This research study extensively used secondary sources, directories, and databases to identify and collect valuable information to analyze the global biosimilars market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess the growth prospects of the market. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
Secondary research was used mainly to identify and collect information for the extensive, technical, market-oriented, and commercial study of the biosimilars market. The secondary sources used for this study are the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA), World Health Organization (WHO), the National Institute for Health and Care Excellence (NICE), Health Canada, Australian Government Department of Health and Aged Care, Ministry of Food and Drug Safety (MFDS) (South Korea), the Brazilian Health Regulatory Agency (ANVISA), Health Products Regulatory Authority (HPRA), the Ministry of Health, Labour, and Welfare (Japan), the Central Drugs Standard Control Organization (CDSCO), the National Medical Products Administration (NMPA) (China), Purple Book, GaBI Generics and Biosimilars Initiative, the National Center for Biotechnology Information (NCBI), IQVIA, Academic Journals, Company Websites, Annual Reports, SEC Filings, Investor Presentations, and MarketsandMarkets Analysis. These sources also obtained key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Primary Research
Following an initial assessment of the global biosimilars market landscape through secondary research, comprehensive primary research was undertaken. This involved conducting in-depth interviews with market experts from the demand side, including stakeholders from pharmaceutical and biotechnology firms, CROs, CMOs, and academic and research institutions. Additionally, interviews were held with key supply-side participants, such as C-suite and senior executives, product managers, and marketing and sales leaders from prominent manufacturers, distributors, and channel partners. The research covered six major geographical regions: North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. Approximately 70% of the primary interviews were conducted with supply-side participants, while 30% involved demand-side experts. Data collection methods included structured questionnaires, email correspondence, online surveys, personal interviews, and telephonic discussions to understand the market dynamics comprehensively. The following is a breakdown of the primary respondents:
The following is a breakdown of the primary respondents:
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
Both bottom-up and top-down approaches were used to estimate and validate the total size of the biosimilars market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
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A list of the major global players operating in the biosimilars market was generated.
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The revenues generated from their biosimilars product have been determined through annual reports and secondary sources (including paid databases)
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The products were mapped according to the segments of the market. Percentage shares and splits were determined based on the revenue contributed to each segment. This was verified using secondary sources and by industry experts.
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All assumptions, approaches, and individual shares/revenue estimates were validated through expert interviews.
Global Biosimilars Market Size: Bottom-up and Top-down Approach
Data Triangulation
After arriving at the market size from the estimation process explained above, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Biosimilars are complex biological products that exhibit high similarity to their reference (originator) biologics, demonstrating comparable efficacy, safety, and quality. These therapeutic alternatives can be developed and brought to market once the patent protection of the original biologic elapses. Per the US FDA's definition, a biosimilar is a biological product highly similar to an already approved reference product, with no clinically significant differences in safety, purity, or potency, despite minor variations in clinically inactive components. The biosimilars market encompasses currently available products and those anticipated for launch within the forecasting horizon. This market includes a diverse array of therapeutic areas, notably oncology and inflammatory and autoimmune diseases, where biosimilars are increasingly utilized as treatment options, providing cost-effective alternatives to reference biologics while ensuring patient safety and therapeutic efficacy.
Stakeholders
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Manufacturers and distributors of biosimilar products
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Pharmaceutical and biotechnology companies
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Contract research organizations (CROs)
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Contract Development & Manufacturing Organizations (CDMOs)
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Market research and consulting firms
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R&D centers
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Academic & research institutes
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Regulatory agencies
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Health insurers and payers
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Venture capitalists
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Government organizations
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Industry associations & professional societies
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Private & government funding organizations
Report Objectives
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To define, describe, and forecast the biosimilars market based on drug class, indication, and region
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To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
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To strategically analyze micromarkets1 concerning individual growth trends, prospects, and contributions to the biosimilars market
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To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
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To forecast the size of the market segments concerning six main regions—North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa
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To profile the key players in the global biosimilars market and comprehensively analyze their product portfolios, market positions, and core competencies
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To track and analyze competitive developments such as product approvals and launches, expansions, agreements, and collaborations in the biosimilars market
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To benchmark players within the biosimilars market using the company evaluation matrix framework, which analyzes market players based on various parameters within the broad categories of business and service strategy
EUROPE COMMANDED HIGHEST MARKET SHARE IN 2024
REST OF EUROPE IS THE FASTEST-GROWING MARKET IN EUROPE
Rachel
Dec, 2022
I would like to know how much Covid-19 impacted the global revenue growth of the Biosimilars Market..
Joey
Dec, 2022
According to your study, what are some of the significant factors driving the growth of the biosimilars market?.
MnM Analyst
Sep, 2023
There are a number of investment opportunities in the biosimilars industry in Saudi Arabia. These include:
Manufacturing: There is a growing demand for biosimilars in Saudi Arabia, and there is a limited supply of these products domestically. This creates an opportunity for investors to establish biosimilar manufacturing facilities in the country.
Research and development: Biosimilars are a relatively new field, and there is still much research and development that needs to be done. Investors can support this research by investing in biosimilar companies or by funding research projects at universities or research institutes.
Marketing and distribution: Biosimilars are still a relatively new product category, and there is a need for education and marketing to raise awareness of these products among healthcare professionals and patients. Investors can support this effort by investing in biosimilar marketing and distribution companies.
In addition to these opportunities, the Saudi government is also supportive of the biosimilars industry. The government has implemented a number of policies to promote the development and use of biosimilars, including:
Waiving import duties on biosimilars: This makes biosimilars more affordable for patients and healthcare providers.
Providing financial incentives for biosimilar manufacturers: This helps to offset the high costs of developing and manufacturing biosimilars.
Working with international organizations to promote the use of biosimilars: This helps to ensure that Saudi Arabia is aligned with global standards for the use of biosimilars.
The size of the market: The Saudi Arabian market for biosimilars is expected to grow significantly in the coming years.
The regulatory environment: The Saudi government is supportive of the biosimilars industry and has implemented a number of policies to promote its development. The competition: The biosimilars industry is still relatively new, but there are a number of companies that are already active in this sector.
The technology: Biosimilars are a complex product, and investors should carefully consider the technology involved in their development..
Jamie
Sep, 2023
Where are investment opportunities in biosimilars industry in saudi arabia.