The global rapid diagnostics market size was valued at USD 35.03 billion in 2023 and is expected to attain around USD 280.03 billion by 2033, growing at a CAGR of 20.8% from 2024 to 2034. The U.S. rapid diagnostics market size was valued at USD 7.62 billion in 2023.
The crucial need to treat many infectious diseases has cause to rapid growth in the diagnostics market. Tests that support early treatment can improve patient outcomes and support effective antiretroviral therapy. Moreover, early detection of infectious diseases allows healthcare services in high-income countries to quickly isolate patients and stop the spread of disease. Together, these factors highlight the important role of rapid diagnosis in improving healthcare and controlling the spread of disease, which in turn leads to rapid diagnostics market growth.
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Rapid Diagnostics Market Insights
The rapid diagnostics market has experienced significant growth, driven by the popularity of rapid diagnostic tests (RDTs) that provide rapid results in 20 minutes or less. RDTs, which are based on immunochromatographic technology similar to home pregnancy tests, provide immediate care results, unlike standard tests that require testing. These tests are rising used in medical settings, especially in limited spaces or primary care settings, to provide timely, effective information for patient care.
The past decade has seen a rise in rapid diagnostic products approved by physicians worldwide for a different of conditions, including gastrointestinal, pulmonary, and respiratory tract infections. RDTs are changing healthcare by improving diagnostic proficiencies and empowering patients to achieve better results through materials such as lateral flow testing and polymerase chain reaction (PCR).
· In September 2022, Global Access Diagnostics (GADx) announced the launch of IT LEISH, a rapid diagnostic test (RDT) for visceral leishmaniasis (VL), after acquiring the manufacturing rights for IT LEISH from Bio-Rad.
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Report Highlights
· U.S. rapid diagnostics market size is expected to reach around USD 62.19 billion by 2034, growing at a CAGR of 21% from 2024 to 2034.
· North America has accounted highest market share of 31% in 2023.
· By product, the Over the Counter (OTC) kits segment has captureed the biggest revenue share in 2023.
· By technology, the lateral flow segment has accounted market share of 36% in 2023.
· By application, the infectious disease testing segment has hold the highest market share of 43% in 2023.
· By end user, the clinics and hospitals segment has generated revenue share of 51% in 2023.
What are the Top Trends in Rapid Diagnostics Market?
- Increased Demand for Point-of-Care Testing: There is a growing preference for tests that provide immediate results. Point-of-care (POC) diagnostics are becoming more popular due to their convenience, speed, and the ability to provide results in various settings like clinics, pharmacies, and even at home.
- Advancements in Technology: Technological innovations are driving the market. Developments in molecular diagnostics, such as PCR (polymerase chain reaction) and next-generation sequencing (NGS), are enhancing the accuracy and speed of tests. Additionally, innovations in biosensors and microfluidics are contributing to more rapid and reliable diagnostics.
- Expansion in Infectious Disease Testing: The COVID-19 pandemic has significantly boosted interest in rapid diagnostic tests, particularly for infectious diseases. This trend is likely to continue with a focus on tests for emerging infections and pandemics, as well as seasonal diseases like influenza.
- Growth in Home Testing Kits: There’s a rising consumer interest in home testing kits for various conditions, including glucose levels, pregnancy, and STI testing. These kits offer privacy, convenience, and the ability to monitor health conditions regularly without visiting a healthcare provider.
- Integration of Digital Health Technologies: The integration of digital health technologies, including smartphone apps and telemedicine, is enhancing the utility of rapid diagnostics. These technologies facilitate data sharing, remote monitoring, and real-time health management.
- Regulatory and Reimbursement Developments: Changes in regulatory policies and reimbursement models are influencing the market. Governments and health organizations are working on streamlining approval processes and improving reimbursement for rapid diagnostic tests, which can enhance market growth and accessibility.
- Personalized Medicine: There’s an increasing focus on personalized medicine, which tailors diagnostic tests and treatments to individual genetic profiles and health conditions. Rapid diagnostics play a crucial role in this trend by providing timely and specific information that supports personalized treatment plans.
- Increased Investment and Mergers: Investment in the rapid diagnostics sector is growing, with venture capital and corporate investments funding new technologies and companies. Mergers and acquisitions are also common as companies seek to expand their product portfolios and technological capabilities.
- Focus on Chronic Disease Management: Rapid diagnostics are being increasingly utilized for managing chronic diseases such as diabetes and cardiovascular conditions. Continuous monitoring and early detection are key to managing these long-term health issues effectively.
Why has North America dominated the rapid diagnostics market?
North America dominated in the rapid diagnostics market, driven by high public healthcare spending and significant investments in healthcare technology. Around 48 million cases of food poisoning occur every year in the United States, with 128,000 hospitalizations and 3,000 deaths, underscoring the critical need for effective treatment. The Canadian government is actively investing in health technology. The Child Development Assessment (CDE) test, developed in Mexico in particular, demonstrates the region commitment to early detection of developmental problems. America’s public health institutions play a critical role in promoting and protecting the health of entire populations. The United States to have 26,519 medical and diagnostic facilities by 2023, contributing to North America’s rapidly growing importance in the rapid diagnostics market.
· In June 2024, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test approved for use in certified point-of-care settings.
Recent Breakthroughs in Rapid Diagnostics Market
· In June 2023, Avacta Group plc announced the acquisition of Coris Bioconcept SRL for an upfront cash consideration of £7.4 million, with a potential earnout of up to £3.0 million based on future business performance.
· In February 2023, Global law firm White & Case LLP advised Biosynex SA on its merger agreement with Chembio Diagnostics, Inc., under which Biosynex will acquire Chembio.
· In May 2023, FIND announced a new partnership with VIA Global Health to provide new routes to market for regional and global manufacturers of high-quality diagnostic tests, expanding access to testing in low- and middle-income countries (LMICs).
· In July 2023, EDP Biotech Corp. and New Day Diagnostics, LLC announced their combination, forming a vertically integrated entity to expedite the development and commercialization of diagnostic tests.
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Report Highlights
By Product
The Over-the-Counter (OTC) segment dominated the rapid diagnostics market due to the popularity of self-testing. Available without a prescription, OTC self-tests allow individuals to self-administer and collect samples outside of a medical or laboratory setting without the need for professional care. Unlike home kits that require testing, self-testing uses a nasal or saliva test to provide instant results and can be a molecular or antigen test. This simplicity and accessibility have contributed to the effective management of the OTC segment in the fast-growing market.
The proficient segment accounts largest share in the rapid diagnostics market evolving healthcare sector. Competency assessment is an important way to increase the capacity and efficiency of the assessment process by comparing results with assessment centers and other participants. This process is important to ensure that the laboratory performs well on a particular test and therefore its results are recognized. A clinical or research performance assessment (PTE) center can implement parallel or diagnostic tools to demonstrate feasibility and compliance, especially in clinical trials. The proven reliability and accuracy of these diagnostic tools is rapidly growing the market.
By Technology
The ateral flow segment led the rapid diagnostics market in 2023. It offers an easy way to realize its benefits. Lateral flow technology, also called as rapid antigen testing, detects bacteria by applying a sample of a patient’s body fluid, such as saliva or urine, to the diagnostic test. Positive results are signified by colored lines indicating an allergic reaction. The technology provides rapid diagnostic results, typically within 10 to 15 minutes, and its speed and ease of use have made it a major strength in the fast-developing medical industry.
The solid-phase technology segment will grow rapidly during the forecast period. Solid phase testing (gel testing) is known for its higher sensitivity compared to tube testing and can be combined with electronic equipment from different manufacturers. The advantages of this technology include high specificity and sensitivity, partial results, multiple studies and automation capabilities. These resources make the technology effective in developing accurate and efficient diagnoses, thus enabling the expansion of rapid diagnostics market.
By Application
The infectious disease testing segment holds a dominant position in the rapid diagnostics market. The ability to diagnose diseases rapidly and accurately is important for immediate treatment of patients, better surveillance and control of disease transmission. Traditional diagnostic methods often require sophisticated equipment and trained personnel in well-equipped laboratories. In contrast, rapid diagnostic technologies provide the advantage of rapid on-site results, making them important for effective disease control and useful in healthcare.
The blood glucose testing segment is projected to grow at the fastest rate during the forecast period. Blood glucose tests measure glucose levels in the blood, which is a primary source of energy for the body. Insulin is a drug that promotes the transfer of glucose from the blood to the cells. The growing prevalence of diabetes and the need for regular blood sugar monitoring are increasing the need for convenient and easy-to-use blood sugar tests. This increasing demand indicates highest expansion of rapid diagnostics market.
By End-use
The clinics and hospitals hold the largest share of the rapid diagnostics market, driven by the increasing adoption of rapid diagnostic tests (RDTs) in clinical practice. These tests provide timely and actionable information that improves patient care directly at the point of care. In particular, the use of rapid diagnostic tests has been shown to shorten the time to effective treatment and shorten the length of hospital stay for patients with blood disorders. This quality and efficiency prove the important role of RDTs in the medical field and ensure their significant position in the market.
The home care end-use segment is the fastest-growing sector in the rapid diagnostics market. The introduction of rapid diagnostic tests (RDTs) for personal use at home has the potential to increase testing and reduce healthcare burden. Home care RDTs facilitate independent patient testing, helping to detect and control colds, and other infection.
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Market Dynamics
Rising Prevalence of Infectious Diseases, a Major Driver for the Market
The rapid diagnostics market is poised for significant growth due to the rising prevalence of infectious diseases globally. Emerging and re-emerging diseases (EIDs) affect humans along with zoonotic diseases transmitted from animals to humans through direct contact, food, water, and the environment. Bacterial infections continue to be a main cause of mortality and morbidity. Rapid diagnostic tests (RDTs) are available in multiple forms and platforms and target disease-specific antigens or nucleic acid sequences as well as antibodies against specific diseases. The diversity of these tests is encouraging the adoption of RDTs, meeting the need for timely and accurate results, and driving rapid diagnostic market expansion.
Challenges in the Rapid Diagnostics to Hamper the Market’s Growth
The rapid diagnostics market faces significant challenges that limit its growth potential. Most rapid diagnostic tests (RDTs) are expensive, and evidence of clinical benefit to justify these costs is often lacking. Moreover, some RDTs may be less sensitive and specific than laboratory tests, limiting their applicability to certain situations where optimal performance is high. Implementation, quality control, and validation are also challenging, especially when RDTs are used outside of traditional clinical settings. These challenges vary worldwide depending on local health policies, resources, local outbreaks, and patient expectations, further limiting rapid diagnostics market expansion.
CRISPR-Based Tools Revolution: to Create Opportunity for the Market
Rapid diagnostic tests are crucial for controlling infections, enhancing clinical care, and preventing disease spread. Recently, CRISPR-based diagnostic tools have made diagnosis very fast. CRISPR-Cas systems are known for their genome editing capabilities and are being used to create advanced, sensitive, and rapid technologies. This new approach, called Specific High Sensitivity Enzyme Reporter Unlocking (SHERLOCK), combines nucleic acid preamplification with CRISPR-Cas enzymology for the detection of DNA or RNA sequences. SHERLOCK’s ability to provide versatile, portable, and highly sensitive RNA or DNA analysis from laboratory samples is beneficial to the rapidly growing rapid diagnostics market.
· In February 2024, Bengaluru-based startup CrisprBits Private unveiled OmiCrisp, a CRISPR-based testing platform for rapid diagnosis and surveillance of SARS-CoV-2, with capabilities to distinguish Omicron variants from other known variants of concern.
Key Players Rapid Diagnostics Market
· 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
Market Segmentation
By Product
· Over the Counter (OTC) Kits
· Professional Kits
By Technology
· Lateral Flow
· Agglutination
· Solid Phase
· Other Technologies
By Application
· Blood Glucose Testing
· Infectious Disease Testing
· Cardiometabolic Testing
· Pregnancy and Fertility Testing
· Fecal Occult Blood Testing
· Coagulation Testing
· Toxicology Testing
· Lipid Profile Testing
· Other
By End Use
· Hospitals & Clinics
· Home Care
· Diagnostic Laboratories
By Geography
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East & Africa (MEA)
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