Preclinical Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global preclinical medical device testing services market size was valued at USD 2.3 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 8.6% from 2022 to 2030. Demand for medical device testing services is being driven by escalating product complexity and strict governmental regulations. However, one of the main factors propelling the market is the rising demand for technologically advanced medical devices. The COVID-19 pandemic has created an unheard-of surge in demand in 2020 for medical device testing services and this pattern was anticipated to continue in 2021 due to the urgent need for medical devices, numerous medical device manufacturers worldwide developed new COVID-19 testing devices. This is likely to have a positive impact on the market. 

Medical devices have improved due to technological advancements over time. IoT and AI are already included in medical devices. Additionally, in order to maintain their position as market leaders, the players in the industry are eager to implement cutting-edge medical devices. For instance, in August 2021, an AI-based imaging platform was introduced in the U.S. by PaxeraHealth, a company that offers imaging health. Therefore, demand for preclinical medical device testing services is predicted as a result of such initiatives.

Preclinical medical device trials were not concentrated on treating and diagnosing diseases associated with cardiovascular, cancer, and other diseases during the COVID-19 pandemic due to the virus's widespread distribution throughout the world at the time. In certain ways, this had slowed the market. But in order to stop the spread of the pandemic, there was a pressing need for PPE masks, kits, IVD kits, and other tools. The emergence of medical devices for the diagnosis and treatment of COVID-19 was eagerly anticipated by public organizations. For instance, the COVID-19 Breathalyzer Test was developed by researchers at Rutgers with funding from the NIH of USD 443,000 in April 2021. Hence, such initiatives are expected to have a positive impact on the market.

Modern preclinical testing continues to depend heavily on animal testing. Even though the morality of using animals in medical testing is still hotly contested, it is a global practice widely accepted and remains a common research methodology used by teams looking into a variety of human diseases. A new drug or vaccine must go through preclinical testing to establish its safety and efficacy before being tested on humans. These tests typically take the form of either in vitro experiments utilizing cultures of human cells or animal experiments using various species of animals to provide a model as to how the novel therapeutic substance could impact a human subject.

The manufacturers emphasize developing new medical devices based on the high prevalence of diseases. Medical device product development and design is a complex process. The demand for preclinical medical device testing services is likely to rise as a result of the high complexity of medical device design and the prevalence of chronic diseases. For instance, by 2020, the prevalence of chronic diseases is predicted to increase by 57%, according to the World Health Organization. Since population growth is expected to be most significant in developing countries, emerging markets would be the hardest hit.

The demand for medical devices and the need for sterilization is rising necessitating the use of all sterilization methods. The majority of single-use medical devices are made of polymers that can only withstand a slight rise in temperature. The two main "cold" sterilization techniques have been ethylene oxide and gamma radiation for several years. Since the 1970s, medical device sterilizations with electron beams have advanced. As the demand for contract electron beam irradiation increased, many large medical device manufacturers are now using electron beam accelerators as an internal sterilization solution. The first high-power X-ray sterilization facility in Switzerland, presently owned by STERIS, began operating in 2011. Since 2020, newer EB-X service facilities have opened than new gamma facilities. The new X-ray capacity has been built or is being constructed in the U.S., Germany, Netherlands, and Thailand.

Services Insights

The Microbiology & sterility testing segment accounted for the maximum revenue share of 34.3% in 2021. It is one of the major tests included in pre-clinical medical device testing. These examinations aid in identifying any microorganisms that could be present in the apparatus. This test can be used to determine whether bacteria, fungi, or yeasts are present in medical devices in a viable form. For validation purposes, the FDA and other regulatory bodies demand these tests. Also, as a part of routine quality control, these tests are carried out.

Based on the test type of microbiology & sterility testing segment is further classified into bioburden determination, pyrogen & endotoxin testing, sterility test & validation, antimicrobial activity testing, and others. Among them, the sterility test & validation segment is further narrowed down into ethylene oxide (EO) gas sterilization, gamma-irradiation, E-beam sterilization, and X-ray sterilization. The sterilization method must be validated by the manufacturers of sterile devices or of devices that would be cleaned and sterilized in between uses. Steam sterilization is the most frequent method of sterilization followed by hospitals as a standard sterilization procedure and it is not well-liked by companies that produce medical devices. Since almost all materials can be safely sterilized with Ethylene Oxide EO gas, manufacturers frequently use this method. However, the radiation can result in material degradation (cracks) and discoloration. Gamma-irradiation is also frequently used. Other techniques exist, such as E-beam sterilization also play a marginal role.

The chemistry test segment is expected to rise with the fastest CAGR of 9.0% in the forecast period. Chemical testing is done for characterizing, identifying, and comprehending the chemicals used for manufacturing medical devices. Chemical testing complies with the ISO 10993-17 and 10993-18T regulations. According to the biocompatibility standards, it is a requirement for all medical devices to obtain chemical information, which results in chemical characterization for the majority of medical devices. From low-risk items like medical spatulas and disinfectants to high-risk items like implants and cardiac pacemakers, this category includes a wide variety of products. Manufacturers could anticipate potential toxicities and take precautions against them by analyzing the chemicals that commute from the device to the patient. The complexities associated with the designing of medical devices are driving the segment growth.

Regional Insights

North America dominated the market for preclinical medical device testing services with the largest revenue share of 37.3% in 2021. This is primarily caused by the fact that there are many players in this region. It serves as a premier manufacturing hub for sophisticated highly dependable, and expensive medical devices. There is a rapid increase in the manufacturing of medical devices to meet the rising demand for efficient and cost-effective healthcare in this region. Moreover, the rise in demand for cutting-edge medical devices and the availability of sophisticated infrastructure for developing complex, highly dependable, and high-end medical devices. In addition, the FDA policies are promoting the expansion of the market for medical device testing services.

The Asia Pacific is expected to rise with the fastest growth of 9.0% in the forecast period. One of the key factors fueling the regional market is the low cost of outsourcing medical device testing services in the Asia Pacific. The region's rise in disease burden and the growing demand for advanced medical devices are both driving the market expansion. Furthermore, the rising demand for medical devices and favorable policies in India & China is driving the growth. For instance, the Government of India strengthened trade policies in October 2021 that enable Indian medical devices to get international acceptance in the global market. This regulation would drive the demand for testing services in India and the rest of the world.

Key Companies & Market Share Insights

Mergers, acquisitions, and partnerships among others were the key strategies adopted by key players to maintain their market share. For instance, the preclinical contract research company Toxikon Corporation was acquired by the life sciences company LabCorp in December 2021. The primary objective of this acquisition was to increase Labcorp's nonclinical development testing capabilities for clients in the pharmaceutical, biotech, and medical device industries. Similar to this, the WuXi AppTec lab testing division expanded its Suzhou, China, toxicology facility in November 2019 to offer full-service toxicology for preclinical and clinical stages. Some prominent players in the preclinical medical device testing services market include:

• SGS SA

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group Plc

• WUXI APPTEC

• TÜV SÜD AG

• Sterigenics International LLC

• Nelson Labs

• North American Science Associates, Inc.

• Charles River Laboratories International, Inc.

Preclinical Medical Device Testing Services Market Report Scope

Global Preclinical Medical Device Testing Services Market Segmentation

This report forecasts revenue growth at regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2018-2030. For this study, Grand View Research has segmented the preclinical medical device testing services market based on services and region:

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Biocompatibility Tests

  • Chemistry Test

  • Microbiology & Sterility Testing

    • Bioburden Determination

    • Pyrogen & Endotoxin Testing

    • Sterility Test and Validation

      • Ethylene Oxide (EO) gas sterilization                        

      • Gamma-irradiation                             

      • E-beam sterilization                           

      • X-ray sterilization

    • Antimicrobial Activity Testing

    • Others

  • Package Validation

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • France

    • Germany

    • U.K.

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Switzerland

    • Russia

    • Sweden

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Malaysia

    • Indonesia

    • Singapore

    • Philippines

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt