The over the counter or OTC test market size has grown rapidly in recent years. It will grow from $24.1 billion in 2024 to $27.55 billion in 2025 at a compound annual growth rate (CAGR) of 14.3%. The growth in the historic period was driven by the expansion of smart home healthcare, increasing adoption of remote patient monitoring, the rise of outpatient clinics, the growth of mHealth (mobile health) solutions, and the emergence of subscription-based services.
The over the counter or OTC test market size is expected to see rapid growth in the next few years. It will grow to $46.38 billion in 2029 at a compound annual growth rate (CAGR) of 13.9%. The growth in the forecast period is expected to be driven by the increasing prevalence of infectious diseases, a rising number of HIV-infected individuals, the expansion of remote patient monitoring, greater smartphone penetration, and the growing incidence of healthcare-associated infections (HAIs). Key trends include the integration of digital health solutions, mobile app connectivity, the adoption of integrated care models, advancements in AI and machine learning, and the development of remote infection control monitoring systems.
The increasing prevalence of chronic diseases is expected to drive the growth of the over-the-counter (OTC) test market. Chronic diseases, which persist for a year or more and require ongoing medical attention, are becoming more widespread due to factors such as aging populations, unhealthy lifestyles, environmental influences, and socioeconomic disparities. OTC tests play a crucial role in managing chronic diseases by enabling early detection, empowering individuals to monitor their health, and facilitating timely interventions, ultimately improving health outcomes through proactive care. For example, in January 2023, the National Center for Biotechnology Information (NCBI) projected that by 2050, the number of individuals aged 50 years and older with at least one chronic illness will rise by 99.5%, from 71.522 million in 2020 to 142.66 million. This growing disease burden is fueling demand for OTC diagnostic solutions.
Leading companies in the OTC test market are focusing on advancing at-home test kits to improve convenience, accuracy, and accessibility for consumers. At-home test kits enable individuals to diagnose specific health conditions from the comfort of their homes, often providing rapid results from blood, saliva, or urine samples. For instance, in December 2023, DiaCarta, a US-based molecular diagnostics company, received OTC approval for its iColon Fecal Occult Blood Test (FOBT) following US FDA 510(k) clearance. This innovative test facilitates early detection of blood in stool, a key indicator of gastrointestinal disorders and colorectal cancer - the third most common cancer worldwide. The iColon FOBT complements DiaCarta's existing ColoScape Test, further strengthening the company’s commitment to improving early cancer detection and intervention.
In December 2024, OraSure Technologies, a US-based medical device company, acquired Sherlock Biosciences for an undisclosed amount. This strategic acquisition aims to enhance OraSure's diagnostic offerings by integrating Sherlock's advanced molecular diagnostics platform, which provides fast, accurate results in a disposable format ideal for home testing. The deal aligns with OraSure’s broader objective of increasing healthcare access and affordability through innovative testing solutions. Sherlock Biosciences, a US-based manufacturer, specializes in OTC disposable molecular tests, particularly for sexually transmitted infections (STIs).
Major players in the over the counter or OTC test market are Pfizer Inc., F. Hoffmann-La Roche Ltd., Abbott Laboratories, Siemens Healthineers AG, Becton, Dickinson and Company (BD), QuidelOrtho Corporation, Kroger Health, Dexcom Inc., Bio-Rad Laboratories Inc., SD Biosensor Inc., OraSure Technologies Inc., Everlywell Inc., LetsGetChecked Inc., Bionime Corporation, Nipro Diagnostics Inc., Chembio Diagnostics Inc., ACON Laboratories Inc., iHealth Labs Inc., Ellume Limited, Geratherm Medical AG, Wondfo Biotech Co. Ltd., bioLytical Laboratories Inc., Watmind USA, First Check Diagnostics LLC.
North America was the largest region in the over the counter or OTC test market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in over the counter or OTC test report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the over the counter or OTC test market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Over-the-counter (OTC) tests are diagnostic tests that consumers can purchase and use without a prescription. Designed for self-administration, these tests enable individuals to monitor or assess various aspects of their health without requiring a doctor's visit.
The primary types of OTC tests include cholesterol monitoring, urine analysis, drug abuse testing, infectious disease testing, fecal occult blood tests, and glucose monitoring. Cholesterol monitoring tests measure blood cholesterol and lipid levels to assess heart health and help prevent cardiovascular diseases. These tests are applied in cardiology, oncology, glucose monitoring, pregnancy and fertility, infectious disease detection, and toxicology. They serve various end users, including hospitals and clinics, home care settings, diagnostic laboratories, and others.
The over the counter or OTC test market research report is one of a series of new reports that provides over the counter or OTC test market statistics, including the over the counter or OTC test industry global market size, regional shares, competitors with the over the counter or OTC test market share, detailed over the counter or OTC test market segments, market trends, and opportunities, and any further data you may need to thrive in the over the counter or OTC test industry. This over the counter or OTC test market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The over-the-counter (OTC) tests market consists of sales of blood glucose meters, fingerstick cholesterol test kits, skin prick allergy tests, and blood pressure monitors. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
The over the counter or OTC test market size is expected to see rapid growth in the next few years. It will grow to $46.38 billion in 2029 at a compound annual growth rate (CAGR) of 13.9%. The growth in the forecast period is expected to be driven by the increasing prevalence of infectious diseases, a rising number of HIV-infected individuals, the expansion of remote patient monitoring, greater smartphone penetration, and the growing incidence of healthcare-associated infections (HAIs). Key trends include the integration of digital health solutions, mobile app connectivity, the adoption of integrated care models, advancements in AI and machine learning, and the development of remote infection control monitoring systems.
The increasing prevalence of chronic diseases is expected to drive the growth of the over-the-counter (OTC) test market. Chronic diseases, which persist for a year or more and require ongoing medical attention, are becoming more widespread due to factors such as aging populations, unhealthy lifestyles, environmental influences, and socioeconomic disparities. OTC tests play a crucial role in managing chronic diseases by enabling early detection, empowering individuals to monitor their health, and facilitating timely interventions, ultimately improving health outcomes through proactive care. For example, in January 2023, the National Center for Biotechnology Information (NCBI) projected that by 2050, the number of individuals aged 50 years and older with at least one chronic illness will rise by 99.5%, from 71.522 million in 2020 to 142.66 million. This growing disease burden is fueling demand for OTC diagnostic solutions.
Leading companies in the OTC test market are focusing on advancing at-home test kits to improve convenience, accuracy, and accessibility for consumers. At-home test kits enable individuals to diagnose specific health conditions from the comfort of their homes, often providing rapid results from blood, saliva, or urine samples. For instance, in December 2023, DiaCarta, a US-based molecular diagnostics company, received OTC approval for its iColon Fecal Occult Blood Test (FOBT) following US FDA 510(k) clearance. This innovative test facilitates early detection of blood in stool, a key indicator of gastrointestinal disorders and colorectal cancer - the third most common cancer worldwide. The iColon FOBT complements DiaCarta's existing ColoScape Test, further strengthening the company’s commitment to improving early cancer detection and intervention.
In December 2024, OraSure Technologies, a US-based medical device company, acquired Sherlock Biosciences for an undisclosed amount. This strategic acquisition aims to enhance OraSure's diagnostic offerings by integrating Sherlock's advanced molecular diagnostics platform, which provides fast, accurate results in a disposable format ideal for home testing. The deal aligns with OraSure’s broader objective of increasing healthcare access and affordability through innovative testing solutions. Sherlock Biosciences, a US-based manufacturer, specializes in OTC disposable molecular tests, particularly for sexually transmitted infections (STIs).
Major players in the over the counter or OTC test market are Pfizer Inc., F. Hoffmann-La Roche Ltd., Abbott Laboratories, Siemens Healthineers AG, Becton, Dickinson and Company (BD), QuidelOrtho Corporation, Kroger Health, Dexcom Inc., Bio-Rad Laboratories Inc., SD Biosensor Inc., OraSure Technologies Inc., Everlywell Inc., LetsGetChecked Inc., Bionime Corporation, Nipro Diagnostics Inc., Chembio Diagnostics Inc., ACON Laboratories Inc., iHealth Labs Inc., Ellume Limited, Geratherm Medical AG, Wondfo Biotech Co. Ltd., bioLytical Laboratories Inc., Watmind USA, First Check Diagnostics LLC.
North America was the largest region in the over the counter or OTC test market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in over the counter or OTC test report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the over the counter or OTC test market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Over-the-counter (OTC) tests are diagnostic tests that consumers can purchase and use without a prescription. Designed for self-administration, these tests enable individuals to monitor or assess various aspects of their health without requiring a doctor's visit.
The primary types of OTC tests include cholesterol monitoring, urine analysis, drug abuse testing, infectious disease testing, fecal occult blood tests, and glucose monitoring. Cholesterol monitoring tests measure blood cholesterol and lipid levels to assess heart health and help prevent cardiovascular diseases. These tests are applied in cardiology, oncology, glucose monitoring, pregnancy and fertility, infectious disease detection, and toxicology. They serve various end users, including hospitals and clinics, home care settings, diagnostic laboratories, and others.
The over the counter or OTC test market research report is one of a series of new reports that provides over the counter or OTC test market statistics, including the over the counter or OTC test industry global market size, regional shares, competitors with the over the counter or OTC test market share, detailed over the counter or OTC test market segments, market trends, and opportunities, and any further data you may need to thrive in the over the counter or OTC test industry. This over the counter or OTC test market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The over-the-counter (OTC) tests market consists of sales of blood glucose meters, fingerstick cholesterol test kits, skin prick allergy tests, and blood pressure monitors. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
Table of Contents
1. Executive Summary2. Over The Counter Or OTC Test Market Characteristics3. Over The Counter Or OTC Test Market Trends And Strategies4. Over The Counter Or OTC Test Market - Macro Economic Scenario Macro Economic Scenario Including the Impact of Interest Rates, Inflation, Geopolitics, and the Recovery from COVID-19 on the Market32. Global Over The Counter Or OTC Test Market Competitive Benchmarking And Dashboard33. Key Mergers And Acquisitions In The Over The Counter Or OTC Test Market34. Recent Developments In The Over The Counter Or OTC Test Market
5. Global Over The Counter Or OTC Test Growth Analysis And Strategic Analysis Framework
6. Over The Counter Or OTC Test Market Segmentation
7. Over The Counter Or OTC Test Market Regional And Country Analysis
8. Asia-Pacific Over The Counter Or OTC Test Market
9. China Over The Counter Or OTC Test Market
10. India Over The Counter Or OTC Test Market
11. Japan Over The Counter Or OTC Test Market
12. Australia Over The Counter Or OTC Test Market
13. Indonesia Over The Counter Or OTC Test Market
14. South Korea Over The Counter Or OTC Test Market
15. Western Europe Over The Counter Or OTC Test Market
16. UK Over The Counter Or OTC Test Market
17. Germany Over The Counter Or OTC Test Market
18. France Over The Counter Or OTC Test Market
19. Italy Over The Counter Or OTC Test Market
20. Spain Over The Counter Or OTC Test Market
21. Eastern Europe Over The Counter Or OTC Test Market
22. Russia Over The Counter Or OTC Test Market
23. North America Over The Counter Or OTC Test Market
24. USA Over The Counter Or OTC Test Market
25. Canada Over The Counter Or OTC Test Market
26. South America Over The Counter Or OTC Test Market
27. Brazil Over The Counter Or OTC Test Market
28. Middle East Over The Counter Or OTC Test Market
29. Africa Over The Counter Or OTC Test Market
30. Over The Counter Or OTC Test Market Competitive Landscape And Company Profiles
31. Over The Counter Or OTC Test Market Other Major And Innovative Companies
35. Over The Counter Or OTC Test Market High Potential Countries, Segments and Strategies
36. Appendix
Executive Summary
Over The Counter Or OTC Test Global Market Report 2025 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses on over the counter or otc test market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for over the counter or otc test ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The over the counter or otc test market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include:
- The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope
Markets Covered:
1) By Product: Cholesterol Monitoring Test; Urine Analysis Test; Drug Abuse Test; Infectious Disease Testing; Fecal Occult Test; Glucose Monitoring Test2) By Application: Cardiology; Oncology; Glucose Monitoring; Pregnancy And Fertility; Infectious Disease; Toxicology
3) By End-User: Hospital And Clinic; Home Care; Diagnostic Laboratory; Other End-Users
Subsegments:
1) By Cholesterol Monitoring Test: Total Cholesterol Test; HDL (High-Density Lipoprotein) Test; LDL (Low-Density Lipoprotein) Test; Triglycerides Test2) By Urine Analysis Test: Urine Dipstick Test; Urine Microscopy Test; Urine Culture Test; Urine Pregnancy Test
3) By Drug Abuse Test: Urine Drug Test; Saliva Drug Test; Hair Follicle Drug Test; Breath Drug Test
4) By Infectious Disease Testing: HIV Test; Hepatitis Test; Influenza Test; COVID-19 Test; Strep Throat Test
5) By Fecal Occult Test: Guaiac-Based Fecal Occult Blood Test (gFOBT); Immunochemical Fecal Occult Blood Test (iFOBT/FIT)
6) By Glucose Monitoring Test: Blood Glucose Meters; Continuous Glucose Monitoring (CGM) Systems; Urine Glucose Test Strips
Key Companies Profiled: Pfizer Inc.; F. Hoffmann-La Roche Ltd.; Abbott Laboratories; Siemens Healthineers AG; Becton, Dickinson and Company (BD)
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain
Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: PDF, Word and Excel Data Dashboard.
Companies Mentioned
The companies featured in this Over The Counter Or OTC Test market report include:- Pfizer Inc.
- F. Hoffmann-La Roche Ltd.
- Abbott Laboratories
- Siemens Healthineers AG
- Becton, Dickinson and Company (BD)
- QuidelOrtho Corporation
- Kroger Health
- Dexcom Inc.
- Bio-Rad Laboratories Inc.
- SD Biosensor Inc.
- OraSure Technologies Inc.
- Everlywell Inc.
- LetsGetChecked Inc.
- Bionime Corporation
- Nipro Diagnostics Inc.
- Chembio Diagnostics Inc.
- ACON Laboratories Inc.
- iHealth Labs Inc.
- Ellume Limited
- Geratherm Medical AG
- Wondfo Biotech Co. Ltd.
- bioLytical Laboratories Inc.
- Watmind USA
- First Check Diagnostics LLC
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 175 |
| Published | January 2025 |
| Forecast Period | 2025 - 2029 |
| Estimated Market Value ( USD | $ 27.55 Billion |
| Forecasted Market Value ( USD | $ 46.38 Billion |
| Compound Annual Growth Rate | 13.9% |
| Regions Covered | Global |
| No. of Companies Mentioned | 25 |
