Point of Care Diagnostics Market Size, Share & Industry 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 Home & Self testing), and Regional Forecast, 2024-2032

The global point of care diagnostics market was USD 30.87 billion in 2023 and is projected to grow from USD 31.57 billion in 2024 to USD 51.19 billion by 2032, exhibiting a CAGR of 6.2% during the forecast period. North America dominated the point of care diagnostics market with a market share of 35.37% in 2023.

Point of care testing (POCT) refers to testing conducted close to the site of patient care where care or treatment is provided. The increasing prevalence of conditions such as cardiac disorders, diabetes, and infectious diseases, among others, and owing to several benefits such as the potential to generate quick results and efficiency, among others, are leading to a growing number of patients undergoing POCT testing procedures globally. According to 2021 data published by the Centers for Disease Control and Prevention (CDC), there are approximately 38.4 million people with diabetes in the U.S. 

Along with this, the rising focus of the players operating in the market on developing and introducing products with advanced technology and features in various testing kits, including infectious diseases testing kits, urinalysis testing kits, and hematology testing kits, is another significant factor contributing to the growing demand of these devices in the market among the healthcare providers and patients.

The COVID-19 pandemic positively impacted the market for point-of-care diagnostics in 2020. Rapid testing for COVID-19 increased during the period, significantly increasing the demand for POC testing among healthcare facilities in the market. However, the market witnessed slower growth in 2021 owing to the reduced number of COVID-19 cases and the rollout of various vaccines globally.

Point of Care Diagnostics Market Trends

Technological Advancements to Expand Point-of-Care Testing Applications

The increasing demand for novel products, along with the robust efforts of the key players, is leading to the development and introduction of products with advanced technology and features.

Major market players have increased their focus on adopting advanced technologies such as artificial intelligence, IoT, and machine learning, among others, to manufacture efficient diagnostic tests. In November 2023, F. Hoffmann-La Roche Ltd. launched Elecsys HBeAg quant, an immunoassay that can determine the presence and quantity of the hepatitis Be antigen (HBeAg) in human serum and plasma.

Miniaturization and increased mobility of the POC testing devices are a few more features that are included in these devices owing to technological advancements. These technological advancements are enabling bioassays, such as microbiological culture, Enzyme-Linked Immunosorbent Assays (ELISA), and polymerase Chain Reaction (PCR), to be used at the point of care. In June 2023, Sysmex Corporation launched a point-of-care testing system for rapid detection of antimicrobial susceptibility in Europe using a unique and proprietary microfluidic technology.

Therefore, the increasing R&D focus of the market players, along with rising initiatives by the government bodies and national and international healthcare organizations to create awareness regarding testing for various chronic conditions, is expected to fuel the technological advancements in the products. 

Point of Care Diagnostics Market Growth Factors

Increasing Prevalence of Infectious Diseases and Chronic Disorders to Foster Demand for Point of Care Diagnostics Products

There has been a significant increase in the occurrence of chronic ailments such as cardiovascular disorders, diabetes, and various infectious diseases worldwide. The rising patient population suffering from chronic conditions, along with increasing awareness regarding early screening and diagnosis, is expected to boost the demand for these testing devices in the market.

According to 2022 data published by WHO, approximately 39.0 million people were living with HIV in 2022. In addition, around 1.3 million people acquired HIV in 2022 globally.

Moreover, the growing prevalence of chronic conditions such as cancer and diabetes, among others, is another major factor contributing to the rising demand for these POCT testing kits and devices among the population.

Thus, the increasing patient population, along with the market players' robust focus on developing and introducing novel products and test kits to cater to the rising demand, is expected to fuel the point-of-care diagnostics market growth during the forecast period.

Proliferation of Decentralized Healthcare Systems to Support Market Expansion

The increase in point-of-care diagnostic 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 diseases has resulted in convenient access to these diagnostics for patients.

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 are expected to influence the market positively.

RESTRAINING FACTORS

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

There are several advantages of POC testing kits and devices, which are rapidly increasing the adoption of these devices in the market. However, there are a few limitations, such as limited accuracy of test results using POC kits and devices, among others.

The high cost associated with the technologies is another major barrier to the limited adoption of these tests among the population. The underdeveloped healthcare infrastructure in emerging countries results in poor connectivity, which requires manual entry of patient medical records into the system, triggering errors, delays, and duplicate testing, which further increases the costs associated with this testing.

Hence, the lack of accuracy, along with the rising cost of the devices, are expected to hamper the market’s growth globally during the forecast period.

Point of Care Diagnostics Market Segmentation Analysis

By Product Analysis

Blood Glucose Monitoring Segment Registered the Largest Share Due to the Rise in Diabetes Prevalence

The market is segmented by product into blood glucose monitoring, infectious disease testing, cardiometabolic disease testing, pregnancy and fertility testing, hematology testing, and others.

The blood glucose monitoring segment dominated the global point-of-care diagnostics market share in 2023. The rising prevalence of diabetes among the population, along with a growing focus of the market players on developing and introducing products with advanced features and technology, are some of the major factors supporting the growth of the segment. In February 2024, Dexcom, Inc. launched Dexcom ONE+, the latest Continuous Glucose Monitoring (CGM), with an aim to bring powerful, new diabetes management technology to patients in the Netherlands.

The pregnancy and fertility testing segment is anticipated to expand significantly during the forecast period. The segment's growth can be attributed to the growing fertility issues and awareness about sexual health. The rising adoption of various testing kits and products, especially in developed countries such as the U.S., Germany, and the U.K., among others, is another major factor contributing to the growth of the segment.

The hematology testing, infectious disease testing, and other segments are also anticipated to grow during the forecast period owing to the growing prevalence of various infectious diseases and chronic conditions such as HIV and cancer, among others, and higher rate of screening and early diagnosis of these conditions, among other factors.

By Sample Analysis

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

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

The blood segment dominated the market and held a significant market share in 2023 and is expected to grow at a significant CAGR during the forecast period. 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 segment growth.

The urine segment is expected to grow at a significant CAGR during the forecast period due to the increasing prevalence of disorders related to kidney functions among the population. According to 2023 data published by the CDC, approximately 35.5 million adults in the U.S. are estimated to have Chronic Kidney Disease (CKD), which accounts for 1 in 7 adults in the country.

By End-User Analysis

Adoption of Advanced Instruments to Spur the Hospital Bedside Segment Growth

The market for point-of-care diagnostics is segregated by end-user into hospital bedside, physician's office lab, urgent care and retail clinics, and home and self-testing.

The hospital bedside segment dominated the market in 2023. The rising adoption of advanced POC testing devices and instruments in hospitals in developed countries, improvement in healthcare infrastructure, and rising investments by public and private sectors in emerging countries owing to rising healthcare expenditure among these countries are some of the vital factors fueling the growth of the segment in the market.

The urgent care & retail clinics segment is expected to witness the highest CAGR during the forecast period. The shift from primary care centers to urgent care clinics for rapid diagnosis of various 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 & retail clinics. According to 2023 data published by The Urgent Care Association, there were approximately 14,075 urgent care centers in the U.S. by the end of 2022, witnessing a growth of around 22.6% as compared to 2019.

The home & self-testing segment is projected to grow at a nominal rate during the forecast period. The growth of the segment is attributed to the growing adoption of home test kits and devices among patients, along with the growing number of product launches supporting home testing.

REGIONAL INSIGHTS

The market for point-of-care diagnostics is divided by region into Asia Pacific, Europe, North America, the Middle East and Africa, and Latin America.

North America generated a revenue of USD 10.92 billion in 2023 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 growth in the region. For instance, in June 2022, Visby Medical announced expanding the 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's market for point-of-care diagnostics captured a notable share in 2023 and is anticipated to grow at a steady CAGR during the forecast period. Key players in Europe are focusing on the launch of rapid diagnostic 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, Asia Pacific is expected to expand at a significant CAGR during the forecast period. The increasing prevalence of infectious and chronic ailments across the region is likely to propel the adoption of point-of-care diagnostic tests. In June 2023, Sysmex Corporation announced the launch of an assay kit in Japan to identify amyloid beta accumulation in the brain, a cause of Alzheimer’s disease.

Key Industry Players in the Point of Care Diagnostics Market

Key Companies Focus on R&D to Boost Their Product Portfolio

The global market for point-of-care diagnostics is a semi-consolidated market, with a few prominent players accounting for a majority of the market share.

F. Hoffmann-La Roche Ltd., Abbott, and Danaher Corporation are some of the major players operating with a wide range of product portfolios. These companies' growing R&D focus on strengthening their product portfolios with a rising number of product approvals and launches and expanding their brand presence globally are some of the major factors supporting their growing market shares.

There are several new entrants in the industry trying to establish their brands with devices and products with advanced technology. The increasing focus of these companies on developing and introducing novel products is a crucial factor contributing to their market shares.

• In May 2022, QuantuMDx Group Limited, a U.K.-based company focusing on developing point-of-care diagnostics, launched a new respiratory panel test for the detection of COVID-19, Flu A, flu B & Respiratory Syncytial Virus (RSV).

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, and others.

LIST OF TOP POINT of CARE DIAGNOSTICS COMPANIES:

• F. Hoffmann-La Roche Ltd. (Switzerland)


• Abbott (U.S.)


• EKF Diagnostics Holdings plc (U.K.)


• Cardinal Health, Inc. (U.S.)


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


• Quest Diagnostics Incorporated (U.S.)


• BD (U.S.)


• bioMérieux SA (France)


• QuidelOrtho Corporation (U.S.)


• Bio-Rad Laboratories Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• October 2023: EKF Diagnostics opened its new state-of-the-art life sciences manufacturing facility in the U.S. The facility is designed to meet the increasing demand of its growing customer base.    


• March 2023: BioLytical Laboratories Inc. received Health Canada authorization for its INSTI Multiplex HIV-1/2 Syphilis antibody testing in point-of-care settings.


• February 2023: bioMérieux received the U.S. FDA approval for its BIOFIRE SPOTFIRE respiratory panel system with the aim of expanding its POC testing product portfolio.


• January 2023: Cipla Limited launched Cippoint, a point-of-care device that offers testing for non-communicable diseases, infectious diseases, and various other health conditions.


• November 2022: Boditech Med Inc. received 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 home test for COVID-19 Ag that uses a saliva sample to detect all virus variants, including the Omicron variant, and produces results in 15 minutes.

REPORT COVERAGE

The global report provides a detailed analysis of the market and focuses on key aspects such as prominent companies, product types, and leading applications of the product. It also 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 market's growth over recent years.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Growth Rate	CAGR of 6.2% from 2024-2032
Historical Period	2019-2022
Unit	Value (USD Billion)
Segmentation	By Product Blood Glucose Monitoring Infectious Disease Testing Cardiometabolic Disease Testing Pregnancy & Fertility Testing Hematology Testing Others
By Sample Blood Nasal and Oropharyngeal Swabs Urine Others
By End-User Hospital Bedside Physician’s Office Lab Urgent Care & Retail Clinics Home & Self testing
By Region North America (By Product, Sample, End-User, and Country) U.S. (By Product) Canada (By Product) Europe (By Product, Sample, End-User, and Country/Sub-region) U.K. (By Product) Germany (By Product) France (By Product) Italy (By Product) Spain (By Product) Scandinavia (By Product) Rest of Europe (By Product) Asia Pacific (By Product, Sample, End-User, and Country/Sub-region) China (By Product) Japan (By Product) India (By Product) Australia (By Product) Southeast Asia (By Product) Rest of Asia Pacific (By Product) Latin America (By Product, Sample, End-User, and Country/Sub-region) Brazil (By Product) Mexico (By Product) Rest of Latin America (By Product) Middle East & Africa (By Product, Sample, End-User, and Country/Sub-region) GCC (By Product) South Africa (By Product) Rest of the Middle East & Africa (By Product)