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The biosimilar market size is estimated to grow by USD 54.35 billion at a CAGR of 23.63% between 2023 and 2028. The expansion of the biosimilar market hinges on various elements, notably the cost-benefit biosimilars offer compared to biologics, the expiration of patents for key biologics, and governmental efforts aimed at promoting the utilization of biosimilar medications, including oncology biosimilars. For the past two decades, biologics have played major roles in cancer treatment along with oncology drugs and account for a significant share of the total market. These factors collectively shape the trajectory of biosimilar adoption and market growth. The comparative affordability of biosimilars, coupled with the availability of previously patented biologics in generic form, drives market dynamics. Additionally, initiatives by governments to encourage the uptake of biosimilars through policy measures and regulatory frameworks play a pivotal role in fostering market expansion. In essence, the interplay of pricing, patent landscapes, and supportive policies delineates the landscape for biosimilar market advancement.
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Based on application, the Monoclonal Antibodies sub-segment is forecasted to have the largest market share. Since oncological and hematological disorders are prevalent, therefore, patients look for less expensive options. They are the ideal option when it comes to a reduction in costs. For the past two decades, biologics have played major roles in cancer treatment and account for a significant share of the total market. The first biosimilar agents, erythropoiesis-stimulating agents, which are used as oncology support, were approved in the EU in 2007. MVASI was the first biosimilar to be approved by the US FDA for the treatment of cancer in September 2017.
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The Monoclonal Antibodies segment was valued at USD 2.87 billion. The first biosimilar agents, erythropoiesis-stimulating agents, which are used as oncology support, were approved in the EU in 2007. MVASI was the first biosimilar to be approved by the US FDA for the treatment of cancer in September 2017.
Endocrinology and immunology hold the second largest share based on application analysis. The use of these in the treatment of immunological conditions is increasing rapidly. The market for the immunology therapy area was valued at USD 2.93 billion in 2020 and is expected to reach USD 9.31 billion by 2025. The expected increase in the market size could be attributed to the possible entry of these following the expiry of patents for presently available biologics for the treatment of autoimmune and rheumatic disorders during the forecast period.AbbVie
Based on product type, the market is segmented into monoclonal antibodies, insulin, human growth hormone, and others. The market share growth by the monoclonal antibodies segment (mAbs) will be significant during the forecast period. Biosimilar mAbs represent an opportunity to increase access to mAbs the patients due to their lower costs. These are key drugs indicated for the treatment of various cancers and autoimmune disorders such as rheumatoid arthritis. The rapid development of complex mAbs is expected to accelerate market growth during the forecast period. The primary factors for this growth include the patent expiry of blockbuster mAbs, coupled with the approval of biosimilar mAbs, and the increasing prevalence of chronic diseases.
Biosimilar monoclonal antibodies (mAbs) are large, complex proteins used by the immune system to identify and neutralize foreign bodies such as bacteria and viruses. They are used for the treatment of cancers such as breast cancer and non-cancer diseases such as rheumatoid arthritis. They are also highly similar to the originator mAbs and cost-effective. Several companies are developing biosimilar mAbs as they are cost-effective treatments. For instance, the European Union and the US FDA recently approved five trastuzumab biosimilars. Such an increasing number of biosimilar mAbs gaining approval will drive the market growth during the forecast period.
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Europe is estimated to contribute 45% to the growth of the global market during the forecast period. Technavioâs analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. The growth momentum in Europe is accelerating and is expected to increase to x% by 2025. Europe approved sixteen biosimilars of seven different biologic products in 2020, thus expanding the biosimilar market into new therapeutic areas and newer classes of biologics for which no biosimilars have been previously approved in the EU.
In many EU countries, including Germany and Sweden, biosimilar substitution is allowed for specific groups of biosimilars manufactured by the same pharmaceutical company. France is among the first EU countries to establish a law for biosimilar substitution in treatment-naive patients or to continue a treatment already initiated with the same biosimilar. However, the implementation decree of the law is still pending, and in practice, biosimilar substitution is not yet implemented. In countries like Poland, the automatic substitution of these may be possible since there is no law or guidance in place.
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
Novartis- The company offers biosimilars for the genetic industry.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market is a significant sector in the healthcare industry, focusing on the development, production, and commercialization of biosimilars. Biosimilars are biological products that are highly similar to original biologic medicines, derived from living cells, organisms, or microorganisms, including bacteria, yeast, human, animal, and plant cells. These products are used for chronic conditions such as diabetes, autoimmune diseases, and cancers, and include active substances like insulin, growth hormone, coagulation factors, monoclonal antibodies, and proteins. The European Union (EU) plays a crucial role in the biosimilars market through its Centralised Procedure, which ensures the clinical experience, immunogenicity profile, safety, efficacy, and interchangeability of these products. The EU scientific experts and national health authorities provide regulatory guidance and pharmacovigilance activities to ensure the pharmaceutical quality and data exclusivity of biosimilars. The market is expected to grow, driven by the increasing prevalence of chronic diseases and the need for cost-effective alternatives to original biologics. The EU's regulatory framework provides an information guide for member states to facilitate the use of biosimilars at the pharmacy level. Rheumatic diseases, infographic, and video resources are also available to help understand the role of biosimilars in healthcare. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges.
The price advantage of biosimilars over biologics is a major driver. The high cost of biologics limits patient access and increases healthcare expenses. Biosimilars, which are authorized copies of biologics, are priced 20%-25% lower than the original products. This cost reduction is due to fewer clinical trials required for biosimilars compared to the original biologics. Clinical trials typically use the original biologic as a comparator to establish equivalence. Additionally, they have no marketing or post-marketing research and development costs.
Advancements in genetic engineering and lower scale-up costs for producing recombinant proteins have made manufacturing biosimilars more cost-effective. Further cost reduction is possible by streamlining the approval process and reducing unnecessary repetition of clinical trials through guideline modifications by organizations like EMA and the US FDA. The Biologics Price Competition and Innovation Act aims to promote biosimilars while still providing incentives for the development of original biologics.
Patients' and physicians' willingness to switch to biosimilars is a major market trend. The global biosimilar market is influenced by patient attitudes toward switching and physician prescribing practices. Many physicians, especially rheumatologists, prefer prescribing bio-originators as first-line or second-line therapy for rheumatology-related diseases. The main barrier to physician acceptance is the perception that biosimilars are less effective than reference products. Limited substitution of biosimilars with bio-originators is permitted in certain countries, primarily in Central and Eastern Europe, at the community pharmacy level.
However, legislation in some regions hinders the widespread adoption of biosimilars. Another challenge arises from the existence of multiple biosimilars approved for a single reference product, with no guidelines available for comparing these biosimilars with each other.
Market access barriers for biosimilars are a major market challenge hindering the growth of the market. They face several challenges in their market entry and competition with biologics. One major challenge is the complex manufacturing process, which requires strict maintenance of product uniformity and can lead to variations between batches. This manufacturing complexity poses a significant hurdle for new companies entering the market, while established biologics manufacturers continue to dominate.
Legal issues related to the approval process for biologics are another challenge. The clinical trial process for a single biosimilar can be time-consuming, hindering timely approvals. Unlike generic drugs, substitution and interchangeability of biosimilars are not as feasible. Safety concerns, pricing considerations, and the acceptance of biosimilars by physicians and patients also present potential barriers to market entry.
The biosimilars market report includes the adoption lifecycle of the market, covering from the innovatorâs stage to the laggardâs stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the biosimilars market growth analysis report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Global Market Customer Landscape
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments.
Autoimmune Diseases, and Cancers Biosimilars, a type of biological therapy, have emerged as a significant alternative to original biologics in the treatment of various chronic conditions such as Diabetes, Autoimmune diseases, and Cancers. These therapeutic agents are derived from living cells, organisms, or microorganisms, including bacteria, yeast, proteins, and human, animal, or microbial sources. Active substances like Insulin, Growth hormone, Coagulation factors, Monoclonal antibodies, and their biosimilar counterparts play a crucial role in managing chronic conditions. The European Union (EU) has been at the forefront of biosimilars development and regulation through the European Medicines Agency (EMA) and the European Commission. Patients and healthcare professionals, including Chief Medical Officers, are increasingly embracing biosimilars due to their potential cost savings. However, the approval process involves addressing molecular micro-heterogeneity, clinical experience, immunogenicity profile, and ensuring pharmaceutical quality, safety, and efficacy. The EU scientific experts have established a centralised procedure for biosimilars, which includes rigorous evaluation of the interchangeability of these medicinal products. The EU Information Guide on Biosimilars provides valuable resources for Member States to facilitate the implementation of biosimilars in their healthcare systems. In conclusion, the EU's commitment to the development and regulation of biosimilars in the treatment of chronic conditions like Diabetes, Autoimmune diseases, and Cancers is crucial. By addressing the unique challenges associated with these complex therapeutic agents, the EU is paving the way for improved patient access to cost-effective, safe, and efficacious treatments.
Industry Scope |
|
Report Coverage |
Details |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 23.63% |
Market growth 2024-2028 |
USD 54.35 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
23.37 |
Regional analysis |
Europe, North America, Asia, and Rest of World (ROW) |
Performing market contribution |
Europe at 45% |
Key countries |
Germany, US, UK, China, and Republic of Korea |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
AbbVie Inc., Amgen Inc., Biocon Ltd., Biogen Inc., Boehringer Ingelheim International GmbH, Celltrion Healthcare Co. Ltd., Dr Reddys Laboratories Ltd., F. Hoffmann La Roche Ltd., Fresenius SE and Co. KGaA, Gedeon Richter Plc, Halozyme Therapeutics Inc., Intas Pharmaceuticals Ltd., Mabion S.A., Novartis AG, Pfizer Inc., Samsung Biologics Co. Ltd., Sanofi SA, Teva Pharmaceutical Industries Ltd., and Viatris Inc. |
Market dynamics |
Parent market analysis, market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for market forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Product Type
7 Market Segmentation by Application
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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