North America Medical Devices Market Size, Share & Industry Analysis, By Type (Orthopedic Devices, Cardiovascular Devices, Diagnostic Imaging, In-vitro Diagnostics, Minimally Invasive Surgery (MIS), Wound Management, Diabetes Care, Ophthalmic, Dental, Nephrology, General Surgery, and Others), By End-User (Hospitals & ASCs, Clinics, and Others) and Regional Forecast, 2025-2032

The North America medical devices market size was valued at USD 207.00 billion in 2024. The market is projected to grow from USD 218.26 billion in 2025 to USD 342.85 billion by 2032, exhibiting a CAGR of 6.7% during the forecast period.

Medical devices are the equipment healthcare facilities use for diagnosing, treating, and caring for patients suffering from certain diseases or requiring care. Medical equipment market includes simple products such as injection pens to complex products such as capnography meters, pacemakers, and others. The growing burden of chronic diseases such as cancer, cardiovascular diseases, diabetes, and Alzheimer’s, along with the improvement in the healthcare infrastructure. Such improvements have been fueling the demand for technologically advanced diagnosis and treatment options.

• For instance, as per the data published by the Canadian Cancer Society, in 2024, approximately 247,100 new cancer cases and 88,100 deaths due to cancer were observed in Canada. Moreover, the prevalence of cancer was highest among male and female patients aged between 65-69, accounting for 16.33% and 13.26%, respectively, out of the cancer cases in males and fema

Market players such as Johnson & Johnson, Medtronic, and Stryker are among the key players focusing on new product launches and partnerships with other companies to expand their regional product offerings.

Market Dynamics

Market Drivers

Growing Burden of Chronic Diseases Fueling Demand for Effective Diagnosis and Treatment Devices

The prevalence of diseases and accidental injuries has been growing significantly across the U.S. and Canada.

• For instance, as per the data published by the Centers for Disease Control and Prevention (CDC), in 2021, around 38.1 million people had diabetes in the U.S. Out of this, around 19.8 million were men and 18.3 million were women. Moreover, diabetes is more common among the population aged above 65 years, accounting for 43.3% of the total diabetes cases in the country.
• Similarly, as per the data published by the Alzheimer's Association in 2025, around 7.2 million people have Alzheimer’s Disease. The disease is more prevalent among the population aged 85 and above, accounting for 33.4% of the total cases.

Moreover, the number of accidental injuries has also been growing in the region. For instance, as per the data published and updated by the Public Health Agency of Canada in 2022, there were around 225,208 injury-related hospitalization cases.

Such a high burden of these diseases and accidental injuries has been fueling the demand for diagnosis and treatment, thereby fueling the demand for the North America medical devices market.

Market Restraints

High Cost of Medical Equipment Limits North America Medical Devices Market Growth 

The increasing burden of chronic disorders and the rising awareness regarding technologically advanced equipment have been fueling the North America medical devices market growth. However, the high cost of these devices poses a significant hurdle to market growth.

• For instance, the cost of capnometers can start from anywhere near USD 1,000.0 and can go as high as up to USD 22,000.0 or above.
• Similarly, the cost of an optical coherence tomography (OCT) device can start from USD 8,000.0 and go as high as around USD 70,000.0.

Such high costs of these devices limit their adoption among the region's small and mid-sized healthcare facilities, thereby acting as a restraining factor for the market growth in the region.

Market Opportunities

Growing Investment by Market Players in New Product Launches is Expected to Create Opportunities for Market Expansion

The growing burden of chronic disorders and increasing hospital admissions in the region has been fueling the demand for medical equipment with advanced technology.  In order to fulfill this, market players have increased their R&D investment to develop and launch technologically advanced products.

• For instance, Medtronic has invested around USD 2.70 billion in the financial year 2025 in the R&D of novel products.
• Similarly, in April 2025, F. Hoffmann-La Roche Ltd announced that it would invest USD 50.00 billion to enhance its manufacturing and R&D sites in the U.S. With such strategic initiatives, the company aimed at strengthening its footprint in the country.

Therefore, the increasing focus of the key players on research and development investment for developing and launching novel products in the region is expected to create opportunities for market growth.

Market Challenges

Complex Regulatory Scenarios and High Development Costs Limit Market Growth

Complex regulatory scenarios, along with the high medical equipment costs, act as a challenge for market growth in the region.

Limited Availability of Skilled Professionals Hinder Market Growth

Complex medical equipment, such as echocardiography devices, positron emission tomography, and ultrasound equipment, requires skilled professionals. Limited availability of skilled professionals acts as a challenge for market growth.

North America Medical Devices Market Trends

Growing Focus of Market Players on Approval and Commercialization of Novel Equipment in Region

Market players have been focusing on getting approval and commercialization of their novel products with an aim to strengthen their presence in the market.

• For instance, in January 2025, SCHOTT Pharma announced the launch of the next generation of SCHOTT TOPPAC infused polymer syringes, intending to improve safety, efficiency, and sustainability in the medical devices industry.
• Similarly, in May 2025, Intuitive Surgical received the U.S. Food and Drug Administration (FDA) approval for the da Vinci Single Port (SP) surgical system for transanal local excision/resection, a form of minimally invasive surgery performed through a natural orifice to avoid abdominal surgical incisions for select procedures.

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Segmentation Analysis

By Type

Increasing Focus of Market Players on Getting Regulatory Approvals is Responsible for In-vitro Diagnostics Segment’s Dominance

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

The in-vitro diagnostics segment dominated the market in 2024 and is expected to grow significantly during the forecast period. The segment’s growth is attributed to the increasing focus of the market players on receiving regulatory approvals for new product launches in the region.

• For instance, in January 2025, F. Hoffmann-La Roche Ltd received 510(k) U.S. Food and Drug Administration (FDA) approval for its VENTANA Kappa and Lambda Dual ISH mRNA probe cocktail, used for in-situ hybridization (ISH) test.

Moreover, the dental segment is expected to grow at the highest growth rate during the forecast period. The segment’s growth is attributed to the increasing focus of the market players on launching campaigns to increase the adoption of their dental products.

• For instance, in June 2025, Align Technology, Inc., a U.S.-based company, launched professional and consumer campaigns to fuel the adoption of Invisalign treatment in kids and teens.

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By End User

High Number of Hospital Admissions is Responsible for Segment’s Dominance

By end user, the market is segmented into hospitals & ASCs, clinics, and others.

The hospitals & ASCs segment dominated the market in 2024. The segment’s growth is attributed to the patients’ preference toward visiting the hospital for accurate diagnosis and effective treatment, fueling hospital admissions.

• For instance, according to the data published by the American Hospital Association, in 2022, around 33.7 million patients were admitted to hospitals in the U.S.

The other segment is expected to grow at the fastest CAGR during the forecast period. The segment’s growth is attributed to the increasing penetration of advanced medical equipment in individual practitioners’ offices.

North America Medical Devices Market Regional Outlook

Based on region, the market is studied across the U.S. and Canada.

U.S.

The U.S. accounted for a major medical devices market share, generating a revenue of USD 188.68 billion in 2024. The market’s growth in the country is attributed to the growing focus of the market players on new product launches.

• For instance, in November 2023, Johnson & Johnson announced the approval of ETHIZIA, an adjunctive hemostat solution indicated to achieve sustained hemostasis in patients' severe internal organ bleeding conditions.

Canada

The market in Canada is expected to grow significantly due to the growing burden of chronic conditions and increasing hospital admissions in the region for effective treatment.

Competitive Landscape

Key Market Players

Increasing Focus of Market Players on Novel Product Launches to Enhance Offerings

Market players such as Johnson & Johnson, GE Healthcare, Medtronic, and Stryker accounted for a significant portion of the North America medical devices market share in 2024. These players have been focusing on new product launches to enhance their product offerings in the region.

• For instance, in April 2023, Johnson & Johnson announced the Food and Drug Administration (FDA) 510(k) approval of its ELITA Femtosecond Laser, intended to create LASIK flaps.

Other players such as Abbott, Koninklijke Philips N.V., Siemens Healthineers AG, BD, and Cardinal Health have been in partnership and collaboration to expand their product offerings in the region.

LIST OF KEY NORTH AMERICA MEDICAL DEVICES COMPANIES PROFILED

• Medtronic (Ireland)
• Johnson & Johnson (U.S.)
• Koninklijke Philips N.V. (Netherlands)
• Hoffmann-La Roche Ltd. (Switzerland)
• Boston Scientific Corporation (U.S.)
• Fresenius Medical Care AG (Germany)
• GE Healthcare (U.S.)
• Siemens Healthineers AG (Germany)
• Stryker (U.S.)
• Abbott (U.S.)
• BD (U.S.)
• Cardinal Health (U.S.)

KEY INDUSTRY DEVELOPMENTS

• July 2025 – Koninklijke Philips N.V. announced its collaboration with Epic, an electronic health record (EHR) company, to incorporate the company’s cardiac ambulatory monitoring and diagnostics services with Aura, a specialty diagnostics suite.
• July 2025 – Boston Scientific Corporation announced the U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for its FARAPULSE pulsed field ablation (PFA) System.
• July 2025 – GE Healthcare announced the commercial availability of Definium, an advanced floor-mounted digital X-ray system.
• April 2025 – Medtronic announced the U.S. Food and Drug Administration (FDA) approval for the OmniaSecure, a defibrillation lead for placement in the right ventricle.
• January 2025 – Medtronic announced the initiation of national coverage analysis (NCA) on renal denervation by the Centers for Medicare & Medicaid Services (CMS). This initiation was on the basis of the company’s request to support Medicare beneficiary access to the Symplicity Spyral renal denervation (RDN) system.

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Report Scope & Segmentation