심혈관 질환의 빈도가 증가하고 조기 발견 및 예방 노력에 대한 지식이 증가함에 따라 심장 마커 검사 솔루션에 대한 수요가 증가하고 있으며, Verified Market Research의 애널리스트에 따르면 심장 마커 검사 시장은 2023년 약 44억 2,000만 달러에 도달했으며, 예측 기간 동안 86억 9,000만 달러에 도달할 것으로 예상됩니다.
고령 인구 증가, 생활습관 변화, 비만 및 당뇨병과 같은 위험요인 증가, 심장 마커 검사 등 첨단 진단 기술에 대한 수요 급증으로 2024년부터 2031년까지 연평균 8.8%의 성장률을 보일 것으로 예상됩니다.
심장 마커 검사 시장 정의/개요
심장 마커 검사는 심근 손상이나 스트레스의 결과로 혈류로 방출되는 특정 단백질을 분석합니다. 트로포닌, 크레아틴 키나아제-MB(CK-MB), 미오글로빈은 심장 손상의 지표로 심장마비, 심근경색, 불안정 협심증 등 다양한 심혈관 질환을 진단하는 데 도움이 됩니다. 심장 마커 검사는 급성 관상 동맥 증후군의 조기 발견, 진단 및 위험 계층화에 가장 일반적으로 사용되어 의료진이 가능한 한 빨리 적절한 치료 및 개입을 시작할 수 있도록합니다.
또한, 심장 마커 검사는 심혈관 질환이 있는 환자를 모니터링하고, 치료 효과를 평가하고, 치료 방침을 결정하는 데 필수적입니다. 응급실, 중환자실 및 외래 환경에서 광범위하게 사용되는 것은 환자의 결과를 개선하고 심장 사건으로 인한 사망률을 낮추는 데 중요한 것으로 나타났습니다.
심근경색, 뇌졸중 및 기타 심장 관련 질환과 같은 심혈관 질환의 전 세계 증가는 심장 마커 검사 시장의 주요 촉진요인입니다. 심혈관 질환은 여전히 전 세계 사망 원인 중 가장 높은 비중을 차지하고 있어 심장 마커 검사를 통해 도움을 줄 수 있는 조기 및 정확한 진단에 대한 요구가 증가하고 있습니다. 이러한 검사는 심장 질환의 심각성을 판단하고 치료를 권고하는 데 매우 중요합니다.
POCT는 환자의 치료 시점 또는 그 근처에서 신속한 진단 검사를 통해 적시에 의사 결정을 내리고 치료를 시작할 수 있도록 도와주는 현장진단검사(POCT) 기술의 발전과 강화는 심장 마커 검사 시장에 큰 영향을 미치고 있습니다. 심장 마커 POCT는 편리하고 신속하며 효율적이기 때문에 급성관상동맥증후군(ACS) 및 기타 심장 질환을 앓고 있는 환자들에게 혜택을 제공하며 시장 성장을 견인하고 있습니다.
또한, 심장병과 그 위험 요인에 대한 인식이 높아지면서 심장 마커의 사용을 포함한 예방 의료와 조기 발견의 필요성이 증가하고 있습니다. 또한, 전 세계 의료비 지출 증가, 특히 가난한 나라에서 개선된 진단 도구에 대한 접근성이 증가하고 있습니다. 각국 정부와 의료 기관은 진단법을 포함한 의료 인프라 및 서비스에 투자하고 있으며, 이는 심장 마커 검사 시장을 촉진하고 있습니다.
새로운 심장 마커 검사 기술의 개발 및 채택에는 첨단 검사 장비에 대한 막대한 재정적 투자와 의료 전문가 교육 등 몇 가지 운영상의 장애물이 있습니다. 또한, 검사 결과의 정확성과 신뢰성을 보장하는 것은 특히 현장 진료 환경이나 현대식 진단 시설에 대한 접근성이 제한적인 저자원 환경에서는 어려운 일이며, 이는 시장 성장을 제한하는 요인이 되고 있습니다.
새로운 심근 지표나 검사법에 대한 규제 승인 절차는 까다롭고 지역마다 크게 다릅니다. 미국 FDA(미국 식품의약국)나 유럽 EMA(유럽의약품청)와 같은 기관으로부터 규제 당국의 승인을 받으려면 임상적 검증과 유효성에 대한 증거를 확보해야 하는데, 이는 시간과 비용이 많이 소요되어 시장 확대에 제약이 됩니다.
또한, 레거시 기술에 비해 심장 시장 검사 사용에 따른 기술적 복잡성은 전 세계적으로 수용되는 데 큰 장벽으로 작용하고 있습니다. 마찬가지로, 심장 시장 검사 솔루션의 지속적인 유지보수 필요성과 높은 비용은 예산 제약에 직면한 제조업체들 사이에서 채택을 억제하고 있습니다.
The increasing frequency of cardiovascular diseases, along with growing knowledge of early detection and prevention efforts, is driving demand for cardiac marker testing solutions. According to the analyst from Verified Market Research, the cardiac marker testing market is estimated to reach a valuation ofUSD 8.69 Billion over the forecast subjugating around USD 4.42 Billion valued in 2023.
Growing elderly population, lifestyle changes is increasing risk factors including obesity and diabetes, surging demand for advanced diagnostic technology, such as cardiac marker testing, enabling the market to grow at a CAGR of 8.8% from 2024 to 2031.
Cardiac Marker Testing Market: Definition/ Overview
Cardiac marker testing analyses specific proteins released into the bloodstream as a result of heart muscle damage or stress. Troponin, creatine kinase-MB (CK-MB), and myoglobin are indications of cardiac injury that aid in the diagnosis of a variety of cardiovascular disorders, including heart attacks, myocardial infarctions, and unstable angina. Cardiac marker testing is most commonly used for the early detection, diagnosis, and risk stratification of acute coronary syndromes, allowing healthcare providers to commence relevant therapies and interventions as soon as possible.
Furthermore, cardiac marker testing serves as essential for monitoring patients with known cardiovascular illnesses, evaluating treatment efficacy, and directing therapeutic decisions. Its broad use in emergency rooms, critical care units, and ambulatory settings demonstrates its importance in improving patient outcomes and lowering mortality rates from cardiac events.
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The global rise in cardiovascular disorders, such as heart attacks, strokes, and other heart-related conditions, is a major driver of the cardiac marker testing market. As cardiovascular disease remains one of the top causes of death worldwide, there is an increased desire for early and precise diagnosis, which can be aided by cardiac marker testing. These tests are crucial in determining the severity of heart problems and making treatment recommendations.
The development and enhancements to point-of-care testing technology have significantly impacted the cardiac marker testing market. POCT enables quick diagnostic testing at or near the point of patient care, allowing for timely decision-making and treatment commencement. POCT for cardiac markers is convenient, fast, and efficient, which benefits patients with acute coronary syndromes (ACS) and other heart problems, supporting market growth.
Furthermore, increased awareness of heart disease and its risk factors is resulting in a greater need for preventative care and early detection, including the use of cardiac markers. Also, increased worldwide healthcare expenditure, particularly in poorer nations, is increasing access to improved diagnostic tools. Governments and healthcare organizations are investing in healthcare infrastructure and services, including diagnostics, which is helping to drive the cardiac marker testing market.
The development and adoption of new cardiac marker testing technologies encounter several operational hurdles, including a significant financial investment in sophisticated testing equipment and healthcare professional training. Also, assuring the accuracy and reliability of test results is difficult, especially in point-of-care settings or low-resource environments with limited access to modern diagnostic facilities, which restricts market growth.
The regulatory approval process for new cardiac indicators and testing methods is stringent and varies greatly between regions. Obtaining regulatory authorization from agencies such as the FDA (US Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe demands significant clinical validation and evidence of efficacy, which is time-consuming and expensive, limiting market expansion.
Also, the technical complexity associated with the use of cardiac market testing compared to the legacy technologies is creating a major barrier for its acceptance worldwide. Similarly, the need for constant maintenance and high cost of the cardiac market testing solutions is restraining the adoption among manufacturers facing budget constraints.
According to VMR analysis, the reagents & kits segment is estimated to hold the largest market share in the product segment during the forecast period. Reagents and kits are consumables used in a large number of tests for cardiovascular disease diagnosis, monitoring, and management. Unlike instruments, which are less frequent capital investments, reagents and kits must be replenished constantly. Their higher market share is due to their recurring use, which is driven by the ongoing demand for cardiac marker testing in hospitals, diagnostic laboratories, and point-of-care settings.
Ongoing research and development in the field of cardiovascular diseases is resulting in the identification of new biomarkers as well as improvements in test sensitivity and specificity. This advancement needs the continual update and purchase of new or improved reagents and kits capable of detecting these markers, resulting in high demand and market dominance.
Furthermore, reagents and kits are intended for convenience of use and ease in integration into existing laboratory processes without requiring significant additional investment in new equipment or training. Their simplicity of integration makes them an appealing option for many healthcare professionals.
The point-of-care testing (POCT) segment is estimated to grow at the highest CAGR in the cardiac marker testing market during the forecast period. POCT facilities provide testing closer to the patient, whether at the bedside, in ambulatory care settings, or community clinics, minimizing the need to send samples to centralized laboratories. This greater accessibility is especially useful in emergencies, where early detection is important for managing acute cardiac events like myocardial infarction. The ease of obtaining quick findings without the requirement for complex laboratory infrastructure makes POCT very appealing.
The short turnaround time of results from point-of-care cardiac marker tests allows for urgent clinical decision-making. In the case of cardiovascular disorders, time is of the essence, and the ability to diagnose and commence therapy swiftly can have a substantial impact on patient outcomes. This promptness can lead to better management of patients with acute cardiac problems, shorter hospital stays, and increased overall healthcare efficiency.
Furthermore, technological advances have greatly increased the accuracy, reliability, and range of POCT for cardiac indicators. Modern point-of-care devices can provide laboratory-quality data for important biomarkers like troponin, natriuretic peptides, and others right at the patient's side. These developments have also made POCT devices more user-friendly and cost-effective, accelerating their adoption in a variety of healthcare settings.
According to VMR analyst, North America is estimated to dominate the cardiac marker testing market during the forecast period. North America has one of the highest rates of cardiovascular disease in the world, owing to an ageing population, lifestyle-related risk factors (such as obesity, physical inactivity, and an unhealthy diet), and a high incidence of comorbid conditions (such as diabetes and hypertension). This high prevalence of CVDs causes a significant demand for early and precise diagnosis, monitoring, and management, which is supporting the region's cardiac marker testing market expansion.
Furthermore, North America, particularly the United States, has a well-developed healthcare infrastructure, with a strong emphasis on innovative diagnostic technology and treatments. This infrastructure enables the widespread availability of cardiac marker testing in a variety of healthcare settings, ranging from top-tier hospitals to community clinics. The availability of cutting-edge medical facilities, together with a robust network of laboratories and point-of-care testing facilities, provides wider access to cardiac marker tests, hence driving their uptake and utilization.
Asia Pacific is experiencing an increase in prevalence of cardiovascular disease as a result of changing lifestyles, urbanization, and ageing populations. Increased tobacco use, poor diets, and physical inactivity all contribute to a rise in the prevalence of heart disease. The growing incidence of CVDs needs early detection and therapy is driving demand for cardiac marker testing in the region.
Furthermore, countries in Asia Pacific are making considerable investments in healthcare infrastructure, such as hospitals, clinics, and diagnostic centers. This expansion is fueled in part by increased economic capacities and a focus on increasing healthcare access and quality. Access to modern diagnostic techniques such as cardiac marker tests grows in tandem with healthcare infrastructure improvements. This rise is especially evident in emerging economies like China and India, where the healthcare industry is rapidly modernizing and expanding.
The competitive landscape of the cardiac market testing market is defined by a dynamic interplay between numerous companies that strive to develop novel solutions that meet the changing needs of patients and healthcare providers. These players are always researching and developing ways to improve the accuracy, efficiency, and accessibility of cardiac testing devices.
Some of the prominent players operating in the cardiac marker testing market include:
Abbott Laboratories
Hoffmann-La Roche Ltd.
Siemens Healthineers AG
Danaher Corporation
Ortho-Clinical Diagnostics
Beckman Coulter Inc.
bioMerieux SA
Koninklijke Philips N.V.
Trinity Biotech plc
Mercadia BioSciences Inc.
LSI Medience Co., Ltd.
Mindray Medical International Limited
Shenzhen Mindray Bio-Medical Electronics Co.
EKF Diagnostics Holdings plc
DiaSorin S.p.A.
Hytest Limited
Stanbio Laboratory LLC
Streck
Thermo Fisher Scientific Inc.
In February 2024, Abbott announced the ARCHITECT Myxovirus Multiplex Assay, which detects numerous respiratory viruses at the same time, including influenza A and B, respiratory syncytial virus (RSV), and parainfluenza viruses. This assay can aid healthcare practitioners in distinguishing between cardiac difficulties and respiratory infections, which can sometimes present with identical symptoms.
In February 2024, Siemens Healthineers obtained FDA approval for its Atellica(R) CH SOAPS Assay, a novel test that detects creatine kinase-MB (CK-MB), an important cardiac marker. This assay is specifically developed to be used on the Atellica(R) CH immunoassay analyzer, which provides shorter turnaround times and increased workflow efficiency.
In January 2024, Danaher Corporation, which owns Beckman Coulter, announced the acquisition of PHC Holdings Corporation, a major global manufacturer of life science equipment. This acquisition is expected to boost Danaher's position in the cardiac marker testing market by providing them with a more diverse array of diagnostic solutions.