US Self Diagnostics Market Report 2025
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The COVID-19 pandemic was a defining moment for diagnostic testing, reshaping how consumers engage with healthcare. At the height of the pandemic, at-home PCR tests became a lifeline, enabling people to screen and monitor their health without leaving the safety of their homes.
The widespread acceptance of these tests was solidified in 2022 and has benefited the category as a whole, increasing comfort using various diagnostic tests and propelling the development of testing and applications, which shows no signs of slowing down.
Several long-term trends, including rising healthcare costs, accessibility concerns, population changes and technological advancements, are shaping the future of at-home diagnostics. To seize opportunities in this rapidly growing market, companies must address accuracy concerns and expand their test applications. This includes developing patient-centric kits that enable seamless remote interactions between patients and providers, as well as consumer-focused kits designed to enhance performance and optimize outcomes.
This report looks at the following areas:
- Market drivers and dynamics impacting self diagnostics
- Self diagnostic usage and interest
- Self diagnostic acquisition location
- Perceived benefits and reasons for use
- Frustrations and barriers to use
- Attitudes toward health data
- Attitudes toward innovation and health
- Innovation and marketing activity
The pandemic gave the self diagnostic market a chance to flourish. A desire for healthier and longer lives will shift focus to proactive health management.
Rebecca Watters, Associate Director, Household & Health
Market Definitions
The self diagnostics market is defined as any product, device or test that is used by the consumer, without medical or professional assistance, to identify or monitor a specific health condition. This includes chemically based at-home testing kits or urine tests and electronic devices, such as monitors or meters.
This Report discusses testing devices and kits including:
- blood glucose monitors
- blood pressure monitors
- lancet/devices
- urine tests/kits
- allergies
- blood cholesterol
- body fat
- coagulation test kits
- cystic fibrosis
- dietary or vitamin deficiencies
- fecal test kits to identify bowel disorders
- genetics (including paternity tests)
- H. pylori
- male fertility testing
- Osteoporosis
- Peak flow meters to identify asthma and lung disorders
Excluded from this Report are tests carried out by hospitals, doctors, nurses, pharmacists or other healthcare workers. Also excluded are devices such as scales, which are used solely to measure weight and other physical measuring devices, such as thermometers.
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EXECUTIVE SUMMARY
- What you need to know
- Market predictions
- What consumers want & why
- Opportunities
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Market Dynamics
- Market context
- Market drivers
- Diagnostics are an attractive alternative amid climbing healthcare costs
- Ageing population will exacerbate healthcare issues
- Graph 1: population by age, 2018-28
- Regulatory changes set to impact various aspects of device industry
- Regulatory changes must adapt to changing technology
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CONSUMER INSIGHTS
- Consumer fast facts
- Self diagnostic usage and interest
- Adoption trends align with shifts in personalized healthcare
- Graph 2: interest in home diagnostic tools, 2025
- Graph 3: usage of home diagnostic tools, 2025
- Self diagnostics represent fertile ground for reproductive care innovation
- Graph 4: usage and interest in fertility tests, by gender and age, 2025
- Ro among the many tapping into fertility market
- Hormone health top of mind for younger women
- Graph 5: usage and interest in hormone tests, by gender and age, 2025
- Self diagnostics present a complex picture for access to healthcare
- Graph 6: usage of home diagnostic tools – net, by household income, 2025
- Self diagnostic acquisition location
- Drug stores maintain the leading position
- Graph 7: acquisition location of home diagnostic tools, 2025
- Consumers shop around for their diagnostic needs
- The landscape is getting more crowded
- Graph 8: acquisition location of diagnostic tools, by age, 2025
- Perceived benefits and reasons for use
- Consumers are taking health into their own hands
- Graph 9: perceived benefits and reasons for use, 2025
- Collaborate with medical professionals to expand reach
- Graph 10: select reasons for use, by age, 2025
- For parents, generational health is wealth
- Graph 11: reasons for use – future health, by parental status, 2025
- Support Gen Z and Millennials’ healthy ageing ambitions
- Graph 12: select reasons for use, by generation, 2025
- Bridge the gap between today and tomorrow by offering multiple benefits
- Frustrations and barriers to use
- Address lingering concerns
- Graph 13: frustrations and barriers to use, 2025
- For women, clinical value is critical
- Don’t stop short: pair data with guidance
- Graph 14: frustrations – implementing test results, by age, 2025
- Offer streamlined, 360° comprehensive care
- Diagnostics fuel shift toward accessible care, but also risk exacerbating existing health disparities
- Graph 15: select frustrations and barriers to use, by financial situation, 2025
- Graph 16: select frustrations and barriers to use, by education, 2025
- Attitudes toward health data
- Data sharing remains a challenge for effective integration into healthcare
- Graph 17: attitudes toward health data, 2025
- 23andMe bankruptcy raises new concerns around data privacy
- Assuage women’s concerns with absolute data privacy
- Create a trusting environment
- Graph 18: select attitudes toward health data, by gender and generation, 2025
- Attitudes toward innovation and health
- A new paradigm in personalized healthcare
- Graph 19: attitudes toward innovation and health, 2025
- Meet evolving expectations of personalization
- Integrate with wearables to expand and strengthen capabilities
- Out-of-pocket payments limit consumer appetite for self diagnostics
- Graph 20: attitudes toward diagnostic costs, by household income, 2025
- In doctors, consumers trust
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INNOVATION AND MARKETING STRATEGIES
- Launch activity and innovation
- Diagnostics fertile ground for reproductive care innovation
- Fertility space: equality, empathy and education is crucial
- Emerging technologies can address health data silos
- Anticipate more brands leveraging AI to enhance diagnostic outcomes
- Hims & Hers strengthens position with diagnostic acquisition
- Diagnostics for mental health on the horizon
- Design with empathy to reduce apprehension
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APPENDIX
- Market definition
- Consumer research questions
- Consumer research methodology
- Generations
- Abbreviations and terms
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