Medical Device Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Services, By Therapeutic Areas ,By Device Type ,By End-use, By Region And Segment Forecasts, 2022 - 2030

Report Overview

The global medical device analytical testing outsourcing market size was valued at USD 5.0 billion in 2021 and is anticipated to grow at a compound annual growth rate (CAGR) of 8.1% over the forecast period. The key factors driving the market are complexity in product design, increased competition, an increase in the number of small-scale manufacturers of medical devices, and strict approval norms. The COVID-19 pandemic has emphasized the significance of developing novel low-cost medical equipment. This crisis has resulted in a global economic and health pandemic. As a result, several enterprises have shut down their manufacturing facilities and halted the majority of the manufacturing process.

Medical device TIC services have always been on the rise since they serve a crucial role in protecting consumers worldwide from hazardous and low-quality medical device products. For example, the demand for masks has increased as a result of COVID-19, and several countries have released appropriate specifications, such as UNE 0064-1, UNE 0065, and UNE 0064-2. Pricing pressure exists in developed countries, such as the U.S., thus operators are seeking ways to reduce costs throughout the value chain. On the other hand, the real potential resides in developing economies. However, developing regions are likely to be price-sensitive.

As a result, market players are working hard to cut the overall cost of gadgets. Outsourcing analytical testing processes allows businesses to focus on product development and marketing initiatives. The COVID-19 pandemic has created a devastating impact on the healthcare industry. However, the market witnessed a considerably minimal negative impact in 2020 compared to other business domains. Moreover, the market even witnessed a significant surge in its growth rate in 2021, owing to the increasing focus on analytical testing of medical devices for COVID-19 infection.

The regulatory authorities also conduct routine post-market surveillance by charging the manufacturers a fee. The receipt of any complaints regarding the product’s flaws results in its removal from the market, demonstrating the stringency of these procedures. Personalized medicine, drug-device combinations, Artificial Intelligence (AI), wearables, and a greater emphasis on real-time patient monitoring have all resulted in a complicated medical device ecosystem. When it comes to chronic disease management, such as diabetes and Cardiovascular Diseases (CVDs), real-time patient monitoring, remote patient monitoring, and continuous patient monitoring are the primary areas of focus.

Service Insights

The material characterization segment dominated the market and accounted for the largest revenue share of 18.2% in 2021. Material characterization forms the basis for understanding the composition of a medical device material and its potential to cause an undesirable biological effect when used. It also acts as a technique for ensuring material uniformity from one lot of devices to the next. As the ISO 10993 standards and FDA criteria become more aligned, the approaches outlined above would be employed to a larger extent by the U.S. device industry to aid in the selection of ideal materials and to control the uniformity of medical devices.

Extractable and leachable, material characterization, physical testing, bioburden testing, sterility testing, and other tests are other services covered in this report. The bioburden testing segment is expected to rise with the fastest CAGR over the forecast period. It is a systematic procedure for determining the population of viable microorganisms on medical equipment. The purpose is to reduce microbiological contamination before sterilization in accordance with International Standards. The results of the tests are reported in Colony Forming Units (CFU). ISO 11737-1:2018 specifies the requirements for determining a medical device’s bioburden.

Device Type Insights

Based on device types, the global market has been further divided into reprocessed devices and others. The reprocessed device segment accounted for the second-largest revenue share of the global market in 2021 and is estimated to expand further at the fastest CAGR of more than 9.5% from 2022 to 2030. Reprocessing aims to save costs, which often jeopardizes patient safety. In the developed regions, particularly in the U.S. and Europe, it is a systematic science authorized by the U.S. (FDA) that offers to reduce long-term healthcare costs and provide cost savings.

Reprocessing includes clearing visible debris, complete sterilization of the device, repackaging & labeling, and, ultimately, the reprocessor being held accountable for any adverse effects generated by the device. Medical device reprocessing is still in its early stages on a global scale, but it has already been demonstrated to deliver significant benefits to healthcare providers. The majority of catheters used in cardiology and nephrology, as well as orthopedic blades, endoscopic devices, fixation devices, electrophysiology catheters, electrosurgical electrodes, endotracheal tubes, and ophthalmic knives, have become reprocessable. They account for a significant 30% of hospital supplies, allowing cost-saving.

End-use Insights

Based on end-uses, the global market has been further sub-segmented into hospitals and others. The hospitals segment dominated the global market in 2021 and accounted for the maximum share of more than 86.00% of the global revenue. This growth can be attributed to the increased patient traffic and increased budget allocation for these operations by hospital administration. Increasing demand for novel technology-based medical devices across hospital facilities is another significant factor supporting the adoption of analytical testing for such devices. The facilities incorporate innovative new technology-based medical devices, which require efficient analytical testing for enhanced performance, thus augmenting the market growth. Moreover, hospital facilities are the major sources of refurbished medical devices that require analytical services, which makes them one of the significant platforms that outsource these services to contract developers.

Other healthcare settings, such as diagnostic centers, ambulatory care centers, and specialty care centers, are expected also to gain significant market shares in the years to come. The hospitals segment is further categorized into equipment and consumables. In 2021, the equipment category accounted for approximately 39.5% of hospital-based medical equipment analytical testing services. Cardiology equipment, imaging equipment, surgical microscopes, surgical devices, and therapeutic & monitoring devices are examples of these devices. These devices are acquired for long-term usage and have calibration, preventive maintenance, and performance checks outsourced.

Therapeutic Areas Insights

The cardiology segment accounted for the maximum revenue share of more than 21.00% in 2021 and is projected to expand further at a significant CAGR over the forecast period. Rising demand for cardiovascular devices, as a result of the increasing prevalence of related conditions, is attributable to the expansion of these products outsourcing. As per the World Health Organization (WHO) statistics in 2019, 17.9 million people died from CVDs and accounted for 32% of global deaths. Furthermore, the significant complexity of cardiovascular devices, as well as the necessity for technical skills, leads to increased outsourcing of these devices. General and plastic surgery device outsourcing, on the other hand, is expected to develop rapidly over the forecast period.

The availability of professional outsourcing organizations that meet regulatory criteria and increased demand for aesthetic surgeries are projected to fuel the growth of this category. According to the American Society of Plastic Surgeons, Americans spent more than $16.6 billion on cosmetic plastic surgery in 2018, with a facelift costing nearly $8,000 on average. Also, during the pandemic-induced lockdown, cosmetic doctors and plastic surgeons around the world reported an increase in bookings for surgical and non-surgical treatments. During this time, the British Association of Aesthetic Plastic Surgeons (BAAPS) reported a 70% increase in requests for virtual consultations during this period.

Regional Insights

The Asia Pacific dominated the global market in 2021 and accounted for more than 41.00% of the global revenue share. The regional market is estimated to expand further at the fastest CAGR retaining its leading position throughout the forecast period. This growth can be attributed to government efforts to improve healthcare infrastructure in the region. Furthermore, economic changes in India and China are likely to support market expansion. Due to the region’s large population base and low per capita income, there is a great demand for economical treatment solutions. Multinational corporations are eager to invest in developing countries, such as India and China.

North America is also anticipated to witness considerable growth during the forecast period. The growth of this regional market is mainly credited to the fact that it is one of the most important production centers for extremely reliable, sophisticated, and high-end medical products. As a result, Original Equipment Manufacturers (OEMs) are increasingly turning to electronics manufacturing service providers to handle the growing volume of electronic components in today’s medical devices. A rapid increase in the production of medical devices to fulfill the region’s growing need for effective healthcare is projected to be one of the primary factors driving the market.

Key Companies and Market Share Insights

Mergers, acquisitions, and partnerships among others were the key strategies adopted by industry participants to maintain their market share. For example, In November 2018, the company opened its new medical device testing center in Suzhou, China.  The new medical device testing center occupies a 15,000-square-meter facility. The new center would provide comprehensive medical device testing services in accordance with international quality standards by transferring the capabilities, operation, and quality management system of WuXi AppTec’s U.S.-based Medical Device Testing Center. Euro fins Medical Device Testing is also dedicated to providing professional assistance in evaluating the safety and efficacy of devices used in the fight against COVID-19. Some of the prominent players in the global medical device analytical testing outsourcing market include:

• SGS

• Toxikon, Inc

• Eurofins Scientific

• Pace Analytical Services LLC

• Intertek Group plc

• Wuxi AppTec

• North American Science Associates, Inc.

• Envigo

• Charles River Laboratories International, Inc.

• Medical Device Testing Services

Medical Device Analytical Testing Outsourcing Market Report Scope

Segments Covered in the Report 

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global medical device analytical testing outsourcing market report on the basis of services, device type, end use, therapeutic areas, and region:

• Services (Revenue, USD Million, 2018 - 2030)

  • Extractable & Leachable

  • Material Characterization

  • Physical Testing

  • Bioburden Testing

  • Sterility Testing

  • Other tests

• Device Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Reprocessed Devices

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital

  • Others

• Therapeutic Areas Outlook (Revenue, USD Million, 2018 - 2030)

  • Cardiology

  • Diagnostic Imaging

  • Orthopedic

  • IVD

  • Ophthalmin

  • General & Plastic Surgery

  • Drug Delivery

  • Endoscopy

  • Dental

  • Diabetes Care

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • UAE

    • Saudi Arabia