Biosimilar Market Size, Share, By Product Type (Human Growth Hormone & Erythropoietin, Monoclonal Antibodies, Insulin, Emerging Players (Interferon, Colony Stimulating Factors) and Others), By Application (Oncology, Blood Disorders, Growth Hormone Deficiency Diseases and Chronic & Autoimmune Diseases), and, By Region - Trends, Analysis and Forecast till 2034

Biosimilar Market accounted for USD 46.6 Billion in 2024 and is estimated to be USD 65.4 Billion by 2034 and is anticipated to register a CAGR of 3.8%.

Biosimilar is a bio therapeutic that is clinically highly like an approved original biologic (reference product) in terms of active ingredients and has no meaningful differences in efficacy and safety. The biosimilars are also known as follow-on biologics or subsequent entry biologics. The biosimilars are produced using living organisms or cells and have a complex molecular structure. When the patent of a biologic drug expires, manufacturers resort to the approval from the regulatory authorities to start the production of biosimilars.

The Food and Drug Administration approves the biosimilar products, providing the new drug application holder with scientific and regulatory advice on bringing forth safe and effective biosimilars to the market. In general, the approval for the biosimilar products helps patients improve their access to care by increasing the number of medication options available and probably driving down the costs. They are game-changers in the world of medications. Much like the generics for small molecules, a biosimilar is a very close duplicate for these complex biological drugs made by living organisms.

 Think of them as close cousins to the original biologic medication but developed by another company. These biosimilars offer the same benefit as the original biologic with regard to safety, purity, and effectiveness but mostly at reduced costs. This opens a wide avenue for extending lifesaving treatments to more patients suffering from chronic conditions such as arthritis, inflammatory bowel disease, and certain cancers. The introduction of biosimilars should provide a shock of competition and innovation within the drug market for biologics and eventually make treatment more accessible and affordable for patients.

Key Drivers of Target Market:

Patent exclusivity on biologics

• When patents for high-cost, brand-name biologic drugs expire, biosimilars will give an affordable alternative likely to result in cost saving for healthcare systems and patients.

Rising healthcare costs

• Biosimilars are going to bring down the total spend on healthcare; hence, this will become very attractive to governments and payers looking for cost control.

Increasing demand for biologics

• Most biologic drugs deal with a large number of chronic and complex diseases. As the prevalence rate of these diseases increases, so will the demand for their biosimilars.

Government support

• Governments generally encourage the use of biosimilars through policies aimed at improving competition and access.

Restrains:

Regulatory

• The process of regulatory approval for biosimilars is rather extended and thus, at times, delays its entry into the market.

Acceptance by physicians and patients

• There are lingering doubts in some healthcare professionals and patients about the safety and efficacy of biosimilars compared to the original biologics. This may need focused education to allay such apprehensions.

Opportunities:

Market expansion in emerging economies

• In developing countries, increases in healthcare spending will allow biosimilars to give access to key biologic treatments at an affordable level. This presents opportunities for manufacturers of biosimilars to develop regional price-based services.

Attention towards biosimilars in new therapeutic areas

• Currently, biosimilars are indicated for a limited number of conditions. The growth of their development into high-cost biologic areas like oncology and autoimmune diseases will go a long way in improving patient access and affordability of treatment.

Biosimilars for orphan drugs

• Orphan drugs treat rare diseases that generally have limited competition and can result in high costs. A biosimilar will greatly improve the affordability and access for patients with rare conditions in such cases.

The market is segmented based on Product Type, Application and Region.

By Product Type:

• Human Growth Hormone and Erythropoietin: Patent expirations of high-priced branded drugs in both these classes are opening up a big window of opportunity for biosimilar adoption. However, the current availability of biosimilars within these segments could be low, hence limiting their short-term growth.
• Monoclonal Antibodies: With already extensive usage of these drugs in treating cancers and autoimmune diseases, this segment is projected to retain its dominance. Biosimilar versions of high-cost branded monoclonal antibodies have huge cost savings attached; hence, they will grow tremendously.
• Insulin: It is highly likely that the increase in diabetes cases worldwide will also spur the growth of biosimilars for insulin. Biosimilars are copies of original brand name insulins but at lower prices that allow greater accessibility to patients and health care systems.
• Emerging Players: Colony stimulating factors and interferons are the categories that are supposed to see entry of biosimilars in the near future. This will add diversity to the product landscape and probably bring cost-effective treatment solutions for such treatments.
• Others: This includes a host of less prevalent types of biosimilar products. With the progressing science of biosimilars, we may get to see more biosimilars entering this category, to cater to niche therapeutic areas.

By Application:

• Oncology: is one such important factor driving the biosimilar market, holding the largest market share in 2022. Biosimilars are used in various forms of cancers, such as breast, colorectal, lung, and lymphoma. They offer a cost-effective avenue for certain high-end biologic drugs, hence significantly contributing to the reduction of treatment costs and, correspondingly, making access to treatment easier for patients with life-threatening diseases like cancer. Currently, the same can be said regarding oncology biologics going off-patent in increasing numbers in the near future; their biosimilars pipeline appears promising, with high potential for development and market growth.
• Blood Disorders: A number of blood disorders, like anemia, neutropenia, and thrombocytopenia, are likely to be treated using biosimilars. Anemia is a condition where there is a lack of either an adequate number of red blood cells or of hemoglobin, the protein in red blood cells that carries oxygen. Commonly indicated symptoms include fatigue, weakness, and shortness of breath. One such very useful treatment option for anemic patients is biosimilars that stimulate the production of erythrocytes, such as erythropoietin biosimilars.
• Growth Hormone Deficiency Diseases: Growth hormone deficiencies in children and adults are now possible to be treated with biosimilars. Growth hormone deficiency is a condition whereby the pituitary gland does not produce enough growth hormone. This will lead to stunted growth and delayed puberty in children, among other health issues. In adults, growth hormone deficiency often makes them tired and weak, causing a reduction in muscle mass and bone mass with an increased incidence of heart disease. For such patients, biosimilar growth hormones are a safe, effective treatment that has improved their quality of life itself.
• Chronic & Autoimmune Diseases: It is in cases of chronic and autoimmune diseases that the potential for biosimilars comes into its own. This class spans a very broad group of diseases involving self-immunity, whereby even healthy tissues become attacked by the immune system. Since an important part of the pathogenesis underlying these diseases involves inflammatory processes driven by specific molecules, the possibilities for more targeted treatment with reduced toxicity, as opposed to traditional drugs, are opened through targeted intervention by biosimilars.

Regional Insights

• North America is the other grand region observed in the biosimilar market. While it comes next to Europe in terms of market size, it is also growing at a stable pace. The introduction of certain conducive regulations, such as the Biologics Price Competition and Innovation Act (BPCIA) provided by the US, streamlined the approval process for biosimilars and caused rigorous competition. This, together with an aging population and a rise in spending on healthcare, drives the North American biosimilar market.
• Asia Pacific region is a high-potential, fast-growing market for biosimilars on account of rising prevalence of chronic diseases, increasing support from the government in building up the development sector of biosimilars, and low-cost manufacturing hubs such as India and China. However, the regulatory framework remains poorly defined in some of the Asian countries and physician awareness regarding the biosimilar segment is relatively low.
• Europe continues to be the clear and dominant leader in the biosimilars market, holding the largest market share in the globe. Among various other reasons, some of the factors may be situated here: Europe has developed a mature market as a result of its well-established regulatory framework for the approval of biosimilars. In particular, a number of European nations have certain policies that accelerate biosimilar uptake, basically helping in cost restraint and affordability within healthcare. This very singular focus on the question of affordability has been greatly helpful in ensuring the high uptake witnessed for biosimilars in the region.
• Latin America: The rise in disposable income of the middle class in some countries from this region is creating demand for more affordable options in healthcare, which can be catered to by biosimilars. Rising investments by governments in healthcare infrastructure and initiatives aimed at better access to medicines are some of the positive indications for the future. Moreover, there is a high burden of chronic diseases like diabetes and cancer in this region, which biosimilars can very effectively attend to.
• Middle East and Africa: It is coupled with the rise in disposable incomes coming with the increased middle class in the Middle East and Africa region. Demand for better healthcare is on the rise. Some governments are keenly increasing their spending on healthcare and are highly implementing very many policies to drive access to medicines. Moreover, this focus on affordability places biosimilars as a critical tool for ensuring long-term sustainability in healthcare systems. Moreover, the regional burden of these chronic diseases in the MEA is at par with that of Latin America, thus setting a very huge potential market for biosimilars used for the treatment of these diseases.

Biosimilar Market Report Scope:

Attribute	Details
Market Size 2024	USD 46.6 billion
Projected Market Size 2034	USD 65.4 billion
CAGR Growth Rate	3.8%
Base year for estimation	2023
Forecast period	2024 – 2034
Market representation	Revenue in USD Billion & CAGR from 2024 to 2034
Market Segmentation	By Product Type - Human Growth Hormone & Erythropoietin, Monoclonal Antibodies, Insulin, Emerging Players (Interferon, Colony Stimulating Factors) and Others By Application - Oncology, Blood Disorders, Growth Hormone Deficiency Diseases and Chronic & Autoimmune Diseases
Regional scope	North America - U.S., Canada Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific Latin America - Brazil, Mexico, Argentina, Rest of Latin America Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa
Report coverage	Revenue forecast, company share, competitive landscape, growth factors, and trends

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study segmented the target market report based on By Product Type, By Application and Region.

By Product Type:

• Human Growth Hormone & Erythropoietin
•  Monoclonal Antibodies
•  Insulin
•  Emerging Players (Interferon, Colony Stimulating Factors)
•  Others

By Application:

• Oncology
• Blood Disorders
•  Growth Hormone Deficiency Diseases
• Chronic & Autoimmune Diseases

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating the Biosimilar Market include Siemens, General Electric, Tesla, Sunverge Energy, Inc., ABB, Next Kraftwerke, AGL Energy, Open Access Technology International, Inc., Flexitricity Limited, Limejump Limited, Toshiba Energy Systems & Solutions, Hitachi, Ltd., Olivene, Inc., AutoGrid Systems, Inc, and Centrica.

• In March 2024, Biocon Biologics gets green light to launch Yesafili biosimilar in Canada Biocon Biologics, a subsidiary of Biocon, has officially announced the settlement with Bayer and Regeneron Pharmaceuticals. This agreement will pave the way for the launch of Yesafili, Biocon Biologics proposed biosimilar to EYLEA Injection, in Canada.
• In August 2023, CVS Health joins biosimilar fray with launch of new subsidiary The new, fully-owned subsidiary, Cordavis, shall work on developing biosimilars that will be able to help ensure a long-term, more affordable supply of medication to patients than currently available, according to CVS on 23 August in a statement. Biosimilars are copies of biologics already approved by the US Food and Drug Administration.

• Pfizer
• Teva Pharmaceuticals
• Amgen
• Biocon
• Dr. Reddy’s Laboratories
• Celltrion
• Samsung Biologics
• Biogen
• Mylan N.V