Biosimilars Market Size & Share, by Product Type (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins, Recombinant Peptides); Technology (Bioassay Technology, Recombinant DNA Technology, Monoclonal Antibody Technology); Application (Hematology, Oncology, Autoimmune Diseases) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2033

  • Report ID: 1376
  • Published Date: Feb 22, 2023
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2023-2033

Biosimilars Market size is poised to cross USD 209 Billion by the end of 2033, growing at a CAGR of 23% during the forecast period, i.e., 2023-2033. In the year 2022, the industry size of biosimilars was over USD 18 Billion. The growth of the market can primarily be attributed to the growing spending on biologics worldwide. Moreover, biologics are medications generated from live organisms that are used to treat a variety of ailments, including cancer, autoimmune disorders, and inflammations. They are often more expensive than ordinary small-molecule medications and can consume a sizable percentage of healthcare spending. It was found that, in Europe, biologics represented almost 34% of medicine spending at list prices, comprising small molecules, biologics, and biosimilar competitors.

Biosimilars help increase access to healthcare for many as it is responsible for the reduction in the healthcare costs associated with the use of biologics. Since biosimilar drugs are a very similar copies of their reference biologics, they require much less research and development for equal efficacy and safety than their reference biologics. The recent approvals of biosimilar drugs are expected to reduce the spending on biologics, resulting in the demand for biosimilars among healthcare service providers, which in turn, is expected to create massive revenue generation opportunities for the key players operating in the global biosimilars market during the forecast period. It is estimated that biosimilars are expected to reduce direct spending on biologic drugs in the United States by ~USD 54 billion from 2017 to 2026, or around 3% of the total estimated biologic spending over the same period.


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Biosimilars Sector: Growth Drivers and Challenges

Growth Drivers

  • Upsurge in the Approval Rates of Biosimilars – which now many other countries are involved in, as biosimilars are safe and effective medications for treating many illnesses and chronic conditions. The surge in the approval of these drugs worldwide is expected to drive the global biosimilar market in the forecasted period. For instance, it was found that 9 new biosimilars were approved in the European Union in 2020 and ~7 were approved in 2021.
  • Growing Number of Cancer Cases – One of the biggest causes of mortality in the world is cancer, and it is predicted that there will be an increase in the number of new cancer cases. The rise in cancer incidence is driving up demand for biological medications, which are frequently used in cancer therapy. It was found that there were approximately 19 million new cancer cases registered worldwide in 2020.
  • Rising Prevalence of Crohn’s disease – The global market for biosimilars is expanding owing to the increased frequency of Crohn's disease. Inflammation of the digestive system is brought on by the inflammatory bowel disorder (IBD) known as Crohn's disease. Although the precise etiology of Crohn's disease is unknown, and it is thought to be the result of a confluence of the immune system, environmental, and genetic variables. As per the data, in North America and Western Europe, ~100 to 300 per 100,000 people suffer from Crohn’s disease every year.
  • Increasing Number of People Suffering from Kidney Disease – End-stage renal disease (ESRD), which necessitates dialysis or a kidney transplant, can develop from kidney disease. Moreover, Erythropoiesis-stimulating agents (ESAs), among other biologic medications, are frequently used to treat anemia in ESRD patients. The high cost of these medications, however, makes biosimilars a desirable substitute for both patients and healthcare professionals. It was estimated that worldwide over 850 million people were suffering from some form of kidney disease in 2021.
  • Rising Cases of Arthritis – Inflammation in the joints is a typical symptom of arthritis, which affects millions of people worldwide. An autoimmune condition called rheumatoid arthritis (RA) damages and inflames the joints, resulting in pain and incapacity. Therefore, the escalating ratio of RA is boosting the requirement of rheumatoid arthritis treatment, which in turn estimated to drive the demand for biological medications. It is observed that in 2021 about 350 million people had arthritis globally.

Challenges

  • Increasing Competition in the Market - There is intense competition in the market for both biosimilar manufacturers and originator biologic manufacturers. When new biosimilar products enter the market, the originator manufacturer may use a variety of strategies to compete with the competition, such as competitive pricing, launching second-generation products, reformulations, and improved dosing measures. Hence, such a factor is projected to impede market growth in the coming years.
  • Manufacturing Process Concerns for Biosimilar Agents
  • The difficulty of Generating an Exact Copy of Biosimilars and Biologics

Biosimilars Market: Key Insights

Base Year

2022

Forecast Year

2023-2033

CAGR

23.0%

Base Year Market Size (2022)

USD 18.0 Billion

Forecast Year Market Size (2033)

USD 209.0 Billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Biosimilars Segmentation

The global biosimilars market is segmented and analyzed for demand and supply by product type segment into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. Amongst these segments, the recombinant non-glycosylated proteins segment garnered the highest market share in the year 2022, backed by the growing concern of rising incidences of diabetes along with the surge in the spread of diabetes worldwide. Furthermore, recombinant non-glycosylated proteins are used for the treatment of the diabetes, and it is predicted to boost the growth of the segment in the market. For instance, it was estimated that ~1.5 million deaths were directly caused by diabetes worldwide, it was the 9th leading cause of death in 2019.

The global biosimilars market is also segmented and analyzed for demand and supply by application into hematology, oncology, and autoimmune diseases. Amongst these segments, the oncology segment garnered the highest market share owing to the rising number of cancer cases across the globe. Moreover, biosimilars have been created and approved to deliver efficient results in breast cancer treatment, colorectal cancer treatment, and other solid tumor treatments. Chemotherapy and other cancer therapies are combined with biosimilars to increase cancer patients' chances of survival and quality of life, and it is expected to increase the segment’s growth in the market. For instance, about 18 million people were suffering from cancer globally in 2020.

Our in-depth analysis of the global biosimilars market includes the following segments:

              By Product Type

  • Recombinant Non-Glycosylated Proteins
  • Recombinant Glycosylated Proteins
  • Recombinant Peptides

             By Technology

  • Bioassay Technology
  • Recombinant DNA Technology
  • Monoclonal Antibody Technology

              By Application

  • Hematology
  • Oncology
  • Autoimmune Diseases

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Biosimilars Industry - Regional Synopsis

Europe Market Forecast

The Europe biosimilars market, amongst the market in all the other regions, is projected to hold the largest market share by the end of 2033. The growth of the market can be attributed majorly to the presence of a strong healthcare network in the region, and the growing number of hospitals and diseases. As per the reported data, nearly 10 percent of the total population in the United States were suffering from diabetes in the year 2021. Moreover, the rising awareness of biosimilars amongst the healthcare service providers, along with the surge in prescribing biosimilars, is further anticipated to drive the growth of the market in the region. Furthermore, the volume of biosimilar prescribing has generated high savings from biosimilar competition, and it is projected to drive the market’s growth in the region.

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Companies Dominating the Biosimilars Landscape

top-features-companies
    • Biocon Limited
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Amgen Inc.
    • Novartis AG
    • Intas Pharmaceuticals Ltd.
    • BioXpress Therapeutics SA
    • Genor Biopharma Co. Ltd
    • Allergan plc (AbbVie Inc.)
    • Coherus BioSciences, Inc.
    • Pfizer Inc.
    • Reliance Life Sciences Private Limited

In the News

  • Biocon Limited - Abevmy (bBevacizumab) is now available in Canada. It is co-developed by Biocon Biologics (a subsidiary of Biocon Limited) and Viatris and is a biosimilar to Roche’s Avastin (Bevacizumab). Health Canada has approved the drug for four oncology indications.

  • Amgen Inc., - announced the approval of RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab) by the U.S. Food and Drug Administration (FDA). It is used for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA).

Author Credits:  Radhika Pawar


  • Report ID: 1376
  • Published Date: Feb 22, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Rising burden of various diseases as well as a reduction in direct spending on biologics along with increasing development and commercialization of biosimilars are some of the major factors anticipated to drive the growth of the market.

The market is anticipated to attain a CAGR of 23 % over the forecast period, i.e., 2023-2033.

Stringent regulatory policies for approval of biosimilars along with concerns about manufacturing processes of biosimilar agents are some of the factors estimated to hamper the market growth.

Stringent regulatory policies for approval of biosimilars along with concerns about manufacturing processes of biosimilar agents are some of the factors estimated to hamper the market growth.

The market in Europe garnered the highest market share in 2022 and is projected to provide more business opportunities in the future.

The company profiles are selected based on the revenues generated from the product segment, geographical presence of the company which determine the revenue generating capacity as well as the new products being launched into the market by the company.

The market is segmented by product type, technology, application, and by region.

The oncology segment garnered the highest market share and display significant growth opportunities.
Biosimilars Market Report Scope
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