Point of Care Diagnostics Market

Market Overview

The global point of care diagnostics market was valued at USD 37.12 billion in 2021. It is projected to reach USD 66.37 billion by 2030, growing at a CAGR of 6.67% during the forecast period (2022–2030). Point of Care diagnostics are approaches utilized for early and rapid disease diagnosis. These methods are susceptible and cost-effective and are utilized in hospitals, clinics, ambulatory care, home healthcare, and research laboratories. The rising incidence of target conditions is the most critical factor driving the market growth. Rising healthcare costs, rising technological advancements, adopting home-based point-of-care devices, and rising government and not-for-profit organization initiatives to raise public awareness of health issues are other significant factors driving the market.

Point of care treatment permits speedy and dependable diagnostic testing with instantaneous results, enabling physicians/patients to make care-related decisions remotely and immediately. The high frequency of infectious diseases, supporting government policies, and the expanding number of CLIA-waived POC tests are the primary growth drivers of the market. In addition, decentralization of healthcare and increased investments and funding for product development are anticipated to provide growth prospects for market participants in point-of-care diagnostics.

Market Dynamics

Global Point of Care Diagnostics Market Drivers

Growing Significance in Environmental Monitoring and Public Health

The growing significance of point-of-care diagnostics in environmental monitoring and public health necessitates the development of technologies that simplify networking, making it more comfortable for medical practitioners to interpret test findings appropriately. For instance, Everything Genetic obtained authorization from the relevant regulatory organizations in the United Kingdom (UK) in March 2022 to begin marketing COVID-19 Antigen Tests in the UK market. The company produces lateral flow devices for a single kit price of GBP 2, which is anticipated to boost the growth of the point-of-care diagnostics market.

Rise of Infectious Diseases

Point-of-care tests can significantly improve the management of infectious diseases, especially in developing countries where timely access to healthcare can be challenging and when the healthcare system is underdeveloped and underfunded. In East and Southern Africa in 2021, UNAIDS estimated approximately 21.2 million HIV-positive individuals. Twenty thousand newly diagnosed cases of HIV were tallied throughout the Middle East and North Africa. In the Asia-Pacific region, 6.1 million people were estimated to be HIV-positive in 2021, with China and India having the highest infection rates. According to UNAIDS, about 2.3 million HIV-positive people in India in 2021. It is anticipated that the demand for diagnostics that can be completed at the point of care will rise, accelerating the process of treating HIV infection.

Global Point of Care Diagnostics Market Restraints

Inaccurate Point of Care Diagnostics

The high expense associated with virus-clearing technologies has limited the widespread inaccuracy of rapid point-of-care diagnostic testing, lowering the number of FDA approvals for rapid tests and limiting market expansion. In the field of point-of-care testing, pre-analytical errors are all too common. Consequently, such occurrences may inhibit introducing of new products, thereby impeding market expansion. For example, Siemens Healthcare issued a Class 2 Instrument Recall for its BGEM Analyze Card In-vitro diagnostic device, which tests un-anticoagulated arterial, venous, or capillary whole blood quantitatively in the laboratory or at the point of care. This occurred due to the conflicting glucose results on card lot 01-20095-10. These factors can hinder the growth of the point of care diagnostics market.

Global Point of Care Diagnostics Market Opportunities

Implementation of Remote Patient Monitoring

It is anticipated that the implementation of digital technology would significantly impact the development of point-of-care solutions in settings with limited availability of resources. As a component of their go-to-market strategy, businesses in the POCT space ought to provide their highest priority to the growing use of telehealth as the industry standard. According to data collected by the Centers for Disease Control and Prevention during the pandemic, approximately 95% of health centers in the United States offered some form of telehealth to patients during the pandemic. Consequently, it is projected that the growth of remote patient monitoring systems such as PixCell Medical, point-of-care technology for CBC testing, will positively impact the market's development.

Segmental Analysis

The global point of care diagnostics market is segmented by product and end-user.

Based on product, the market is divided into Glucose Testing, Hb1Ac Testing, Coagulation Testing, Fertility/Pregnancy, Infectious Disease, Cardiac Markers, Thyroid Stimulating Hormone, Hematology, Primary Care Systems, Decentralized Clinical Chemistry, Feces, Lipid Testing, Cancer Marker, Blood Gas/Electrolytes, Ambulatory Chemistry, Drug of Abuse (DOA) Testing, and Urinalysis/Nephrology.

The infectious disorders segment owns a significant market share and is expected to grow during the forecast period. The change from centralized to decentralized POC testing for infectious illness has improved patient care. The rising demand is pushing the market for rapid tests, which has compelled industry participants to provide POC solutions to decentralized regions. For example, Abbott has created ID NOW, the world's quickest molecular POC test, which offers COVID-19 results in 13 minutes and is applicable in a range of decentralized healthcare settings, such as doctor's offices and urgent care centers.

The glucose testing segment holds the second-largest revenue share due to the rising prevalence of diabetes and the need for regular monitoring of blood sugar levels. According to data compiled by the International Diabetes Federation, the global prevalence of diabetes will rise from 396 million in 2021 to 575 million in 2035. The increasing prevalence of diabetes and the advent of portable diagnostic equipment are anticipated to support the segment's growth.

Based on end-user, the market is segmented into clinics, hospitals, homes, assisted living healthcare facilities, and laboratories.

The clinic segment is the most dominant in the global point of care diagnostics market, and pharmacy and retail clinics as the most significant contributors to this segment revenue. Access to novel diagnostic technology, improvement in healthcare coverage, and cost are the primary drivers driving the expansion of POC diagnostic applications. Increased frequency of infectious diseases, improved access to healthcare for the aging population, and increasing pressure on traditional clinics are important drivers driving the global market expansion. As hospital adoption of POCTs increases, regulatory organizations have increased the validation/verification requirements for POCT devices.

The residential end-use market sector is anticipated to grow at a CAGR of 7.5% during the forecast period. Home care is a lucrative market due to the cost-effectiveness and convenience of POCT administered to patients in their homes. Point of care in the home healthcare industry helps patients solve healthcare concerns at home and make instantaneous decisions. As the focus of healthcare shifts toward early disease detection and disease prevention, the POC diagnostics-based home healthcare market is anticipated to have lucrative growth during the forecast period.

Regional Analysis

The global point of care diagnostics market is segmented into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.

North America maintained the largest revenue share in the global point of care diagnostics market due to the rapidly increasing number of COVID-19 cases and critical players in both the United States and Canada. For example, in March 2022, the company bioLytical Laboratories Inc., situated in Canada, was awarded CE marking for the iStatis COVID-19 Antigen Home Test.

Asia-Pacific is expected to expand at a CAGR of 15.9% during the forecast period due to a growing pool of local diagnostic kits and reagents manufacturers in this region to offer a wide range of testing solutions for diagnosing coronavirus infection. The nations continually expand their testing capabilities to keep up with the COVID-19 epidemic.

Recent Developments

• June 2022- Roche launches the VENTANA DP 600 slide scanner for digital pathology, enhancing patient care with precision diagnostics.
• June 2022- Roche launches human papillomavirus (HPV) self-sampling solution, expanding cervical cancer screening options.
• May 2022- QIAGEN launches therascreen EGFR Plus RGQ PCR Kit featuring C797S detection to help guide non-small cell lung cancer (NSCLC) treatment.
• June 2022- BD Collaborates with Mayo Clinic Platform, Leveraging Real-World Clinical Data to Improve Post-Market Device Surveillance, Drive Innovation for Patient Care.

Point of Care Diagnostics Market Segmentation

By Product

• Glucose Testing
• Hb1Ac Testing
• Coagulation Testing
• Fertility/Pregnancy
• Infectious Disease
• Cardiac Markers
• Thyroid Stimulating Hormone
• Hematology
• Primary Care Systems
• Decentralized Clinical Chemistry
• Feces
• Lipid Testing
• Cancer Marker
• Blood Gas/Electrolytes
• Ambulatory Chemistry
• Drug of Abuse (DOA) Testing
• Urinalysis/Nephrology

By End-User

• Clinics
• Hospitals
• Home
• Assisted Living Healthcare Facilities
• Laboratories

By Regions

• North America
• Europe
• Asia-Pacific
• LAMEA