Over The Counter Test Market Size and Industry Growth in 2025: Key Changes and Transformations

The Business Research Company’s report on the Over The Counter Test Market provides insights into the global market size, growth rate, regional distribution, competitive landscape, key segments, emerging trends, and strategic opportunities.

What are the key drivers behind the over the counter test market’s growth in recent years?

The rising prevalence of chronic diseases is expected to propel the growth of the over the counter test market going forward. Chronic diseases refer to long-lasting conditions that persist for a year or more and require ongoing medical attention or limit daily activities. The rising prevalence of chronic diseases is attributed to factors such as unhealthy lifestyles, poor dietary habits, physical inactivity, and the aging population, which collectively contribute to the increased risk of conditions such as heart disease, diabetes, and obesity. Over-the-counter tests are essential for managing chronic diseases, as they allow individuals to track their health consistently, identify potential issues early, and adjust their treatment plans promptly. For instance, in June 2024, according to the Australian Institute of Health and Welfare, an Australia-based government agency, the death rate associated with chronic conditions increased to 459 per 100,000 population in 2021 and rose further to 490 per 100,000 population in 2022. Therefore, the rising prevalence of chronic diseases is driving the growth of the over the counter test market.

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How does the future projection of the over the counter test market size compare to its historical growth?

The over the counter test market size has grown rapidly in recent years. It will grow from $23.79 billion in 2024 to $27.20 billion in 2025 at a compound annual growth rate (CAGR) of 14.3%. The growth in the historic period can be attributed to rise of smart home healthcare, rising remote patient monitoring, rise of outpatient clinics, growth of mHealth (mobile health) solutions and rise of subscription-based services.

The over the counter test market size is expected to see rapid growth in the next few years. It will grow to $46.11 billion in 2029 at a compound annual growth rate (CAGR) of 14.1%. The growth in the forecast period can be attributed to increasing prevalence of infectious diseases, increasing number of HIV-infected, rising remote patient monitoring, increasing penetration of smartphones and rising healthcare-associated infections (HAIS). Major trends in the forecast period include integration of digital health, integration with mobile apps, integrated care models, integration of AI and machine learning and remote infection control monitoring.

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Which key players are shaping the future of the over the counter test market?

Major companies operating in the over the counter test market are Johnson & Johnson, Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Becton Dickinson and Company, Viatris Inc., Roche Diagnostics Corporation, Hologic Inc., Nipro Diagnostics Inc., Quidel Corporation, Dexcom Inc., Bio-Rad Laboratories Inc., SD Biosensor Inc., Everlywell Inc., LetsGetChecked Inc., OraSure Technologies Inc., Ellume Health Ltd., Bionime Corporation, ACON Laboratories Inc., Wondfo Biotech Co. Ltd., Geratherm Medical AG.

What trends will propel the growth and evolution of the over the counter test market?

Major companies operating in the over the counter test market are focusing on developing innovative products, such as non-invasive at-home diagnostics, to improve accuracy, convenience, and early disease detection for self-monitoring. Non-invasive at-home diagnostics are medical tests and monitoring devices that allow individuals to assess their health conditions without penetrating the skin or requiring invasive procedures. These diagnostics use technologies such as biosensors, saliva or urine testing, wearable devices, and imaging tools to measure vital signs, detect diseases, or monitor chronic conditions from home. For instance, in December 2023, DiaCarta Inc., a US-based molecular diagnostics company that provides molecular diagnostics solutions, launched the iColon test, an over-the-counter (OTC) at-home Fecal Occult Blood Test (FOBT) that received US FDA 510(k) clearance. This non-invasive test enables individuals to detect blood in their stool, a crucial indicator of gastrointestinal disorders and colorectal cancer, from the comfort of their homes. The iColon test aims to improve early disease detection and encourage proactive health monitoring, ultimately enhancing patient outcomes.

Which regions are expected to become dominant players in the over the counter test market?

North America was the largest region in the over-the-counter test market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the over the counter test market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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What are the emerging key segments in the over the counter test market, and how are they evolving?

The over the counter test market covered in this report is segmented –

1) By Product Type: Glucose Monitoring Test, Pregnancy And Fertility Test, Coagulation Monitoring Test, Urinalysis Test, Cholesterol Test, Other Tests

2) By Technology: Immunoassays, Lateral Flow Assays, Dipsticks

3) By Application: Cardiology, Oncology, Glucose Monitoring, Pregnancy And Fertility, Infectious Disease, Toxicology

4) By End-User: Hospital And Clinic, Home Care, Diagnostic Laboratory, Other End Users

Subsegments:

1) By Glucose Monitoring Test: Blood Glucose Meters, Glucose Test Strips, Continuous Glucose Monitors (CGMs), Lancets

2) By Pregnancy And Fertility Test: Pregnancy Test Strips, Digital Pregnancy Tests, Ovulation Prediction Kits, Fertility Monitors

3) By Coagulation Monitoring Test: Prothrombin Time (PT/INR) Test Kits, Activated Partial Thromboplastin Time (aPTT) Test Kits, D-Dimer Test Kits

4) By Urinalysis Test: Dipstick Test Kits, Urine Test Strips, Digital Urinalysis Devices, Home Drug Test Kits

5) By Cholesterol Test: Total Cholesterol Test Kits, HDL And LDL Cholesterol Test Kits, Triglyceride Test Kits, Lipid Panel Test Kits

6) By Other Tests: Infectious Disease Test Kits, Allergy Test Kits, Vitamin And Mineral Deficiency Test Kits, Thyroid Function Test Kits, Cancer Screening Kits

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What defines the structure and scope of the over the counter test market?

An over-the-counter test is a self-diagnostic medical test that individuals can purchase without a prescription for personal use. It allows users to detect or monitor health conditions at home without professional supervision. These tests provide quick and accessible results, aiding in early detection and health management.

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