Diagnostics is evolving. Are you prepared? As the industry shifts toward self- and home-based testing, find out what this means for diagnostics companies and the strategic adjustments that must be employed to effectively cater to patients and consumers.
The diagnostics industry is entering a new phase. What began as a surge in demand during the COVID-19 pandemic is now driving a lasting shift toward self- and home-based testing. While some categories, like consumer DNA kits and rapid COVID tests, saw short-term spikes that later declined, the broader trend toward decentralization is proving to be more long-lasting.
According to the 2025 Simon-Kucher Global IVD Trend Study, over half of experts1 in both the US and Europe expect that 10-25% of all diagnostic tests will be performed at home by 2035. US respondents are slightly more likely than their European counterparts to anticipate higher adoption levels. Almost a third expect more than 25% of tests to shift into the home.
Expected share of diagnostic testing performed at home by 2035
Share of at-home tests Region  US | <10% | 10-25% | 25-40% | >40% |
18% | 55% | 21% | 7% | |
 EU | 19% | 65% | 15% | 1% |
| Total | 19% | 62% | 17% | 3% |
1130 diagnostics experts and lab directors surveyed in our Global IVD Trend Study 2025
Experts’ estimates of the share of diagnostic tests likely to be done at home by 2035, based on four percentage ranges
This expected growth is not uniform across all areas of diagnostics. Some types of testing are seen as much more likely to move into home settings than others.
Where the market is heading
Simon-Kucher research highlights four key areas where home-based diagnostics are expected to grow most:
Chronic disease monitoring
Women’s health and fertility
Infectious disease testing
Cardiovascular health
North America is leading in adoption. The US market shows a stronger shift toward home testing, driven by consumer/patient interest and regulatory openness. Europe is moving slowly in a similar direction, with a more cautious approach to adoption. Experts in the US ranked cancer screening and genetic testing as more likely to shift to home use than in the EU, likely due to regulatory differences.
Diagnostic areas expected to shift into home and self-testing by 2035
| Rank | Diagnostic area | |
| US | EU | (Expert % predicting home shift) |
 |  | |
| 1 | 2 | Chronic disease monitoring (49%) |
| 3 | 1 | Women’s health and fertility (41%) |
| 2 | 3 | Infectious disease testing (38%) |
| 3 | 2 | Cardiovascular health (35%) |
| 6 | 5 | Nutritional and wellness monitoring (27%) |
| 8 | 4 | Urinary and renal health (25%) |
| 7 | 6 | Sleep and respiratory health (22%) |
| 9 | 8 | Hormonal health and endocrine function (15%) |
| 10 | 7 | Liver and detoxification health (15%) |
| 4 | 10 | Cancer screening (13%) |
| 11 | 9 | Mental health and cognitive function (11%) |
| 5 | 11 | Genetic, ancestry, and DNA testing (9%) |
Experts’ forecasts of diagnostic areas most likely to transition to home and self-testing in the EU and US markets by 2035 as surveyed in our Global IVD Trend Study 2025
As this growth continues, diagnostics is starting to move beyond one-time testing. More people are now using it regularly in their everyday lives.
At-home diagnostics as a lifestyle
As home testing gains more momentum, it is becoming easier to use and more integrated into daily routines. This shift is changing how people manage their health and make decisions.
Consider this example: Maria, a 47-year-old working mother, starts her day by checking sleep and heart rate data from a wearable device. Over breakfast, she uses her phone to take a quick hormone test and check her cholesterol. When her daughter’s school notifies families about a flu outbreak, she uses an at-home infection test and shares the results with a doctor through a telehealth app.
In this kind of setting, diagnostics is not a one-time event, but a part of everyday health habits.
What this means for diagnostics companies
The shift toward home-based testing creates new opportunities, but also new challenges, and not every company will benefit in the same way. Success will depend on how well businesses adjust their strategies and product offerings.
A few key questions to consider:
Is your product portfolio ready for the home? Tests must not only be clinically valid but also simple and robust enough for non-professionals to use correctly.
Are you focusing on the right segments? Areas like chronic care, women’s health, and infectious diseases are showing the most consistent demand.
Are your solutions readily accessible to consumers/patients? Effective distribution through direct-to-consumer channels and strategic retail or online partnerships is essential, as tests must be easily and promptly available when needed.
At-home testing is becoming a consistent part of healthcare routines. The trend is gaining traction and is expected to continue. For diagnostics companies, this calls for timely adjustments in strategy, product design, and delivery models.
In our next article, we will examine the key barriers to the adoption of at-home diagnostics and the steps companies can take to address them.
Thanks to contributions from Olga Gavrilenko and Dhiren Nitsche!
