Global Biosimilar Market Expected to Reach USD 185.1 Billion by 2033 - IMARC Group

Global Biosimilar Market Statistics, Outlook and Regional Analysis 2025-2033

The global biosimilar market size was valued at USD 26.5 Billion in 2024, and it is expected to reach USD 185.1 Billion by 2033, exhibiting a growth rate (CAGR) of 24.1% from 2025 to 2033.

The global biosimilar market is growing tremendously due to a few key factors, the most important of which is cost-effectiveness. Biologic drugs are usually expensive, according to the Biologic Med, they range from $3,000 to $30,000 per year for diseases such as asthma, allergies, eczema, urticaria, arthritis, and certain cancers and more serious conditions, the annual costs exceed $100,000. This high cost acts as a financial barrier for many patients, mainly in regions that have limited healthcare budgets. Biosimilars thus offer a more affordable alternative to such expensive biologic therapies without compromising safety, efficacy, or quality. The cost advantage of biosimilars is vital for healthcare systems worldwide struggling with rising medical expenses. Biosimilars improve access to life-saving treatments by making these more affordable. This increases the access of patients to these treatments, especially in therapeutic areas such as oncology and immunology, where biologics are commonly applied. The increasing prevalence of chronic diseases, including cancer, autoimmune disorders, and diabetes, further fuels the demand for biologics, thereby amplifying the need for biosimilars as a sustainable solution to meet the increasing treatment demand.

Expansive regulatory steps and mounting marketplace receptivity also power the advance of the market for biosimilars. Key agencies, the European Medicines Agency and the US Food and Drug Administration have designed quicker lanes to clearance that let in biosimilars much more freely. Their work ensures high standards around biosimilar safety and quality, among other values that increase adoption among all types of consumers. Rising markets are making physicians increasingly aware about use in practice, thereby increasing market adoption. More clinical evidence that is emerging concerning the use of biosimilars has further enhanced confidence levels in these therapies. Recent launches of biosimilars targeting more conditions ophthalmology as well as rare diseases growth in addition to the development of biosimilars for more complex biologic drugs. The continued innovation in the development of biosimilars and growth in treatment options will help solidify the position of the biosimilar market further in offering affordable and accessible alternatives for expensive biologic therapies.

Global Biosimilar Market Statistics, By Region

The market research report has also provided a comprehensive analysis of all the major regional markets, which include Europe (Germany, France, Italy, Spain, United Kingdom, Rest of Europe), United States, Japan, India, South Korea, Rest of the World, and Others. According to the report, Europe accounted for the largest market share on account of robust technological advances, rapid urbanization and rising disposable income.

Europe Biosimilar Market Trends:

The European biosimilar market is experiencing a significant rise due to the increasing demand for cost-effective alternatives to expensive biologic treatments. ISPOR states that up to May 2024, 17 biosimilars have been launched in the European Union. The average launch price per pack falls between €581 and €1,128. The regulatory environment, particularly in the European Medicines Agency, supports the market. They ensure that a smooth and efficient process of approval of biosimilars occurs, thus boosting their market demand. Acceptance by healthcare providers and patients of this type of product is increasingly on the rise since it assures safety, efficacy, and cost-effectiveness. The increasing incidence of chronic diseases like cancer, autoimmune disorders, and diabetes have added further momentum to the need for biologic therapy, contributing to the higher uptake of biosimilars. Furthermore, a significant extension of the portfolio of leading pharmaceutical companies on biosimilars has resulted in more treatment choices in almost all therapeutic areas, like oncology and immunology, which are highly innovative. Favorable policies in various European countries also shape the biosimilar market. Reimbursement policies are key drivers in improving access to markets.

United States Biosimilar Market Trends:

The biosimilar market in the United States is driven by increasing healthcare costs and the demand for cheaper biologics. The FDA approval of more biosimilars has opened the market, giving physicians and patients a cost-effective alternative to originator biologics. Furthermore, the growing prevalence of chronic diseases, such as autoimmune disorders and cancer, has further fueled the demand for biologics. The presence of strong reimbursement policies, coupled with increasing insurance coverage for biosimilars, enhances market growth prospects in the U.S.

Japan Biosimilar Market Trends:

The geriatric population drives Japan's biosimilar market as these people develop more chronic conditions, requiring biological therapy, at a much higher rate than other demographics. Reimbursement policy support from the Japanese government has also added encouragement for growth within the market. The approval process for biosimilars by regulatory authorities of this country is also becoming less stringent day by day, making its stakeholders even more confident. Healthcare costs are skyrocketing, so the more cost-effective alternative to an original biologic is focusing on the growth of the market for biosimilars in Japan and increasing patient access.

India Biosimilar Market Trends:

Biosimilar markets in India are witnessing exponential growth, as large patient populations have been faced with the increasing burden of chronic diseases like cancer and diabetes. The country's strong manufacturing capabilities, and a rising demand for accessible healthcare solutions, make it an ideal market for biosimilars in India. More importantly, the government initiative to introduce price caps for essential medicines and promote local manufacturing of medicines has also been encouraging the production and availability of biosimilars. The growing acceptance among healthcare professionals of biosimilars is also paving the way for market expansion.

South Korea Biosimilar Market Trends:

The strong regulatory incentive along with an expedited approval process through government policies have become major drivers for the South Korea-based biosimilar market. Many Korean companies are innovators of biosimilars with Samsung Bioepis, a leading biosimilar producer, and others of notable caliber. South Korea leads biosimilar production and features infrastructure. The increased prevalence of chronic conditions augments the demand for such therapy. Increasing healthcare spending and efforts to reduce the cost of treatment have made biosimilars an attractive option both for patients and healthcare providers, contributing to market growth.

Top Companies Leading in the Biosimilar Industry

Some of the leading biosimilar market companies include Sandoz International GmbH, Pfizer Inc., Teva Pharmaceutical Industries Limited, Celltrion Inc., Biocon Limited, Samsung Biologics, Amgen, Inc., Dr. Reddy's Laboratories Limited, Stada Arzneimittel Ag, among many others.

• On 03 October 2024, Teva Pharmaceutical Industries and mAbxience reported a global licensing agreement for an anti-PD-1 oncology biosimilar to develop. This is the company's second agreement, however, the previous deal, which was agreed upon in April 2024, focuses on a different oncology biosimilar. It hopes to offer affordable, high-quality therapies addressing unmet oncology needs.

Global Biosimilar Market Segmentation Coverage

• On the basis of molecules, the market has been categorized into infliximab, insulin glargine, epoetin alfa, etanercept, filgrastim, somatropin, rituximab, follitropin alfa, adalimumab, pegfilgrastim, trastuzumab, bevacizumab, and others. Infliximab occupies the maximum market share, which can be attributed to a wide variety of its indication and also has excellent efficiency for autoimmune diseases. It covers diseases like rheumatoid arthritis, Crohn's disease, and ulcerative colitis. As a monoclonal antibody, Infliximab inhibits the effect of a pro-inflammatory cytokine-TNF-alpha in a quite effective disease-modifying therapy approach for chronic diseases. Thus, the trend of spreading the use of Infliximab has been driven by the steady increase in the global prevalence of autoimmune diseases and the subsequent rise of patients diagnosed with these illnesses. The persistent clinical evidence of its long-term efficacy and safety profile improves its market position, thus making it the most desired biologic treatment.
• Based on the indication, the market is segmented into auto-immune diseases, blood disorders, diabetes, oncology, growth deficiency, female infertility. Auto-Immune diseases dominate the market due to the growing global incidence of autoimmune diseases like rheumatoid arthritis, lupus, psoriasis, and Crohn's disease. The treatment of most such chronic conditions has to be primarily by biologics, while other drug-based therapy, being palliative, proves insufficient. It is primarily driven by high unmet medical need with effective long-term treatments that encourage greater demand for biologics within the indications. Additionally, biologics like Infliximab, Etanercept, and Adalimumab have shown significant success in reducing inflammation and improving quality of life for patients with autoimmune diseases, further consolidating this segment's dominance in the market.
• On the basis of manufacturing type, the market has been divided into in-house manufacturing, contract manufacturing, and others. Among these, in-house manufacturing accounts for the majority of the market share due to the willingness of pharmaceutical companies to keep control over its product production in-house in light of full control over every parameter, from quality, the need to comply strictly with regulatory standards, protection of the drug's intellectual property, avoiding any dependence on third-party manufacturers, and faster production and better chain-of-supply management. Companies are very keen on having control over the process, mainly to minimize risks on quality assurance and production delay as well as potential disruption. Consequently, the large biopharma companies continue investing in their internal manufacturing capacity, thus making this market segment strong.

Browse IMARC Related Reports on Biosimilar Market:

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• Japan Biosimilar Market Report
   
• Saudi Arabia Biosimilar Market Report
   
• India Biosimilar Market Report
   
• United States Biosimilar Market Report