Medical Device Testing Market

Medical Device Testing Market: By Services, Sourcing, Technology, and Region

Market Synopsis:

The global Medical Device Testing Market is valued at USD 9.76 billion in 2024 and is projected to reach a value of USD 27.5 billion by 2035 at a CAGR (Compound Annual Growth Rate) of 9.95% between 2025 and 2035.

A rise in medical device recalls has prompted many medical device companies to consider their testing and quality control measures, and this is on the rise. Many of these companies are now conducting independent testing or hiring third-party firms for testing so they can ensure that the devices they sell don't create more harm than good.

The number of issues related to medical devices is on the rise as well, with over 3,000 such problems reported in 2018 alone. These issues include malfunctions within specific products as well as those instances when a product doesn't quite live up to expectations – no matter how rare those events may be – which might lead patients to file lawsuits. By ensuring that their devices meet certain standards and regulations before selling them, companies can help reduce some of the risks involved.

Market Segmentation:

The global Medical Device Testing and certification market is segmented into, service type, sourcing type, device class. On basis of service type, market is segmented into testing services, inspection services, certification services, and other services. On basis of sourcing type, market is segmented into in-house and outsourced. On basis of device class, market is segmented into Class I, Class II, and Class III. On basis of technology, market is segmented into active implant medical device, active medical device, non-active medical device, in vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, and other technologies.

Hospitals and Medical Device Companies are Under Increased Pressure to Outperform

Hospitals and medical device companies are also under increased pressure to ensure that patients get everything they need, even if it means providing multiple devices to make the patients life easier. This is especially important when it comes to hospital beds, wheelchairs, special wound care equipment, respiratory aids for sleep apnea sufferers and many other specific types of devices.

Another factor playing into this rise in testing has been changes made by regulatory agencies like the FDA (U.S. Food and Drug Administration). These agencies have begun placing stricter controls on certain kinds of procedures involving medical device manufacturers because often times these corporations aren't doing enough to ensure their products do what they're supposed to do putting them out on the market. As a result, manufacturers and hospitals alike are now taking the time to conduct more thorough testing on their products before putting them out there. In addition to this, medical device companies have increased their internal quality control measures so they can catch any issues earlier in the process when its likely less expensive to fix them.

Testing Services to Dominate the Global Medical Device Testing Market

The Food and Drug Administration (FDA) regulates medical devices, which is a broad category that includes everything from contraceptives to heart valves. It has been estimated that more than 1 million of these products are used in the US every day. Given this huge number, it goes without saying that failure of which can lead to serious injury and even death of the patient. It is therefore, crucial for manufacturers of these devices to be sure their products do not fail. One way they ensure such quality is by subjecting them to stringent tests before releasing them on the market following approval by the FDA on compliance with standards on safety and usefulness.

While device testing is done before they are bought to market, there comes a time when manufacturers must subject their products to further testing to make sure there are no defects. With the need for quality assurance ever increasing, related service industries have sprung up that provide Medical Device Testing services for manufacturers and other businesses.

A lot of these companies offer these services for devices that already made it to the market as well. This is because products may fail after release to the public due to mishandling or use beyond how they were intended by design. A good example of this is faulty heart valves implanted inside patients' bodies which were later found out to be defectively designed leading them malfunction thus requiring replacement surgery.

Asia Pacific to Witness Fastest Growth in Medical Device Testing Market

The medical device market in Asia Pacific is expected to grow at a CAGR of 5.4% during the forecast period propelled by the continuous growth of ageing population coupled with increasing healthcare expenditure management. The growing number of skilled medical professionals and evolving reimbursement framework are further expected to boost the market growth during the forecast period. Asia-pacific accounted for around 32% share of global revenue, growing at a CAGR of 5.4%. China alone accounts for over 35% share of the regions revenue as it comprises a significant portion of total Asian population. India and Japan are other major contributor accounting for more than 45% share of the regional market collectively.

Competitive Landscape:

The med-tech market is full of competition. Huge companies are constantly developing new products to compete for the biggest share of the market. With so many companies in the med-tech business, whats being done to protect consumers? After all, these are life supporting devices people are putting in their bodies. The three largest players in Medical Device Testing industry are Medtronic plc (US), Siemens AG (Germany), and Terumo Corporation (Japan). These companies have seen steady growth over the past five years.

Some of the key players in the global Medical Device Testing market are Medtronic plc (US)

The Medical Device Testing is Segmented as Follows: