Biosimilars Market (By Product: Monoclonal Antibodies, Somatropin, Insulin, Erythropoietin, Follitropin, and Others; Application: Oncology, Growth Hormonal Deficiency, Blood Disorders, Chronic & Autoimmune Disorders, Infectious Diseases and Others) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

Biosimilars Market Size and Growth 2024 to 2033

The global biosimilars market size was valued at USD 29.42 billion in 2023 and it is predicted to surpass around USD 151.39 billion by 2033 with a CAGR of 17.8% from 2024 to 2033. The biosimilars market is experiencing significant growth, driven by advancements in biotechnology and increasing healthcare needs. Biosimilars, which are highly similar to approved reference biologics, offer a cost-effective alternative and are becoming a crucial component of global healthcare strategies.

Key Pointers

• Europe dominated the global market with the largest market share of 34% in 2023.
• North America is expected to experience substantial growth during the forecast period.
• By Product, the monoclonal antibodies segment captured the largest revenue share of 42% in 2023.
• By Product, the erythropoietin segment is anticipated to grow the fastest during the forecast period.
• By Application, the oncology segment captured the maximum market share of 25% in 2023.

What are the Growth Factors of Biosimilars Market?

The biosimilars market is witnessing robust growth driven by the demand for cost-effective healthcare solutions, as biosimilars offer significant savings compared to their reference biologics. This cost advantage is particularly important in addressing the escalating global healthcare expenses. Additionally, the growing prevalence of chronic diseases such as cancer and diabetes fuels the need for biologic treatments, and as patents for major biologics expire, biosimilars provide a viable alternative. The supportive regulatory environment further accelerates market expansion, with regulatory agencies streamlining the approval processes for biosimilars. Advances in biotechnology and manufacturing techniques also contribute to the market's growth by enhancing the quality and production efficiency of biosimilars. Together, these factors create a favorable landscape for the continued expansion of the biosimilars market.

What are the Trends in Biosimilars Market?

• Rising Adoption of Biosimilars: There is an increasing acceptance of biosimilars among healthcare providers and patients due to their cost-effectiveness and efficacy, leading to broader use across various therapeutic areas.
• Expansion into New Therapeutic Areas: Biosimilars are progressively being developed for a wider range of therapeutic indications beyond oncology and endocrinology, including rheumatology and hematology, diversifying the market landscape.
• Technological Advancements: Innovations in biotechnology and manufacturing processes are enhancing the quality and production efficiency of biosimilars, making them more competitive with reference biologics.
• Regulatory Evolution: Regulatory frameworks are continually evolving to facilitate the development and approval of biosimilars, with many regions implementing more streamlined processes and guidelines.

What are the Key Challenges Faced by Biosimilars Market?

• Regulatory Complexities: Navigating the regulatory approval process for biosimilars remains intricate and costly. Despite supportive frameworks, the stringent requirements for demonstrating similarity to reference biologics pose significant hurdles for manufacturers.
• Market Acceptance: Gaining acceptance among healthcare providers and patients can be challenging due to concerns about the efficacy and safety of biosimilars compared to their reference counterparts. Overcoming skepticism and building trust is crucial for market penetration.
• Intellectual Property Issues: Patent disputes and intellectual property rights related to both the reference biologics and the biosimilars themselves can lead to delays in market entry and increased development costs. Legal battles can hinder the availability of biosimilars and affect their pricing strategies.
• High Development Costs: The development and manufacturing of biosimilars involve substantial investment in research, clinical trials, and production facilities. These high costs can impact the pricing and overall profitability of biosimilars.

Which Region Dominates the Biosimilars Market?

In 2023, Europe led the global market with the largest market share of 34% and is projected to maintain its leading position throughout the forecast period. This dominance is attributed to the increased adoption of biosimilars across the region and the proactive role of regulatory authorities. European regulators have implemented favorable changes to facilitate the approval of biosimilar drugs, further supporting market growth.

North America is expected to experience substantial growth during the forecast period. The growing acceptance of biosimilars and significant investments by numerous market players in research and development are anticipated to drive this growth. In 2020, the FDA approved around 20 biosimilars, including Pfizer’s Nyvepria, aimed at reducing infection rates. These developments are expected to boost the biosimilars market in North America.

Product Insights

In 2023, the monoclonal antibodies segment captured the largest revenue share. These antibodies are widely used for treating conditions such as cancer, rheumatoid arthritis, cardiovascular diseases, and multiple sclerosis. Their ability to target specific infected cells makes them particularly effective in cancer treatment, solidifying their position as the leading segment in the market.

The erythropoietin segment is anticipated to grow the fastest during the forecast period. Erythropoietin is crucial for stimulating red blood cell production in the bone marrow and is effective in treating anemia. The increasing incidence of kidney-related diseases is expected to drive growth in this segment.

Application Insights

The oncology segment was the largest revenue generator in the global biosimilars market in 2023 and is expected to continue leading throughout the forecast period. This dominance is due to the affordability of biosimilars for cancer treatment and the rising global incidence of cancer. According to the International Agency for Research on Cancer, there were approximately 19.3 million new cancer cases and 10 million cancer-related deaths globally in 2020. The prevalence of breast cancer, which accounted for 11.7% of new cases, followed by lung cancer at 11.4% and colorectal cancer at 10.0%, underscores the growing demand for biosimilars in oncology.

On the other hand, the growth hormonal deficiency segment is projected to be the fastest-growing. The increasing incidence of growth hormone deficiencies in children, with a reported 50% chance during pregnancy according to the National Organization for Rare Disorders, is expected to drive this segment’s growth.

Who are the Top Manufactures in Biosimilars Market?

• Novartis
• Synthon Pharmaceuticals, Inc.
• TevaPharmaceutical Industries Ltd.
• LG Life Sciences
• Celltrion
• Biocon
• Hospira
• Merck Serono
• Biogen idec, Inc.
• Genentech

Biosimilars Market Segmentation:

By Product

• Monoclonal Antibodies
• Somatropin
• Insulin
• Erythropoietin
• Follitropin
• Others

By Application

• Oncology
• Growth Hormonal Deficiency
• Blood Disorders
• Chronic & Autoimmune Disorders
• Infectious Disease
• Others

By Manufacturer

• Contract Research and Manufacturing Services
• In-house

By Region

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