Home Diagnostics Market

Home Diagnostics Market Outlook (2023 to 2033)

The global home diagnostics market is valued at US$ 6.21 billion in 2023 and is forecasted to expand at a healthy 5.2% CAGR over the next ten years. Worldwide home diagnostics demand is estimated to reach a market size of US$ 10.32 billion by 2033-end.

Diagnostic kits that can be used by people at home without any medical expertise come under the category of home diagnostics. The surging prevalence of chronic diseases and the increasing need to monitor people periodically to ensure their well-being are prospects that are projected to primarily uplift sales of home diagnostic kits over the coming years.

High incidence of diabetes, growing use of at-home pregnancy tests, increasing awareness regarding benefits of self-testing, expanding senescent population, rising preference for home healthcare, and advancements in point-of-care diagnostics are other key aspects that could promote sales of cholesterol tests, fertility tests, allergy tests, sleep apnea tests, etc. from 2023 to 2033.

• In June 2022, Mylab Discovery Solutions, a biotechnology company based in India, announced the launch of its new at-home pregnancy test kit. This earmarked the company’s entry into the female healthcare category as it looks to expand its business horizons.

Surging prevalence of infectious diseases and the advent of the COVID-19 pandemic in 2020 being a testament to how dangerous infections could get has propelled the demand for at-home infection tests and rapid test kits. High demand for at-home testing can directly be attributed to customized medical help, which is now accessible to the masses because of the use of advanced molecular diagnostics, genomics, and proteomics technologies. Home diagnostics kits help detect the presence of foreign antigens or organisms in the body that are possible causes of contagious diseases/infections.

“Influence of International Health Organizations on Self-testing”

International health organizations such as WHO, Global Health Council. UNICEF, etc. are also projected to have a major impact on sales and demand for home diagnostics in the long run. Guidelines issued by these organizations could have a drastic impact on sales and could also result in regulatory changes, which could very well make or break the demand for at-home diagnostics in the long run.

Report Attributes	Details
Home Diagnostics Market Size (2023)	US$ 6.21 Billion
Projected Market Value (2033F)	US$ 10.32 Billion
Global Market Growth Rate (2023 to 2033)	5.2% CAGR
Urine Sample Market Share (2023)	40%
Cassette Home Diagnostics Products Market Share (2023)	30%
Key Companies Profiled	True Diagnostics Inc. Bionime Corporation Quidel Corporation Sekisui Diagnostics LLC Roche Holding AG Abbott Laboratories ACON Laboratories Inc. BTNX Inc. Thermo Fisher Scientific Inc. Becton Dickinson & Company

Is Making Home Diagnostic Kits Profitable for Start-ups?

“Creating Rapid Diagnostic Tests Could Offer Home Diagnostic Companies Moneymaking Opportunities”

New home diagnostics providers are focusing on developing new products to identify different diseases and conditions from the comfort of one’s home. Incoming home diagnostics device manufacturers are also raising new capital to fund their R&D and business expansion efforts that allow them to compete with established players in the global marketplace.

• Simple HealthKit, a start-up based in the United States, is working on offering high-quality, accessible healthcare. The company revealed in February 2023, that it was working on expanding its diagnostic testing portfolio to accommodate diabetes and sexual health tests.
• In July 2023, SiPhox Health, a new company focusing on bringing blood testing at home, announced that it had raised US$ 17 million in a Series A financing round led by Intel Capital and participation from other investors. The company used the capital to expand its team and advance its business offerings.

Start-ups can benefit by learning more about aspects such as local supply, pricing trends, product standards, safety regulations, and new developments that have been discussed extensively in this home diagnostics industry study by skilled analysts at Fact.MR, a market research and competitive intelligence provider.

What Challenges are Troubling Home Diagnostic Companies?

“Stringent Regulatory Landscape Prime Roadblock”

The diagnostics industry is heavily reliant on precision, reliability, and customer trust. Even though health organizations have lauded the use of home diagnostics for the betterment of healthcare, companies still have to adhere to stringent rules and regulations laid down by regulatory bodies governing this sector.

Damage to reputation is especially difficult to salvage in case of issues, as companies are looking to portray themselves as brands providing sustainable, trustworthy healthcare.

• The FDA regulates all products that are released in the home diagnostics market; all products must be made in compliance with regulations of Section 510(k) of the Food, Drug, and Cosmetic Act, and get Premarket Approval Application (PMA) approval to enter the U.S. market.
• The European Union has also imposed certain conditions that must be adhered to by manufacturers - Medical Devices Regulation 2017/745/EU and In Vitro Diagnostic Medical Devices Regulation 2017/746/EU.

Such stringent regulations lead to an increase in the cost of production, which is a major cause for the unpopularity of home diagnostics, especially in developing countries. Developing economies can turn out to be lucrative markets if companies come up with affordable products. Constrained healthcare budgets in developing economies are hindering the adoption of home diagnostics. Scaling the charts in these economies can prove to be a difficult task without the help of a highly-specialized marketing strategy.

Country-wise Insights

Why Should Home Diagnostic Providers Invest in Canada?

“Longer Wait Time of Canadian Healthcare System Promoting Demand for Home Diagnostics”

Demand for home diagnostics in Canada is projected to increase rapidly over the coming years. This is because using a home diagnostic kit in Canada is comparatively cheaper and faster than relying on the country’s healthcare. Growing awareness regarding different diseases is also projected to encourage more people in Canada to opt for home tests rather than sit around and wait for their turn in the healthcare ecosystem.

• According to a report by Statistics Canada, the biggest concern of the Canadian healthcare system is the wait time.

Surging prevalence of chronic disorders such as cancer, expanding population of the country, and the rising availability of products such as home DNA tests, home ovulation tests, strep tests, home UTI tests, etc. are other prospects that could promote the market development going forward. Hence, it can be concluded that Canada is a highly rewarding marketplace for home diagnostics device vendors.

Why are Home Diagnostic Providers Flocking to the Indian Market?

“Supportive Government Initiatives to Promote Accessibility of Home Testing”

India is a lucrative market and is forecasted to showcase notable demand for at-home testing kits over the study period. The presence of several supportive government initiatives to bolster healthcare infrastructure and promote the general well-being of its population is slated to primarily augment market growth in India through 2033.

Increasing individual awareness regarding physical well-being and easy accessibility of home testing devices in urban and semi-urban areas of the country are also projected to boost shipments of home testing kits going forward.

A surging plurality of chronic ailments such as hypertension, diabetes, and cardiovascular diseases is also projected to play a crucial role in altering the course of the at-home diagnostics marketplace in India. However, the inaccuracy of test results, affordability, and accessibility of these devices in rural areas are still projected to withhold companies from reaching their full potential in the future.

How Will Home Diagnostics Providers Fare in the United Kingdom?

“Increasing Senescent Population Prime Growth Initiator”

Sales of home diagnostics in the United Kingdom account for a sizeable share in the global home diagnostics market and this can directly be ascribed to the rapidly expanding geriatric population in the country. Increasing healthcare expenditure in the country and the prevalence of chronic diseases are also projected to contribute to the rising demand for home healthcare services in the United Kingdom going forward.

Increasing adoption of sedentary lifestyles, poor eating habits, rising incidence of obesity, and growing number of cases of cancer and diabetes are other aspects influencing market development. Hence, the United Kingdom is considered to be an opportune space for players involved in the manufacturing and distribution of home diagnostic kits.

Category-wise Insights

Which Home Diagnostic Solution is Spearheading Revenue Generation?

“Glucose Monitoring Devices Slated to Maintain Hegemony through 2033”

Sales of glucose monitoring devices and at-home blood glucose tests are predicted to have a bright outlook across the study period. This can be primarily attributed to the surging prevalence of diabetes on a global scale.

• As per data provided on the International Diabetes Federation website, around 783 million people are estimated to be living with diabetes by the year 2045, which would be a 46% increase from the numbers recorded in 2021.

Monitoring blood sugar levels is a crucial part of diabetes management and care, which is why glucose monitoring devices are projected to be of utmost importance for people dealing with Type 1 and Type 2 diabetes. Increasing urbanization and growing spending on healthcare are also estimated to contribute to surging sales of blood glucose test kits over the coming years.

Which Form Factor is Popular for Home Diagnostics?

“Cassette Form Preferred for Most Home Diagnostic Solutions”

Diagnostics in the form of cassettes have been proven to be easy to use, simple to operate, and not heavy on patients’ pockets. These factors play a huge role in their popularity among the masses, and the trend is expected to continue over the next ten years as well.

• Cassettes account for a significant share of 30% in the global home diagnostics market in 2023.

Which Sample is Widely Used for Diagnostic Procedures?

“Most Diagnostic Tests Require Urine Samples”

Testing for various conditions and monitoring of health is done mostly by sampling urine, blood, saliva, or other biological specimens.

• Urine sampling is the most prevalent in the global home diagnostics industry with a revenue share close to 40% at present.

Urine samples have been synonymous with the detection of pregnancy, ovulation, or drugs, which is what contributes to the high demand for urine sample testing at present, and its dominance is projected to continue in the future too. However, the surging use of rapid testing kits that use saliva as a sample is slated to hurt sales of diagnostic devices that use urine as a sample.

Competitive Landscape

Leading home diagnostics providers are expanding their product portfolio by launching novel tests and test kits that make at-home testing more convenient than before.

• In March 2023, Cue Health, a leading company providing at-home tests and based in the United States, announced the launch of its new at-home diagnostic tests. All of the new tests include supplies that an individual might need for safe sample collection and the test results are directly delivered to the patient in the Cue Health application on their smartphones.

Key Segments of Home Diagnostics Industry Research

• By Test Type :

  • Glucose Monitoring Devices
  • Pregnancy Tests
  • HIV Test Kits
  • Ovulation Predictor Test Kits
  • Cholesterol Detection Test Kits
  • Drug of Abuse Test Kits
    • Marijuana Kits
    • Opiates Kits
    • Benzodiazepines Kits
    • Alcohol Abuse Kits
    • Others
  • Others
    • Male Infertility Test Kits
    • Urinary Tract Infection Tests
    • Menopause Test Kits
    • Fecal Occult Blood Tests
    • Others

• By Form :

  • Cassettes
  • Strips
  • Midstream
  • Digital Monitoring Instruments
  • Test Panels
  • Cups
  • Dip Cards
  • Others

• By Sample Type :

  • Urine
  • Blood
  • Saliva
  • Others

• By Distribution Channel :

  • Retail Pharmacies
  • Drug Stores
  • Hypermarkets/Supermarkets
  • Online Pharmacies

• By Region :

  • North America
  • Latin America
  • Europe
  • APAC
  • MEA