Biosimilars Market Analysis

Global Biosimilars Market Overview

The Biosimilars Market Size was valued at USD 29.7 billion in 2023 and is projected to grow from USD 36.79 Billion in 2023 to USD 161.95 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 20.35% during the forecast period (2024 - 2032). Rising demand for biosimilars can be attributed to their cost-effectiveness and rise in prevalence of chronic diseases across the globe.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

in 2023, Sandoz expects to offer at least five additional biologic drugs, its CEO Richard Saynor said, as the generics drugs company of Switzerland's Novartis, opens new tab strives to strengthen its investor attractiveness ahead of its market debut next month. Its launch objectives coincide with the general expectation among Novartis shareholders to approve the Sandoz spin-off at Friday's extraordinary general meeting.

In an effort to increase accessibility for diabetics, biotech startup Biogenomics and pharmaceutical company USV announced in 2023 the launch of INSUQUICK, India's first biosimilar Insulin Aspart.As a "Made in India" product, InsuQuick has undergone extensive clinical testing to guarantee international quality standards. It is designed and produced entirely with technology that is native to India.

The FDA approved Amgen's biosimilar of Johnson & Johnson's autoimmune medication, Stelara, in 2023. However, don't hold your breath for the California biotech company's upcoming product release. Wezlana is probably going to be the first Stelara biosimilar to be introduced in the United States thanks to the agreement. J&J and Alvotech and Teva reached a similar settlement in June to postpone the release of their biosimilar version of Stelara, which has not yet received FDA approval.

Biosimilars Market Trends

• Growing Demand for Biosimilars to Boost Market Growth

Increase in demand for biosimilars will result in promoting business growth in the future. According to the American Journal of Managed Care (AJMC), biosimilar drugs are priced 20% to 30% lower than their reference drugs. The study conducted by the AJMC also revealed that the use of these drugs will lead to savings of USD 102.5 billion, from 2018-2025. Their lower cost of results in effective treatment of patients as well as cost-cutting of the treatment will be a major growth factor. Also, the price competition between follow-on biologics and reference drugs induces a downward effect on the prices of reference biologics, thereby augmenting the business expansion.

The 2010 Affordable Care Act (ACA) empowered the FDA to develop a specialized regulatory pathway for the approval of biosimilars, wherein the FDA also indicated that the manufacturers would require lesser costs and decreased approval times compared to the reference product manufacturers. Similarly, the European Union (EU) also developed a separate pathway for the approval of biosimilars. These regulations by the FDA and EU in turn ensured price competition amongst the manufacturers and lesser prices for the payers. The cost-effectiveness of these drugs also improves overall healthcare spending in two ways, the lower unit price of a biologic due to its competitor drug, and increased accessibility to a variety of biosimilars for the patients. Thus, the overall competitive costs of the subsequent entry biologics are projected to aid their demand over the analysis period. However, to cater the biosimilars market demand there has been significant advances to attribute to their cost-effectiveness.

The graph that follows illustrates the number of biosimilars in the development pipeline by US launchable dates. Ability to launch requires all government-granted marketing exclusivities related to the biosimilars reference product are expired upon product launch both relevant patents and regulatory-granted market exclusivities, including orphan status and 12-year data exclusivity granted to all new full biologics license applications.

Figure 1: US Biosimilars Launchable Dates by Reference Products

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Biosimilars Market Segment Insights

Biosimilars Product Insights

The market segments of biosimilars, based on product, includes recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins segment held the majority share in 2021 in respect to the biosimilars market revenue. This is primarily owing to the rising prevalence of cancer patients and high treatment adoption rate. Also, the technological advancements have led to cancer being a somewhat manageable disease in the recent times. The chemotherapy and radiotherapy prescribed to cancer patients have also led to some of the major side effects such as neutropenia or low white blood cells. For instance, according to the American Cancer Society, around 200,000 new cases of breast cancer and 60,000 new cases of leukemia were diagnosed in the US in 2022. Thus, the rising prevalence of cancer is one of the major drivers for the demand for the biosimilars industry, for treatment as well as adjunctive therapies.

July 2021:Viatris Inc. and Biocon Biologics Ltd. announced the US Food and Drug Administration (FDA) approval of Semglee injection for the treatment of diabetes. It is the first interchangeable biosimilar product under the 351(k) regulatory pathway.

December 2020: Amgen received US Food and Drug Administration (FDA) approval for its RIABNI, a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin's lymphoma, granulomatosis with polyangiitis, chronic lymphocytic leukemia, and microscopic polyangiitis.

Figure 2: Biosimilars Market, by Product, 2022 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Biosimilars Application Insights

The market segmentation of biosimilars, based on application, includes oncology, chronic diseases, autoimmune diseases, blood disorders, growth hormone deficiency, infectious diseases, and others. The oncology segment dominated the market in 2021 in respect to the biosimilars market revenue. This is due to the high incidence of cancers worldwide. According to the International Agency for Research on Cancer (IARC), the estimated number of new leukemia cases in 2021 was 1,898,160 in US. According to the same source, the disease also had significantly high mortality, with a total death toll of 23,660. Additionally, according to the same source by 2040, the burden of cancer is expected to grow to 27.5 million and 16.3 million deaths worldwide. Also, the increasing incidence of cancer cases is expected to drive the need for advanced cancer drugs for the effective treatment of patients. Hence, rising incidence of cancers for positively impacts the biosimilars market growth.

May 2022: Amneal Pharmaceuticals, Inc. received United States Food and Drug Administration (FDA) approval for a Biologics License Application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.

December 2021: Coherus BioSciences, a leading biosimilar developer, received US food and drug administration (FDA) approval for adalimumab biosimilar and Yusimry (CHS-1420) for the treatment of tumor.

Biosimilars End User Insights

The biosimilars market segmentation, based on end user, includes hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies held the largest market share in 2021 in respect to the market revenue of biosimilars. This is owing to the easy accessibility of these drugs coupled with improved treatment options for key diseases with the use of these drugs in hospital pharmacies. On the other hand, retail pharmacies held the second-largest market share in 2021. The estimated growth of this segment is attributable to the growing investment in the healthcare sector coupled with the increasing number of retail pharmacies globally.

June 2020: Pfizer Inc. received United States approval for its pegfilgrastim biosimilar, Nyvepria, indicated for lowering infection incidence. This approval has further broadened the growth opportunity for the Biosimilars industry.

February 2021: Coherus BioSciences, Inc. announced that US Food and Drug Administration (FDA) has accepted for review 351(k) Biologics License Application for CHS-1420, a Humira (adalimumab) biosimilar product candidate.

Biosimilars Regional Insights

By Region, the study segments the market into North America, Europe, Asia-Pacific and Rest of the World. North America Biosimilars held the largest market share in 2021. This is attributed to the growing incidence of chronic diseases, such as cancers, and along with the increased investment in research and development activities by the major players across the region.

Further, the major countries studied are: The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: Biosimilars Market Share by Region 2022 (%)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe biosimilars market accounts for the second-largest market share due to the rising incidence of chronic disorders, the implementation of the patent expiry of biological products, the emergence of new players, and the launch of new biosimilars. Further, the Germany market of biosimilars held the largest market share, and the UK market of biosimilars was the fastest growing market in the European region.

The Asia-Pacific biosimilars Market is expected to grow at the significant growth rate during the forecast period. This is due to growing number of pharmaceutical companies and large R&D investment in development of biosimilars. Moreover, China market of biosimilars held the largest market share, and the India market of biosimilars was the fastest growing market in the Asia-Pacific region.

For instance, India market of biosimilars is the favored destination for medical travelers due to the availability of surgeons, cutting-edge technology, & cost-effective treatments. On the other hand, Singapore is famous for the presence of well-trained doctors, state-of-the-art facilities, and quality care. As per the data cited in the Medical Tourism Index 2021-21 published by Medical Tourism Association in July 2021, Singapore is ranked at 2nd position, Japan at 3rd, India at 10th, South Korea at 14th, and China at 33rd out of the top 46 international healthcare destinations. Hence, Asia-Pacific is anticipated to register the highest growth rate over the forecast period from 2024–2032.

Biosimilars Key Market Players & Competitive Insights

Major market players are spending a lot of money on R&D to increase their product lines, which will help the market of biosimilars grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, including new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the biosimilars industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

One of the primary business strategies adopted by manufacturers in the biosimilars industry to benefit clients and expand the market of biosimilars sector is to manufacture locally to reduce operating costs. In recent years, biosimilars has provided medicine with some of the most significant benefits.

Biocon Biologics (India) is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high. With Covidien, the company has accelerated and advanced its ability to create meaningful innovations for hospitals, health systems, and healthcare providers to deliver the best care possible to patients and their families worldwide. In May 2022, Biocon Biologics, and Viatris Inc. launched Abevmy, a bevacizumab drug in Canada. This drug is a biosimilar to Avastin, that is developed by Roche and was approved by Health Canada for four oncology indications. This launch has helped the company to further broaden their oncology portfolio in Canada, thereby expanding patient access to cost-effective biologics for cancer treatment.

Key Companies in the Biosimilars Market Includes

• Pfizer (US)


• Sandoz (Germany)


• Biocon (India)


• Biogen (US)


• Fresenius Kabi AG (Germany)


• Boehringer Ingelheim (Germany)


• Merck KgaA (Germany)


• Mylan (US)


• Eli Lilly (US)


• Teva Pharmaceutical (Israel)

Biosimilars Industry Developments

November 2023: Fresenius Kabi AG (Germany) launched tyenne, a biosimilar to aciclovir, in the European Union. Tyenne provides enhanced accessibility and an affordable, better, and safer treatment option for European tocilizumab patients 

October 2023: The U.S. Food and Drug Administration (FDA) has designated Pfizer's ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). Abrilada (adalimumab or adalimumab-afzb) is used to treat many different inflammatory conditions, like arthritis, Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis. It's injected under the skin and can be used at home

September 2023: Biocon (India) expanded its global reach with the assistance of Viatris Biosimilars' North American business. This will additionally enable Biocon Biologics to offer products in cutting-edge therapeutic areas like ophthalmology, as well as more affordable and easily accessible alternatives for the treatment of cancer, diabetes, and autoimmune diseases. Additionally, we'll be able to keep expanding the pool of patients who have access to our premium biosimilars 

March 2023: The US FDA has approved Sandoz's high-concentration biosimilar Hyrimoz (adalimumab-adaz). With this approval, US patients will have access to a reduced injection volume in a citrate-free formulation of Sandoz's adalimumab HCF  biosimilar

Biosimilars Market Segmentation

Biosimilars Product Outlook

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  Recombinant Non-Glycosylated Proteins

  
  
  
  
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    Human Growth Hormone (RHGH),

    
    
  
  
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    Granulocyte Colony-Stimulating Factor (Filgrastim),

    
    
  
  
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    Insulin

    
    
  
  
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    Interferons

    
    
  
  
  
  


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  Recombinant Glycosylated Proteins

  
  
  
  
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    Erythropoietin (EPO),

    
    
  
  
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    Monoclonal Antibodies (MABS),

    
    
  
  
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    Follitropin

    
    
  
  
  
  


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  Recombinant Peptides

  
  
  
  
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    Glucagon

    
    
  
  
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    Calcitonin

    
    
  
  
  
  

Biosimilars Application Outlook

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  Oncology

  
  


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  Chronic Diseases

  
  


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  Autoimmune Diseases

  
  


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  Blood Disorders

  
  


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  Growth Hormone Deficiency

  
  


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  Infectious Diseases

  
  


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  Others

  
  

Biosimilars End User Outlook

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  Hospital Pharmacies

  
  


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  Retail Pharmacies

  
  


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  Online Pharmacies

  
  

Biosimilars Regional Outlook

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  North America

  
  

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  US

  
  


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  Canada

  
  

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  Europe

  
  

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  Germany

  
  


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  France

  
  


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  UK

  
  


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  Italy

  
  


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  Spain

  
  


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  Rest of Europe

  
  

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  Asia-Pacific

  
  
  
  
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    China

    
    
  
  
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    Japan

    
    
  
  
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    India

    
    
  
  
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    Australia

    
    
  
  
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    South Korea

    
    
  
  
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    Rest of Asia-Pacific

    
    
  
  
  
  


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  Rest of the World

  
  
  
  
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    Middle East

    
    
  
  
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    Africa

    
    
  
  
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    Latin America