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Rapid Diagnostics Market Size, Share, and COVID-19 Impact Analysis By Product (Reagents & Kits and Instruments), By Type (OTC and Prescription), By Technology (Lateral Flow Immunoassay, Solid Phase, Agglutination, Microfluidics, and Others), By Application (Infectious Disease Testing, Cardiometabolic Testing, Pregnancy Testing, Blood Glucose Testing, Lipid Profiling, Drug of Abuse Testing, and Others), By Sample (Blood, Urine, Saliva, and Others), By End-User (Hospitals & Clinics, Diagnostic Laboratories, Home Care Settings, and Others) and Regional Forecast, 2024-2032

Region :Global | Report ID: FBI107871 | Status : Ongoing



Rapid diagnostic tests play a crucial role in the etiologic diagnosis of diseases in several scenarios. According to the World Health Organization (WHO), rapid diagnostic tests are used when a preliminary screening test result is required and are useful in resource-limited countries. These tests have several advantages such as being easy to perform, high quality, requiring little or no additional equipment, rapid results, and others. With the growing demand for easy-to-use, rapid diagnostics to facilitate testing outside of laboratory settings, the market for rapid diagnostics has gained momentum in recent years. Moreover, the increasing adoption of POC testing, the growing prevalence of infectious diseases, and intense competition among the operating players are some of the factors boosting the market growth.

  • For instance, according to the Centers for Disease Control and Prevention (CDC), in 2018, the number of physician office visits for infectious and parasitic diseases was 7.2 million in the U.S. Similarly, the number of emergency department visits reached 3.2 million in 2018.

Moreover, the growing accessibility of rapid diagnostic test kits through online platforms, the increasing number of CLIA-waved rapid diagnostic tests, and the growing focus of local industry participants towards the development of new products, and supportive regulatory bodies are expected to accelerate the rapid diagnostics market growth in the near future. In addition, increasing adoption and demand of rapid testing kits and high prevalence of infectious diseases in developing as well as low-income countries would propel the market growth in coming years.

Impact of COVID-19 on the Rapid Diagnostics Market

The outbreak of the COVID-19 pandemic had a positive impact on the rapid diagnostics market. The pandemic created lucrative opportunities for manufacturers to develop rapid diagnostic tests for accurate and timely diagnosis of the infection. RDTs played an important role in the effective management of COVID-19 patients and in limiting the propagation of the infection. Additionally, the introduction of at-home tests for COVID-19

  • For instance, in December 2020, Abbott’s BinaxNOW COVID-19 Ag Card received Emergency Use Authorization (EUA) from the U.S. FDA. This at-home test is easy-to-use, highly portable, and delivers results in 15 minutes.

Key Insights

The report will cover the following key insights:

  • Prevalence of Key Infectious Diseases, By Key Countries/Regions.

  • Regulatory Framework, By Key Regions.

  • Key Industry Developments -Mergers, Acquisitions and Partnerships.

  • New Product Launches.

  • Technological advancements in rapid diagnostic testing.

  • Impact of COVID-19 on the Global Rapid Diagnostics Market.

Analysis by Type

The over-the-counter (OTC) segment constituted a major share of the global rapid diagnostics market. Since the COVID-19 pandemic, several companies have entered this space to capture the untapped avenues of the market. Moreover, the easy availability of RDTs through local pharmacies, and increasing use in near-patient settings have also supplemented the segment growth. The OTC rapid tests are usually used in homecare settings providing a cost-effective alternative to costly laboratory tests. As per the report published by the Consumer Healthcare Products Association, the clinical cost savings amounted USD 94.8 billion due to the comparatively low prices of OTC diagnostic products.

Regional Analysis

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North America captured the largest market share in the global rapid diagnostics market. This is attributed to the presence of well-established market players, supportive regulatory framework and well developed healthcare infrastructure. Other factors driving the regional growth include increasing number new product launches by operating companies, high adoption of point-of-care diagnostics and increasing number of approvals by the U.S. FDA.

Key Players Covered

The report will include profiles of key players such as Abbott, Becton, Dickinson and Company, bioMérieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Creative Diagnostics, F. Hoffmann-La Roche AG, Cardinal Health, ACON Laboratories, Inc., Artron Laboratories Inc., and BTNX, Inc.


By Product

By Type

By Technology

By Sample

By Application

By End-User

By Geography

  • Reagents & Kits

  • Instruments

  • Over-the-counter (OTC)

  • Prescription/Professional

  • Lateral flow Immunoassay

  • Solid Phase

  • Agglutination

  • Microfluidics

  • Others

  • Blood

  • Urine

  • Saliva

  • Others

  • Infectious Disease Testing

    • Respiratory tract infections

    • HIV

    • Hepatitis

    • Influenza

    • Others

  • Cardiometabolic Testing

  • Pregnancy Testing

  • Blood Glucose Testing

  • Lipid Profiling

  • Drug of Abuse Testing

  • Others

  • Hospitals & Clinics

  • Diagnostic Laboratories

  • Home Care Settings

  • Others

  • North America (U.S. and Canada)

  • Europe (U.K., Germany, France, Spain, Italy, Rest of Europe)

  • Asia Pacific (Japan, China, Australia, India, Rest of Asia Pacific)

  • Latin America (Brazil, Mexico, and Rest of Latin America  

  • Middle East & Africa (GCC, South Africa, and the Rest of the Middle East and Africa)

Key Industry Developments

  • November 2022: Abbott introduced Panbio HIV Self-Test, an OTC rapid test that offers results in 15-20 minutes. This HIV home test is available through e-commerce channels in Hong Kong.

  • October 2022: Roche launched next-generation COVID-19 rapid antigen test for professional as well as self-testing. This test kit is available in countries accepting CE marking. It aids in diagnosis of the infection with or without symptoms.

  • Ongoing
  • 2023
  • 2019-2022

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