Point of Care Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Product (Blood Glucose Monitoring, Infectious Disease Testing, Cardiometabolic Disease Testing, Pregnancy & Fertility Testing, Hematology Testing, and Others), By Sample (Blood, Nasal and Oropharyngeal Swabs, Urine, and Others), By End-user (Hospital Bedside, Physician’s Office Lab, Urgent Care & Retail Clinics, and Homecare/Self-Testing), and Regional Forecast, 2023-2030

The global point of care diagnostics market size was USD 43.93 billion in 2022 and is projected to reach USD 78.11 billion by 2030, exhibiting a CAGR of 7.9%. A diagnostics test carried out in the presence of a patient using a device or a kit is known as point of care testing.

In point of care testing, the sample does not need to send to a laboratory for analysis, as the device or kit used to produce rapid and reliable results that further aid in the rapid diagnosis of acute and chronic diseases. According to National Community Pharmacists Association (NCPA), there are four primary goals of point of care testing, i.e., disease identification, disease monitoring, behavior modification, and reduced barriers to care. The products include glucose monitoring kits, pregnancy and fertility testing kits, infectious diseases testing kits, urinalysis testing kits, hematology testing kits, cardiometabolic monitoring kits, and other such testing devices and are used in hospitals, professional clinics, and at home.

The demand for quality these kits rapidly increases with the increasing prevalence of acute and chronic diseases worldwide. For instance, according to a joint news release in June 2022 by WHO and the World Hepatitis Alliance, around 350 million people live with viral hepatitis globally, where chronic hepatitis B and C are the leading cause of liver cancer. Owing to the rising prevalence of hepatitis, several programs were enacted to use poc tests to diagnose the Hepatitis B virus (HBV) and Hepatitis C virus (HCV). For instance, in November 2022, the Commonwealth Department of Health funded Flinders University International Centre for Point-of-Care Testing and Kirby Institute at UNSW Sydney to establish a National Australian Hepatitis C Point-of-Care Testing Program. The program consisted of a network of sites to scale up point-of-care Hepatitis C Virus (HCV) RNA testing in settings providing services to people at high risk of acquiring HCV infection. Considering the above facts and figures, the demand for these products is likely to increase in the forthcoming years, thus boosting the market growth from 2023-2030.

COVID-19 IMPACT

COVID-19 Pandemic Propelled the Market Growth Due to Increased Demand for COVID-19 Diagnosis

The sudden rise in COVID-19 cases and lack of effective treatment against it increased the demand for diagnostics against the virus to manage its spread effectively. Major players such as F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Quidel Corporation, and a few others witnessed tremendous growth in their segment revenue in 2020 due to the outbreak COVID-19 pandemic. This was majorly attributable to the growing demand for products for diagnosis at the point of care, offered by companies to tackle the COVID-19 pandemic.  

• For instance, as per the 2020 annual report of F. Hoffmann-La Roche Ltd., the diagnostics division held 23.0% of the company’s total revenue, increasing by 6.3% from 2019. In FY2021, the company generated a revenue of USD 68,710.1 million, increasing 7.7% from the prior year. The major growth area in the diagnostics division was Molecular Diagnostics, which grew by 90% compared to the previous year, primarily driven by the cobas SARS-CoV-2 PCR test.

Furthermore, increasing government initiatives such as funding for the rapid development of diagnostic test kits coupled with the growing demand for such devices amidst the COVID-19 pandemic caused a significant surge in the manufacturer’s revenue, thus contributing to significant market growth in 2021 and 2022. As a result, many companies increased their focus on developing and manufacturing diagnostic tests against the SARS-CoV-2 virus. For instance, in December 2021, F. Hoffmann-La Roche Ltd launched the SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets accepting CE Mark.

LATEST TRENDS

Request a Free sample to learn more about this report.

Technological Advancements to Expand Point-of-Care Testing Applications

Major market players have increased their focus on adopting advanced technologies such as artificial intelligence to manufacture efficient diagnostic tests. For instance, Creative Biolabs, a contract research organization, provides AI-based POCT development services. Significant advances in testing devices have emerged from lab-on-a-chip platforms, wearable technology, and innovations in smartphone-based technology. Cloud-based deep learning systems have paved the path for future revolutions.

Miniaturization in chip technology, microfluidics, and new biosensors has innovated the design of new systems for point of care diagnostics. Lab-on-a-chip technology is a major trend, particularly in infectious disease diagnosis. Lab-on-a-chip technology means various bioassays, such as microbiological culture, enzyme-linked immunosorbent assays (ELISA), and polymerase chain reaction (PCR), can now be used at the point of care. For instance, in May 2022, researchers at the University of Minnesota completed the development of a novel microfluidic chip that can detect bacteria, viruses, other pathogens, and biomarkers in liquid samples. Also, manufacturers are focusing on incorporating ELISA in infectious disease diagnosis. For instance, In January 2021, Trinity Biotech plc. received CE Mark approval and registration for Captia SARS-CoV-2 IgG ELISA.

Furthermore, several players have focused on the development of nanoparticle-based point of care platforms. Nanotechnology has facilitated healthcare providers to take advantage of the distinct features of nanoparticles in the diagnosis and detection of various conditions. Therefore, new technologies for testing kit manufacturing are expected to boost the global market growth during the forecast period.

DRIVING FACTORS

Growing Incidence of Chronic and Infectious Diseases to Foster Demand for Point of Care Diagnostics

A significant increase in the occurrence of chronic ailments such as cardiovascular disorders, diabetes, and various infectious diseases has been observed across the globe. The high prevalence rate of such ailments is one of the major factors boosting demand for diagnosis during the forecast timeframe.

According to United Nations, 38.4 million were living with HIV in 2021, out of these, 54.0% were females. The prevalence and incidence of HIV are expected to increase due to unawareness and social stigma associated with the diagnosis of HIV. In such cases, at-home rapid diagnostic test plays a significant role and recently gained the traction of market players and consumers. For instance, in November 2022, Abbott announced the launch of the Panbio (TM) HIV Self-Test, a fingerstick blood test that detects HIV-1 and HIV-2 antibodies in 15-20 minutes.

The human respiratory syncytial virus (RSV) is one of the most common viruses to cause respiratory tract infections. As per CDC, 4-5 million children worldwide annually develop respiratory syncytial virus (RSV) lower respiratory tract infection. Similarly, according to IDF Diabetes Atlas, in 2021, approximately 537 million adults had diabetes globally. Furthermore, the global number of diabetic adults is expected to rise to 643 million by 2030 and 783 million by 2045.

A significant surge in the prevalence of diabetes and above mentioned chronic diseases across the globe has created a demand for rapid point of care diagnostics with an aim to manage such ailments efficiently and is anticipated to reflect a positive growth of the market globally.

Proliferation of Decentralized Healthcare Systems to Support Market Expansion

The increase in the point of care diagnostics testing has become crucial for patient-centric healthcare due to the rapid diagnosis results required for accurate and quicker treatment decisions. A shift from centralized point-of-care testing to decentralized testing for chronic and infectious and chronic has resulted in convenient access for patients to these diagnostics.

The increase in the demand for fast turnover testing has allowed many players to develop infectious disease tests for decentralized locations. Thus, the increasing demand for fast and effective diagnostics, which can be performed at home or physician’s offices for patient ease, has been boosting the demand for decentralized healthcare settings. For instance, in February 2023, Anavasi Diagnostics received the FDA's Emergency Use Authorization (EUA) for its AscencioDx Molecular Detector and AscencioDx COVID-19 Test. The portability and affordability of the products enabled quality point-of-care molecular testing in mobile testing sites, urgent care centers, and assisted nursing care centers.

The adoption of rapid diagnostic testing is related to an increase in decentralized settings as it enables easy accessibility of medical devices and eliminates the need for transportation. These trends will positively influence the market.

RESTRAINING FACTORS

Lack of Accuracy of Point of Care Tests to Limit Adoption of the Devices  

The high cost associated with the technologies used for virus clearing has limited the adoption of point of care tests. Also, the lack of accuracy of the rapid point of care diagnostic tests reducing the number of FDA approvals for rapid tests, thus restricting the overall market growth.

Pre-analytical errors are quite frequent in the area of point-of-care testing. Hence, such instances might restrict new product launches, hampering market expansion. For instance, in February 2022, CELLTRION INC. had a Class I recall for its DiaTrust COVID-19 Ag Rapid Tests owing to many false positive reports and unauthorized shelf life, which was 12 months but labeled as 18 months.

Hence, the lack of accuracy in these tests is expected to restrict the market’s growth globally during the forecast period.

SEGMENTATION

By Product Analysis

To know how our report can help streamline your business, Speak to Analyst

Blood Glucose Monitoring Segment to Have the High Share Due to Rise in Diabetes Prevalence

Based on the product, the global market is segmented into blood glucose monitoring, infectious disease testing, cardiometabolic disease testing, pregnancy & fertility testing, and hematology testing. The blood glucose monitoring segment accounted for the largest share of the market in 2022. The high market share is attributable to the higher sales of diabetes rapid diagnostics kits. These are available over-the-counter without a prescription and help the patients self-test and monitor their glucose levels. Therefore, as the kits are readily available, they are highly preferred, increasing the product's sales. Owing to the increased adoption of these point of care blood glucose monitors, many market players are focusing on strategic alliances and new product launches to cater to market demand. For instance, in August 2022, DxGen Corp. announced that it had entered into an exclusive agreement with Precision Diabetes, Inc. to launch Epithod AutoDx. Epithod AutoDx is a point of care and fully automated analyzer that measures C-reactive protein, hemoglobin A1c (A1C), urinary albumin, and many other diagnostic tests. The device is small and suitable for outpatient clinics, physician offices, hospitals, and smaller laboratories.

The pregnancy & fertility testing segment is anticipated to grow at a significant growth rate. The segment's growth was attributed to the growing fertility issues and awareness about sexual health.

By Sample Analysis

Application of Blood Sample in Various Disease Diagnosis to Contribute to the Growth of Blood Sample Segment

Based on the sample, the market is divided into blood, nasal and oropharyngeal swabs, urine, and others.

The blood segment held the significant point of care diagnostics market share in 2022 and is expected to grow at a lucrative CAGR. Blood tests can help doctors effectively diagnose the patient for various diseases, including HIV/AIDS, coronary artery disease, and the functioning of organs such as the kidney, liver, and thyroid. Hence, the application of blood tests to diagnose various diseases, and their efficiency in diagnosing various diseases has been boosting the market growth.

The nasal and oropharyngeal swabs segment held a considerable share of the market in 2022. The growth of this segment is attributable to the increasing prevalence of infectious diseases caused by respiratory viruses.

The urine segment is expected to grow at a significant CAGR due to the increasing prevalence of disorders related to kidney functions is responsible.

By End-User Analysis

Adoption of Advanced Instruments to Lead to Dominance of Hospital Bedside Segment

By end-user, the market share is segregated into hospital bedside, urgent care & retail clinics, physician's office lab, and homecare/self-testing.

The hospital bedside segment dominated the market in 2022. This is majorly due to the rising adoption of advanced instruments in these settings and rapid investments by public and private sectors in hospital infrastructure in emerging countries. This leads to higher demand for kits and instruments in these global market settings.

The urgent care & clinics segment is expected to witness a lucrative CAGR. The shift from primary care centers to urgent care clinics for rapid diagnosis of infectious diseases and the growing number of urgent care centers in many developed countries are likely to boost the demand for rapid diagnostic testing in urgent care and retail clinics. For instance, according to an article published in January 2023, the number of urgent care centers is increasing continuously, and currently, there are around 11,150 urgent care centers in the U.S.

REGIONAL INSIGHTS

To get more information on the regional analysis of this market, Request a Free sample

North America generated a revenue of USD 15.14 billion in 2022 and is projected to dominate the market during the forecast period. The intense penetration of advanced point of care diagnostics to detect various chronic and infectious diseases, the growing funding environment, and the availability of favorable reimbursement policies are likely to boost the market in the region. For instance, in June 2022, Visby Medical announced expanding Series E Round to get an additional USD 35 million fund totaling over USD 135 million raised in the same round. The funding was used to scale up the production capacity of at-home diagnostic tests for antimicrobial resistance panels and advanced respiratory health tests.

Europe captured a notable market share and is anticipated to grow at a significant CAGR during the forecast period. Key players in Europe are focusing on the launch of rapid diagnostics tests for the time-efficient diagnosis of infectious diseases. Moreover, the government has invested in R&D activities to strengthen the diagnostics sector pertaining to highly advanced point-of-care diagnostic tests. These factors support the market growth in the region.

Moreover, the Asia Pacific is expected to expand at a significant CAGR during the forecast period. The increasing prevalence of infectious and chronic ailments across the Asia Pacific is likely to propel the adoption of point of care diagnostic tests. Moreover, the increasing focus and investment of market players in R&D are fueling the expansion. For instance, in September 2022, Boditech Med Inc., a South Korea-based IVD solution provider, announced the opening of its new R&D center in a 6600㎡ wide land area with an investment of USD 8.7 million.

KEY INDUSTRY PLAYERS

Companies with a Diversified and Strong Products Portfolio to Hold Key Market Share

Based on the competitive landscape, several market players such as Abbott, F. Hoffman-La Roche AG, and Danaher (Cepheid Inc.) accounted for the major share of the market. Continuous investments in research and development activities coupled with a strong portfolio of products are some of the considerable factors supporting these companies' growth. For instance, in FY 2022, F. Hoffmann-La Roche Ltd invested USD 15,375.3 million in R&D, around 3% up from USD 14,997.8 million in 2021.

However, several new players are entering the industry, pose a challenge to the semi-consolidated nature of the market, and are projected to lead to intense competition in the market during the forecast period. For instance, in March 2022, Digital Diagnostics entered into a long-term strategic partnership with Baxter International Inc. to combine the Welch Allyn RetinaVue 700 Imager with IDx-DR autonomous AI software to detect diabetic retinopathy at the point of care.

Other major players, including bioMérieux and Becton Dickinson and Company (BD), have a strong focus on developing point of care testing devices pertaining to incorporating newer technologies such as nanotechnology, Artificial Intelligence, etc.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Switzerland)


• Thermo Fisher Scientific Inc. (U.S.)


• Abbott Laboratories (U.S.)


• Quest Diagnostics Incorporated (U.S.)


• BD (U.S.)


• bioMérieux SA (France)


• Cardinal Health, Inc. (U.S.)


• Cepheid (U.S.)


• Trinity Biotech (Ireland)


• Quidel Corporation (U.S.)


• Bio-Rad Laboratories Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• November 2022: Boditech Med Inc. received an approval for domestic use of the Boditech Quick COVID-19 Ag Saliva test from the Ministry of Food and Drug Safety (MFDS). Quick COVID-19 Ag Saliva is an advanced COVID-19 Ag home test with a saliva sample that detects all COVID-19 virus variants, including the Omicron variant and produces results in 15 minutes.


• October 2022 - F. Hoffmann-La Roche Ltd announced the launch of SARS-CoV-2 Rapid Antibody Test 2.0 for point-of-care settings. The test possesses a sensitivity of 95.83%.


• September 2022: QuantuMDx Group Ltd., a U.K.-based medical technology company, announced a collaboration deal with Sansure Biotech, an IVD solution provider. The collaboration aimed to accelerate the commercialization of the Q-POC platform and its assays in China.


• April 2022 - bioLytical Laboratories Inc., a Canadian company, received Health Canada’s approval for iStatis COVID-19 Antigen Home Test. The approval enabled the company to commercialize the product across Canada.


• December 2021 - Thermo Fisher Scientific and Color Health collaborated to launch a k-12 readycheckgo covid-19 testing solution for Texas schools.

REPORT COVERAGE

An Infographic Representation of Point-of-Care Diagnostics Market

View Full Infographic

To get information on various segments, share your queries with us

The global market report provides a detailed analysis of the market and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the Point of Care Diagnostics market trends and highlights key industry developments and market share analysis for key companies. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation