North America Medical Devices Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032

Growth Factors of North America Medical Devices Market

The North America Medical Devices Market is positioned for consistent expansion, supported by the growing prevalence of chronic diseases, technological innovation, and the modernization of healthcare infrastructure. According to Fortune Business Insights, the market was valued at USD 207.00 billion in 2024, is projected to grow to USD 218.26 billion in 2025, and is anticipated to reach USD 342.85 billion by 2032, exhibiting a steady CAGR of 6.7% during the forecast period (2025-2032).

Medical devices play a crucial role in improving diagnosis, treatment, and patient care across hospitals, clinics, and home healthcare settings. The market encompasses a wide range of equipment-from basic instruments such as injection pens to complex technologies like pacemakers, digital imaging systems, and robotic surgical equipment. The demand for advanced devices continues to rise due to an aging population and increasing incidence of cancer, cardiovascular diseases, diabetes, and neurological disorders across the U.S. and Canada.

Market Dynamics

Market Drivers - Growing Burden of Chronic Diseases Accelerates Demand for Medical Devices

The rising number of chronic and lifestyle-related diseases is a key driver for the North America medical devices market. In 2021, around 38.1 million Americans were living with diabetes, with 43.3% of cases occurring in people aged 65 years and above, according to the Centers for Disease Control and Prevention (CDC). Similarly, the Alzheimer's Association reported that in 2025, 7.2 million individuals in the U.S. are projected to be affected by Alzheimer's disease, with 33.4% of cases among individuals aged 85 and older.

The rising prevalence of cancer further supports this growth trend. The Canadian Cancer Society revealed that in 2024, there were 247,100 new cancer cases and 88,100 cancer-related deaths in Canada, with the majority of cases seen in patients aged 65-69. Additionally, trauma-related hospitalizations remain high-225,208 injury-related cases were reported by the Public Health Agency of Canada in 2022. Collectively, these data points underscore the growing need for accurate diagnostic tools and effective treatment devices across North America.

Market Restraints - High Cost of Equipment Limits Accessibility

The primary restraint for market expansion is the high cost of advanced medical devices. Products such as optical coherence tomography (OCT) systems, priced between USD 8,000 and USD 70,000, and capnometers, ranging from USD 1,000 to USD 22,000, are often out of reach for smaller healthcare facilities. These high acquisition and maintenance costs limit adoption among mid-sized clinics and ambulatory care centers, restricting widespread technological deployment.

Market Opportunities - Rising R&D Investments and New Product Launches

Increased investment in research and development (R&D) by key manufacturers is generating opportunities for innovation in diagnostic imaging, surgical robotics, and patient monitoring systems. Medtronic, for instance, invested USD 2.70 billion in R&D during the 2025 fiscal year, while F. Hoffmann-La Roche Ltd. committed USD 50.00 billion toward enhancing its U.S. manufacturing and R&D facilities. These investments aim to strengthen product portfolios and accelerate the commercialization of next-generation technologies.

Market Challenges - Complex Regulations and Skill Shortages

Strict regulatory approval processes, combined with a shortage of trained professionals to operate sophisticated medical devices, pose significant challenges. Equipment such as ultrasound systems, PET scanners, and echocardiography machines demand specialized skills, and the limited availability of trained operators can impede optimal device utilization across North America.

Market Trends

Growing Focus on Regulatory Approvals and Commercialization of Innovative Equipment

Manufacturers are prioritizing regulatory clearances and new product launches to expand their presence in North America. For example, in January 2025, SCHOTT Pharma unveiled next-generation SCHOTT TOPPAC polymer syringes to improve safety and sustainability in drug delivery systems. Similarly, in May 2025, Intuitive Surgical received FDA approval for the da Vinci Single Port (SP) surgical system-enabling transanal minimally invasive surgeries that reduce hospital stays and post-operative complications.

Segmentation Insights

By Type:

The market is segmented into orthopedic, cardiovascular, diagnostic imaging, in-vitro diagnostics (IVD), minimally invasive surgery, wound management, diabetes care, ophthalmic, dental, nephrology, and general surgery devices.

The in-vitro diagnostics (IVD) segment dominated in 2024, supported by increased regulatory approvals and innovation in molecular diagnostics. In January 2025, Roche received FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA probe cocktail, expanding its IVD portfolio. The dental segment is expected to register the fastest growth, propelled by rising consumer awareness and product marketing campaigns. For instance, Align Technology, Inc. launched a June 2025 campaign to promote Invisalign adoption among children and teens.

By End User:

The hospitals and ambulatory surgical centers (ASCs) segment led the market in 2024, driven by high patient admission volumes and preference for accurate, hospital-based diagnostics. According to the American Hospital Association, approximately 33.7 million patients were admitted to U.S. hospitals in 2022. The clinics and other healthcare facilities segment is expected to grow steadily due to expanding access to compact, user-friendly diagnostic equipment.

Regional Outlook

The United States dominated the North America medical devices market, generating USD 188.68 billion in 2024. This dominance stems from the strong presence of global manufacturers, a high incidence of chronic diseases, and rapid regulatory approvals for new medical technologies. For example, Johnson & Johnson received FDA approval in November 2023 for ETHIZIA, a hemostatic solution for severe bleeding management.

In Canada, the market is growing significantly, driven by rising hospital admissions and an increasing focus on patient safety and advanced treatment technologies. The growing prevalence of chronic diseases, particularly cancer and diabetes, continues to boost demand for medical equipment.

Competitive Landscape

Key players include Medtronic, Johnson & Johnson, GE Healthcare, Siemens Healthineers, Boston Scientific, Abbott, Stryker, and Philips. These companies are focusing on product innovation, partnerships, and regulatory approvals to reinforce their market positions.

Recent industry developments include:

• July 2025: Philips collaborated with Epic Systems to integrate cardiac diagnostics with electronic health records (EHR).
• July 2025: Boston Scientific received FDA approval for expanded labeling of the FARAPULSE Pulsed Field Ablation System.
• April 2025: Medtronic gained FDA approval for its OmniaSecure defibrillation lead for right ventricle placement.
• July 2025: GE Healthcare launched Definium, a new floor-mounted digital X-ray system with enhanced image accuracy.

Conclusion

Between 2024 and 2032, the North America Medical Devices Market is expected to grow from USD 207.00 billion to USD 342.85 billion, driven by technological advancements, an increasing burden of chronic diseases, and rising healthcare investments. With the U.S. leading in innovation and Canada expanding its medical infrastructure, the region will continue to dominate the global medical devices landscape. As companies focus on automation, connectivity, and precision medicine, North America is poised to remain a powerhouse in medical device innovation through the next decade.

Segmentation By Type

• Orthopedic Devices
• Cardiovascular Devices
• Diagnostic Imaging
• In-vitro Diagnostics
• Minimally Invasive Surgery (MIS)
• Wound Management
• Diabetes Care
• Ophthalmic
• Dental
• Nephrology
• General Surgery
• Others

By End-user

• Hospitals & ASCs
• Clinics
• Others

By Region

• North America (By Type, By End-user, and By Country)
  • U.S. (By Type, By End-user)
  • Canada (By Type, By End-user)