The global medical device analytical testing outsourcing market was valued at USD 5.14 billion in 2021 and is expected to reach USD 9.62 billion in 2030 expanding at a compound annual growth rate (CAGR) of 8.16% from 2022 to 2030. To cut costs, reduce business risks, and hasten product market launch, many medical device makers outsource analytical testing procedures. Due to the significant rise in costs caused by these processes, original equipment manufacturers of medical devices have turned to outsourcing as a cost-saving measure. The manufacturer must pay the regulatory agencies for routine post-market surveillance. The strictness of these processes is evidenced by the fact that products are often taken off the market after receiving complaints about faults. A successful medical device ecosystem depends on a number of critical improvements, including personalised treatment, drug-device combinations, wearable technology, and a stronger emphasis on real-time patient monitoring. To reduce direct human interaction in surgical procedures, technology such as surgical robots, surgical microscopes, ophthalmic surgical equipment, and neurosurgical techniques have been created. To preserve accuracy and precision and guarantee effective performance, regular maintenance and quality checks are necessary. Outsourcing quality testing of such equipment makes sense when a high level of expertise and skill is required.
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The Market Is Expanding as A Result of the Growing Need for Medical Device Testing and Validation
The healthcare business makes considerable use of a variety of verification and validation techniques, reflecting the industry's widespread adoption of these practises. In general, verification is the phase of product development in which it is determined whether or not a product complies with the requirements that have been specified, whereas validation determines whether or not the intended use has been met and, as a result, whether or not usability requirements have been met. Additionally, the size of medical gadgets is shrinking, and their designs are getting more intricate, often including high-tech polymers. As a result, the validation and verification (V&V) process takes on an even higher level of significance. As a consequence, the process is more repeatable, generates fewer errors, requires less rework and redesign, shortens the amount of time required to bring the product to market, increases its competitiveness, and reduces manufacturing costs. Additionally, growing standards and regulations relating to medical device validation and verification services are projected to fuel the expansion of the medical device testing market. This is a major driver of the growth of the medical device testing market.
The ever-increasing prevalence of chronic diseases around the globe is pushing up the demand for analytical testing of medical devices that are outsourced.
A significant obstacle faced by the industry is the requirement of highly creative technology to guarantee accurate testing, as well as the presence of complicated government rules in a variety of nations.
The primary obstacle that might impede the growth of the business is problems associated with the lengthy preparation time required for international qualification examinations.
It is anticipated that developments in technology and the incorporation of advanced technologies like artificial intelligence (AI) and the internet of things (IoT) into a variety of medical devices would generate profitable prospects for the expansion of the market.
The medical device analytical testing outsourcing market is segmented into the following categories: Services, Therapeutic Areas, Device Type, End-use, Region.
Based on service the market is divided into: Extractable & Leachable, Material Characterization, Physical Testing, Bioburden Testing, Sterility Testing and Other tests. With a revenue share of 18.2 % in 2021, the material characterisation segment led the market. Understanding a material's composition and propensity to have adverse biological effects when employed in a medical device begins with material characterisation. It serves as a method of verifying material homogeneity between different lots of devices. The methodologies indicated above would be used to a greater extent by the U.S. device industry to help in the selection of suitable materials and to manage the uniformity of medical devices as the ISO 10993 standards and FDA requirements become more aligned.
Other services addressed in this study include extractable and leachable, material characterisation, physical testing, bioburden testing, sterility testing, and other tests. Over the projection period, the bioburden testing category is anticipated to grow at the quickest CAGR. Finding the number of live bacteria on medical equipment is a methodical process. Prior to sterilisation, there will be less microbiological contamination in compliance with international standards. Colony Forming Units include a report of the test findings (CFU). The criteria for calculating the bioburden of a medical device are laid forth in ISO 11737-1:2018.
Based on Therapeutic areas the market is divided into: Cardiology, Diagnostic Imaging, Orthopaedic, IVD, Ophthalmin, General & Plastic Surgery, Drug Delivery, Endoscopy, Dental, Diabetes Care and Others. Cardiology is anticipated to grow further at a considerable CAGR during the projection period, accounting for the highest revenue share of more than 21.00 % in 2021. The growth of these goods' outsourcing is responsible for the rise in demand for cardiovascular devices, which is brought on by the rising prevalence of connected disorders. According to data from the (WHO), 17.9 million deaths worldwide in 2019 were attributable to CVDs, or 32% of all fatalities. The enormous complexity of cardiovascular devices and the requirement for technical expertise also contribute to a growth in the outsourcing of these devices. On the other hand, general and cosmetic surgery device outsourcing is anticipated to grow quickly throughout the projection period.
The availability of regulated professional outsourcing companies and rising demand for cosmetic surgery are expected to drive this category's expansion. The average cost of facelift in 2018 was close to $8,000, according to the American Society of Plastic Surgeons, with Americans spending more than $16.6 billion on cosmetic plastic surgery. Additionally, aesthetic physicians and plastic surgeons from all over the world reported an upsurge in appointments for surgical and non-surgical procedures during the pandemic-induced lockdown.
The market for reprocessed devices had the second-largest revenue share globally in 2021, and it is anticipated that it would grow at the quickest CAGR of more than 9.5 % between 2022 and 2030. Reprocessing is done to cut expenses, which frequently puts patient safety at danger. It is a systematic science approved by the U.S. (FDA) that provides to lower long-term healthcare expenditures and give cost savings in the developed countries, especially in the U.S. and Europe.
Reprocessing include cleaning up any apparent debris, completely sterilising the device, packing and labelling it, and eventually holding the reprocessor responsible for any negative impacts the item may have. On a worldwide level, medical device reprocessing is still in its infancy, but it has already been shown to offer considerable advantages to healthcare practitioners. The majority of cardiology and nephrology catheters, orthopaedic blades, fixation devices, electrophysiology catheters, electrosurgical electrodes, endotracheal tubes, and ophthalmic knives may now be recycled. They represent a sizable 30% of medical supplies, enabling cost savings.
In 2021, the hospitals sector led the global market and accounted for the highest revenue share of more than 86.00 %. The rise in patient volume and the additional funding provided for these operations by hospital management can be credited with this expansion. Another important element encouraging the implementation of analytical testing for such devices is the rising demand for cutting-edge technologically based medical equipment across hospital facilities. The facilities use cutting-edge, technology-based medical gadgets that require effective analytical testing for improved performance, which boosts market growth. Hospitals are another important platform for contract developers to outsource analytical services since they are the primary suppliers of refurbished medical devices that need these services.
In the upcoming years, additional healthcare venues such diagnostic centres, ambulatory care centres, and specialised care centres would also attain sizable market shares. Equipment and consumables are other categories within the hospitals industry. About 39.5 % of hospital-based medical equipment analytical testing services in 2021 were categorised as equipment. Examples of these devices include cardiology equipment, imaging equipment, surgical microscopes, surgical instruments, and therapeutic & monitoring equipment. Calibration, preventative maintenance, and performance tests for these equipment are outsourced and purchased for long-term use.
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In 2021, the Asia Pacific region led the world market and generated more than 41.0 % of worldwide revenue. The regional market is anticipated to keep dominating over the projected period while growing at the quickest CAGR. Government initiatives to upgrade the area's healthcare system are responsible for this expansion. Additionally, market expansion is probably supported by economic shifts in China and India. There is a high need for cost-effective treatment options because of the area's substantial population and low per capita income. International businesses are keen to make investments in growing nations like China and India.
During the projection period, North America is also expected to have significant expansion. The fact that this region is one of the most significant production hubs for highly dependable, complex, and expensive medical items is largely responsible for the growth of this industry. Due to the rising number of electronic components in modern medical equipment, Original Equipment Manufacturers (OEMs) are increasingly resorting to electronics manufacturing service providers. One of the key reasons expected to drive the market is a significant rise in the manufacture of medical devices to meet the region's expanding need for high-quality healthcare.
List of key players
The business inaugurated its brand-new medical device testing facility in Suzhou, China, in November 2018. A 15,000 square metre space is used by the new medical device testing centre. By transferring the capabilities, operations, and quality management system of WuXi AppTec's U.S.-based Medical Device Testing Facility, the new centre would offer full medical device testing services in compliance with international quality standards.