Medical Device Testing Services Market Size, Share & Trends Report

Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), By Phase, By Region, And Segment Forecasts, 2024 - 2030

  • Report ID: GVR-2-68038-115-3
  • Number of Report Pages: 137
  • Format: PDF, Horizon Databook
  • Historical Range: 2018 - 2023
  • Forecast Period: 2023 - 2030
  • Industry: Healthcare

Research Methodology

A three-pronged approach was followed for deducing the medical device testing services market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for medical device testing services market to gather the most reliable and current information possible.

  • We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
  • We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
  • We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
  • We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
  • We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of medical device testing services market data depending on the type of information we’re trying to uncover in our research.

  • Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

  • Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

  • Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

  • Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

  • Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

  • Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

  • This step also entails the finalization of the report scope and data representation pattern.

  • Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Medical Device Testing Services Market Categorization:

The medical device testing services market was categorized into three segments, namely service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), phase (Preclinical, Clinical), and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

Segment Market Methodology:

The medical device testing services market was segmented into service, phase, and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

  • Demand estimation of each product across countries/regions summed up to from the total market.

  • Variable analysis for demand forecast.

  • Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

  • Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

  • Used extensively for new product forecasting or analyzing penetration levels.

  • Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

  • Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

  • This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The medical device testing services market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into thirty-five countries, namely, the U.S.; Canada; the UK; Germany; France; Italy; Spain; Netherlands; Belgium; Switzerland; Russia; Sweden; Denmark; Norway; Japan; China; India; Australia; South Korea; Malaysia; Indonesia; Singapore; Philippines; Thailand; Brazil; Mexico; Argentina; Colombia; Chile; South Africa; Saudi Arabia; UAE; Israel; Egypt; Kuwait.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Medical device testing services market companies & financials:

The medical device testing services market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

  • SGS SA (SGS Société Générale de Surveillance SA) - SGS SA (SGS) provides clinical research, quality assurance, inspection, testing, and certification services worldwide. It operates through nine reportable segments: agriculture, food & life, minerals, oil, gas & chemicals, consumer retail, certification & business enhancement, industrial, environment, health & safety, transportation, and governments & institutions. Under clinical research services, it offers clinical development consultancy, pharmacovigilance & drug safety services, and early-phase clinical services (patent & clinical trials and bioequivalence & bioavailability studies). It also provides verification & certification services to enable its customer’s products to be in line with international standards, outsourcing, consulting, and data analytic services. Moreover, SGS caters to its services through a network of 2,600 offices and laboratories.

  • Laboratory Corporation of America Holdings - It is a global life sciences company. Through its Labcorp Drug Development (DD) and Labcorp Diagnostics (Dx) segments, the company provides drug development, diagnostic, & technology-enabled solutions for over 160 million patient encounters annually. Its key services include analysis, research models, lead optimization, pharmaceutical consulting, clinical testing & development, and commercialization. With over 80,000 employees, the company offers its products in over 100 countries. In addition, the company supports clinical trial activity with its preclinical & clinical development and central laboratory businesses.

  • Nelson Laboratories, LLC - Sterigenics International LLC is a contract sterilization services company. The company has a global network of 46 facilities. Its three operating companies are Nelson Labs, Nordion, and Sterigenics. In addition, it has multiple certifications, such as ISO 13485:2003 & EN ISO 13485:2012 and ISO 9001:2008, and Eudralex Good Manufacturing Practice (GMP) regulatory certificate. In 2016, the company acquired Nelson Laboratories, a laboratory testing and consulting services company.

  • TÜV SÜD - TUV SUD A.G. is a technical service organization present in 850 locations across the globe. The company has an extensive network of accredited laboratories, offices, and multidisciplinary experts. It operates through four segments: industry, certification, mobility, and others. The services offered by the company are auditing & system certification, inspection, global market access, knowledge services, product certification, testing, and training.

  • Charles River Laboratories - Charles River Laboratories is a global provider of products and services to support the drug discovery, development, & safety testing processes for pharmaceutical, biotechnology, & other life sciences companies. It operates through three segments: discovery & safety assessment, research models & services, and manufacturing support. The company serves customers in over 100 countries and has facilities in North America, Europe, and Asia Pacific.

  • Element Minnetonka - Element Minnetonka, formerly Medical Devices Testing Services, offers various analytical testing services for medical device companies. The services include consulting, mechanical testing, characterization, inspection, compliance with standards, and maintenance of instruments & fixtures. The company’s tests are compliant with regulatory bodies, such as the U.S. FDA and Conformité Européenne (CE), and it also has certifications from the International Standardization Organization (ISO) and the American Society for Testing & Materials (ASTM). In 2017, the company was acquired by Element Materials Technology.

  • North America Science Associates LLC (NAMSA) - North American Science Associates, LCC (NAMSA) is the provider of regulatory consulting, laboratory testing, and compliance services. The company offers various services, such as medical device testing, regulatory, reimbursement & quality consulting, and clinical research services. It also provides sterilization products, such as biological & chemical indicators, and test suspensions. In addition, it offers NAMSA Test Navigator, an online test selection tool. It also caters its services through network of distributors & sales representatives in the U.S. and across the globe.

  • Eurofins Scientific - Eurofins Scientific SE (Eurofins) is a provider of preclinical services across the globe. It has a portfolio of 150,000 analytical methods for evaluating the composition, authenticity, and purity of biological substances. It also provides AgroTesting, consumer product testing, environment testing, medical device testing, and chemical registration & authorization services. Eurofins caters its portfolio of services to pharmaceutical, consumer products, food, and the environment with a network of 375 laboratories in 44 countries.

  • Pace Analytical Services, LLC - It offers chemistry services, such as method development, validation, verification, and method transfer services, including raw material testing, extractable & leachable testing, quality testing, residual solvents testing, environment monitoring, impurities testing, and microbiology laboratory testing. It also provides other services, such as scientific staffing, instrument sales & services, and consulting.

  • Intertek Group Plc - Intertek Group plc (IGP) provides quality and safety solutions. The company operates through three reportable segments: product, trade, and resources. Its product segment’s key offerings include biopharmaceutical services, protein structure analysis, impurity testing, inspection & certification services, laboratory testing, quality & performance testing, and sustainability analysis. Its trade and resources segment offers technical services, analytical testing services, calibration, and asset integrity services. IGP caters to life sciences, food, pharmaceuticals, and healthcare industries. It has a presence in 1,000 locations in over 100 countries.

Value chain-based sizing & forecasting

Supply Side Estimates

  • Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

  • Segment revenue determination via variable analysis and penetration modeling.

  • Competitive benchmarking to identify market leaders and their collective revenue shares.

  • Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

  • Identifying parent markets and ancillary markets

  • Segment penetration analysis to obtain pertinent

  • revenue/volume

  • Heuristic forecasting with the help of subject matter experts

  • Forecasting via variable analysis

Medical Device Testing Services Market Report Objectives:

  • Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

  • Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

  • Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Medical Device Testing Services Market Report Assumptions:

  • The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

  • The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

  • We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

  • All market estimates and forecasts have been validated through primary interviews with the key industry participants.

  • Inflation has not been accounted for to estimate and forecast the market.

  • Numbers may not add up due to rounding off.

  • Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

  • Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

  • Latin America includes Central American countries and the South American continent

  • Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

  • Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

  • Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.

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