U.S. Medical Device Manufacturers Market (2025 - 2030)

Market Size & Trends

The U.S. medical device manufacturers market size was estimated at USD 256.2 billion in 2024 and is projected to grow at a CAGR of 5.9% from 2025 to 2030. The market is expected to grow due to factors such as the growing geriatric population, high adoption of minimally invasive procedures, increasing number of sports and road accidents, and growing geographic reach of the market players. According to the USA Today news article, the number of fatal car crashes consistently rose from 36,835 in 2018 to an estimated 42,795 in 2022 within the U.S.

The COVID-19 pandemic, which is now endemic in major regions and countries, has negatively impacted some U.S. medical device manufacturing industries. According to Stryker’s financial report in 2020, the company witnessed a marginal revenue downfall, nearly 3.58% from its 2019 sales. Orthopedic companies witnessed revenue losses due to shutdowns related to elective procedures. Furthermore, another leading cardiovascular firm, Medtronic, reported a revenue decline of nearly USD 1.3 billion in fiscal year 2020. However, the pandemic had a positive impact on the drug delivery devices industry due to the medical necessities facilitated by COVID-19 complications.

The medical device manufacturers market in the U.S. is expected to witness significant growth due to the increasing geographic reach of market players and divestiture from existing businesses. Expanding into new geographic areas via acquisitions and collaborations allows manufacturers to tap into diverse markets, reach a broader customer base, and foster innovation. For instance, in February 2023, Abbott acquired Cardiovascular Systems, Inc. (CSI) as a part of its strategic expansion, which brought two significant players in the critical cardiovascular device industry. The equity value of the acquisition was estimated at USD 890 million.

Furthermore, in July 2023, 3M invested USD 468 million to expand its healthcare facility in Brookings, South Dakota, to broaden its geographic presence. This move suggested an intent to cater to the healthcare demands of the region, potentially introducing new medical devices or enhancing existing ones. In addition, specific players divested from their current businesses to improve their position in other industries. For instance, in May 2023, Baxter International, Inc., a MedTech player, entered into a definitive agreement to sell its BioPharma Solutions (BPS) business to Advent International and Warburg Pincus. The cash transaction was valued at USD 4.25 billion, with estimated net after-tax proceeds of about USD 3.4 billion.

Market Concentration & Characteristics

The market growth stage is high, with an accelerating pace. The market is characterized by a high degree of innovation owing to the rapid technological advancements driven by factors such as smart devices, increased use of AI & machine learning for diagnostics, growth in wearable medical technology, greater focus on cybersecurity for connected devices, and ongoing development of telehealth solutions, which seamlessly integrates digital healthcare for better patient outcomes and accessibility.

The market is also characterized by the leading and emerging players' high level of merger and acquisition (M&A) activity. This is due to several factors, including the desire to access newer technologies that address newer indications or grow their portfolio in newer geographies. For instance, in 2023, Eli Lily and Company acquired Sigilon Therapeutics, Inc. to expand its diabetes cell therapy research and development.

The market is subjected to increasing regulatory scrutiny. Furthermore, the U.S. has one of the world’s most exhaustive medical device regulatory bodies and policies, which creates hurdles for market players while securing patient’s interests. Manufacturers must obtain FDA approval before marketing a new medical device. Class III devices, representing the highest risk, require Premarket Approval (PMA), involving a rigorous review of safety and effectiveness. Class II devices may undergo the 510(k)-clearance, demonstrating substantial equivalence to a legally marketed device.

There are limited direct product substitutes for medical devices for specific uses. Specialized medical devices with unique functionalities restrict the availability of direct substitutes. Furthermore, high switching costs and the critical nature of medical devices contribute to a diminished threat from substitute products.

End-user concentration is a critical factor in the market. Since several end-user players drive demand for medical devices. Buyers, including healthcare facilities, hold moderate power, which drives the need for high-quality and innovative devices. However, the high concentration of buyers in the medical device manufacturers market and their reliance on specialized devices limit their ability to exert excessive bargaining pressure.

Application Insights

The others segment led the market and accounted for 35.7% of the revenue in 2024. The segment primarily comprises devices used in IVD diagnostics, medical imaging, dental, ear-nose-and-throat (ENT), wound care, and general surgery. According to an article by Midwestern University Clinics, over 36 million U.S. citizens are currently edentulous, and an additional 120 million are missing at least one tooth. Projections for the next 15 years anticipate a substantial increase in prevalence, with over 200 million individuals predicted to experience partial tooth loss in the country.

This emphasizes the relevance of dental devices within the market. Furthermore, the ENT devices segment is driven by the increasing demand for advanced solutions in otolaryngology. Innovations & advancements are expected to enhance diagnostic precision and therapeutic interventions for ENT conditions.

Cardiology devices are expected to register the fastest CAGR of 7.7% over the forecast period. Heart diseases are one of the leading causes of mortality in the U.S. According to a CDC article published in May 2023, the high mortality, with one death due to cardiovascular disease every 33 seconds, creates a substantial market demand for innovative medical devices that can contribute to the prevention, early diagnosis, & effective treatment of heart-related conditions. The significant economic burden of heart disease, costing the U.S. about USD 239.9 billion annually, presents challenges and opportunities for growth in the medical device industry.

Key U.S. Medical Device Manufacturers Company Insights

Some key players operating in the market include Stryker, Medtronic, and Abbott.

• Stryker is a medical device manufacturing company that offers powered surgical instruments, joint replacement solutions, micro & spine implant systems, trauma products, orthobiologics, endoscopic products, emergency equipment, surgical navigation systems, and patient handling equipment. Stryker Osteosynthesis is a subsidiary of Stryker and operates in craniomaxillofacial & traumatological products. The company has a market presence in over 100 countries.

• Medtronic is a global healthcare products company that manufactures medical devices. It operates in various healthcare verticals, such as patient monitoring, renal care, and pulse oximetry. It also manufactures advanced energy-based surgical devices, gastrointestinal devices, brain monitoring equipment, and mechanical ventilation.

• Abbott is a healthcare and pharmaceutical company with four core business segments: pharmaceuticals, medical devices, nutrition, and diagnostics. The company has a presence in more than 150 countries through research, manufacturing, sales, and distribution facilities.

Gelmetix and LOCI Orthopedics are emerging market participants in the U.S. medical device manufacturers market.

• Gelemetix focuses on the treatment of chronic lower back pain. The degeneration of intervertebral discs causes such pain. The company markets its polymer gel, which restores disc integrity.

• LOCI Orthopedics is a medical device company specializing in developing orthopedic devices and technologies. The company provides solutions for orthopedic extremities.

Recent Developments

• In September 2023, Abbott acquired Bigfoot Medical, a global leader in developing intelligent insulin management systems for people with diabetes. Bigfoot manufactures Bigfoot Unity, an FDA-approved connected insulin pen with an integrated continuous glucose monitoring system.

• In June 2023, Eli Lily and Company acquired Sigilon Therapeutics, Inc. Sigilon develops functional cures for acute and chronic diseases. Moreover, both companies have worked together since 2018 to develop encapsulated cell therapies to treat type 1 diabetes.

• In May 2023, Stryker acquired Cerus Endovascular Ltd., a manufacturer of neurointerventional devices. Some of the critical products marketed by the acquired company are the Contour Neurovascular System and the Neqstent Coil Assisted Flow Diverter.

U.S. Medical Device Manufacturers Market