Dilated Cardiomyopathy (DCM) - Market Insights, Epidemiology and Market Forecast - 2030

This report delivers an in-depth understanding of the Dilated Cardiomyopathy, historical and forecasted epidemiology as well as the Dilated Cardiomyopathy market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The Dilated Cardiomyopathy market report provides current treatment practices, emerging drugs, Dilated Cardiomyopathy market share of the individual therapies, current and forecasted Dilated Cardiomyopathy market size from 2017 to 2030 segmented by seven major markets. The Report also covers current Dilated Cardiomyopathy treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain and the United Kingdom)
• Japan

Study Period: 2017-2030

Dilated Cardiomyopathy (DCM): Disease Understanding and Treatment Algorithm

Dilated Cardiomyopathy Overview

Cardiomyopathy is a general term that refers to the disorders of the cardiac muscle that cause mechanical or electrical dysfunction resulting in dilated, hypertrophic or restrictive pathophysiology. In Cardiomyopathy, the walls of the heart chambers become stretched, thickened or stiff; this affects the heart's ability to pump blood around the body.

Dilated Cardiomyopathy (DCM) is characterized by left ventricular or biventricular dilation and impaired contraction, which lessens the heart effectiveness at pumping blood that is not explained by abnormal loading conditions like hypertension, valvular heart disease or coronary artery disease. It is a nonischemic heart muscle disease with structural and functional myocardial abnormalities.

The World Health Organization (WHO) defines DCM as a severe cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to substantial morbidity and mortality owing to complications such as heart failure and arrhythmia.

Familial dilated cardiomyopathy is a genetic form of heart disease affecting around 30% cases of DCM. The most common genes involved in DCM are LMNA44, MYH7, TNNT2, TTN46, RBM20, and BAG3. TTN truncating mutations are a common cause of DCM, occurring in 15-20% of familial cases of DCM
Usually, the first symptoms of DCM are shortness of breath during exertion and fatigue; these symptoms result from a weakening of the heart's pumping action. Some people have chest pain. Also, when DCM resulted from an infection, the initial symptoms may be a sudden fever and flu-like symptoms.

Dilated Cardiomyopathy Diagnosis

The diagnosis of DCM is mainly based on the person's symptoms, the results of a physical examination, and additional tests. Diagnosis usually includes blood test for common viruses which can cause DCM and when doctors suspect infection as an underlying cause. Additionally, electrocardiography (ECG) may detect abnormalities in the electrical activity of the heart. However, these abnormalities are not sufficient evidence for diagnosis usually.

DCM is typically diagnosed between 20 and 50 years of age. Clinical diagnosis of DCM has been defined by the presence of the following:

• Fractional shortening < 25% (>2 SD) or ejection fraction < 45% (>2 SD).
• LV end-diastolic diameter >117% (>2 SD of the predicted value of 112% corrected for age and body surface area), excluding any known cause of myocardial disease.

Dilated Cardiomyopathy Treatment

Currently, the treatment pattern of DCM is mainly dependent on pharmacological therapy, pacing therapy, surgical options, and Corlanor (ivabradine). The pharmacological therapies consist of diuretics, inotropic agents, afterload reducing agents, beta-blockers, anticoagulation medications, anti-arrhythmia medications. The main diuretics that are prescribed for the treatment are furosemide, spironolactone, bumetanide, and metolazone. Common side effects of diuretics include dehydration and abnormalities in the blood chemistries particularly potassium loss. Intropic agents that are prescribed for the treatment are digoxin, dobutamine, dopamine, epinephrine, norepinephrine, vasopressin, and milrinone. Some afterload reducing medications include angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril, enalMay, lisinopril, monopril, angiotensin I blocker such as losartan. Losartan and milrinone is an inotropic agent that also relaxes the arteries. Stronger anticoagulation drugs are warfarin, heparin, and enoxaparin; these drugs require careful monitoring with regular blood testing. Common beta-blockers include carvedilol, metoprolol, propranolol, and atenolol. The choice of anticoagulation drugs depends on how likely it is that a blood clot will form. Less strong anticoagulation medications include aspirin and dipyridamole. Common anti-arrhythmia medications include amiodarone, procainamide, and lidocaine.

Also, Corlanor (ivabradine) is an approved therapy for the treatment of 6 months to 18 years old patient affected by Dilated Cardiomyopathy.

Dilated Cardiomyopathy Epidemiology

The Dilated Cardiomyopathy epidemiology division provides the insights about historical and current Dilated Cardiomyopathy patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

The disease epidemiology covered in the report provides historical as well as forecasted Dilated Cardiomyopathy epidemiology segmented as [Total Prevalent Population of Dilated Cardiomyopathy, Total Diagnosed Population of Dilated Cardiomyopathy, Familial and non-familial cases of Dilated Cardiomyopathy, Gender-Specific Cases of Dilated Cardiomyopathy, and Total Treated Cases of Dilated Cardiomyopathy] scenario of Dilated Cardiomyopathy in the 7MM covering the United States, EU5 countries (Germany, France, Italy , Spain, and United Kingdom), and Japan from 2017 to 2030.

Key Findings

• The total prevalent cases of Dilated Cardiomyopathy in the 7MM were found to be 2,486,633 in 2017 which is expected to grow during the study period, i.e., 2017-2030.
• As per the analysis, the total diagnosed cases of Dilated Cardiomyopathy in the 7MM were 846,615 cases in 2017 which is expected to grow during the study period, i.e., 2017-2030.
• As per the analysis, the total prevalent cases of Dilated Cardiomyopathy in the United States were 1,006,256 cases in 2017 which is expected to grow during the study period, i.e., 2017-2030.
• The total gender-specific diagnosed cases of Dilated Cardiomyopathy in the 7MM were observed as 592,631 cases for males and 253,985 cases for females in the year 2017 which is expected to grow during the study period, i.e., 2017-2030.
• The total familial and non-familial cases of Dilated Cardiomyopathy in the United States were observed as 120,751 (~30% of DCM cases) and 281,752 respectively in the year 2017 which is expected to grow during the study period, i.e., 2017-2030.

Dilated Cardiomyopathy Drug Chapters

Drug chapter segment of the Dilated Cardiomyopathy report encloses the detailed analysis of Dilated Cardiomyopathy marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Dilated Cardiomyopathy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Dilated Cardiomyopathy Approved Drug

Corlanor (ivabradine): Amgen
Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility.

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 primary endpoint of the study was ≥ 20% reduction in resting heart rate from baseline without bradycardia or symptoms after an initial titration period.

Dilated Cardiomyopathy Emerging Drugs

PF-07265803/ARRY-371797/ARRY-797: Pfizer

ARRY-371797 which is also known as ARRY-797 is an oral, p38 mitogen activated protein kinase (MAPK) inhibitor discovered by Array scientists. Compared to other p38 MAPK inhibitors ARRY-797 has unique and differentiated properties: it is highly selective, retains exceptional potency in whole blood and possesses a favorable pharmacokinetic profile. It is currently under phase III trial for the treatment of patients affected with dilated cardiomyopathy due to a Lamin A/C gene mutation. In the year 2019 Pfizer completed the acquisition of Array Biopharma to expand its pipeline and currently this drug is in phase III pipeline drugs of Pfizer with name PF-07265803 for the treatment of patients affected by dilated cardiomyopathy.

Ixmyelocel-T: Vericel
Ixmyelocel-T is an investigational autologous expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. Ixmyelocel-T has been designated as an orphan drug by the U.S. Food and Drug Administration for use in the treatment of DCM. However, currently the development of this drug is at halt because as per the recent news the company do not have current plans to initiate or fund a phase III trial for this drug at their own.

BC007: Berlin Cures GmbH
BC007 is a DNA aptamer-based compound that binds to and eliminates pathogenic autoantibodies directed against the beta-1 adrenoceptor, a receptor belonging to the large family of cell surface receptors known as G-protein coupled receptors that regulate the heart's rate and contraction strength.

Ifetroban: Cumberland Pharmaceuticals
Ifetroban is a potent and selective inhibitor of the thromboxane receptor (TPr), preventing fibrosis and an inflammatory response. It was initially developed by Bristol-Myers Squibb as an anti-platelet agent to prevent blood clots (blood thrombus), and was acquired by Cumberland in 2011. It is believed that this drug molecule is able to stop important molecular signals that mediate inflammation and fibrosis (tissue scaring) mechanisms in the heart, triggered by the loss of dystrophin protein.

Danicamtiv/MYK-491: MyoKardia
MYK-491 is an orally-administered small molecule designed to increase the number of myosin-actin cross-bridges formed during cardiac muscle contraction while having minimal impact on diastolic function. In the heart, myosin is the motor protein that binds to actin to generate the force and movement of contraction. In patients with dilated cardiomyopathy and systolic heart failure, in which the left ventricle of the heart is too distended and weak to adequately pump blood to meet the body's needs, MYK-491 is intended to increase myosin-actin engagement, thereby targeting the biomechanical defects underlying disease and improving cardiac contractility.

CAP-1002: Capricor Therapeutics
CAP-1002, Capricor's lead product candidate, is a proprietary allogeneic adult stem cell therapy for the treatment of heart disease. The product is derived from donor heart tissue. The cells are expanded in the laboratory using a specialized process and then introduced directly into a patient's heart via infusion into a coronary artery using standard cardiac catheterization techniques. CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a unique population of cells that has been shown to exert potent immunomodulatory activity and alters the immune system's activity to encourage cellular regeneration.

Products detail in the report.

Dilated Cardiomyopathy Market Outlook

Besides treating any recognizable and reversible underlying causes, the management and treatment of DCM are in concordance with the standard heart failure guidelines. Currently, the treatment pattern of DCM is mainly dependent on pharmacological therapy, pacing therapy, surgical options, and Corlanor (ivabradine).

The pharmacological therapies consist of diuretics, intropic agents, afterload reducing agents, beta-blockers, anticoagulation medications, anti-arrhythmia medications. The main diuretics that are prescribed for the treatment are furosemide, spironolactone, bumetanide, and metolazone. Common side effects of diuretics include dehydration and abnormalities in the blood chemistries particularly potassium loss. Intropic agents that are prescribed for the treatment are digoxin, dobutamine, dopamine, epinephrine, norepinephrine, vasopressin, and milrinone. Some afterload reducing medications include angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril, enalMay, lisinopril, monopril, angiotensin I blocker such as losartan Losartan and milrinone is an inotropic agent that also relaxes the arteries. Stronger anticoagulation drugs are warfarin, heparin, and enoxaparin; these drugs require careful monitoring with regular blood testing.

Angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) have shown benefit in the treatment of heart failure with reduced ejection fraction and are suggested for the patients affected with DCM. Aldosterone receptor blockade with spironolactone or eplerenone also is recommended in patients with New York Heart Association (NYHA) heart failure class II-IV and systolic dysfunction. Similarly, beta-blockade with carvedilol, bisoprolol, or long-acting metoprolol is recommended in all patients with heart failure with reduced ejection fraction without any contraindications. The addition of isosorbide dinitrate plus hydralazine also has shown to increase survival amongst those with advanced disease.

In some cases, beta-blockers allow an enlarged heart to become more normal in size. Common beta-blockers include carvedilol, metoprolol, propranolol, and atenolol. Side effects include dizziness, low heart rate, low blood pressure, and, in some cases, fluid retention, fatigue, impaired school performance, and depression. The choice of anticoagulation drugs depends on how likely it is that a blood clot will form. Less strong anticoagulation medications include aspirin and dipyridamole. Common anti-arrhythmia medications include amiodarone, procainamide, and lidocaine. Also, Corlanor (ivabradine) is an approved therapy for the treatment of 6 months to 18 years old patient affected by Dilated Cardiomyopathy.

Key Findings

According to the publisher, Dilated Cardiomyopathy market in the 7MM is expected to change in the study period 2017-2030. The total therapeutic market of Dilated Cardiomyopathy in seven major markets was found to be USD 244 million in 2017 which is expected to increase during the study period (2017-2030).

The United States Market Outlook

In 2017, the total market size of Dilated Cardiomyopathy therapies was estimated to be USD 142.9 million in the United States which is expected to increase in the study period (2017-2030).

EU-5 Countries: Market Outlook

In 2017, the total market size of Dilated Cardiomyopathy therapies was found to be USD 74.4 million in the EU-5 countries which is expected to increase in the study period (2017-2030).

Japan Market Outlook

The total market size of Dilated Cardiomyopathy therapies in Japan was found to be USD 27.1 million in 2017 which is also expected to increase during the study period (2017-2030).

Dilated Cardiomyopathy Pipeline Development Activities

The drugs which are in pipeline include:

1. PF-07265803/ARRY-371797/ARRY-797: Pfizer
2. Ixmyelocel-T: Vericel
3. BC007: Berlin Cures GmbH
4. Ifetroban: Cumberland Pharmaceuticals
5. Danicamtiv/MYK-491: MyoKardia
6. CAP-1002: Capricor Therapeutics

Access and Reimbursement Scenario in Dilated Cardiomyopathy Therapies

The record published in United HealthCare Services, in the United States, stated that reimbursement is eligible for the CPT codes related to various genetic testing for cardiac disease. CPT code 81439 includes indications such as hereditary cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), genomic sequence analysis panel - must include sequencing of at least five cardiomyopathy-related genes (e.g., DSG2, MYBPC3, MYH7, PKP2, TTN). Moreover, cardiomyopathies that present primarily as neuromuscular disorders and related genetic testing are also covered in the Medical Policy.

KOL - Views

To keep up with current market trends, we take KOL's and SME's opinion working in Dilated Cardiomyopathy domain through primary research to fill the data gaps and validates our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns and Dilated Cardiomyopathy market trend. This will support the clients in the introduction of potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs Competitive and Market Intelligence analysis of the Dilated Cardiomyopathy Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Dilated Cardiomyopathy, explaining its causes, signs and symptoms, pathophysiology and currently available therapies
• Comprehensive insight has been provided into the Dilated Cardiomyopathy epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Dilated Cardiomyopathy are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of Dilated Cardiomyopathy market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Dilated Cardiomyopathy market

Report Highlights

• In the coming years, Dilated Cardiomyopathy market is set to change due to the increasing prevalence rate, increasing healthcare spending, and emerging treatment options, which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academicians are working to assess challenges and seek opportunities that could influence Dilated Cardiomyopathy R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Dilated Cardiomyopathy. Launch of emerging therapies, will significantly impact the Dilated Cardiomyopathy market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Dilated Cardiomyopathy.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase II and Phase I/II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Dilated Cardiomyopathy Report Insights

• Patient Population
• Therapeutic Approaches
• Dilated Cardiomyopathy Pipeline Analysis
• Dilated Cardiomyopathy Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Dilated Cardiomyopathy Report Key Strengths

• 11 Years Forecast
• 7MM Coverage

Dilated Cardiomyopathy Epidemiology Segmentation

• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Dilated Cardiomyopathy Report Assessment

• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• Conjoint Analysis

Key Questions Answered

Market Insights:

• What was the Dilated Cardiomyopathy share (%) distribution in 2017 and how it would look like in 2030?
• What would be the Dilated Cardiomyopathy total market size as well as market size by therapies across the 7MM during the study period (2017-2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Dilated Cardiomyopathy market size during the study period (2017-2030)?
• At what CAGR, the Dilated Cardiomyopathy market is expected to grow in the 7MM during the study period (2017-2030)?
• What would be the Dilated Cardiomyopathy market outlook across the 7MM during the study period (2017-2030)?
• What would be the Dilated Cardiomyopathy market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
• Dilated Cardiomyopathy patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the Dilated Cardiomyopathy market? And how the development of gene therapy will going to impact the therapeutic market of Dilated Cardiomyopathy?
• What are the various patient pools targeted by emerging therapies in clinical trials and which pool is most lucrative in terms of commercial opportunity?

Epidemiology Insights:

• What is the historical Dilated Cardiomyopathy patient pool in the 7MM covering the United States, EU5 (Germany, Spain, France, Italy, the United Kingdom) and Japan?
• What would be the forecasted patient pool of Dilated Cardiomyopathy in the 7MM covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Dilated Cardiomyopathy?
• Out of all the 7MM countries, which country would have the highest prevalent population of Dilated Cardiomyopathy during the study period (2017-2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2017-2030)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of Dilated Cardiomyopathy?
• What are the different types of diagnosed specific segment cases (Familial and Non-familial, Gender Specific) in Dilated Cardiomyopathy? And among them, which are more prominent in Dilated Cardiomyopathy patients?
• What proportion of Dilated Cardiomyopathy patients are suffering from moderate to severe symptoms?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Dilated Cardiomyopathy along with the approved therapy?
• What are the current treatment guidelines for the treatment of Dilated Cardiomyopathy in the United States, Europe and Japan?
• What are the Dilated Cardiomyopathy marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Dilated Cardiomyopathy?
• How many therapies are developed by each company for the treatment of Dilated Cardiomyopathy?
• How many emerging therapies are in mid stage, and late stage of development for the treatment of Dilated Cardiomyopathy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Dilated Cardiomyopathy therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Dilated Cardiomyopathy and their status?
• What are the key designations that have been granted for the emerging therapies for Dilated Cardiomyopathy?
• What is the global historical and forecasted market of Dilated Cardiomyopathy?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Dilated Cardiomyopathy market.
• To understand the future market competition in the Dilated Cardiomyopathy market and Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for Dilated Cardiomyopathy in the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan
• Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for Dilated Cardiomyopathy market
• To understand the future market competition in the Dilated Cardiomyopathy market