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The biosimilars market size is forecast to increase by USD 54.35 billion at a CAGR of 23.63% between 2023 and 2028. The market has witnessed significant growth in recent years, driven by the approval and increasing use of biosimilars for various therapeutic areas such as insulin, growth hormones, coagulation factors, and monoclonal antibodies by the European Medicines Agency (EMA). One of the primary growth factors is the price advantage of biosimilars over their original biologic counterparts, making them a cost-effective alternative for patients and healthcare systems in biopharma. However, market access barriers, such as regulatory and reimbursement challenges, remain a significant hurdle for biosimilars. The market is expected to grow due to the increasing acceptance and adoption of biosimilars by patients, physicians, and payers. The price differential, regulatory approval processes, and reimbursement policies are key factors influencing the market dynamics.
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The market is witnessing significant growth due to the increasing prevalence of chronic conditions such as diabetes, autoimmune diseases, and cancers. These conditions require the use of active substances derived from living cells, organisms, or microorganisms, including human, animals, bacteria, yeast, and proteins. Insulin, growth hormone, coagulation factors, monoclonal antibodies, and other active substances are commonly used to treat various chronic conditions. Biosimilars are biological medicinal products that have similar properties and efficacy as the original biological medicinal products, known as reference products. These biosimilars are developed based on the active substance's structure and function, rather than its sequence.
The European Union (EU) has established a centralized procedure for the approval of biosimilars and cancer biologics, ensuring consistent regulatory guidance and pharmaceutical quality. This procedure involves clinical experience evaluation, immunogenicity profile assessment, and comparability studies with the reference product. Biosimilars are produced using various biological sources, including human, animal, and microbial cells. The EU scientific experts provide regulatory guidance on the production process, ensuring safety, efficacy, and data exclusivity. Interchangeability of biosimilars with the reference product is also evaluated at the member states' pharmacy level. Rheumatic diseases, such as rheumatoid arthritis and psoriasis, are among the conditions for which biosimilars are increasingly being used.
The European Medicines Agency (EMA) has approved several biosimilars for these indications, providing patients with more treatment options and potentially lower costs. National health authorities and regulatory agencies play a crucial role in pharmacovigilance related to biosimilars. They monitor safety and efficacy data and provide guidance on the use of these products. Regulatory guidance on biosimilars is available in various formats, including videos, infographics, and information guides, in multiple European languages. The market is expected to continue growing, driven by the increasing prevalence of chronic conditions and the need for cost-effective treatment options. The EU's centralized procedure ensures a consistent regulatory framework, promoting the development and approval of high-quality biosimilars.
The biosimilars market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.
The monoclonal antibodies segment is estimated to witness significant growth during the forecast period. Biosimilar monoclonal antibodies (mAbs), which are large protein molecules that mimic the immune system's response to foreign substances, have gained significant attention in the healthcare industry due to their potential to increase patient access to effective treatments for various conditions, including cancers and autoimmune disorders such as rheumatoid arthritis. These complex proteins, highly similar to their originator mAbs, offer cost savings without compromising efficacy and safety. The European Commission's approval of biosimilars has paved the way for increased competition in the market, enabling healthcare professionals to offer more affordable treatment options to patients. The development of biosimilars for complex mAbs is expected to accelerate market growth, as these drugs become increasingly important for the treatment of various diseases.
The market is anticipated to expand significantly due to the increasing demand for cost-effective alternatives to reference medicines. Chief Medical Officers and healthcare professionals play a crucial role in ensuring the safety and efficacy of biosimilars. They collaborate with pharmaceutical companies to evaluate the clinical data and comparability studies of biosimilars to their reference medicines. This rigorous evaluation process ensures that biosimilars meet the same high standards as their originator counterparts, providing patients with confidence in the safety and efficacy of these treatments. In conclusion, the market in the United States offers significant potential for growth, driven by the increasing demand for cost-effective alternatives to reference medicines.
The development of biosimilars for complex mAbs is expected to accelerate market growth, providing patients with access to effective treatments for various diseases at a lower cost. The role of healthcare professionals and Chief Medical Officers in ensuring the safety and efficacy of biosimilars is crucial, as they collaborate with pharmaceutical companies to evaluate the clinical data and comparability studies of these drugs.
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The Monoclonal antibodies segment accounted for USD 2.87 billion in 2018 and showed a gradual increase during the forecast period.
Europe is estimated to contribute 45% to the growth of the global biosimilars market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
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The market is experiencing significant growth due to the approval and pipeline of these biologic alternatives by national health authorities. Regulatory guidance from the Food and Drug Administration (FDA) plays a crucial role in the market's expansion. Pharmacovigilance activities are essential to ensure patient safety and maintain the quality of biosimilars. European companies are major contributors to the market's growth with their robust biosimilar pipelines. In several European countries, including Germany and Sweden, biosimilar substitution is permitted for specific groups of biosimilars manufactured by the same pharmaceutical company.
France was among the first EU countries to pass a law allowing biosimilar substitution in treatment-naive patients or for patients already on the same biosimilar. However, the implementation of this law is still pending, and in practice, biosimilar substitution is not yet widespread.
Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
Price advantage of biosimilars over biologics is the key driver of biosimilars market growth. Biosimilars are copies of original biologic drugs that offer more affordable treatment options for patients with chronic conditions such as diabetes, autoimmune diseases, and cancers. These copies are authorized for use and are priced significantly lower than their original counterparts, with cost savings ranging from 20% to 25%.
The reduced cost of biosimilars can be attributed to fewer clinical trials required for approval, as equivalence to the original biologic is demonstrated through pharmacokinetic and pharmacodynamic studies. Additionally, biosimilars do not incur marketing costs or post-marketing research and development expenses, further contributing to their affordability. The availability of biosimilars is crucial in expanding patient access to these essential medicines and reducing overall healthcare costs.
Patients and physician's willingness to switch to biosimilars is the upcoming trend in the biosimilars market. The biosimilar market is significantly influenced by various factors, including patient attitudes and physician prescribing habits. In the realm of biosimilars, insulin, growth hormone, coagulation factors, and monoclonal antibodies are common therapeutic areas. In the US, the Food and Drug Administration (FDA) regulates the approval of biosimilars. Physicians, particularly those specializing in rheumatology, often prefer prescribing the original biologic over a biosimilar for the initial or secondary treatment of rheumatology-related diseases. This reluctance stems from concerns regarding the biosimilar's effectiveness compared to the reference product. At the pharmacy level, biosimilar substitution is permitted in some countries, primarily in Europe.
However, the number of patients and physicians transitioning to biosimilars remains low due to legislative restrictions in certain regions. Despite these challenges, the adoption of biosimilars is gradually increasing as patients and healthcare providers gain more familiarity with these cost-effective alternatives. In summary, patient perceptions and physician preferences play a crucial role in the growth of the biosimilar market. Addressing concerns around efficacy and increasing awareness of the benefits of biosimilars are essential to encourage wider adoption.
Market access barriers for biosimilars is a key challenge affecting biosimilars market growth. Biosimilars, which are biological versions of human, animal, microorganism, bacteria, and yeast-derived proteins, present significant challenges for market entry due to their intricate manufacturing processes. Maintaining product uniformity is crucial, as slight variations can occur between batches.
The production of biosimilars and biologics entails a complex process, posing a substantial barrier for new companies. Legal issues surrounding the approval process for biologics add another layer of complexity. Despite these challenges, companies with experience in manufacturing biologics will continue to dominate the market.
The biosimilars market forecasting 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 biosimilars market growth analysis report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
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.
AbbVie Inc. - The company introduces biosimilars to the market under the brand name Humira. Biosimilars are advanced biological medicines that replicate the effectiveness and safety of original biologic drugs. These medicines offer cost-effective alternatives without compromising patient care. The FDA rigorously evaluates the similarity of biosimilars to their reference biologics, ensuring they meet the same standards of quality, safety, and efficacy. By introducing biosimilars, the company aims to expand access to essential medicines, improve patient outcomes, and reduce healthcare costs.
The biosimilars market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
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.
Biosimilars have emerged as a significant alternative to original biological medicines in the treatment of various chronic conditions, including diabetes, autoimmune diseases, and cancers. These treatments are derived from active substances sourced from living cells, organisms, and microorganisms such as humans, animals, bacteria, and yeast. Insulin, growth hormone, coagulation factors, monoclonal antibodies, and proteins are common active substances used in biosimilars. The European Union (EU) and its regulatory bodies, such as the European Medicines Agency (EMA) and the European Commission, have established a centralised procedure for the approval of biosimilars. This process ensures the clinical experience, immunogenicity profile, safety, efficacy, interchangeability, and pharmaceutical quality of biosimilars are comparable to their reference medicines.
Patients and healthcare professionals, including chief medical officers, benefit from the availability of biosimilars as they offer cost savings without compromising on safety and efficacy. The EU scientific experts have developed an information guide to facilitate the understanding of biosimilars in European languages. National health authorities and regulatory guidance play a crucial role in the pharmacovigilance activities of biosimilars. Rheumatic diseases, such as arthritis, are among the conditions where biosimilars have shown significant impact. The use of biosimilars is subject to interchangeability at the pharmacy level, making them an essential addition to the healthcare system. An infographic and video resources are available to provide a visual representation of the market landscape and its regulatory framework. The EU member states continue to collaborate to ensure the continuous improvement of the market, focusing on molecular micro-heterogeneity and regulatory compliance.
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Market Scope |
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Report Coverage |
Details |
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Page number |
180 |
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Base year |
2023 |
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Historic period |
2018-2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 23.63% |
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Market growth 2024-2028 |
USD 54353.3 million |
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Market structure |
Fragmented |
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YoY growth 2023-2024(%) |
23.37 |
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Regional analysis |
Europe, North America, Asia, and Rest of World (ROW) |
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Performing market contribution |
Europe at 45% |
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Key countries |
Germany, US, UK, China, and Republic of Korea |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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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. |
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Market dynamics |
Parent market analysis, market growth inducers and obstacles, market forecast, fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the forecast period |
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Customization purview |
If our biosimilars market forecast report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
We can help! Our analysts can customize this biosimilars market research report to meet your requirements. Get in touch
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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