Dilated Cardiomyopathy Therapeutics Market Size, Competitive Landscape and Market Forecast - 2029

SKU: DM2586 | Last Updated On: Jul 05 2022 | Available Formats

> Global Dilated Cardiomyopathy Therapeutics Market is Expected to reach a high CAGR of nearly 4% By 2029: DataM Intelligence

Global Dilated Cardiomyopathy Therapeutics Market is segmented By Drug class (Angiotensin-converting enzyme (ACE) Inhibitors, Beta-blockers, Aldosterone antagonists, Angiotensin II Receptor Blockers, Others), By Distribution Channel (Hospitals & Clinics, Online Channels, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2022-2029

 

Market Overview

The Global "Dilated Cardiomyopathy Therapeutics Market" is expected to grow at a high CAGR of nearly 4,0% during the forecasting period (2022-2029).

Dilated cardiomyopathy (DCM) is an abnormality of the heart muscle, usually starting in your heart's main pumping chamber (left ventricle). The ventricle becomes weakened and enlarged and can't pump blood. A common cause of heart failure is the heart's inability to supply the body with enough blood, and dilated cardiomyopathy also contributes to irregular heartbeats (arrhythmias), blood clots, or sudden death. People of all ages are affected by DCM, including infants and children, but it is most common in men ages 20 to 50.

Market Dynamics

The global dilated cardiomyopathy therapeutics market growth is majorly driven by the rising prevalence of heart problems, the increasing number of people suffering from cardiac muscle infections, and drug or alcohol abuse. Cardiovascular disease (CVD) is a major cause of death in the United States, responsible for 840,768 deaths (635,260 cardiac) in 2016. From 2006 to 2016, the US death rate from CVD declined by 18.6% and from coronary heart disease by 31.8%.

According to the World Health Organization (WHO), 17.5 million deaths in 2013 were related to heart disorders. Dilated cardiomyopathy accounts for 30-40% of the total number of congestive heart failures each year. The estimated prevalence of dilated cardiomyopathy is 1:2500. This condition is one of the most common causes of heart failure. The incidence of dilated cardiomyopathy discovered at autopsy is estimated to be 4.5 cases per 100,000 population per year, whereas the clinical incidence is 2.45 cases per 100,000 population per year. The increasing incidence of congestive heart diseases has created an urgent need for effective drugs and treatment, thereby benefitting the dilated cardiomyopathy therapeutics market.

With the rising demand for dilated cardiomyopathy treatment, several major companies have initiated to carry out clinical trials to develop drugs for dilated cardiomyopathy. There is no specific FDA-approved drug for dilated cardiomyopathy because of which the treatment administered is the same as that for congestive heart failure.

Some of the emerging drugs for the treatment of dilated cardiomyopathy are:

  • ARRY-371797, also known as ARRY-797, is an oral, p38 mitogen-activated protein kinase (MAPK) inhibitor discovered by Array scientists. It is under phase III trial to treat patients suffering from dilated cardiomyopathy because of a Lamin A/C gene mutation. In 2019, Pfizer acquired Array Biopharma to expand its pipeline. This drug is in phase III pipeline drugs of Pfizer under the name PF-07265803 for the treatment of patients affected by dilated cardiomyopathy.
  • Ifetroban is a selective inhibitor of the thromboxane receptor (TPr), preventing fibrosis and inflammatory response, which was initially developed by Bristol-Myers Squibb and acquired by Cumberland 2011.
  • Ixmyelocel-T is an autologous expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. It has been designated as an orphan drug by the U.S. FDA to treat dilated cardiomyopathy. However, now, this drug's development is at a halt as the company does not have current plans to initiate or fund a phase III trial for this drug on its own.
  • BC007 ( Berlin Cures GmbH) is a DNA aptamer-based compound that binds to and eliminates pathogenic autoantibodies directed against the beta-1 adrenoceptor to regulate the heart's rate and contraction strength.
  • Danicamtiv/MYK-491 (MyoKardia) is an orally-administered to increase the number of myosin-actin cross-bridges formed during cardiac muscle contraction while having minimal impact on diastolic function.
  • CAP-1002 (Capricor Therapeutics) is a proprietary allogeneic adult stem cell therapy for treating heart disease and derived from donor heart tissue.

In February 2020, a Keio University research team was given the green light to transplant heart muscle cells derived from iPS cells into patients who have experienced severe heart failure. The study aims to conduct study by the end of 2020 and targets patients with dilated cardiomyopathy, which lowers the systolic function of heart muscle cells.

Hence, these clinical trials' success will positively influence the global dilated cardiomyopathy therapeutics market over the forecast period (2020-2027).

MyoKardia aims to develop drugs for genetically defined patient groups, which is also reflected in its second program, MYK-491, under development for dilated cardiomyopathy. Sanofi has a partnership in 2014 involved in developing three programs through discovery and into clinical development for the treatment of hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM). However, in January 2019, MyoKardia had regained the global rights to all the programs (including mavacamten and MYK-491) under the research and collaboration agreement with Sanofi, which will not be extended beyond the initial research term, which ended on December 31, 2018.  As part of the deal, MyoKardia received roughly $230 million funding from Sanofi and has advanced mavacamten from the preclinical development into a late-stage pivotal study for the treatment of HCM and MYK-491 from discovery to a Phase II proof-of-concept study in patients with DCM.

The severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) is emerging as a global threat due to the virus's high transmission rate. Patients with pre-existing cardiovascular diseases may favor more severe clinical manifestations, and conversely, SARS-CoV-2 may cause myocardial injury. The exponential need for hospitalization and intensive care due to COVID-19 infections thoroughly changed healthcare systems' priorities globally. Hospitals were in part or completely dedicated to Covid-19 patients, and therefore, routine management of patients with inherited channelopathies and cardiomyopathies was suspended in most hospitals.

However, the side effects of dilated cardiomyopathy therapeutics that cause serious discomfort to the patients are restraining the market. Moreover, the availability of implantable devices and promising gene therapy are acting as roadblocks to the market.

Segment Analysis

Based on drug class, the dilated cardiomyopathy therapeutics market is segmented by drug class into angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, aldosterone antagonists, angiotensin II receptor blockers, and others. The angiotensin II receptor blockers drug class is estimated to account for the largest market share, owing to the rising demand for blockbuster drugs in dilated cardiomyopathy treatment, especially in developed regions.

On the other hand, the aldosterone antagonists are expected to grow at the highest CAGR over the forecast period due to the identified positive impact of aldosterone antagonists when used in combination with either ARBs or ACE inhibitors in reducing the progression of Duchenne muscular dystrophy (DMD). Approval for this indication would further accelerate the overall sales of aldosterone antagonists, which would positively impact market growth. According to some studies, the angiotensin receptor blockers such as valsartan can reduce the probability of hospitalization by 28%. These drugs are also effective for patients with systolic heart disease by reducing deaths by 37% and reducing hospitalization frequency. Common anti-arrhythmia medications include amiodarone, procainamide, and lidocaine.  Corlanor is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the cardiac sinus node's spontaneous pacemaker activity. The US FDA approval of Corlanor (ivabradine) for the treatment of stable symptomatic heart failure (HF) due to dilated cardiomyopathy in pediatric patients aged 6 months to 18 years was based on a randomized, double-blind, placebo-controlled trial in 116 patients aged 6 months to less than 18 years with symptomatic DCM in sinus rhythm, NYHA/Ross class II to IV HF, and left ventricular ejection fraction ≤45%. The study's primary endpoint was ≥ a 20% reduction in resting heart rate from baseline without bradycardia or symptoms after an initial titration period.

Geographical Analysis

North American region dominates the global dilated cardiomyopathy therapeutics market, accounting for the largest market share in 2019. The rising incidence of cardiovascular diseases, well-established insurance policies, and the availability of advanced healthcare infrastructure are the major factors. The annual total cost of CVD in the United States was estimated at $351.2 billion in 2014-2015, with $213.8 billion in direct cost, including 46% for inpatient care. In this region, the United States holds the largest market share due to rising geriatric populations, an increasing number of heart diseases in the country, which boosts the demand in this region. Hence, as the number of cardiovascular diseases increases, the market for dilated cardiomyopathy also increases.

Besides, the market players are investing in research and development to conduct new treatment drugs for dilated cardiomyopathy. For instance, in July 2019, Recursion Pharmaceuticals, which uses artificial intelligence to discover drugs, has raised $121 million in a round led by Baillie Gifford. The company is a new drug discovery start-up to raise funds in 2018, as investors flock to the sector hoping that the costly and cumbersome process of finding a drug will be transformed by techniques such as computer vision and machine learning. Recursion is trying to make its own drugs for rare diseases and partner with major pharmaceutical companies such as Takeda and Sanofi on other rare diseases, and hoping to sign deals with pharma companies in areas such as oncology and inflammation.

Competitive Landscape

The dilated cardiomyopathy therapeutics market is moderately competitive with several major players, including Zensun Shanghai Sci & Tech Co Ltd, Capricor Therapeutics, Inc, AstraZeneca plc., Vericel Corporation, Pfizer Inc., t2cure GmbH, MyoKardia, Kasiak Research Pvt. Ltd., among others.

The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, contributing to the growth of the dilated cardiomyopathy therapeutics market globally. For instance,

  • In October 2019, Novartis received the U.S. Food and Drug Administration (FDA) approval for Entresto® (sacubitril/valsartan) for the treatment of symptomatic heart failure (HF) with systemic left ventricular systolic dysfunction in pediatric patients aged 1 year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes.
  • In February 2017, Myokardia Inc., a biopharmaceutical company, announced a first-time administer of MYK-491 to a batch of healthy subjects. MYK-491 is a treatment for dilated cardiomyopathy, which is in Phase 1. However, in January 2019, MyoKardia had regained the global rights to all the programs (including mavacamten and MYK-491) under the research and collaboration agreement with Sanofi, which will not be extended beyond the initial research term, which ended on December 31, 2018

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