Point of Care Diagnostics Market Size, Share & Trends Analysis Report By Product (Glucose Monitoring Kits, Infectious Diseases Testing Kits, Pregnancy And Fertility Testing Kits, Hematology Testing Kits, Cardiometabolic Monitoring Kits, Urinalysis Testing Kits, Cholesterol Test Strips, Others, Drugs Abuse Testing Kits), By Mode of Prescription (Prescription Based Devices, OTC Based Devices), By End User (Professional Diagnostic Centers, Research Laboratories, Home Care, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global point of care diagnostics market size was valued at USD 44.09 billion in 2023. It is estimated to reach USD 78.83 billion by 2032, growing at a CAGR of 6.67% during the forecast period (2024–2032). The rising frequency of infectious illnesses and chronic ailments, such as cardiovascular diseases, cancer, diabetes, etc., along with infectious diseases like HIV/AIDS, malaria, and others, has increased the demand for point-of-care testing. Furthermore, technological advancements in the point-of-care diagnostic technique are estimated to create opportunities for global market growth. 

Highlights

• Glucose Monitoring Kits dominate the product segment.
• Prescription Based Devices dominate the mode of prescription segment. 
• Home care dominates the end-user segment
• North America is the highest shareholder in the global market

Market Overview

Point of Care Diagnostics (POC Diagnostics) refers to medical testing conducted at or near the site of patient care. These diagnostic tools provide immediate results, enabling rapid decision-making and timely treatment. POC diagnostics encompass a wide range of tests, including blood glucose monitoring, pregnancy tests, infectious disease detection, and more. These tests are designed for use in various settings such as hospitals, clinics, and even at home.

The primary advantage of POC diagnostics is their ability to deliver quick and accurate results, reducing the need for multiple patient visits and extensive laboratory work. This convenience enhances patient care by facilitating prompt diagnosis and treatment, ultimately improving health outcomes. Advances in technology have led to the development of more sophisticated and user-friendly POC devices, making them an integral part of modern healthcare systems.

Market Dynamics

Global Point of Care Diagnostics Market Drivers

Rise in Chronic and Infectious Diseases

The global point-of-care diagnostics market is driven by the escalating prevalence of chronic and infectious diseases worldwide. Chronic conditions like diabetes, cardiovascular diseases, and respiratory ailments are increasingly burdening healthcare systems globally. As per the WHO, each year, chronic diseases result in the mortality of 41 million individuals, which is equivalent to 74% of all global fatalities. Concurrently, infectious diseases like HIV/AIDS, malaria, and tuberculosis remain significant public health challenges, especially in developing regions.

Point-of-care diagnostics offer rapid and accurate detection of these diseases, enabling timely intervention and management. These tests facilitate immediate decision-making at the point of care, reducing treatment delays, improving patient outcomes, and optimizing healthcare resource utilization. The surging demand for early disease detection and personalized medicine further propels market growth as healthcare providers prioritize efficient diagnostic tools that enhance diagnostic accuracy and patient management strategies.

Global Point of Care Diagnostics Market Restraint

High Costs and Regulatory Challenges

Despite the numerous advantages of POC diagnostics, high costs, and stringent regulatory requirements pose significant restraints to market growth. The development and commercialization of POC devices involve substantial investment in research and development, manufacturing, and quality control, resulting in high product costs. For instance, advanced POC systems incorporating sophisticated technologies like nucleic acid amplification or multiplexing can be expensive, limiting their affordability and accessibility, particularly in low- and middle-income countries.

Moreover, POC diagnostics must comply with rigorous regulatory standards to ensure their safety, efficacy, and reliability. Obtaining regulatory approvals from authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) can be a lengthy and costly process, hindering the timely introduction of new products into the market. These cost and regulatory challenges can impede the widespread adoption of POC diagnostics, particularly in resource-constrained settings.

Global Point of Care Diagnostics Market Opportunities

Technological Advancements in POC Diagnostics

Technological advancements in POC diagnostics are estimated to create opportunities for market growth by enhancing the accuracy, speed, and convenience of diagnostic tests. Innovations such as microfluidics, lab-on-a-chip technology, and biosensors have revolutionized the POC diagnostics landscape. These technologies enable the development of portable, user-friendly devices capable of delivering rapid results with high precision.

For example, Abbott's i-STAT system is a handheld blood analyzer that uses microfluidic technology to perform a wide range of tests, including blood gases, electrolytes, and hematology, providing results in minutes. Additionally, the integration of connectivity features, such as Bluetooth and Wi-Fi, allows for seamless data transfer and remote monitoring, further improving the utility of POC devices in various healthcare settings. Continuous technological advancements are expanding the capabilities of POC diagnostics and driving their adoption across hospitals, clinics, and home care settings.

Regional Analysis

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America holds a dominant position in the global point of care (POC) diagnostics market, driven by several critical factors. The region boasts a high prevalence of chronic diseases, like diabetes, cardiovascular diseases, and cancer, which necessitates frequent and rapid diagnostic testing. According to the Centers for Disease Control and Prevention (CDC), about 60% of adults in the U.S. have at least one chronic disease, and 40% have two or more, underscoring the substantial demand for POC diagnostics to manage these conditions effectively. Additionally, the advanced healthcare infrastructure in North America supports the widespread adoption of cutting-edge POC diagnostic technologies. Hospitals, clinics, and home healthcare settings in the region are equipped with the latest diagnostic devices, facilitating timely and accurate patient care. Furthermore, North America is a hub for technological innovation in the healthcare sector. Companies such as Abbott, Roche Diagnostics, and Danaher Corporation are leading the way in developing sophisticated POC diagnostic tools that offer high precision and rapid results.

Moreover, regulatory support and favorable reimbursement policies further drive the POC diagnostics market in North America. The U.S. Food and Drug Administration (FDA) has established a clear regulatory framework for the approval and commercialization of POC devices, ensuring their safety and efficacy. Additionally, insurance providers in the U.S. and Canada often cover the costs of POC diagnostic tests, making them more accessible to patients. The ongoing shift towards personalized medicine and home-based healthcare is another significant factor propelling market growth in North America. The COVID-19 pandemic has augmented the adoption of telemedicine and remote patient monitoring, increasing the demand for home-based POC diagnostic devices. This trend is likely to persist, driven by the convenience and efficiency of home-based healthcare solutions. Thus, North America's robust healthcare ecosystem, technological advancements, and supportive regulatory environment make it a crucial market for POC diagnostics.

The Asia-Pacific region is poised for significant growth in the point of care (POC) diagnostics market, driven by several key factors. The rising prevalence of chronic diseases, like diabetes and cardiovascular conditions, is a major driver. As per the International Diabetes Federation, the region has over 230 million people living with diabetes, a number expected to rise dramatically. Increased healthcare spending and the expansion of healthcare infrastructure in nations like China and India are also contributing to market growth. The region's large and aging population demands efficient and accessible healthcare solutions, making POC diagnostics highly attractive. Furthermore, increasing awareness about early disease detection and the benefits of rapid diagnostics are boosting market adoption. Governments in the region are also investing in healthcare reforms and digital health initiatives, further supporting the expansion of POC diagnostics. As a result, the Asia-Pacific region is expected to witness the highest growth rate in the global POC diagnostics market.

Segmental Analysis

The global market is bifurcated into product, mode of prescription, and end-user.

Based on product, the market is segmented into glucose monitoring kits, infectious diseases testing kits, pregnancy and fertility testing kits, hematology testing kits, cardiometabolic monitoring kits, urinalysis testing kits, cholesterol test strips, drug abuse testing kits, and others.

Glucose monitoring kits are pivotal in the product segment of the global point-of-care diagnostics market, driven by the escalating prevalence of diabetes worldwide. These kits enable continuous monitoring of blood glucose levels, which is critical for effective diabetes management. The market's expansion is fueled by factors like the growing diabetic population and the necessity for reliable, real-time glucose measurements. Patients benefit from the kits' ability to deliver rapid and precise results, empowering them to proactively manage their health. Future market growth is anticipated, propelled by ongoing technological advancements enhancing kit performance and increasing awareness about diabetes management. As such, glucose monitoring kits are poised to play a pivotal role in shaping the landscape of point-of-care diagnostics, offering essential tools for healthcare providers and patients alike.

Based on the mode of prescription, the market is segmented into prescription-based devices and OTC-based devices.

Prescription-based devices dominate the mode of prescription segment in the global point-of-care diagnostics market due to their high accuracy and reliability. These devices, which require a prescription from a qualified medical practitioner, are crucial for diagnosing diseases and medical conditions with precision. Their superiority over over-the-counter testing kits makes them the preferred choice in healthcare settings. The market for prescription-based devices is expected to expand significantly in the coming years, driven by the surging prevalence of chronic illnesses, an aging global population, and increasing healthcare costs. These devices are widely used in various healthcare facilities, including hospitals, clinics, and doctor's offices, to test patients for a range of diseases and conditions. This growth is further supported by the continuous advancements in medical technology and the surging demand for efficient and accurate diagnostic tools in the healthcare industry.

Based on end-users, the market is bifurcated into professional diagnostic centers, research laboratories, home care, and others.

The home care segment is emerging as the dominant force among the end-users of the global point-of-care diagnostics market. With a growing number of individuals suffering from chronic diseases like diabetes, cardiovascular diseases, and cancer, the demand for home care and self-testing devices has surged. These devices enable patients to effectively manage their health conditions by providing rapid and accurate results. Numerous factors contribute to the expansion of this market segment. Firstly, there is increasing awareness about the benefits of home healthcare. Patients and caregivers are recognizing the convenience and efficiency of managing health conditions from the comfort of their homes. Secondly, there is a significant rise in spending on home healthcare, driven by both individual investments and supportive healthcare policies. Lastly, the availability of user-friendly and advanced point-of-care diagnostic products plays a crucial role. These innovative devices are designed to be easy to use, making it simpler for patients to conduct self-tests and monitor their health regularly.

Impact of covid-19

COVID-19 has positive and negative market consequences, as carbon emissions have decreased globally due to the lockout. COVID-19's reduction in emissions is a short-term benefit. Still, when industries and enterprises attempt to recoup some of their financial losses in the first quarter of the year, carbon emissions will rise dramatically. COVID-19 had a negative impact on global recycling efforts. Countries, notably the United States, have halted or decreased recycling programs to focus on collecting additional domestic waste or because services have been disrupted by the virus.

Also, with industries slowly returning to normalcy following the COVID-19 outbreak, this shift in workplace health and safety is expected to increase due to mandatory social distancing and continuous personal care through sanitization to eliminate even the tiniest possibility of COVID-19 spread. COVID-19 has impacted various companies' revenues, and if the lockdown is lifted, companies will turn their attention to operations to make up for their losses.

Recent Developments

• January 2024- LumiraDx, a diagnostics business, has entered into an agreement to sell its point-of-care technology to Roche, a pharmaceutical giant, for $295 million. Additionally, Roche will provide an extra payment of $55 million to support the platform until the transaction is finalized.
• May 2024- Cipla has declared its intention to invest an additional amount of up to Rs 26 crore in Achira Labs, a firm that specializes in the production of point-of-care medical test kits.