According to Nova one advisor, The global oncology biosimilars market was valued at USD 6.50 billion in 2024 and is projected to reach USD 35.79 billion by 2034, registering a CAGR of 18.6% from 2024 to 2034.
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The changing therapeutic landscape and rising prevalence of cancer is encouraging various organizations and biotech industries for the development of oncology biosimilars which are highly effective, precise and are a cost-effective alternative leading to better medication adherence among patients.
The passing of Hatch-Waxman Act in 1984 laid the groundwork for the approval of generic drugs market in the U.S. which further paved the pathway of developing abbreviated drug approval pathways for biosimilars by regulatory agencies worldwide. Furthermore, the rise in expiring patents in biologics used for oncology is accelerating biosimilar development for creating cost-effective, safe and efficient oncology therapies options.
Biosimilars are medicines made from living systems such as bacteria, animal cells or contain components of living organisms and are similar compared to biologics. Biologic agents manufacturing is expensive and can become a financial burden for the government, industries, healthcare systems and patients which can further result in limited accessibility of patients to potentially life-saving medications.
Governments are supporting the expansion of oncology biosimilars market by adopting faster regulatory processes for biosimilars approvals and developing biosimilars with low developmental costs and risks thereby providing a low-cost alternative to cancer biologics. Furthermore, the integration of artificial intelligence (AI) for development of biosimilars for cancer treatment by applying them in biosimilar safety evaluation, patient selection for suitable biosimilar treatment, cancer drug development and precision thus, providing personalized treatments and improving life quality by increasing patient convenience for cancer treatments.
Oncology Biosimilars Market Trends:
· Loss of Exclusivity of Key Oncology Drugs: Several blockbuster oncology drugs, such as Rituxan (rituximab), Herceptin (trastuzumab), and Avastin (bevacizumab), have lost or are about to lose patent protection, opening the door for the development of biosimilars.
· Support form Regulatory Bodies: Global regulatory bodies, such as the FDA, European Medicines Agency (EMA), and National Medical Products Administration (NMPA) in China, have created clearer and more efficient approval pathways for biosimilars. This has fostered greater confidence in the safety and efficacy of biosimilars, making it easier for companies to enter the market.
Current Biosimilars Used in Oncology Globally
Regulatory agencies around the world—including the European Medicines Agency (EMA), the Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA) in Australia, and Health Canada in Canada—have approved a few biosimilars in the field of oncology. Biosimilars can be used for various indications and in many therapeutic areas; for example, the biosimilars filgrastim and epoetin are utilized in the treatment of CHM-induced NTP and for the treatment of ANE induced by CHM in cancer patients. The small alteration in the original biological product can lead to the loss of efficacy and facilitates the occurrence of adverse events that induce immunogenicity, and these are the main concerns that oncologists are facing in switching from original biological products to biosimilars.
There are many ways by which immunogenicity can occur, such as distinctive routes of administration, patient characteristics, and storage setup. Moreover, a limited number of studies have evaluated the utilization of biosimilars in the field of oncology due to the arduous nature of biosimilars. Despite many studies having been conducted on biosimilars of rituximab for the management and treatment of rheumatoid arthritis (RA), there are many uncertainties as to whether or not rituximab can be extrapolated in oncology. Risks associated with biosimilars can be detected by preclinical studies in which original biological products are compared with biosimilars, along with conducting post-marketing surveillance studies in order to evaluate their benefit–risk profiles in clinical practice. Furthermore, data obtained by pharmacovigilance departments are essential to monitor the safety and efficacy of any biosimilar in long-term clinical practice, and such information related to adverse events—including medication errors and safety concerns—must be reported by healthcare professionals
The majority of biosimilars have been marketed in Europe for various indications since 2006 for the management and treatment of cancer. The EMA is the decentralized regulatory authority in the European Union, whose framework for biosimilars is also followed by other countries. The first biosimilar approved under the EMA was Abseamed, produced by the marketing authorization holder Medice Arzneimittel Putter GmbH & Co. Kg, as depicted in The FDA is another regulatory authority with a framework for biosimilars, which was approved in the USA in 2009 when the Biologics Price Competition and Innovation Act was passed Currently, biosimilars have proven to be safe and efficacious in the last 10 years, and recently many biosimilars have been approved globally for the management and treatment of cancer, as demonstrated in . In the near future, there are many biological products for which biosimilars are expected to be marketed—not only for the management of cancer, but also for other diseases such as Crohn’s disease, colitis, psoriasis, RA, and other autoimmune diseases.
Oncology Biosimilars Market Segment insights
By Indication
By indication, breast cancer segment dominated the market in 2024. The rising incidents and deaths from breast cancer are developing the need for effective biosimilars in oncology therapies. Several factors lead to the development of breast cancer such as age, genetics, lifestyle habits, reproductive history, use of oral contraceptives, exposure to radiation and psychological conditions. Improved diagnostic imaging techniques for detection, advancements in biosimilar based therapies, availability of better treatment options, rising government support, studying of demographic trends and heightened awareness among women are the factors expanding the market. Biosimilars can be used for treating early and metastatic breast cancer while reducing the cost of medications and increasing the access to treatments. Currently, there are multiple approved biosimilars by the U.S. FDA available in the market which can used for treating breast cancers and their side effects also.
Lung cancer segment is anticipated to grow rapidly over the forecast period. The rising prevalence of non-small cell lung cancer (NSCLC) is propelling the market growth. Lung cancer can be caused due to various factors such as smoking, passive smoking, radon, family history, radiation therapy, age, HIV infection and other diseases. The ongoing researches for studying safety, potency and long-term side effects of biosimilars, alternatives for original biologics and clinical trials demanding effective treatment options for lung cancer is driving the market growth. Moreover, the accelerated approvals by regulatory agencies is increasing the acceptance and adoption of the biosimilars in the market. For instance, in Dec 2024, Merus, a clinical-stage oncology company has entered in an agreement with Partner Therapeutics by licensing the right to commercialize zenocutuzumab, branded as Bizengri drug for the targeted treatment of NRG1 fusion-positive (NRG1+) NSCLC and NRG1 fusion-positive pancreatic adenocarcinoma in patients who have had disease progression during or after prior systemic therapy. Also, the FDA has granted an accelerated approval for Bizengri.
By Drug Class
By drug class, the granulocyte colony-stimulating factor (G-CSF) segment dominated the market in 2024. They are used for preventing neutropenia (low white blood cell [WBCs] count) in cancer patients taking chemotherapy by stimulating the bone marrow to produce more WBCs proving as a safe, efficient and cost-effective alternative. Furthermore, the integration of AI can be applied for analysing patient data to predict who will benefit most from G-CSF biosimilars prophylaxis and provide personalized treatment plans by monitoring potential side effects which will ultimately improve patient care. The rising expirations of G-CSF biologics, increased regulatory approvals, driving competition among market players to expand their biosimilars portfolio are embracing the adoption of oncology biosimilars thereby expanding the market. For instance, in Oct 2024, Meithal pharmaceuticals, a biopharmaceutical company expanded its biosimilars portfolio by signing a licensing agreement with its parent company, Hong Kong King-Friend Industry Co., for the marketing and distribution of two oncology biosimilars pegfilgrastim and filgrastim in the U.S. These medications are bone marrow stimulants which work by binding to G-CSF receptors supporting WBCs production in patients undergoing chemotherapy.
Monoclonal antibody (mAb) biosimilars segment is anticipated to grow rapidly during the forecast period. The biosimilars are effective in targeting tumors and slowing progression thereby boosting the immune responses. Additionally, the development of chimeric antigen receptors T (CAR-T) cells which are engineered by utilizing a part of monoclonal antibody called as single-chain variable fragment (scFv) within their CAR for specifically targeting cancer cells by using antibody-like recognition ability from a mAb. Furthermore, the advancements in R&D of new mAb with increased availability and affordability and the rise in regulatory approvals is expanding the market growth of this segment. For instance, in June 2024, Biocon Biologics Ltd., a biosimilars company announced its regulatory approval from European Medicines Agency (EMA) for manufacturing biosimilar Bevacizumab which is applied for targeted cancer treatment of various types. The biosimilar will be manufactured in Bengaluru at the company’s new multi-product mAbs drug substance facility.
By Route of Administration
The intravenous segment dominated the market in 2024. Most of the oncological biosimilars are administered intravenously (IV) i.e. they are directly injected into the patient’s bloodstream which the commonly used route of administration for cancer biosimilars just like their reference biologics. The IV route allows for a controlled and targeted drug while eliminating the first-pass metabolism and thereby helping achieve 100% bioavailability. These factors make them a popular option for drug delivery in chemotherapy and cancer treatments which helps in fuelling the market growth of this segment. Moreover, the accessibility and availability of IV oncology biosimilars helps in reducing treatment costs leading to increased adoption and improved life quality for patients. Some of the commonly administered intravenous oncology biosimilars include bevacizumab (for various cancers), trastuzumab (breast cancer), rituximab (lymphoma).
By End-Users
By end-users, the hospital segment dominated the market share in 2024. Hospitals are the primary treatment centres which provide treatments for cancers. They actively utilize oncology biosimilars for bringing safer, cost-effective and affordable treatments for patients. Furthermore, hospitals often lead the way in adopting new biosimilars and also carefully supervise clinical trials and evaluations for ensuring the safety and efficacy of their biosimilars in their patient population. Additionally, oncologists in hospitals play an important role in educating patients about biosimilars thereby promoting the market growth of this segment.
The rise in specialty clinics is experiencing the fastest growth in the market. The increasing popularity and collaborations among oncologists for implementing safe, effective treatments for cancer patients has given rise to the adoption of specialty clinics which include specialized cancer diagnosis, treatment and research facilities. These clinics are well equipped with cutting edge cancer diagnosis and treatment equipment which fuel to the market growth of this segment. Furthermore, they specialize in developing new therapies, conducting clinical trials and also provide chemotherapy to the patients which includes prescribing biosimilars for providing cost-effective treatments and increases the adoption of the patients to treatment thereby promoting the overall market growth.
By Distribution Channel
Based on distribution channel, the hospital pharmacy segment dominated the market generating the most profit. Hospitals are the major centres for providing cancer therapies and treatments alongwith the administration of biosimilars for cancer patients. Hospital pharmacies can help in contributing towards the biosimilars market by including formulary management systems for identifying and selecting suitable biosimilars, using clinical decision support tools for educating providers on using biosimilars, tracking patient medication records for biosimilar substitutions, and educating the pharmacists on proper handling and effective communication strategies on biosimilars for increasing awareness among patients which will ultimately facilitate the safe and effective distribution network on oncology biosimilars within the hospital setting thereby fuelling the market growth of this segment.
The retail pharmacy distribution channel is experiencing the fastest growth in the market. The availability, accessibility and the rising demand of oncology biosimilars from retail pharmacy stores by dispensing them directly to the cancer patients is expanding the market. Furthermore, by educating the patients the benefits of switching to a biosimilar option, actively promoting their availability, communicating the price transparency, managing formularies to include biosimilars and interacting with healthcare providers for ensuring proper patient selection and switching can help in providing safer, cost-effective treatment options to patients while maintaining the standards can help in improve patient life quality. Also, by implementing patient support programs, understanding the interchangeability status of biosimilars, staying updated with latest clinical data and training the staff on the applications of biosimilars is driving the market growth of this segment.
By Region
North America dominated the oncology biosimilars market in 2024. The presence of advanced healthcare infrastructure, rising awareness among people on using biosimilars and the support from government initiatives attributes to the dominance of this region in the market. Moreover, the increasing drug approvals from the FDA for biosimilars, strategic collaborations among industries, researchers and academia as well as the investments and funding’s from various organizations to improve the life quality for the large cancer population in this region are driving the market growth.
The Asia Pacific oncology biosimilars market is expected to grow rapidly during the forecast period. The rising prevalence of cancer patients in the region and the increased adoption of the people to use biosimilars due to their cost-effectiveness is driving the market growth. Moreover, the growing patient awareness for early detection and treatment with advances in the healthcare infrastructure and researches in clinical trials are increasing the use of oncology biosimilars in this region. Further, the rising regulatory approvals are increasing the presence of companies developing and manufacturing oncology biosimilars in this region. For instance, in June 2024, Aurobindo Pharma received marketing authorisation for Trastuzumab drud in India. The drug is indicated in treatment of some types of breast cancer.
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Some of the major players operating in the oncology biosimilars market are:
· Pfizer Inc. (U.S.)
· GlaxoSmithKline plc (U.K.)
· Novartis AG (Switzerland)
· Mylan N.V. (U.S.)
· Teva Pharmaceutical Industries Ltd.(Israel)
· Sanofi (France)
· F. Hoffmann-La Roche Ltd. (Switzerland)
· Zydus Cadila (India)
· Lupin (India)
· Amneal Pharmaceuticals LLC. (U.S.)
· Cipla Inc. (U.S.)
· Aurobindo Pharma (India)
· Glenmark Pharmaceuticals Limited (India)
· Eli Lilly and Company (U.S.)
· Sun Pharmaceutical Industries Ltd. (India)
· Allergan (Ireland)
· Bristol-Myers Squibb Company (U.S.)
· Takeda Pharmaceutical Company Limited (Japan)
· BIOCAD (Russia)
· Apotex Inc. (Canada)
· Endo International plc (Ireland)
Oncology Biosimilars Market Recent Developments
· In Dec 2024, Coherus Biosciences announced a deal to divest its third biosimilar Udencya franchise which is a copycat version of Amgen’s Neulasta, to Indian drug maker Intas Pharmaceuticals bagging $558 million for the deal which expected to close in the first quarter of 2025.
· In Nov 2024, Samsung Bioepis announced the positive opinion of European Medicines Agency’s (MEA) Committee for Medicinal Products for Human Use (CHMP) for two denosumab biosimilars Obodence referencing Prolia (denosumab) and Xbryk referencing Xgeva (denosumab) also known as SB16. Obodence targets bone loss in prostate cancer, whereas Xbryk addresses giant cell tumor and skeletal events in malignancies.
· In Oct 2024, Poseida Therapeutics announced a collaboration in which it received a payment of $15 million from Roche for the development of new CAR-T candidate. Applied for the treatment of blood cancers, the new candidate is an allogenic, dual CAR-T which targets known antigens which are expressed in these type of cancers, including multiple myeloma.
· In Oct 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group strengthened their alliance by announcing a second collaboration this year of a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate.
Segments covered
By Indication
· Breast Cancer
· Lung Cancer
· Colorectal Cancer
· Cervical Cancer
· Blood Cancer
· Others
By Drug Class
· Monoclonal Antibodies
· Granulocyte Colony-Stimulating Factor
· Others
By Route of Administration
· Intravenous
· Subcutaneous
· Others
By End-Users
· Hospitals
· Specialty Clinics
· Homecare
· Others
By Distribution Channel
· Hospital Pharmacy
· Retail Pharmacy
· Online Pharmacy
· Others
By Regional
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East and Africa (MEA)
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