Marché des tests de dispositifs médicaux en Amérique du Nord – Tendances et prévisions du secteur jusqu’en 2030

Analyse et perspectives du marché des tests de dispositifs médicaux en Amérique du Nord

Les dispositifs médicaux sont essentiels car ils ont un impact direct sur la vie humaine. Les fabricants de dispositifs médicaux suivent les meilleures pratiques en matière de tests, de vérification et de validation pour garantir la qualité et la fiabilité des équipements médicaux afin de fournir des services de santé sûrs et efficaces aux patients. Il existe un aperçu de haut niveau de la mise en œuvre des stratégies de test des dispositifs médicaux. De nombreux organismes de réglementation et de conformité régissent les dispositifs médicaux. D'autre part, les utilisateurs finaux attendent des performances, une efficacité et une sécurité exceptionnelles de l'appareil qu'ils utilisent. Cela oblige les fabricants de dispositifs médicaux à créer et à déployer des stratégies de test qui fonctionnent tout au long du cycle de développement, du concept et de la conception à la production.

Le besoin croissant de vérification et de validation des dispositifs médicaux à l'échelle mondiale a stimulé la croissance du marché. Certains des principaux acteurs du marché se concentrent fortement sur divers lancements et approbations de services au cours de cette période cruciale. En outre, la demande croissante de tests in vitro contribue également à la demande croissante de tests de dispositifs médicaux. Le marché nord-américain des tests de dispositifs médicaux connaît une croissance au cours de l'année de prévision en raison de l'augmentation du nombre d'acteurs du marché et de la disponibilité de services avancés.

Toutefois, les obstacles au développement local des dispositifs médicaux et le coût élevé des dispositifs médicaux pourraient entraver la croissance du marché des tests de dispositifs médicaux en Amérique du Nord au cours de la période de prévision.

Data Bridge Market Research analyse que le marché nord-américain des tests de dispositifs médicaux devrait atteindre la valeur de 4 904,16 millions USD d'ici 2030, à un TCAC de 12,0 % au cours de la période de prévision.  

Market Definition

Medical device testing is the process of demonstrating that the device is reliably and safely performed in use. In new product development, extensive design validation testing is applied. This includes performance testing, toxicity, chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This usually includes dimensional checks, some functional tests, and packaging verification. Various types of medical testing services are available there in the market, such as inspection services, certification services, and others.

North America Medical Device Testing Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:    

Drivers

• Rising Need for Verification Validation of Medical Devices

Medical device testing is the process of demonstrating that the device will reliably and safely perform diagnosis and treatment. The demand for medical devices is constantly rising as there is a high prevalence of various diseases seen among various regions across the globe.

The methods of verification and validation are widespread and extensively being used in the healthcare industry. In general, verification is the developmental phase of a product if it complies with the specified requirements, whereas validation checks if the intended use has been met and, thus, usability specifics are fulfilled. The most common types of verification and validation for medical devices are design, process, and software verification and validation.

Medical devices are also becoming smaller and more complex in design using advanced, engineered plastics. This makes the process of validation and verification (V&V) all the more important. The results in better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower production costs. Additionally, increasing standards and regulations about medical device validation and verification services are anticipated to drive the growth of the medical device testing market.

• Increasing Demand for In-Vitro Tests

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.

In-vitro tests are used in various disease detections, such as HIV infections, malaria, and hepatitis, among others. The prevalence of such diseases is rapidly increasing across the globe, which leads to the increasing demand for in-vitro tests and various medical devices. As medical devices have become widely available for various diseases due to the rapid manufacturing of medical testing companies, it is a major factor driving the growth of the market.

Opportunities

• Rise in Healthcare Expenditure

Healthcare expenditure has increased worldwide as disposable income in various countries is increasing. Moreover, to accomplish the population requirements, government bodies and healthcare organizations are taking the initiative to accelerate healthcare expenditure. The rise in healthcare expenditure simultaneously helps healthcare settings to improve their treatment facilities for various disorders in the countries.

Growing healthcare expenditure is also beneficial for further economic growth and healthcare sector growth, and it is primarily fruitful as it significantly affects the development of better and more advanced medical products. Therefore, the surge in healthcare expenditure is a greater opportunity for the North America medical device testing market growth.

• Development in Ai And Iot in Various Medical Devices

Artificial intelligence (AI) is a powerful and ever-emerging technology that has the potential to improve capabilities across a multitude of industries. Medical devices with artificial intelligence hold the promise of revolutionizing the healthcare industry, helping medical professionals more accurately and effectively diagnose and treat their patients and improve their overall care. Along with its benefits, medical device artificial intelligence also faces challenges, including the need for regulation to keep up with technological advancement.

Thus, the North America medical device testing market is witnessing a series of developments in drug-device combination, personalized medicine, and elevated adaption of various portable and wearable medical devices. Implementing technological advancements such as IoT and Artificial Intelligence in various devices is a key growth parameter for the global medical device testing service market, creating a huge opportunity.

Challenges/ Restraints

• High Competition in Medical Technology Industry

Many global companies face significant competition from many companies, from large medical device manufacturing companies with multiple product lines. Several players have wide financial and marketing resources than others. The common competition in healthcare involves various elements such as price, quality, convenience, and brand name. Competition can also be based on new technologies and innovation. In general, competition reduces inefficiencies that would otherwise yield high costs of output, which are eventually passed to consumers by high costs of health care and delivery. Products on the market are marketed based on product specifications, product consistency, supply, and price. Consumers, however, benefit from competition that offers rewards for continuing product upgrades and facilitates a higher degree of service efficiency among industry participants. The company’s ability to compete in the market is also impacted by changes in consumer preferences and requirements, such as the growing demand for more eco-friendly medical devices that can be easily dumped without harming the environment and the products incorporated with digital capabilities. This shows high competition in the market, which is a major challenge for the market.

• Barriers to the Local Development of Medical Devices

While promoting standards and control of medical devices is essential, excessive regulations, particularly in the domestic context, can also act as a barrier to local innovation of these devices.

It can potentially hinder domestic innovation by subjecting new technologies to a lengthy and expensive licensing procedure, subsequently increasing the cost and the time that local manufacturers have to spend in addition to the manufacturing cost of the medical equipment. A few products, which are of significant value to low-income countries, may be removed from the market due to the perceived risks associated with their use.

Various factors, such as licensing procedures, the cost of the medical equipment, and various other regulations for the production of medical devices faced by local development manufacturers, all these causes may hamper the growth of the medical device testing market.

Recent Developments

• In April 2021, TÜV SÜD announced that it had presented itself at Medtec LIVE to exhibit its ability to be a one-stop shop for medical device testing. The company’s services cover testing in electrical and functional safety, cyber security and software, EMC, and biocompatibility. The experts from TÜV SÜD featured in the program of the online trade show and congress with various talks, a live hack, and an elevator pitch.
• In June 2020, Intertek announced the expansion of its personal protective equipment services to include precertification testing of N95 respirators to requirements set by the National Institute for Occupational Safety and Health (NIOSH). The new services are the result of the successful accreditation to NIOSH Standard Test Protocols, in accordance with ISO 17025. With these new services, Intertek expands upon its solutions and resources to support customers and the global community during the COVID-19 pandemic.

North America medical device testing market Scope

North America medical device testing market is segmented into service type, testing type, phase, sourcing type, device class, and product. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.  

Service Type

• Testing Services
• Inspection Services
• Certification Services

On the basis of service type, the North America medical device testing market is segmented into testing services, inspection services, and certification services.

Testing Type

• Physical Testing
• Chemical/Biological Testing
• Cybersecurity Testing
• Microbiology And Sterility Testing
• Others

On the basis of testing type, the North America medical device testing market is segmented into physical testing, chemical/biological testing, cybersecurity testing, microbiology and sterility testing, and others.  

Phase

• Preclinical
• Clinical

On the basis of phase, the North America medical device testing market is segmented into preclinical and clinical.

Sourcing Type

• In-House
• Outsourced

On the basis of sourcing type, the North America medical device testing market is segmented into in-house and outsourced

Device Class

• Class I
• Class II
• Class III

On the basis of device class, the North America medical device testing market is segmented into class I, class II, and class III.

Product

• Active Implant Medical Device
• Active Medical Device
• Non-Active Medical Device
• In Vitro Diagnostic Medical Device
• Ophthalmic Medical Device
• Orthopedic and Dental Medical Device
• Vascular Medical Device
• Others

On the basis of product, the North America medical device testing market is segmented into active implant medical device, active medical device, non-active medical device, in vitro diagnostics medical device, opthalmic medical device, orthopedic and dental medical device, vascular medical device, and others.

North America Medical Device Testing Market Regional Analysis/Insights

Le marché nord-américain des tests de dispositifs médicaux est segmenté en type de service, type de test, phase, type d'approvisionnement, classe d'appareil et produit.

Les pays couverts dans ce rapport de marché sont les États-Unis, le Canada et le Mexique.

Les États-Unis devraient dominer le marché en raison de la forte prévalence des tests de dispositifs médicaux dans la région et de l’augmentation des dépenses de santé.

La section par pays du rapport fournit également des facteurs individuels ayant un impact sur le marché et des changements dans la réglementation sur le marché national qui ont un impact sur les tendances actuelles et futures du marché. Des points de données tels que les nouvelles ventes, les ventes de remplacement, la démographie du pays, les actes réglementaires et les tarifs d'importation et d'exportation sont quelques-uns des principaux indicateurs utilisés pour prévoir le scénario du marché pour les différents pays. En outre, la présence et la disponibilité des marques européennes et les défis auxquels elles sont confrontées en raison de la concurrence importante ou rare des marques locales et nationales, ainsi que l'impact des canaux de vente sont pris en compte lors de l'analyse prévisionnelle des données nationales.

Analyse du paysage concurrentiel et des parts de marché des tests de dispositifs médicaux en Amérique du Nord

Le paysage concurrentiel du marché des tests de dispositifs médicaux en Amérique du Nord fournit des détails par concurrent. Les détails inclus sont la présentation de l'entreprise, les finances de l'entreprise, les revenus générés, le potentiel du marché, les investissements en R&D, les nouvelles initiatives du marché, les sites et installations de production, les forces et les faiblesses de l'entreprise, le lancement de produits, les pipelines d'essais de produits, les approbations de produits, les brevets, la largeur et la portée du produit, la domination des applications, la courbe de survie technologique. Les points de données ci-dessus fournis ne concernent que l'orientation de l'entreprise vers le marché des tests de dispositifs médicaux en Amérique du Nord.

Français Certains des principaux acteurs opérant sur le marché des tests de dispositifs médicaux en Amérique du Nord sont Intertek Group plc, SGS SA, Bureau Veritas, TUV SUD, TUV Rheinland, Pace, Charles River Laboratories., Biomedical Device Labs, UL LLC, North American Science Associates, LLC, WuXi AppTec, NSF., Laboratory Corporation of America Holdings, Eurofins Scientific, NELSON LABORATORIES, LLC- A SOTERA HEALTH COMPANY, Gateway Analytical., Element Materials Technology, Hohenstein, Cigniti, Q Laboratories et IMR Test Labs, entre autres.

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