Cholesterol Testing Products and Services Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Product (Testing Kits, Testing Strips, Others), By Test (Total Cholesterol Tests, High Density Lipoprotein (HDL) Cholesterol Tests, Low Density Lipoprotein (LDL) Cholesterol Tests, Triglyceride Tests, Others), By Age Group (Geriatric, Adult, Pediatric), By Application (Cardiovascular Diseases, Diabetes, Obesity, Hyperlipidemia, Others), By Service Providers (Hospitals and Clinics, Diagnostic Laboratories, Ambulatory Care Centers, Others), By Region, & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 20.38 Billion
CAGR (2026-2031)	8.88%
Fastest Growing Segment	Testing Kits
Largest Market	North America
Market Size (2031)	USD 33.95 Billion

Market Overview

The Global Cholesterol Testing Products & Services Market will grow from USD 20.38 Billion in 2025 to USD 33.95 Billion by 2031 at a 8.88% CAGR. The Global Cholesterol Testing Products & Services Market comprises diagnostic instruments, reagents, and test kits as well as professional laboratory services intended for the detection and management of hyperlipidemia. Key drivers facilitating growth include the rising incidence of cardiovascular conditions and an aging global demographic necessitating consistent lipid profile monitoring. Additionally, the increasing emphasis on preventive medicine fosters a sustained demand for early detection capabilities across various healthcare settings.

However, market progression is tempered by challenges such as inconsistent reimbursement structures that can restrict patient access to essential testing procedures. According to the British Heart Foundation, in 2025, approximately 7.6 million people in the United Kingdom were living with heart and circulatory diseases. This statistic highlights the substantial burden of disease requiring diagnostic intervention, yet economic constraints in healthcare funding remain a formidable obstacle to widespread product adoption.

Key Market Drivers

The rising global prevalence of cardiovascular diseases serves as the primary catalyst for the Global Cholesterol Testing Products & Services Market, necessitating frequent and accurate lipid monitoring to mitigate mortality risks. As the incidence of heart-related conditions escalates worldwide, healthcare systems are prioritizing diagnostic interventions to identify at-risk populations early. This burden is particularly evident in developed nations; according to the Centers for Disease Control and Prevention, October 2024, in the 'Heart Disease Facts' report, 919,032 people in the United States died from cardiovascular disease in 2023. This substantial mortality rate underscores the critical need for robust testing infrastructure to manage patient health effectively. Consequently, the heightened demand for diagnostic solutions is reflected in commercial performance; according to Abbott, October 2024, in the 'Third-Quarter 2024 Financial Results', global Core Laboratory Diagnostics sales increased 4.5% on an organic basis, driven by the sustained adoption of routine diagnostic testing systems.

Supportive government initiatives for routine health screenings are further propelling market expansion by actively removing barriers to preventive care and enhancing diagnostic accessibility. Public health bodies are increasingly implementing large-scale screening programs to manage long-term cardiovascular risks, thereby securing a steady volume of testing procedures. For instance, according to the National Audit Office, November 2024, in the 'Progress in preventing cardiovascular disease' report, the NHS in England has set a national ambition to prevent 150,000 heart attacks and strokes by 2029 through improved detection and management of high cholesterol and blood pressure. Such state-sponsored mandates not only validate the clinical necessity of regular lipid profiling but also incentivize the adoption of advanced testing services across community health settings, fostering a conducive environment for market growth.

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Key Market Challenges

Inconsistent reimbursement structures and economic constraints in healthcare funding represent a significant barrier to the expansion of the Global Cholesterol Testing Products & Services Market. When insurance coverage is variable or limited, patients are often required to pay out-of-pocket for routine lipid profiling, which discourages widespread participation in preventive screening programs. This financial inaccessibility directly reduces the volume of diagnostic tests administered, particularly among asymptomatic populations who might otherwise seek early detection, thereby stalling revenue generation for reagents and laboratory services.

The massive financial pressure on healthcare infrastructures further exacerbates this issue, causing payers to scrutinize and restrict spending on diagnostic procedures. According to the European Society of Cardiology, in 2024, cardiovascular disease was estimated to cost the EU economy €282 billion annually. This staggering economic burden compels health administrations to prioritize funds for acute interventions rather than preventive diagnostics. Consequently, manufacturers face a restrictive market environment where budgetary limitations and reimbursement caps hinder the procurement of testing products, directly impeding the industry's ability to sustain growth.

Key Market Trends

The expansion of Direct-to-Consumer (DTC) laboratory testing services is enabling individuals to order screenings without physician consultation, fundamentally altering patient engagement models. This shift empowers consumers to proactively manage cardiovascular health, increasing the volume of lipid panels processed outside traditional pathways. Diagnostic providers are scaling these platforms to capture health-conscious users seeking convenience. For instance, according to Quest Diagnostics, January 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company expanded its consumer-initiated platform to include approximately 135 tests, broadening access to screenings like high-risk Lipoprotein(a) cholesterol testing. This strategy diversifies laboratory revenue while stimulating demand for direct-access reagent kits.

The adoption of artificial intelligence for predictive lipid profiling is revolutionizing risk stratification by identifying high-risk patients who might otherwise remain undiagnosed. Algorithms now analyze electronic medical records to flag individuals with probable genetic lipid disorders before cardiovascular events occur. This technological integration shifts the market focus from reactive testing to proactive, data-driven surveillance. Highlighting this advancement, according to Cardiovascular Business, August 2025, in the 'Health systems use AI to target patients who may have elevated Lp(a) levels' article, the Family Heart Foundation partnered with seven large healthcare systems to utilize artificial intelligence for identifying patients with undiagnosed high lipoprotein(a) levels. This drives the utilization of confirmatory diagnostic assays.

Segmental Insights

The Testing Kits segment is the fastest-growing category in the Global Cholesterol Testing Products & Services Market, primarily driven by the increasing consumer demand for convenient preventive healthcare. This expansion is largely attributed to the shift toward at-home monitoring, which allows individuals to track lipid levels without frequent laboratory visits. As the prevalence of cardiovascular diseases rises globally, patients are prioritizing regular self-management to mitigate health risks. Furthermore, the availability of devices cleared by regulatory bodies such as the U.S. Food and Drug Administration has strengthened consumer trust, ensuring these products are viewed as reliable tools for personal health assessment.

Regional Insights

North America maintains a dominant position in the Global Cholesterol Testing Products and Services Market, primarily attributed to the growing prevalence of cardiovascular diseases and hyperlipidemia. The region benefits from a developed healthcare infrastructure that enables broad access to diagnostic services and encourages regular patient screening. Furthermore, the proactive involvement of regulatory entities such as the U.S. Food and Drug Administration ensures the consistent approval and monitoring of diagnostic devices. This supportive regulatory environment, combined with a strong emphasis on preventive healthcare and early disease management, secures North America’s leading status in the global marketplace.

Recent Developments

• In January 2025, Roche Diagnostics received FDA clearance for the Tina-quant Lipoprotein (a) Gen.2 molarity assay, marking the first FDA-cleared blood test to measure lipoprotein(a) (Lp(a)) in nanomoles per liter. This regulatory approval enables clinicians to assess Lp(a) levels with greater accuracy by eliminating the bias caused by variable particle sizes, which affects traditional mass-based measurements. The new assay supports the National Lipid Association’s recommendations for Lp(a) screening and is designed to improve cardiovascular risk assessment for patients with suspected atherosclerotic cardiovascular disease.
• In October 2024, Verichem Laboratories launched a new line of liquid-stable reference materials intended for the calibration verification of cholesterol assays in clinical laboratories. These reference materials are designed to support total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) testing on a variety of automated chemistry analyzers. The product release aimed to enhance laboratory quality assurance and regulatory compliance by providing ready-to-use, protein-based standards that mimic human serum, ensuring accurate and reliable lipid profile results for patient diagnosis and monitoring.
• In September 2024, Endless Health collaborated with the Family Heart Foundation to launch the Cholesterol Connect program, a national initiative providing free at-home lipid screening kits to the public. Through this partnership, Endless Health facilitates the distribution and processing of diagnostic kits that measure total cholesterol, LDL, HDL, triglycerides, and lipoprotein(a). The program was established to increase awareness of cardiovascular risk factors and connect individuals with elevated levels to care navigation services, addressing the underdiagnosis of lipid disorders such as familial hypercholesterolemia.
• In May 2024, Roche Diagnostics, in collaboration with Amgen, received FDA Breakthrough Device Designation for the Tina-quant lipoprotein Lp(a) RxDx assay. This designation recognized the potential of the assay to serve as a companion diagnostic for identifying patients who might benefit from emerging Lp(a)-lowering therapies currently in development. The regulatory milestone highlighted the companies' joint commitment to advancing personalized medicine in cardiovascular care by developing tools that can stratify patients based on their hereditary risk for heart disease associated with elevated Lp(a) levels.

Key Market Players

• Roche Diagnostics
• Abbott
• Siemens Healthineers
• Beckman Coulter
• Ortho Clinical Diagnostics
• Thermo Fisher Scientific
• Bio-Rad
• Danaher
• Sekisui Diagnostics
• NowDiagnostics

By Product	By Test	By Age Group	By Application	By Service Providers	By Region
Testing Kits Testing Strips Others	Total Cholesterol Tests High Density Lipoprotein (HDL) Cholesterol Tests Low Density Lipoprotein (LDL) Cholesterol Tests Triglyceride Tests Others	Geriatric Adult Pediatric	Cardiovascular Diseases Diabetes Obesity Hyperlipidemia Others	Hospitals and Clinics Diagnostic Laboratories Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cholesterol Testing Products & Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cholesterol Testing Products & Services Market, By Product:

• Testing Kits
• Testing Strips
• Others

• Cholesterol Testing Products & Services Market, By Test:

• Total Cholesterol Tests
• High Density Lipoprotein (HDL) Cholesterol Tests
• Low Density Lipoprotein (LDL) Cholesterol Tests
• Triglyceride Tests
• Others

• Cholesterol Testing Products & Services Market, By Age Group:

• Geriatric
• Adult
• Pediatric

• Cholesterol Testing Products & Services Market, By Application:

• Cardiovascular Diseases
• Diabetes
• Obesity
• Hyperlipidemia
• Others

• Cholesterol Testing Products & Services Market, By Service Providers:

• Hospitals and Clinics
• Diagnostic Laboratories
• Ambulatory Care Centers
• Others

• Cholesterol Testing Products & Services Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE