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Over-The-Counter Diagnostic Tests Market Forecast to Grow at 10.96% CAGR Through 2031 Amid Rising Prevalence of Chronic and Infectious Diseases

06-16-2025 08:12 AM CET | Health & Medicine

Press release from: Insightace Analytic Pvt Ltd.

Over The Counter Tests Market

Over The Counter Tests Market

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Over The Counter Tests Market Size, Share & Trends Analysis Report By Technology (Lateral Flow Assays, Immunoassays, Dipsticks), By Product (Infectious Disease Tests, Glucose Monitoring Tests, Pregnancy and Fertility Tests), Region, Market Outlook And Industry Analysis 2031"

The Global Over The Counter Tests Market is estimated to reach over USD 43.40 billion by 2031, exhibiting a CAGR of 10.96% during the forecast period.

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The over-the-counter (OTC) pregnancy test market is projected to witness steady growth in market share, driven by increasing consumer demand for non-invasive diagnostic solutions. Among these, urine-based pregnancy tests continue to be widely utilized due to their convenience and accessibility. Additionally, there is a growing inclination toward saliva-based testing methods, which offer a more discreet and user-friendly alternative, eliminating the need for blood or urine samples. Technological advancements in diagnostic tools are further enhancing the competitiveness of companies operating in the OTC segment. For example, in November 2021, Salignostics-a Jerusalem-based diagnostic device company-announced the successful completion of clinical trials for SaliStick, the world's first saliva-based rapid pregnancy test. This innovative product can detect human chorionic gonadotropin (hCG) as early as one day following a missed menstrual cycle.

List of Prominent Players in the Over The Counter Tests Market:
• 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.

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Market Dynamics
Drivers:
The global over-the-counter (OTC) diagnostic test market is experiencing significant growth, primarily attributed to the rising incidence of chronic and infectious diseases such as cardiovascular conditions, diabetes, and respiratory infections. This trend is further reinforced by increasing consumer demand for point-of-care and OTC diagnostic solutions that offer convenience and timely results. Moreover, substantial investments from both public and private sectors aimed at advancing the pharmaceutical and biotechnology industries are bolstering market expansion. According to data from the Centers for Disease Control and Prevention (CDC), U.S. hospitals report approximately 1.7 million healthcare-associated infections and 99,000 related deaths annually, emphasizing the urgent need for effective diagnostic technologies.

Challenges:
Despite favorable growth drivers, the OTC diagnostic test market faces several challenges. The high cost associated with OTC diagnostic kits and subsequent treatments can pose affordability issues for a significant portion of the population. Additionally, limited public awareness regarding the availability and benefits of OTC testing technologies remains a critical hurdle. Inadequate diagnostic infrastructure and insufficient in-vitro testing capabilities-particularly in emerging economies-also hinder market development and limit potential revenue generation during the forecast period.

Regional Trends:
As of 2022, North America accounted for the largest share of the OTC diagnostic test market, supported by a high prevalence of chronic illnesses, an expanding portfolio of approved OTC testing products, strong presence of leading market participants, and continuous advancements in healthcare technology. This regional dominance is expected to persist over the coming years. In contrast, the Asia-Pacific region is projected to witness robust market growth, fueled by a rising burden of chronic and infectious diseases, a growing aging population, increasing healthcare expenditures, and greater adoption of OTC diagnostic solutions.

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Recent Developments:
• In October 2021, As part of its continued commitment to giving its clients the greatest resources and user experience, VirgoCX introduced the much-anticipated OTC Direct revamp to its over-the-counter (OTC) trading platform, VirgoCX Wealth.
• In June 2021, The authorised generic versions of a few over-the-counter medications were purchased by Glenmark Pharmaceuticals Ltd. from Wockhardt Ltd. in the US. The company's wholly-owned subsidiary Glenmark Pharmaceuticals Inc. has acquired the authorised abbreviated new drug applications (ANDAs) for the 10 mg and 20 mg famotidine tablets used to treat and prevent stomach and intestine ulcers.

Segmentation of Over The Counter Tests Market-
By Product-
• Cholesterol Test
• Fecal Occult Blood Test
• Pregnancy Test
• Glucose Monitoring Tests
• Drug abuse Test
• Others
By End-Use-
• Online pharmacies
• Retail pharmacies
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of Middle East and Africa

Read Overview Report- https://www.insightaceanalytic.com/report/over-the-counter-tests-market-/1888

About Us:
InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

Contact us:
InsightAce Analytic Pvt. Ltd.
Visit: www.insightaceanalytic.com
Tel : +1 607 400-7072
Asia: +91 79 72967118
info@insightaceanalytic.com

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