Feb 27, 2023

English - UK

Pramod Pawar

Biosimilars Market to Cross USD 34.4 Bn in 2032 | 14.1% CAGR

Biosimilars are biological drugs which are identical to the original product in terms of quality and safety as well as efficacy. These drugs are created after the original biologic product's patent expires. Due to rising chronic disease prevalence and increasing demand for cost-effective treatment options, the global market for biosimilars is expected to expand at a rapid pace.

The global biosimilars market size is expected to be worth around USD 34.4 billion by 2032 from USD 9.5 billion in 2022, growing at a CAGR of 14.1% during the forecast period from 2022 to 2032.

A biosimilar is a biologic medical product that is very similar to an approved biologic. These biosimilars can be approved on the basis of their efficacy and safety. They also meet all standards for pharmaceutical quality applicable to biologic medicines.

Biosimilars are generic versions or derivatives of biologics that have not yet reached their patent expiration date. Biosimilars will be driven by the expiration of patents on well-known biologics. The sales and approval of biosimilars have led to a decline in the sales of biologics which had been in steady or increasing demand.

Globally, the burden of chronic diseases is increasing. The increasing prevalence of chronic diseases is mainly due to an aging population and a changing lifestyle. Some of the most common chronic diseases include diabetes, stroke, hypertension and obesity. Biosimilar monoclonal antibody biosimilars are widely used to treat rheumatoid and cancer.

Key Takeaways

  • Biosimilars are biological products that have a high degree of similarity to an approved biological product. They are also called a reference product.
  • Global biosimilars demand is expected to rise significantly over the next few years due to increasing demand for cost-effective treatment options, expiry of patents on biologic drugs and favorable government regulations.
  • Oncology, which is the most important therapeutic application segment, is followed closely by immunology, endocrinology, and immunology.
  • Biosimilars can be cost-savings but they face many challenges. These include high development costs and complex manufacturing processes as well as safety and efficacy concerns.
  • These challenges are expected to be overcome as the market for biosimilars matures, which will lead to increased acceptance and adoption of these products both by patients and healthcare providers.

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Regional Snapshot

The market for biosimilars is divided into North America and Europe, Asia Pacific and Latin America. North America is the dominant market because of its well-established healthcare system and favorable regulatory framework. It also has a high demand for affordable treatments. Europe is the second largest market, due to rising healthcare costs, increasing chronic disease prevalence, and presence of large players in the region. Due to rising demand for biosimilars, and increasing emphasis on the development of healthcare infrastructure, the Asia Pacific region will experience significant growth over the next few years.

Drivers

  • There is a growing demand for affordable treatments
  • Blockbuster biologics expire
  • Increasing prevalence of chronic diseases
  • Favorable regulatory framework
  • Rising healthcare expenditure
  • Healthcare infrastructure development is gaining more attention

Biological drugs are the result of cutting-edge research. These discoveries could open the door to new treatments that offer more options for patients. The development of personalized treatments has been possible thanks to better understanding the genetic and molecular bases of disease.

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Restraints

  • Biosimilar development is complex and takes a lot of time
  • Research and development require high capital requirements
  • Stringent regulatory requirements

It takes a lot of expertise to develop a biosimilar medicine. This is because it must be "highly similar" (or close to) to the reference biologic without clinically significant differences in safety, efficacy or potency. This requires extensive identification and comparison of the structural and functional characteristics of the biosimilar using the most current technology. Comparative structural and functional characterizations will make the most contribution to clinical predictability for a biosimilar. Biosimilar development is a complex and expensive process. It requires substantial investments, technical expertise, clinical trial expertise and scientific standards. Quality systems are also required. The manufacturing of biosimilars requires the ability to control variability in the manufacturing process so that the end products can be identical to biological products.

Opportunities

  • Biosimilars are in high demand in emerging countries.
  • Biosimilars are being increasingly used in the treatment and prevention of cancer and other chronic diseases.
  • Biosimilars are being developed for new indications
  • Research and development activities are being given more attention

Challenges

  • Intellectual property issues
  • Patients and healthcare professionals are not aware of biosimilars.
  • Stringent regulatory requirements

Recent Developments

  • The first interchangeable biosimilar was approved by the FDA in 2021 for treatment of stomach and breast cancer.
  • The European Commission approved a biosimilar in 2021 for treatment of several inflammatory conditions.
  • Biocon Biologics was granted regulatory approval in 2021 for its European biosimilar insulin product.
  • Alvotech and Stada have announced a partnership in 2021 to market biosimilars in Europe.

Biogen and Samsung Bioepis announced in September 2021 that BYOOVIZ (ranibizumab–nuna) was approved by the Food and Drug Administration (FDA). This biosimilar to LUCENTIS is used for the treatment of neovascular choroidal nevascularization, macular edema after retinal vein occlusion and neovascular age related macular degeneration. BYOOVIZ was approved as the first biosimilar in ophthalmology in the United States.

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Market Segmentation

By Product Type

  • Monoclonal Antibodies
  • Recombinant Hormones
  • Immunomodulators
  • Anti-inflammatory Agents

By Application

  • Blood Disorders
  • Growth Hormonal Deficiency
  • Chronic and Autoimmune Disorders
  • Oncology

Market Key Players

  • Novartis
  • Amgen Inc.
  • Pfizer Inc.
  • Viatris Inc.
  • Eli Lilly
  • Synthon Pharmaceuticals Inc.
  • Teva Pharmaceutical Industries Ltd.
  • LG Life Sciences
  • Celltrion
  • Biocon Biologics Ltd.
  • Coherus Biosciences, Inc.
  • Bio-Thera Solutions
  • Intas Pharmaceuticals Ltd.
  • Hoffmann-La Roche Ltd.
  • Samsung Bioepis Co.
  • Hospira
  • Merck Serono
  • Biogen Idec Inc.
  • Genentech

Report Scope

Report AttributeDetails
The market size value in 2022USD 9.5 Bn
Revenue forecast by 2032USD 34.4 Bn
Growth RateCAGR Of  14.1%
Regions CoveredNorth America, Europe, Asia Pacific, Latin America, and Middle East & Africa, and Rest of the World
Historical Years2017-2022
Base Year2022
Estimated Year2023
Short-Term Projection Year2028
Long-Term Projected Year2032

FAQ

Q: What is biosimilarity?

A: Biosimilars are biological drugs with characteristics that are similar to the original product, such as safety or efficacy. They are created following the expiration of or cancellation of the patent on the original biological product.

Q: What are the major drivers of the biosimilars market?

A: The key drivers of the biosimilars market are the growing demand for cost-effective treatment options, the demise of blockbuster biologics, and the rising incidence of chronic disease.

Q: Which region has the largest market for biosimilars products?

A: North America is the leader in biosimilars

Q: What is the growth rate for the biosimilars market in the United States?

A: The market for biosimilars is forecast to grow at 14.1% over the 2022-2032 period.

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Author

Prudour Private Limited



Email:

Pramod@market.biz

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