The Global "Rapid Medical Diagnostics Market" is expected to grow at a CAGR of 4.5% during the forecasting period (2022-2029).
Rapid Medical Diagnostic tests are diagnostic assays designed for use at the point-of-care (POC) which can be adapted for use in low-resource settings. An RDT is low-cost, simple to operate and read, sensitive, specific, stable at high temperatures, and works in a short period of time. These tests are intended to provide diagnostic results conveniently and immediately to the patient while still at the health facility, screening site, or other health care provider.
The Global Market for Rapid Medical Diagnostics is driven by the increasing prevalence of cardiovascular and gastrointestinal disorders, STDs, and other lifestyle disorders such as diabetes, the rising trend towards on-site diagnosis in the US, improvements in technology, and increasing awareness combined with low rates of diagnosis of diseases such as Hepatitis and TB along with improvement in healthcare availability in emerging markets.
The rise of lifestyle disorders such as obesity has resulted in a significant increase in the number of cardiovascular and other disorders. Over 422 million people globally are estimated to be affected by diabetes, with a significant portion remaining undiagnosed. Increasing awareness of such disorders in emerging markets is expected to drive the demand for rapid diagnostic kits.
H. pylori are one of the most common bacterial infections in humans, affecting nearly 50% of the world’s population and it has been associated with the development of serious upper gastrointestinal (GI) conditions including chronic gastritis, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT). The reduction in cost and rising availability of rapid diagnostic tests for the infection is expected to increase demand for diagnostic kits.
The market is also being driven by the improvements in technology leading to higher sensitivity, wider coverage, and lower costs which is driving the adoption of these tests.
The Global market for Rapid Medical Diagnostics is restrained by the low sensitivity of current methods, stringent regulations, and reduction in reimbursed costs through medic-aid in the USA.
The most common technology used for rapid medical diagnosis is LFIA. This technology has a relatively lower rate of sensitivity compared to clinical ELISA machines leading to greater false positives for diseases. This has led to stricter regulations and warnings from the WHO and the US FDA. The market is also affected by the cutback in Medicaid reimbursement due to budgetary constraints in the US.
Based on product the global market for Rapid Medical Diagnostics is broadly segmented as – By Technology, By Type, and By End-User
By Technology, the global market for rapid medical diagnostics is segmented into Lateral Flow immunoassays, Agglutination assays, Flow-Through immunoassays, Solid-Phase assays (Dipsticks), and microfluidic chips. The global market for rapid diagnostic tests is led by lateral flow immunoassays (LFIA) due to their low development costs and ease of production. However, the LFIA technology tends to have lower sensitivity compared to other methods. Microfluidic chips are expected to be the fastest growing segment during the forecast period due to their potential to provide a fully integrated POC device for sample processing, fluid handling, and signal generation.
By Type, The Global Market for Rapid Medical Diagnostics is segmented into Infectious Diseases, Toxicology, Gastrointestinal and Cardiac disorders, and Others. The Global Market is led by Infectious Disease diagnostics. This is due to the higher prevalence of these diseases relative to other disorders along with their continuous evolution which necessitates response leading to higher demand. A prime example of this trend can be seen from the rise of the Zika virus, which led to a sharp increase in demand for diagnostic kits in the segment.
By End-User, The Global Market for Rapid Medical Diagnostics is segmented into Hospitals, Clinics, and Self-care. The global market is led by hospitals and clinics*1] due to the preparation process required for these tests. Clinics are expected to be the fastest-growing segment during the forecast period due to the growing trend towards decentralization of healthcare combined with the relative ease of use and speed of these tests.
The global rapid medical diagnostics market is segmented into North America, Europe, Asia Pacific, South America, and Middle-East and Africa.
North America dominates the global market for rapid medical diagnostics by the revenue due to its excellent healthcare infrastructure combined with high awareness and a large population base. The market is expected to grow slowly or remain flat due to reductions in healthcare spending and insurance reimbursement.
Asia-Pacific is expected to be the fastest-growing market in the projected timeframe due to improvement in healthcare infrastructure combined with increasing disposable incomes and rising awareness. The region’s large population combined with under-penetration of medical technologies is expected to drive demand in the projected timeframe. Key players expect the region to be their growth driver with the Chinese market being the prime source of demand.
The market for rapid medical diagnostics is highly fragmented overall due to the simplicity of development and manufacture of the technology involved leading to intense competition in major segments such as malaria diagnosis. Due to the breadth of the market, most companies don’t cover the entire spectrum of diagnosis with Abbott Laboratories being a prime exception. Individual market segments have companies holding large or even majority market shares; for instance, AccessBio Inc holds the majority market share in the malaria diagnosis segment. The industry is highly competitive and is innovating rapidly through investments in new technologies such as the microfluidic chips. Significant R&D expenditure is also being directed to expand the disease detection capabilities of the products.
Key players in the market are merging or acquiring other players, increasing R&D spending, and launching new products. The market is consolidating with many large players such as Alere being acquired by giant healthcare corporations such as Abbott Laboratories. These developments are in line with the general trend of consolidation seen through the healthcare industry.
List of major market players –
Recent News –
May 2, 2019 - Abbott announced that its m-PIMA™ HIV-1/2 VL, the world's first point-of-care viral load diagnostic test, had received the World Health Organization's Prequalification approval (WHO PQ). The test received the CE Mark in December 2018.
February 20, 2019 - Abbott announced that it had received the CE Mark for the world's most sensitive rapid diagnostic test for the detection of hepatitis B surface antigen, the Determine™ HBsAg 2 test for use with serum, plasma, or whole blood.
February 07, 2019 - DiabetOmics launched its Lumella rapid POC test for Preeclampsia Assessment. Lumella provides an accurate and reliable estimate of Glycosylated Fibronectin (GlyFN) - a protein biomarker that is elevated in pregnant women with a high risk for developing Preeclampsia.
December 18, 2018 - Quidel received the CE Mark for Point-of-Care Sofia® 2 Lyme+ Fluorescent Immunoassay for Use with Sofia 2 Instrument.