Biosimilar Market

Biosimilar Market Size:

The global biosimilar market size reached USD 26.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 185.1 Billion by 2033, exhibiting a growth rate (CAGR) of 24.1% during 2025-2033. The expiration of patents for major biological drugs, growing awareness about the efficacy and cost-effectiveness of biosimilars, the rising prevalence of chronic diseases worldwide, and continual advancements in biopharmaceutical manufacturing technologies are some of the major factors propelling the market growth.

Biosimilar Market Analysis:

• Major Market Drivers: The expiration of patents for blockbuster biologic drugs opens opportunities for biosimilar entry which represents a major driver of the market. This, coupled with the escalating need for cost-effective treatments for chronic diseases such as cancer and autoimmune disorders, drives demand. Supportive regulatory frameworks and initiatives by governments to reduce healthcare expenditure bolster the development and adoption of biosimilars, offering a significant boost to market growth.
• Key Market Trends: The increasing investment in research and development (R&D) by pharmaceutical companies to enhance biosimilar pipelines represents the key trend of the market. There is also a notable rise in strategic partnerships and collaborations aimed at accelerating market entry and expanding global reach.
• Geographical Trends: According to the biosimilar market overview, Europe accounts for the largest region in the market. The patent expirations of key biologics, strong regulatory support from agencies like EMA, and the growing demand for cost-effective treatment are driving the growth of the market across the region. The initiatives promoting biosimilar adoption and high healthcare expenditure on biologics enhance market growth, making biosimilars a viable alternative in Europe’s healthcare system.
• Competitive Landscape: Some of the major market players in the biosimilar industry 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.
• Challenges and Opportunities: The biosimilar market recent opportunities include the increasing number of patent expirations of major biologics, growing demand for affordable treatment options, and supportive government policies promoting biosimilar adoption. Advances in biotechnology and strong investment in research and development (R&D) also present significant growth prospects for the market, enabling the development and acceptance of biosimilars. However, the market also faces several challenges such as strict regulatory requirements, high development costs, and the complexity of the manufacturing process which can hinder market entry. In addition to this, there is resistance from healthcare providers and patients due to concerns about biosimilar efficacy and safety as compared to original biologics.

Biosimilar Market Trends:

Increasing Patent Expirations of Blockbuster Biologics

The expiration of patents for major biological drugs is a primary driver of the market growth. Many blockbuster biologics, which have been essential in treating various chronic diseases, are reaching the end of their patent protection. According to industry reports, big pharmaceutical companies such as Bristol Myers Squibb, Merck, and Johnson & Johnson face a looming threat that will put tens of billions of dollars in sales at risk between now and 2030, as blockbuster drugs will tumble off a so-called patent cliff. That refers to when a company’s patents for one or more leading branded products expire, which opens the door for competitors to sell copycats of those drugs, often at a lower price. That typically causes revenue to fall for drugmakers and costs to drop for patients, who can access more affordable options. This opens opportunities for biosimilar manufacturers to develop and market lower-cost alternatives. The increased competition leads to reduced prices, which makes these vital treatments more accessible to a broader patient population, thus expected to fuel the biosimilar market revenue.

Growing Regulatory Support and Streamlined Approval Processes

Regulatory agencies such as the FDA and EMA have established robust frameworks and guidelines to ensure the safety, efficacy, and quality of biosimilars. These supportive regulatory environments facilitate the approval and market entry of biosimilars. For instance, in February 2024, the European Medicines Agency (EMA) proposed to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as monoclonal antibodies and recombinant proteins, to reduce the need for human studies in comparing a biosimilar medicine under development with the reference product. Clear regulatory pathways and streamlined approval processes enhance confidence among healthcare providers and patients, encouraging the adoption of biosimilars. According to the biosimilar market forecast, the ongoing efforts to educate stakeholders about the benefits and safety of biosimilars are projected to influence the market growth positively over the coming years.

Rising Healthcare Costs and Demand for Affordable Treatments

The escalating cost of healthcare, particularly in the management of chronic diseases such as cancer, diabetes, and autoimmune disorders, is driving the demand for cost-effective alternatives to expensive biologics. For instance, in a recent study conducted by the Postgraduate Institute of Medical Education and Research (PGI), it was found that the cost of cancer treatment during outpatient department (OPD) visits is significantly higher than the expenses incurred during hospitalization. The study, which involved surveying 9,787 patients across seven cancer centers in India to assess out-of-pocket expenditures, sheds light on the financial challenges faced by cancer patients and their families. Diagnostics accounted for a substantial 36.4% of the total expenditure, with medicines making up an additional 28%. Biosimilars offer similar therapeutic benefits at a fraction of the cost, making them an attractive option for both healthcare providers and patients. The push for affordable healthcare solutions is further supported by governments and insurance companies looking to manage healthcare expenditures without compromising on the quality of care.

Biosimilar Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on molecule, indication, and manufacturing type.

Breakup by Molecule:

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
• Pegfilgrastim
• Trastuzumab
• Bevacizumab
• Others
   

Infliximab accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the molecule. This includes Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, Adalimumab, Pegfilgrastim, Trastuzumab, Bevacizumab, and others. According to the report, infliximab accounted for the majority of the share in the market.

The demand for Infliximab biosimilars is driven by several key factors. The expiration of patents for the original biologic, Remicade, opens the market to cost-effective biosimilar alternatives, making treatments more accessible. The rising prevalence of chronic inflammatory diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis is significantly boosting the biosimilar demand. Additionally, healthcare cost pressures and the need for affordable treatment options propel the adoption of biosimilars. Regulatory approvals and increasing acceptance among healthcare providers and patients also enhance market growth, ensuring the availability and trust in these effective therapies.

Breakup by Indication:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility
• Others
   

Auto-immune diseases holds the largest share of the industry

A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes auto-immune diseases, blood disorders, diabetes, oncology, growth deficiency, female infertility, and others. According to the biosimilar market report, auto-immune diseases accounted for the largest market share.

Autoimmune diseases include conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are prevalent worldwide, affecting millions of people. This high prevalence results in a substantial increase in the demand for effective treatments. These diseases are typically chronic, requiring long-term treatment, leading to a consistent demand for the associated therapies. Additionally, the original biologics used to treat autoimmune diseases can be expensive, placing a financial burden on healthcare systems and patients. Since biosimilars offer a more affordable alternative, they are becoming the preferred choice for patients and healthcare professionals. Furthermore, the increasing acceptance of biosimilars among physicians, patients, and healthcare systems for treating autoimmune diseases owing to their similar efficacy and safety profiles to the reference biologics is also fueling the biosimilar market growth.

Breakup by Manufacturing Type:

• In-house Manufacturing
• Contract Manufacturing
   

In-house manufacturing accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the manufacturing type. This includes in-house and contract manufacturing. According to the report, in-house manufacturing represented the largest segment.

In-house manufacturing allows complete control over the product quality, which is essential for biosimilars. Given the complexity of biologics and the strict regulations surrounding their manufacture, companies usually prefer to handle production themselves to ensure high standards are met. Moreover, biological manufacturing processes often involve proprietary methods and technologies. In-house production helps protect these trade secrets, making it the preferred choice of manufacturing type. While the initial setup cost may be high, maintaining production in-house can significantly reduce costs per unit over time. In-house manufacturing enables companies to minimize the risk of supply chain disruptions, ensuring a consistent supply of their products while facilitating flexibility and agility in production, including making adjustments or adaptations to the product or process as needed.

Breakup by Region:

• Europe
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom
  • Rest of Europe
• United States
• Japan
• India
• South Korea
• Others
   

Europe leads the market, accounting for the largest biosimilar market share

The report has also provided a comprehensive analysis of all the major regional markets, which include Europe (Germany, France, Italy, Spain, the United Kingdom, and the Rest of Europe); the United States, Japan, India, South Korea, and Others. According to the report, Europe accounted for the largest market share.

Europe held the biggest share of the market since the region has a supportive regulatory environment, allowing several biosimilars to enter the European market well before other regions. This early start enabled Europe to gain a significant share of the market. Furthermore, the European Medicines Agency (EMA) has been a forerunner in creating a clear and supportive regulatory framework for the approval of biosimilars since 2005, earlier than many other regions. This early framework encouraged the development and marketing of biosimilars in the region. Apart from this, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients in Europe is fueling their uptake, which in turn is expected to create a positive biosimilar market outlook across the region. For instance, in January 2024, Sandoz, the global leader in generic and biosimilar medicines, announced the launch of Tyruko® (natalizumab) in Germany on February 1. Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat RRMS.

Competitive Landscape:

• The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the biosimilar industry include Sandoz International GmbH, Pfizer Inc., Teva Pharmaceutical Industries Limited, Celltrion Inc., Biocon Limited, Samsung Biologics, Amgen, Inc., Dr. Reddy's Laboratories Limited, and Stada Arzneimittel Ag.
  
  (Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
   
• The market for biosimilars is highly competitive, with key players including Pfizer, Amgen, Novartis (Sandoz), and Biocon. These biosimilar companies invest heavily in research and development (R&D) and leverage strategic partnerships to enhance their biosimilar portfolios. For instance, in October 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The interchangeable designation applies to all approved indications of ABRILADA, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurative, and uveitis. Competition is driven by patent expirations of major biologics, regulatory approvals, and the push for cost-effective therapies. Some of the key biosimilar market recent developments further include the entry of emerging players, which is intensifying competition and driving the commercialization.

Biosimilar Market News:

• In May 2024, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases.
• In May 2024, Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Alvotech announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa, and adult uveitis.
• In May 2024, Celltrion USA announced that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-aaty will be priced as a WAC list price at an 85% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is also available from Celltrion USA under the brand name YUFLYMA®, which launched in July 2023 and is available at a 5% discount to the current WAC list price of HUMIRA.

Biosimilar Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the biosimilar market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global biosimilar market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the biosimilar industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.