미국의 혈압 측정 기기 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the united states blood pressure monitoring devices market size was valued at USD 2.04 billion in 2025 and is estimated to grow from USD 2.22 billion in 2026 to reach USD 3.39 billion by 2031, at a CAGR of 8.82% during the forecast period (2026-2031).

This report is Segmented by Product Type (Aneroid, Digital, Ambulatory, Cuffless Wearables, Cuffs), Technology (Traditional, Smart Connected, Cuffless), End User (Hospitals, Ascs, and More), Distribution Channel (Institutional, Retail, E-Commerce, DTC RPM), and Application (Hypertension, RPM, Preventive Screening, Pregnancy). Market Forecasts are Provided in Terms of Value (USD).

United States Blood Pressure Monitoring Devices Market Trends and Insights

High Uncontrolled Hypertension Burden

The strongest demand base in the United States blood pressure monitoring devices market comes from low control rates rather than rising prevalence, because national prevalence has stayed near the same broad range for years while control remains weak. During August 2021 to August 2023, only 20.7% of hypertensive adults had blood pressure controlled below 130/80 mmHg, which left a very large pool of patients needing repeated measurement and follow-up. That care burden cannot be managed through occasional office visits alone, since 94.9 million adults are recommended for lifestyle modification and medication support under current clinical guidance. The 2025 AHA and ACC guideline reinforced this demand pattern by making home blood pressure monitoring a standard part of hypertension management and by linking treatment decisions more closely to out-of-office data. The demand runway is even broader among younger adults and men, where control rates remain lower, which points to sustained adoption potential for app-linked and easy-to-use devices in the United States blood pressure monitoring devices market.

RPM Reimbursement Supporting Connected Monitoring

Connected monitoring is gaining traction because reimbursement now supports a wider set of remote care workflows, which improves the provider business case for keeping hypertensive patients under continuous observation. This shift matters in the United States blood pressure monitoring devices market because the cost of adoption moves away from the patient alone and becomes part of an organized care pathway managed by health systems and physician groups. Providers can justify a larger installed base of connected cuffs when monitored readings feed chronic care programs, billing workflows, and risk-management models at the same time. Cellular-enabled devices benefit more than Bluetooth-only devices in these settings, because they reduce the number of patient actions required before data reaches the care team. Reimbursement design is therefore shaping product strategy in the United States blood pressure monitoring devices market almost as strongly as accuracy, especially for vendors selling into large RPM programs.

Cuffless Accuracy And Evidence Gaps

Cuffless devices are drawing high commercial interest, but the evidence gap is still limiting their use in diagnosis and treatment decisions across the United States blood pressure monitoring devices market. Even after Aktiia received FDA 510(k) clearance for over-the-counter use in July 2025, the broader clinical category still lacks the depth of comparative evidence that providers want before changing practice patterns. The American Heart Association stated in December 2025 that cuffless technologies had not yet shown enough accuracy to diagnose hypertension or guide treatment with confidence, which keeps them closer to wellness use than to core care pathways. The FDA's January 2026 draft guidance raises the bar further by specifying clinical performance testing expectations for future submissions, which increases time and evidence demands for new entrants. Until head-to-head validation becomes broader, premium institutional and RPM channels in the United States blood pressure monitoring devices market are likely to remain anchored in cuff-based standards.

Other drivers and restraints analyzed in the detailed report include:

1. Home-Based Chronic-Care Management Adoption
2. Validated-device Initiatives Improving Clinician Confidence
3. Premium Pricing For Connected And Cuffless Devices

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Aneroid blood pressure monitors held 36.31% of the United States blood pressure monitoring devices market share in 2025, while digital blood pressure monitors are projected to grow at an 11.38% CAGR through 2031. Aneroid devices kept the lead because hospitals and clinics still value their low cost, familiar workflow, and continued fit with supervised auscultatory measurement in trained settings. That installed base gives the legacy segment resilience, especially in large provider systems that replace equipment gradually and prefer proven operating routines. Digital monitors are still advancing faster because home care, connected apps, and the decline of mercury alternatives are making automated measurement the default choice for new household and outpatient demand. This split shows that the United States blood pressure monitoring devices market is moving in two speeds, with institutional inertia on one side and home-led upgrading on the other.

Ambulatory blood pressure monitors remain a smaller product class, but they hold a strong clinical role because the 2025 guideline continues to treat ABPM as the reference standard for confirming white-coat and masked hypertension. That recommendation supports demand in nephrology and cardiology outpatient settings where 24-hour profiles shape treatment adjustments more directly than single office readings. Cuffs and accessories also remain important inside the blood pressure monitoring devices industry because replacement cycles, size variation, and calibration needs create recurring revenue after the initial device sale. Cuffless wearables are still the smallest product segment, but regulatory milestones such as Aktiia's July 2025 over-the-counter clearance and Nanowear's FDA-cleared continuous monitoring pathway show that innovation is pushing the edge of future category change. The near-term outcome is a product mix where conventional categories still carry most revenue, while newer formats influence investment priorities across the United States blood pressure monitoring devices market.

Traditional non-smart devices retained 63.24% of the United States blood pressure monitoring devices market share in 2025, while smart connected devices are set to grow at a 10.52% CAGR through 2031. Legacy devices remain dominant because many hospital systems already own validated inventories, and large procurement teams still favor products that are easy to standardize across care sites. Cost discipline also supports this segment, since traditional monitors can fill routine measurement needs without the extra software stack required by connected ecosystems. Smart connected devices are growing faster because the value of a monitor now extends beyond a reading and into data movement, remote management, and clinical documentation. This shift is pushing the United States blood pressure monitoring devices market toward platform competition rather than pure hardware competition.

Omron's FDA De Novo authorization in November 2024 for AFib detection inside a standard upper-arm monitor shows how algorithmic layering can change product positioning without changing the core act of measurement. Bluetooth-connected devices still suit broad retail demand because they work naturally with patient smartphones and familiar app behavior. Cellular devices are gaining strength in formal RPM programs because they lower patient friction and improve the chances that readings move into the provider system without interruption. Cuffless sensor-based technologies remain small in revenue terms, yet standards such as IEEE 1708 and ISO 81060-2 are already shaping which products can pursue clinical credibility and third-party review pathways. In the blood pressure monitoring devices industry, early compliance with both validation and software integration requirements is becoming the main route to premium institutional access.

List of Companies Covered in this Report:

1. A&D Medical
2. Aktiia
3. American Diagnostic
4. Baxter International (Welch Allyn)
5. Beurer
6. Braun Healthcare
7. ForaCare AG
8. GE Healthcare
9. Greater Goods
10. iHealth Labs
11. Microlife
12. Midmark
13. Mindray
14. OMRON
15. Koninklijke Philips
16. Rossmax
17. Spacelabs Healthcare
18. SunTech Medical
19. Veridian Healthcare
20. Withings

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 High Uncontrolled Hypertension Burden
  • 4.2.2 RPM Reimbursement Supporting Connected Monitoring
  • 4.2.3 Home-Based Chronic-Care Management Adoption
  • 4.2.4 Validated-Device Initiatives Improving Clinician Confidence
  • 4.2.5 Maternal-Health Remote Monitoring Expansion
• 4.3 Market Restraints
  • 4.3.1 Cuffless Accuracy and Evidence Gaps
  • 4.3.2 Premium Pricing for Connected and Cuffless Devices
  • 4.3.3 Lack of Reimbursement for Home BP Cuffs
  • 4.3.4 Cuff-Size Mismatch Limiting Patient Eligibility
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Buyer Power
  • 4.7.2 Supplier Power
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Aneroid Blood Pressure Monitors
  • 5.1.2 Digital Blood Pressure Monitors
  • 5.1.3 Ambulatory Blood Pressure Monitors
  • 5.1.4 Cuffless Blood Pressure Wearables
  • 5.1.5 Blood Pressure Cuffs and Accessories
• 5.2 By Technology
  • 5.2.1 Traditional Non-smart Devices
  • 5.2.2 Smart Connected Devices
  • 5.2.3 Cuffless Sensor-based Devices
• 5.3 By End User
  • 5.3.1 Hospitals and Clinics
  • 5.3.2 Ambulatory Surgical Centers
  • 5.3.3 Home Healthcare Settings
  • 5.3.4 Other End Users
• 5.4 By Distribution Channel
  • 5.4.1 Institutional Direct Sales and Group Purchasing
  • 5.4.2 Retail Pharmacies and Drug Stores
  • 5.4.3 E-commerce
  • 5.4.4 Direct-to-Consumer RPM Programs
• 5.5 By Application
  • 5.5.1 Hypertension Diagnosis and Ongoing Management
  • 5.5.2 Remote Patient Monitoring
  • 5.5.3 Preventive Screening and Wellness Monitoring
  • 5.5.4 Pregnancy and Preeclampsia Monitoring

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 A&D Medical
  • 6.3.2 Aktiia
  • 6.3.3 American Diagnostic Corporation
  • 6.3.4 Baxter International (Welch Allyn)
  • 6.3.5 Beurer GmbH
  • 6.3.6 Braun Healthcare
  • 6.3.7 ForaCare AG
  • 6.3.8 GE HealthCare
  • 6.3.9 Greater Goods
  • 6.3.10 iHealth Labs
  • 6.3.11 Microlife Corporation
  • 6.3.12 Midmark Corporation
  • 6.3.13 Mindray
  • 6.3.14 Omron Healthcare
  • 6.3.15 Philips
  • 6.3.16 Rossmax International
  • 6.3.17 Spacelabs Healthcare
  • 6.3.18 SunTech Medical
  • 6.3.19 Veridian Healthcare
  • 6.3.20 Withings

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment