미국의 맥박산소포화도 측정기 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the U.S. pulse oximeters market size is projected to expand from USD 0.98 billion in 2025 and USD 1.03 billion in 2026 to USD 1.33 billion by 2031, registering a CAGR of 5.10% between 2026 to 2031.

This report is Segmented by Product Type (Fingertip, Handheld, Tabletop and Bedside, Wrist-Worn, and More), Technology (Conventional, Smart, and More), Measurement Mode (Spot-Check, Continuous), Patient Age Group (Adult, Pediatric, Neonatal), End User (Hospitals, Home Healthcare, and More), and Application (Respiratory Disease Monitoring, and More). Market Forecasts are in Terms of Value (USD).

U.S. Pulse Oximeters Market Trends and Insights

Rising COPD, Asthma, and Sleep Apnea Burden Driving Oxygen Saturation Monitoring

Chronic respiratory diseases are driving demand in the United States pulse oximeters market. In 2024, 4.2% of adults in the United States were diagnosed with COPD, emphysema, or chronic bronchitis. Additionally, 83.7 million adults, or 32.4% of the adult population, were estimated to have obstructive sleep apnea, with many cases undiagnosed. Severe and moderate cases, accounting for 18% and 30% respectively, are increasing the need for clinical-grade overnight pulse oximetry. Sleep apnea screening is the fastest-growing application, with a 6.98% CAGR projected through 2031. Nonin Medical's 2025 launch of its Nonin Health platform addresses remote overnight testing for over 1.5 million Americans requiring supplemental oxygen. Broader diagnoses and protocol adoption are expected to sustain long-term device demand.

FDA Pressure for Accuracy Across Skin Tones Elevating Premium Device Replacement

The FDA's 2025 draft guidance significantly impacts the United States pulse oximeters market by increasing clinical study pool requirements and mandating diverse skin tone representation. These changes favor advanced multi-wavelength systems over older products, prompting hospitals to replace low-cost devices with next-generation platforms. This shift is transforming routine replacement cycles into premium upgrade opportunities. Masimo's MightySat Medical, cleared by the FDA in 2024, highlights the rising clinical expectations for consumer-accessible devices.

Persistent Accuracy Variability Limiting Clinical Confidence in Edge Populations

Accuracy issues remain a significant challenge in the United States pulse oximeters market, particularly in scenarios involving motion, low perfusion, and darker skin tones. A 2026 study revealed that the Masimo MightySat Rx, a leading clinical fingertip device, recorded an Arms of 3.52% at oxygen saturation levels below 88%. This result approaches the upper limit of clinical acceptability, highlighting variability in confidence across patient groups and care settings. These challenges are most evident in ICUs, post-surgical wards, and home respiratory monitoring, where factors like poor circulation, movement-related noise, and skin-tone biases impact reliability. Additionally, a 2024 meta-analysis by the FDA reported a pooled mean overestimation of 1.52% in Black and African American patients, further emphasizing equity concerns. The market remains divided between premium devices with advanced algorithms and commodity products facing reliability issues.

Other drivers and restraints analyzed in the detailed report include:

1. Remote Patient Monitoring Reimbursement Expanding Connected Pulse Oximeter Adoption
2. Shift From Spot-Check to Continuous Monitoring Restructuring the Device Mix
3. Intensifying Regulatory Review Compressing Entry Windows and Raising Validation Costs

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

Segment Analysis

In 2025, fingertip pulse oximeters captured 31.1% of the U.S. pulse oximeters market by product type, establishing themselves as the top revenue format. Their dominance stems from being cost-effective, easy to operate, and versatile for both clinical spot-checks and home monitoring. The segment gained traction when Masimo's MightySat Medical, received FDA clearance for OTC sale in February 2024, marking a significant milestone in consumer accessibility. However, this broader access doesn't diminish the demand for hospital-grade products, as many clinical settings still prioritize stronger validation and seamless workflow integration.

Forecasted to grow at a 6.55% CAGR through 2031, handheld pulse oximeters are emerging as the fastest-growing product format in the U.S. market. Their primary users include home health aides, visiting nurses, and staff at ambulatory surgical centers, all of whom seek portability combined with enhanced functionality over basic fingertip models. Meanwhile, tabletop and bedside systems maintain their essential role in ICUs and step-down units, where fixed-position monitoring is routine.

In 2025, wearable pulse oximeters dominated the U.S. market, accounting for 25.6% of the revenue. Their prominence is largely attributed to the surge in home monitoring adoption during the pandemic. Wearables have carved a niche for themselves, excelling in continuous patient monitoring, sleep diagnostics, and remote care, outpacing traditional fixed or episodic formats. This established presence has also helped integrate home-based SpO2 tracking into routine monitoring, moving it away from being solely an emergency measure.

Forecasted to grow at a 7.45% CAGR through 2031, connected and wireless pulse oximeters are leading the charge among technology categories in the U.S. market. Health systems are gravitating towards devices that seamlessly transfer data into electronic medical records, nurse alert systems, and remote patient monitoring workflows, minimizing manual intervention. Masimo's expanded partnership with Philips in September 2025 is a testament to this trend, as it weaves SET, Radius PPG, and AI-driven monitoring into Philips' patient monitoring ecosystem, extending through 2026 and beyond.

Complete Report Scope:

• By Product Type
  • Fingertip Pulse Oximeters
  • Handheld Pulse Oximeters
  • Tabletop and Bedside Pulse Oximeters
  • Wrist-Worn Pulse Oximeters
  • Portable and Palm-Sized Pulse Oximeters
• By Technology
  • Conventional Pulse Oximeters
  • Smart Pulse Oximeters
  • Connected and Wireless Pulse Oximeters
  • Wearable Pulse Oximeters
• By Measurement Mode
  • Spot-Check Monitoring
  • Continuous Monitoring
• By Patient Age Group
  • Adult
  • Pediatric
  • Neonatal
• By End User
  • Hospitals
  • Home Healthcare
  • Ambulatory Surgical Centers
  • Others
• By Application
  • Respiratory Disease Monitoring
  • Cardiac Monitoring
  • Perioperative Monitoring
  • Sleep Apnea Screening
  • Others

List of Companies Covered in this Report:

1. Beurer
2. Cardinal Health
3. ChoiceMMed America
4. Contec Medical Systems
5. GE HealthCare Technologies Inc.
6. Honeywell International
7. iHealth Labs, Inc.
8. Koninklijke Philips
9. Masimo
10. Medline Industries
11. Medtronic
12. Nihon Kohden
13. Nonin Medical
14. Mindray
15. Smiths Group
16. Spacelabs Healthcare, Inc.
17. Tenovi, Inc.
18. Vivify Health, Inc.
19. 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 and 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 Rising COPD, Asthma, and Sleep Apnea Burden Requiring Oxygen Saturation Screening
  • 4.2.2 Shift From Spot-Check Devices to Continuous Monitoring in Home and Post-Acute Care
  • 4.2.3 FDA Pressure For Better Accuracy Across Skin Tones Elevates Premium Device Replacement
  • 4.2.4 Remote Patient Monitoring Reimbursement Expands Connected Pulse Oximeter Adoption
  • 4.2.5 Hospital Standardization Toward Integrated Monitoring Platforms Improves Sensor Pull-Through
  • 4.2.6 Consumer Awareness Of Silent Hypoxemia Sustains OTC and Retail Demand
• 4.3 Market Restraints
  • 4.3.1 Persistent Accuracy Variability In Motion, Low Perfusion, and Darker Skin Tones
  • 4.3.2 Intensifying Regulatory Review Increases Validation Cost and Time To Market
  • 4.3.3 Reimbursement Pressure In Basic Commodity Oximeters Compresses Margins
  • 4.3.4 Substitution From Multi-Parameter Wearables and Smart Rings Limits Standalone Unit Growth
• 4.4 Value/Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 Fingertip Pulse Oximeters
  • 5.1.2 Handheld Pulse Oximeters
  • 5.1.3 Tabletop and Bedside Pulse Oximeters
  • 5.1.4 Wrist-Worn Pulse Oximeters
  • 5.1.5 Portable and Palm-Sized Pulse Oximeters
• 5.2 By Technology
  • 5.2.1 Conventional Pulse Oximeters
  • 5.2.2 Smart Pulse Oximeters
  • 5.2.3 Connected and Wireless Pulse Oximeters
  • 5.2.4 Wearable Pulse Oximeters
• 5.3 By Measurement Mode
  • 5.3.1 Spot-Check Monitoring
  • 5.3.2 Continuous Monitoring
• 5.4 By Patient Age Group
  • 5.4.1 Adult
  • 5.4.2 Pediatric
  • 5.4.3 Neonatal
• 5.5 By End User
  • 5.5.1 Hospitals
  • 5.5.2 Home Healthcare
  • 5.5.3 Ambulatory Surgical Centers
  • 5.5.4 Others
• 5.6 By Application
  • 5.6.1 Respiratory Disease Monitoring
  • 5.6.2 Cardiac Monitoring
  • 5.6.3 Perioperative Monitoring
  • 5.6.4 Sleep Apnea Screening
  • 5.6.5 Others

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, Products and Services, Recent Developments)
  • 6.3.1 Beurer GmbH
  • 6.3.2 Cardinal Health, Inc.
  • 6.3.3 ChoiceMMed America
  • 6.3.4 Contec Medical Systems Co., Ltd.
  • 6.3.5 GE HealthCare Technologies Inc.
  • 6.3.6 Honeywell International Inc.
  • 6.3.7 iHealth Labs, Inc.
  • 6.3.8 Koninklijke Philips N.V.
  • 6.3.9 Masimo Corporation
  • 6.3.10 Medline Industries, LP
  • 6.3.11 Medtronic plc
  • 6.3.12 Nihon Kohden Corporation
  • 6.3.13 Nonin Medical, Inc.
  • 6.3.14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • 6.3.15 Smiths Group plc
  • 6.3.16 Spacelabs Healthcare, Inc.
  • 6.3.17 Tenovi, Inc.
  • 6.3.18 Vivify Health, Inc.
  • 6.3.19 Withings

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment