Rapid Diagnostics Market Size, Share, Forecast, & Trends Analysis by Product (Kits [OTC, Professional], Readers) Platform (Lateral Flow, Serological, PCR) Application (Diabetes, Infectious Diseases, Pregnancy, HIV) Sample (Blood) - Global Forecast to 2031

The Rapid Diagnostics Market was valued at $14.74 billion in 2023. This market is expected to reach $22.65 billion by 2031 from an estimated $14.57 billion in 2024, at a CAGR of 6.5% during the forecast period from 2024 to 2031.

Rapid Diagnostics Market Size & Forecast

RDT kits are extensively utilized in hospitals and clinical laboratories for the qualitative and quantitative detection of specific antigens, antibodies, and genetic material or proteins related to particular health conditions or diseases. These kits help uncover the underlying mechanisms of disease and empower doctors and healthcare professionals to make critical medical decisions.

The rapid growth of the rapid diagnostics market is driven by several key factors, including the increasing demand for point-of-care (POC) diagnostics, the rising prevalence of chronic diseases alongside an aging population, the need for swift decision-making in emergency departments, and ongoing technological innovations.

Rapid Diagnostics Market Growth Drivers

Rising Prevalence of Infectious Diseases

The exponential growth of the human population has resulted in the expansion of human settlements into new geographical areas, increasing the likelihood of contact with animals that may serve as potential hosts for infectious disease agents. This phenomenon has contributed to the emergence of various infectious diseases throughout history. Additionally, there is a rising prevalence of infectious diseases on a global scale. For example, a July 2022 article in the United Nations’ Africa Renewal digital magazine highlighted that the risk of outbreaks caused by zoonotic pathogens, such as the Ebola and monkeypox viruses, is increasing. According to the WHO, there has been a 63% rise in zoonotic disease outbreaks in Africa from 2012 to 2022 compared to the period from 2001 to 2011.

• In September 2023, the Ministry of Health and Family Welfare of India reported six confirmed cases of the Nipah virus in the state of Kerala. As of September 27, 2024, 1,288 contact cases related to the Nipah virus have been reported.
• The global epidemiological burden of sepsis has risen significantly in recent years. According to the WHO, sepsis is estimated to affect over 30 million people worldwide, resulting in approximately 6 million deaths annually.
• In 2021, approximately 38.4 million people were living with HIV, including 1.7 million children. Of this total, 20.6 million (53%) resided in eastern and southern Africa, 5 million (13%) in western and central Africa, 6 million (15%) in Asia and the Pacific, and 2.3 million (5%) in Western and Central Europe and North America.

Rapid diagnostic tests enable the early detection of infectious diseases, which is valuable for controlling their spread. The rising prevalence and outbreaks of infectious diseases are expected to drive the market's growth.

Increasing Need for Rapid Decision-making

Emergency departments in hospitals play a vital role in delivering both inpatient and outpatient services, essential for preventing death or serious health impairment. However, overcrowding in these departments is a well-documented challenge, driven by factors such as the increasing geriatric population and referrals from primary care. To address this issue, rapid diagnostics are being increasingly adopted in emergency departments to improve clinical decision-making related to patient diagnosis, treatment, monitoring, and prognosis. This approach also aims to optimize resource utilization and alleviate overcrowding. The rising number of patient admissions in emergency departments globally further fuels the demand for rapid diagnostic kits.

Rapid Diagnostics Market Trends

Lateral Flow Assays Containing DNA Nanostructures

A lateral flow assay is a rapid diagnostic test designed to confirm the presence or absence of target analytes, such as pathogens or biomarkers, in human samples like blood, serum, urine, or saliva. These assays utilize antibodies on a conjugate pad that bind to the target antigen to generate results. Traditional antibodies can be substituted with DNA nanostructures that offer high binding affinity and specificity for the target antigen. For instance, Atom Bioworks Inc. (U.S.) has developed the DNA Star Rapid Diagnostics Platform, a lateral flow assay kit that incorporates nanoengineered DNA nanostructures instead of conventional antibodies. In 2021, the company received the Rapid Testing Innovation Award at the Advanced Lateral Flow Conference organized by DCN Diagnostics (U.S.) and DIALUNOX GmbH (Germany).

Smartphone-based Detection Platforms

The demand for high-quality medical services continues to rise. Technological advancements, such as portable devices for use at home or in remote areas, significantly enhance both the quantity and quality of medical care. Smartphone-based platforms are increasingly applied in tele-imaging, food technology, and education, demonstrating their versatility across various medical applications. Rapid diagnostics are crucial for screening patients in any healthcare setting. Given the high costs of diagnosis and the limited availability of benchtop readers in resource-constrained areas, the demand for smartphone-based rapid diagnostics is steadily increasing.

Many companies in the rapid diagnostics market are developing smartphone-based, end-to-end platforms that integrate with mobile applications to streamline test result generation in point-of-care environments. These platforms often incorporate deep learning methods to improve device efficiency. Additionally, smartphone-based detection methods facilitate automated result detection and analysis while supporting human expertise. Patient data transactions are secured and validated through blockchain technology, ensuring trust and security in data handling.

Rapid Diagnostics Market Opportunity

Emerging Markets

Emerging economies worldwide are driving demand for healthcare services and treatments due to rapid urbanization, improving healthcare infrastructure and expenditures, expanding health insurance coverage, rising disposable incomes, and a growing prevalence of both non-communicable and infectious diseases.

According to the International Diabetes Federation, in 2021, the number of individuals with diabetes in middle-income countries—including China, Brazil, Bangladesh, India, and Indonesia—was 414 million. This figure is projected to rise to 623.3 million by 2045. Additionally, the World Health Organization reported in May 2022 that, in low- and middle-income countries, 15 out of every 100 patients in acute-care hospitals acquire at least one healthcare-associated infection (HAI) during their hospital stay, with one out of ten of these infections leading to mortality.

Rapid Diagnostics Market Study: Key Findings

The Kits Segment to Account for a Large Share of the Rapid Diagnostics Market in 2024

Based on product, the rapid diagnostics market is segmented into kits and equipment. In 2024, the kits segment is expected to account for the largest share of 67.6% of the rapid diagnostics market. The significant share of this segment can be attributed to the increasing adoption and frequent use of kits. Additionally, the expanding portfolio of disease-specific rapid kits for the early diagnosis of chronic and infectious diseases, along with ongoing technological advancements, further supports the segment's substantial market share. Moreover, this segment is expected to register the highest CAGR of 7.2% during the forecast period.

The Immunoassay Segment to Account for a Large Share of the Rapid Diagnostics Market in 2024

Based on platform, the rapid diagnostics market is segmented into immunoassays, molecular detection tests, and other rapid diagnostic platforms. In 2024, the immunoassay segment is expected to account for the largest share of 54.2% of the rapid diagnostics market. The substantial share of this segment can be attributed to the high prevalence of infectious and chronic diseases, the lower costs of rapid immunoassay tests compared to traditional laboratory-based tests, ongoing technological innovations, and the increasing demand for lateral flow assay kits suitable for home use.

However, the molecular detection tests segment is expected to register the highest CAGR of 6.2% during the forecast period. The factors driving the segment growth are the high sensitivity and accuracy of these tests, the growing need for advanced diagnostic techniques, and the widening applications of molecular detection tests in various fields.

The Infectious Disease Segment to Account for a Large Share of the Rapid Diagnostics Market in 2024

Based on application, the rapid diagnostics market is segmented into blood glucose testing, cardiac metabolism testing, infectious diseases testing, pregnancy & fertility testing, hematology testing, tumor/cancer markers testing, urinalysis, cholesterol testing, and other tests. In 2024, the infectious disease segment is expected to account for the largest share of the rapid diagnostics market. The large share of this segment is mainly attributed to the rising prevalence of infectious diseases, high awareness, and major efforts regarding early diagnosis, monitoring, and surveillance of infectious diseases after the COVID-19 pandemic.

However, the tumor/cancer markers testing segment is expected to register the highest CAGR during the forecast period. The factors attributed to this segment’s growth are the rising prevalence of cancer worldwide, growing investments and funding for cancer biomarker research, and advancements in cancer diagnostic technologies.

The Blood Segment to Account for the Largest Share of the Rapid Diagnostics Market in 2024

Based on sample type, the rapid diagnostics market is segmented into blood, saliva, nasal, and oropharyngeal, urine, and other samples. In 2024, the blood segment is expected to account for the largest share of the market. The large share of this segment is attributed to the high availability of rapid tests requiring blood as the sample, the high tendency of the blood samples to retain the genetic material intact without altering its properties compared to other samples, and easy extraction and storage options for blood samples.

Moreover, the blood segment is expected to register the highest CAGR during the forecast period due to players' growing focus on launching rapid tests that require blood samples.

The Hospitals & Clinics Segment to Account for the largest share of the Rapid Diagnostics Market in 2024

Based on end user, the rapid diagnostics market is segmented into hospitals & clinics, diagnostic laboratories, home care/self-testing, and other end users. In 2024, the hospitals & clinics segment is estimated to account for the largest share of the rapid diagnostics market. The large share of this segment is mainly attributed to the increasing number of patient visits to hospitals for various healthcare services, such as diagnosis, treatments, and surgeries with well-equipped operating & diagnostic rooms, the presence of highly skilled healthcare professionals, the ease of accessibility, and better health coverage for hospital-based healthcare services from various private and group insurance plans.

However, the home care/self-testing segment is expected to register the highest CAGR during the forecast period. The rising incidence of chronic diseases necessitating ongoing care and regular monitoring, coupled with the expanding utilization of home healthcare services and the enhanced availability of accessible and advanced point-of-care diagnostic products, are key drivers fueling the demand for rapid diagnostics in home environments.

Geographical Analysis

Based on geography, the rapid diagnostics market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In 2024, North America is expected to account for the largest share of 41% of the rapid diagnostics market. The large share of North America is attributed to the region’s highly developed diagnostic infrastructure, the high number of laboratory tests performed annually, the rising prevalence of chronic diseases coupled with growth in the aging population, the rising number of inpatient admissions, increasing awareness, and the growing adoption of self-testing kits among the general population.

However, Asia-Pacific is expected to be the fastest-growing regional market, registering a CAGR of 10.1% during the forecast period. The aging population, the rising prevalence of infectious and chronic diseases, and various government initiatives to promote health awareness drive the rapid diagnostics market in Asia-Pacific.

Rapid Diagnostics Market: Key Companies

The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market participants in the last three to four years. The key players profiled in the rapid diagnostics market report include Abbott Laboratories (U.S.), Becton, Dickinson and Company (U.S.), Bio-Rad Laboratories, Inc. (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), ACON Laboratories, Inc. (U.S.), Creative Diagnostics (U.S.), Danaher Corporation (U.S.), Thermo Fisher Scientific Inc. (U.S.), BioMérieux S.A. (France), Alfa Scientific Designs, Inc. (U.S.), BTNX Inc. (Canada), Meridian Bioscience, Inc. (U.S.), and Trinity Biotech plc (Ireland).

Rapid Diagnostics Market Industry Overview: Latest Developments from Key Industry Players

• In February 2024, Bio-Rad Laboratories Inc. (U.S.) launched the Vericheck ddPCR Replication Competent Lentivirus Kit and the Vericheck ddPCR Replication Competent AAV Kit. These provide rapid results for absolute quantification of replication-competent lentivirus (RCL) and replication-competent adeno-associated virus.
• In March 2023, Abbott Laboratories (U.S.) received approval from the U.S. FDA for the company’s new traumatic brain injury (TBI) blood test.
• In February 2023, Beckton, Dickinson, and Company (U.S.) received emergency use approval from the U.S. FDA for its new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV).

Rapid Diagnostics Market Research Summary

Key questions answered in the Rapid Diagnostics Market report: