the most expensive treatments in the healthcare sector. Biologic therapies, which use living organisms to produce drugs, are often prohibitively expensive. Oncology biosimilars, which are highly similar versions of branded biologic drugs, offer a more cost-effective alternative without compromising on safety or efficacy. The growing demand for affordable treatment options, especially as cancer rates rise globally, is a major factor contributing to the increased adoption of biosimilars. Healthcare systems, especially in resource-constrained settings, are looking to biosimilars as a way to reduce healthcare costs and improve patient access to essential medications.

Regulatory Advancements: The regulatory framework around biosimilars has become clearer and more supportive in recent years. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have developed well-defined pathways for the approval of oncology biosimilars. These guidelines help streamline the development process, making it faster and more predictable for biosimilars to enter the market. The approval process for oncology biosimilars is increasingly based on clinical trials that demonstrate similarity in terms of quality, safety, and efficacy to the reference biologic, allowing for easier market access.

Patent Expirations of Leading Biologics: A significant driver of the oncology biosimilars market is the expiration of patents for many leading biologic cancer therapies. For instance, monoclonal antibodies like Herceptin (trastuzumab) and Avastin (bevacizumab) have been key treatments in cancer care but are now losing patent protection as they approach the end of their patent terms. This creates a gap for biosimilar versions of these drugs to enter the market. As patents expire, biosimilars are able to compete with the branded versions, providing patients with more affordable treatment options while maintaining similar clinical outcomes.

Expanding Oncology Indications: Initially, biosimilars were developed for a limited number of cancer indications, primarily those related to common cancers like breast and colorectal cancer. However, the scope of oncology biosimilars is expanding rapidly. New biosimilars are being introduced for a broader range of oncology indications, including more complex cancers such as non-Hodgkin’s lymphoma, lung cancer, and even certain types of blood cancers. This expansion increases the therapeutic potential of biosimilars and widens the target patient population, making them viable for a more diverse group of cancer patients.

Innovative Partnerships and Collaborations: The development of oncology biosimilars is a highly complex and resource-intensive process. To accelerate innovation and bring products to market more quickly, many pharmaceutical companies and biotech firms are entering into strategic partnerships and collaborations. These partnerships often involve joint ventures between established pharmaceutical companies and smaller biotech firms, pooling expertise, technology, and financial resources to create high-quality biosimilars. By collaborating, companies can navigate the complexities of biosimilar development, scale production, and ensure compliance with regulatory requirements, ultimately enhancing their market competitiveness.

Market Opportunities:

The global oncology biosimilars market presents significant opportunities driven by the growing demand for cost-effective cancer treatments. With many blockbuster biologics such as Herceptin and Avastin losing patent protection, there is a clear market gap for biosimilars to provide more affordable alternatives. This shift opens up opportunities for pharmaceutical companies to develop and market biosimilars that can cater to a wider patient base, particularly in regions with high cancer incidence but limited access to expensive biologics. Additionally, healthcare systems worldwide are under increasing pressure to reduce costs, and biosimilars provide an economically viable solution that maintains high efficacy and safety standards. This offers a lucrative opportunity for biosimilar manufacturers to capture a share of the rapidly expanding oncology market.

Moreover, emerging markets present untapped growth potential for oncology biosimilars. Regions such as Asia-Pacific, Latin America, and Africa are experiencing rising cancer rates, coupled with healthcare infrastructure challenges and high treatment costs. As a result, these markets are actively seeking affordable alternatives like biosimilars to make cancer treatments more accessible to a larger population. Government initiatives, such as favorable pricing policies and regulatory incentives for biosimilars, are further fueling this growth. With the increasing adoption of biosimilars in these markets, companies can capitalize on this demand by expanding their presence and establishing partnerships with local healthcare providers and distributors, unlocking a substantial opportunity for global market penetration.

Market Restraints:

The global oncology biosimilars market faces several restraining factors that could hinder its growth. One of the primary challenges is the complexity of biosimilar development, which requires extensive clinical trials to prove similarity in terms of safety, efficacy, and immunogenicity to the reference biologic. This high development cost and lengthy approval process can discourage some companies from entering the market. Additionally, market acceptance remains a hurdle, as some oncologists and patients remain cautious about switching from established biologics to biosimilars, despite growing evidence of their equivalency. Regulatory hurdles also persist, particularly in markets with less-developed biosimilar frameworks or more stringent approval processes, further slowing market penetration. Moreover, the intellectual property (IP) landscape, including ongoing patent litigations and patent extension strategies by original biologic manufacturers, can delay the launch of biosimilars, limiting the speed at which these products can enter the market.

Market Insights:

The global oncology biosimilars market is bifurcated into drug class, indication, route of administration, end-user, and geography. On the basis of drug class, the monoclonal antibodies (mAbs) segment is the dominant segment in the global market. Monoclonal antibodies have become a cornerstone of cancer treatment, targeting specific antigens on cancer cells to inhibit tumor growth or mark them for immune system destruction. This class includes some of the most widely prescribed cancer treatments, such as Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab). As these blockbuster biologics lose patent protection, the market for mAb biosimilars has rapidly expanded, presenting a huge opportunity for companies to produce lower-cost alternatives. The large market share of mAb-based therapies, combined with their broad use in treating various cancers (e.g., breast cancer, colorectal cancer, and non-Hodgkin lymphoma), ensures that this segment remains the leading contributor to the oncology biosimilars market.

Moreover, the growing acceptance and adoption of mAb biosimilars by healthcare professionals and patients further strengthens their dominance. With increasing clinical evidence supporting the safety and efficacy of biosimilars, oncologists are more willing to prescribe them, and patients are benefiting from more affordable alternatives to expensive branded biologics. The high prevalence of cancers requiring monoclonal antibody treatments, coupled with the economic pressures on healthcare systems to reduce drug costs, positions mAb biosimilars as a major driver of market growth. As a result, the monoclonal antibody biosimilar segment is expected to continue its dominance, with increasing competition and availability contributing to broader access to effective cancer therapies.

Market Driving factors for Monoclonal Antibodies Sub-category:

• Patent Expirations and Biosimilar Development: One of the primary drivers for the growth of the mAb biosimilars market is the expiration of patents for several blockbuster biologic drugs, such as Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab). With these patents expiring, the market for biosimilars is opening up, allowing manufacturers to develop more affordable alternatives. The entry of biosimilars into the market is fueling competition, driving down the cost of treatment, and making oncology care more accessible, particularly in regions where cost constraints are significant.
• Cost-Effectiveness and Economic Pressure: The rising cost of cancer treatments is a major concern for healthcare systems globally. mAb biosimilars offer a cost-effective alternative to branded biologics, enabling healthcare providers to provide treatment at a lower price while maintaining therapeutic efficacy. As healthcare systems, particularly in developed countries, look for ways to control escalating healthcare costs, biosimilars are becoming an attractive option. The ability to reduce treatment costs without compromising on quality is a significant factor driving the adoption of mAb biosimilars.
• Regulatory Support and Evolving Approval Pathways: Regulatory bodies like the FDA and EMA have developed streamlined approval pathways for biosimilars, particularly for mAb-based treatments. These regulatory incentives are encouraging the development of biosimilars by providing clearer guidelines for approval, thus reducing the time and cost associated with bringing these therapies to market. The regulatory environment is becoming more favorable, with increased confidence in biosimilar safety and efficacy, which further drives market growth.

The oncology biosimilars market research report presents the analysis of each segment from 2020 to 2030 considering 2023 as the base year for the research. The compounded annual growth rate (CAGR) for each respective segment is calculated for the forecast period from 2024 to 2030.

Historical & Forecast Period

• 2020-22 – Historical Year
• 2023 – Base Year
• 2024-2030 – Forecast Period

Market Segmentation:

By Drug Class:

• Monoclonal Antibodies
• G-CSF
• Others

By Indication:

• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Cervical Cancer
• Blood Cancer
• Others

By Route of Administration:

• Intravenous
• Subcutaneous
• Others

By End-User:

• Hospitals
• Specialty Clinics
• Homecare
• Others

By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Regional Analysis:

Geographically, the Europe dominated the global oncology biosimilars market in the benchmark year with the largest revenue share of around 1/3 of the market. This dominance is driven by several factors, including a well-established regulatory framework, widespread healthcare access, and strong government support for biosimilar adoption. The European Medicines Agency (EMA) has been at the forefront of biosimilar approvals, with many mAb biosimilars being approved and launched in European markets well before other regions. The early introduction and availability of biosimilars in Europe have led to higher adoption rates by healthcare providers and patients, particularly in countries like Germany, France, and the UK. Furthermore, the European Union has implemented various policies and reimbursement schemes that encourage the use of biosimilars, making them an attractive option for cost-conscious healthcare systems.

Additionally, Europe’s healthcare systems have increasingly embraced biosimilars as a solution to rising healthcare costs, particularly in oncology, where biologic drugs are often prohibitively expensive. With the high prevalence of cancer and the growing demand for cost-effective treatments, mAb biosimilars are seen as a key to ensuring broader access to essential therapies. The combination of a favorable regulatory environment, extensive clinical data supporting the efficacy of biosimilars, and the increasing adoption of these therapies by healthcare professionals makes Europe a dominant region in the oncology biosimilars market. The trend is expected to continue as more biosimilars are introduced and as healthcare systems across Europe continue to prioritize affordability and sustainability in cancer care.

Competitive Landscape:

Some of the leading market players operating in the global oncology biosimilars market are Pfizer Inc., GlaxoSmithKline plc, Novartis AG, Mylan N.V., Teva Pharmaceutical Industries Ltd., and Sanofi. Companies are exploring markets by expansion, new investment, the introduction of new services, and collaboration as their preferred strategies. Players are exploring new geography through expansion and acquisition to gain a competitive advantage through joint synergy.

Key Companies:

• Pfizer Inc.
• GlaxoSmithKline plc
• Novartis AG
• Mylan N.V.
• Teva Pharmaceutical Industries Ltd.
• Sanofi
• Hoffmann-La Roche Ltd.
• Zydus Cadila
• Lupin
• Amneal Pharmaceuticals LLC.
• Cipla Inc.
• Aurobindo Pharma
• Glenmark Pharmaceuticals Limited
• Eli Lilly and Company
• Sun Pharmaceutical Industries Ltd.
• Allergan

Key Questions Answered by Oncology Biosimilars Market Report

• Global oncology biosimilars market forecasts from 2024-2030
• Regional market forecasts from 2024-2030 covering Asia-Pacific, North America, Europe, Middle East & Africa, and Latin America
• Country-level forecasts from 2024-2030 covering 15 major countries from the regions as mentioned above
• Oncology biosimilars submarket forecasts from 2024-2030 covering the market by drug class, indication, route of administration, end-user, and geography
• Various industry models such as SWOT analysis, Value Chain Analysis about the market
• Analysis of the key factors driving and restraining the growth of the global, regional, and country-level oncology biosimilars markets from 2024-2030
• Competitive Landscape and market positioning of top 10 players operating in the market