Global Medical Device Testing and Certification Market to Grow at a CAGR of 5.2% by 2032.

Introduction

Pharmaceutical products and medical devices must adhere to quality assurance requirements. Product validation and verification aim to ensure that the product functions as intended. The rising demand for the validation and verification of medical devices, the increasing consumption of medical devices in developing countries, the harmonization of standards, the imposition of stringent government regulations, and the growing trend of outsourcing medical device testing services and standards are anticipated to drive the demand for medical device testing and certification over the forecast period.

Market Dynamics

Increasing Need for Validation and Verification (V&V) for Medical Devices to Drive the Global Medical Device Testing and Certification Market

Validation and verification operations must be thorough and well-documented to ensure the highest quality designs and production processes. With validation and verification, medical equipment errors are reduced, less redesign is required, and a quicker production process can be ensured. These validation and verification developments contribute to the market's expansion.

Validation and verification (V&V) services are in greater demand due to the expansion of the medical device industry and the increased complexity of product engineering and design. Due to the incorporation of software, medical devices are shrinking and becoming more complicated. The complexity of requirements and customer needs has increased the complexity of medical devices, thereby increasing the demand for validation and verification.

In addition, the prevalence of chronic diseases, such as cancer, is rising, increasing the demand for developing advanced technologies and the necessity for validation and verification. Compared to the past, validation and verification are now more uniform, which has expedited the overall manufacturing process and the approval procedure. It is further improved by automated testing and effective diagnostic and data collection instruments. As a result of the considerations mentioned above, it is evident that the validation and verification process is gaining significance and positively influencing market expansion.

Acquisition Opportunities to Provide Immense Potential for the Global Medical Device Testing and Certification Market

As these gadgets must comply with strict rules, manufacturers are investing considerably in testing and certification. In addition, as major pharmaceutical and biopharmaceutical companies emphasize developing numerous therapeutics and medical devices intended to provide effective treatment for various chronic diseases, the future demand for medical device testing and certification services is anticipated to increase.

In September 2020, the French private equity group ArchiMed announced the acquisition of North American Science Associates, an American provider of testing and consulting services to manufacturers of medical devices. In addition, 2020 Biogroup-LCD announced in August the acquisition of Medisch Labo Medina, a medical laboratory for testing and diagnosis in Belgium. In January 2020, SGS announced the addition of Stephens & Associates, a US-based provider of safety, efficacy, and contract research services to the pharmaceutical, device, cosmetic, and personal care product industries.

In light of the trends mentioned above, it is evident that medical device testing companies are engaging in acquisitions and strategic investments in medical device testing services, thereby creating enormous growth opportunities for the market.

Regional Insights

By Region, the global medical device testing and certification market is segmented into North America, Europe, Asia Pacific, and LAMEA.

North America accounted for the largest market share and is estimated to grow at a CAGR of 4.3% during the forecast period. The Food and Drug Administration (FDA) regulates the testing and certification of medical devices in the United States. The FDA expanded the Abbreviated 510(k) Program for medical device development and premarket notification submissions in February 2019. The FDA has implemented a new device approval procedure in this expanded advice. In this method, a 510(k)-eligible device manufacturer could seek clearance by demonstrating substantial equivalence by meeting FDA-identified performance requirements. Later in September 2019, the FDA issued several draught guidance documents outlining performance criteria and testing methodology for four types of class II devices. These improvements and regulatory amendments by the FDA have simplified the product approval process while simultaneously requiring devices to meet validation and verification standards, which is anticipated to stimulate market growth.

Europe is the second largest region. It is projected to reach an expected value of USD 3,435 million by 2030, registering a CAGR of 4%. The medical equipment market in Germany is advanced and robust. Established firms like Siemens, Carl Zeiss, and Draegerwerk. Germany's medical technology market is the third largest in the world, behind the United States and Japan, and by far the largest in Europe. All medical devices marketed in Germany must undergo a testing and certification procedure; therefore, expanding the medical device market is anticipated to increase the demand for testing and certification. The German market for medical devices is governed by German and European Union (EU) directives, standards, and safety laws that require medical equipment to meet stringent safety and certification requirements before it may be sold in Germany. The EU Medical Device Regulation (MDR) is set to take effect in Germany in May 2021, increasing testing, certification, and compliance requirements for medical devices.

 The Asia Pacific is the third largest region. China's medical equipment industry is one of the largest in Asia-Pacific. Before being introduced to the Chinese market, the Chinese government mandates that all medical devices undergo proper testing and compliance procedures. For most medical equipment, the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration, demands in-country testing and significant clinical data. The State Council of China enacted new Medical Device Regulations. The new regulations have increased post-market product safety inspections and penalized producers. The liability for noncompliance with the standards has increased due to the new rules. For instance, the production and distribution of unlicensed medical devices can result in fines ranging from 15 to 30 times the product's sales value. In addition, it is anticipated that this regulation will increase the demand for medical testing and standard certifications, as manufacturers will emphasize safety and risk assessment more before marketing medical devices in China.

Key Highlights

• The global medical device testing and certification market size was valued at USD 10.6 billion in 2023. It is estimated to reach an expected USD 15.83 billion by 2032, registering a CAGR of 5.2% during the forecast period (2024-2032).
• By Service Type, the global medical device testing and certification market is segmented into testing services, inspection services, and certification services. The testing services segment accounted for the largest market share and is estimated to grow at a CAGR of 4.2% during the forecast period. 
• By sourcing type, the global medical device testing and certification market is segmented into in-house and outsourced. The in-house segment accounted for the largest market share and is estimated to grow at a CAGR of 4% during the forecast period. 
• By Device Class, the global medical device testing and certification market is segmented into Class I, Class II, and Class III. Class II accounted for the largest market share and is estimated to grow at a CAGR of 3.8% during the forecast period. 
• By technology, the global medical device testing and certification market is segmented into active implant medical devices, active medical devices, non-active medical devices, ophthalmic medical devices, in vitro diagnostic medical devices, vascular medical devices, orthopedic and dental medical devices, and other technologies. The active medical device accounted for the largest market share and is estimated to grow at a CAGR of 3.8% during the forecast period. 

Competitive Players

1. Charles River Laboratories
2. American Preclinical Services
3. North America Science Associates Inc (NAMSA)
4. Element Materials Technology
5. WuXiAppTec Group
6. Eurofins Scientific
7. Labcorp (Toxikon, Inc)
8. TUV SUD AG
9. Medistri SA
10. BSI Group
11. Ente Certificazione Macchine
12. GMED
13. IMQ Group SRL
14. Pace Analytical Services LLC
15. Gateway Analytical LLC

Recent Developments

• August 2022 - TÜV Rheinland has granted the world's first certification for a drone following the new EU regulation for civil unmanned aircraft systems (UAS) as an official Notified Body.
• June 2022 - Conenergy and TÜV Rheinland have partnered to increase services along the whole hydrogen value chain and to aid clients in their transition to a more sustainable energy source.

Segmentation

1. By Service Type
   1. Testing
   2. Inspection
   3. Certification
   4. Others
2. By Sourcing Type
   1. In-house
   2. Outsourced
3. By Device Class
   1. Class I
   2. Class II
   3. Class III
4. By Technology
   1. Active Implant Medical Device
   2. Active Medical Device
   3. Non-Active Medical Device
   4. In Vitro Diagnostic Medical Device
   5. Ophthalmic Medical Device
   6. Orthopedic and Dental Medical Device
   7. Vascular Medical Device
   8. Others
5. By End User
   1. Medical Device Manufacturers
   2. Hospitals and Clinics
   3. Research Laboratories & Academic Institutions
   4. Contract Research Organizations (CROs)