Oncology Biosimilars Market

Oncology Biosimilars Market Outlook 2025 to 2035

The Oncology Biosimilars Market is estimated to be worth USD 10.9 billion in 2025, according to Fact.MR's report states that the valuation will expand at an 8.1% CAGR during the forecast period and account for USD 24 billion by 2035. The growth in revenue is fueled mainly by the increasing worldwide cancer burden and the imperative necessity to decrease the high expenditure of biologic cancer treatments, thus making biosimilars a viable option for healthcare systems as well as patients.

Oncology biosimilars are increasingly becoming important in the global health environment because they can provide clinically similar therapeutic outcomes as reference biologics but at much lower prices. Since cancer therapy remains costly, both public and private payers are promoting the use of biosimilars to enhance access to life-saving medicines. Patent losses of blockbuster oncology biologics have presented a huge opportunity for biosimilar companies to bring cost-saving treatment options.

With improving acceptance among oncologists and widening regulatory approvals, the oncology biosimilars market is becoming mature and competitive. Stepped-up investments in pharmacovigilance, comparative clinical trials, and education programs have enhanced stakeholder trust in biosimilar safety and efficacy. The advent of high-tech manufacturing technologies has also been instrumental in improving scalability and consistency in biosimilar manufacture.

Regionally, North America and Europe lead because of favorable reimbursement systems, biosimilar substitution policies, and established regulatory processes. Asia-Pacific is, however, becoming a major growth base driven by growing cancer incidence, an expanding generic pharmaceutical industry, and amenable government policies encouraging biosimilar adoption. Companies are creating strategic partnerships with hospitals, payers, and pharmacy chains to drive sales expansion.

Ongoing regulatory convergence, stepped-up approval routes, and competitive pricing strategies will influence growth in the industry. Such firms that manage to balance affordability, therapeutic comparability, and strong commercialization models will best be able to dominate the oncology biosimilars market in the next decade.

Key Metrics

Metric	Value
Estimated Global Size in 2025	USD 10.9 billion
Projected Global Size in 2035	USD 24 billion
CAGR (2025 to 2035)	8.1%

Fact.MR Survey Results: Industry Dynamics Based on Stakeholder Perspectives

Fact.MR's survey results indicate that the oncology biosimilars market is underpinned by three key stakeholder priorities: clinical equivalence, affordability, and regulatory harmonization. A total of 83% emphasized clinician confidence building through open safety and efficacy data, while 76% of healthcare administrators are optimizing affordability without compromising on treatment outcomes.

Local trends differ, with North America having payer education at its core, Europe depending on substitution policies and central tenders, and Asia-Pacific leading in hospital-level uptake. To enhance operating performance, 66% of companies are using AI-enabled process optimization and 60% are implementing digital pharmacovigilance to monitor in real time.

Supply chain complexity remains a challenge, nonetheless, particularly with respect to cold-chain logistics and public procurement integration. Seven-three percent of the stakeholders pointed to infrastructure as a major challenge.

In the future, 75% plan to increase investment in local clinical trials and regulatory submissions, though regional strategies vary-North America is driving digital education, Europe is fostering value-based contracts, and Asia-Pacific is enhancing localized production.

In all regions, there is strong agreement that biosimilar uptake is contingent on continued investment in scalable infrastructure, intelligent technologies, and provider trust-building activities. Those companies that meet these expectations will be best placed to drive the next stage of biosimilar adoption worldwide.

Shifts in the Oncology Biosimilars Market from 2020 to 2024 and Future Trends 2025 to 2035

Between 2020 and 2024, the oncology biosimilars market saw substantial growth, driven by the expiration of patents for key biologic drugs and a growing demand for cost-effective cancer treatments. The transition to biosimilars in clinical oncology was driven by increasing cancer prevalence, demands for accessible therapies, and regulatory progress that facilitated the entry of biosimilars.

Throughout this time, biosimilars for monoclonal antibodies such as trastuzumab, bevacizumab, and rituximab became widely available, making treatment more cost-effective for patients and enhancing accessibility to healthcare systems.

In the future, between 2025 and 2035, the oncology biosimilars market will continue its growth path. The introduction of additional biosimilars with other oncology indications and the ongoing advancement in manufacturing technology will enhance the quality and credibility of these products.

Personalized medicine, or treatment customized according to the individual patient, will also increase the demand for biosimilars, further widening their applications in cancer therapy. In addition, emerging regions are likely to be major drivers of the adoption, thus enabling the treatment to reach a wider population of patients.

A Comparative Market Shift Analysis 2020 to 2024 vs. 2025 to 2035

2020 to 2024	2025 to 2035
Patent expirations, cost containment pressures, regulatory support	Launch of new biosimilars, process improvements in manufacturing, personalized medicine
Better manufacturing processes, approval by regulators	Better product quality, individualized treatment options
Monoclonal antibody biosimilars (e.g., trastuzumab, bevacizumab, rituximab)	Extension to further oncology indications targeted therapies
Greater use in developed countries	Emerging markets growth, development of healthcare infrastructure
Fast-track approvals, favorable policies	Sustained regulatory support, emphasis on interchangeability of biosimilars

Country-wise Analysis

Countries	CAGR (2025 to 2035)
USA	9.5%
UK	8.8%
France	8.2%
Germany	8.5%
Italy	7.9%
South Korea	9.0%
Japan	8.0%
China	10.2%
Australia-NZ	7.7%

The USA

The USA will expand at 9.5% CAGR throughout the study. The growth path of the USA oncology biosimilars market is driven by a supportive regulatory environment, rising healthcare spending, and a high rate of cancer incidence. Significant research and development efforts by major pharmaceutical players in the country facilitate strong growth. An increasing focus on cost-cutting in healthcare has triggered the embrace of biosimilars as cost-effective substitutes for biologics.

Reimbursement support and collaborations between healthcare providers and biosimilar manufacturers continue to influence adoption. The blend of regulation incentives and educational campaigns directed toward healthcare professionals will further speed up growth over the forecast period.

UK

The UK will witness growth at 8.8% CAGR over the forecast period. The oncology biosimilars market in the UK is reaping the advantage of an established healthcare system along with strong governmental support for the adoption of biosimilars. The National Health Service (NHS) is actively promoting the utilization of biosimilars in order to properly contain healthcare expenditure. The increasing incidence of cancer, in addition to population aging, highlights the need for cost-controlled treatment.

Synergistic collaborations between biosimilar manufacturers and healthcare providers are helping players to stay in the competition. Confidence-building educational programs for physicians and patients on biosimilar safety and efficacy are contributing toward increased adoption. Additionally, continuous policy efforts to simplify biosimilar adoption in clinical practice will shape the trend over the next decade.

France

France will grow at a rate of 8.2% CAGR over the forecast period. A strong regulatory system and an active healthcare system are underpinning the fast-track uptake of biosimilars in France. The nation focuses on biosimilar substitution procedures and encourages healthcare professionals to prescribe affordable substitutes, which is also playing a large role in growth. Rising cancer incidence rates, especially among the elderly population, are increasing the need for biosimilar treatments.

Drug companies are also actively undertaking promotional campaigns to make biosimilars acceptable among oncologists and patients. Pricing reforms and strategic procurement policies under the initiative of public health authorities have also increased biosimilar availability. As biosimilar penetration increases in key oncology indications, a steady growth momentum is expected.

Germany

Germany is forecast to register a growth of 8.5% CAGR during the period under study. Germany is a leading player in the European oncology biosimilars market, led by positive healthcare policies and a well-established biosimilar environment. Regulatory requirements incentivizing biosimilar adoption in the inpatient and outpatient environments have helped propel growth substantially. A very formal reimbursement framework facilitates rapid access to biosimilars for patients, supporting increased adoption.

The rising incidence of cancer morbidity coupled with cost-containment efforts is also supporting demand. Strong liaison between manufacturers and healthcare organizations facilitates greater biosimilar adoption. With sustained research investments and strategic collaborations between clinical networks and biopharmaceutical firms, Germany is set to register stable growth during the forecast period.

Italy

Italy's oncology biosimilars market is projected to record a 7.9% CAGR throughout the study. Italy is making steady progress because of regulatory support and increased demand for cost-effective cancer treatments. Local healthcare authorities have an important part to play in promoting biosimilar utilization, especially by incentivizing cost-effective tendering.

Growing cancer incidence among the aging population base highlights the need for affordable and sustainable treatment. Local production of biosimilars, facilitated by the emergence of international biosimilar developers, is increasing competition and extending product access. Continuous efforts to make healthcare providers and patients aware of the safety and efficacy of biosimilars are improving market acceptance. Government policies aimed at reducing healthcare expenditures are expected to reinforce biosimilar adoption, sustaining expansion over the next decade.

South Korea

South Korean oncology biosimilars market is expected to grow at 9.0% CAGR during the study period. Top-notch biotechnology capabilities and government-led initiatives support South Korea. Top local biopharmaceutical companies have developed a robust global presence, further boosting the country's competitiveness in biosimilar development and production. Increasing cancer incidence rates, combined with growing healthcare awareness, are fueling demand for effective yet cost-saving therapeutic alternatives.

Regulatory bodies provide simplified approval routes for biosimilars, ensuring quicker and enhanced access to the industry. Public-private partnerships to stimulate biosimilar innovation are also bolstering South Korea's dominance. Continued research infrastructure investments and international commercialization plans are expected to drive high growth in the industry.

Japan

Japan is expected to register 8.0% CAGR growth over the forecast period. Japan's oncology biosimilars market is building up as healthcare professionals and policymakers increasingly appreciate the value proposition of biosimilars in oncology. Cost-containment policies by the government, in the face of an aging population and increasing cancer incidence, have further pushed the efforts to adopt biosimilars. The regulatory environment is favorable, with well-defined guidelines supporting biosimilar approvals and post-marketing surveillance to guarantee safety.

Pharmaceutical firms are increasingly participating in awareness drives and interacting with healthcare professionals to build higher confidence in biosimilars. A focus on pharmacoeconomic advantages, along with a transition towards outpatient cancer treatment settings, is further increasing the market potential. Key players in the oncology biosimilars market are emphasizing the growth of portfolios to meet unmet needs in cancer treatment.

China

China will grow at a 10.2% CAGR during the study period. China is becoming one of the most profitable oncology biosimilars market, spurred by an ambitious healthcare reform agenda and accelerating investment in biopharmaceutical manufacturing. Growing cancer incidence, particularly in an aging population, has stimulated demand for cost-effective treatment options. The Chinese government has placed biosimilar development on the policy priority list through supportive policies, accelerated regulatory approaches, and beneficial pricing plans.

The domestic drug industry is increasing its production capacity while multinational companies are making strategic partnerships. A significant focus on healthcare accessibility and affordability lies behind the accelerated growth in the oncology biosimilars market. With ongoing improvement in healthcare infrastructure and increased awareness of biosimilar choices, China is likely to experience strong growth in the forecast period.

Australia-New Zealand

The Australia-New Zealand oncology biosimilars market will expand at 7.7% CAGR throughout the study. Australia and New Zealand are growing steadily, aided by government policies for biosimilar adoption and low-cost delivery of healthcare. Regulatory bodies in both nations have put in place policies to ease the entry of biosimilars and promote substitution practices where possible. Increased prevalence of cancer and growing demand for affordable oncology therapies are the major drivers of growth.

Healthcare professionals are increasingly adopting biosimilars as treatment options, aided by education and awareness campaigns. Strategic partnerships between biosimilar manufacturers and healthcare facilities are boosting the growth. Attempts to incorporate biosimilars into routine cancer treatment regimens are anticipated to sustain industry growth, allowing for increased patient access to cheap oncology drugs throughout the forecast period.

Segment-wise Analysis

By Drug Class

In 2025, the oncology biosimilars market is segmented by drug class into Monoclonal Antibodies and Hematopoietic Agents, with Monoclonal Antibodies holding a significant 40% share, while Hematopoietic Agents account for 35%.

Monoclonal antibodies dominate a huge 40% share in the oncology biosimilars market. Biologics engineered against specific molecules involved in the cancer growth process are also quite widely used for treating multiple types of cancers, such as breast cancer, colorectal cancer, and lymphoma. This increased incidence of cancers, along with the growing acceptance of targeted therapies, is majorly contributing to the demand for monoclonal antibody biosimilars.

It becomes evident in the patent expirations of major monoclonal antibody treatments such as Rituxan, Herceptin, and Avastin, which have led to a tremendous increase in the production and use of biosimilars as cheaper alternatives, making monoclonal antibodies the largest class used in making biosimilars.

Companies such as Celltrion Healthcare (South Korea), Sandoz (a Novartis division, Switzerland), and Amgen (USA) are leaders in this line, with products such as Truxima, Herzuma, and Mvasi, respectively. These biosimilars thus make cancer treatment affordable and accessible, particularly in emerging regions where cost is still a major barrier to treatment.

Hematopoietic Agents account for a share of 35% of the oncology biosimilars market. They stimulate blood cell formation and serve as therapies for various cancers, such as leukemia and lymphoma. Hematopoietic agents also manage side effects from chemotherapy, like neutropenia and anemia. Zarxio (filgrastim) and Nivestim are gaining popularity because healthcare systems are opting for more economical pathways that include biosimilars.

The growing number of patients diagnosed with cancer, most notably chemotherapy patients, is responsible for their increasing demand. Major players in this segment are Pfizer and Teva Pharmaceuticals, and both have come forward to advance hematopoietic agent biosimilars through their lower-cost therapies geared at cutting hospital overheads and positively impacting patient outcomes.

By Disease Indication

In 2025, the oncology biosimilars market is further segmented by disease indication into Non-Small Cell Lung Cancer (NSCLC) and Blood Cancer (Leukemia & Lymphoma), with Blood Cancer accounting for 30% of the share, while NSCLC holds a 25% share.

Blood Cancer (Leukemia & Lymphoma) is the leading disease indication in the oncology biosimilars market, holding a 30% share. There is a significant increase in the incidence of blood cancer globally and the rising demand for targeted biologic therapies. The most common use of biosimilars in blood cancers is in their applications for treating leukemia and lymphoma; this may include such monoclonal antibodies as Rituxan, biosimilars like Truxima, and the key feature of offering affordability to patients.

Important drugs for blood cancer treatment include chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Thus, this segment is being propelled by the following factors: increasing adoption of biosimilars in place of expensive branded biologics, as well as increased awareness regarding their clinical efficacy. Companies such as Celltrion and Sandoz offer biosimilar versions of Rituxan.

Non-Small Cell Lung Cancer (NSCLC) holds a 25% share in the oncology biosimilars market. Cancer has high incidence rates and is being increasingly treated with biosimilars. NSCLC is still one of the most common and aggressive cancers, with monoclonal antibodies, such as Bevacizumab (Avastin), and biosimilars, like Mvasi, in a central role in its treatment.

A growing concern in personalized medicine and the development of biosimilar substitutes for these medicines is increasing momentum in this segment. Key players, such as Amgen and Pfizer, include more biosimilars in their product portfolios for NSCLC to lower treatment costs without affecting treatment efficacy.

Competitive Outlook

The oncology biosimilars market is highly competitive, with established pharmaceutical giants and emerging biopharma firms battling for dominance in a rapidly maturing therapeutic space. Sandoz International GmbH, a division of Novartis, remains a key leader with an expansive biosimilar portfolio spanning rituximab, filgrastim, and pegfilgrastim biosimilars.

Its early entry into the industry, global regulatory reach, and cost-effective manufacturing make it a formidable competitor. Pfizer, Inc. follows closely with a strong commercial infrastructure and strategic focus on oncology monoclonal antibodies, including trastuzumab and bevacizumab biosimilars.

Celltrion Inc., a pioneer in biosimilar monoclonal antibodies, continues to expand its footprint globally, leveraging its R&D strength and alliances with marketing partners. Dr. Reddy’s Laboratories and Biocon are also making significant inroads, particularly in emerging regions, by offering affordable, WHO-prequalified oncology biosimilars with global distribution strategies.

Meanwhile, Teva Pharmaceuticals and STADA Arzneimittel AG are scaling aggressively through licensing agreements and co-development models, targeting both USA and European markets. Players like Apobiologix, Intas Pharmaceuticals, and BIOCAD are also gaining recognition through regional dominance, strategic partnerships, and deep pipelines targeting oncology blockbusters.

Market Share Analysis by Company

Company	Estimated Market Share (%)
Sandoz International GmbH	18-22%
Pfizer, Inc.	14-18%
Celltrion Inc.	12-15%
Dr. Reddy’s Laboratories Ltd.	10-13%
Biocon	9-12%
Other Players	22-29%

Key Company Insights

The oncology biosimilars market has been estimated to be 18-22% captive by Sandoz International GmbH, which is in a very strong position. Sandoz is credited with developing the product range since the earliest days and has commercialized biosimilars of blockbuster oncology molecules in the USA, EU, and APAC. Investments in manufacturing scalability, regulatory access, and post-marketing vigilance will keep Sandoz leading in this field.

fizer, Inc. has been credited with 14-18% of the oncology biosimilars market. Its portfolio consists of biosimilars for trastuzumab and bevacizumab, with strategies focused on engaging with stakeholders. Pfizer is also keeping an eye on the USA for penetration and volume growth across Europe, mainly through competitive pricing consolidation and reliability in supply chain efforts.

Celltrion Inc. found its share somewhere between 12-15% with vertically integrated production and a strong pipeline for biopharmaceutical development. The focus of Celltrion on high-volume oncology biosimilars and co-marketing partnerships, particularly in the European and Latin American markets, has enhanced its brand visibility and credibility.

Dr. Reddy's Laboratories Ltd. holds around 10-13% of the oncology biosimilars market, with a growing repertoire of oncology biosimilars adding strength to the regulatory weight the company enjoys in India and semi-regulated markets. Slowly, the company is foraying into North America through licensing and strategic alliances.

Biocon has an estimated share of about 9-12%, which rests on the joint venture with Viatris and its well-established biosimilar pipeline. Biocon's trastuzumab and pegfilgrastim biosimilars are well accepted in both emerging and developed markets, consolidating their presence on the transparent global landscape of oncology biosimilars.

Key Players

• Sandoz International GmbH
• Pfizer, Inc.
• Celltrion Inc.
• Dr. Reddy’s Laboratories Ltd.
• Biocon
• Teva Pharmaceutical Industries Ltd.
• STADA Arzneimittel AG
• Apotex Inc. (Apobiologix)
• Intas Pharmaceuticals Ltd.
• BIOCAD

Segmentation

• By Drug Class:

  • G-CSF
  • Monoclonal Antibody
  • Hematopoietic Agents

• By Disease Indication:

  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Blood Cancer
    • Leukemia
      • Myeloid Leukemia
      • Chronic Lymphocytic Leukemia
      • Others
    • Non-Hodgkin Lymphoma
  • Colorectal Cancer
  • Neutropenia
  • Others

• By Distribution Channel:

  • Hospital Pharmacy
  • Online Pharmacy
  • Retail Pharmacy

• By Region:

  • North America
  • Europe
  • Asia Pacific
  • Rest of the World