Heart Failure POC & LOC Devices Market Research Report: Information by Test type (Proteomic Testing, Metabolomic Testing, Genomic Testing), by Technology (Microfluidics, Array-based Systems), by End User (Hospitals & Clinics, Homecare, Specialty Centers, and Others), and by Region (North America, Europe, Asia-Pacific, and Rest of the World)—Forecast till 2030

Heart Failure POC & LOC Devices Market Forecast

The heart failure POC & LOC devices market is expected to cross ~USD 70 million by 2030 at a CAGR of~16.50%.

Market Overview:

Point-of-Care (POC) devices are used to get diagnostic results near the patients, where as Lab-On-Chip (LOC) devices integrate many laboratory operations on a single circuit to provide automation and high through put screening. POC assays are available to diagnose heart failure, and LOC device technology can be used for POC and central lab testing. For tackling the difficulties of health disparities, point-of-care testing detects cardiac indicators and other time-critical indicators. The factors such as an increase in cardiovascular diseases (CVDs),rise in the geriatric population, and increasing R&D for POC &LOC devicesare driving the global heart failure POC & LOC devices market. However, unfavorable reimbursement policies might hamper the market growth in the forecast period.

COVID-19 Analysis

The current pandemic of COVID-19 has affected people across the globe and resulted in the shutdown of operational facilities worldwide. The global economy has also suffered significantly, with the global GDP contracting by an estimated 5.2%, according to the World Bank in June 2020. During the lockdown, the healthcare business faced unforeseen challenges. As the manufacturing operations were shut down, production of medical devices and other healthcare products came to a halt. Furthermore, the medical supplies’ supply chain for was disrupted, leadingto an increase in stockpiling of manufactured goods.

This COVID-19 pandemic is also creating opportunities for the companies involved in the heart failure POC & LOC devices industry.According to a report by Northwestern University, US, in November 2020, many COVID-19 survivors will be at risk of chronic right heart failure, pulmonary hypertension, and diastolic dysfunction, especially those who have recovered from severe illness with significant hypoxemic respiratory failure and thromboembolic consequences.Furthermore, with the high demand for electronic health records, telehealth, and restrictions preventing patients from making in-person visits to diagnostic labs and hospitals,the demand for POC & LOC devices for heart failure is expected to increase.

Market Dynamics

Drivers

• Increase in cardiovascular diseases

The increase in CVDs globally is expected to significantly drive the market for heart failure POC & LOC devices.LOC technology has the potential to improve disease diagnostics, whereas POC devices help measure specific cardiac biomarkers such as troponin.According to WebMD, in December 2020, heart disease was the leading cause of death in the world, accounting foraround one-third of deaths in 2019, and the death toll is expected tocontinue rising. China accounted for the highest number of heart disease deaths in 2019, followed by India, Russia, the US, and Indonesia.Furthermore, as statedin a CDC report in 2018, about 655,000 Americans die from heart disease each year, i.e., 1 in every 4 deaths, the number onecause of death in the US. Thus, several major companies are racing to introduce high-quality devices and accessories for better management of data for patients with CVD. This rising patient pool has ultimately increased the demand for POC & LOC devices which would fuel the growth of the market.Rise in geriatric population

• Increasing R&D for POC & LOC devices

Market Opportunities

• Increased funding for heart and cardiovascular disease research

As the global burden for CVD increases, there is a need for extensive R&D to find more efficient treatments and diagnostic methods to prevent the rapid rise of CVD disorders. The increase in R&D investments for heart and CVD will drive the heart failure POC & LOC devices market in the future as point-of-care testing (POCT) is a vital technology to diagnose CVDs such as heart failure.According to a report published by New South Wales Government in June 2018, an investment of USD 190 million will be made over the decade for heart disease-related research. Furthermore, NIH funding for cardiovascular conditions has increased from USD 1,964 million in 2013 to an estimated USD 2,496 million in 2020. Therefore, such an increase in funding will supplement the heart failure POC & LOC devices market in the future.

• Development of newer POC & LOC compatible heart failure biomarkers

Market Restraints

• Ambiguous reimbursement policies

In most countries, delayed reimbursement, or lack of funding for diagnostics acts as a key barrier tomarket growth. Reimbursement for diagnostic tests is a complex process. The complexity in the reimbursement process itself acts as a challenge for this market. In most cases, reimbursement is granted for the process or technology, not for the value.The problems in invoicing POC & LOC devices, effectively recording information, and a lack of acquaintance with regulatory rules are the reasons for the emergence of reimbursement concerns.Multiple techniques and Current Procedural Terminology (CPT) codes used for the same name are the main causes of billing issues forPOCT. This primarily applies to POCT devices that produce several findings simultaneously (many tests with one cartridge), where one test may be reimbursed but another may not. Hence, the ambiguity and complexity of reimbursement filing pose a barrier to heart failure POC & LOC devices market growth.Regulatory Implications

• The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulate all clinical testing in the US, regardless of where it is performed. POCT refers to non-laboratory employees doing CLIA waived or non-waived laboratory tests at remote locations. While there is little federal regulation of POCT, states and accrediting bodies frequently impose additional restrictions. POC testing regulatory requirements normally focus on two areas:


• Personnel training and competency


• Verification of strict adherence to the manufacturer-specified protocol for each test

• The regulatory challenges for POC & LOC devices are the quality issues that arise as a result of users who are not trained or who lack the necessary competencies. Furthermore, factors such as the inadequate frequency of quality control, the complex documentation process, the cleaning and disinfection processes that should be followed, and maintaining consistency among central laboratory processes with POCT processes, as well as differences between different POCT device models, lead to more regulatory implications.

Segment OverviewBy Test Type

• Proteomic Testing

Circulating protein biomarkers can provide crucial information to clinicians about pathways in heart failure (HF). Researchers may now assess a largenumber of proteins simultaneously with high sensitivity and selectivity to detect low-abundance proteins due to advances in proteomics.Some protein markers that POC devices detect for heart failure areC-reactive protein (CRP),troponin, andB-type natriuretic peptide (BNP). Proteomic testing held the largest share in this segment due to factors like increased demand for accurate and efficient protein biomarkers such as troponin for the diagnosis and prevention of heart failure. 

• Metabolomic Testing

Metabolomics refers to the study of small organic molecules found within different biochemical pathways.Patients with systolic heart failure have metabolomic profiles produced through serum and breath analysis, which can be used clinically for diagnosis and prognosis of heart failure. One example of metabolomic testing with POC & LOC devices for diagnosis of heart failure is blood lipid profile testing. 

• Genomic Testing

Genomic testing enables diagnosis of heart failure by identifying whether the patient possesses an altered gene or genetic fault that may lead toInherited Heart Condition (IHC). In resource-constrained situations, laboratory-based detection technologies such as Polymerase Chain Reaction (PCR) are often unavailable due to a lack of advanced infrastructures, reliable electricity, and experienced operators. On the other hand, POCT allows for on-the-spot detections in these settings.By Technology

• Microfluidics

Microfluidics has inherent characteristics that make it particularly well suited to modeling the cardiovascular system.By incorporating microfluidics into POC testing, fluid manipulation and detection may be done in one device with minimum sample requirements. Microfluidics held the largest share in thetechnology segment in 2020 due to several advantages such as low reagent requirement, minimum sample, and high throughput. Moreover, microfluidics-based POC & LOC devices help in the detection and measurement of heart failure-related biomarkers, essential for heart failure diagnosis.

• Array-based Systems

Array-based POC & LOC devices for heart failure work on two major principles of sandwich and competitive modes. Saliva analysis for the detection of heart failure symptoms is one application ofarray-basedPOC & LOC devices. The electronic taste chip (ETC) method is used in such LOC devices. On the ETC LOC system, C-reactive protein (CRP)is measured using a sandwich-type immunoassay.By End User

• Hospitals & Clinics

Point-of-care testing has tremendous applications in hospitals & clinics. Compared to central laboratory testing, POCT has a faster turnaround time for results and allows patients to return home sooner. This helps clinicians make quick medical decisions. All these factors make POC &LOC devices much advantageous for clinics to efficiently provide outpatient care and treat a larger patient pool in a short period.

• Homecare

The use ofPOC & LOC devices for home use is also increasing as caretakers and patients prefer minimally invasive methods for health monitoring purposes. Furthermore, the ease of testing at home rather than visiting healthcare centers supplements the growth of this segment.

• Specialty Centers

Specialty centers provide a complete range of heart failure diagnoses and treatment, including the use of heart failure POC & LOC devices. They contain specialists ranging from sleep disorders specialists to palliative care specialists to cover the complete process of diagnosis, treatment, and care of heart failure patients.

• Others

Other end users include research laboratories and assisted living healthcare facilities where heart failure POC & LOC devices are employed.Regional AnalysisNorth America

• Increasing prevalence of heart disorders is driving the growth of the North American heart failure POC & LOC devicesmarket

North Americaholds the largest share in the heart failure POC & LOC devices market. This share is attributed to the high prevalence of heart diseases in the region. According to the Centers for Disease Control and Prevention (CDC), from 2015 to 2020, heart disease was the number one cause of death in the US. Furthermore, deaths from heart diseases increased by 4.8% in 2020, the highest number of deaths related to heart disease since 2012.  Hence, there is an increased demand for heart failure POC & LOC devices in the region. In addition, the presence of key players supplements the market growth in the region. Europe

• Government initiatives and rising heart failure cases arefueling the Europeanheart failure POC & LOC devicesmarket

The Europeanheart failure POC & LOC devices market accounted to hold a significant market share in 2021. According to a report by United Arab Emirates University (UAE) in July 2020, Eastern European countries showed the highest prevalence of ischemic heart disease in the world in 2017, with a prevalence rate of 3,547 per 100,000 individuals. Furthermore, increase in government initiative such as fully funding the Kardiatool Project which ran from 2017 to 2021 aimed at monitoring heart failure patients with the help of an integrated POC solution is driving the market. In 2020, the European Commission funded the project with another USD 5.8 million. Therefore, the increasing prevalence of heart failure disorders and supporting government initiatives will drive the market in the forecast period.Asia-Pacific

• Increasing geriatric population and emerging economies are driving the growth of the heart failure POC & LOC devices market in the region

An increase in age has a direct correlation with heart failure cases, as higher age makes a person more susceptible to cardiovascular disorders. Countries within this region possess a high percentage of old age population, driving the growth of the market in the region. For instance, according to Population Reference Bureau in 2019, China had the highest population of old aged people (65 years and older),166.37 million older people in 2019.Rest of the World

• Improving healthcare facilities and supportive government regulations drive growth for the market in this region

The improving healthcare infrastructure in the region and government initiatives are driving the growth of the market. For instance, in February 2019, Phillips (Netherlands) collaborated with the Saudi Arabia Ministry of Health (MOH) to implement a Cardiovascular Information System (CVIS) integrated across the country, which will make heart failure diagnosis and treatment more efficient.Competitive Landscape

• Several global and local industry players are contributing to the market growth. One of the key players is Abbott (US). The companydiscovers, develops, manufactures, and sells healthcare products across the globe. It operates through four reportable segments, namely, established pharmaceutical products, diagnostic products, nutritional products, and vascular products. The medical devices segment offers devices for various treatments, including cardiac arrhythmias & heart failure, vascular, neuromodulation, structural heart, and diabetes care. Cholestech LDX analyzer and i-STAT Handheld product are two of its offerings for heart failure point-of-care testing. Abbott sells its products to customers in more than 160 countries.

List of companies with HQ

• Abbott (US)


• Hoffmann-La Roche Ltd. (Switzerland)


• Danaher (US)


• Abaxis, Inc. (US)


• Quidel Corporation (US)


• Siemens Healthineers (Germany)


• Jant Pharmacal Corporation (US)


• Trinity Biotech (Ireland)


• bioMérieux S.A (France)


• Instrumentation Laboratory Company (US)


• Others

Recent Developments

• In April 2021, Siemens Healthineers received the CE mark approval for the AtellicaVTLi Patient-Side Immunoassay Analyzer, a device that provides a point-of-care test to aid in the diagnosis of heart attacks.


• In May2020, the FDA approved the use of Philips ultrasound portfolio to manage COVID-19-related pulmonary and heart problems. This will allow the performing ofcardiac ultrasound exams in different settings like an emergency department, an intensive care unit,or a specially designated ward for COVID-19 patients, which will reduce the risk of transmission of the virus.


• In October 2020, Butterfly Network Inc. launched Butterfly iQ+ point-of-care-ultrasound (POCUS), which can help diagnose heart failure at the point-of-careand transform a mobile phone into an imaging system.

Report Overview

• The study covers the existing short-term and long-term market effects. It helps decision-makers to draught short-term and long-term business plans by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's five forces, value chain, and impact of COVID-19 on the market.

Market Segmentation:Global Heart Failure POC & LOC Devices Market,By Test Type

• Proteomic Testing


• Metabolomic Testing


• Genomic Testing

Global Heart Failure POC & LOC Devices Market, By Technology

• Microfluidics


• Array-based Systems


• Others

Global Heart Failure POC & LOC Devices Market, By End User

• Hospitals &Clinics


• Homecare


• Specialty Centers


• Others

Global Heart Failure POC & LOC Devices Market, by Region

• North America




• US


• Canada




• Europe




• Germany


• France


• UK


• Italy


• Spain


• Rest of Europe




• Asia-Pacific




• China


• Japan


• India


• Australia


• South Korea


• Rest of Asia-Pacific




• Rest of the World




• Middle East


• Africa


• Latin America