Medical Device Analytical Testing Outsourcing Market

The global medical device analytical testing outsourcing market size was valued at USD 5.58 billion in 2022 and is expected to surpass USD 10.97 billion by 2031, expanding at a CAGR of 7.8% during the forecast period, 2023–2031. The growth of the market is attributed to the complexity in product design, increased competition, an increase in the number of small medical device makers, and tight regulatory criteria.

Several medical device manufacturers engage in outsource of analytical testing processes in order to decrease costs, eliminate business risks, and accelerate product market introduction. These procedures result in a large increase in expenditures, prompting original equipment makers of medical instruments to turn to outsourcing as a cost-cutting strategy.

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The regulatory authorities also charge the producer a fee for routine post-market surveillance. The receipt of any complaints regarding a product's flaws generally results in its removal from the market, demonstrating the strictness of these procedures. Personalized medicine, drug-device combinations, wearables, and a greater focus on real-time patient monitoring are key changes to ensure an effective medical device ecosystem.

Surgical robots, surgical microscopes, ophthalmic surgical equipment, and neurosurgical technologies have been developed to eliminate direct human intervention in surgical processes. Periodic maintenance and quality inspections are essential to maintain precision and accuracy to ensure successful performance. When a high degree of knowledge and competence is required, outsourcing quality testing of such equipment is a sensible choice.

The need for novel low-cost medical devices has been widely highlighted among healthcare community and medical professional with the outbreak of the COVID-19 pandemic. This pandemic had catastrophic effects in the global economy and caused a massive wave of health disaster worldwide. Various enterprises have shut down their production operations and halted the majority of the manufacturing process as a result of emergency lockdown.

Medical device TIC services have always been in demand as they serve a key role in safeguarding customers from dangerous and low-quality medical devices. The need for masks has grown as a result of COVID 19, and several nations have released related specifications such as UNE 0064-1, UNE 0065, and UNE 0064-2.

Market Trends, Drivers, Restraints, and Opportunities

• Rising demand for less invasive operations for disease treatment and availability of cost-effective testing devices for medical activities are expected to drive the market growth during the forecast period.

• Strict regulation to ensure medical device validation and verification for several testing equipment presents another key driver of the market.

• Requirement of high innovative technology to ensure testing accuracy and complex government regulations across countries act as a major challenge of the market.

• Issues related to long lead time for foreign qualification tests is a key hurdle that can hamper the market expansion.

• Technological advancement and integration of high technology such as Artificial Intelligence (AI) and Internet of Things (IoT) for various medical devices are expected to create lucrative opportunities for the market growth.

Scope of Medical Device Analytical Testing Outsourcing Market Report

The report on the global medical device analytical testing outsourcing market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Medical Device Analytical Testing Outsourcing Market Segment Insights

Material characterization segment to expand at a considerable CAGR

On the basis of services, the medical device analytical testing outsourcing market is segmented into physical testing, bioburden testing, sterility testing, extractable & leachable, material characterization, and others. The material characterization segment is projected to expand at a considerable CAGR during the forecast period due to the growing demand for high-quality and industry-standard products.

On the other hand, the extractable & leachable segment is anticipated to account for a major market share during the forecast period. These are any solutes or chemicals on the surface of the medical devices that might be removed or leached out into the environment if they are used with the intended liquids.

Reprocessed devices segment to hold a significant share of the market

In terms of device types, the market is divided into reprocessed devices and others. The reprocessed devices segment is further categorized as hospital and others. The reprocessed devices segment is expected to hold a significant share of the market ascribed to rising demand for single-use treatment and monitoring devices.

Cardiology segment to grow at a high rate during the forecast period

Based on therapeutic areas, the medical device analytical testing outsourcing market is segregated into IVD, ophthalmic, general & plastic surgery, drug delivery, endoscopy, dental, diabetes care, cardiology, diagnostic imaging, orthopedic, and others. The cardiology segment is expected to grow at a high rate during the projected period due to to the rising prevalence of cardiac disorders.

Moreover, the general & plastic surgery segment is expected to be a fast-growing segment during the forecast period as the availability of professional outsourcing organizations that comply with regulatory regulations as well as increased demand for aesthetic operations.

Hospital segment to dominate the market

On the basis of end-users, the market is bifurcated into hospital and others. The hospital segment is further classified as equipment and consumables. The hospital segment is likely to dominate the market during the projected timeline due to an increase in patient traffic and a higher budget allocation for these operations by hospital administration.

Asia Pacific is anticipated to constitute a key market share

In terms of regions, the medical device analytical testing outsourcing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. Asia Pacific is expected to constitute a key share of the market during the projected period due to governments’ program aimed at strengthening healthcare infrastructure.

However, the market of North America is anticipated to expand at a rapid pace during the forecast period owing to wide expansion of production centers for extremely dependable, sophisticated, and high-end medical products in the region.

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Segments

The global medical device analytical testing outsourcing market has been segmented on the basis of

Services

• Physical Testing
• Bioburden Testing
• Sterility Testing
• Extractable & Leachable
• Material Characterization
• Others

Device Types

• Reprocessed Devices
  • Hospital
  • Others
• Others

Therapeutic Areas

• IVD
• Ophthalmic
• General & Plastic Surgery
• Drug Delivery
• Endoscopy
• Dental
• Diabetes Care
• Cardiology
• Diagnostic Imaging
• Orthopedic
• Others

End-users

• Hospital
  • Equipment
  • Consumables
• Others

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• NORTH AMERICAN SCIENCE ASSOCIATES INC.
• Envigo
• Charles River Laboratories International Inc.
• Medical Device Testing Services
• SGS SA
• Toxikon, Inc.
• Eurofins Scientific
• Pace Analytical Services, LLC
• Intertek Group plc
• WuXi AppTec

Competitive Landscape

Key players competing in the global medical device analytical testing outsourcing market are NORTH AMERICAN SCIENCE ASSOCIATES INC.; Envigo; Charles River Laboratories International Inc.; Medical Device Testing Services; SGS SA; Toxikon, Inc.; Eurofins Scientific; Pace Analytical Services, LLC; Intertek Group plc; and WuXi AppTec.

To maintain their market position, key companies are focused on different growth methods such as partnerships, mergers and acquisitions, and product range development. The market participants are expected to benefit from the development of their service portfolios as well as regional penetration.