Biosimilars Market

Market Size

The global biosimilars market is estimated to be worth USD 12.15 billion in 2024 and is anticipated to reach USD 148.23 billion by 2029 with a CAGR of 39.39% during the forecast period.

Market Drivers

The rising prevalence of chronic diseases and the cost-effectiveness of biosimilars compared to branded drugs are the major factors propelling the market growth of biosimilars. The requirement of lower investments in research activities for drug development to produce biosimilars is reducing healthcare expenditure and proliferating market revenue growth. The increased profits in biosimilar production are influencing the market players to accelerate their investments, boosting market growth opportunities. The favorable regulatory framework for product approvals and continuous product launches worldwide is augmenting the market growth rate. The increasing focus of the primary industry players on developing novel drugs is estimated to accelerate market growth in the coming years. For Instance, according to a study published by RAND Corporation in 2022, Biosimilar drugs are estimated to reduce the prices of expensive medicines that are widely used to treat cancer and rheumatoid arthritis, where the savings are expected to be USD 38.4 billion of the projected total U.S. expenditure on biologics from 2021 to 2025.

Market Restraints

The high manufacturing costs associated with biosimilar production are the major factor restraining the global market growth. Various factors, such as high production complexity and the necessity of producing them at lower costs for competitive pricing and profits, hamper the adoption rate among the small and middle organizations for production, leading to restricted market growth. The stringent regulations regarding product approvals and delays in product launches, which involve high complexity, are significant challenges for market expansion. The side effects associated with biosimilar drugs may impede the market revenue growth.

Market Segmentation

Global Biosimilars Market Analysis – By Product Type

The recombinant glycosylated proteins segment dominated the global biosimilars market revenue and is expected to maintain the domination during the forecast period. The glycosylated proteins involve the modification of proteins. They are extensively used in various cellular processes, which include one response, cell adhesion, and cell signaling, meaning the segment growth rate. The increased adoption of recombinant glycosylated proteins in pharmaceuticals owing to their therapeutic applications in vaccines and anti-cancer medications propels the market growth rate.

The monoclonal antibodies segment is estimated to proliferate during the forecast period. The extensive utilization of monoclonal antibodies in diagnostics, research, and disease treatment in healthcare creates segment growth opportunities.

Global Biosimilars Market Analysis – By Technology

The recombinant DNA technology segment accounted for the most significant global market share and is estimated to have prominent growth during the forecast period. The expanding research in the healthcare industry is driving the adoption rate of recombinant DNA technology, leading to segment revenue growth. The increased applications of DNA technology in medicine for the production of vaccines, gene therapy, gene cloning, diagnosis, and others contribute to expanding segment size.

The bioassay segment is projected to register substantial growth in the coming years. The wide applications of bioassay in drug development and clinical diagnosis are proliferating the segment growth rate.

Global Biosimilars Market Analysis – By Disease

The chronic and autoimmune diseases segment holds a significant global market share and is anticipated to record prominent growth during the forecast period. The rising prevalence of chronic diseases, along with the growing geriatric population with autoimmune diseases, is escalating the demand for efficient and innovative therapies, which is leading to substantial segment growth. The rising investments by the market players in research activities to develop innovative and high-efficiency safety therapeutics are driving the segment growth.

The cancer segment is predicted to grow fastest, with notable CAGR during the forecast period. The growing cancer prevalence worldwide, the increased investments by the market players in research for innovative therapies for various types of cancers, and the presence of pipeline candidates in clinical trials are creating segment growth opportunities.

Regional Analysis

The North American region has the largest share in the global biosimilars market and is estimated to register notable growth during the forecast period. The increasing number of product approvals by the U.S. FDA and the escalating prevalence of chronic diseases, especially cancer, are propelling the regional market share growth. The presence of major market players across the region, well-established infrastructure, and robust regulatory framework augment regional market revenue. For Instance, according to the U.S. Generic Biosimilars Saving Report 2021, 31 biosimilars have been approved, and 20 have been launched in the United States. Cost reduction, ease of availability, increasing population, and incidence contribute to market expansion.

The Asia Pacific region is projected to grow notably during the forecast period. The rising population with chronic diseases, growing healthcare expenditure, and increasing awareness regarding the disease prevalence are escalating the market growth opportunities across the region. For Instance, according to World Bank data retrieved in April 2023, health expenditure in China has increased from 4.98% in 2015 to 5.59% in 2020. The increased investments in research activities by the market players enhance the market growth opportunities during the forecast period.

Recent Market Developments

• In October 2023, Pfizer announced the receipt of approval from the U.S. FDA for Abrilada, the second interchangeable Humira biosimilar. This initiative is expected to enhance the company's market position across the industry.