CARDIAC BIOMARKERS MARKET ANALYSIS

Cardiac markers are used for the diagnosis and risk stratification of patients with chest pain and suspected acute coronary syndrome (ACS) and for management and prognosis in patients with acute heart failure, pulmonary embolism, and other disease states.

Cardiac biomarker is a protein-based substance that can be quantified for prognostic and diagnostic analysis of heart conditions. Cardiac biomarkers are released into the blood when the heart is suffering from an injury or stress such as lack of oxygen. Measurement of cardiac biomarkers such as cardiac troponin, creatinine kinase, myoglobin, and others are used to diagnose several cardiovascular conditions such as acute coronary syndrome (ACS) and cardiac ischemia.

ACS occurs due to the buildup of plaque in the arteries, which results in the narrowing of artery walls. Plaque rupture leads to a sudden decrease in the amount of oxygenated blood reaching the heart. Shortage of blood supply leads to prolonged chest pain. On the other hand, cardiac ischemia reduces the capability of heart muscles to pump enough blood to meet the requirement of heart cells. Reduced flow of blood causes symptoms such as shortness of breath, chest pain, sweating, and others. Blockage of blood supply for a longer period of time can cause death of the heart cells. This condition is called acute myocardial infarction (AMI) or heart attack. Permanent damage to heart muscles can result in irregular heart contractions also called as arrhythmia, which can be fatal. Cardiac biomarker is an essential tool to detect the presence of ACS or cardiac ischemia in patients and also evaluate the severity of their conditions accurately.

The global cardiac biomarker market is estimated to be valued at US$ 8,099.9 Mn in 2021 and is expected to exhibit a CAGR of 10.2% during the forecast period (2021-2028).

Figure 1. Global Cardiac Biomarkers Market Share (%) in Terms of Value, by Product Type, 2021

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The increasing prevalence of cardiovascular diseases is the major factor that is expected to drive the market growth over the forecast period.

The rising number of patients of cardiovascular disease is expected to drive the growth of global cardiac biomarkers market over the forecast period. For instance, according to the American College of Cardiology Foundation, in 2019, there were approximately 1.05 million people suffering from coronary diseases in the U.S. Moreover, according to the Centers for Disease Control and prevention (CDC) report 2020, around 805,000 Americans have a heart attack every year.

Figure 2. Global Cardiac Biomarker Market Share (%), by Location of Testing, 2021

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Increasing number of research and development activities for improving the effectiveness of cardiac biomarkers-based tests is expected to aid in the growth of the market over the forecast period.

There is rising need for research activities for the improvement of effectiveness if cardiac biomarkers-based tests. Hence, increasing R&D activities have fueled the growth of cardiac biomarkers market during the forecast period. For instance, in 2019, Ortho Clinical Diagnostics, a U.S. based in-vitro diagnostics company, developed a more rapid and accurate assay for the detection of heart attack. This newly developed Vitros High Sensitivity Troponin I Assay is based on the quantitative measurement of troponin, which is a cardiac biomarker.

Global Cardiac Biomarkers Drug Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization declared it a public health emergency on 30 January 2020. According to the World Health Organization’s report, the manifestation of Coronavirus (COVID-19) has resulted in more than 245 million infected individuals worldwide as of October 27, 2021.

COVID-19 pandemic has adversely affected the healthcare industry. However, COVID-19 pandemic is expected to have a positive impact on the global cardiac biomarkers market as cardiovascular diseases are associated with COVID-19 disease.

For instance, according to an article published by the National Centers for Biotechnology Information in March 2021, it is expected that cardiac biomarkers would be used along with diagnostic markers for other organs for proper diagnosis and prognosis of COVID-19 infection. The same source confirmed that elevated levels of troponin were reported in COVID-19 patients worldwide. This source also stated that higher levels of cardiac biomarkers: NT-pro BNP and CK-MB were observed in severely affected COVID-19 patients and non-survivors of COVID-19 infection, which implies that higher levels of these cardiac biomarkers are associated with the worst outcomes. This is expected to drive the market growth of cardiac biomarkers as a diagnostic tool for better understanding of cardiovascular complications related to COVID-19.

COVID-19 is expected to have a negative impact on the supply of raw materials required for production of cardiac biomarkers due to the forced quarantine and lack of labor. As the link between regional warehouses was not smooth, transportation of raw materials between regions could not be carried out successfully. This shortage of raw materials and components has severely affected the supply chain of the global cardiac biomarkers market.

However the demand of cardiac biomarkers will definitely increase as COVID-19 has a major impact on the upper respiratory tract and causes a number of cardiac diseases such as arrhythmia, cardiac injury due to septic shock, and acute coronary syndrome. Hence the demand for cardiac biomarkers used for the diagnosis of these diseases will increase over the forecast period.

Global Cardiac Biomarker Market: Restraint

Lack of specificity and the need for a more sensitive cardiac biomarker analysis system acts as a major restraint for the market. For instance, according to an article by the American Association for Clinical Chemistry (AACC) in June 2020, use of cardiac biomarkers as point-of-care testing (POCT) requires a high sensitivity diagnostic tool, as POCT fails to detect minute levels of cardiac biomarker- troponin. Hence, such assays cannot be used for rapid decision-making as one has to wait for several hours before troponin levels increases in the patient and the system is able to detect it.

Moreover, strict validation by U.S. Food and Drug Administration (FDA) and technical issues related to sample collection & storage acts a restraint for the market. The FDA has created a FDA's Biomarker Qualification Program, where the companies may request regulatory qualification of a biomarker for a particular context of use in drug development. Only the qualified biomarker can be used in multiple drug development programs without a need for Centre for Drug Evaluation and Research (CDER) to reconfirm the suitability of the biomarkers, which hampers the market of cardiac biomarkers. Moreover, the list of qualified biomarkers is too short.

Furthermore, the sample which needs to be tested by biomarker for research study purpose or diagnostic, has technical issues related to sample collection & storage. This is owing to the fact that handling, labeling, processing, aliquoting, storage, and transportation may affect the results of the study. The sample needs to be placed on dry ice and shipped on the same day in a bubble-wrap bag, if the process is not carried out properly, it may affect the quality of the sample. The issues which arise during sample collection & storage could hamper the global cardiac biomarkers market growth.

Key Players

Major players operating in the global cardiac biomarker market include Abbott Laboratories, F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Danaher Corporation, Randox Laboratories Ltd., Siemens Healthineers, and BioMérieux SA.