PUBLISHER: The Business Research Company | PRODUCT CODE: 1826963
PUBLISHER: The Business Research Company | PRODUCT CODE: 1826963
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.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.
The over the counter or OTC test market research report is one of a series of new reports from The Business Research Company 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 or otc test market size has grown rapidly in recent years. It will grow from $24.1 billion in 2024 to $27.47 billion in 2025 at a compound annual growth rate (CAGR) of 14.0%. The growth in the historic period can be attributed to the rise of smart home healthcare, rising remote patient monitoring, the rise of outpatient clinics, the growth of mHealth (mobile health) solutions, and the rise 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 $45.96 billion in 2029 at a compound annual growth rate (CAGR) of 13.7%. The growth in the forecast period can be attributed to the 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 the integration of digital health, integration with mobile apps, integrated care models, the integration of AI and machine learning, and remote infection control monitoring.
The forecast of 13.7% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. The imposition of tariffs may disrupt U.S. consumer health access by increasing costs for rapid COVID-19 and cholesterol test strips imported from China and Germany, potentially leading to reduced preventive screening and higher out-of-pocket expenses. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
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.
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.
Over The Counter Or OTC Test Global Market Report 2025 from The Business Research Company 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.
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, including technological disruption, regulatory shifts, and changing consumer preferences? The over the counter or otc test market global report from the Business Research Company 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 forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.