CARDIAC BIOMARKERS MARKET ANALYSIS

Market Size and Trends

The global cardiac biomarkers market is estimated to be valued at USD 15.10 Bn in 2024 and is expected to reach USD 36.30 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 13.3% from 2024 to 2031.

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The increasing prevalence of cardiovascular diseases and the growing demand for point-of-care testing are the major factors contributing to the market growth. The market is witnessing various trends such as increased adoption of high sensitivity troponin tests and launch of novel cardiac biomarkers by key players. Moreover, rising investments by public and private players to develop innovative biomarkers with high sensitivity and specificity for accurate detection of acute myocardial infarction and other heart conditions are expected to offer lucrative opportunities for the market players over the forecast period.

Rising Burden of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases is one of the major drivers of growth in the cardiac biomarkers market. Cardiovascular diseases have become one of the leading causes of mortality globally. According to the World Health Organization, cardiovascular diseases account for over 17 million deaths each year, which is estimated to grow to over 23.6 million by 2030. The key factors responsible for the rising cardiovascular disease burden include rapidly aging populations, increasing adoption of sedentary lifestyles and unhealthy diets, rising stress levels, smoking, and a growing prevalence of conditions like obesity and diabetes. With cardiovascular diseases posing such a huge threat to public health and economies, focus on early detection, diagnosis, and management of these conditions has increased substantially. Cardiac biomarkers have emerged as vital tools supporting clinicians in making critical treatment decisions, such as confirming or ruling out occurrences of heart attacks. The widespread application of cardiac biomarkers in clinical practice for evaluating patients with signs and symptoms of acute coronary syndrome is boosting the market growth. For instance, according to data from the British Heart Foundation released in January 2022, the most prevalent heart conditions globally in 2021 included coronary heart disease (affecting 200 million), peripheral arterial disease (110 million), stroke (100 million), and atrial fibrillation (60 million). Regional variations were noted, with North America reporting 46 million cases, Europe 99 million, Africa 58 million, South America 32 million, and Asia/Australia 310 million. This widespread prevalence is expected to increase the demand for early detection and treatment, potentially broadening the market's scope over the forecast period.

Market Concentration and Competitive Landscape

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Rising Focus on Innovation and Development of Novel Biomarkers

The growing focus of leading industry players and research institutions on innovation and development of novel cardiac biomarkers is another major factor fueling the growth of this market. Currently available biomarker tests only facilitate the detection of myocardial necrosis and injury. However, clinicians also require biomarkers that can provide accurate information on other aspects such as myocardial stress, ischemia, remodeling, and other pre-damage states. Therefore, newer biomarkers are being pursued that can enable the detection of cardiac abnormalities at early pre-damage stages as well. Considerable investments are being made for identifying novel biomarkers through omics-based techniques like proteomics and metabolomics. Some of the promising novel cardiac biomarkers in clinical trials or early stages of development include soluble ST2, galectin-3, matrix metalloproteinases, placental growth factor, ischemia-modified albumin, and others. The development of panels of multiple biomarkers is also gaining attention for facilitating comprehensive cardiac risk assessment. The pipeline of innovative biomarkers in the clinical development and approval phases will continue fueling market revenue in the coming years.

 Key Takeaways of Analyst:

The global cardiac biomarkers market holds significant growth potential over the next decade. The rising burden of cardiovascular diseases worldwide will be a major driver, as biomarkers play a crucial role in the diagnosis, treatment monitoring, and management of conditions like heart attacks and heart failure. Additionally, the growing elderly population prone to heart issues, increasing awareness about cardiac care, and technological advancements enabling more sensitive assays are expected to propel the market forward.

However, certain factors may pose challenges. Unfavorable reimbursement scenarios and regulatory policies in some countries may limit the broader adoption of biomarker tests. Technical limitations and lack of standardization also affect the clinical use of certain biomarkers.

The cardiac biomarkers market is dominated by reagents and kits used for detecting troponin and BNP/NT-proBNP levels. North America currently leads the global market but Asia Pacific is anticipated to witness the fastest growth owing to rising healthcare expenditure, growing the incidence of cardiovascular disease, and increasing focus on preventative healthcare in countries like China and India.

Market Challenges: Lack of specificity and the need for a more sensitive cardiac biomarker analysis system

The market faces hurdles due to lack of specificity and the need for more sensitive analysis systems. Point-of-care testing (POCT) requires highly sensitive diagnostic tools to detect minute levels of cardiac biomarkers like troponin, delaying rapid decision-making. Additionally, strict FDA validation and technical issues in sample collection and storage impact the market growth. The FDA's Biomarker Qualification Program aims to address these challenges, but the list of qualified biomarkers remains limited. Furthermore, issues in handling, labeling, and transporting samples may affect research and diagnostic accuracy, posing further obstacles to market expansion.

Market Opportunities: Development of novel cardiac biomarkers

The development of novel cardiac biomarkers holds tremendous potential and opportunity in the global cardiac biomarkers market. Currently available cardiac biomarkers like Troponin and CK-MB are indicative of cardiac injury only after onset of symptoms. However, novel biomarkers which can predict cardiac events before onset of symptoms can facilitate early clinical intervention and prevent adverse outcomes. For example, recent studies have shown biomarkers like ST2, Galectin-3 and others may serve as prognostic indicators, providing crucial information on predicting heart failure exacerbations days in advance. Such predictive biomarkers addressing unmet needs could transform cardiac treatment pathways globally. As per WHO, cardiovascular diseases remain the leading cause of death worldwide with an estimated 17.9 million lives lost each year. Nearly half of these deaths are premature in people under 70 years of age.

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By Product Type: Troponins Dominate Due to Higher Sensitivity and Specificity

In terms of product type, Troponins is expected to contribute the highest share of the market, accounting for 35.5% in 2024. This is owing to their higher sensitivity and specificity compared to other cardiac biomarkers. Troponins, including Troponin T and Troponin I, are regulatory proteins that control the contractions of cardiac muscle. Even small amounts of Troponin released into the bloodstream can accurately indicate damage to the heart muscle. This makes Troponins the gold standard for the diagnosis of myocardial infarction as they can detect any heart muscle damage within 4-6 hours of the onset of chest pain. Compared to other biomarkers such as CK-MB and myoglobin which are less heart specific and can be released due to other medical conditions as well, Troponins are highly specific to cardiac tissue injury. Their ability to precisely diagnose acute coronary syndromes with higher accuracy than alternatives has boosted their adoption among clinicians worldwide. Additionally, continuous technological advancements have made Troponin assays more precise and improved their ability to detect even minute amounts of cardiac injury. This increased diagnostic resolution provided by Troponins tests further expands their role in diagnosing conditions like unstable angina or detecting re-infarctions.

By Application: Myocardial Infarction Dominates Application Space Due To High Disease Prevalence

In terms of application, myocardial infarction is expected to contribute the highest share of the market, accounting for 35.5% in 2024. This is owing to its high prevalence and mortality rates globally. Myocardial infarction, commonly known as a heart attack, is a leading cause of death and disability worldwide. It occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. According to estimates, over 8 million people suffer from MIs annually, and it is responsible for one in seven deaths in the U.S. alone. The high incidence of MIs has boosted the demand for precise and early diagnosis of the condition. Since cardiac biomarkers play a crucial role in confirming suspected MIs by detecting heart muscle damage, their usage is concentrated majorly in MI diagnosis. Biomarkers like Troponins, CK-MB, and myoglobin allows clinicians to diagnose MI with higher accuracy than electrocardiograms or chest pain history alone. This supports clinicians in streamlining treatment decisions such as use of medications or angioplasty procedures. The need for quick rule-in or rule-out of MIs in emergency departments and intensive cardiac care units continues to drive the adoption of cardiac biomarkers globally, especially for applications related to MI diagnosis and management.

By Location of Testing: Laboratory Testing Leads Due to Higher Sensitivity and Broader Menu

In terms of location of testing, laboratory testing is expected to contribute the highest share of the market, accounting for 70.1% of the market share in 2024. This is owing to its ability to offer higher sensitivity cardiac biomarker tests and a broader menu of tests compared to point-of-care formats. Although point-of-care testing provides the benefit of rapid availability of test results at patients' bedside, laboratory testing has distinct advantages. High complexity laboratory testing platforms are capable of detecting much lower concentration of biomarkers with their highly sensitive assays. This higher analytical sensitivity allows them to help clinicians detect sub-clinical cases of cardiac damage. Furthermore, clinical laboratories have the capability to run a wide spectrum of cardiac biomarker tests including those for myoglobin, CK-MB, and different Troponin isoforms. This expansive cardiac test menu supports laboratories in precisely characterizing widespread cardiac damage. Additionally, clinical laboratories have well-established processes, skilled personnel, and robust quality assurances in place to deliver reliable test results.

Regional Insights

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North America has dominated the global cardiac biomarkers market and is expected to continue its dominance over the forecast period. The region is expected to account for 40.2% of the market share in 2024. This can be attributed to the high prevalence of cardiovascular diseases in the U.S. and Canada coupled with growing elderly population. In addition, well-established healthcare infrastructure and rising healthcare spending in the region are supporting the demand for advanced cardiac diagnostic tests. The presence of leading cardiac biomarkers manufacturers and availability of reimbursement are further propelling the market growth.

Asia Pacific has emerged as the fastest growing region in the global cardiac biomarkers industry. Rapid economic development, growing medical tourism industry, and rising chronic disease burden are the key factors fueling the market in Asia Pacific countries. Countries like China and India represent huge market potential with their large geriatric population and unmet medical needs. Additionally, increasing awareness about cardiac condition diagnosis and management is boosting the adoption of cardiac biomarkers. Leading global manufacturers are shifting their focus towards the Asia Pacific region in view of opportunities for business expansion. This has enhanced the accessibility to advanced testing technologies in the region.

Market Report Scope

Key Developments

• On 27 January 2024, An international academic collaboration, led by Mr.Johns Hopkins University, the Chinese University of Hong Kong, and Lund University, has identified 13 biomarkers that significantly enhance the accuracy of predicting cardiovascular disease risk in individuals with type 2 diabetes. Despite type 2 diabetes doubling the risk of cardiovascular disease, traditional risk scores are outdated and ineffective in diverse populations, posing a challenge for clinicians in determining the most at-risk individuals.
• On 29 February 2024, According to data published by Healthline Media UK Ltd, A recent study has pinpointed six biomarkers in individuals with rheumatoid arthritis (RA) that correlate with changes in artery inflammation, potentially aiding in predicting heart disease risk more accurately than current methods. Published in the Journal of the American Heart Association, the study analyzed 109 participants and identified these biomarkers as indicators of heightened cardiovascular disease risk in RA patients.
• In October 2023 Mindray, a global provider of medical devices and solutions, has unveiled two new cardiac biomarkers, hs-cTnI and NT-proBNP, expanding its range of tools for diagnosing and treating cardiovascular diseases. The announcement was made through a recent statement, marking the global launch of these additions to Mindray's portfolio.
• In September 2022, SRL Diagnostics, Diagnostics Company in India introduced "Heart Assure," a specialized examination designed to forecast an individual's likelihood of experiencing a cardiac event. This test utilizes high-sensitivity troponin I, a straightforward blood test, to accurately gauge the risk of cardiac injury by generating a heart health risk score.
• In June 2022, SCIEX, a prominent player in life science analytical technologies and a subsidiary of Danaher Corporation, unveiled the Zeno SWATH DIA, marking a substantial advancement in biomarker exploration and application workflows. 

*Definition: A cardiac biomarker refers to a protein-based substance that can be measured to analyze heart conditions for both prognostic and diagnostic purposes. These biomarkers are discharged into the bloodstream when the heart undergoes injury or stress, such as oxygen deprivation. Assessing cardiac biomarkers like cardiac troponin, creatinine kinase, and myoglobin, among others, aids in diagnosing various cardiovascular ailments like acute coronary syndrome (ACS) and cardiac ischemia.

Market Segmentation

• Product Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Myocardial Muscle Creatine Kinase (CK MB)
  • Myoglobin
  • Troponins (T and I)
  • Brain Natriuretic Peptide (BNPs) or NT-proBNP
  • Ischemia-modified Albumin (IMA)
  • Others
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
  • Myocardial Infarction
  • Congestive Heart Failure
  • Acute Coronary Syndrome
  • Atherosclerosis
  • Others
•  Location of Testing Insights (Revenue, USD Bn, 2019 - 2031)
  • Laboratory Testing
  • Point of Care Testing
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Abbott Laboratories
  • Life Diagnostics
  • Roche Diagnostics
  • Siemens Healthineers
  • Danaher Corporation
  • Becton, Dickinson and Company (BD)
  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific Inc.
  • PerkinElmer Inc.
  • bioMérieux SA
  • Randox Laboratories Ltd.
  • Ortho Clinical Diagnostics
  • Myriad RBM
  • DiaDexus Inc.
  • Response Biomedical Corp.
  • BG Medicine, Inc.
  • Boston Scientific Corporation
  • Cardiovascular Systems, Inc.
  • Quidel Corporation