RAPID DIAGNOSTICS MARKET ANALYSIS

The global rapid diagnostics market was valued at US$ 33.4 Bn in 2022 and is forecast to reach a value of US$ 70.27 Bn by 2030 at a CAGR of 9.8% between 2023 and 2030. The global rapid diagnostics market is experiencing strong growth due to the rise in prevalence of infectious/chronic diseases and favorable government initiatives. Moreover, outbreak of COVID-19 (pandemic) and rise in usage of point-of-care diagnostics across the globe is expected to boost the market growth. However, factors such as stringent regulations and product recalls and challenges associated with rapid diagnostics are expected to hamper the market growth.

Global Rapid Diagnostics Market: Regional Insights

Based on geography, the global rapid diagnostics market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period owing to the increasing prevalence of chronic and infectious disease, growing demand for point of care (POC) diagnostics, and rise in adoption of portable rapid testing devices in the region. For instance, according to the U.S. Centers for Disease Control and Prevention (USCDC), the 2021 flu season resulted in nine million illnesses, four million medical visits, and 10,000 hospitalizations in the United States. Moreover, the CDC is actively engaged in mapping data on the incidence and prevalence of infectious diseases to control such disease systematically.

Europe and Asia Pacific are also expected to witness robust growth in the global rapid diagnostics market due to the rise in burden of infectious and chronic disease, rise in adoption of rapid testing devices, rise in demand for POC diagnostics, and favorable government initiatives in these regions. For instance, in India, consumer awareness has led to an increase in number of tests & diagnostics for infectious diseases over the past few years. While, in Europe, the European Centre for Disease Prevention and Control is actively engaged in mapping data on the incidence and prevalence of infectious diseases to control the disease systematically.

Figure 1. Global Rapid Diagnostics Market Share (%), By Region, 2023

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Global Rapid Diagnostics Market Drivers:

Rise in prevalence of infectious/chronic disease to augment market growth

One of the key factors expected to augment the growth of the global rapid diagnostics market over the forecast period is the rise in prevalence of infectious/chronic diseases worldwide. For instance, with the increasing prevalence of infectious diseases, the use/adoption of rapid diagnostics devices is also increasing with the rapid pace. In January 2023, Cipla announced the launch of a diagnostic device to test various medical conditions, such as infectious diseases, cardiac markers, diabetes, thyroid function, and others. Cippoint will allow healthcare professionals to get test results in 3 to 15 minutes, enabling a faster clinical decision-making process.

Favorable government initiatives to underpin market growth

Another factor which is driving the growth of the global rapid diagnostics market is the favorable government initiatives. For instance, government initiatives for the diagnosis of infectious diseases are fueling the growth of the market. In September 2021, The World Health Organization (WHO) recommended using molecular NAATs for Tuberculosis detection instead of smear microscopy, since they detect Tuberculosis more correctly, especially in patients with paucibacillary illness and persons living with HIV. It is not only available to detect and identify mycobacterium tuberculosis complex in clinical specimens but also to diagnose multi-drug resistant strains.

Global Rapid Diagnostics Market Opportunities:

The outbreak of COVID-19 (global pandemic) across the globe is expected to provide significant growth opportunities for players in the global rapid diagnostics market. For instance, an accurate and rapid diagnosis of COVID-19 is an effective strategy for a pandemic control, allowing disease screening & timely therapeutic intervention. In September 2020, the National Institutes of Health (NIH), as part of its Rapid Acceleration of Diagnostics (RADx) initiative, reported the funding of around US$ 129.3 million to nine companies to scale-up the manufacturing support for COVID-19 testing technologies. This in turn is driving the market growth.

Rise in usage of point-of-care diagnostics across the world is expected to offer significant growth opportunities for players active in the global rapid diagnostics market. For instance, point-of-care diagnostics allows for faster test results, potentially enhancing active medical care. Point-of-care testing for glucose levels is a common procedure performed several times a day worldwide. Thus, with rise in burden of diabetes, the usage of point-of-care diagnostics is also increasing rapidly. In August 2022, DxGen Corp. and Precision Diabetes, Inc. teamed up to launch Epithod AutoDx, a point-of-care analyzer that measures a comprehensive profile of diabetes tests.

Global Rapid Diagnostics Market Trends:

High demand for rapid tests is a recent trend

With the increasing number of diagnostic laboratories and rapid technological advancements, the use and/or demand for rapid diagnostics tests is also increasing rapidly, worldwide. For instance, according to National Accreditation Board for Testing and Calibration Laboratories (NABL) as of September 2021, there are around 8000 NABL accredited medical labs present in India. This trend is expected to continue over the forecast period, driving the market growth.

Collaborations and partnerships is another trend

Several hospital groups from developed countries as well as emerging economies are collaborating with diagnostic companies to offer effective & extensive diagnostic services to patients worldwide. For instance, in May 2021, Aster DM Healthcare and Roche Diagnostics signed a MoU, allowing both to continue fulfilling its commitment towards prevention, diagnosis, and treatment of various disease. This trend is also expected to continue over the forecast period.

Global Rapid Diagnostics Market Restraints:

Stringent regulations and product recalls to hinder market growth

One of the key factors expected to hamper the growth of the global rapid diagnostics market is the stringent regulations and product recalls. For instance, all rapid diagnostic products are subject to the regulations of various regulatory bodies worldwide. For instance, the Federal Food, Drug, and Cosmetic Act, as implemented/enforced by the FDA, governs the approval and commercialization of medical devices. The process is time-consuming and requires high investment as vendors need to conduct many clinical trials to evaluate the safety and efficacy of their products.

Challenges associated with rapid diagnostics to hamper market growth

Another major factor which is hampering the growth of the global rapid diagnostics market is the challenges associated with rapid diagnostics. Rapid testing helps make faster medical decisions. The risk of errors often raises concern over the reliability of test results. This is attributed to the lack of understanding or training of non-laboratory staff involved in testing or test limitations and misuse in extreme environmental conditions. However, larger healthcare facilities often employ dedicated coordinators to ensure proper usage of equipment.

Figure 2. Global Rapid Diagnostics Market Share (%), By Application, 2023

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Global Rapid Diagnostics Market Segmentation:

The global rapid diagnostics market report is segmented into Product, Application, Prescription, End User, and Geography.

Based on Product, the market is segmented into Consumables and Instruments/Analysers. Out of which, Consumables Segment is expected to dominate the global rapid diagnostics market over the forecast period and this is attributed to the rise in burden of chronic disease. Consumables are used to obtain quick and accurate results for diagnosing several acute and chronic diseases.

Instruments/Analysers Segment is also expected to witness significant growth in the near future and this is owing to the increasing demand for rapid testing and POC analyzers.

Based on Prescription, the market is segmented into Professional Diagnostics and at-Home/OTC-Based Testing. Out of which, Professional Diagnostics Segment is expected to dominate the market over the forecast period and this is attributed to the rise in demand for compact and portable handheld analyzers, benchtop analyzers, and professional rapid test kits to diagnose various acute and chronic diseases in low- resource and ambulatory care settings.

At-Home/OTC-Based Testing Segment is also expected to witness significant growth in the near future and this is owing to increase in awareness among people about rapid diagnostics.

Based on Application, the market is segmented into Blood Glucose Testing, Cardiometabolic Testing, Infectious Disease Testing, Blood Coagulation Testing, Hematology Testing, Cancer Testing, Drug of Abuse Testing, and Pregnancy and Fertility/Ovulation Testing. Out of which, Blood Glucose Testing Segment is expected to dominate the market over the forecast period and this is attributed to the increasing prevalence of diabetes worldwide.

Infectious Disease Testing Segment is also expected to witness significant growth in the near future and this is owing to increasing prevalence of infectious disease worldwide.

Based on End User, the market is segmented into Hospitals and Clinics, Laboratories, Individuals/Home Healthcare Settings, and Others. Out of which, Hospitals and Clinics Segment is expected to dominate the market over the forecast period and this is attributed to the increasing number of hospitalizations due to chronic and infectious disease.

Laboratories Segment is also expected to witness significant growth in the near future and this is owing to the increasing number of diagnostic laboratories worldwide.

Global Rapid Diagnostics Market: Key Developments

In March 2022, Brain Chemistry Labs and Arlington Scientific teamed up to develop an easy-to-use rapid test kit. This kit will detect the presence of β-methylamino-L-Alanine (BMAA), a toxin present in cyanobacterial blooms, which may cause a fatal paralytic disease, called Amyotrophic Lateral Sclerosis (ALS).

In March 2022, GenBody America, LLC announced the opening and ramping up the production of anterior nasal swabs, which will be visually readable at its Jurupa Valley, California Factory. This facility will be capable of manufacturing 7.5 million such nasal swab kits per week.

In July 2021, IIT Hyderabad, India, developed an AI-powered rapid test kit for COVID-19 named COVIHOME. This test kit can detect symptomatic and asymptomatic patients in less than 30 minutes and can be performed without medical expert supervision.

In May 2021, Aster DM Healthcare and Roche Diagnostics signed Memorandum of Understanding (MoU). Through the partnership, Aster DM Healthcare’s hospitals, clinics, and laboratories across the region can now access advanced diagnostic technology offering efficient systems to support doctors in providing treatment solutions to their patients.

In May 2020, Quidel Corporation received Emergency Use Authorization (EUA) from the Food and drug administration for its Sofia 2 SARS Antigen FIA for rapid diagnosis of COVID-19.

Global Rapid Diagnostics Market: Key Companies Insights

The global rapid diagnostics market is highly competitive. This is attributed to the rise in demand for rapid diagnostics testing devices across the globe, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global rapid diagnostics market are Abbott, Danaher, Quidel, BD, LifeScan, Siemens Healthineers, F. Hoffmann-La Roche, and Ascensia Diabetes Care Holdings.

*Definition: Rapid diagnostic tests (RDTs), also known as rapid tests, are easy-to-use tests that provide quick results, usually in minutes or less. These are quick field tests that can be performed in under 30 minutes and detect the presence of a pathogen quickly and accurately.