The growing incidences of cancer and rare disorders and increasing launch of biosimilars and rising healthcare costs are driving the growth of the Biosimilar Market at a CAGR of 14.74% during the forecast period 2025 to 2035

Market Research Future (MRFR) has published a cooked research report on the “Global Biosimilar Market” that contains the information from 2019 to 2035.

The Global Biosimilar Market is estimated to register a CAGR of 14.74 % during the forecast period of 2025 to 2035.

MRFR recognizes the following companies as the key players in the Global Biosimilar Market — Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Samsung Bioepis, Amgen Inc., Pfizer Inc., Novartis AG, Biogen, Biocon, Dr. Reddy's Laboratories Ltd., Fresenius Kabi USA, LLC and others.

The Global Biosimilar Market accounted for registering a CAGR of 14.74 % during the forecast period and is estimated to reach USD 30.81 billion by 2035.

The growing incidences of cancer and rare disorders play a pivotal role in boosting the growth of the global biosimilar market. As the prevalence of these complex and often life-threatening conditions continues to rise, there is an increasing demand for effective and affordable treatment options. Biosimilars, which are highly similar to reference biologic drugs, provide a cost-efficient alternative to expensive therapies, making critical treatments more accessible to patients. For instance, according to the International Agency for Research on Cancer, there were cancer cases of nearly 9,826,539 in Asia, 4,471,422 in Europe, 2,673 174 in Northern America, 1,551,060 in Latin America and the Caribbean, 1,185,216 in Africa, and 269 088 in Oceania cancer cases of both genders in 2022. Furthermore, India also reported increasing incidences of cancer, which is contributing to the growth of the global biosimilar market. 

As per the International Agency for Research on Cancer, there were 192,020 breast cancer cases, 143,759 lips, oral cavities, 127,526 cervix uteri, 81,748 lungs, 70,637 oesophagus, 70,038 colorectum, and 727,588 cancer cases of others. These increased cases of cancer are increasing the demand for biosimilar by healthcare providers and patients which leads to the frequent launches of biosimilar. For instance, in May 2023, The FDA has granted approval to Yuflyma, the ninth biosimilar of adalimumab. Celltrion USA recently announced that Yuflyma (adalimumab-aaty), a citrate-free, high-concentration (100mg/mL) version of Humira, has been approved for use. This biosimilar is authorized to treat eight inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. Moreover, as per the American Lung Association, there were about 30,000 people with cystic fibrosis in the US and nearly 70,000 people worldwide in 2022. Also, in April 2024, the Centers for Disease Control and Prevention reported that nearly 6,000 babies born with Down syndrome in the United States.

Furthermore, the expiration of patents for several high-cost biologics has further accelerated the development and approval of biosimilars, enabling healthcare systems to reduce costs without compromising on quality. This trend is driving the rapid expansion of the biosimilar market, as it addresses the dual challenges of rising disease burden and the need for sustainable healthcare solutions.

Thus, the increasing incidences of cancer and rare disorders across the globe and rising innovative product launches to treat these diseases are boosting the growth of the market.

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Segmental Analysis

The Global Biosimilar Market has been segmented based on Drug Class, by Application, by Route of Administration, by Distribution Channel.

Based on Drug Class, this segment includes Monoclonal Antibodies (Adalimumab, Infliximab, Rituximab, Bevacizumab, Trastuzumab, Ustekinumab, Tocilizumab, Aflibercept, Dupilumab, Denosumab, Others), Insulin, Granulocyte Colony- stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Anticoagulants, Others. The Monoclonal Antibodies segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. Monoclonal antibodies offer targeted treatment with improved efficacy and reduced side effects, increasing their adoption among healthcare providers. The segment's dominance is also supported by continuous innovations, expanding indications, and favorable reimbursement policies. Looking ahead, it is projected to be the fastest-growing segment due to a strong pipeline of biosimilars, rising healthcare expenditure, and increasing demand for personalized medicine. Additionally, advances in biotechnology and increasing approvals by regulatory agencies are expected to further boost the growth of this segment, solidifying its leadership position in the global drug market over the forecast period.

Based on Application, this segment includes Oncology (Breast Cancer, Lung Cancer, Prostate Cancer, Leukemia, Bladder Cancer, Colorectal Cancer, Others), Autoimmune Diseases, Infectious Diseases, Blood Disorders, Others. The Oncology segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period. Based on Application, this segment includes Oncology (Breast Cancer, Lung Cancer, Prostate Cancer, Leukemia, Bladder Cancer, Colorectal Cancer, Others), Autoimmune Diseases, Infectious Diseases, Blood Disorders, Others. The Oncology segment dominated the global market in 2024, while it is projected to be the fastest–growing segment during the forecast period.

Based on Route of Administration, this segment includes Subcutaneous and Intravenous. The Intravenous segment dominated the global market in 2024, while the Subcutaneous segment is projected to be the fastest–growing segment during the forecast period. The Intravenous (IV) segment dominated the global market based on route of administration, primarily due to its widespread use in hospitals and clinical settings for delivering biologics such as monoclonal antibodies, insulin, and growth factors. IV administration allows for rapid drug absorption and controlled dosing, making it the preferred method for critical and acute treatments, particularly in oncology and autoimmune diseases.

Based on Distribution Channel, this segment includes Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Specialty Pharmacies. The Hospital Pharmacies segment dominated the global market in 2024, while the Online Pharmacies segment is projected to be the fastest–growing segment during the forecast period. The Hospital Pharmacies segment dominated the global market based on distribution channel, driven by the high volume of biologics administered in clinical settings, particularly for critical conditions such as cancer, autoimmune disorders, and rare diseases. Hospital pharmacies play a central role in managing complex therapies that often require professional supervision, including intravenous biologics and specialty medications. Their integration with healthcare providers ensures accurate dosing, patient monitoring, and adherence to treatment protocols, contributing to their market leadership. However, the Online Pharmacies segment is projected to be the fastest growing during the forecast period, fueled by the rising adoption of digital health platforms, increasing internet penetration, and the growing preference for home delivery of prescription drugs.

Regional Analysis

Geographically, the Global Biosimilar Market has been segmented into North America, Europe, Asia-Pacific, Rest of the World.

Major demand factors driving the Europe market are the growing incidences of cancer and rare disorders and increasing launch of biosimilars and rising healthcare costs. The European Medicines Agency (EMA) has been at the forefront of biosimilar approvals, encouraging market penetration and physician confidence. Additionally, the rising healthcare costs across the region have pushed governments and healthcare systems to adopt cost-effective alternatives to branded biologics, further fueling biosimilar uptake. The presence of leading pharmaceutical companies and active initiatives to educate healthcare providers and patients have also supported market growth. However, the Asia-Pacific region is projected to be the fastest-growing during the forecast period due to expanding healthcare infrastructure, a large patient population, and increasing investments by domestic and international biopharma companies. Supportive regulatory reforms and growing awareness of affordable treatment options are expected to accelerate biosimilar adoption across emerging markets like India, China, and South Korea.

Key Findings of the Study

• The Global Biosimilar Market is expected to reach USD 134.83 billion by 2035, at a CAGR of 14.74% during the forecast period.


• The Europe region accounted for the fastest-growing global market.


• Based on the Distribution Channel, the Hospital Pharmacies segment was attributed to holding the largest market in 2024.


• Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Samsung Bioepis, Amgen Inc., Pfizer Inc., Novartis AG, Biogen, Biocon, Dr. Reddy's Laboratories Ltd., Fresenius Kabi USA, LLC are some of the players in the market.