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, 2022-2029

The global point of care diagnostics market size was valued at USD 46.65 billion in 2021 and is projected to grow from USD 36.37 billion in 2022 to USD 51.94 billion by 2029, exhibiting a CAGR of 5.2% during the forecast period. Based on our analysis, the global market exhibited a rise of 62.2% in 2020 as compared to 2019. The global COVID-19 pandemic has been unprecedented and staggering, with experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels.

The point of care (POC) diagnostics include glucose monitoring kits, pregnancy & fertility testing kits, infectious diseases testing kits, urinalysis testing kits, hematology testing kits, cardiometabolic monitoring kits, and other such testing devices. These type of diagnostics are used in hospitals, professional clinics, and home.

The demand for quality point of care diagnostics kits rapidly increases with acute and chronic diseases worldwide. For instance, as per the Journal of Hepatology report, in 2020, around 257-291 million people were chronically infected with hepatitis B virus (HBV) and were at risk of cirrhosis and hepatocellular carcinoma (HCC). The amount of cirrhosis due to HBV varies globally. Globally, HBV is adssociated with one-third of deaths due to HCC. Considering the above statistics, the demand for diagnosis products among patients is likely to increase in the forthcoming years, thus boosting the point of care diagnostics market growth from 2022-2029. Furthermore, technological developments in diagnostic kits have resulted in fewer manual errors and emerged as a prominent driving factor for the market. This is expected to boost the adoption of point of care diagnostics kit in emerging and lower economic countries.

COVID-19 IMPACT

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

The sudden rise in the number of COVID-19 cases and lack of any effective treatment against it increased the demand for diagnostics against the virus to effectively manage its spread. As a result, many companies increased their focus on developing and manufacturing new diagnostics against the SARS-CoV-2 virus. For instance, F. Hoffmann-La Roche Ltd announced the plan to launch SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets accepting CE Mark.

Moreover, major players such as F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Quidel Corporation, and a few others witnessed tremendous growth in their point of care diagnostics segment revenue in the year 2020 due to the outbreak COVID-19 pandemic. This is majorly attributable to the growing demand for this type of diagnostics offered by these 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 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 POC test kits coupled with the growing demand for such devices amidst the COVID-19 pandemic has caused a significant surge in the manufacturer’s revenue, thus contributing to significant market growth in 2021 and across.

LATEST TRENDS

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Technological Advances 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 point of care diagnostics. Significant advances in POCT devices have been emerging 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 this type of diagnostics. Lab-on-a-chip technology is one of the major drivers of POCT, 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. Manufacturers are focusing on the incorporation of 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 POC 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 POC testing kits manufacturing are expected to boost the global market growth during the forecast period.

DRIVING FACTORS

Growing Incidence of Chronic and Infectious Diseases across the Globe 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 point of care diagnostics during the forecast timeframe.

The United Nations reports that nearly 38 million people had HIV/AIDS in 2019. Out of these, 1.8 million were children and 36.2 million were adults. Additionally, the human respiratory syncytial virus (RSV) is one of the most common viruses to cause respiratory tract infections. As per CDC, annually, 4-5 million children around the world develop respiratory syncytial virus (RSV) lower respiratory tract infection. Similarly, according to IDF Diabetes Atlas, in 2021, 206.0 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 demand for rapid point of care diagnostics with an aim to efficiently manage such ailments and is anticipated to reflect a positive growth of the point of care diagnostics market globally.

Proliferation of Decentralized Healthcare Systems to Support Market Expansion

Point-of-Care 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 office for patient ease has been boosting the demand for decentralized healthcare settings.

In October 2020, Abbott rolled out ID NOW a rapid molecular point-of-care test that detects COVID-19 infection within 13 minutes. The test was being used at decentralized healthcare locations such as urgent care clinics and physicians' offices.

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

RESTRAINING FACTORS

Lack of Accuracy of POC Diagnostics to Limit Adoption

The high cost associated with the technologies used for virus clearing has restricted the global 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, thereby hampering market expansion. For instance, in August 2020, Siemens Healthcare had a Class 2 Device Recall for its BGEM Test Card In-vitro diagnostic device, used to test un-anticoagulated arterial, venous or capillary whole blood quantitatively in the laboratory or at the point of care. This was due to the inconsistent glucose results on card lot 01-20095-10. This could cause a delay in diagnosing hyperglycemia or unnecessary treatment for hypoglycemia.

Hence, the lack of accuracy in POC testing is expected to restrict the growth of the market growth globally during the forecast period.

SEGMENTATION

By Product Analysis

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Blood Glucose Monitoring Segment to Register Highest Growth Rate 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, hematology testing, and others.

The blood glucose monitoring segment held a significant point of care diagnostics market share in 2021. This segment is also anticipated to grow at the highest CAGR. 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 in self-testing and monitoring their glucose levels. Therefore, as the kits are readily available, they are highly preferred, increasing the product's sales. For example, in May 2020, EKF Diagnostics announced the launch of STAT-Site WB to manage diabetes. The test delivers results within 10 minutes and is specifically designed to be used at point of care diagnostics such as the physician's office, diagnostic laboratories, and clinics.

The infectious disease testing segment is anticipated to grow at a significant growth rate. The segment's growth was attributed to the sudden rise in the number of COVID-19 cases. For instance, as of 9th March 2021, there were around 450.1 million COVID-19 cases worldwide. The increase in the number of COVID-19 cases increased the demand for COVID-19 diagnostics to effectively control the spread of the disease.  

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 maximum market share in 2021 and is expected to grow at a lucrative CAGR. Blood tests can help the doctors effectively diagnose the patient for various diseases, including HIV/AIDS, coronary artery disease, and the functioning of organs such as 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 2021. 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 Dominance of Hospital Bedside Segment

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

The hospital bedside segment dominated the market in 2020. This is majorly due to the rising adoption of advanced instruments in these settings, along with 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 lucrative CAGR. The shift from primary care centers to urgent care clinics for rapid diagnosis of infectious disease 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 the report published by Sekisui Diagnostics, in 2019, there were approximately 9,000 urgent care centers in the U.S.

REGIONAL INSIGHTS

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North America generated a revenue of USD 14.48 billion in 2021 and is projected to dominate the market during the forecast period. The strong penetration of advanced point-of-care diagnostics to detect various chronic and infectious diseases and the availability of favorable reimbursement policies is likely to boost the point of care diagnostics market in the region.

Europe dominated the global 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 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 this type of diagnostics.

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.) account for the major share of the market. Continuous investments in the research and development activities coupled with a strong portfolio of products in the point of care diagnostics segment are some of the considerable factors supporting these companies' growth.

However, several new players are entering this 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 July 2020, Precipio Inc. joined the POC diagnostics market by partnering with ADS Biotech to develop COVID-19 detection test kits based on a lateral flow immunoassay.

Other major players, including bioMérieux and 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.)


• Mesa Biotech (U.S.)


• Cepheid (U.S.)


• Trinity Biotech (Ireland)


• Quidel Corporation (U.S.)


• Bio-Rad Laboratories Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

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


• July 2021: Abbott announced the launch of the Panbio COVID-19 Antigen Self-Test, which can be used to detect the SARS-CoV-2 virus in adults and children. The test received CE Mark approval and is also approved by the ICMR advisory in India.

REPORT COVERAGE

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The global point of care diagnostics 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