Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Application, By Class, By Region, And Segment Forecasts, 2024 - 2030

Research Methodology

A three-pronged approach was followed for deducing the medical device 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 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 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 Outsourcing Market Categorization:

The medical device outsourcing market was categorized into four segments, namely service (Quality Assurance, Regulatory Affairs Services, Product Design and Development Services, Product Testing & Sterilization Services, Product Implementation Services, Product Upgrade Services, Product Maintenance Services, Contract Manufacturing), application (Cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic,General and plastic surgery, Drug delivery, Dental, Endoscopy, Diabetes care), class (Class I, Class II, Class III), and regional (North America, Europe, Asia Pacific, Latin America, Middle East and Africa).

Segment Market Methodology:

The medical device outsourcing market was segmented into services, application, class, and region. 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 outsourcing 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-three countries, namely, the U.S.; Canada; the UK; Germany; France; Italy; Spain; Netherlands; Switzerland; Sweden; Belgium; Russia; India; Japan; China; Australia; South Korea; Singapore; Indonesia; Malaysia; Thailand; Taiwan; Philippines; Brazil; Mexico; Argentina; Colombia; Chile; South Africa; Saudi Arabia; UAE; Israel; and Egypt.

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 outsourcing market companies & financials:

The medical device 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: 

• TÜV SÜD - TÜV SÜD operates through four segments: industry, mobility, certification, and others. Its key services include auditing & system certification, global market access, inspection, knowledge services, product certification, testing, and training.

• Mandala International – Founded in 2007, situated in France. The company’s regulatory services include product registration, preaudit inspection, licensing, and pharmacovigilance. The company also provides other services in business development and business creation.

• RJR Consulting - RJR Consulting provides consulting services in pharmaceuticals, medical devices, biologics, combination products, food & dietary supplements, cosmetics & consumer products, and chemicals & plastics.

• Medical Devices Testing Services – Established in 1990 and situated in U.S. The firm offers various analytical testing services for medical devices companies; services include consulting, mechanical testing, characterization, inspection, compliance with standards, and maintenance of instruments & fixtures.

• WuXi AppTec, Inc - Wuxi AppTec, Inc is a pharmaceutical services include safety pharmacology, pharmacokinetics, bioanalysis, drug metabolism, and medicinal & analytical chemistry. It also offers biocompatibility testing, preclinical services, toxicology testing, package & validation testing, genetic toxicology, and material characterization services.

• Intertek Group plc – Established in 1988 and situated in U.K. The company operates through three segments: product, trade, and resources. In the product segment, the company offers laboratory testing, quality & performance testing, supplier auditing, vendor compliance, sustainability analysis, and inspection & certification services. In the trade and resources segments, it offers technical services, analytical testing services, calibration, and asset integrity services.

• Pace Analytical Services, Inc - Pace Analytical Services, Inc 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 sale & services, and consulting.

• Eurofins Scientific SE – Eurofins Scientific SE was established in 1987 in Luxembourg. The company provides agro-testing, consumer product testing, environment testing, medical device testing, and chemical registration & authorization services.

• West Pharmaceutical Services, Inc. - Established 1923 and situated in U.S. The company caters to the needs of biotechnology, medical devices, pharmaceuticals, and generic companies. It also offers contract manufacturing services. The company manufactures stoppers & seals for blood collection, drug packaging, injection systems, and syringe components.

• SGS SA – SGS SA offers inspection and product testing services for agriculture, food & life, minerals, oil, gas & chemicals, consumer retail, certification & business enhancement, industrial, environment, health & safety, transportation, and governments & institutions.

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 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 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.