Medical Device Analytical Testing Outsourcing Market 2023-2030: Rising Demand for Reprocessed Devices

Dublin, Aug. 30, 2023 (GLOBE NEWSWIRE) -- The "Medical Device Analytical Testing Outsourcing Market 2023-2030" report has been added to ResearchAndMarkets.com's offering.

The global medical device analytical testing outsourcing market is projected to attain a substantial size, reaching USD 10.57 billion by 2030, growing at an impressive Compound Annual Growth Rate (CAGR) of 8.2% from 2023 to 2030. This dynamic growth is fueled by the strategic outsourcing of analytical testing operations by numerous medical device companies, driven by the desire to mitigate business risks, expedite product market entry, and reduce costs.

Trend of Outsourcing for Cost Efficiency

Medical device Original Equipment Manufacturers (OEMs) are embracing outsourcing as a cost-saving strategy, a response to the escalating expenditure levels. This strategic shift is propelled by the medical device sector's dedication to cutting-edge technology and innovation. As a result, medical device manufacturers (MDMs) are increasingly outsourcing testing requirements to navigate the evolving landscape of the medical and healthcare market, particularly in light of the recovery from the COVID-19 slowdown.

Regulatory Pressures and Testing Challenges

In 2021, the demand for compliance with European Medical Device Regulation (MDR) standards, coupled with heightened regulatory expectations in leachables and extractables (E&L) testing, significantly influenced testing efforts. However, capacity expansion for laboratories has been restricted due to delays, labor shortages, and external resource constraints. Regulatory authorities are placing heightened emphasis on validation of testing techniques, especially data quality encompassing repeatability and reproducibility. This drive towards more deterministic testing methods enables companies to obtain statistically robust data for product compliance assessment.

Navigating Complex Testing Regulations

In the context of ISO 10993-18:2020 E&L testing regulations, the medical device sector and testing laboratories are encountering obstacles while ensuring compliance with FDA expectations. Throughout 2021, the FDA advised conservative testing techniques to minimize potential inaccuracies in E&L testing. Amidst increasing competition within the medical device industry, the market is poised to generate growth opportunities. As companies vie for market share, the need to streamline time-to-market processes becomes crucial. However, navigating complex regulatory norms necessitates a deep understanding of updated protocols, making outsourcing a logical choice for specialized expertise.

Diverse Opportunities for Industry Players

Research indicates promising opportunities for both suppliers and buyers within the medical device industry. For smaller companies, outsourcing manufacturing and development activities prove cost-effective. On the other hand, larger corporations can enhance their core business focus by outsourcing non-core activities. The report highlights the dominant revenue share of the hospital segment in 2022, attributed to high patient volumes and increased allocation in hospital management budgets for surgical procedures.

Rising Demand for Reprocessed Devices

Furthermore, the reprocessed devices segment is projected to witness the highest CAGR during the forecast period. These devices present a more affordable option, costing around 30-40% less than new devices. This cost efficiency aligns with the demand observed in price-sensitive low- and medium-income countries.

Market Highlights

• The material characterization services segment led the revenue in 2022, playing a pivotal role in quality maintenance, risk mitigation, regulatory adherence, and cost optimization.
• The cardiology therapeutic area segment dominated the revenue share in 2022, driven by increased demand for cardiovascular devices due to the rising prevalence of related conditions.
• Asia Pacific emerged as the market leader in 2022 and is expected to experience rapid growth due to its large population base, affordability concerns, and demand for accessible treatment solutions.
• North America is also anticipated to witness substantial growth, aided by the presence of multinational players like Charles River Laboratories, WuXi AppTec, and SGS SA.
• As the medical device sector faces increasing scrutiny over quality, reclassification, and regulatory shifts, partnering with laboratories to meet these requirements economically becomes crucial.

Key Attributes

Key Topics Covered

Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Medical Device Analytical Testing Outsourcing Market Variables, Trends, & Scope
Chapter 4. Medical Device Analytical Testing Outsourcing Market: Service Estimates & Trend Analysis
Chapter 5. Medical Device Analytical Testing Outsourcing Market: Therapeutic Areas Estimates & Trend Analysis
Chapter 6. Medical Device Analytical Testing Outsourcing Market: Device Type Estimates & Trend Analysis
Chapter 7. Medical Device Analytical Testing Outsourcing Market: End-Use Estimates & Trend Analysis
Chapter 8. Medical Device Analytical Testing Outsourcing Market: Regional Estimates & Trend Analysis
Chapter 9. Competitive Landscape

• SGS SA
• 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

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• Global Medical Device Analytical Testing Outsourcing Market