Rapid Medical Diagnostic Kits Market Size, Share & Trends Analysis Report By Product (OTC Kits, Professional Kits), By Technology (Lateral Flow, Solid Phase), By Application, By End Use, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global rapid medical diagnostic kits market size was valued at USD 13.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 3.4% from 2022 to 2030. The market for rapid medical diagnostic kits is set to gain momentum in the coming years owing to the rising need and awareness regarding the rapid medical evaluation of chronic diseases, growing demand for point of care (POC) diagnostics, a high influx of portable rapid testing devices in the market, rise in the number of infectious disease cases, and expanding geriatric population base. The European Centre for Disease Prevention and Control, the WHO, and the CDC are actively engaged in mapping data on the incidence and prevalence of infectious diseases to control the disease systematically. Collaborative efforts of the government bodies with local authorities to achieve overall control of treatment and management of infectious diseases are expected to supplement the adoption of rapid tests.

A vast pool of local industry participants and intense competition among players impact the buying behavior of consumers. The growing prevalence of chronic diseases is leading to an increase in the need for rapid disease diagnosis, which is further positively impacting the buying behavior process of rapid medical supplies for diagnostic applications.

The increasing prevalence of multidrug-resistant bacterial infections is set to propel the demand for rapid medical evaluation. Moreover, the outbreak of COVID-19 has created a significant opportunity for manufacturers to develop rapid diagnostic test supplies to contain the spread of COVID-19 infection. Expanding population, genetic variation in hosts and pathogens, and environmental change are some of the aspects contributing to the increased demand for rapid medical supplies, thereby boosting the industry expansion.

Contrastingly, with the advent of advanced technologies, such as lab-based PCR and molecular diagnostics, the demand for rapid diagnostic tests is expected to observe a sluggish growth. Although rapid diagnostic tests have high sensitivity and specificity for detecting malaria, PCR and molecular diagnostic technologies have proved to be more sensitive. Thus, infectious disease diagnosis has been revolutionized through advanced molecular techniques, such as PCR, which may emerge as a threat to the market.

Product Insights

Over the counter (OTC) kits dominated the market in 2020 with a share of 54.3%. This is attributed to the fact that these tests are easy to use in the “near-patient setting” and are a cost-effective alternative to expensive laboratory testing. These tests are typically used in home care settings, providing an easy and cost-effective alternative to laboratory testing. Rapid Diagnostic Tests (RDTs) commonly make use of saliva, urine, and blood to diagnose diseases.

According to the Consumer Healthcare Products Association, clinical cost savings amounted to over USD 77 billion owing to the low pricing of OTC diagnostic products. These tests also aid in the detection of various infectious and chronic diseases with limited or no symptoms, facilitating early treatment and reducing other complications associated with the disease. While these tests are most often used in home care settings, these tests are also used in hospitals, clinics, and diagnostic laboratories.

Professional rapid diagnostic test kits accounted for a significant revenue share in 2020. These tests most often make use of techniques, such as PCR and molecular diagnostics, providing higher test sensitivity and specificity. Professional laboratory tests are typically performed after a positive RDT has been obtained to confirm disease diagnosis. As RDTs have low sensitivity, they often provide false negatives, thus the use of professional tests is considered to be the gold standard in diagnostic settings.

Technology Insights

The lateral flow technology segment accounted for the largest revenue share of 35.1% in 2020. The low development cost and easy manufacturing of lateral flow assays have led to the expansion of these tests into several rapid testing applications. Lateral flow assays are commonly adopted across qualitative and quantitative identification of specific antigens, gene amplification products, and antibodies in hospitals, clinics, and diagnostic laboratories, thus further contributing to the segment growth.

Expanding application of lateral flow tests in the early detection of COVID-19 has been witnessed recently. For instance, in March 2020, Ozo Life announced the launch of its OZO COVID-19 Rapid Test Kits-a latex-enhanced lateral flow immunoassay, which ensures testing of the SARS-CoV-2 infection with enhanced sensitivity. Moreover, an increase in the public and private partnerships for the development of novel lateral flow tests targeted toward COVID-19 diagnosis is set to propel the segment growth.

The solid-phase technology segment accounted for a significant revenue share in 2020. These are used to detect multiple targets in a single test, maximizing the use of the patient sample. The presence of a broad spectrum of biomarkers, pathogens, and environmental contaminants is detected by lateral flow testing, resulting in the increasing demand for these products.

Application Insights

The infectious disease testing segment held the largest revenue share of nearly 42.0% in 2020. The outbreak of the novel coronavirus (COVID-19) has created an urgent demand for its rapid diagnostic solutions as it is a cornerstone of the management of the COVID-19 pandemic. As of January 2021, more than 99 million COVID-19 patients have been reported across the globe, contributing to the segment’s revenue generation capacity.

Countries including the U.S., Brazil, Russia, the U.K., Spain, Italy, India, Germany, Turkey, and Colombia have reported the highest number of COVID-19 cases. Mass testing has increased to manage this pandemic. To fulfill this growing need, numerous diagnostics companies are focusing on R&D activities for the development of novel COVID-19 rapid medical diagnostic kits and gaining approval from different regulatory bodies.

The blood glucose testing segment is anticipated to register the fastest growth rate during the forecast period. The sheer volume of rapid blood glucose tests marketed and currently under usage is the key contributor to the segment growth. Besides, abundant adoption of these tests for the immediate measurement of elevated blood cholesterol levels across assisted living centers, home care, clinics, and laboratories is expected to boost the segment growth.

End-use Insights

In 2020, hospitals and clinics held the largest share of 46.5% as they serve as primary care settings for the diagnosis and treatment of all diseases. Furthermore, increasing hospitalization due to the outbreak of COVID-19 is expected to support segment growth. Constant changes in the healthcare industry have led to an increase in the need for hospitals with enhanced diagnostic services.

A rise in healthcare expenditure globally has also significantly contributed to the growth of the market. As hospitals maintain and collect data on disease prevalence, regulatory bodies often collaborate with them for disease surveillance. On the other hand, with the advent of POC diagnostics or at-home diagnosis, there has been a steady rise in the number of rapid diagnostic tests being performed globally.

The home care end-use segment is expected to witness significant growth over the forecast period. Most rapid influenza diagnostic kits that are Clinical Laboratory Improvement Amendments (CLIA) waived are typically used in POC settings. Lateral flow rapid antigen assay that helps detect pregnancy at home is widely used, thus driving the demand for home use kits. Blood glucose testing strips are also commonly used at home, which are a safe, easy, and affordable way to check diabetes. The aforementioned factors are collaboratively set to contribute to the growth of the home care end-use segment.

Regional Insights

North America dominated the market in 2020 with a share of more than 30.0% and is expected to maintain its lead from 2021 to 2028. The U.S. emerged as the key revenue-generating segment in 2020. Numerous diagnostics companies are involved in the development of novel COVID-19 rapid diagnostic tests and are striving to gain approval from the FDA to launch these tests in the U.S.

For instance, as early as May 2020, Quidel Corporation, an American diagnostic healthcare company, received Emergency Use Authorization (EUA) from the FDA for its new Sofia 2 SARS Antigen FIA for rapid diagnosis of COVID-19. Asia Pacific countries are expected to register the highest cumulative growth rate of 5.1% from 2021 to 2028. Japan and China both generated robust revenues in 2020 and are expected to maintain this trend in the next 10 years.

Key Companies & Market Share Insights

The companies are keen on adopting strategic moves targeted toward catering to the needs associated with the management of the COVID-19 pandemic outbreak. For instance, in May 2020, ACON Laboratories launched its new SARS-COV-2 IgG/IgM Rapid Test, a lateral flow immunoassay for the identification of (IgM & IgG) antibodies generated in response to COVID-19. This helped expand the company’s portfolio in the rapid diagnostic tests market. Some prominent players in the global rapid medical diagnostic kits market include:

• ACON Laboratories, Inc.

• Abbott Laboratories

• Artron Laboratories Inc.

• Alfa Scientific Designs, Inc.

• Becton, Dickinson and Company

• BTNX, Inc.

• bioMérieux SA

• Cardinal Health

• Bio-Rad Laboratories, Inc.

• Danaher Corporation

• Creative Diagnostics

• Meridian Bioscience, Inc.

• F. Hoffmann-La Roche AG

• McKesson Medical-Surgical, Inc.

• Sight Diagnostics Ltd.

• Trinity Biotech

• Zoetis

Rapid Medical Diagnostic Kits Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global rapid medical diagnostic kits market report on the basis of product, technology, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Over the Counter (OTC) Kits

  • Professional Kits

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Lateral Flow

  • Agglutination

  • Solid Phase

  • Other Technologies

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Blood Glucose Testing

  • Infectious Disease Testing

    • COVID-19

    • Hepatitis

    • HIV

    • Influenza

    • Others

  • Cardiometabolic Testing

  • Pregnancy and Fertility Testing

  • Fecal Occult Blood Testing

  • Coagulation Testing

  • Toxicology Testing

  • Lipid Profile Testing

  • Other Applications

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals & Clinics

  • Home Care

  • Diagnostic Laboratories

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE