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The Biosimilars Market size is estimated to grow by USD 42.23 billion between 2022 and 2027 accelerating at a CAGR of 23% during the forecast period.
This market report extensively covers market segmentation by product type (monoclonal antibodies, insulin, human growth hormone, and others), application (oncology and hematology, endocrinology, immunology, and nephrology), and geography (Europe, North America, Asia, and Rest of World (ROW)). It also includes an in-depth analysis of drivers, trends, and challenges.
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Based on application, the oncology, and hematology sub-segment is forecasted to have the largest market share. Since oncological and hematological disorders are prevalent, therefore, patients look for less expensive options. For the past two decades, biologics are playing major roles in cancer treatment and account for a significant share of the total market. Biosimilars are the ideal option when it comes to a reduction in costs. For the past two decades, biologics are playing 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 oncology and hematology segment was valued at USD 5.01 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, immunology holds the second largest share based on application analysis. The use of biosimilars in the treatment of immunological conditions is increasing rapidly. The global biosimilars market for the immunology therapy area was valued at USD 2.93 billion in 2020 and is expected to reach USD9.31 billion by 2025. The expected increase in the market size could be attributed to the possible entry of biosimilars 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 biosimilars for 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 vendors 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 46% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers 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 country 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 biosimilars may be possible since there is no law or guidance at place.
The COVID-19 pandemic had a negative impact on the demand for biosimilars due to reduced focus on cancer and delays in cancer treatment procedures. However, key vendors are engaging in collaborations and mergers to adapt to the pandemic situation. Additionally, government initiatives, like the NIH's ACTIV partnership, are expected to support market growth by prioritizing and accelerating the development of effective treatments and vaccines for COVID-19.
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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 genetical 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.
There are multiple factors influencing market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges.
The price advantage of biosimilars over biologics is a major biosimilars 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, biosimilars 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 aim to promote biosimilars while still providing incentives for the development of original biologics.
Patients' and physicians' willingness to switch to biosimilars is a major biosimilars 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 biosimilars market challenge hindering the growth of the market. Biosimilars 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.
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The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Global Biosimilars Market Customer Landscape
The biosimilars market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027.
Biosimilars Market Scope |
|
Report Coverage |
Details |
Page number |
172 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 23% |
Market growth 2023-2027 |
USD 42.23 billion |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
22.9 |
Regional analysis |
Europe, North America, Asia, and Rest of World (ROW) |
Performing market contribution |
Europe at 46% |
Key countries |
US, Germany, 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 growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for 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 Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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