Adalimumab, Infliximab and Etanercept Biosimilars Market Report 2025

The adalimumab, infliximab and etanercept biosimilars market size has grown rapidly in recent years. It will grow from $4.37 billion in 2024 to $4.98 billion in 2025 at a compound annual growth rate (CAGR) of 14.1%. The growth in the historic period can be attributed to increased healthcare expenditure, regulatory changes, regulatory changes, government initiatives and rising healthcare costs.

The adalimumab, infliximab and etanercept biosimilars market size is expected to see rapid growth in the next few years. It will grow to $7.44 billion in 2029 at a compound annual growth rate (CAGR) of 10.5%. The growth in the forecast period can be attributed to a rise in healthcare expenditure, an aging population and an increase in healthcare access will drive market growth. Major trends in the forecast period include focus on launching new products, focus on mergers and acquisitions, focus on establishing strategic partnerships, and focus on increasing investments.

The entrance of biosimilars into the market for adalimumab, infliximab, and etanercept is facilitated by the patent expiration of branded drugs. Notably, the FDA approved Hospira's Inflectra post the patent expiry of the branded drug Remicade, enabling treatment for various autoimmune diseases such as rheumatoid arthritis, adult ulcerative colitis, and plaque psoriasis in the United States. Similarly, in the EU, Amgen's Enbrel patent expiration led to the approval of Benepali, a biosimilar of Enbrel, by the European Commission. Following the expiry of Humira's patent, multiple biosimilars have become available in the market, including the recent approval (July 2020) of Hulio, the sixth biosimilar of Humira by the FDA. Consequently, the patent expiry of branded biologic drugs such as Humira, Enbrel, and Remicade is expected to propel demand in the adalimumab, infliximab, and etanercept biosimilars market.

The escalating prevalence of autoimmune diseases is anticipated to drive growth in the market for adalimumab, infliximab, and etanercept biosimilars. Autoimmune diseases arise from immune system dysfunction, leading immune cells to attack the body's healthy cells. Adalimumab, infliximab, and etanercept, as biological drugs with tumor necrosis factor (TNF) alpha inhibitors, are employed in treating various autoimmune diseases. According to Johns Hopkins University in 2023, approximately 10 million individuals in the US, constituting 3% of the population, are affected by diverse autoimmune illnesses. Consequently, the surge in autoimmune diseases' prevalence significantly contributes to driving the growth of the adalimumab, infliximab, and etanercept biosimilars market.

The brand-name versions of biosimilar drugs are expensive, and many are now being replaced by biosimilar versions following the expiration of their patents. The costs of branded biological drugs have nearly doubled in recent years. For example, in September 2022, the biologic medication Humira, used to treat autoimmune conditions such as rheumatoid arthritis and Crohn's disease, was priced at over $6,000 for a carton containing two pens without insurance. The transition to lower-cost biosimilar drugs is primarily due to the absence of clinically significant differences in safety and efficacy between the biosimilars and the original biologics. After the patent on the original adalimumab product, Humira, expired, the Danish healthcare system nearly completely transitioned to adalimumab biosimilars, resulting in an 82% reduction in medication costs.

Major companies in the adalimumab, infliximab, and etanercept biosimilars market are prioritizing the development of innovative products, such as citrate-free adalimumab, to offer enhanced services to consumers. Citrate-free adalimumab represents a formulation of the biological medication adalimumab devoid of citrate. For instance, in December 2022, Fresenius Kabi, a German-based manufacturer specializing in medicines and technologies for infusion, transfusion, and clinical nutrition, announced FDA approval for the biosimilar Idacio (adalimumab). This biosimilar is sanctioned for use in managing chronic autoimmune disorders across all permissible uses of the reference product. It has been meticulously crafted employing advanced analytical methodologies, intended for the treatment of various chronic conditions.

In February 2022, the Indian biopharmaceutical company Biocon Limited successfully acquired the biosimilar assets of Viatris, Inc., a U.S.-based biopharmaceutical and healthcare company, for a total of $3.34 billion. This strategic acquisition positions Biocon as a unique and vertically integrated global leader in biosimilars, providing an impetus for the expedited commercialization of its existing and future biosimilar portfolio on a global scale. The move is set to significantly enhance Biocon's product reach across international markets. Viatris, Inc. is recognized for its expertise in the development and specialization of biological and therapeutic agents.

Major companies operating in the adalimumab, infliximab and etanercept biosimilars market include Biogen, Novartis (Sandoz), Pfizer, Amgen, Celltrion, Samsung Bioepis (Samsung Biologics), Hetero Drugs Limited, Fresenius Kabi AG, Boehringer Ingelheim, Biocon, Zydus Lifesciences Limited, Reliance Life Sciences, Torrent Pharmaceuticals Ltd, Sun Pharmaceutical Industries Ltd, Cipla Limited, Zhejiang Hisun Pharmaceutical Co. Ltd, Bio-Thera Solutions, Ltd, Innovent Biologics (Suzhou) Co. Ltd, Janssen Biologics BV, Shanghai CP Guojian Pharmaceutical Co. Ltd, Sansheng Guojian, Shanghai Junshi Biosciences Co. Ltd, Mabwell Bioscience Co. Ltd, LG Chem, Nippon Kayaku, Mochida Pharmaceutical Co. Ltd, mAbxience, Allergan, Microgen, Geropharm, Valenta, NovaMedica Veropharm, Biocad, Roche, Bristol-Myers Squibb, Celon Pharma, SynBio, Ache, Eurofarma, Teva Pharmaceuticals, Oramed Pharmaceuticals, Entera Bio, Julphar, Hikma Pharmaceuticals, Mylan, BIOPHARMA-MEA, NeoTX, AID Genomics Limited, Altis Biologics, Next Biosciences, Viome, Inqaba Biotechnical Industries (Pty) Ltd.

North America was the largest region in the adalimumab, infliximab, and etanercept biosimilars market in 2024. The regions covered in the adalimumab, infliximab, and etanercept biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the adalimumab, infliximab and etanercept biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain.

Adalimumab, infliximab, and etanercept biosimilars represent an innovative class of medications designed to inhibit the effects of the inflammatory mediator tumor necrosis factor-alpha (TNF-alpha). Infliximab biosimilars, in particular, are chimeric monoclonal antibodies targeting TNF-alpha and are utilized in the treatment of immune system disorders.

These medications include various products such as adalimumab, infliximab, cipleumab, and etanercept. Adalimumab, classified as a biological drug, operates on the immune system to mitigate inflammation. Its diverse applications encompass treating conditions such as Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and others. These products are made available through different distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies.

The adalimumab, infliximab, and etanercept biosimilars market research report is one of a series of new reports that provides adalimumab, infliximab, and etanercept biosimilars market statistics, including adalimumab, infliximab, and etanercept biosimilars industry global market size, regional shares, competitors with adalimumab, infliximab, and etanercept biosimilars market. This adalimumab, infliximab, and etanercept biosimilars market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The adalimumab, infliximab, and etanercept biosimilars market consists of sales of Amgevita, Hyrimoz, and Idacio. Values in this market are ""factory gate values,"" that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

This product will be delivered within 3-5 business days.