Cardiac Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Troponin, CK-MB, Myoglobin, BNP and NT-proBNP, Others), By Application (Acute Coronary Syndrome, Myocardial Infarction, Congestive Heart Failure, Others), By Region and Competition, 2019-2029F

Market Overview

Global Cardiac Biomarkers Market was valued at USD 16.31 Billion in 2023 and is anticipated to project steady growth in the forecast period with a CAGR of 7.36% through 2029. The global cardiac biomarkers market is experiencing dynamic growth, driven by advancements in healthcare diagnostics, increasing prevalence of cardiovascular diseases (CVDs), and the growing emphasis on early disease detection and personalized medicine. Cardiac biomarkers, crucial indicators measured in blood or urine, provide valuable insights into the heart's health status, aiding in diagnosis, risk stratification, and treatment monitoring.

Cardiac biomarkers are proteins, enzymes, hormones, or other molecules released into the bloodstream in response to cardiac stress, injury, or dysfunction. These biomarkers serve as sensitive indicators of myocardial damage, inflammation, ischemia, and other cardiovascular conditions. Widely used biomarkers include troponin, B-type natriuretic peptide (BNP), creatine kinase (CK-MB), and myoglobin, each offering unique diagnostic capabilities depending on the clinical context.

CVDs, including coronary artery disease, heart failure, and myocardial infarction, remain leading causes of morbidity and mortality worldwide. The rising incidence of these conditions underscores the critical need for effective diagnostic tools like cardiac biomarkers to facilitate early intervention and improve patient outcomes.

Innovations in immunoassay and molecular diagnostics have enhanced the sensitivity, specificity, and multiplexing capabilities of cardiac biomarker tests. High-sensitivity assays enable the detection of biomarkers at lower concentrations, improving diagnostic accuracy and clinical utility. Increasing focus on personalized healthcare drives the demand for biomarker-based diagnostics that enable tailored treatment strategies based on individual patient profiles. Biomarker panels aid in risk assessment, treatment selection, and therapeutic monitoring, fostering a more targeted approach to cardiac care.

Despite significant growth prospects, the global cardiac biomarkers market faces challenges such as stringent regulatory requirements, reimbursement issues, and variability in biomarker expression among patient populations. Addressing these challenges requires ongoing investment in research and development, clinical validation studies, and collaboration with regulatory authorities to ensure compliance and market access.

Key Market Drivers

Increasing Incidence of Cardiovascular Diseases

Cardiovascular diseases encompass a range of conditions affecting the heart and blood vessels, including coronary artery disease, heart failure, stroke, and hypertension. The escalating prevalence of cardiovascular diseases worldwide drives the demand for cardiac biomarkers as essential tools for disease management and patient care. Biomarker testing aids in early diagnosis, which is crucial for improving treatment outcomes and reducing healthcare costs associated with advanced disease stages.

According to statistics released by the World Health Organization in June 2021, Cardiovascular diseases (CVDs) stand as the primary cause of death worldwide. In 2019, approximately 17.9 million individuals succumbed to CVDs, accounting for 32% of global mortality. Of these fatalities, 85% were attributed to heart attacks and strokes. The vast majority of CVD-related deaths, more than three quarters, occur in low- and middle-income countries. Among the 17 million premature deaths due to noncommunicable diseases in 2019, 38% were linked to CVDs. Many cardiovascular diseases are preventable through addressing behavioral and environmental risk factors such as tobacco use, unhealthy diet, obesity, physical inactivity, excessive alcohol consumption, and air pollution. Early detection of cardiovascular disease is crucial to initiate timely management through counseling and medication.

Technological advancements in assay development, including high-sensitivity assays and point-of-care testing, enhance the accuracy, sensitivity, and speed of biomarker detection. These innovations enable clinicians to obtain rapid and reliable diagnostic results, facilitating prompt clinical decision-making.

There is a growing emphasis on personalized medicine approaches tailored to individual patient profiles. Cardiac biomarkers provide valuable information for risk assessment, treatment selection, and monitoring response to therapy, supporting personalized treatment strategies and improving patient outcomes.

Rising Healthcare Expenditure

Healthcare expenditure refers to the total amount of money spent on healthcare goods and services, including medical treatments, diagnostic tests, pharmaceuticals, and hospital care. Globally, healthcare spending has been on the rise, driven by factors such as population aging, the burden of chronic diseases, technological advancements, and improving access to healthcare services.

Cardiovascular diseases (CVDs) are among the leading causes of mortality and morbidity worldwide. As healthcare expenditures increase, there is a heightened focus on preventing, diagnosing, and managing cardiovascular conditions effectively. Cardiovascular health initiatives and disease management programs benefit from increased funding, enabling healthcare providers to adopt advanced diagnostic tools and biomarker testing for early detection and personalized treatment strategies.

Advancements in diagnostic technologies have transformed cardiac biomarker testing, enhancing its accuracy, efficiency, and clinical utility. High-sensitivity assays and point-of-care testing have streamlined biomarker detection, enabling rapid results and informed clinical decision-making. These technological innovations are supported by increased healthcare spending, which drives research and development in biomarker discovery, validation, and commercialization.

The growth in healthcare expenditure contributes to the expansion of the global cardiac biomarkers market by expanding access to advanced healthcare services and diagnostic tools. Developed economies with robust healthcare infrastructures lead in adopting new biomarker technologies, while emerging markets benefit from healthcare investments aimed at improving healthcare access and quality. This global accessibility fosters market growth by broadening the adoption of biomarker testing across diverse healthcare settings and patient populations.

Regulatory agencies play a crucial role in ensuring the safety, efficacy, and quality of cardiac biomarker tests. As healthcare expenditure increases, regulatory frameworks evolve to establish standardized guidelines for biomarker testing, ensuring consistency in diagnostic practices and results interpretation. Compliance with regulatory standards enhances market confidence and facilitates market entry for new biomarker technologies, driving innovation and market competitiveness.

Key Market Challenges

Patient Awareness and Compliance

Patient awareness and compliance play pivotal roles in the effective utilization of cardiac biomarkers, yet they present significant challenges in the global healthcare landscape. As advancements in medical diagnostics continue to evolve, understanding and addressing these challenges are crucial for maximizing the clinical utility and impact of cardiac biomarkers in managing cardiovascular diseases.

Patient awareness regarding cardiac biomarkers encompasses understanding their role in disease detection, monitoring, and treatment decision-making. Many patients may not be familiar with biomarkers such as troponin, B-type natriuretic peptide (BNP), or C-reactive protein (CRP), which are crucial indicators of heart health. Awareness gaps can lead to delayed testing, misinterpretation of symptoms, and suboptimal disease management strategies.

Educational initiatives are essential to bridge these gaps, empowering patients to recognize the significance of biomarker testing in cardiovascular health. Healthcare providers play a pivotal role in patient education, explaining the relevance of biomarkers in assessing cardiac risk, diagnosing conditions like myocardial infarction or heart failure, and guiding treatment interventions.

Patient compliance with biomarker testing recommendations is influenced by various factors, including perceived necessity, convenience, cost, and emotional factors. For instance, asymptomatic individuals or those with mild symptoms may underestimate the urgency of biomarker testing, potentially delaying diagnosis and treatment initiation. Moreover, logistical challenges such as scheduling appointments, accessing testing facilities, and financial considerations can deter patients from undergoing timely biomarker assessments.

The lack of patient awareness and non-compliance with biomarker testing recommendations can compromise diagnostic efficacy and treatment outcomes in cardiovascular care. Delayed or missed diagnoses may lead to progression of cardiovascular diseases, increased healthcare costs, and poorer patient outcomes. Conversely, early detection facilitated by biomarker testing enables prompt intervention and personalized treatment strategies, significantly improving prognosis and quality of life.

Healthcare providers should implement comprehensive educational programs to enhance patient understanding of cardiac biomarkers, their clinical significance, and the benefits of early diagnosis. Clear communication of test results and their implications is crucial for fostering patient engagement.

Incorporating biomarker testing into integrated care pathways promotes standardized protocols for cardiovascular disease management. Seamless coordination between primary care providers, specialists, and diagnostic laboratories facilitates timely testing and treatment initiation.

Tailoring communication strategies to individual patient preferences and health literacy levels enhances comprehension and promotes informed decision-making regarding biomarker testing. Engaging patients as partners in their healthcare journey fosters a collaborative approach to disease management.

Key Market Trends

Expansion of Point-of-Care Testing

Cardiac biomarkers play a crucial role in the early detection, diagnosis, and monitoring of cardiovascular conditions, such as myocardial infarction (heart attack) and heart failure. Traditionally, biomarker testing required samples to be sent to centralized laboratories, resulting in delays in diagnosis and treatment initiation. The expansion of POCT addresses these challenges by bringing diagnostic capabilities closer to the patient, often within clinical settings like emergency departments, ambulatory care centers, and physician offices.

The adoption of POCT for cardiac biomarkers offers several strategic advantages. It enables healthcare providers to obtain test results rapidly, typically within minutes, facilitating prompt decision-making and timely interventions. This immediacy is critical in emergency situations where every minute counts in determining the appropriate course of treatment.

In February 2019, Government Medical College, Thiruvananthapuram, acquired a state-of-the-art Point of Care (POC) system designed to facilitate early identification of suspected acute myocardial infarction (heart attack) using blood tests. The newly installed POC device, cobas h 232, is now operational at the HDS lab at MCH. It enables rapid detection and diagnosis of heart attacks by assessing cardiac biomarkers including Troponin T, NT-proBNP, D-dimer, CK-MB, and Myoglobin in blood, providing results within 14 minutes.

POCT reduces the logistical complexities associated with sample transportation and processing times, thereby streamlining workflow efficiencies within healthcare facilities. This streamlined process not only enhances patient care but also contributes to cost savings by minimizing unnecessary hospital admissions and reducing overall healthcare expenditures.

Technological advancements have been pivotal in driving the expansion of POCT for cardiac biomarkers. Innovations in assay sensitivity and specificity have led to the development of highly accurate and reliable testing platforms that can deliver precise results even at the point of care. These advancements include the miniaturization of testing devices, integration of automated processes, and improvements in data connectivity for seamless result reporting and integration into electronic health records (EHRs).

The global market for cardiac biomarkers is poised for continued growth, fueled by the increasing prevalence of cardiovascular diseases worldwide and the ongoing shift towards personalized medicine. Regulatory support and guidelines endorsing the use of biomarkers in clinical practice further bolster market expansion. Strategic collaborations between healthcare providers, diagnostic companies, and technology developers are also expected to drive innovation and market penetration of POCT solutions.

Segmental Insights

Type Insights

Based on Type, BNP and NT-proBNP have emerged as the fastest growing segment in the Global Cardiac Biomarkers Market in 2023. BNP and NT-proBNP are peptides secreted by the heart in response to increased cardiac wall stress, particularly in conditions like heart failure. Elevated levels of these biomarkers in the blood indicate myocardial strain and are indicative of heart failure severity. They are instrumental in diagnosing heart failure, distinguishing it from other causes of dyspnea (difficulty breathing), and guiding treatment decisions.

BNP and NT-proBNP are used for risk stratification and prognosis assessment in patients with acute coronary syndromes and chronic heart conditions. Their ability to predict adverse cardiovascular events, such as myocardial infarction and cardiovascular mortality, enhances their clinical utility and adoption in routine practice.

Advancements in assay technologies have improved the sensitivity, specificity, and reliability of BNP and NT-proBNP tests, making them more accessible and cost-effective for healthcare providers. Point-of-care testing and high-sensitivity assays enable rapid and accurate measurement of these biomarkers, facilitating timely clinical decision-making and patient management.

Application Insights

Based on Application, Acute Coronary Syndrome have emerged as the dominating segment in the Global Cardiac Biomarkers Market during the forecast period. ACS encompasses a spectrum of conditions ranging from unstable angina to myocardial infarction (heart attack), all of which pose substantial risks to cardiovascular health. Globally, ACS is a leading cause of morbidity and mortality, necessitating urgent medical intervention to prevent irreversible damage to the heart muscle. The prevalence of ACS continues to rise due to aging populations, sedentary lifestyles, and increasing incidence of risk factors such as hypertension, diabetes, and obesity.

Diagnosing ACS promptly is crucial for initiating timely treatments that can mitigate cardiac damage and improve patient outcomes. Cardiac biomarkers play a pivotal role in the diagnostic pathway by providing objective measurements of myocardial injury or stress. Biomarkers such as troponin, CK-MB (creatine kinase-MB), and B-type natriuretic peptide (BNP) are widely utilized to assess cardiac damage, risk stratify patients, and guide clinical decision-making in ACS management.

Advancements in biomarker testing technologies, particularly high-sensitivity assays, have revolutionized ACS diagnosis by enhancing the sensitivity and specificity of biomarker detection. High-sensitivity troponin assays, for example, can detect minute elevations in troponin levels, enabling earlier identification of myocardial injury and more accurate risk assessment for adverse cardiac events. These technological innovations support faster triaging of patients in emergency departments and facilitate personalized treatment strategies tailored to individual patient needs.

ACS exerts a significant economic burden on healthcare systems worldwide due to the high costs associated with hospitalization, emergency care, and long-term management of cardiovascular complications. The adoption of effective biomarker testing protocols in ACS diagnosis helps optimize resource utilization, improve patient flow, and reduce healthcare costs by minimizing unnecessary admissions and expediently addressing critical cardiac conditions.

Regional Insights

Based on Region, North America have emerged as the dominating region in the Global Cardiac Biomarkers Market in 2023. North America benefits from a robust healthcare infrastructure and extensive research capabilities, particularly in the field of cardiovascular medicine. The region is home to renowned medical institutions, research universities, and biotechnology companies that drive continuous innovation in biomarker discovery, validation, and clinical application. These institutions leverage state-of-the-art technologies and collaborative research networks to accelerate the development and commercialization of novel cardiac biomarkers.

North America has historically been an early adopter of technological innovations in healthcare, including cardiac biomarker assays and diagnostic platforms. The region's healthcare providers and laboratories embrace cutting-edge technologies such as high-sensitivity assays, point-of-care testing devices, and digital health solutions that enhance the accuracy, efficiency, and accessibility of biomarker testing. This proactive approach positions North America at the forefront of cardiovascular diagnostics globally.

Collaborative partnerships between academia, industry, and government entities in North America foster synergies in biomarker research and development. These partnerships facilitate interdisciplinary collaborations, clinical trials, and regulatory advancements, accelerating the translation of biomarker discoveries from bench to bedside. Strategic alliances with global pharmaceutical companies and diagnostic manufacturers further amplify North America's capabilities in commercializing innovative biomarker-based diagnostics.

North America benefits from a well-established regulatory framework and clear reimbursement policies that support the adoption and commercialization of cardiac biomarkers. Regulatory agencies such as the FDA (Food and Drug Administration) in the United States ensure rigorous evaluation of biomarker assays for safety, efficacy, and clinical utility. Clear reimbursement pathways through public and private healthcare systems incentivize investment in biomarker development and facilitate market access for innovative diagnostic products.

North America's leadership in the global cardiac biomarkers market extends beyond domestic consumption to influence international trends and standards. The region serves as a pivotal market for global biomarker manufacturers and diagnostic companies, setting benchmarks for product innovation, quality assurance, and regulatory compliance. Market dynamics such as mergers, acquisitions, and strategic investments further consolidate North America's position as a hub of biomarker development and commercialization.

Recent Development

• In March 2024, the U.S. Food and DrugAdministration approved a new indication for Wegovy (semaglutide) injection.This approval allows Wegovy to be used to reduce the risk of cardiovasculardeath, heart attack, and stroke in adults diagnosed with cardiovascular diseaseand either obesity or overweight. It is recommended that Wegovy be usedalongside a reduced calorie diet and increased physical activity.Cardiovascular disease encompasses a range of conditions affecting the heartand blood vessels. Wegovy contains semaglutide, a glucagon-like peptide-1(GLP-1) receptor agonist, and should therefore not be administered concurrentlywith other semaglutide-containing products or other GLP-1 receptor agonists.

Key Market Players

• Abbott Laboratories Inc.           
• QuidelOrthoCorporation
• SiemensHealthineers AG
• F.Hoffmann-La Roche Ltd
• DanaherCorporation
• Bio-RadLaboratories, Inc.
• RandoxLaboratories Ltd.
• CreativeDiagnostics
• LifeDiagnostics Inc.
• BIOMÉRIEUXInc.