The global over-the-counter (OTC) test market size was valued at $13,498.50 million in 2020, and is estimated to reach $39,937.90 million by 2030, growing at a CAGR of 11.7% from 2021 to 2030. Over-the-counter (OTC) testing medical devices are directly available to the consumer and they do not require a prescription for sale. They can be used outside healthcare facilities, such as home, school, office, and communities. The over-the-counter testing products are adequately labelled with proper instruction such that the consumer is able to understand its usage, without any help from a physician. According to Food and Drug Administration (FDA), the safety margin of over-the-counter medical device and testing products are such that the benefits of having an available over-the-counter device outweighs the risks.
Growth of the global over-the-counter test market is majorly driven by increase in prevalence of chronic and infectious disease such as heart disease, diabetics, respiratory infection; rise in demand for point-of-care, over-the-counter diagnostic test; increase in funding from private & government organizations for development of pharmaceutical and biotechnology industry; and advancements in technologies for over-the-counter test products. According to the Centers for Disease Control and Prevention (CDC), in 2018, it was reported that approximately 1.7 million infections and 99,000 associated deaths occur every year in American hospitals.
Furthermore, surge in demand for point-of-care testing is anticipated to fuel the growth of the over-the-counter (OTC) test market. For instance, in April 2021, Food and Drug Administrative (FDA), announced the approval of over-the-counter (over-the-counter) and point-of-care (POC) testing for COVID-19. The combination of POC and over-the-counter test products such as Abbott BinaxNOW COVID-19 Ag self-test, Quidel Quicdel QuickVue at-home over-the-counter COVID-19 test and BD veritor system are used for detecting and screening of respiratory infection in school, workplaces, and communities. In addition, rise in geriatric population fuels the OTC market growth, owing to the fact that aged individuals are susceptible to chronic and infectious diseases. According to the U.S. Food and Drug Administration (FDA), in 2020, it was reported that around 300,000 individuals aged 50 and above are diagnosed with pneumococcal pneumonia, every year.
Moreover, in 2018, Roche, a multinational healthcare company, announced the launch of CoaguCheck vantus system, which is a self-test device designed with advanced feature for monitoring blood coagulation, specially for patient on warfarin therapy. Thus, technological advancements in development of over-the-counter test and rise in awareness among individual regarding early diagnosis propel the growth of the OTC test market. However, high cost associated with over-the-counter test products is expected to restrict the over-the-counter market growth during the forecast period.
Over-the-counter Test Market Segmentation
The over-the-counter test market is segmented into product type, technology, distribution channel, and region. By product type, the market is categorized into glucose monitoring test, pregnancy & fertility test, coagulation monitoring test, urinalysis test, cholesterol test, and other test. The glucose monitoring test segment is further classified into blood glucose meters, testing strips, and lancets. The pregnancy & fertility test segment is further divided into pregnancy test and fertility test.
Depending on technology, it is categorized into lateral flow assays, immunoassays, and dipsticks. By distribution channel, the OTC test market is fragmented into hospital pharmacy, retail pharmacy, and online pharmacy.
By Product
Glucose Monitoring Tests segment held a dominant position in 2020 and would continue to maintain the lead over the forecast period.
Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, Saudi Arabia, South Africa, and rest of LAMEA).
Segment Review
Depending on product type, the glucose monitoring test segment dominated the market in 2020, and this trend is expected to continue during the forecast period, owing to increase in prevalence of diabetics, and surge in demand for glucometer. However, the pregnancy & fertility test segment is expected to witness considerable growth during the forecast period, owing to increase in prevalence of infertility disorder, increasing birth rate, availability of the fertility testing device, and advancement in technology to develop pregnancy and fertility test product.
By Technology
Lateral Flow Assays segment held a dominant position in 2020 and would continue to maintain the lead over the forecast period.
On the basis of technology, the lateral flow assays segment dominated the market in 2020, and this trend is expected to continue during the forecast period, owing to rise in prevalence of infectious diseases, increasing number of key players for manufacturing of lateral flow assay kits and surge in demand for home based lateral flow assay devices However, the immunoassays segment is expected to witness considerable growth during the forecast period, owing to increase in prevalence of chronic disease, advancement in technology for development of advanced immunoassays, and increase in demand for immunoassay for detection of antibody.
By distribution channel, the hospital pharmacies segment was the major contributor in 2020, and is expected to maintain its lead during the forecast period, owing to rise in prevalence of diabetics, surge in demand for self-monitoring devices and initiative taken by government for advancement of hospital pharmacy. However, the online pharmacies segment is expected to witness considerable growth during the forecast period, due to advancement in technology in the healthcare sector and a rise in demand for remote service.
By Distribution Channel
Hospital Pharmacy segment is projected as one of the most lucrative segment.
North America garnered the major share in the over-the-counter test market in 2020, and is expected to continue to dominate during the forecast period, owing to rise in prevalence of chronic disease, increase in number of approval for over-the-counter test product, the presence of key players, and development in technology for healthcare in the region. However, Asia-Pacific is expected to register the highest CAGR of 13.2% from 2021 to 2030, owing to increase in prevalence of chronic and infectious disease, rise in number of geriatric population, growth in health care expenditures, and rise in adoption of over-the-counter test product.
The key players operating in the global over-the-counter test market include Abbott Laboratories, Abingdon Health PLC, AccuBioTech Co., Ltd., Acon Laboratories Inc., B. Braun Melsungen AG, Becton Dickinson and Company, Clip Health, Dario Health Corp, Ellume Health Ltd, Eurofins Scientific Group, F. Hoffmann-La Roche AG, Lia Diagnostics Inc, Lifescan IP Holdings, LLC, Lucira Health, Inc, Now Diagnostics Inc, Orasure Technologies Inc, PHC Holdings Corporation, Quidel Corporation, SD Biosensor Inc., and Sinocare Inc.
By Region
North America was holding a dominant position in 2020 and would continue to maintain the lead over the analysis period.
Key Benefits for Stakeholders
- The study provides an in-depth analysis of the over-the-counter test market, and the current trends & future estimations to elucidate imminent investment pockets.
- It presents a quantitative analysis of the market from 2021 to 2030 to enable stakeholders to capitalize on the prevailing OTC test market opportunities.
- Extensive analysis of the market based on procedures and services assists to understand the trends in the industry.
- Key players and their strategies are thoroughly analyzed to understand the competitive outlook of the over-the-counter test market.
Key Market Segments
By Product Type
- Glucose Monitoring Test
- Blood Glucose Meters
- Testing Strips
- Lancets
- Pregnancy & Fertility Test
- Pregnancy Test
- Fertility Test
- Coagulation Monitoring Test
- Urinalysis Test
- Cholesterol Test
- Other Test
By Technology
- Lateral Flow Assays
- Immunoassays
- Dipsticks
By Distribution Channel
- Hospital Pharmacy
- Retail Pharmacy
- Online pharmacy
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- Australia
- India
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- Abbott Laboratories
- Abingdon Health PLC
- AccuBioTech Co., Ltd.
- Acon Laboratories Inc.
- B. Braun Melsungen AG
- Becton Dickinson and Company
- Clip Health
- Dario Health Corp
- Ellume Health Ltd
- Eurofins Scientific Group
- F. Hoffmann-La Roche AG
- Lia Diagnostics Inc
- Lifescan IP Holdings, LLC
- Lucira Health, Inc
- Now Diagnostics Inc
- Orasure Technologies Inc
- PHC Holdings Corporation
- Quidel Corporation
- SD Biosensor Inc.
- Sinocare Inc.
Over The Counter (OTC) Test Market Report Highlights
| Aspects | Details |
 By PRODUCT TYPE |
|
 By TECHNOLOGY |
|
 By DISTRIBUTION CHANNEL |
|
 By Region |
|
 Key Market Players | Abbott Laboratories, Acon Laboratories, INC., Ellume Health Ltd., Eurofins Scientific Group, Becton, Dickinson and Company, Dario Health Corp., Abingdon Health PLC, Clip Health, .B. Braun Melsungen AG, .AccuBioTech Co., Ltd |
Analyst Review
Growth of the over-the-counter test market is attributed to factors such as technological advancements in the healthcare sector; rise in prevalence of chronic and infectious diseases such as diabetic, cardiovascular disease, HIV, & COVID-19; increase development of healthcare sector for manufacturing advanced over-the-counter test products; and rise in awareness about early diagnosis. The over-the-counter test market gains interest of pharmaceutical and biotechnology companies, owing to surge in demand for point-of-care over-the-counter diagnostic testing. This leads to increase in adoption of over-the-counter testing for detection and monitoring of chronic diseases. Moreover, advancement in technology, such as lateral flow assay, immunoassay, and dipstick, have gained high traction in the market in recent years, as these having its application in over-the-counter test products.
North America is expected to witness the highest growth, in terms of revenue, owing to rise in prevalence of chronic disease, increase in number of approval for over-the-counter test product, the presence of key players, and development in technology for healthcare in the region.
Asia-Pacific was the second largest contributor to the market in 2020, and is expected to register the fastest CAGR during the forecast period, owing to increase in prevalence of chronic and infectious disease, rise in number of geriatric population, growth in health care expenditures, and rise in adoption of over-the-counter test product.
However, high cost associated with over-the-counter testing products is anticipated to restrain the market growth during the forecast period.
The total market value of Over the Counter Test market is $13,498.5 million in 2020.
The forecast period in the report is from 2021 to 2030
The market value of Over the Counter Test market in 2021 was $14,741.71 million
The base year for the report is 2020.
Yes, Over the Counter Test companies are profiled in the report
The top companies that hold the market share in Over the Counter Test market are Abbott Laboratories, Abingdon Health PLC, AccuBioTech Co., Ltd., Acon Laboratories Inc., B. Braun Melsungen AG, Becton Dickinson and Company, Clip Health, Dario Health Corp, Ellume Health Ltd, Eurofins Scientific Group, F. Hoffmann-La Roche AG, Lia Diagnostics Inc, Lifescan IP Holdings, LLC, Lucira Health, Inc, Now Diagnostics Inc, Orasure Technologies Inc, PHC Holdings Corporation, Quidel Corporation, SD Biosensor Inc., and Sinocare Inc
Asia-Pacific is expected to register the highest CAGR of 13.2% from 2021 to 2030, owing to increase in prevalence of chronic and infectious disease, rise in number of geriatric population, growth in health care expenditures, and rise in adoption of over the counter tests product
The key trends in the Over the Counter Test market are by increase in prevalence of chronic and infectious disease such as heart disease, diabetics, respiratory infection; rise in demand for point-of-care over-the-counter diagnostic test; increase in funding from private & government organizations for development of pharmaceutical and biotechnology industry; and advancements in technologies for over the counter tests products.
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