U.S. Medical Devices Market Size, Share & COVID-19 Impact Analysis, By Type (Orthopedic Devices, Cardiovascular Devices, Diagnostic Imaging, In-vitro Diagnostics, Minimally Invasive Surgery, Wound Management, Diabetes Care, Ophthalmic Devices, Dental Devices, Nephrology, General Surgery, and Others); By End User (Hospitals & ASCs, Clinics, and Others), and Regional Forecast, 2023-2030

The U.S. medical devices market size was valued at USD 184.61 billion in 2022. The market is anticipated to grow from USD 192.78 billion in 2023 to USD 291.04 billion by 2030, exhibiting a CAGR of 6.1% during the forecast period.

The U.S. has witnessed substantial growth in the geriatric population over the years. A demographic research projection published by the University of Washington in July 2021 since the beginning of the 21st century assumed that every other person born in the U.S. will live up to 100 years. The rising geriatric population is leading to the increasing prevalence of age-related disorders such as cataracts, chronic obstructive pulmonary disease, hypertension, osteoarthritis, diabetes, depression, and dementia.

• According to the U.S. Census Bureau report, by 2060, the number of patients suffering from diabetes is projected to increase by 25.1% to 162 million.

The growing prevalence and increasing cost burden of chronic and lifestyle diseases have led growing emphasis of healthcare agencies, government, and healthcare providers on the timely and routine treatment of patients. Thus, through awareness programs and campaigns, several national and regional healthcare agencies have actively promoted the diagnosis and treatment of common diseases.

This factor increased awareness among the geriatric population toward products and services for diagnosis and treatment, which is presenting a large patient pool undergoing treatment. Further, high treatment rates are driving the demand for these devices in hospitals, clinics, and other healthcare settings.

Additionally, to cater to the growing demand for advanced devices, medical devices companies are now investing in R&D to introduce healthcare devices with various advanced capabilities, such as AI intelligence, 3D imaging, wearable heart rate trackers, and others. Thus, rising launches of such advanced devices and their increased presence across the globe have further propelled market growth.

• For instance, in April 2022, Biotricity, a U.S. medical device company, announced the launch of Biotres, a wireless wearable cardiac monitoring device. Biotres is a three-lead device designed to continuously monitor heart activity and record electrocardiogram data for early detection of cardiac arrhythmias.

COVID-19 IMPACT 

Declining Elective Surgeries Restrained the Market amid the COVID-19 Pandemic

The COVID-19 pandemic has significantly affected the development and deployment of these devices in the U.S. The restrictions imposed during the pandemic led to the postponement or cancellation of non-essential and elective procedures such as dental, orthopedic, and ophthalmic surgeries.

• For instance, a study published by LAC+USC Medical Center revealed that during the initial wave of the COVID-19 pandemic, the average surgical case rate for elective colorectal procedures declined to approximately 2.4 patients/week from an average of 9.2 patients/week in the previous two years. This decline indicates a 74% relative decrease.

Medical device manufacturers providing medical equipment for elective procedures such as diagnostic imaging and dental procedures witnessed a considerable decline in revenues for 2020 as compared to 2019.

• For instance, according to Johnson & Johnson Services, Inc. statistics 2020, surgery device sales were USD 8.20 billion in 2020, a decrease of 13.4% from 2019. The decline in advanced surgery was attributed to the negative impact of COVID-19.

However, the increasing patient pool for COVID-19 diagnosis led to increasing adoption of COVID-19 tests compared to decreasing routine IVD tests such as diabetes and cancer screening in 2020. Furthermore, after the pandemic, routine tests regained substantial growth coupled with high demand for COVID-19 tests. Thus, these cumulative factors propelled the in-vitro diagnostics segment share in 2021.

Similarly, leading industry players in the manufacturing of in-vitro diagnostic devices and devices in other segments, such as beds, gloves, masks, respirators, and other hospital supplies, witnessed high demand for these products in 2020 and 2021.

• For instance, Thermo Fisher Scientific Inc. generated a revenue of USD 39.21 billion in the financial year 2021, with a growth of 22.0% compared to USD 32.22 billion in 2020. The growth was attributed to high sales of IVD devices during the COVID-19 pandemic.

Moreover, in 2021, to re-establish the country's manufacturing potency, the U.S. government focused on building strong supply chains across the globe. Similarly, high product approvals, the introduction of technologically advanced devices, and the rising demand for home healthcare devices propelled the market growth in 2021.

• For instance, in May 2022, GE Healthcare entered the homecare segment with a strategic investment of USD 50 million in Pulsenmore, an Israel-based company. The investment aimed to accelerate the adoption of Pulsenmore’s homecare ultrasound solutions.

LATEST TRENDS

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Rising Remote Monitoring Preference by Healthcare Providers in the U.S. Propelled Industry Growth

A growing number of adults and children participating in leisure and competitive sports activities such as cycling, running, and other sports have splurged the demand for activity trackers. Similarly, the rising focus on diagnosis and real-time monitoring of patients by regional and national healthcare agencies has been pivotal in the higher demand for wearable devices.

• For instance, according to MSI International survey outcome published in June 2021, 80% of Americans were oriented toward remote patient monitoring. Around half of these Americans favored including it in medical care. Also, according to the same survey, 88% of patients had healthcare performed remotely in the last 12 months.


• In October 2021, AliveCor, Inc. announced the launch of AliveCor Labs, an Independent Diagnostic Testing Facility (IDTF) in the U.S. The IDTF helped healthcare providers with enhanced and reimbursed cardiac monitoring services, including access to real-time data to help inform clinical decision-making.

This factor presents enormous opportunities for new entrants, domestic players, and established global market players to focus on this segment and introduce new devices to cater to the ever-increasing demand. Thus, the population's sheer size and the country's potential market aids entrants in providing remote monitoring devices at competitive pricing.

DRIVING FACTORS

Robust Pipeline and Increasing Investments in R&D by Industry Players to Propel Market Growth

Major industry players are actively investing in the research and development of advanced devices. The presence of potential devices in the end stage of development is expected to boost the demand for these devices.

• For instance, in January 2022, Cook Medical received the U.S. FDA Breakthrough Designation for a new drug-eluting stent for below the knee (BTK) to treat patients with chronic limb-threatening ischemia (CLTI).

The U.S. medical device manufacturers with a strong emphasis on R&D are shifting their strategies to introduce devices enhanced with new technologies. Thus, rising investments in R&D and breakthrough technologies to accelerate the manufacturing of these devices are expected to propel the market growth.

• For instance, in October 2022, GlucoTrack Inc. announced its plan to expand its product pipeline under its new R&D program for a long-term Continuous Glucose Monitor (CGM). With R&D focus on an implantable glucose management platform, the company will enter the Type I diabetes market.

Therefore, such a robust pipeline of advanced devices and high investments by the manufacturers is anticipated to fuel the adoption of these devices, further propelling the market growth.

RESTRAINING FACTORS

High Cost of Devices to Limit their Adoption in Small & Mid-sized Facilities

Medical devices have witnessed significant developments in the last decade by integrating new technologies, modifications in design, and updating other parameters. However, these devices' overall cost is higher, including acquisition and maintenance costs. Along with capital-intensive devices, some advanced healthcare devices are associated with various components, including cameras, batteries, chips, sensors, and other accessories that need periodic replacement.

• For instance, INUMAC MRI scanner is a neuro disease imaging equipment and can generate a power of 11.75 Tesla, whereas conventional MRI systems generate a power ranging between 1.5-3 Tesla. The development of INUMAC MRI system took seven years and owing to its advanced features and huge investment in R&D, the scanner cost is approximately USD 270 million.

Moreover, the increasing utilization of medical devices with current costs imposes an economic burden on small & mid-sized healthcare facilities such as health clinics, Ambulatory Surgical Centers (ASCs), and imaging centers. Compared to independent hospitals, rising costs in these facilities will further restrain the U.S. medical devices market growth.

• For instance, according to American Hospital Association, the hospital supplies expenses for hospitals were 15.9% higher by the end of 2021 compared to 2019. Also, ICUs and medical supplies expenditures were 31.5% higher in 2021 compared to 2019.

Thus, such high medical device costs limit the adoption of these devices, further hampering the demand for these devices and the growth of this industry.

SEGMENTATION

By Type Analysis

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Increasing Cardiovascular Surgeries to Drive the Cardiovascular Devices Segment

Based on type, the market is segmented into orthopedic devices, cardiovascular devices, in-vitro diagnostics, diagnostic imaging devices, Minimally Invasive Surgery (MIS) devices, wound management devices, diabetes care devices, ophthalmic devices, nephrology, dental, and others.

Among types, the cardiovascular devices segment is projected to register a comparatively higher CAGR owing to the rising prevalence of cardiovascular diseases in the U.S., the rising number of cardiovascular surgeries, and product launches by the U.S. medical device manufacturers.

• For instance, according to American Heart Association, about 805,000 Americans witness at least one heart attack annually, and out of these cases, 605,000 cases are of first heart attack. The increasing patient pool is anticipated to use different types of medical devices such as implantable cardioverter defibrillators, cardiac ablation catheters, Automated External Defibrillators (AEDs), and others as a part of their treatment, thereby contributing to increased demand for cardiovascular devices in coming years.


• In December 2022, Abbott launched Navitor, a Transcatheter Aortic Valve Implantation (TAVI) system, to make minimally invasive devices available for people with severe aortic stenosis.

In addition, the orthopedic segment is anticipated to grow significantly due to rising patient pool suffering from orthopedic disorders, mainly arthritis and an increasing number of joint replacement procedures in the U.S.

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  • According to an article published by the Centers for Disease Control and Prevention (CDC), about 54.4 million U.S. adults have some form of arthritis. This prevalence is projected to reach 78.0 million by the year 2040.
  
  
  
  

Moreover, the increasing uptake of real-time diagnostic tests to diagnose chronic diseases, such as diabetes and cancer, contributes to the segment growth. Similarly, growing R&D investments by industry players to launch new IVD products, such as disease-specific markers and tests, further propelled the segment share.

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  • According to an article published by the PEW Charitable Trusts in October 2021, an estimated 3.3 billion IVD tests, including both FDA-reviewed and Lab-Developed Tests (LDTs) are performed in the U.S. every year.
  
  
  
  

The other segment accounted for the largest market share in 2022. The dominance is attributed to the rising burden of chronic diseases in the country coupled with increasing demand for rehabilitation and palliative care devices in homecare settings in the U.S. In September 2021, OMRON Healthcare Co., Ltd. announced that cumulative global sales of its home-use blood pressure monitors reached more than 300.0 million units since releasing its first electronic blood pressure monitor nearly 50 years ago.

By End User Analysis

Rising Number of Admissions to Drive the Growth of the Hospitals & Ambulatory Surgery Centers (ASCs) Segment

Based on end user, the market is segmented into hospitals & Ambulatory Surgery Centers (ASCs), clinics, and others.

The hospitals & Ambulatory Surgery Centers (ASCs) segment accounted for the highest U.S. medical devices market share in 2022. The increasing patient population with chronic and life-threatening diseases resulting in a higher hospitalization rate in the U.S. is primarily responsible for the growing demand and adoption of healthcare devices in these settings.

• For instance, according to American Hospital Association, around 6,093 hospitals in the U.S. reported 36.2 million hospital admissions in 2021. Also, the number of non-government community hospitals increased to 2,946 in 2021 from 2,937 in 2020.

The others segment is projected to grow at a substantial CAGR during the forecast period. The increasing healthcare expenditure in the U.S. leading to the rising number of healthcare facilities, such as nursing homes, long-term care centers, and others, offering treatment for different diseases, is expected to increase the demand and adoption of these devices and will subsequently drive the growth of these segments during the forecast period.

KEY INDUSTRY PLAYERS

Mergers and Acquisitions by Key Players to Propel Market Progress

The market is fragmented, with leading players such as Medtronic, Johnson & Johnson Services, Inc., and Abbott accounting for less than 25% share in 2022. The focus of top market players is adopting strategies such as joint ventures, expansion, collaborations, and acquisitions to develop novel devices for patients suffering from chronic diseases.

• December 2022 - Johnson & Johnson Services, Inc. announced the acquisition of Abiomed, Inc. The acquisition aimed to accelerate growth in MedTech business and deliver innovative medical technologies to more people worldwide.


• September 2022 - Abbott acquired Walk Vascular, LLC, a medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove blood clots to broaden its cardiovascular portfolio segment.

Other prominent market players are Stryker Corporation, Boston Scientific Corporation, Siemens Healthineers AG, Roche, GE Healthcare, Danaher, Fresenius Medical Care AG & Co. KgaA, and BD. A significant rise in the prevalence of chronic diseases, extensive device approvals, and favorable reimbursement scenarios for high-end instruments is projected to propel the number of emerging players in the U.S. medical devices industry by 2030.

LIST OF KEY COMPANIES PROFILED:

• Medtronic (Ireland)


• Abbott (U.S.)


• Johnson & Johnson Services, Inc. (U.S.)


• Stryker (U.S.)


• BD (Becton, Dickinson, and Company) (U.S.)


• Boston Scientific Corporation (U.S.)


• Siemens Healthineers AG (Germany)


• F. Hoffmann-La Roche AG (Switzerland)


• Danaher (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• February 2023 - Abbott received approval from the U.S. FDA and CE mark as European approval for TactiFlex Ablation Catheter, Sensor Enabled. The catheter helps treat people with abnormal heart rhythms such as atrial fibrillation (AFib).


• February 2023 - Siemens Healthineers AG signed an agreement with Unilabs. Under the agreement, Unilabs invested in Siemens Healthcare GmbH’s top-notch technology. It will acquire more than 400 laboratory analyzers and improve its laboratory infrastructure to offer a consummate service to its customers.


• January 2023 - BD announced the launch of a robotic track system that automates lab specimen processing, which may help to reduce manual labor and wait time for results.


• January 2023 - Koninklijke Philips N.V. announced an expansion of its partnership with Masimo to augment patient monitoring capabilities in home telehealth applications with the Masimo W1 advanced health tracking watch.


• January 2023 - Abbott received U.S. FDA approval for Proclaim XR Spinal Cord Stimulation (SCS) system to treat painful Diabetic Peripheral Neuropathy (DPN).

REPORT COVERAGE

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The market report provides a detailed market analysis and focuses on crucial aspects such as manufacturers, products, and end users. Additionally, it offers insights into market trends, key industry developments such as collaboration, partnerships, & acquisitions, and the impact of COVID-19 on the market. In addition to the above-mentioned factors, the report includes the factors that have contributed to the market growth in recent years with a regional analysis of different segments.

Report Scope & Segmentation