This research study involved the extensive use of secondary sources, directories, and databases to identify and collect valuable information for the analysis of the global biologics safety testing 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 biologics safety testing market. The secondary sources used for this study include US Food and Drug Administration (FDA), World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), National Center for Biotechnology Information (NCBI), Organisation for Economic Co-operation and Development (OECD), National Institutes of Health (NIH), American Society for Microbiology (ASM), and Biotechnology and Biological Sciences Research Council (BBSRC), Statista; corporate filings such as annual reports, SEC filings, investor presentations, and financial statements; press releases; trade, business, professional associations and among others. These sources were also used to obtain key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global biologics safety testing market scenario through secondary research. Several primary interviews were conducted with market experts from the demand side, such as pharmaceutical and biotechology companies, CROs and CMOs, academic and research institutes, and experts from the supply side, such as C-level and D-level executives, product managers, marketing & sales managers of key manufacturers, distributors, and channel partners. These interviews were conducted across six major regions, including the Asia Pacific, North America, Europe, Latin America, Middle East, and Africa. Approximately 60% and 40% of the primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
The following is a breakdown of the primary respondents:
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Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the biologics safety testing 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:
Bottom-up Approach
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The key players in the industry and market have been identified through extensive secondary research
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The revenues generated from the biologics safety testing business of leading players have been determined through primary and secondary research
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All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources
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Top-down Approach
After arriving at the overall market size from the market size estimation process, the total market was split into several segments and subsegments.
Data Triangulation
After arriving at the market size from the market size 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
A biologic drug (biologics) is a product produced from living organisms or contains components of living organisms. Biologics safety testing is carried out by manufacturers to detect contaminants like bacterial toxins, mycoplasma, and viruses. The biologics safety testing market includes instruments, kits, reagents, and services used to identify or quantify contaminants in biologics. Biologics testing is a critical process during development and production, as these large molecules are sensitive to and altered by changes in the manufacturing process, and therefore, quality, safety, and efficacy must be continually monitored in order to meet strict regulatory requirements.
Stakeholders
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Biologics Safety Testing Product Manufacturers, Vendors, and Distributors
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Biologics Safety Testing Service Providers
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Academic and Research Institutes
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Pharmaceutical and Biotechnology Companies
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Venture Capitalists and Investors
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Government Organizations
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Private Research Firms
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Contract Research Organizations (CROs)
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Contract Development and Manufacturing Organizations (CDMOs)
Report Objectives
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To define, describe, and forecast the global biologics safety testing market based on the product & service, test type, application, end user, and region
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To provide detailed information regarding the major factors influencing the growth of the market (such as drivers, restraints, opportunities and challenges)
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To strategically analyze micro-markets with respect to individual growth trends, future prospects, and contributions to the overall biologics safety testing market
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To analyze 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 with respect to six main regions, namely, North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
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To strategically profile the key players and comprehensively analyze their product and service portfolios, market positions, and core competencies
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To track and analyze competitive developments such as acquisitions, product launches, expansions, and R&D activities in the biologics safety testing market.
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report:
Portfolio Assessment
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Product Matrix, which gives a detailed comparison of the product portfolios of the top five companies.
Company Information
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Detailed analysis and profiling of additional market players (up to five).
Geographical Analysis
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A further breakdown of the Rest of Asia Pacific biologics safety testing market into countries
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A further breakdown of the Rest of Europe biologics safety testing market into countries
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A further breakdown of the Rest of Latin American biologics safety testing market into countries
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A further breakdown of the Rest of Middle East biologics safety testing market into countries
Biocompatibility
Nov, 2020
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