Medical Device Analytical Testing Outsourcing Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2030

The global Medical Device Analytical Testing Outsourcing market size is expected to be worth around US$ 19.7 billion by 2030, according to a new report by Vision Research Reports.

The global Medical Device Analytical Testing Outsourcing market size was valued at US$ 14.8 billion in 2020 and is anticipated to grow at a CAGR of 17.6% during forecast period 2021 to 2030.

Growth Factors

 Numerous medical device companies outsource analytical testing operations to minimize business risks, hasten product market entry, and reduce costs. These procedures lead to a significant rise in expenditure levels and, therefore, original equipment manufacturers of medical instruments rapidly switch to outsourcing as one of the effective cost curbing tools.

Implantable Medical Devices (IMDs) are being used increasingly in order to improve patients’ health outcomes. Designers of IMDs have to balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation rather than non-core activities and, therefore, outsourcing these activities to launch efficient instruments. All these factors are expected to drive the market over the forecast period.

In this complex ecosystem, it is necessary for the equipment to provide accurate results, to have durability, and easy operation. To match these parameters, devices now have to undergo shear checking in accelerated conditions to obtain marketing approval and have a competitive advantage. Conducting this in-house is a matter of time, labor, and cost; outsourcing these tests helps overcome these limitations. For instance, the ISO 10993 has revised the Analytical Evaluation Threshold (AET) for better toxicological safety assessment. Lack of awareness with regards to these tests among the manufacturers of medical instruments may lead to reworking, which is usually avoided when outsourced to third-parties. Hence it is very important to be aware of AET as regulators will review the analytical report to check whether the AET was followed or not. Also, it is the duty of the medical device manufacturer to ensure that AET is applied to the checking process.

Various companies globally have increased the manufacturing of medical devices such as personal protective equipment (PPE) kits, ventilators, and N-95 masks. This has created opportunities for the players in the Testing, Inspection, and Certification (TIC) Market to test and certify these instruments. Many companies such as TÜV SÜD and Eurofins have started checking these medical instruments, thus increasing the demand for analytical testing services from the healthcare industry. Also with increasing cases of COVID-19 globally, the demand for analytical testing services will surge in the coming months.

Report Highlights

Material characterization services held a substantial share of 18.3% in 2020 and are anticipated to grow at a rate of 7.4% over the forecast period. Other tests are inclusive of cleaning, reprocessing, method development and validation, accelerated stability testing, biocompatibility, validation testing for packaging materials (container closure permeation), and transport stability. Medical devices are also subjected to extractable and leaching tests along with pharmaceutical formulations. This is undertaken to identify if any solutes and/or chemicals are present on the surface of the medical devices, which may be removed or leached out into the surrounding when used with the intended liquids.

Based on services, the market is segmented into extractable and leachable, material characterization, physical testing, bioburden testing, sterility testing, and other testing services.

Cardiology medical device testing outsourcing held the largest revenue share of 20.9% in 2020 and it is also expected to witness remunerative growth over the forecast period. The rising demand for cardiovascular devices as a result of the increasing prevalence of associated conditions is attributed to the growth of outsourcing of these devices. As per the World Health Organization (WHO) statistics in 2015, 17.3 million people died due to cardiovascular diseases, and this number is expected to reach 23.6 million in 2030.

Moreover, the high complexity of cardiovascular devices and the need for technical expertise results in higher outsourcing of these devices. On the other hand, general and plastic surgery devices outsourcing is anticipated to exhibit lucrative growth over the forecast period. The availability of competent outsourcing firms that comply with the regulatory requirements, & rising demand for cosmetic surgeries are expected to be responsible for the growth of this segment.

Analytical testing outsourcing for other devices, which include single-use and expensive therapeutic and monitoring devices, held around 80.1% revenue share in 2020. Reprocessed devices are likely to grow at a lucrative rate over the forecast period.

Hospitals dominated the end-use segment and accounted for the largest revenue share of around 86.7% in 2020. This can be attributed to greater patient volume and greater budget allocation for these operations by hospital management. Other healthcare settings such as diagnostic centers, ambulatory centers, and specialty care centers are also likely to gain lucrative share over the forecast period.

The hospital segment is further sub-segmented into equipment and consumables. Equipment held around 39.7% share in hospital-based medical device analytical testing services market in 2020. These devices include imaging equipment, cardiology equipment, surgical devices, surgical microscopes, and therapeutic and monitoring devices. These devices are purchased for long-term use and outsourced for calibration tests, preventive maintenance tests, and performance tests.

Asia Pacific dominated the medical device analytical testing outsourcing market and accounted for the largest revenue share of 41.8% in 2020. This is owing to improving healthcare infrastructure with government initiatives. Moreover, economic developments in countries such as India and China are expected to help market growth. A huge population base with low per capita income in the Asia Pacific led to high demand for affordable treatment options. Multinational companies are looking forward to investing in developing countries such as India and China.

North America held commanding shares in 2020. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices. Consequently, original equipment manufacturers are increasingly moving toward electronics manufacturing service providers to efficiently handle the increasing volume of electronic components in the current medical devices. The rapid increase in the manufacture of medical devices to meet the rising demand for efficient healthcare in the region is expected to be one of the major factors propelling the development of the market

Key Players

• SGS SA

• Toxikon, Inc.

• Eurofins Scientific

• Pace Analytical Services, LLC

• Intertek Group plc

• WuXi AppTec.

• NORTH AMERICAN SCIENCE ASSOCIATES INC.

• Envigo

• Charles River Laboratories International Inc.

• Medical Device Testing Services

Market Segmentation

• Service Outlook 

  • Extractable and leachable

  • Material characterization

  • Physical testing

  • Bioburden testing

  • Sterility testing

  • Other tests

• Therapeutic Areas Outlook 

  • Cardiology

  • Diagnostic Imaging

  • Orthopedic

  • IVD

  • Ophthalmic

  • General & Plastic Surgery

  • Drug Delivery

  • Endoscopy

  • Dental

  • Diabetes Care

  • Others

• Device Type Outlook Reprocessed Devices

  • • Hospital

    • Others

  • Others

• End-use Outlook 

  • Hospital

    • Equipment

    • Consumables

  • Others

• Regional Outlook

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

The Medical Device Analytical Testing Outsourcing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Medical Device Analytical Testing Outsourcing market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Medical Device Analytical Testing Outsourcing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Medical Device Analytical Testing Outsourcing market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Medical Device Analytical Testing Outsourcing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Medical Device Analytical Testing Outsourcing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Medical Device Analytical Testing Outsourcing by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Medical Device Analytical Testing Outsourcing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Medical Device Analytical Testing Outsourcing market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Medical Device Analytical Testing Outsourcing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Medical Device Analytical Testing Outsourcing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Medical Device Analytical Testing Outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Medical Device Analytical Testing Outsourcing market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Medical Device Analytical Testing Outsourcing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Medical Device Analytical Testing Outsourcing market. These factors have benefited the growth of the global market for Medical Device Analytical Testing Outsourcing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Medical Device Analytical Testing Outsourcing. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Medical Device Analytical Testing Outsourcing are as follows:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

To strategically profile the key players and comprehensively analyze their growth strategies.