Market Overview
The Total Addressable Market (TAM) for Medical Device Analytical Testing Outsourcing size was valued at USD 5.17 billion in 2022. It is expected to reach USD 10.08 billion by 2031, growing at a CAGR of 7.70% during the forecast period (2023–2031).
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.
Market Dynamics
Medical Device Analytical Testing Outsourcing Market Drivers
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.
Medical Device Analytical Testing Outsourcing Market Restraints
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.
Medical Device Analytical Testing Outsourcing Market Opportunity
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.
Segmental Analysis
The medical device analytical testing outsourcing market is segmented into the following categories: Services, Therapeutic Areas, Device Type, End-use, Region.
On the Basis of Service
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.
On the Basis of Therapeutic Area
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.
On the Basis of Device Type
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.
On the Basis of End User
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.
Top Key Players
Cardinal Health, Inc.
Onex Corporation
Te Connectivity Ltd.
Flex Ltd.
Heraeus Holding GmBH
Integer Holdings Corporation
Nortech Systems Incorporated
Plexus Corp.
Sanmina Corporation
West Pharmaceutical Services, Inc.
Others
