Heart failure (HF), also referred to as Congestive Heart failure (CHF), is a condition in which the heart muscle fails to pump blood as efficiently as it should. This causes an accumulation of blood and fluid in the lungs, resulting in shortness of breath. Certain heart conditions, such as narrowed arteries in the heart (coronary artery disease) or high blood pressure, gradually weaken or stiffen the heart, making it unable to fill and pump blood properly. In Congestive Heart failure, the heart’s main pumping chambers (the ventricles) may stiffen and fail to fill correctly between beats. In some people, the heart muscle may become damaged and weakened. The ventricles may swell to the point where the heart cannot pump enough blood through the body.

At first, the heart failure signs and symptoms are subtle, and they are frequently misdiagnosed as typical signs of ageing. The most common symptoms of HF are caused by extra fluid or congestion, which leads to vessel blockage. The beginning of the congestion in the lungs is carried forward to other parts of the body. The cardiac output decreases as the disease progresses. Congestion of the lung and left side of the heart, congestion of the right heart, and low cardiac output are the three stages of these symptoms.

The most common causes of Congestive Heart failure include lowering the left ventricular myocardial utility and the dysfunction of the pericardium, myocardium, endocardium, heart valves or large vessels alone or in combination. Other pathogenic mechanisms that can lead to Heart failure include excessive neurohumoral stimulation, irregular myocyte calcium cycling, augmented hemodynamic overload, ischemic dysfunction, ventricular remodelling, extreme or inadequate extracellular matrix production, enhanced apoptosis, and genetic mutations. Congestive Heart failure progresses through four stages (Stage A, B, C and D). The stages range from “high risk of developing heart failure” to “advanced heart failure,” and treatment plans are provided for each. These stages differ from the clinical classifications (Class I-II-III-IV) of heart failure used by the New York Heart Association (NYHA), which reflect the severity of symptoms or functional limitations caused by heart failure.

Heart failure is a global health problem. The condition is a cause of significant healthcare expenditure, poor quality of life, and morbidity. It has become a global pandemic with an estimated worldwide prevalence of approximately 26 million, with a further expected increase in the next decade. As per the DelveInsight estimates, the Heart failure diagnosed prevalence was  12,602,028 in the 7MM in 2020. The estimates show that the United States accounted for the highest diagnosed Heart failure prevalent population of 5,163,119 cases in 2020 in the 7MM, which is expected to increase at a CAGR of 40.97% by 2030 significantly.   According to Heart Failure, Market Analysis reports have suggested that this number is predicted to rise rapidly over the next decade due to a globally ageing population, increasing prevalence of diabetes, obesity and other metabolic disorders, lifestyle modifications that have led to a sedentary life, and an increase in smoking and alcohol intake. 

How is Heart failure diagnosed?

Heart failure does not indicate that the heart has stopped working, but rather that it requires some assistance to function correctly. According to Katz’s study, chronic heart failure is common, with over 5 million people in the United States alone having this diagnosis and over 600,000 patients being diagnosed each year. Congestive Heart failure can be caused by various clinical conditions, the most common of which is coronary artery disease. In fact, nearly half of all patients with heart failure have idiopathic cardiomyopathy, which lacks a common aetiology.

Heart failure can occur at any age, but it is most common in older people. Various parameters are used in the evaluation of Heart failure. Physical examination to determine the presence of heart failure signs and symptoms, blood tests, including a complete blood count, urinalysis, and a complete metabolic profile for serum electrolytes (including calcium and magnesium), blood urea nitrogen, serum creatinine, glucose, fasting lipid profile, liver function tests, and thyroid-stimulating hormone levels are the different parameters that are used in the diagnosis of heart failure. Other Heart failure diagnostic tests include a chest X-ray, transthoracic echocardiography (TTE), Computerised tomography (CT) scans, and magnetic resonance imaging (MRI), Echocardiogram, Stress test, Coronary angiogram, Myocardial biopsy, Ejection fraction, and others. However, a person could lead a healthy life with proper care and management, even with a heart failure diagnosis. 

Heart Failure Therapeutics Market

Congestive Heart failure (CHF) is global morbidity that is increasing as the world’s population ages and (acute) care for patients with cardiovascular diseases improves. Without treatment, patients with HF have a very poor prognosis. Furthermore, hospitalizations for cardiac decompensation place an increasing economic burden on the healthcare system. It is a long-term chronic condition that worsens over time. The condition has no cure; however, many people manage to lead a quality life with lifestyle changes and pharmacological interventions. The primary goals of congestive heart failure treatment are to improve prognosis, reduce mortality, and relieve symptoms and reduce morbidity by reversing or slowing cardiac and peripheral dysfunction.

The Heart failure market is heavily crowded with pharma and MedTech companies working in the space to deliver the best class therapeutics and medical devices to lower down the burden of Heart failure. Recently, In January 2021, the US Food and Drug Administration (FDA) approved Verquvo (Merck), a soluble guanylate cyclase (sGC) stimulator, is being studied in adults with symptomatic chronic heart failure and an ejection fraction less than 45 per cent to reduce the risk of cardiovascular death and heart failure hospitalisation following a heart failure hospitalisation or need for outpatient intravenous (IV) diuretics. 

Moreover, Farxiga (dapagliflozin) (AstraZeneca) was approved by the US FDA in May 2020 to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) and reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).

In addition, back in April 2019, the US FDA approved another drug Corlanor (ivabradine) (Amgen), an oral solution used to reduce the risk of hospitalisation for worsening heart failure in adults with stable, symptomatic chronic heart failure with a low left ventricular ejection fraction, and for stable symptomatic heart failure treatment due to dilated cardiomyopathy (DCM) in children aged six months and older. It is also approved in Europe as well as in Japan. 

Furthermore, Entresto (sacubitril/valsartan) (Novartis) got FDA approval in July 2015 for the treatment of heart failure. Entresto is a medication used to treat chronic heart failure in conjunction with other heart failure therapies. It also got approval in Europe. 

Besides the approved therapies by the leading pharmaceutical companies, the MedTech companies are not so far behind. They are manufacturing and delivering their product in the heart failure treatment market. Boston Scientific Corporation, one of the renowned medical devices in the world, offers its four major products, namely, S-ICD™ System, VALITUDE™ X4 CRT-P, Maverick2 ™ PTCA Balloon Catheters, and ACCOLADE™ Pacing Systems, in the heart failure market. Despite that, several other pharmaceutical and MedTech companies such as Boehringer Ingelheim, Eli Lilly, Merck, Bayer, Medtronic, B. Braun Melsungen AG, Abbott, Oscor, Abiomed, Edwards Life Sciences, Teleflex Incorporated, and others are showing their presence in the heart failure market and trying to come up with the novel therapies and devices. 

Upcoming therapies and devices in the Heart failure Market

DelveInsight estimates that the Heart failure pipeline is robust and brimming with several therapeutics and medical devices in different clinical trial phases expected to enter the market soon. The current pipeline holds many significant products such as Empagliflozin ((Boehringer Ingelheim/Eli Lilly and Company), Vericiguat (Merck Sharp & Dohme Corp/Bayer), AZD4831 (AstraZeneca), Dapagliflozin (AstraZeneca), Omecamtiv mecarbil (Amgen) and others, which are expected to make a significant impact on the Heart failure market. 

Besides pharmacological therapies, technological advancements and artificial intelligence have facilitated better management of CVDs enabling better monitoring, connectivity between patients and physicians and lifestyle modification. Major medical devices in the Heart failure pipeline include pacemakers, implantable cardioverter devices, cardiac resynchronization therapy (CRT) devices, coronary stents, ventricular assist devices (VAD), PTCA catheters, and others, out of which, DelveInsight estimates that Pacemakers are expected to capture the maximum market share. This can be attributed to the ease of device operation and product longevity. Although a lower diagnosis rate is expected to dim the growth of the Heart failure market size, a high incidence of obesity/ diabetes, increase in healthcare expenditure, the influx of pharma and MedTech companies, better awareness rate, and expected launch of pipeline therapies and medical devices are anticipated to push the market growth significantly in the coming decade. 

Way Ahead

Heart failure is a complex disease that has long been a leading cause of morbidity and mortality in both developing and developed countries. In the early stages of HF, standardised medical therapy has been effective. Current medical treatment for heart failure only alleviates symptoms, delays deterioration, and modestly prolongs life. As science has advanced, the idea of rejuvenating the failing myocardium began to appear feasible when preclinical studies demonstrated that rejuvenating the myocardium at the molecular and cellular level can be accomplished through stem cell transplantation. Gene therapy, in addition to stem cell therapy, holds promise in the field of HF. The specific genes, vector types determine the success of gene therapy and application routes used.