Biosimilars Market Size & Share 2023 to 2032
Market Size by Product (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins), by Application (Hematology, Oncology, Autoimmune Disease, Growth Hormone Deficiency), by Manufacturer, by Technology, Global Forecast.
Report ID: GMI3328
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Published Date: July 2023
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Report Format: PDF
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Authors:
Mariam Faizullabhoy, Gauri Wani
Biosimilars Market Size
Biosimilars Market size was worth more than USD 35 billion in 2022 and is poised to witness substantial growth at 13% CAGR from 2023 to 2032 driven by the high prevalence of chronic diseases globally.
Biosimilars Market Key Takeaways
Market Size & Growth
Key Market Drivers
Challenges
The surging burden of higher obesity rates, poor diets, and persistent physical inactivities has compelled several healthcare systems to look for multiple methods to provide patients with affordable treatments. According to the WHO, 167 million adults and children will have greater health issues by 2025 as a result of being overweight or obese. In contrast to costly biologic medications used to treat diseases, including autoimmune disorders, cancer, and diabetes, biosimilars have emerged as more affordable alternatives. Additionally, organizations, such as the Canadian Diabetes Association recommend using biosimilar insulins before starting treatment, further adding to the business progress.
The high cost of pharmaceuticals, especially biologics is among the major factors restraining the market expansion. The investments needed to develop and market biosimilars is substantially more than USD 1 to $4 million. Additionally, the process of producing one biosimilar takes about 7 to 8 years, accounting for $100 million to $250 million in expenditure. Additionally, the intricacy of developing monoclonal antibodies results in substantially greater production costs than biosimilars, further slowing down the industry development.
COVID-19 Impact
The pandemic had mixed influence on market growth driven by the rising focus on healthcare and the thriving necessity for affordable treatment choices. The importance of diversified supply chains led to the need to produce crucial medications, including biosimilars on local basis. However, the pandemic raised concerns about difficulties, such as delays in clinical studies, global supply chain disruptions, and regulatory approval procedures. Additionally, the reallocation of healthcare resources towards COVID-19 management also impacted the market progress.
Biosimilars Market Trends
The major trend promoting better market accessibility and competitiveness is the rise in the number of biosimilar products receiving regulatory authority clearance. For instance, in July 2021, the U.S. FDA authorized Glenmark Pharmaceuticals' Ryaltris (olopatadine hydrochloride and mometasone furoate), a biosimilar of Dymista, for the treatment of allergic rhinitis. Similarly, in June 2021, the European Commission authorized the sale of Aybintio (bevacizumab), a biosimilar of Avastin created by Samsung Bioepis. Additionally, the market is witnessing an increase in R&D activities as businesses engage in cutting-edge manufacturing techniques and innovative analytics for the development of biosimilars, which will support industry landscape.
Biosimilars Market Analysis
The recombinant non-glycosylated proteins segment, comprising human growth hormone, granulocyte stimulating factor, insulin and interferon, in the biosimilars market is expected to grow at 12.8% CAGR from 2023-2032. These biosimilar products are largely used in the treatment of growth hormone deficiencies, infections during chemotherapy, diabetes, malignant myeloma, and renal carcinoma among others. The rising focus on treating various chronic diseases, such as blood disorders and growth hormone deficiencies as well as offering comparable safety and efficacy profiles will add to the segment expansion.
Biosimilars market size from the hematology segment is projected to generate more than USD 52 billion by 2032. The development of monoclonal antibodies for the treatment of blood diseases has provided lucrative growth prospects for the expansion of the biosimilars industry. Healthcare professionals are looking for more reasonably priced treatment alternatives to meet the demands of patients on account of the rising frequency of hematology-related disorders. The presence of supportive regulatory frameworks along with the increasing patient and physician awareness is also driving the use of biosimilars in hematology.
North America biosimilars market recorded significant growth in 2022 and is expected to reach over USD 26.5 billion by 2032. Biosimilars are gaining popularity as viable replacements for expensive biologics as the preference for cost-effective healthcare solutions is increasing across the region. Additionally, the presence of supportive regulatory frameworks such as the US Biologics Price Competition and Innovation Act, have simplified the clearance process for biosimilars, promoting market access and competition. Furthermore, the patent expiration of numerous bestselling biologics has opened opportunities for new biosimilar producers to enter the market, further augmenting the market outlook.
Biosimilars Market Share
The competitive landscape of the biosimilars market includes:
Biosimilars Market News
The biosimilars market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:
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By Product
By Application
By Manufacturer
By Technology
The above information is provided for the following regions and countries:
Research methodology, data sources & validation process
This report draws on a structured research process built around direct industry conversations, proprietary modelling, and rigorous cross-validation and not just desk research.
Our 6-step research process
1. Research design & analyst oversight
At GMI, our research methodology is built on a foundation of human expertise, rigorous validation, and complete transparency. Every insight, trend analysis, and forecast in our reports is developed by experienced analysts who understand the nuances of your market.
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2. Primary research
Primary research forms the backbone of our methodology, contributing nearly 80% to overall insights. It involves direct engagement with industry participants to ensure accuracy and depth in analysis. Our structured interview program covers regional and global markets, with inputs from C-suite executives, directors, and subject matter experts. These interactions provide strategic, operational, and technical perspectives, enabling well-rounded insights and reliable market forecasts.
3. Data mining & market analysis
Data mining is a key part of our research process, contributing nearly 20% to the overall methodology. It involves analysing market structure, identifying industry trends, and assessing macroeconomic factors through revenue share analysis of major players. Relevant data is collected from both paid and unpaid sources to build a reliable database. This information is then integrated to support primary research and market sizing, with validation from key stakeholders such as distributors, manufacturers, and associations.
4. Market sizing
Our market sizing is built on a bottom-up approach, starting with company revenue data gathered directly through primary interviews, alongside production volume figures from manufacturers and installation or deployment statistics. These inputs are then pieced together across regional markets to arrive at a global estimate that stays grounded in actual industry activity.
5. Forecast model & key assumptions
Every forecast includes explicit documentation of:
✓ Key growth drivers and their assumed impact
✓ Restraining factors and mitigation scenarios
✓ Regulatory assumptions and policy change risk
✓ Technology adoption curve parameter
✓ Macroeconomic assumptions (GDP growth, inflation, currency)
✓ Competitive dynamics and market entry/exit expectations
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Our triple-layer validation process ensures maximum data reliability:
✓ Statistical Validation
✓ Expert Validation
✓ Market Reality Check
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Verified data sources
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Regulatory filings
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Academic research
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GMI archive
13,000+ published studies across 30+ industry verticals
Trade data
Import/export volumes, HS codes, and customs records
Parameters studied & evaluated
Every data point in this report is validated through primary interviews, true bottom-up modelling, and rigorous cross-checks. Read about our research process →