Medical Device Analytical Testing Outsourcing Market Analysis By Services (Extractable and leachable, Material characterization, Physical testing, Bioburden testing, Sterility testing), By Region, And Segment Forecasts, 2018 - 2025

Industry Insights

The global medical device analytical testing outsourcing market was valued at USD 2.7 billion in 2015 and is expected to grow with CAGR of 11.6% over the forecast period. Complexity in product design, intensifying competition, increase in the number of small size medical devices manufacturers, and strict approval norms are the key factors driving market growth.

The regulatory authorities also perform routine post-market surveillance by levying a fee from the manufacturer. Receipt of any complaints about the drawbacks of the product entails its withdrawal from the market, thereby proving the stringent nature of these procedures.

Emergence of personalized medicine, drug device combination, artificial intelligence, wearables and increased focus on real-time patient monitoring resulted in complex medical devices ecosystem. Real-time patient monitoring, remote patient monitoring, and continuous patient monitoring are the focal areas of interest when it comes to chronic disease management, such as diabetes and cardiovascular diseases.

U.S. medical device analytical testing outsourcing market, by services 2014 - 2025 (USD Million)

Development of advanced devices such as surgical robots, surgical microscopes, ophthalmic surgical devices, and neurosurgery devices has reduced the direct human interference in surgical procedures. In addition, increasing demand for minimally invasive surgeries bolstered the lucrative growth of this market. To maintain precision and accuracy, periodic maintenance and quality checks are required to meet the desired performance. Outsourcing quality checks of such devices is a wise option where high level of experience and expertise is required.

Medical device companies today are operating in different worlds. In developed countries, such as the U.S., there is pricing pressure, hence, operators are exploring every possible way reduce cost throughout the value chain. On the other hand, it is in the developing economy where the actual potential lies. However, developing regions are likely to be price sensitive. Hence, market players today are really striving hard to reduce the overall cost of devices. Outsourcing analytical testing operations helps companies focus on product development and enhance marketing efforts.

Services Insights

Based on services, themedical device analytical testing outsourcing market is segmented intoextractable and leachable, material characterization, physical testing, bioburden testing, sterility testing, and other testing services. Material characterization services held substantial share of 18.4% in 2015 and are anticipated to grow at a rate of 11.9% over the forecast period. Other tests are inclusive of cleaning, reprocessing, method development & validation, accelerated stability testing, biocompatibility, validation testing for packaging materials (container closure permeation), and transport stability.

Global medical device analytical testing outsourcing market, by service, 2015

• 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. A few methods routinely used to perform the analysis are:

  • High Performance Liquid Chromatography (HPLC): This is used for conducting tests such as UV detection, refractive index analysis, mass spectrometer detection, etc.

  • Gas Chromatography (GC)

  • Ion Chromatography (IC): determination of anionic or cationic solutes

  • Elemental Metals Analysis: It is performed by means of Optical Emission Spectroscopy (OES) and Inductively Coupled Plasma (ICP)

  • Others

Regional Insights

North America held commanding shares in 2015. 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 increasing volume of electronic components in the current medical devices. The rapid increase in the manufacture of the medical devices to meet the rising demand for efficient healthcare in the region is expected to be one of the major factors propelling development of the market.

Asia Pacific is expected to witness lucrative growth over the forecast period owing to improving healthcare infrastructure with government initiatives. Moreover, economic developments in countries such as India and China are expected to help market growth. Huge population base with low per capita income in Asia Pacific led to high demand for affordable treatment options. Multinational companies are looking forward to invest in developing countries such as India and China.

Competitive Insights

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.; and Medical Device Testing Services are the key players in this market.

Service portfolio expansion along with regional penetration is anticipated to positively affect the market players. For Instance, in December 2016, company acquired Exova’s environment testing laboratories in Eastern Canada. This initiative is expected to help the company enhance geographical footprints in North America.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the medical device analytical testing outsourcing market on the basis of services and region: 

• Services Outlook (Revenue, USD Million, 2014-2025)

  • Extractable & Leachable

  • Material Charecterization

  • Physical Testing

  • Bioburden Testing

  • Sterility Testing

  • Others

• Regional Outlook (Revenue, USD Million, 2014-2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa (MEA)

    • South Africa