U.S. Home Diagnostics Market - Databook 2025 to 2034

The U.S. home diagnostics market size accounted for USD 4.17 billion in 2024 and is predicted to touch around USD 7.49 billion by 2034, growing at a CAGR of 6.03% from 2025 to 2034.

Highlights of the U.S. Home Diagnostics Market

• By test type, the glucose monitoring devices segment held a dominant presence in the market in 2024.
• By type insight, the infection testing kits segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• By form insight, the cassettes segment accounted for a considerable share of the market in 2024.
• By form insight, the strips segment is projected to experience the highest growth rate in the market between 2025 and 2034.
• By distribution channel insight, the retail pharmacies segment led the U.S. home diagnostics market.
• By distribution channel insight, the drug stores segment is set to experience the fastest rate of market growth from 2025 to 2034.

Industry Valuation and Growth Rate Projection

The U.S. home diagnostics market is a branch of the healthcare industry that supplies tools and devices that assist in health monitoring and diagnosis at home. Convenience, affordability, and timeliness are the qualities that eliminate the need for multiple visits to the clinic. With technological advancements, manufacturers can now offer diagnostic instruments that are highly accurate and user-friendly. Market development received a boost through the increasing relevance of preventive healthcare and people's desire to take an active role in health-related matters. Self-diagnosis test kits for chronic diseases, infectious diseases, miscellaneous diseases, and pregnancy have become common just because to the ease of access. Higher consumer awareness about health, better healthcare access, and more availability of such products are offering a big push to market demand. Promotion and advertising through various media can help create consumer awareness and foster confidence in the product offerings. Innovation, convenience, and consumer awareness regarding personal health management will have an infinite number of bases for generating a positive growth trend in the home diagnostics market.

What are the Market Trends in the U.S. Home Diagnostics Market?

The market trends in the U.S. home diagnostics market are defined by telehealth integration, mobile health apps, and a focus on self-testing

• Telehealth Integration: For remote consults and diagnoses.
• Mobile Health Apps: Empower the users by providing them with tracking tools and experts to consult.
• User-Friendly Devices: Consumers look for diagnostic kits that are intuitive and require minimal work.
• Shift toward Self-Testing: Rapid adoption of home tests for chronic and infectious diseases by the general consumer.
• Preventive and Personalized Care: Concentrating on early detection and personalized diagnostic solutions.

What are the Major Market Restraints in the U.S. Home Diagnostics Market?

The growth of the U.S. home diagnostics market is restrained by factors such as a lack of a regulatory framework, accuracy, reliability, and data availability

• Limited Healthcare Access: Disparities in digital infrastructure and provision of healthcare services create bottlenecks to general acceptance.
• Regulatory Uncertainty: Deficiently laid guidelines for AI and digitally originated diagnosis hamper its compliance.
• Resistance by the Medical Community: A clinical resistance to the acceptance of AI was put into the diagnoses.
• Accuracy & Reliability Concerns: The skepticism on whether the at-home diagnosis or confirmed with AI is far from being reliable.
• Shortage of Skilled Workforce: The dearth of talent in AI and diagnostic technologies hinders the pace of innovation.

What are the Market Opportunities in the U.S. Home Diagnostics Market?

The opportunities in the U.S. home diagnostics market are associated with improved patient experience, enhanced diagnostic accuracy, and cost reduction.

• AI-Enhanced Accuracy: Several algorithms exist to improve diagnostic accuracy.
• Early Disease Detection: Home diagnostics are set to detect issues even before symptoms show up.
• Personalized Healthcare: Diagnoses and treatment plans are tailored depending upon each individual's health profile.
• Cost Savings for Healthcare: Service automation, both remote and on-site, cuts costs of operation and becomes less burdensome for the patient.
• Entry Into Emerging-Issue Markets: Booming demand for AI-powered home diagnostics.

Recent Developments in the Home Diagnostics Market:

• In March 2025, Wisp, the largest US telehealth company, launched its diagnostics vertical, Wisp At-Home Testing & Follow-Up Care, offering convenient at-home test kits for various health conditions.

U.S. Home Diagnostics Market Companoes:

• Abbott Laboratories
• Roche Diagnostics
• Siemens Healthineers
• Becton, Dickinson and Company (BD)
• Labcorp
• Quest Diagnostics

U.S. Home Diagnostics Market Segmentation:

By Product Type

• Devices
  
  • Blood Glucose Monitors
  • Blood Pressure Monitors
  • Pulse Oximeters
  • Pregnancy & Fertility Tests
  • Cholesterol & Lipid Profile Tests
  • Urine Analysis Devices
  • Other Home Diagnostic Devices (e.g., thermometers, otoscopes)
• Consumables
  
  • Test Strips (Glucose, Ketone, etc.)
  • Swabs & Test Kits
  • Reagents
  • Other Consumables

By Test Type

• Infectious Disease Testing
  
  • COVID-19 Testing
  • Influenza & Respiratory Infections
  • HIV & STD Testing Kits
  • Hepatitis Testing
  • Other Infectious Diseases
• Chronic Disease Testing
  
  • Diabetes Testing
  • Cardiovascular Health Testing
  • Cholesterol Testing
  • Kidney Function Testing
• Lifestyle and Wellness Testing
  
  • Pregnancy & Fertility Tests
  • Ovulation Prediction Kits
  • DNA & Genetic Testing
  • Allergy Testing
  • Fitness and Nutritional Deficiency Tests
• Drug of Abuse Testing
  
  • Marijuana
  • Opioids
  • Alcohol
  • Other Substances

By Technology

• Immunoassay-based Tests
• Molecular Testing (e.g., PCR tests)
• Dipsticks and Test Strips
• Digital Health & Wearable Technology (e.g., smartwatches with diagnostic capabilities)
• Lateral Flow Tests (LFTs)

By Distribution Channel

• Retail Pharmacies
• Online Pharmacies
• Hospital & Specialty Clinics
• Supermarkets and Hypermarkets
• Direct-to-Consumer (DTC)

By End Use

• Individual Consumers
• Healthcare Providers
• Research and Academic Institutes