The global biosimilars market was valued at USD 20.44 billion in 2022 and is projected to rise from USD 23.96 billion in 2023 to USD 73.03 billion by 2030, reflecting a CAGR of 17.3% during the forecast period. In 2022, Europe led the market, accounting for 50.44% of the overall share.
The biosimilars market is expanding rapidly, fueled by the rising demand for affordable biologic therapies, patent expirations of blockbuster drugs, and increasing acceptance among healthcare providers and patients. Governments and regulatory bodies are supporting biosimilar adoption to reduce healthcare costs and improve access to life-saving treatments for chronic diseases such as cancer, diabetes, and autoimmune disorders. Growing investments in biopharmaceutical research, advancements in manufacturing technologies, and strategic collaborations between pharmaceutical companies are further driving market growth. However, challenges such as complex regulatory pathways, high development costs, and concerns regarding interchangeability and patient trust remain key restraints. Despite these hurdles, the biosimilars market is expected to continue its strong trajectory as cost-effectiveness and clinical effectiveness strengthen global adoption.
Learn more here:
https://www.fortunebusinessinsights.com/biosimilars-market-108928
Market Segmentation
The biosimilars market can be segmented by drug class into monoclonal antibodies, granulocyte-colony stimulating factors, insulin, erythropoietin, recombinant human growth hormone, and other biologics. By disease indication, the market is categorized into oncology, autoimmune diseases, diabetes, blood disorders, and other therapeutic areas. Segmentation by distribution channel includes hospital pharmacies, retail pharmacies, and online pharmacies. Additionally, the market can be segmented by manufacturing type into in-house manufacturing and contract manufacturing.
List Of Key Companies Profiled:
Celltrion Inc. (South Korea)
Pfizer Inc. (U.S.)
Novartis AG (Switzerland)
Amgen Inc. (U.S.)
Biocon (India)
Biogen (U.S.)
Coherus BioSciences (U.S.)
Samsung Bioepis (South Korea)
Shanghai Henlius Biotech, Inc. (China)
Market Growth
The biosimilars market is experiencing strong growth fueled by the rising demand for cost-effective biologic therapies, patent expirations of blockbuster biologic drugs, and increasing acceptance of biosimilars by healthcare providers and patients. Supportive government initiatives, favorable regulatory pathways, and efforts to reduce healthcare expenditure are further accelerating market expansion. Growing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is also boosting demand for biosimilars across global markets.
Market Restraining Factors
The market faces restraints such as complex and lengthy regulatory approval processes, high costs associated with development and clinical trials, and lack of awareness or trust among patients and healthcare professionals in certain regions. Patent litigations and intellectual property rights disputes often delay market entry for biosimilars. Moreover, pricing pressures, strong competition from established biologics, and challenges related to interchangeability with reference products further hinder widespread adoption.
Regional Analysis
North America is showing significant growth in the biosimilars market due to rising healthcare costs, favorable regulatory reforms, and expanding adoption of biosimilars in therapeutic areas such as oncology and autoimmune diseases. Europe remains a leading region with well-established regulatory frameworks, high awareness among patients and physicians, and strong government support to reduce healthcare expenditure. The Asia-Pacific region offers substantial growth opportunities, driven by large patient populations, expanding biopharmaceutical manufacturing capabilities, and increasing approvals of biosimilars. Latin America is gradually expanding with greater focus on affordable biologics and government initiatives to improve healthcare access, while the Middle East and Africa face slower growth due to limited infrastructure, restricted awareness, and economic challenges.