“The harmonization of standards, growing consumption of medical devices in emerging countries, increasing need of validation and verification for medical devices, the imposition of rigorous government regulations, the growing trend of outsourcing medical device testing services and standards across medical devices will drive the growth of medical device testing market.”
The medical device testing market was valued at USD 9.3 billion in 2020 and is projected to reach USD 11.8 billion by 2025; growing at a CAGR of 4.8% from 2020 to 2025. The medical device testing market is growing due to the increasing need of verification and validation for medical devices. The in-vitro diagnostic (IVD) medical device segment held the largest share of the medical device testing market in 2019, owing to the increasing demand for rapid testing kits and other diagnostics devices across regions. The active implant medical device segment is projected to witness the highest CAGR during the forecast period, owing to the implementation of stringent regulations to ensure that the implantable medical devices are fit for the human body.
The market for medical device testing is primarily driven by the continuously rising number of COVID-19 cases leading to the increasing number of ICU beds, which leads to the growing demand for COVID-19 priority medical devices.
The market is also driven by factors such as the increased requirement for PPE kits and N95 masks globally and rising demand for ventilators for the effective management of critical COVID-19 patients. The demand for in-vitro diagnostic products due to the COVID-19 pandemic is expected to increase mainly due to factors such as market demand for rapid-test products and a sharp rise in the target patient population in a few countries. However, delays in non-urgent treatment and surgical procedures and the impact on supply chain and logistics due to lockdown are likely to restrain the growth of this market
“Testing services are likely to hold the largest share of the medical device testing market, in terms of value, in 2025 and a similar trend is expected to continue until 2025”
The medical device testing market for certification services is projected to grow at the highest CAGR during the forecast period. Certification services are required to check whether the medical devices and services have complied with the required standards and regulations.
“The market for class II medical devices hold the largest share while Class III will grow at a higher CAGR during the forecast period”
There has been a high surge in demand for class III devices since they include life-critical medical devices that are needed in treating COVID-19 patients also these devices have to go through critical testing, inspection, and certification processes.
“Asia Pacific: The fastest-growing region in the medical device testing market.”
The Asia Pacific region is estimated to dominate the medical device testing market and is projected to grow at the highest CAGR during the forecast period. The market growth in this region can be attributed to the increase in regulatory focus on quality control for manufacturing operations and additional safety, testing, and reporting measures, which require advanced test equipment and instrumentation on-site in manufacturing facilities and laboratories.
Breakdown of primaries
The study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows:
- By Company Type– Tier 1- 52%, Tier 2- 14% Tier 3 - 34%
- By Designation? C level - 49%, Managers & Other Level - 51%
- By Region? North America - 21%, Europe - 42%, Asia Pacific - 32%
The medical device testing market is dominated by a few globally established players such as SGS (Switzerland), Eurofins Scientific (UK), Bureau Veritas (UK), Intertek (UK), T?V S?D (UK), and DEKRA (UK).
The report segments the medical device testing market and forecasts its size, service type, sourcing type, device class, technology and region (Asia Pacific, Europe, North America, and RoW).
The report also provides a comprehensive review of market drivers, restraints, opportunities, and challenges in the medical device testing market. The report also covers qualitative aspects in addition to the quantitative aspects of these markets.
Key Benefits of Buying the Report:
- The report will help the leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall market and the sub-segments.
- This report will help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies.
- The report also helps stakeholders understand the pulse of the medical device testing market and provides them information on key market drivers, restraints, challenges, and opportunities.
- This report would help understand the pre and post-COVID-19 scenarios as to how would the penetration of medical device testing will look like for the forecast period. The region segment includes the country wise impact analysis of COVID-19 and initiatives taken to overcome these impacts.