The global Preclinical Medical Device Testing Services Market garnered a market value of USD 2.8 Billion in 2022 and is expected to accumulate a market value of USD 6.63 Billion by registering a CAGR of 9% in the forecast period 2022 to 2032.
Growth of the preclinical medical device testing services market can be attributed to escalating product complexity and strict governmental regulations. The market for preclinical medical device testing services registered a CAGR of 5.5% in the historical period 2017 to 2021.
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.
| Data Points | Key Statistics |
|---|---|
| Expected Market Value of Preclinical Medical Device Testing Services in 2022 | USD 2.8 Billion |
| Projected Market Value of Preclinical Medical Device Testing Services in 2032 | USD 6.63 Billion |
| Growth Rate (2022 to 2032) | 9% CAGR |
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According to market research and competitive intelligence provider Future Market Insights- the market for preclinical medical device testing services registered a CAGR of 5.5% in the historical period 2017 to 2021.
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 was 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.
As a result, the demand for preclinical medical device testing services market is expected to register a CAGR of 9% in the assessment period 2022 to 2032.
Advancements in technology bolstering the use of Preclinical Medical Device Testing Services
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.
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.
Extensive Sterilization of Medical Equipment to encourage uptake of Preclinical Medical Device Testing Services
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 USA, Germany, Netherlands, and Thailand.
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Expensive licensing procedures affecting market growth
While promoting standards and control of medical devices is essential, excessive regulations, especially in a domestic context, can impede the local innovation of these devices.
It can impede domestic innovation by subjecting new technologies to a lengthy and costly licencing procedure, thereby increasing the time and money local manufacturers must spend and the cost of manufacturing medical equipment.
Due to the perceived risks associated with their use, a few products of great value to low-income countries may be removed from the market. This, in turn, is restraining the market growth of preclinical medical device testing services market.
Research and expansion of products bolstering market growth in North America
North America is expected to be the dominant market share holder for preclinical medical device testing services market. This is owing to the strong healthcare sector along with presence of established players in the region. In addition, key players are undertaking research and are keen on taking approval from the FDA to expand product portfolio.
Moreover, an increase in the patient pool along with technology advancements in the field of healthcare is positively influencing the growth of the market. Thus, North America is expected to dominate the market for preclinical medical device testing services with the largest revenue share of 38% in 2022.
Technological integration advancing growth of preclinical medical device testing services market
The Asia Pacific region is the hotspot of patients owing to the increasing number of populations that comprises of geriatric population. The increasing dependency on testing services by nearly all age groups for taking treatments on time is fueling the growth of preclinical medical device testing services market.
Moreover, developing regions such as India and South Korea along with developed region like China is constantly innovating and integrating technology to cater to a wide pool of medical requirements.
Furthermore, the increasing dependency on testing device services by healthcare professionals is augmenting the growth of preclinical medical device testing services market. The Asia Pacific is expected to rise with the fastest growth of 8.5% in the forecast period.
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Strong presence of established players shaping preclinical medical testing services market in North America
The presence of established players in the North American region is a primary factor contributing to the growth of the market. USA, specifically serves as a premier manufacturing hub for expensive medical devices and sophisticated highly dependable tools.
In addition, 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 in the country. All these factors are contributing to the growth of the preclinical medical device testing services.
Favorable Policies opening Opportunistic Doors for Preclinical Medical Device Testing Services in India
One of the key factors fueling the regional market is the low cost of outsourcing medical device testing services in India. 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.
Mandatory requirements for testing boosting usage of Microbiology and Sterility Tests
Microbiology & sterility testing 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 microbiology & sterility testing segment accounted for the maximum revenue share of 35% in 2022.
Designing of Medical Devices driving the growth of Chemistry Test Segment
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. Thus, the chemistry test segment is expected to rise with the fastest CAGR of 9.0% in the forecast period.
Key start-up players in the Preclinical Medical Device Testing Services Market are Proov, Senzo, Garwood Medical Devices and Parasym Health.
Key players in the preclinical medical device testing services market are SGS SA, Eurofins Scientific, PaxeraHealth Intertek Group Plc, WUXI APPTEC, TÜV SÜD AG, Sterigenics International LLC, EAS Group, Labcorp, Nelson Labs, North American Science Associates, Inc, Charles River Laboratories International Inc and Pace Analytical Services LLC
| Report Attributes | Details |
|---|---|
| Market Value in 2022 | USD 2.8 Billion |
| Market Value in 2032 | USD 6.63 Billion |
| Growth Rate | CAGR of 9% from 2022 to 2032 |
| Base Year for Estimation | 2021 |
| Historical Data | 2016 to 2021 |
| Forecast Period | 2022 to 2032 |
| Quantitative Units | Revenue in USD Million and CAGR from 2022 to 2032 |
| Report Coverage | Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends and Pricing Analysis |
| Segments Covered | Service, Region |
| Regions Covered | North America; Latin America; Europe; Asia Pacific; Middle East and Africa |
| Key Countries Profiled | USA, Canada, Brazil, Mexico, Germany, UK, France, Spain, Italy, Russia, China, Japan, South Korea, India, Australia, South Africa, Saudi Arabia, U.A.E, Israel |
| Key Companies Profiled | SGS SA; Eurofins Scientific; Intertek Group Plc; WUXI APPTEC; TÜV SÜD AG; Sterigenics International LLC; Nelson Labs; North American Science Associates Inc.; Charles River Laboratories International Inc.; Pace Analytical Services LLC |
| Customization | Available Upon Request |
From 2017 to 2021, the preclinical medical device testing services market grew at a CAGR of 5.5%
The global preclinical medical device testing services market is expected to grow with a 9% CAGR during 2022 to 2032.
As of 2032, the preclinical medical device testing services market is expected to reach USD 6.3 Billion
Microbiology & sterility testing segment is expected to account for revenue share of 35% in 2022.
North America is expected to dominate the market for preclinical medical device testing services with the largest revenue share of 38% in 2022.
The Asia Pacific is expected to rise with the fastest growth of 8.5% in the forecast period.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast, 2022 to 2032 5. Global Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Service 5.1. Biocompatibility Tests 5.2. Chemistry Test 5.3. Microbiology & Sterility Testing 5.3.1. Bioburden Determination 5.3.2. Pyrogen & Endotoxin Testing 5.3.3. Sterility Test and Validation 5.3.3.1. Ethylene Oxide Gas Sterilization 5.3.3.2. Gamma-irradiation 5.3.3.3. E-beam Sterilization 5.3.3.4. X-ray Sterilization 5.3.4. Antimicrobial Activity Testing 5.3.5. Others 5.4. Package Validation 6. Global Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Region 6.1. North America 6.2. Latin America 6.3. Europe 6.4. Asia Pacific 6.5. Middle East and Africa 7. North America Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 8. Latin America Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 9. Europe Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 10. Asia Pacific Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 11. Middle East and Africa Preclinical Medical Device Testing Services Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country 12. Key Countries Preclinical Medical Device Testing Services Market Analysis 13. Market Structure Analysis 14. Competition Analysis 14.1. SGS SA 14.2. Eurofins Scientific 14.3. Intertek Group Plc 14.4. WUXI APPTEC 14.5. TÜV SÜD AG 14.6. Sterigenics International LLC 14.7. Nelson Labs 14.8. North American Science Associates, Inc. 14.9. Charles River Laboratories International Inc. 14.10. Pace Analytical Services LLC 15. Assumptions & Acronyms Used 16. Research Methodology
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Preclinical Medical Device Testing Services Market
