Point of Care Lipid Test Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Instruments, Consumables), By Application (Hyperlipidemia, Hypertriglyceridemia, Tangier Disease, Hyperlipoproteinemia, Familial Hypercholesterolemia, Others), By Disease Indication (Lipid and Lipoprotein Disorders, Atherosclerosis, Liver and Renal Diseases, Diabetes Mellitus, Others), By End User (Hospitals, Clinics, Research and Diagnostic Laboratories, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Point of Care Lipid Test Market was valued at USD 735.61 Million in 2024 and is expected to reach USD 1072.48 Million by 2030 with a CAGR of 6.46%. The Global Point of Care Lipid Test Market is witnessing steady expansion, fueled by the increasing burden of cardiovascular diseases and a growing emphasis on early detection of lipid abnormalities. Point-of-care (POC) lipid testing offers quick, accurate, and convenient diagnostic results, enabling timely clinical decisions and intervention, particularly in primary care settings and emergency departments. Rising healthcare awareness and a shift toward preventive health screenings have accelerated the demand for lipid tests that can deliver immediate insights. These devices are gaining traction among physicians and patients alike for their ability to facilitate personalized treatment approaches and improve patient compliance. The integration of lipid testing in community pharmacies and mobile clinics is also contributing to higher accessibility and market growth.

Key trends transforming the market include the rapid development of handheld and user-friendly lipid analyzers equipped with Bluetooth and cloud-based data transmission capabilities. These features support better monitoring, electronic medical record integration, and remote patient management. Manufacturers are focusing on enhancing the accuracy, speed, and ease-of-use of lipid test devices, catering to both clinical professionals and home users. There is a rising preference for multi-analyte systems that can test for lipids, glucose, and other biomarkers simultaneously, saving time and reducing the need for multiple devices. The increasing adoption of decentralized diagnostic models and value-based care frameworks is further propelling the use of POC lipid testing solutions.

Despite the growth momentum, the market faces several challenges that could limit adoption. One key hurdle is the limited accuracy and sensitivity of certain POC lipid tests compared to central laboratory methods, leading to hesitancy among some healthcare providers. Regulatory requirements and reimbursement disparities across different healthcare systems present another barrier, especially for smaller market entrants. Cost constraints in low- and middle-income countries and limited awareness of POC diagnostic benefits among both providers and patients continue to restrict market penetration. These challenges require coordinated efforts in terms of innovation, clinical validation, and health policy alignment to fully unlock the potential of point-of-care lipid testing technologies.

Key Market Drivers

Rising Prevalence of Cardiovascular Diseases and Dyslipidemia

The rising prevalence of cardiovascular diseases (CVDs) and dyslipidemia has become a critical driver for the Global Point of Care (POC) Lipid Test Market. Cardiovascular conditions such as coronary artery disease, hypertension, and stroke remain leading causes of death worldwide. Dyslipidemia, characterized by elevated low-density lipoprotein (LDL) cholesterol or triglycerides, significantly increases cardiovascular risk. In the United States, nearly 12% of adults had high total cholesterol in 2020, with more than 38% showing borderline or elevated levels that necessitate regular monitoring. These alarming figures highlight a growing need for accessible and efficient lipid testing solutions.

Point-of-care lipid testing addresses this need by offering immediate results without the delays associated with central laboratories. In primary care clinics, outpatient facilities, and community screening events, patients receive real-time feedback on lipid levels, enabling clinicians to initiate therapeutic interventions such as statins or lifestyle counselling during the same visit. This capability supports improved patient compliance and better management of cardiovascular risk factors. Public health initiatives aimed at reducing heart disease have further boosted POC test adoption. For example, government-funded screening programs in rural and underserved areas now routinely incorporate rapid lipid testing to enhance early detection and management of dyslipidemia.

Healthcare expenditure trends also reflect this shift toward preventive care: nations are investing more in early-detection tools that curb long-term costs associated with hospitalizations and chronic disease complications. In response, POC lipid testing devices have evolved with improved accuracy and user-friendly designs, often integrating with mobile and cloud-based health systems. This evolution aligns with global goals to reduce the burden of non-communicable diseases by promoting routine health checks. As sedentary behavior, poor nutrition, and obesity continue their upward trajectories, the role of rapid, decentralized lipid testing becomes more central to public health strategies. This combination of epidemiological trends, technological readiness, and policy support positions the Global POC Lipid Test Market for sustained growth over the next decade.

Technological Advancements in Point-of-Care Testing Devices

Technological advancements in point-of-care (POC) testing devices are playing a pivotal role in driving the growth of the Global Point of Care Lipid Test Market. New-generation POC lipid analyzers are increasingly compact, intuitive, and capable of delivering rapid, lab-quality results at the patient’s bedside. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 39% of American adults around 95 million people had elevated total cholesterol levels in 2020–2021, highlighting a significant unmet need for accessible diagnostic tools. Enhanced by microfluidic systems, biosensors, and real-time analytics, modern testers enable efficient lipid profiling and immediate intervention in settings such as clinics, emergency departments, and remote health outposts.

Integration of Bluetooth and cloud-enabled data connectivity ensures seamless transfer of lipid readings to electronic health records, supporting coordinated treatment plans and patient monitoring. Manufacturers are also pushing the development of devices that can perform simultaneous tests such as LDL, HDL, and triglycerides, streamlining diagnostics and improving clinical workflow. Ongoing miniaturization efforts are creating devices suitable for home use and telehealth platforms, thereby expanding reach into underserved populations with limited lab infrastructure. Regulatory agencies are increasingly facilitating accelerated reviews for validated POC technologies, helping to fast-track integration into clinical practice.

This convergence of precision diagnostics and digital health not only enhances patient engagement but also empowers clinicians to manage dyslipidemia more proactively, supporting public health goals. With rising chronic disease burdens and growing demand for personalized care, investment in advanced POC lipid testing solutions is expected to remain strong, reshaping standards in cardiovascular health management.

Rising Geriatric Population and Lifestyle-Related Risk Factors

The Global Point of Care Lipid Test Market is experiencing strong growth driven by the expanding geriatric population and an uptick in lifestyle-related risk factors, particularly poor diet, sedentary habits, and obesity. These elements contribute to a higher incidence of dyslipidemia among older adults, who require frequent lipid monitoring to manage conditions like hyperlipidemia and atherosclerosis. According to recent data from the U.S. National Center for Health Statistics, approximately 11.2% of adults aged 20 and older had high total cholesterol (≥240 mg/dL), and around 14.2% had low high-density lipoprotein (HDL) cholesterol as of August 2021–August 2023.

Furthermore, 25.5% of U.S. adults recorded low-density lipoprotein cholesterol (LDL) levels of 130 mg/dL or higher between 2017 and 2020. These trends highlight the critical need for accessible, rapid lipid testing solutions capable of supporting regular monitoring among at-risk individuals.

Point-of-care (POC) lipid test devices are increasingly filling this clinical gap, offering rapid results in a matter of minutes at the location of patient care whether in clinics, pharmacies, or home settings. Older patients often benefit from these decentralized testing strategies, which reduce the need for frequent laboratory visits. This convenience supports better patient compliance and enables timely treatment decisions, such as initiating statin therapy or lifestyle interventions. Additionally, younger individuals affected by lifestyle-related risk factors are turning to POC testing for early detection, empowering both individuals and healthcare providers to take proactive steps against cardiovascular disease.

Manufacturers are addressing the demand by enhancing device accuracy, usability, and integration with digital health platforms. Modern POC lipid analyzers now feature user-friendly interfaces and require minimal training, making them suitable for diverse settings. Cloud connectivity enables seamless data sharing, remote monitoring, and integration into electronic health records, improving patient management. The convergence of demographic trends aging populations at higher risk for dyslipidemia and the rise of unhealthy lifestyle patterns in younger cohorts is shaping a favorable landscape for the POC lipid testing market. These products help bridge diagnostic gaps, bringing cholesterol screening directly to patients and supporting broader preventive health strategies.

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Key Market Challenges

Concerns Regarding Accuracy and Reliability

Concerns regarding the accuracy and reliability of point-of-care (POC) lipid tests represent a significant challenge in the global market. While POC testing offers convenience and rapid results, skepticism remains among healthcare professionals regarding its diagnostic precision compared to centralized laboratory methods. Inconsistent calibration, environmental sensitivity, and operator-dependent variability can affect test performance, leading to inaccurate readings. This uncertainty in results can impact critical clinical decisions, especially in cardiovascular risk assessment where precise lipid measurements are vital. Variability in device sensitivity and specificity, particularly when used outside of controlled clinical environments, also raises concerns among physicians and regulatory authorities. Inaccurate lipid profiles may result in underdiagnosis or overtreatment, undermining patient trust and the overall utility of the technology.

Quality control remains another hurdle, as not all devices meet rigorous international standards. While some point-of-care lipid testing systems have gained regulatory approval, others face scrutiny due to inconsistent manufacturing practices or a lack of transparent validation data. This situation has led to hesitancy in widespread adoption by hospitals, primary care physicians, and pharmacies. The challenge is further amplified in low-resource settings where lack of trained personnel and infrastructure hampers proper device usage, increasing the risk of erroneous results. Addressing these concerns will require stronger regulatory oversight, standardized quality benchmarks, user training initiatives, and continued innovation to bridge the performance gap between POC devices and traditional lab-based diagnostics.

Regulatory and Reimbursement Hurdles

Regulatory and reimbursement hurdles pose a significant challenge to the growth of the Global Point of Care (POC) Lipid Test Market. Securing regulatory approval for POC lipid testing devices involves stringent and often time-consuming evaluations by health authorities such as the U.S. FDA, the European Medicines Agency (EMA), and other regional bodies. These processes require extensive clinical validation data, performance benchmarks, and safety assurances to prove device reliability across varied healthcare settings. For smaller companies or startups, meeting these regulatory requirements can be cost-prohibitive, delaying market entry or limiting geographical expansion. Even when regulatory clearance is achieved, continuous compliance with evolving standards adds to the operational burden, especially when integrating new features like wireless connectivity or cloud-based data storage.

Reimbursement remains a complex issue that limits the accessibility and widespread adoption of POC lipid testing. In many healthcare systems, especially in low- and middle-income countries, reimbursement policies are not yet aligned with the pace of innovation in diagnostic technologies. Inconsistent or low reimbursement rates can disincentivize clinics and diagnostic centers from adopting newer, potentially more expensive POC devices, despite their long-term clinical and economic benefits. Insurance coverage policies vary significantly across markets, and some payers still prioritize traditional laboratory testing over decentralized, rapid diagnostics. These gaps in reimbursement frameworks contribute to a fragmented market landscape and slow the adoption of POC lipid tests in primary care and home-testing environments.

Key Market Trends

Integration of Digital Health Technologies

The Global Point of Care (POC) Lipid Test Market is experiencing a significant transformation with the integration of digital health technologies, reshaping the way lipid disorders are diagnosed and managed. Digital connectivity in POC lipid testing devices enables seamless transfer of patient data to electronic health records (EHRs), allowing clinicians to access real-time lipid profiles and make more informed decisions during patient consultations. This digital integration enhances workflow efficiency in clinical settings and supports better patient outcomes through continuous monitoring and follow-up care. Cloud-based platforms linked with POC lipid testing devices offer centralized data storage, analytics, and remote access, enabling healthcare providers to detect trends, predict risks, and implement timely interventions.

Smartphone-compatible testing devices and mobile health (mHealth) applications are also playing a critical role in personalizing lipid management. These technologies empower patients to monitor cholesterol levels at home, track medication adherence, receive lifestyle recommendations, and share data with healthcare professionals in real time. This patient-centric approach not only improves engagement but also supports long-term disease management. The adoption of artificial intelligence (AI) and machine learning (ML) in interpreting lipid test results is further enhancing diagnostic accuracy by minimizing human error and identifying subtle risk patterns. As health systems continue to prioritize value-based care and preventive strategies, the integration of digital health tools into POC lipid testing is becoming a key differentiator, fostering more connected, accessible, and proactive healthcare delivery.

Rising Demand for Multiplex Testing Devices

The Global Point of Care (POC) Lipid Test Market is witnessing a notable trend toward the adoption of multiplex testing devices, which allow for the simultaneous analysis of multiple biomarkers from a single patient sample. This shift is largely driven by the increasing need for efficient, accurate, and time-saving diagnostic tools in clinical and decentralized healthcare settings. Multiplex testing devices offer significant benefits to both clinicians and patients by reducing turnaround time, minimizing the need for repeat blood draws, and enabling comprehensive health assessments during a single consultation. This capability is particularly important for lipid testing, where monitoring of multiple parameters such as total cholesterol, HDL, LDL, and triglycerides is essential for accurate cardiovascular risk assessment.

Healthcare providers are increasingly adopting these multifunctional platforms to manage chronic conditions such as diabetes, hypertension, and metabolic syndrome, which often require ongoing lipid monitoring. Multiplex devices are proving especially valuable in primary care clinics, emergency departments, and rural healthcare centers where access to centralized labs is limited. The convenience and efficiency of these platforms align with global healthcare goals to streamline diagnostics and personalize treatment strategies. The rise in preventive health checkups, coupled with growing awareness among consumers about lipid-related disorders, is accelerating the demand for such advanced diagnostic solutions across both developed and developing economies.

Segmental Insights

Product Insights

Based on the Product, Consumables emerged as the dominant segment in the Global Point of Care Lipid Test Market in 2024. This is driven by their recurring demand and essential role in diagnostic procedures. Consumables such as test strips, cartridges, lancets, and reagents are integral to the daily operations of POC testing. These products are designed for single-use applications, ensuring accurate and hygienic testing environments, which directly supports their continuous consumption across healthcare facilities, diagnostic centers, and home testing setups. With increasing patient awareness and routine lipid monitoring becoming a standard part of preventive healthcare, the frequency of testing has surged, consequently boosting the consumption of these materials. Moreover, advancements in consumable design, including improved accuracy, faster reaction times, and ease of use, have enhanced the efficiency of point-of-care testing.

Application Insights

Based on the Application, Hyperlipidemia emerged as the dominant segment in the Global Point of Care Lipid Test Market in 2024. This is due to several key factors. Hyperlipidemia, characterized by elevated levels of cholesterol and triglycerides, is a major risk factor for cardiovascular diseases (CVDs), which remain the leading cause of mortality worldwide. The increasing prevalence of hyperlipidemia, driven by sedentary lifestyles, poor dietary habits, and rising obesity rates, has heightened the demand for rapid and accurate lipid testing. POC lipid tests offer immediate results, enabling healthcare providers to diagnose and manage hyperlipidemia efficiently, particularly in outpatient and primary care settings. The convenience and speed of POC testing facilitate timely interventions, such as lifestyle modifications or statin therapy, reducing the risk of CVD complications. Additionally, growing awareness about preventive healthcare and regular lipid monitoring has further boosted adoption.

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Regional Insights

North America emerged as the dominant region in the Global Point of Care Lipid Test Market in 2024. This is driven by advanced healthcare infrastructure, high prevalence of cardiovascular diseases (CVDs), and strong adoption of rapid diagnostic technologies. The U.S. and Canada have a significant burden of hyperlipidemia and obesity, key risk factors for CVDs, fueling demand for convenient lipid testing solutions. The region’s leadership is also attributed to favorable reimbursement policies, widespread availability of POC devices, and increasing emphasis on preventive healthcare. Government initiatives, such as the National Cholesterol Education Program (NCEP) in the U.S., promote routine lipid screening, boosting POC test adoption in clinics, pharmacies, and homecare settings.

Asia-Pacific emerged as the fastest growing region in the Global Point of Care Lipid Test Market during the forecast period. This is driven by a combination of demographic, economic, and healthcare factors. The region is experiencing a rapid rise in cardiovascular diseases (CVDs) due to urbanization, sedentary lifestyles, and dietary shifts toward high-fat, processed foods. Countries like China, India, and Japan are witnessing an alarming increase in hyperlipidemia and diabetes, creating a pressing need for accessible and rapid diagnostic solutions. Governments and healthcare providers are increasingly prioritizing early detection and management of lipid disorders to curb the growing CVD burden. Additionally, the expansion of healthcare infrastructure in emerging economies, along with rising disposable incomes, has made POC lipid testing more affordable and accessible. The proliferation of private diagnostic centers and the adoption of digital health technologies further accelerated market growth, enabling remote and decentralized testing in rural and underserved areas.

Recent Developments

• In February 2025, the U.S. Food and Drug Administration approved Ctexli (chenodiol) as the first treatment for cerebrotendinous xanthomatosis (CTX), a rare genetic lipid storage disorder. CTX results from a CYP27A1 gene mutation, leading to impaired cholesterol breakdown and harmful cholesterol metabolite buildup in tissues such as the brain, liver, and tendons. Ctexli addresses this by restoring bile acid levels, helping reduce these abnormal deposits.
• In August 2024, VION Biosciences, a life science platform backed by Iron Path Capital, acquired Echelon Biosciences, a Salt Lake City-based supplier of lipid-based excipients critical for mRNA-based therapies. This marks VION’s second strategic acquisition and strengthens its capabilities from drug discovery to manufacturing. The move enables VION to expand its portfolio and better support mRNA-based vaccines and gene therapies through Echelon’s expertise in lipid synthesis and nanoparticle engineering.
• In July 2024, Roche successfully completed the acquisition of LumiraDx’s Point-of-Care (POC) technology assets, a strategic move aimed at strengthening its global diagnostics portfolio and expanding its presence in decentralized healthcare settings. The acquisition includes LumiraDx’s next-generation diagnostic platform, known for its ability to perform a broad range of immunoassay and clinical chemistry tests on a compact, single device. The platform is designed to deliver lab-quality results within minutes, making it highly suitable for use in primary care clinics, emergency rooms, and remote settings.
• In December 2023, BD (Becton, Dickinson and Company) received FDA 510(k) clearance for its BD MiniDraw Capillary Blood Collection System, a less invasive device that collects lab-quality blood samples from a fingerstick. Designed to eliminate the need for traditional venous draws, the system enables convenient blood collection by trained healthcare workers in non-traditional settings such as retail pharmacies. The innovation aims to enhance patient comfort and broaden access to diagnostic testing.
• In January 2023, Cipla Limited, a leading Indian pharmaceutical and healthcare company, announced the launch of Cippoint, a state-of-the-art point-of-care testing device. The device is engineered to deliver rapid and accurate diagnostic results across multiple health conditions, including cardiometabolic disorders, infectious diseases, and inflammatory markers. Cippoint represents Cipla’s commitment to broadening access to quality diagnostics, especially in resource-limited settings.
• In January 2023, Bruker Corporation acquired ACQUIFER Imaging GmbH to strengthen its capabilities in big-data management for bioimaging and high-content microscopy. The acquisition enhances Bruker’s advanced fluorescence microscopy portfolio by integrating ACQUIFER’s HIVE systems for high-speed data processing and scalable storage, along with the IM04 automated imaging platform for phenotypic screening.

Key Market Players

• Callegari Srl
• Sinocare Inc.
• Abbott Laboratories
• MiCoBio
• Nova Biomedical
• VivaChek Biotech (Hangzhou) Co., Ltd.
• F. Hoffmann-La Roche Ltd.
• Menarini Group
• SD Biosensor, Inc.
• Becton, Dickinson and Company

Report Scope:

In this report, the Global Point of Care Lipid Test Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Point of Care Lipid Test Market, By Product:

o   Instruments

o   Consumables

• Point of Care Lipid Test Market, By Application:

o   Hyperlipidemia

o   Hypertriglyceridemia

o   Tangier Disease

o   Hyperlipoproteinemia

o   Familial Hypercholesterolemia

o   Others

• Point of Care Lipid Test Market, By Disease Indication:

o   Lipid and Lipoprotein Disorders

o   Atherosclerosis

o   Liver and Renal Diseases

o   Diabetes Mellitus

o   Others

• Point of Care Lipid Test Market, By End User:

o   Hospitals

o   Clinics

o   Research and Diagnostic Laboratories

o   Others

• Point of Care Lipid Test Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Point of Care Lipid Test Market.

Available Customizations:

Global Point of Care Lipid Test Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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