According to a new report by the market research firm Fact.MR, Dublin, Ireland, the home-use diagnostics market will grow at a healthy 3.5% CAGR over the next 7 years, surpassing $6.3 billion by 2026.1

According to the report, sales will remain buoyant in developed regions, with revenues in Europe and North America collectively accounting for more than a 50% share of the market. Nevertheless, the Fact.MR report remains bullish on the prospects for home-use diagnostics in developing countries, as a growing focus on health and wellness—and the emergence of many Asian countries as hubs for medical tourism—continues to create opportunities.

Increasing preference for self-diagnosis continues to be a trigger for the sale of home-use diagnostics, but a wide variety of industry-specific and regulatory factors are influencing the strategies of market players. Governing bodies such as FDA and the European Commission regulate home-use diagnostics, imposing strict quality control regulations and labeling requirements.

Home-use diagnostics

The home-use diagnostics market. Infographic courtesy Fact.MR.

According to the Fact.MR report, gaining regulatory approval and maintaining compliance with ever-evolving regulations remains both an opportunity and challenge for market players. Gaining the CE mark, or FDA premarket notification (510(k)) clearance or premarket approval (PMA), continues to be a primary focus for home-use diagnostics manufacturers that are looking to scale-up their presence in developed markets. Abbott, for instance, recently received FDA approval to market its FreeStyle Libre 14-day flash glucose monitoring system in the United States. Acon Laboratories, another prominent player in the home-use diagnostics market, announced that it has received FDA clearance of its Mission U120 urine reagent strips.

The Fact.MR report also finds that home-use diagnostics manufacturers are focusing on incorporating advanced technologies in order to differentiate their offerings in the market. To upgrade its 10-day FreeStyle Libre system to the FreeStyle Libre 14-day flash glucose monitoring system, for instance, Abbott adopted next-generation sensor technologies with improved accuracy and better mean absolute relative difference.

Glucose monitoring devices dominate the home-use diagnostics market—with more than an 80% revenue share in the market—and will continue to witness robust demand. According to the World Health Organization (WHO), the number of people suffering from diabetes reached 422 million in 2014, and the disease will soon become a leading cause of death. The increasing prevalence of diabetes worldwide, and the growing need for monitoring glucose levels among diabetes patients, are likely to boost the adoption of glucose monitoring devices during the assessment period. Manufacturers of home-use diagnostics are aware of the surging demand for glucose monitoring devices, and are focusing on increasing their product portfolio in this segment. Other lucrative segments in the home-use diagnostics market include pregnancy tests and ovulation prediction kits.

Although demand for home-use diagnostics is concentrated in developed countries, the Fact.MR report indicates that the manufacturers of home-use diagnostics are making efforts to boost uptake in developing regions. According to statistics published by WHO, the prevalence of diabetes has been the highest in middle- and low-income countries.

Anticipating the burgeoning demand for glucose monitoring devices in emerging Asia, manufacturers of home-use diagnostics are shifting their focus toward developing nations, including China and India. Arkray Inc, a Japanese manufacturer in the home-use diagnostics market, recently announced that it will strengthen its diabetes testing instrument production capacity in China. Leading manufacturers in the home-use diagnostics market are modifying their marketing strategies to improve awareness about cost-effective and efficient home-use diagnostics to leverage lucrative opportunities in the Asia-Pacific region.

For further information, visit Fact.MR.


  1. Home Diagnostics Market Forecast, Trend Analysis, and Competition Tracking: Global Market Insights, 2018 to 2026. Dublin, Ireland: Fact.MR, 2018. Available at: Accessed December 11, 2018.