Biosimilars Market Size, Share, and Trends 2024 to 2034

The global biosimilars market size was exhibited at USD 29.39 billion in 2023 and is expected to surpass around USD 126.01 billion by 2032, growing at a CAGR of 17.6% from 2023 to 2032. The key players operating in the market are focused on adopting inorganic growth strategies like acquisition and merger to develop advance technology for manufacturing biosimilars which is estimated to 

Key Takeaways:

• Europe dominated the market with the largest market share of 33.49% in 2023.
• Asia Pacific is expected to expand at the fastest CAGR of 18.5% during the forecast period.
• By product, the monoclonal antibodies segment has captured around 41.11% of revenue share in 2023.
• By product, the insulin segment is projected to grow at a double-digit CAGR of 17.8% during the forecast period.
• By application, the oncology segment has contributed the largest market share of 24.43% in 2023.
• By application, the chronic and autoimmune disorders segment is growing at a CAGR of 17.9% during the forecast period.
• By manufacturer, the in-house segment accounted for the biggest market share of 84.71% in 2023.
• By manufacturer, the contract research and manufacturing services segment is poised to grow at a remarkable CAGR of 17.9% during the forecast period.

Biosimilars Market in Europe 2023 to 2032

The Europe biosimilars market size was valued at USD 9.84 billion in 2023 and is estimated to reach around USD 40.34 billion by 2032, growing at a CAGR of 17% between 2023 and 2032.

Based on region, Europe dominated the global biosimilars market in 2023, in terms of revenue and is estimated to sustain its dominance during the forecast period. The increased adoption of the biosimilars in Europe has boosted the market growth. Moreover, the regulatory authorities have played a crucial role in the adoption of biosimilars by making appropriate and favorable changes towards the approval of biosimilar drugs.

On the other hand, North America is estimated to witness a significant growth rate during the forecast period. The growing popularity of the biosimilars in North America and the presence of numerous market players in the region are investing heavily in the research of the biosimilars, which arew expected to drive the growth of the market in this region. The FDA in US approved around 20 biosimilars in the year 2020. In 2020, Pfizer obtained the FDA approval for its Nyvepria, which is used for lowering the infection incidences. All these factors are anticipated to drive the growth of the biosimilars market in North America, during the forecast period.

• North America biosimilars market size accounted for USD 6.43 billion in 2023 and is expected to reach around USD  27.06 billion by 2032, growing at a CAGR of 17.3% from 2023 to 2032.
• Asia Pacific biosimilars market size was valued at USD 8.43 billion in 2023 and is projected to surpass around USD 38.82 billion by 2032, expanding at a CAGR of 18.5% from 2023 to 2032.

Asia Pacific Biosimilars Market Trends:

• The expanding pharma sector in APAC is driving investments in biotechnology and biosimilar research. Countries like China, India, and South Korea are becoming global hubs for biosimilar development due to their cost-effective research environments and skilled workforce.
• Asia Pacific governments are improving regulatory frameworks for biosimilars to streamline approvals and ensure safety and efficacy. Harmonization of guidelines with global standards (e.g., EMA and FDA) enhances market confidence. Low production and operational costs in Asia Pacific enable competitive pricing of biosimilars. Established manufacturing infrastructure in countries like India and China reduces production barriers.
• Rising healthcare expenditures and insurance coverage in APAC drive demand for affordable biologic treatments. Biosimilars offer cost-effective alternatives to high-priced biologics, meeting the needs of a growing patient population.
• In India major biosimilars hub with regulatory initiatives like the "Make in India" program, the biosimilars market is estimated to grow. The significant investment in biotech company and improving regulatory pathways through the National Medical Products Administration (NMPA) in China, drive the growth of the biosimilars market. A leader in biosimilar innovation with companies like Celltrion and Samsung Bioepis in South Korea, supports the growth of the biosimilars market in South Korea region. 

Biosimilars Market: Treats Various Autoimmune Disease 

Biosimilars are biologic medical products that are highly similar to an already approved original ("reference") biologic drug. They are designed to have the same safety, efficacy, and quality as the reference product, but they are not identical due to the complexity of biologics, which are made from living organisms. 

Biosimilars closely resemble the reference biologic in terms of function, structure, and clinical performance. They must demonstrate no clinically meaningful differences in terms of effectiveness and safety compared to the original drug. Typically, less expensive than the reference biologic, making them more accessible to patients. Subject to rigorous testing and evaluation by regulatory agencies like the FDA or EMA to ensure they meet the required standards.

Biosimilars are utilized to treat various conditions, such as cancers, autoimmune disorders, and chronic diseases like diabetes. Examples include biosimilar versions of insulin, monoclonal antibodies, and growth factors.

Biosimilars Market Growth Factors

• The key players operating in the market are focused on geographic expansion and launching their biosimilar drug products in other countries which has increased the demand for biosimilars and is expected to drive the growth of the biosimilars market in the near future. 
• Increasing focus on cost reduction and production efficiency can drive the specialty market growth further.
• Emerging markets and trends for biosimilars is expected to drive the growth of the global biosimilars market over the forecast period. 
• Increasing regulatory support is estimated to drive the growth of the market over the forecast period. 
• Increasing in adoption of the advanced technology for the production of biosimilars is estimated to drive the growth of the global biosimilars market in the near future. 
• As patents for major biologic drugs expire, biosimilar manufacturers can enter the market with lower-cost alternatives, driving growth.
• Growing cases of chronic diseases like cancer, diabetes, and autoimmune disorders create higher demand for biologic treatments, including biosimilars.
• Regulatory bodies like the FDA and EMA have streamlined approval processes for biosimilars, encouraging innovation and market entry.
• Rising Healthcare Expenditure, has estimated to drive the growth of the global biosimilar market. Increasing global healthcare spending, particularly in emerging markets, is boosting access to biosimilars.
• Strategic alliances between pharmaceutical companies, contract manufacturing organizations (CMOs), and research organizations are accelerating biosimilar development and commercialization.

How Can AI Improve the Biosimilar Industry? 

AI models like AlphaFold can predict protein structures with high accuracy, expediting the development of biosimilars by ensuring molecular similarity to reference biologics. AI-driven simulations can replace some physical experiments, speeding up the preclinical phase and reducing reliance on expensive lab testing.

AI algorithms can analyze real-time data to optimize production processes, ensuring consistent quality and yield in cell culture and purification stages. Machine learning models can identify potential equipment failures, minimizing downtime and maintaining production schedules. AI can detect deviations in production and identify quality issues early, reducing the risk of batch failures. Advanced analytics can ensure compliance with stringent regulatory requirements by continuously monitoring product consistency.

AI tools can streamline the generation of regulatory submissions by extracting and organizing relevant data. Predictive analytics can manage supply chain logistics, ensuring timely availability of raw materials and distribution of finished products.

Scope of the Biosimilars Market

Product Insights

Based on product, the monoclonal antibodies segment accounted largest revenue share in 2023. Monoclonal antibodies are extensively used in the treatment of diseases such as cancer, rheumatoid arthritis, cardiovascular diseases, and multiple sclerosis. Monoclonal antibodies targets the specific infected cells in the treatment and hence is extensively used in the treatment of cancer, which led this segment to become the most dominant segment.

The erythropoietin segment is estimated to be the fastest-growing segment during the forecast period. The erythropoietin helps in the production of red blood cells in the bone marrow. Moreover it also treats the anemia effectively. The rising number of kidney related diseases are expected to propel the growth of this segment.

• Monoclonal antibodies segment was valued at USD 12.08 billion in 2023 and will grow at a CAGR of 18.1% during the forecast period
• Somatropin segment was valued at USD 3.95 billion in 2023 and is expected to grow at a CAGR of 17.4% during the forecast period
• Insulin segment was estimated at USD 4.88 billion in 2023 and is expanding at a notable CAGR of 17.8% over the forecast period.
• Erythropoietin antibodies segment accounted for USD 2.09 billion in 2023 and will grow at a CAGR of 17.1% during the forecast period.

Application Insights

Based on application, the oncology segment dominated the global biosimilars industry in 2023, in terms of revenue and is estimated to sustain its dominance during the forecast period. This is attributed to the availability of biosimilars at lower prices for the treatment of cancer and the rising prevalence of cancer among the global population. According to the International Agency for Research on Cancer, around 19.3 million new cancer cases and around 10 million cancer related deaths were reported in the year 2020, across the globe. Prevalence of breast cancer in the female population is surging, accounting for around 11.7% of the new cancer cases followed by the lungs cancer that accounted for 11.4% and colorectal cancer accounted for 10.0% in 2020. Hence, the growing demand for the biosimilar drugs for the treatment of cancer is boosting the segment growth.

On the other hand, the growth hormonal deficiency segment is expected to be the fastest-growing segment during forecast period. The rising chances of kids getting affected with rare growth hormone deficiency during pregnancy is expected to drive the market. According to the National Organization for Rare Disorders, there are 50% chances of getting growth hormone deficiency to the child during pregnancy.

By Drug Class

• For instance, in July 2024, Referring to XOLAIR, Amneal Pharmaceuticals, Inc., healthcare company declared that omalizumab has been added to its biosimilar pipeline. One humanized monoclonal antibody that targets free immunoglobulin E (1gE) is omalizumab. Food allergies, chronic spontaneous urticaria, severe persistent allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSWNP) are among the chronic illnesses that can be treated with this injectable prescription medication. Usually, a hospital or clinic is where it is given. The Phase Ill clinical trial for the biosimilar, which was created by Kashiv BioSciences, LLC, started in the third quarter of 2024. "Omalizumab's accession to our biosimilar pipeline and our foray into a new therapeutic area outside of oncology excite us. 

By Indication

The oncology held a dominant presence in the biosimilars market in 2024, in terms of revenue and is estimated to sustain its dominance during the forecast period. This is attributed to the availability of biosimilars at lower prices for the treatment of cancer and the rising prevalence of cancer among the global population. 

According to the International Agency for Research on Cancer, around 19.3 million new cancer cases and around 10.1 million cancer related deaths were reported in the year 2024, across the globe. Prevalence of breast cancer in the female population is surging, accounting for around 11.7% of the new cancer cases followed by the lungs cancer that accounted for 11.4% and colorectal cancer accounted for 10.3% in 2024. Hence, the growing demand for the biosimilar drugs for the treatment of cancer is boosting the segment growth.

By Manufacturer

The contract research and manufacturing services segment registered its dominance over the global biosimilars market in 2024. Biosimilar development requires significant investment in R&D, manufacturing infrastructure, and regulatory compliance. Outsourcing to Contract Research and Manufacturing Services providers helps companies reduce costs and avoid capital-intensive investments. Contract Research and Manufacturing Services providers often have specialized knowledge, state-of-the-art facilities, and expertise in biologics and biosimilars manufacturing. This enables biosimilar developers to leverage advanced technologies without building their own infrastructure. 

Contract Research and Manufacturing Services providers can accelerate biosimilar development by offering ready-made infrastructure, streamlined processes, and established supply chains, helping companies bring products to market more quickly. Many Contract Research and Manufacturing Services providers are based in emerging markets like India and China, which offer cost advantages and access to large pools of skilled labor. These markets are also key targets for biosimilar adoption.

Key Companies & Market Share Insights

The market is moderately fragmented with the presence of several local companies. These market players are striving to gain higher market share by adopting strategies, such as investments, partnerships, and acquisitions & mergers. Companies are also spending on the development of improved products. Moreover, they are also focusing on maintaining competitive pricing.

• In May 2020, Fresenius Kabi acquired approval for its MSB11455, a pegfilgrastim biosimilar, from both the FDA and EMA.

The various developmental strategies like acquisition, partnerships, mergers, and government policies fosters market growth and offers lucrative growth opportunities to the market players.

Recent Developments:

• In March 2024, Dr Reddy’s Laboratories, pharmaceutical company, revealed the launch of the Versavo, a bevacizumab biosimilar, in the UK. In November 2024, the UK authorized Versavo, a bevacizumab biosimilar of Roche's original Avastin, for sale. A humanized monoclonal antibody is bevacizumab. By preventing vascular endothelial growth factor A (VEGF-A) from doing its job, it prevents angiogenesis, or the creation of new blood vessels. Bevacizumab is used to treat a variety of cancers because it can prevent the formation of new blood vessels in tumors.
• In September 2024, The U.S. Food and Drug Administration has authorized Accord BioPharma's Hercessi (trastuzumab-strf), a 420 mg strength biosimilar to Herceptin, to treat gastric and breast malignancies that overexpress the human epidermal growth factor receptor 2 (HER2). The regulatory action comes after the FDA approved Hercessi at a level of 150 mg for the same use in April 2024.
• In August 2024, Sandoz Canada, a pioneer in generics and biosimilars, announced the release of Jubbonti and Wyost, two denosumab biosimilars. Approved for treating osteoporosis and promoting bone mass, Jubbonti comes in a 60 mg/mL solution in a single-use prefilled syringe. In the near future, the product should appear on all provincial formularies. Wyost is licensed to treat adult bone giant cell tumors and prevent bone fractures in patients with bone metastatic malignancies. It comes as a 120 mg/1.7 mL subcutaneous injection solution. To facilitate identification, GS1 standard barcoding is incorporated into both external and internal packaging.

Bbiosimilars Market Companies

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

Segments Covered in the Report

By Drug Class:

• Monoclonal Antibodies
• Infliximab
• Trastuzumab
• Rituximab
• Adalimumab
• Other monoclonal antibodies
• Insulin
• Granulocyte Colony-Stimulating Factor
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Anticoagulants
• Other drug class

By Indication:

• 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
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait