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Rapid Diagnostics Market Size

ID: MRFR//10167-HCR | 128 Pages | Author: Kinjoll Dey| December 2024

By 2032, the rapid diagnosis market size is expected to reach USD 177.3 billion at a CAGR of 21.3% during the forecast period. Rapid Diagnostics Market operates in complex settings influenced by numerous factors that collectively shape its growth and development. The dynamics of the Rapid Diagnostics Market are significantly affected by research and development (R&D) efforts. Diagnostic companies continuously work on new and improved rapid diagnostic technologies for better speed, accuracy, and ease of use purposes. Ongoing developments in lateral flow assays, nucleic acid amplification methods, and microfluidics are expanding the range of applications for rapid diagnostics and, hence, positively influencing market dynamics. The need to introduce innovative solutions for better diagnostics drives this industry.
Moreover, technological advancements play an important role in shaping the market dynamics of rapid diagnostics devices. Innovations in sensor technology, detection techniques, and miniaturization have led to more sophisticated rapid diagnostic products with enhanced sensitivity levels. Furthermore, data management and result interpretation can be improved through incorporation into digital platforms or connectivity solutions. Regulatory considerations, as well as quality standards, also influence market trends regarding rapid diagnostics products. Stringent regulatory measures ensure that rapid diagnostic products are safe, efficient, and dependable; hence, adherence to these measures is important for a firm's credibility in the market space. Compliance with regulations such as Clinical Laboratory Improvement Amendments (CLIA) or meeting requirements set forth by quality management systems affects adoption rates using fast diagnostic technologies, among other factors leading to their approval. As these organizations seek compliance with regulations within which they operate or develop, they may change their internal control processes, thus affecting the overall industry trend.
In addition, competition among various players involved in diagnosing patients or suppliers who provide them with services is essential when it comes to determining how dynamic any given market may be at any point over time. Companies resorting to launching new products, acquisitions, and collaborations have been considered relevant ways that they employ to improve their market positions and diversify their fast diagnostic product portfolios. Moreover, the economic environment also determines the market dynamics of rapid diagnostics. Healthcare budgets are influenced by economic conditions and spending patterns, which in turn affect the affordability and accessibility of rapid diagnostic products for health facilities. For instance, during periods of recession, healthcare procurement may be more budget-conscious, which may impact market growth. In this context, consumer preferences refer to those of clinicians or patients. Increased awareness of the benefits of using quick diagnosis, such as faster results and point-of-care testing with a reduced reliance on central laboratories, drives healthcare institutions to procure rapid tests that cater to their testing needs. Preferences for better user experience devices, resilient analytical performance, and sync ability with electronic health records have driven changes in healthcare providers' choices, thereby fostering innovation.

Covered Aspects:

Report Attribute/Metric Details
Growth Rate 21.3% (2023-2032)

Global Rapid Diagnostics Market Overview


The Rapid Diagnostics Market Valued at USD 28.9 billion in 2023, projected to grow from USD 31.4 billion in 2024 to USD 57.60 billion by 2032, exhibiting a CAGR of 8.80% during the forecast period (2023 - 2032). The rise in the frequency of chronic diseases, increasing government initiatives, and growing awareness regarding rapid diagnostic test kits for fast and easy diagnosis are key market drivers propelling the market forward.
Rapid Diagnostics Market Overview


 Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review


Rapid diagnostic testing (RDT) is mostly used in initial or emergency medical screening and in healthcare facilities with constrained resources. RDTs' quick and simple operations make point-of-care testing in primary healthcare possible. Infectious diseases' rising prevalence will spur industry growth. This expansion will be accelerated by the high incidence of viral and microbial disease variations and the development of accurate diagnostic techniques. Among the most common diseases worldwide are coronavirus, dengue, hepatitis, and influenza. Significant technological advances and advancements are now taking place in the market for quick diagnostics. Accuracy, precision, sensitivity, and quickness of diagnosis have all grown due to the introducing of new and sophisticated diagnostic techniques. Microfluidics, lab-on-a-chip, and biosensor technologies have produced mobile, user-friendly point-of-care testing equipment. Additionally, AI and ML have enhanced test result interpretation, leading to more precise and trustworthy diagnoses. By cutting down on the time and expense involved with conventional diagnostic techniques, these developments have increased patient treatment standards and healthcare systems' effectiveness.


Numerous traditional diagnostic techniques contain rapid diagnostics, including rapid plasma recovery, rapid antibody tests (including the rapid HIV test), and rapid antigen tests (including the rapid influenza diagnostic test and the rapid malaria antigen detection test, among others), which are all types of rapid diagnostics. Rapid diagnostic tests are widely used for screening, epidemiology, patient management, and diagnosis. Rapid diagnostics' inaccurate results could impede market growth. Misdiagnosis as a result of poor test performance could cause considerable harm. Rapid diagnostic testing errors can result in ineffective therapy and other consequences. To reduce the drawbacks of quick diagnostic tests, several market competitors, however, are stressing the use of novel methodologies to achieve exceptionally precise rapid diagnostic testing. Increased demand for quick diagnostic tests in decentralized environments and increased public awareness of the benefits of early diagnosis are the main drivers of market expansion. Additionally, the market is expected to rise due to the growing demand for accurate diagnostic tests at affordable prices.


News:


A group of Johns Hopkins University student biomedical engineers called DioTeX Diagnostics is creating a portable, trustworthy, and reachable interior hemorrhage diagnostic tool. Their strategy entails developing a quick immunochemistry-based test employing a specific biomarker connected to hemorrhage. This instrument can quickly determine which individuals are bleeding inside with just a little blood sample. This technique can change the identification of internal hemorrhages since people with little to no training can perform it consistently and accurately. Faster and more effective bleeding care is promised by this breakthrough, which could annually save thousands of lives.


Rapid Diagnostics Market Trends



  • Emerging technological advancements and innovations in rapid diagnostic testing to drive market growth


Rapid diagnostic testing (RDT) is mostly used in preliminary or emergency medical screening and facilities with limited resources. RDTs provide point-of-care testing in primary care by allowing for rapid and simple operations. Rapid diagnostics is used in various traditional diagnostic procedures, including rapid antibody testing, such as the rapid HIV test, rapid plasma regain, and rapid antigen tests, such as the rapid influenza diagnostic test and malaria antigen detection assays. Rapid diagnostic tests are widely used in diagnosis, medical care, epidemiology, and screening. The primary factors driving the market CAGR include increased demand for rapid diagnostic tests in decentralized settings and increased public awareness about the need for early diagnosis.


The rapid diagnostics market is experiencing significant technological advancements and innovations. The development of new and advanced diagnostic tools has resulted in increased accuracy, specificity, sensitivity, and speed of diagnosis. Technological advancements, such as microfluidics, lab-on-a-chip, and biosensors, have developed portable, user-friendly devices for point-of-care testing. Besides, using AI and ML has improved the interpretation of test results, resulting in more accurate and reliable diagnoses. These advancements have enhanced the quality of patient care and improved the efficiency of healthcare systems by reducing the time and cost associated with traditional diagnostic methods.


Researchers employ new medical technology to create or alter rapid medical test kits in home health care settings, hospitals, clinics, and health care centers, providing accurate test findings. Based on market requirements, highly qualified specialists build speedy medical diagnostic kits. For example, In June 2021, scientists from SANKEN at Osaka University revealed that machine learning is accurate enough to recognize a single virus particle traveling through a nanopore. They devised test platforms that were so sensitive that they could distinguish between coronaviruses that cause SARS, the common cold, MERS, and COVID. This research leads to speedy, simple, and extremely accurate diagnostic assays for COVID-19 and other viral illnesses. The rising global prevalence of chronic diseases combined with an aging population, the increasing need for rapid decision-making in emergency departments, and growing technological innovations are the key growth factors driving the rapid diagnostics market revenue.


Rapid Diagnostics Market Segment Insights


Rapid Diagnostics Product Insights


Based on product, the Market segments of Rapid Diagnostics includes over-the-counter (OTC) and professional kits. The over-the-counter (OTC) segment dominated the global market, accounting for 61% of market revenue (19 billion). These tests are simple to employ in the ‘near-patient setting’ and are a less expensive alternative to expensive laboratory testing. These tests are commonly utilized in home care settings, providing a simple, cost-effective alternative to laboratory testing. Rapid diagnostic tests (RDTs) frequently use saliva, urine, and blood to identify diseases. As per the Consumer Healthcare Products Association, clinical cost savings from OTC diagnostic items were more than USD 77 billion. These tests can also help diagnose infectious and chronic diseases with few or no symptoms, allowing for early treatment and lowering other problems. While these tests are mostly used in home care settings, they are also used in hospitals, clinics, and diagnostic laboratories.


Figure 1: Rapid Diagnostics Market by Product, 2022 & 2032 (USD billion)Rapid Diagnostics Market by Product, 2022 & 2032Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review


The professional kits segment is expected to grow at the fastest CAGR in the rapid diagnostics industry in the coming years. These tests frequently employ techniques like PCR & molecular diagnostics, which provide greater test sensitivity and specificity. Professional laboratory tests are often conducted following a positive RDT to confirm disease diagnosis. Professional tests are used in diagnostic settings since RDTs have low sensitivity and frequently give false negative results, making them the gold standard. The growing portfolio of disease-specific professional kits for the early diagnosis of chronic diseases, as well as technological advancements, are further driving the growth of this segment.


Rapid Diagnostics Application Insights


The Rapid Diagnostics Market segmentation is based on the application that includes blood glucose testing, infectious disease testing, cardiometabolic testing, pregnancy & fertility testing, fecal occult blood testing, coagulation testing, and toxicology testing. In 2022, the infectious disease testing category had the highest revenue share of approximately 38%. The new coronavirus outbreak has produced an urgent need for quick diagnostic tools critical to managing the COVID-19 pandemic. More than 99 million COVID-19 patients had been reported globally as of January 2022, contributing to the segment's revenue generation capacity. The United States, Brazil, Russia, the United Kingdom, Spain, Italy, India, Germany, Turkey, and Colombia have recorded the highest COVID-19 instances. Multiple diagnostics businesses are devoting R&D efforts to developing novel COVID-19 rapid medical diagnostic kits and obtaining approval from various regulatory agencies to meet this expanding demand.


The blood glucose testing segment is expected to increase fastest over the projection period. The sheer volume of rapid blood glucose tests marketed and used is the primary driver of segment expansion. In addition, the widespread adoption of these tests to immediately measure elevated blood cholesterol levels in assisted living facilities, home care, clinics, and laboratories is expected to drive segment growth.


News:


The World Health Organization (WHO) just published the WHO standard for the first time: Access to WHO-recommended quick diagnostics (WRDs) for tuberculosis should be ubiquitous, and there should be criteria set for increasing bacteriologically confirmed cases of the disease, identifying treatment resistance, and speeding up diagnosis times. Rapid diagnostics are extremely accurate and affordable, hasten the start of treatment and impact outcomes that are crucial for patients.


Rapid Diagnostics Regional Insights


By region, the report provides market insights into Europe, North America, Asia-Pacific, and the Rest of the World. The North American rapid diagnostics market will likely exhibit a significant CAGR growth in the study period. The North American region is the largest market for rapid diagnostics due to well-established healthcare infrastructure, the increasing prevalence of infectious diseases, and the rising demand for point-of-care testing. The United States dominates the market in this region due to the high demand for early diagnosis and treatment. In the United States, chronic diseases are the primary cause of death and disability. As per the Centers for Disease Control & Prevention (CDC), 6 in 10 Americans have at least one chronic illness as of February 2021. These and other chronic diseases are the leading causes of death and disability in the United States and the major cause of healthcare costs.


Also, the major countries studied in the market report are the U.S., German, Canada, France, the U.K., Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.


Figure 2: RAPID DIAGNOSTICS MARKET SHARE BY REGION 2022 (%)RAPID DIAGNOSTICS MARKET SHARE BY REGION 2022Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review


The European rapid diagnostics market accounts for the second-largest global market share. Europe is a key market for rapid diagnostics owing to the rising incidence of chronic diseases, the expanding need for personalized medication, and the growing understanding of the value of early diagnosis. The region also sees the introduction of novel technologies such as lab-on-a-chip and microfluidics, boosting market growth. Further, the German market of rapid diagnostics held the largest market share, and the U.K. market of rapid diagnostics was the fastest-growing market in the European region.


The Asia Pacific Rapid Diagnostics Market is expected to grow at the fastest CAGR from 2023 to 2032 due to the increasing burden of infectious diseases, rising healthcare expenditure, and growing demand for affordable and accessible diagnostic testing. Emerging economies such as China and India are driving market growth in this region due to their large patient pool and increasing healthcare spending. The region also offers significant opportunities for market players owing to a large untapped market. Moreover, the China market of rapid diagnostics held the largest market share, and the Indian market of rapid diagnostics was the fastest-growing market in the Asia-Pacific region.


Rapid Diagnostics Key Market Players & Competitive Insights


Leading market players, such as Abbott Laboratories, Roche Diagnostics, and Danaher Corporation, invest heavily in R&D to expand their product portfolios and gain a competitive advantage. With the increasing demand for rapid diagnostics due to the COVID-19 pandemic, global rapid diagnostics industry players are investing in capacity expansion and production scale-up to meet the rising demand. New product releases, strategic alliances, collaborations, and mergers and acquisitions among leading competitors are key market developments in the rapid diagnostics sector.


Major players in the rapid diagnostics market, such as Bio-Rad Laboratories Inc, Becton, Dickinson & Company, Bio-Rad Laboratories, and Quidel Corporation, also focus on expanding their global presence through acquisitions and collaborations with local players in emerging markets. Moreover, the trend towards personalized medicine and point-of-care testing propels the rapid diagnostics industry forward, with companies focusing on developing innovative and cutting-edge products to fulfill increasing demands.


Roche Diagnostics is a branch of F. Hoffmann-La Roche Ltd, a Swiss multinational healthcare firm. The firm is a market leader in in vitro diagnostics and medical imaging equipment. Roche Diagnostics employs about 120,000 people worldwide and operates in over 150 countries. Roche Diagnostics provides a wide range of products, including point-of-care testing solutions, fast antigen tests, and molecular assays for infectious disease detection. Roche introduced its Cobas Pulse System in certain countries that accept the CE Mark in January 2022. This is the latest generation of integrated point-of-care solutions for professional blood glucose management.


ACON Laboratories Inc. is a privately held firm in San Diego, California. The company was created in 1996 to develop reliable, high-quality, cost-effective medical diagnostic and healthcare solutions. ACON produces and distributes medical diagnostic devices such as rapid diagnostic tests for infectious diseases, fertility, illicit drugs, hematology instruments, and reagents. ACON Laboratories has increased its global presence, opening offices and subsidiaries in China, Canada, Mexico, and Germany. ACON Laboratories announced the release of their new rapid test, the Flowflex SARS-CoV-2 Antigen Rapid Test, in 2021. This test is intended to detect the presence of the SARS-CoV-2 virus in patients with COVID-19 symptoms, and it offers results in as little as 15 minutes.


Key Companies in the market of rapid diagnostics include



  • Abaxis

  • Becton

  • Dickinson & Company

  • Bio-Rad Laboratories

  • Accriva Diagnostics

  • ACON Laboratories Inc

  • Hologic Inc

  • Abbott Laboratories

  • Roche Diagnostics

  • Bayer HealthCare Pharmaceuticals LLC

  • Cepheid Inc


Rapid Diagnostics Industry Developments


November 2023Abbott Laboratories announces the launch of its new Alinity™ m Resp-5 Dx rapid antigen test for the detection of respiratory syncytial virus (RSV), influenza A, influenza B, parainfluenza virus 1, and adenovirus. The test is designed to provide rapid and accurate results in 15 minutes or less, and it can be used in point-of-care settings.Becton Dickinson announces the launch of its new BD Veritor™ Plus System rapid antigen test for the detection of SARS-CoV-2, influenza A, and influenza B. The test is designed to provide rapid and accurate results in 15 minutes or less, and it can be used in point-of-care settings.Roche Diagnostics announces the launch of its new cobas® Liat™ System for the detection of a variety of infectious diseases, including SARS-CoV-2, influenza A, influenza B, RSV, and chlamydia. The system is designed to provide rapid and accurate results in 20 minutes or less, and it can be used in point-of-care settings.March 2022: Brain Chemistry Labs, a non-profit research center, and Arlington Scientific, a medical test kit company based in Utah, agreed to collaborate on developing an easy-to-use rapid test kit. This test will detect the presence of -methylamino-L-Alanine (BMAA), a toxin found in cyanobacterial blooms that causes Amyotrophic Lateral Sclerosis (ALS).


March 2022: Boditech Med formed a strategic alliance with Novo Integrated Sciences Inc to develop its biomarker-based rapid diagnostic product line throughout North America.


Rapid Diagnostics Market Segmentation


Rapid Diagnostics Product Outlook



  • Over the Counter (OTC) Kits

  • Professional Kits


Rapid Diagnostics Application Outlook



  • Blood Glucose Testing

  • Infectious Disease Testing

  • Cardiometabolic Testing

  • Pregnancy & Fertility Testing

  • Fecal Occult Blood Testing

  • Coagulation Testing

  • Toxicology Testing


Rapid Diagnostics Regional Outlook



  • North America

    • The U.S.

    • Canada



  • Europe

    • Germany

    • France

    • The U.K.

    • Italy

    • Spain

    • Rest of Europe



  • Asia-Pacific

    • China

    • Japan

    • India

    • Australia

    • South Korea

    • Australia

    • Rest of Asia-Pacific



  • Rest of the World

    • Middle East

    • Africa

    • Latin America



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