Oncology Biosimilars Market
Report ID: SQMIG35H2399
Report ID: SQMIG35H2399
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Report ID:
SQMIG35H2399 |
Region:
Global |
Published Date: January, 2026
Pages:
177
|Tables:
92
|Figures:
71
Global Oncology Biosimilars Market size was valued at USD 7.65 Billion in 2024 and is poised to grow from USD 8.47 Billion in 2025 to USD 19.24 Billion by 2033, growing at a CAGR of 10.8% during the forecast period (2026–2033).
The market is experiencing steady growth due to the increasing global cancer burden, along with rising pressures of healthcare costs. As the patent cliff of blockbuster oncology biologics continues, biosimilars offer a fraction of the prices of branded products and so, regulatory agencies such as the EMA and FDA have expedited pathways for approvals with the emergence of biosimilars. Also, increased physician and hospital sites of use, especially in the U.S., Germany, and India have consistently increased uptake. In part due to expanded government support and favourable reimbursement opportunities among others, all of which are contributing to a more favourable environment for the oncology biosimilars market to grow. The oncology biosimilars market continues to grow, driven by the rising demand for low-cost cancer therapies in addition to international priorities for better access to healthcare overall. As biosimilar technology advances and better alignment in the regulatory environment occurs, the oncology biosimilars market is poised to grow significantly, across the projected period.
Although the market faces constraints like software creation and cost of development, it impeded product commercialization speed, especially for smaller players. Additionally, there are brand loyalty barriers to originator biologics among oncologists, as well as limited awareness in low-income countries which hinder complete market penetration. Difficult pharmacovigilance regulations and the requirement for large scale clinical trials limit entry for developers of new biosimilars as well.
How are Emerging Technologies like AI and IOT Transforming the Oncology Biosimilars Market?
Artificial Intelligence (AI) and the Internet of Things (IoT) are revolutionizing the oncology biosimilars industry by improving drug development, drug manufacturing, and post-market surveillance. The use of AI-powered algorithms is accelerating biosimilar development through advances in clinical trial data analysis, immunogenicity prediction, and selection of the best patient cohort for matching. This speeds up the time to get new biosimilars to market. In parallel, IoT devices are often being used to improve real time monitoring of patient responses, compliance with the drug treatment, and ultimately pharmacovigilance by integrating sensors, wearables and other technologies that will improve clinical outcomes. So, both technologies eliminate waste, create faster workflow, prevent production failures, ensuring regulatory compliance and much needed in the biosimilars environment.
In May 2025, Biocon Biologics began cooperation with Microsoft Azure to deploy AI and IoT technology across its oncology biosimilars manufacturing plants. The partnership is focused on predictive maintenance, automated quality control systems, and the capability to track real-time manufacturing time. These capabilities are expected to drive greater consistency and accuracy, including regulatory compliance. By adopting an integrated smart technology approach, Biocon is demonstrating an innovative approach to biosimilars manufacturing, to be digitally enabled, and accelerate market positioning and regulatory preparedness.
Market snapshot - 2026-2033
Global Market Size
USD 6.21 Billion
Largest Segment
Monoclonal Antibodies
Fastest Growth
Vaccines
Growth Rate
10.25% CAGR
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Global Oncology Biosimilars Market is segmented by Indication, Drug Class, Route of Administration, End User, Distribution Channel and region. Based on Indication, the market is segmented into Breast Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Blood Cancer and Others. Based on Drug Class, the market is segmented into Monoclonal Antibodies, Granulocyte Colony-Stimulating Factor and Others. Based on Route of Administration, the market is segmented into Intravenous, Subcutaneous and Others. Based on End User, the market is segmented into Hospitals, Specialty Clinics, Homecare and Others. Based on Distribution Channel, the market is segmented into Hospital Pharmacy, Retail Pharmacy, Online Pharmacy and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Based on the global oncology biosimilars market forecast, Monoclonal antibodies dominate largely owing to the high uptake of biologics and the growing use of monoclonal antibodies for targeted therapy in cancer space. First-in-class biologics are replacing or augmenting traditional chemotherapies for treating complex cancers, including breast cancer, colorectal cancer, and lung cancer. To date, a smaller share of monoclonal antibody biosimilars have reached the market, but manufacturers focus on monoclonal antibody biosimilars going forward due to their immense commercial potential.
Peptides are emerging as the fastest-growth product type, due to their molecular size, simpler structure and less complex development process than full-length proteins or antibodies. They have the potential to selectively target receptors in cancer cells and have lower toxicity profiles which makes them very appealing in the field of oncology therapeutics.
Breast cancer is the leading therapeutic area due to the overall incidence rate and the potential for several well-established biologics that are suitable for biosimilar copying. Drugs like trastuzumab has opened the door further as trastuzumab biosimilars become available, they will increase the number of patients who have access to relatively lower-cost treatment. Lastly, in emerging healthcare systems in Europe and the Asia-Pacific region, biosimilars are being included in their standards of care and treatment protocols.
Non-small cell lung cancer (NSCLC) sees a rapidly expanding market as it is driven by two of the largest forces at play in oncology an increasing incidence of the cancer and a significant interest in affordable therapies. The recent increase in clinical trials and new guidelines using biosimilars as a preferred first-line therapy is fueling the expansion.
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As per the global oncology biosimilars market analysis, North America dominates the global market with advanced healthcare systems, supportive reimbursement policies, and a rising demand for affordable cancer treatment options. The clarity of regulatory bodies and their rapid approvals for biosimilars have certainly led to biosimilars being launched in much greater frequency since the basis of regulatory transparency. In addition, a rise in health care expenditure is facilitating growth in the oncology biosimilar market.
The U.S. has the largest regional market due to the high cancer prevalence, healthcare expenditures, and regulatory pathways that encourage biosimilar competition. Efforts to reduce the treatment costs of biologics have bolstered access to biosimilars in oncology. They observed a regional hospital system incorporating biosimilars into their facility’s oncology protocols, allowing for better and more accessible treatment options across multiple states. The increase in physician awareness and acceptance by government lead to biosimilar availability.
In Canada, oncology biosimilars are growing rapidly, particularly due to cost containment measures and national substitution policies. The government has implemented education programs to help increase confidence in biosimilars for both patients and clinicians. In addition, one of the provincial health authorities has required cancer patients to switch from the originator biologics to biosimilars, and as a result, there has been increased uptake of biosimilars. With increased adoption of biosimilars Canada has become one of the fastest-growing market.
Europe represents an advanced market for oncology biosimilars, built upon strong regulatory harmonization and early support in many cases from national health services. Countries are pursuing biosimilars as a viable way to incorporate more affordable treatments to improve patient access. After leveraging regulatory harmonization, trust in biosimilar effectiveness in Europe is strong, all of which means an aero dynamic or staged approach to oncology biosimilars is an option for European countries, as markets are strong and continuing to grow.
Germany has the highest biosimilar penetration, favorable pricing policies, and strong push from payers to encourage substitution. In addition, hospitals and payers work together to encourage substitution and switching practices. Their healthcare policy around biosimilars in oncology drove more uptake in the early years among large oncology centers, and their efforts are continuing to cement Germany's leadership in biosimilar utilization across oncology indications.
France is clearly moving forward at a fast pace with respect to biosimilar uptake, supported by both cost-containment efforts, and evidence-based education to health care providers regarding these products. They were able to achieve that the national health service organization publicly supported extension of biosimilar initiatives within oncology clinics based on the new clinical recommendations. Overall, these collective efforts are yielding increased trust, and expedited uptake within the public health system nationally.
The UK's NHS-led adoption strategies and structured switching policies are critical to growing the biosimilars market. Hospital procurement frameworks are now actively specifying biosimilars in oncology. Specifically, there were updates to different NHS cancer sites included in the national roll out of oncology biosimilars in NHS cancer centers, thereby bending, expanding and improving access and reducing the waiting times for biologics, thereby growing the market and system-level support.
The Asia Pacific region has emerged as the leading regional market for oncology biosimilars owing to increasing cancer rates, healthcare reforms, and domestics manufacturing initiatives. Government officials are encouraging biosimilar development to lower import dependency to alleviate the burden of cancer treatment costs. The aging population and greater access to thorough cancer diagnosis for patients create greater demand for lower-cost biosimilar treatment to meet the demands for increasing cancer registries throughout the Asia Pacific region.
Japan is the clear leader in biosimilar regional markets because of stricter quality control measures, early biosimilar adoption, and national insurance coverage. Hospitals are beginning to systematically enqueue biosimilars into guidelines for major cancers and a national chemotherapy protocol reaffirmed oncology biosimilars, resulting in increased hospital acquisition and use, publicly and privately.
South Korea is the fastest growing country from a regional perspective due to its aggressive biosimilar innovation strategies and government cantered R&D investments. The regulatory reforms created a fast-track approval for oncology biosimilars. Their initiative at an exemplary hospital network included pilot programs for oncology biosimilar use in rural and urban settings, highlighting their efforts to increase the affordability of treatment and access across the country.
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Patent Expiry of Blockbuster Biologics
Increasing Burden of Cancer and Demand for Affordable Treatments
Complex Manufacturing and High Development Costs
Physician and Patient Hesitancy
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The global oncology biosimilars market outlook is highly competitive, the major competitors being Pfizer Inc.,Amgen Inc., Biocon Biologics, Celltrion Healthcare and Sandoz which have been prominent via product launches, regulatory approvals, and global expansions. Amgen has grown its oncology biosimilar portfolio across Europe and the U.S at an aggressive pace and focuses on biosimilars for trastuzumab and bevacizumab. Sandoz is building early-stage R&D and has recently entered strategic partnerships/ alliances and acquisitions in Asia. All these competitors prioritize affordable pricing, time‐to‐market, and continuing clinical outcomes to help protect their competitive position globally.
As per the global oncology biosimilars industry analysis, the startup scene is rapidly evolving, with innovative ways of drug development, cost-effectiveness, and rapid regulatory mechanisms. Emerging companies focus on the advanced biotechnologies available, including AI-based drug design, CRISPR, and others with the aim of expediting drug development timelines. Many startups prefer to partner with local academic institutions and established biopharma companies to obtain expertise and access to clinical networks. With an announcement of significant cash infusions to expand, allowing them idiosyncratic disruptions in the current competitive landscape.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the global oncology biosimilars industry is currently experiencing rapid growth, driven by an increasing incidence of cancer, perceived cost benefits with respect to biologics, and growing usage in developing countries. Technological innovations like AI and IoT are altering the sector by increasing efficiencies in drug development, improving the accuracy of manufacturing, and enhancing clinical subjective and objective monitoring. AI increases the speed at which biosimilars can be designed and taken through a clinical trial, while IoT devices ensure that data is tracked in real-time further increasing efficiencies. However, the market faces restraints, such as regulatory constraints and worries over whether biosimilars will be as effective as originator biologics.
While there may be constraints, the combination of AI and IoT is being anticipated to reduce development costs and time, creating opportunities for broader market development. North America is the leader due to the impressive healthcare infrastructure, and the Asia-Pacific region is developing quickly, attributed to increased investments and plans for providing low-cost therapies. As innovation, through AI and IoT, continues to reduce differences in access and prices, the oncology biosimilars market will be pivotal in global cancer care by providing sustainable interventions for patients across the world.
| Report Metric | Details |
|---|---|
| Market size value in 2024 | USD 7.65 Billion |
| Market size value in 2033 | USD 19.24 Billion |
| Growth Rate | 10.8% |
| Base year | 2024 |
| Forecast period | 2026-2033 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
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| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Oncology Biosimilars Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Oncology Biosimilars Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Oncology Biosimilars Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
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