Medical Device Testing Services Market - Forecasts from 2022 to 2027

The global medical device testing services market is estimated to surge at a CAGR of 14.79% from a market value of US$32.434 billion in 2020, to achieve a market value of US$85.156 billion by the end of 2027.

Medical device testing services are the most commonly utilized testing services and solutions performed within the medical industry. Hence, with the growing medical device industry globally, the market is projected to hold strong growth prospects during the forecast period. The growing prevalence of chronic diseases requiring state-of-the-art medical devices for testing and treatment purposes further augments the market demand during the forecast period. The presence of companies offering varied medical device testing services further fuels the market growth in the forecast period. For example, companies offer medical device testing services for biocompatibility testing, biological safety, chemical characterization, analytical chemistry, environmental monitoring, and long-term and accelerated shelf-life testing. Furthermore, with the growing need for testing the quality and reliability of medical devices, the market for medical device testing services holds strong growth opportunities during the forecast period.

Companies also offer medical device testing services that provide full support right from the device concept designing design to post-market applications. These services are highly beneficial due to stringent regulations for product development; hence, any defect in a medical device or inability of a medical device to serve the required medical purpose would lead to product disqualification. Therefore, strict regulations for device development and approval contribute to surging market demand during the forecast period. NAMSA, a medical organization based in Toledo, Ohio, USA, aids in the acceleration of product development for medical devices, in-vitro diagnostics, regenerative medicine, and combination products. For example, NAMSA, a medical organization based out of Toledo, Ohio, United States, helps speed product development for medical devices, In-Vitro Diagnostics, regenerative medicine, and combination products. By utilizing its MRO® approach, the company plays a significant role in translational research. By applying its unique combination of solutions that include medical device testing, regulatory, reimbursement, quality consulting, and clinical research services, the company offers support throughout the full development continuum, from bench to actual patient applications. The company’s offices are located across the Asian, European, and North American regions and support fast-track market introduction in the world's major markets.

Geographically, North America is projected to hold a significant market share. At the same time, the Asia Pacific region is estimated to be the fastest-growing market in the global medical device testing services market during the forecast period.

The impact of COVID-19 on the medical device testing services market: COVID-19 impact on the medical device testing services market.

The sector for medical device testing is driven mainly by a growing percentage of COVID-19 cases, which leads to an increase in the quantity of ICU beds, which results in a higher trend for COVID-19 priority medical devices. Factors such as increased sales for PPE kits and N95 masks global level and growing preference for ventilators for the effective identification of critical COVID-19 patients are also driving the market. The COVID-19 disease has increased the demand for in-vitro diagnostic product lines due to market demand for rapid-test goods and a marked rise in the target patient population in a few countries. According to a study article published in May 2020 by A. Chandimal Nicholas, in Canada, throughout the COVID-19 pandemic 2020, the Minister of Health signed the Provisional Order Recognizing the Import and Sale of Medical Devices to be used in Regards to COVID-19, which permitted healthcare providers speeded up access to COVID-19 medical devices. Furthermore, according to Health Canada, the Provisional Order aided in the quick approval of importing goods and sale of COVID-19 medical devices. However, disruptions in non-urgent therapies and surgical techniques and the impact on the supply chain and logistics have been reported. It has been noticed at the global level that the novel coronavirus pandemic has severely affected medical device manufacturing. This is mainly because medical device manufacturers depend on healthcare facilities for their clinical trial data collection. It is required that almost every medical device must pass through different stages of clinical trials that include pre-market and post-market studies before the medical device certification is certified for market approval. As the COVID-19 pandemic continues to increase, medical device companies face difficulties making informed decisions regarding their products, supply chain, and regulatory obligations. Hence, the market is projected to be impacted in the current year compared to the previous years amid the novel coronavirus pandemic scenario.

The growing medical device industry will continue to surge and drive the market demand during the forecast period and the emergence of novel and innovative medical devices.

The global medical device industry is projected to grow steadily during the forecast period. Industrial growth is further supported by the growing demand for innovative medical devices, including wearables and innovative health services like health data. This is mainly because lifestyle diseases are gaining momentum with time due to the adoption of unhealthy living conditions. Hence, this is creating a high demand for the development of portable medical devices to keep a constant check on the vital parameters, further providing robust market growth prospects during the forecast period. The Governments around the globe are working on cutting healthcare costs (especially on lowering the number of hospital visits) and demand greater value regarding improved patient outcomes. Companies are expected to step out of their traditional device manufacturing to achieve this. Instead, a need for integrating services and data intelligence coupled with their products is being realized to deliver holistic solutions, further bolstering the B2B activities and strengthening the creation of the new business-to-consumer (B2C) activities. This will further require the manufacturers to adopt different strategies in the form of mergers & and acquisitions and strategic partnerships and collaborations. The medical device companies will ultimately play a bigger role in the value chain and will get an opportunity to interact with the end consumers closely. This would further aid in increasing the company’s revenues and, in turn, would contribute to lowering the number of hospital visits.

Additionally, with medical devices directly impacting human lives, these devices must deliver safe and effective healthcare services to patients. To achieve this, it is expected that all medical device manufacturers follow the proper medical device testing procedures, including verification and validation practices, and ensure that the quality and reliability of medical devices are maintained following the required medical needs.

By utilizing the various medical device testing strategies, it is expected of a medical device manufacturer that the company checks every functionality of its medical device right from the concept designing stage to the post-market applications. In the case of any defect being found, it would lead to huge losses to the company. Hence, with the growing medical device industry, medical device testing services hold importance to assist in properly manufacturing the device. Testing services can be provided in-house or can be outsourced. Furthermore, with the surging number of chronic diseases worldwide, the market is projected to hold strong growth prospects and develop novel medical devices through continuous innovations and technological advancements.

Key Development

January 2022, TÜV SÜD's medical device testing laboratory in New Brighton, Minnesota, has grown. The cutting-edge laboratory will perform biological and chemical testing on medical devices, supplementing TÜV SÜD's active service medical device probes.

January 2022, DNV, a global provider of assurance, certification and risk management, procured MEDCERT in addition to expanding its medical device assurance footprint.

Segmentation:

By Type

• Medical Device Testing Solution
• Certification & Auditing
• Scientific Support Services

By Services

• Cardiovascular Device Testing
• Orthopedic Implant Testing
• Microbiological Analysis
• Shelf-Life Testing

By Sourcing Type

• In-House Testing
• Outsourced Testing

By Geography

• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Europe
• UK
• Germany
• France
• Spain
• Middle East and Africa
• UAE
• Israel
• Saudi Arabia
• Asia Pacific
• Japan
• China
• India
• South Korea
• Thailand
• Indonesia
• Taiwan