Biosimilars Market Size to Hit $76.2 Billion by 2030 - Driving Value-Based Care for Drugmakers, Regulators & Emerging Markets | The Research Insights

CHICAGO and PUNE, India, July 1, 2025 /PRNewswire/ --

What's Fuelling the US$76.2 Billion Biosimilars Market?

The Global Biosimilars Market size is projected to be valued at USD 27.20 billion in 2023 and reach USD 76.20 billion by 2030, growing at a CAGR of 15.9% according to a new report by The Research Insights. This growth is driven by several key factors, including a rising number of regulatory approvals and product launches, the patent expiries of major biologics, and the increasing prevalence of chronic diseases that require effective and affordable treatment options. The report runs an in-depth analysis of market trends, key players, and future opportunities. In general, the Biosimilars Market growth of 15.9% comprises a vast array of product, application and geography which are expected to register strength during the coming years.

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Why Are Biosimilars Emerging as the Backbone of Affordable Biologic Therapies?

According to an exhaustive report by The Research Insights, the Biosimilars Market is experiencing significant growth. The rapidly evolving global pharmaceutical industry is characterized by several unique and trending factors contributing to shaping the current landscape and competitive dynamics of the biosimilars market. The key factors include the increasing demand for affordable biologic therapies driven by the rising healthcare expenditures and the burgeoning prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes across the globe. The impending or already occurred patent expiries of several blockbuster biologics drugs have created a conducive environment for biosimilar manufacturers, opening the market to more competition and new entrants at an accelerated rate. Additionally, the establishment of supportive regulatory frameworks and streamlined approval pathways in key markets such as the United States, European Union, and emerging economies, is enabling the fast-paced development and acceptance of biosimilars. Furthermore, growing awareness, education, and positive experience among physicians and patients is also contributing to a greater acceptance and adoption of biosimilars by effectively reducing the resistance to switching from reference products. The enhanced technological advancements in biologic drug manufacturing and analytical characterization are also driving down the cost of production while maintaining the high quality of biosimilar products. Collaborative efforts and strategic partnerships among key players such as biopharma companies, Contract Development and Manufacturing Organizations (CDMOs), and supportive government initiatives to increase the access to affordable biologics are also playing a vital role in facilitating the growth of the biosimilars market. Some of the other trends observed in the biosimilars space, which are set to influence the competitive dynamics, include the incorporation of digital health platforms, personalized medicine, and the application of artificial intelligence in biosimilar development.

What Role Do Patent Expirations and Budget Constraints Play in the Biosimilars Boom?

The loss of patents and exclusivity rights of several key biologic drugs is a major driver of the biosimilars market. Many of the high-cost, blockbuster biologic drugs such as Humira (adalimumab), Remicade (infliximab), Herceptin (trastuzumab), Enbrel (etanercept), etc., have already lost their patents or are about to, which has paved the way for the entry of biosimilar versions in the market. As biologics are some of the highest spending drugs across the globe, and since many of these medications are used for the treatment of chronic and complex diseases, such as cancer, rheumatoid arthritis, inflammatory bowel disease, diabetes, etc., healthcare systems are actively looking for more cost-effective alternatives to the originator products. In addition, biosimilars help in reducing the costs of expensive biologics, which often represent a major share of national drug budgets, and insurers' spending. Biosimilars typically provide a cost-saving alternative at 15–30% less expensive than the originator biologic products, while also assuring similar safety and efficacy profiles as demonstrated in head-to-head trials. This increased price competition helps in reducing the financial burden of these specialty drugs on the national healthcare systems, the health insurers, and the patients and thus will encourage faster uptake and deeper market penetration.

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How Are Chronic Disease Burdens and Biologic Demand Powering the Biosimilars Market?
The surging global burden of chronic and lifestyle-related diseases, such as cancer, autoimmune disorders, and diabetes, has led to the high demand for biologic therapies and subsequently for their biosimilar versions as well. Biologics are fast becoming the standard of care for many diseases for which either the existing therapies are not very effective, or patients do not respond to them adequately. However, their high cost can be a major barrier to the use of these biologic therapies, especially in low- and middle-income countries. Biosimilars present an excellent opportunity to address this unmet need by improving access to lifesaving medicines at reduced prices. Given the demographic shift toward the older population and the concomitant increase in the incidence of chronic diseases around the world, the demand for biosimilars is expected to grow at a much faster pace, especially in oncology, endocrinology, and immunology therapeutic areas, in the coming years. This is also further corroborated by the fact that healthcare providers and policy decision-makers are looking for cheaper ways to manage therapies for long-term diseases.

Are Governments and Payers Creating the Perfect Storm for Biosimilar Expansion?

The establishment of streamlined and accelerated regulatory pathways for biosimilars in key global markets, such as the U.S. FDA's Biologics Price Competition and Innovation Act (BPCIA) and the EMA's well-defined and established biosimilar guidelines, have also been key factors propelling the growth of this space. The approval requirements for biosimilarity, interchangeability, labeling, and pharmacovigilance have been clearly defined by the respective regulatory authorities, which will in turn increase the confidence of physicians, pharmacists, and patients in using biosimilars. In addition, several countries and health insurance providers have introduced supportive policies and strategies to promote the use of biosimilars over biologic originators, such as substitution laws, tendering, and reimbursement policies. For instance, countries such as Germany, the UK, and Norway have witnessed a significant uptake in biosimilar products due to national incentive programs, recommendations for substitution, and mandatory switching policies. Such policy support not only helps lower the entry barriers for the manufacturers and increase the safety and efficacy of biosimilar products, but also builds greater market confidence, which will in turn provide a favourable environment for greater adoption of biosimilars.

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Where Is Biosimilar Adoption Accelerating Fastest—and Why Now?

North America has long held its ground as the dominant regional player in the global biosimilar market, accounting for 40.4% of the total revenue generated in this space.
Asia Pacific is anticipated to exhibit a Compound Annual Growth Rate (CAGR) of 18.4% during the forecast period. The presence of key players such as Dr. Reddy's Laboratories, Biocon, Pfizer Inc., and Celltrion, has significantly influenced the development and commercialization of biosimilars in the region.

How Are Product, Application, and Regional Dynamics Shaping the Global Biosimilars Market Landscape?

• Based on Product, the biosimilars market is divided into, Recombinant Non-glycosylated Proteins, and Recombinant Glycosylated Proteins. The recombinant non-glycosylated proteins segment led in terms of revenue share, accounting for approximately 54.9%.
• Based on Application, the biosimilars market is divided into, Oncology, Blood Disorders, Growth Hormonal Deficiency, Rheumatoid Arthritis, Chronic and Autoimmune Disorders, and Others. The segment that accounts for the largest share in terms of revenue is the chronic and autoimmune disorders category, accounting for around 21.6% of the market's total.
• The Biosimilars Market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

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Which Companies Are Defining the Biosimilars Landscape—and What's Powering Their Momentum?

The Global Biosimilars Market is characterized by the presence of several major players, including:

• Amgen Inc.
• F Hoffman-La Roche Ltd.
• Sandoz International GmbH
• Dr. Reddy's Laboratories Ltd.
• Teva Pharmaceutical Industries Ltd.
• Pfizer Inc.
• Samsung Biopis
• Biocon
• Viatris Inc.
• Celltrion Healthcare Co.,Ltd.
• AbbVie Inc.

These companies are adopting strategies such as new product launches, joint ventures, and geographical expansion to maintain their competitive edge in the market.

What's Driving Innovation in the Global Biosimilars Market Today?

• In April 2025, Sandoz entered into a collaboration with Shanghai Henlius Biotech to commercialize a biosimilar of ipilimumab, a leading oncology therapy to treat certain types of cancers like colorectal cancer, esophageal cancer, hepatocellular carcinoma, malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma.
• In April 2025, Biocon and Regeneron formed a license agreement to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar to aflibercept, in the US.
• In April 2025, Biocon Biologics received approval from the US FDA for Jobevne (bevacizumab-nwgd), a biosimilar of Bevacizumab for intravenous use to treat several different types of cancer.
• In March 2025, Celltrion launched ZYMFENTRA (infliximab-dyyb) across the US market to treat ulcerative colitis (UC) or Crohn's disease (CD).

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Frequently Asked Questions (FAQs):

Conclusion:

The biosimilars market is undergoing a transformation driven by advancements in biotechnology, evolving regulatory landscapes, and expanding manufacturing capabilities. The increasing prevalence of chronic diseases and the rising economic burden on healthcare systems have heightened the demand for affordable and accessible biologic treatments. This demand is driving the accelerated adoption of biosimilars, which are recognized for their clinical efficacy, cost-effectiveness, and improved accessibility. Biosimilars are poised to play a crucial role in broadening patient access to life-saving biologic therapies, especially in oncology, immunology, and endocrinology. The continuous enhancements in analytical characterization, real-world evidence generation, and pharmacovigilance are building confidence in the safety and interchangeability of biosimilars. Strategic collaborations, streamlined regulatory pathways, and supportive policies are propelling market penetration. As the global healthcare landscape shifts towards value-based care, biosimilars are emerging as indispensable components of sustainable healthcare delivery and pharmaceutical innovation.

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The report from The Research Insights, therefore, provides several stakeholders— pharmaceutical companies, healthcare providers, regulatory agencies, patients, payers/insurance companies, and government health authorities—with valuable insights into how to successfully navigate this evolving market landscape and unlock new opportunities.

With projected growth to US$ 76.20 billion by 2030, the Global Biosimilars Market represents a significant opportunity for, contract manufacturing organizations (CMOs), biotechnology startups, academic research institutions, investment firms, and technology providers can position themselves for success in this dynamic and evolving market landscape.

The Critical Questions to be Asking:

Rather than "Should we pursue biosimilars?", the strategic questions to be asking are:

• Which therapeutic areas provide the quickest route to biosimilar profitability in the context of upcoming patent expirations?
• Where should we build or acquire manufacturing capabilities to scale and meet global demand for biosimilars?
• How can we position our company as a trusted brand in the biosimilar space in an increasingly price sensitive market?
• Who should we partner with to effectively manage regulatory complexity and speed to global market access?
• Why is now the time to invest in biosimilars in order to compete in the changing landscape of chronic disease care and value-based healthcare?

Check out more related studies published by The Research Insights:

• Biosimilar Contract Manufacturing Market: The Global Biosimilar Contract Manufacturing Market is expected to reach at USD 25.73 billion by 2030, according to a new report by The Research Insights. It is projected to expand at a CAGR of 15.9% during the forecast period. The rising prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes has created a substantial demand for biosimilars, which offer comparable efficacy to their reference biologics while being more cost-effective.
• Biosimilar Monoclonal Antibodies Market: According to a report by The Research Insights, the growth of the global biosimilar monoclonal antibodies market is driven by several key factors, including the increasing number of monoclonal antibody patent expirations, ongoing innovations in mAb technology, growing demand for cost-effective therapies, and the rising prevalence of chronic and autoimmune diseases such as cancer and rheumatoid arthritis.

Browse More related reports on Healthcare Industry Market Reports – https://www.theresearchinsights.com/categories/healthcare

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