Medical Device Testing Market Size, Share & Growth Analysis

Updated on : October 22, 2024

Medical Device Testing Market Size & Growth

The global medical device testing market size is expected to be valued at USD 10.6 billion in 2023 and is projected to reach USD 13.5 billion by 2028; growing at a CAGR of 4.9% from 2023 to 2028.

Global medical device testing market is experiencing significant growth, driven by an increasing demand for high-quality and reliable medical devices amid stringent regulatory requirements. As healthcare providers and manufacturers prioritize patient safety and efficacy, comprehensive testing of medical devices—from concept development to post-market surveillance—has become essential. Key trends influencing this market include the rising adoption of advanced testing technologies, such as automation and digital solutions, which enhance testing efficiency and accuracy. Additionally, the integration of IoT and connected devices in healthcare is necessitating more rigorous testing protocols to ensure cybersecurity and data integrity. The ongoing emphasis on innovation in medical technology, particularly in areas like wearable health monitors and diagnostic devices, further fuels the demand for robust testing solutions. As regulatory bodies continue to tighten standards and the global focus on healthcare quality increases, the medical device testing market is poised for substantial growth, with investments in advanced testing methodologies and technologies becoming a top priority for manufacturers.

The expansion of the global healthcare sector presents a substantial opportunity for stakeholders in the market. With healthcare accessibility improving, especially in emerging markets, the demand for advanced medical devices is on the rise due to factors such as a growing population, increased disposable incomes, and heightened awareness of healthcare and well-being.

Medical Device Testing Market Forecast to 2028

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Medical Device Testing Market Trends:

Driver: The global expansion of the healthcare industry

The global expansion of the healthcare industry represents a significant opportunity for various stakeholders within the medical device testing market. As healthcare access improves across the world, particularly in emerging markets, there is a growing demand for advanced medical devices. This demand is fueled by an increasing population, rising disposable incomes, and a growing awareness of healthcare and wellness. Consequently, there is a need for robust testing services to ensure the safety, efficacy, and compliance of these devices with stringent regulatory standards. Testing facilities and services play a vital role in supporting the global expansion of the healthcare industry by providing the necessary assurance to manufacturers, healthcare providers, and patients, thus contributing to the overall growth and credibility of the medical device sector on a global scale.

Restraint: Quality concerns and product recalls for medical devices

Quality concerns and the associated risk of product recalls represent a critical restraint for the medical device testing market share. Ensuring the quality and safety of medical devices is paramount, particularly for high-risk devices like pacemakers, coronary stents, and artificial heart valves. A lapse in quality control can have severe consequences, including injuries to end-users or even fatalities. Any compromised quality can lead to product recalls, causing financial losses and reputational damage for manufacturers. Moreover, the potential consequences of poor quality in medical devices, such as product recalls and harm to patients, intensify the need for meticulous testing. Inadequate testing or failure to meet regulatory standards can result in legal, financial, and reputational damage for manufacturers. The need to avoid these significant risks necessitates thorough and meticulous testing processes, adding complexity and costs to the development and testing phases of medical devices. Achieving optimal quality and reducing the risk of recalls are persistent challenges for companies in the medical device testing market.

Opportunity: Connectivity of mobile devices with medical equipment

The merging of mobile technology with medical devices is revolutionizing healthcare. Through dedicated applications and connectivity, mobile devices seamlessly connect with medical equipment, empowering individuals to monitor and manage their health on-the-go. This integration improves accessibility and facilitates timely interventions, resulting in enhanced health outcomes. Rapid advancements in wireless technologies and sensor-based devices have given rise to a new wave of mobile medical devices, significantly enhancing patient quality-of-life while reducing healthcare costs for both providers and patients. The compact size and networking capabilities of these mobile medical devices offer considerable advantages, allowing patients to make fewer hospital visits and giving healthcare providers the benefit of reduced administrative overheads and care expenses.

Challenge: Intricate nature of supply chains in medical device testing

The medical device testing supply chains face rigorous regulatory demands, presenting a notable challenge. As components are often procured worldwide, ensuring a smooth supply chain while upholding stringent quality control and compliance standards proves difficult. The complexity arises from the need to manage multiple suppliers, coordinate logistics, and ensure consistent safety and quality standards throughout the testing process in today's interconnected global economy. In contemporary manufacturing, optimizing costs and profits involves sourcing components globally. However, this approach introduces heightened risks in managing intricate supply chains, further complicated by evolving international trade regulations. The ongoing reviews and frequent changes in trade agreements among nations add to the complexity, influenced by economic and geopolitical factors.

Medical Device Testing Market Ecosystem

The medical device testing market share is dominated by established and financially sound manufacturers with extensive experience in the industry. These companies have diversified product portfolios, cutting-edge technologies, and strong global sales and marketing networks. Leading players in the market include Knowles Eurofins Scientific from Luxembourg, Intertek Group plc from the UK, SGS Société Générale de Surveillance SA. from Switzerland, Bureau Veritas from France, and TÜV SÜD from Germany.

Medical Device Testing Market Segmentation

Testing services segment is expected to hold the highest market share during the forecast period

Testing services hold a significant market share in the medical device testing industry due to their crucial role in ensuring regulatory compliance, safety, and quality of medical devices. The healthcare sector is highly regulated, necessitating comprehensive testing to meet stringent standards set by regulatory bodies like the Food & Drug Administration of US (FDA) and European Commission (EC). Through thorough evaluations, testing services confirm that devices function effectively, pose no risks to patients, and meet specified performance benchmarks. This instills confidence in healthcare professionals and end-users, facilitating market access and fostering trust. Outsourcing to specialized testing facilities grants access to expertise and advanced technology, further driving the prominence of testing services in the medical device testing industry.

Based on device class, the class III to hold the highest market share during the forecast period

Class III medical devices, the highest risk category, require the most rigorous testing and scrutiny in the medical device testing market. These devices, such as pacemakers and implantable defibrillators, undergo extensive testing to ensure their safety, efficacy, and compliance with strict regulatory standards imposed by bodies like the FDA. The complexity and criticality of Class III devices necessitate comprehensive evaluation across multiple parameters, including biocompatibility, performance, sterility, and more. The growth of Class III devices in the market is propelled by their increasing complexity and critical nature, necessitating comprehensive and stringent testing procedures. Regulatory requirements for Class III devices are particularly demanding, driving the demand for rigorous testing to ensure compliance and safety. Additionally, the rising development and adoption of advanced medical technologies, such as implantable devices, contribute to the expanding market for Class III device testing. Manufacturers' emphasis on thorough testing to meet regulatory standards and deliver high-quality, innovative healthcare solutions further fuels the growth of Class III devices in the medical device testing sector.

IVD medical devices for medical device testing market to hold the highest market share

In Vitro Diagnostic (IVD) medical devices, ranging from diagnostic kits to molecular assays, hold a significant market share in medical device testing. These devices play a pivotal role in healthcare, aiding in disease diagnosis, monitoring, and treatment decisions. The demand for IVD medical device testing stems from the critical importance of accurate and reliable diagnostic results in healthcare decision-making. Stringent regulatory requirements necessitate rigorous testing to ensure precision, sensitivity, and specificity of these devices. Furthermore, the increasing prevalence of infectious diseases and chronic conditions fuels the demand for innovative IVD devices, driving the growth of testing services to validate their effectiveness and compliance with regulatory standards.

Medical Device Testing Industry Regional Analysis

Medical device testing market in Asia Pacific to hold the highest CAGR during the forecast period

Rapid economic development and industrialization in countries like China and India are driving substantial investments in healthcare and technology, fueling the demand for medical device testing services. Moreover, evolving regulatory frameworks in the region are placing increased emphasis on quality and safety standards for medical devices, necessitating comprehensive testing. Additionally, the burgeoning middle-class population with higher disposable income is demanding superior healthcare services, boosting the need for advanced medical devices and, consequently, the testing thereof. Lastly, the surge in medical tourism and the aspiration to meet international market standards are further propelling the growth of the market in the Asia-Pacific region.

Medical Device Testing Market by Region

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Top Medical Device Testing Companies - Key Market Players

 The medical device testing companies is dominated by players such as

• Eurofins Scientific (Luxembourg),
• Intertek Group plc (UK),
• SGS Société Générale de Surveillance SA. (Switzerland),
• Bureau Veritas (France),
• TÜV SÜD (Germany) and others.

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Scope of the Report

Medical Device Testing Market Highlights

The study categorizes the medical device testing market based on the following segments:

Recent Developments

• In June 2023, TÜV SÜD has opened a laboratory in New Brighton, Minnesota, accredited to ISO 17025 for biological and chemical testing of medical devices. Staffed by experienced scientists and technicians, the lab will cater to both domestic and international medical device companies, aiding in research and development through microbiology, reusable device testing, chemistry, biocompatibility, and packaging testing services.
• In September 2022, Bureau Veritas has acquired Galbraith Laboratories Inc., known for advanced analytical solutions in healthcare. This acquisition amplifies Bureau Veritas' presence in Consumer Healthcare and Industrial Chemicals supply chains, bolstering support for research, development, and product testing. Galbraith Laboratories' expertise will enhance Bureau Veritas' service portfolio, particularly in medical device testing, expanding its reach and influence in the US.
• In July 2022, Eurofins Scientific acquired WESSLING (Hungary) to enhance its environmental, food, and BioPharma product testing offerings in the European region.
• In October 2021, SGS acquired Groupe IDEA TESTS (IDEA), a leading provider of clinical, microbiological, and in-vitro testing and regulatory services to cosmetic & personal care product manufacturers in France. The acquisition is likely to help SGS to offer enhanced services to customers from the strategic markets of cosmetics & hygiene.

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