Biosimilars Market - By Product (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins), By Application (Hematology, Oncology, Autoimmune Disease, Growth Hormone Deficiency), By Manufacturer, By Technology, Global Forecast, 2023-2032

Biosimilars Market Size

Biosimilars Market size was worth more than USD 35 billion in 2022 and is poised to witness substantial growth at 13% CAGR from 2023 to 2032 driven by the high prevalence of chronic diseases globally.
 

The surging burden of higher obesity rates, poor diets, and persistent physical inactivities has compelled several healthcare systems to look for multiple methods to provide patients with affordable treatments. According to the WHO, 167 million adults and children will have greater health issues by 2025 as a result of being overweight or obese. In contrast to costly biologic medications used to treat diseases, including autoimmune disorders, cancer, and diabetes, biosimilars have emerged as more affordable alternatives. Additionally, organizations, such as the Canadian Diabetes Association recommend using biosimilar insulins before starting treatment, further adding to the business progress.
 

The high cost of pharmaceuticals, especially biologics is among the major factors restraining the market expansion. The investments needed to develop and market biosimilars is substantially more than USD 1 to $4 million. Additionally, the process of producing one biosimilar takes about 7 to 8 years, accounting for $100 million to $250 million in expenditure. Additionally, the intricacy of developing monoclonal antibodies results in substantially greater production costs than biosimilars, further slowing down the industry development.
 

COVID-19 Impact

The pandemic had mixed influence on market growth driven by the rising focus on healthcare and the thriving necessity for affordable treatment choices. The importance of diversified supply chains led to the need to produce crucial medications, including biosimilars on local basis. However, the pandemic raised concerns about difficulties, such as delays in clinical studies, global supply chain disruptions, and regulatory approval procedures. Additionally, the reallocation of healthcare resources towards COVID-19 management also impacted the market progress.
 

Biosimilars Market Trends

The major trend promoting better market accessibility and competitiveness is the rise in the number of biosimilar products receiving regulatory authority clearance. For instance, in July 2021, the U.S. FDA authorized Glenmark Pharmaceuticals' Ryaltris (olopatadine hydrochloride and mometasone furoate), a biosimilar of Dymista, for the treatment of allergic rhinitis.  Similarly, in June 2021, the European Commission authorized the sale of Aybintio (bevacizumab), a biosimilar of Avastin created by Samsung Bioepis. Additionally, the market is witnessing an increase in R&D activities as businesses engage in cutting-edge manufacturing techniques and innovative analytics for the development of biosimilars, which will support industry landscape.
 

Biosimilars Market Analysis

The recombinant non-glycosylated proteins segment, comprising human growth hormone, granulocyte stimulating factor, insulin and interferon, in the biosimilars market is expected to grow at 12.8% CAGR from 2023-2032. These biosimilar products are largely used in the treatment of growth hormone deficiencies, infections during chemotherapy, diabetes, malignant myeloma, and renal carcinoma among others. The rising focus on treating various chronic diseases, such as blood disorders and growth hormone deficiencies as well as offering comparable safety and efficacy profiles will add to the segment expansion.
 

Biosimilars market size from the hematology segment is projected to generate more than USD 52 billion by 2032. The development of monoclonal antibodies for the treatment of blood diseases has provided lucrative growth prospects for the expansion of the biosimilars industry. Healthcare professionals are looking for more reasonably priced treatment alternatives to meet the demands of patients on account of the rising frequency of hematology-related disorders. The presence of supportive regulatory frameworks along with the increasing patient and physician awareness is also driving the use of biosimilars in hematology.
 

North America biosimilars market recorded significant growth in 2022 and is expected to reach over USD 26.5 billion by 2032. Biosimilars are gaining popularity as viable replacements for expensive biologics as the preference for cost-effective healthcare solutions is increasing across the region. Additionally, the presence of supportive regulatory frameworks such as the US Biologics Price Competition and Innovation Act, have simplified the clearance process for biosimilars, promoting market access and competition. Furthermore, the patent expiration of numerous bestselling biologics has opened opportunities for new biosimilar producers to enter the market, further augmenting the market outlook.
 

Biosimilars Market Share

The competitive landscape of the biosimilars market includes:

• prominent enterprises
•  such as Dr. Reddy’s Laboratories
•  Sandoz
• Coherus Biosciences
• Viatris
• Bio-Thera Solutions
•  Pfizer
•  Apobiologix
• Amgen
• Teva Pharmaceuticals
•  Fresenius Kabi
•  Biocon Ltd
•  Biocad
•  Reliance Life Sciences
•  Intas Pharma
•  Celltrion
•  Zydus Cadila
•  Lupin Pharma, and Samsung Bioepis.
   

Biosimilars Market News

• In May 2023, Boehringer Ingelheim received U.S. FDA clearance for Cyltezo Pen, a novel autoinjector choice for Cyltezo (adalimumab-adbm), an FDA-approved interchangeable biosimilar to Humira.
   
• In June 2022, Biogen Inc. partnered with Samsung Bioepis Co., Ltd. to introduce BYOOVIZ (ranibizumab-nuna), a biosimilar of LUCENTIS (ranibizumab) in the U.S.
   

The biosimilars market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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By Product

• Recombinant Non-Glycosylated Proteins
  • Human Growth Hormone
  • Granulocyte Colony-Stimulating Factor (Filgrastim)
  • Insulin
  • Interferon
    • Alfa
    • Beta
• Recombinant Glycosylated Proteins
  • Erythropoietin
    • Alfa
    • Zeta
  • Monoclonal Antibodies
    • Infliximab
    • Rituximab
    • Adalimumab
    • Trastuzumab
    • Bevacizumab
    • Etanercept
  • Follitropin
    • Alfa
    • Beta
  • Low Molecular Weight Heparin (LMWHs)

By Application

• Hematology
  • Neutropenia
  • Anemia
  • Other hematology applications
• Oncology
  • Lung cancer
  • Brain cancer
  • Breast cancer
  • Cervical cancer
  • Colorectal cancer
  • Leukemia
    • Non-Hodgkin Lymphoma (NHL)
    • Chronic Lymphocytic Leukemia (CLL)
    • Others
  • Other cancers
• Autoimmune Disease
  • Arthritis
    • Rheumatoid arthritis
    • Psoriatic arthritis
    • Juvenile arthritis
    • Ankylosing spondylitis
    • Other arthritis
  • Inflammatory Bowel Disease (IBD)
    • Ulcerative Colitis
    • Crohn's disease
    • Other IBD
  • Psoriasis
  • Other autoimmune diseases
• Growth hormone deficiency
• Diabetes
• Other applications

By Manufacturer

• Contract research and manufacturing services
• In-house

By Technology

• Recombinant DNA Technology (rDNA technology)
• Monoclonal Antibodies (MAb) Technology

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Turkey
  • Austria
  • Belgium
  • Bulgaria
  • Czech Republic
  • Denmark
  • Finland
  • Greece
  • Hungary
  • Ireland
  • Netherlands
  • Norway
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • Switzerland
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • New Zealand
  • Singapore
  • Malaysia
  • Rest of Asia Pacific
• Latin America
• Middle East & Africa