The global medical device validation and verification market size was valued at USD 477.2 million in 2019 and is anticipated to expand at a CAGR of 11.1% over the forecast period. International regulatory standards by leading bodies, such as the U.S. Food and Drug Administration (FDA), are constantly evolving due to stringent regulatory policies set by different countries.
With the advancement in technology, medical devices are becoming smaller in size with a more complex design. Hence, validation and verification of medical device has become even more important. This validation and verification process helps in designing the highest quality medical devices with minimum error. Validation and verification also help to reduce the production cost of medical devices.
Rising demand for advanced and quality medical products and increasing complexity with respect to product designing and engineering are boosting the demand for medical device validation and verification. In addition, there has been a rise in the complexity and connectivity of a medical device. Digital technology is easily available and adopted in almost every area of the healthcare sector.
Medical devices are becoming more complex due to the incorporation of software. Earlier, the software in medical devices was used to manually turn the equipment on and off and display readings. Complexity in requirements and customer needs has made the medical device software far more complex, thereby increasing the need for validation and verification.
Additionally, recent regulatory changes in Europe pertaining to medical device validation and verification services are anticipated to increase the demand for the validation and verification process, thus contributing to the regional market growth.
On the basis of application, the global medical device validation and verification market is segmented into diagnostics, therapeutic, and implants. The diagnostics segment held the largest share of 44.2% in 2019. Diagnostic technologies are increasingly used in healthcare to identify the cause or nature of a disease. Fast and precise diagnosis is very crucial for providing the most effective and potentially life-saving treatments in a timely manner. Diagnostic medical devices have seen a shift in design preferences over recent years. The combination of mechanical engineering, software engineering, electronics, and medical science governs the development of this equipment.
As stated by the co-founder of a medical equipment manufacturing company from Bengaluru, India, designing a product begins from the hardware. Most medical devices use embedded software, and hence hardware requires more attention. For medical devices, application-specific integrated circuit (ASIC) system-on-chips are preferable over field-programmable gate array (FPGA) chips, as ASICs provide higher power efficiency, purpose specificity, and better performance. Advanced image processing technologies have superior applications, such as MRI scan tests and CT.
Based on technology, the market is segmented into mechanical testing, biological, EMC/ECI, and electrical safety testing. The mechanical testing segment held the largest share of 40% in 2019 due to an increase in the outsourcing of therapeutic devices in recent years. Mechanical testing is a small but critical component during the product development and regulatory analysis process. It includes bond strength testing, coating adhesion, coefficient of expansion, coefficient of friction, compressive properties, flexural properties, hardness, and impact testing. Medical device companies have increased the outsourcing of mechanical testing owing to low-cost services offerings by contract research organizations (CROs), lack of internal capabilities, and an increase in focus on core activities.
The biological testing segment is expected to expand at the highest CAGR of 11.6% during the forecast period. A medical device is expected to perform its function without any adverse effects on patients. Potential medical device adverse effects can be categorized as acute, subacute, chronic, and subchronic. As a result, each medical device is subject to biocompatibility testing and biological evaluation to assess the interaction between a device and patients. The primary purpose of biological testing is to protect patients from potential adverse effects.
Oncology held the largest share of 25.8% in 2019 and is also expected to exhibit the fastest growth during the forecast period due to the increasing prevalence of cancer worldwide. For instance, according to the Organization for Economic Co-operation and Development (OECD), in 2016, about 4.5 million people died (or 16.3% of total deaths) in Asia Pacific due to cancer. Similarly, as per the American Cancer Society, in 2018, about 609,640 people died in the U.S. due to cancer. This can be attributed to the growing geriatric population and increasing exposure to risk factors.
Owing to the high prevalence of cancer and related mortality, most of the medical device companies are focusing on developing advanced technologies. This is expected to drive the oncology segment over the forecast period. Growing awareness about advancements in cancer treatment and an increase in the outsourcing of cancer device development activities by medical device companies are likely to boost market growth during the forecast period.
North America held the largest share of 44.88% in 2019 due to recent technological advancements in medical devices and increasing complexity in product design. Moreover, medical device manufacturers are focusing on North America due to the booming healthcare industry in the region. Thus, North America is anticipated to dominate the global market during the forecast period.
Europe held the second-largest share in the global market in 2019 due to a well-developed healthcare infrastructure. Asia Pacific is expected to hold a significant market share over the forecast period due to increasing regulatory focus on quality control while manufacturing medical devices, especially in emerging economies, such as China and India. In addition, growing medical tourism in emerging economies is expected to drive the market in Asia Pacific. Certain regions such as the Middle East & Africa and Latin America are projected to exhibit lucrative growth in the near future due to rapidly growing healthcare industry.
The market is characterized by intense competition. Some of the players operating in the market are SGS SA; QuEST Global Services Pte. Ltd; Intertek; Element Materials Technology; TÜV SÜD AG; North American Science Associates, Inc. (NAMSA); Eurofins Scientific SE; Charles River; Sterling Medical Devices; Pacific Biolabs; Toxikon Corporation; and Steris Laboratories.
The rapid adoption of advanced healthcare technology for improved healthcare is one of the key parameters affecting competition in the market. Moreover, major players are undertaking strategies, such as mergers & acquisitions and new product launches, in order to retain market share and diversify the product portfolio.
Base year for estimation
Actual estimates/Historical data
2015 - 2018
2020 - 2027
Revenue in USD Million and CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Spain, China, India, Japan, Australia, South Korea, Mexico, Brazil, Argentina, South Africa, Saudi Arabia, and UAE
Revenue forecast, company share, competitive landscape, growth factors and trends
15% free customization scope (equivalent to 5 analysts working days)
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This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2015 to 2027. For the purpose of this study, Grand View Research has segmented the global medical device validation and verification market report on the basis of therapeutic area, application, technology, and region:
Therapeutic Area Outlook (Revenue, USD Million, 2015 - 2027)
Application Outlook (Revenue, USD Million, 2015 - 2027)
Active Implantable Medical Device
Technology Outlook (Revenue, USD Million, 2015 - 2027)
Electrical safety testing
Regional Outlook (Revenue, USD Million, 2015 - 2027)
Middle East & Africa
b. The global medical device validation and verification market size was estimated at USD 477.2 million in 2019 and is expected to reach USD 530.3 million in 2020.
b. The global medical device validation and verification market is expected to grow at a compound annual growth rate of 11.1% from 2020 to 2027 to reach USD 1,109.2 million by 2027.
b. North America dominated the medical device validation and verification market with a share of 44.9% in 2019. This is attributable to recent technological advancements in medical devices and increasing complexity in product design.
b. Some of the players operating in the market are SGS SA; QuEST Global Services Pte. Ltd; Intertek; Element Materials Technology; TÜV SÜD AG; North American Science Associates, Inc. (NAMSA); Eurofins Scientific SE; Charles River; Sterling Medical Devices; Pacific Biolabs; Toxikon Corporation; and Steris Laboratories.
b. Key factors that are driving the market growth include increasing product complexity, increasing medical device recalls, and stringent regulations.
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With Covid-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for Covid19 as a key market contributor.