Medical Device Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Service (Sterility Testing, Physical Testing), By Therapeutic Areas, By Device Type, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Research Methodology

A three-pronged approach was followed for deducing the medical device analytical testing outsourcing 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 analytical testing outsourcing 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 analytical testing outsourcing 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 Analytical Testing Outsourcing Market Categorization:

The medical device analytical testing outsourcing market was categorized into five segments, namely service (Extractable & Leachable, Material Characterization, Physical Testing, Bioburden Testing, Sterility Testing), device type (Reprocessed Devices), therapeutic areas (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General & Plastic Surgery, Drug Delivery, Endoscopy, Dental, Diabetes Care), end-use (Hospital), and regions (North America, Europe, Asia Pacific, Latin America, Middle East & Africa).

Segment Market Methodology:

The medical device analytical testing outsourcing market was segmented into service, device type, therapeutic areas, end-use, 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 analytical testing outsourcing market was analyzed at a regional level. The global 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 twenty-three countries, namely, the U.S.; Canada; the UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Australia; Thailand; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; 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 analytical testing outsourcing market companies & financials:

The medical device analytical testing outsourcing 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 SA is a worldwide entity that offers services in quality assurance, inspection, testing, and certification. The firm's operations are divided into nine notable segments: agriculture; food & life; minerals, oil, gas, & chemicals; consumer retail; certification & business enhancement; industrial & environmental; health & safety; transportation; and governments & institutions. It provides inspection & product testing services aimed at minimizing risk exposure and ensuring quantity & quality control. Additionally, it offers verification & certification services, along with outsourcing, consulting, & data analytic services, to help its customers' products comply with international standards. The company delivers its services via a network of 2,600 laboratories and offices.

• TOXIKON, CORP. - Toxikon Corp. (TC) is an organization that specializes in preclinical contract research. It provides bioanalytical & product development services catered to the medical devices, biotechnology, and pharmaceutical sectors. The firm's primary services encompass safety & medical device contract manufacturing services. Additionally, it offers services such as chemical characterization, impurity analysis, toxicokinetics, bioavailability, toxicology, Absorption, Distribution, Metabolism, Excretion (ADME), pharmacokinetics, and bioanalytical services. As part of its medical device contract manufacturing services, it provides drug & device discovery research services, biocompatibility studies, and custom services. The company caters to the pharmaceutical sector through various verticals: in vivo, in vitro, analytical, and additional services, like drug-drug interactions. Furthermore, the company has established offices in Belgium, Japan, India and Germany.

• EUROFINS SCIENTIFIC - Eurofins Scientific (Eurofins) is a global provider of analytical testing services. The company's service offerings encompass over 200,000 analytical methods for assessing the composition, purity, and authenticity of biological substances. In addition, it offers services such as agro-testing, consumer product testing, environment testing, medical device testing, and chemical registration & authorization services. Eurofins extends its analytical testing services to industries such as pharmaceuticals, consumer products, food, and the environment. The company operates more than 800 laboratories across more than 47 countries globally. It has a significant presence in regions like North America, Europe, and the Asia Pacific.

• PACE ANALYTICAL SERVICES, LLC - Operating under the umbrella of LAB Holdings, Inc., Pace Analytical Services, LLC is a company that specializes in sampling and analytical testing services. Their offerings encompass a wide range of chemistry services, including but not limited to, the development, validation, verification, and transfer of methods. These services extend to testing of raw materials, examination for extractable and leachable substances, quality assurance testing, residual solvents analysis, environmental monitoring, impurities assessment, and microbiology lab testing. In addition to these, they also offer scientific staffing, sales and servicing of instruments, and consulting services. They maintain a widespread network of analytical laboratories and service centers across the U.S.

• INTERTEK GROUP PLC - Intertek Group plc is a provider of solutions aimed at ensuring quality and safety. It functions through three distinct segments—product, trade, and resources. The product segment of the company encompasses services such as laboratory testing, auditing of suppliers, compliance of vendors, sustainability scrutiny, and services related to inspection & certification. The trade and resources segments provide services like technical assistance, services for analytical testing, and calibration, and services for maintaining asset integrity. The company serves industries like life sciences, food, pharmaceuticals, and healthcare through its services. Its operations span across more than 1,000 locations in over 100 countries globally.

• WUXI APPTEC  - WuXi AppTec provides an open-access technology platform to companies in the medical devices, biopharmaceutical, and pharmaceutical sectors, with a presence in both China and the U.S. The company's portfolio of services encompasses both discovery and development services. The discovery services offered include chemistry, biology, pharmacology, safety pharmacology, pharmacokinetics, and bioanalysis. On the development side, the company provides services such as analytical development, commercial manufacturing, and pharmaceutical development. In addition, it offers preclinical services like toxicology testing, safety pharmacology, and bioanalysis. WuXi AppTec is a subsidiary of WuXi PharmaTech (Cayman) Inc. and has several other subsidiaries that serve specific regions or categories. For example, Wuxi Biologics provides regulatory affairs services within China.

• NORTH AMERICAN SCIENCE ASSOCIATES, LLC - North American Science Associates, LLC, also known as NAMSA, is a company that specializes in providing regulatory consulting, laboratory testing, and compliance services. Its service offerings include testing of medical devices, research & development support, and assistance for post-market needs. The company also supplies sterilization products, which include biological and chemical indicators, as well as test suspensions. Furthermore, it provides the NAMSA Test Navigator, a tool for online test selection. The company extends its services both domestically and internationally through a network of distributors and sales representatives.

• NELSON LABORATORIES, LLC - A subsidiary of Sotera Health, Nelson Laboratories, LLC is at the forefront of providing expert advisory services and laboratory testing. The company conducts close to 700 microbiological and analytical laboratory tests in the medical device, pharmaceutical, and tissue industries. It boasts a team of over 450 scientists and operates 13 laboratories globally, with locations in the U.S., Europe, Mexico, and China. The facilities of the company are accredited with ISO 17025 and are registered with the FDA as GTP, GLP, and GMP testing labs. The company has established its presence in regions like North America, Europe, and Asia Pacific.

• CHARLES RIVER LABORATORIES INTERNATIONAL, INC - A leading supplier of preclinical and clinical laboratory services to industries in the pharmaceutical and biotechnology sectors, Charles River Laboratories' operations are divided into three segments: Research Models and Services (RMS), Discovery and Safety Assessment (DSA), and support for manufacturing. The DSA segment provides services such as bioanalysis, drug metabolism studies, toxicology, and pharmacokinetics. The company's products and services are designed to meet the needs of a diverse clientele, including biotechnology and pharmaceutical companies, manufacturers of medical devices, hospitals, clinics, and academic institutions.

• ELEMENT MINNETONKA  - Established in 1990 and based in the U.S., Element Minnetonka, previously recognized as Medical Devices Testing Services or MDT, provides a range of analytical testing services tailored for companies in the medical device sector. These services encompass consulting, mechanical testing, characterization, inspection, adherence to standards, and upkeep of instruments and fixtures. The company's tests meet the requirements of regulatory authorities such as the U.S. FDA and CE, and it also holds certifications from ISO and ASTM.

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 Analytical Testing Outsourcing 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 Analytical Testing Outsourcing 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.