Point of Care Diagnostics Market Report: Size, Share and Outlook by 2031

The global market for point of care diagnostics is projected to grow significantly, reaching approximately US$ 70.89 billion by 2027, up from US$ 26.60 billion in 2018. This growth trajectory indicates a compound annual growth rate (CAGR) of 11.8% from 2019 to 2027.

Several factors are driving the expansion of the point of care diagnostics market. The rising prevalence of infectious diseases, along with continuous product launches and advancements in product development, are key contributors. Additionally, the increasing availability of CLIA-waived point of care (POC) tests has further bolstered market growth. Emerging markets in developing nations are also expected to positively influence the market's expansion in the foreseeable future. However, challenges such as product recalls may hinder growth prospects in the coming years.

Point of care testing (POCT) refers to medical diagnostic testing conducted at or near the site of patient care, providing immediate information to healthcare providers regarding a patient's condition. POCT serves as a crucial diagnostic tool utilized in various hospital settings, including critical care environments like the intensive care unit (ICU), operating room (OR), and emergency department (ED).

Despite the promising growth, the market faces potential setbacks due to product recalls. Such recalls can significantly impact market growth during the forecast period, particularly in light of global supply chain complexities and increasingly stringent regulatory requirements. For instance, in 2018, the PTS Panels CHOL+GLU test strips, classified as in vitro diagnostic medical devices (IVDs), were recalled in Australia. This recall was prompted by concerns regarding the potential loss of glucose analyte activity before the designated shelf life. According to the Therapeutic Goods Administration, these devices, produced by Point Of Care Diagnostics Australia Pty Ltd, exhibited a risk of under-recovery of glucose analyte, which could lead to inaccurate glucose test results. Such inaccuracies may delay disease diagnosis, ultimately undermining consumer confidence in point of care devices.

The global point of care diagnostics market is categorized based on product type, prescription mode, and end user. In terms of product segmentation, the market includes glucose monitoring products, infectious disease testing products, cardiometabolic testing products, pregnancy and fertility testing products, coagulation testing products, tumor/cancer marker testing products, cholesterol testing products, urinalysis testing products, hematology testing products, and various other POC products. In 2018, glucose monitoring products dominated the market share within the product category.

Regarding prescription mode, the market is divided into prescription-based testing and over-the-counter (OTC) testing. Additionally, the end user segmentation encompasses professional diagnostic centers, home care settings, research laboratories, and other categories.

To compile the report, a variety of primary and secondary sources were utilized, including reputable organizations such as the Food and Drug Administration, World Health Organization, Public Health Agency of Canada, Canadian Diabetes Association, National Healthcare Safety Network (NHSN), International Diabetes Federation, Diabetes Education Society of South Africa (DESSA), Canadian Breast Cancer Foundation, National Cancer Institute (NCI), National Institute of Cancer Prevention and Research (NICPR), and the Pancreatic Cancer Network South Africa, among others.

In summary, the point of care diagnostics market is on a robust growth path, driven by various factors including the rising incidence of infectious diseases and advancements in testing technologies. However, the market must navigate challenges such as product recalls and regulatory hurdles to maintain its growth momentum.