확장성 심근병증은 가장 흔한 심근증의 일종으로 보통 20-60대에 발병합니다. 심근이 정상적으로 수축하는 것이 어려워져 부정맥, 혈전, 돌연사 등을 유발할 수 있습니다. 시간이 지남에 따라 심장이 약해져 심부전을 일으킬 수 있습니다.
확장성 심근병증은 초기에는 증상이 나타나지 않을 수 있습니다. 무증상부터 심각한 심부전까지 증상이 서서히 또는 빠르게 악화될 수 있습니다. 증상으로는 운동 시 호흡곤란, 피로감, 다리 부종, 기침, 심장 리듬 이상 등이 있습니다. 확장성 심근병증의 정확한 원인은 아직 밝혀지지 않은 경우가 많지만(특발성), 발병 위험을 증가시킬 수 있는 몇 가지 요인이 확인되었습니다. 이러한 위험요인은 크게 유전적 요인, 환경적 요인, 생활습관 요인(약물남용, 화학요법제)으로 나뉩니다.
확장성 심근병증의 진단은 심장 기능 장애의 다른 가능한 원인을 배제하고 심장의 구조적 및 기능적 이상을 확인하기 위해 방법론적 접근 방식을 사용합니다. 병력, 신체 검사, 영상 검사, 심장 MRI, 심전도, 심초음파, 혈액 검사 등 심장 검사 및 기타 검사를 종합적으로 평가합니다.
7개 주요 국가의 확장성 심근병증 시장 규모는 2023년 약 4억 6,360만 달러로 예측 기간(2024-2034년) 동안 확대될 것으로 예상됩니다. 미국의 확장성 심근병증 시장 규모는 2023년 약 3억 2,940만 달러로, 질환에 대한 인식이 개선되고 새로운 치료법이 출시됨에 따라 증가할 것으로 예상됩니다.
EU 4개국과 영국의 2023년 시장 규모는 약 1억 달러로 주요 7개국 총 시장 수익의 약 22%에 해당하며, EU 4개국과 영국 중 2023년 시장 규모가 가장 큰 국가는 독일로 약 2,560만 달러, 프랑스 약 2,080만 달러, 영국 약 2,070만 달러로 나타났습니다.
이 보고서는 주요 7개국의 확장성 심근병증 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 의료 미충족 수요 등을 제공합니다.
DelveInsight's "Dilated Cardiomyopathy - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of dilated cardiomyopathy, historical and forecasted epidemiology, as well as the dilated cardiomyopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The dilated cardiomyopathy market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM dilated cardiomyopathy market size from 2020 to 2034. The report also covers dilated cardiomyopathy treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
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. According to the National Organization for Rare Disorders (NORD), dilated cardiomyopathy is a disease of the heart muscle, which primarily affects the heart's main pumping chamber, the left ventricle.
It is the most common type of cardiomyopathy and typically affects those aged 20-60. The heart muscle has difficulty contracting normally, which can lead to irregular heartbeats (arrhythmia), blood clots, or sudden death. Over time, the heart becomes weaker, and heart failure can occur.
In its early stages, dilated cardiomyopathy may not produce any symptoms. Symptoms may worsen gradually or quickly from asymptomatic to severe heart failure. Some symptoms include shortness of breath during exercise, fatigue, swelling in the legs and other areas, coughing, abnormal heart rhythms, and others. While the exact cause of dilated cardiomyopathy is often unknown (idiopathic), several factors have been identified that may increase the risk of developing the condition. These risk factors can be broadly categorized into genetic, environmental, and lifestyle factors (substance abuse, and chemotherapeutic agents).
Dilated cardiomyopathy diagnosis
A methodical approach is used to diagnose dilated cardiomyopathy to rule out other possible causes of cardiac dysfunction and identify structural and functional abnormalities in the heart. A comprehensive evaluation of medical history, physical examination, imaging tests, and cardiac tests-such as cardiac MRI, ECG, echocardiogram, and blood tests-as well as other tests are performed.
Further details related to country-based variations are provided in the report...
Dilated cardiomyopathy treatment
The management and treatment of dilated cardiomyopathy are in concordance with the standard heart failure guidelines. Currently, the treatment pattern of dilated cardiomyopathy is mainly dependent on pharmacological therapy, pacing therapy, and surgical options.
ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists are commonly prescribed to manage symptoms and improve heart function. However, the response to these medications can vary among individuals, and some patients may not achieve adequate improvement with pharmacotherapy alone. Even CRT involving the implantation of a device to coordinate the contractions of the heart's ventricles can be beneficial for some patients, particularly those with conduction abnormalities or dyssynchrony in their heart muscle contraction but not all patients with dilated cardiomyopathy may benefit from CRT, and response rates might vary.
In severe cases of dilated cardiomyopathy, surgical interventions such as heart transplantation may be considered. Heart transplantation remains the gold standard for end-stage dilated cardiomyopathy, but it is limited by donor availability and the need for lifelong immunosuppression.
As the market is derived using a patient-based model, the dilated cardiomyopathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of dilated cardiomyopathy, total diagnosed prevalent cases of dilated cardiomyopathy, gender-specific cases of dilated cardiomyopathy, familial and non-familial cases of dilated cardiomyopathy in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the dilated cardiomyopathy report encloses a detailed analysis of dilated cardiomyopathy-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps 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.
Marketed Drugs
CORLANOR (ivabradine): Amgen/Les Laboratoires Servier
CORLANOR (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. Its mechanism of action involves the inhibition of the IF channels in the sinoatrial node of the heart.
CORLANOR is also approved to reduce the risk of hospitalization for worsening HF in adult patients with stable, symptomatic chronic HF with left ventricular ejection fraction =35%, who are in sinus rhythm with a resting heart rate =70 bpm and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Moreover, the drug candidate is marketed as PROCORALAN in the EU, for the symptomatic treatment of stable angina and chronic heart failure in patients with elevated heart rates. Additionally, through a collaboration with Servier, Amgen has the rights to commercialize ivabradine in the US.
In April 2019, the US FDA approved the marketing authorization of CORLANOR (ivabradine) for the treatment of stable symptomatic HF due to dilated cardiomyopathy in pediatric patients aged 6 months and older who are in sinus rhythm with an elevated heart rate.
Emerging Drugs
Danicamtiv (MYK-491): Bristol Myers Squibb
Danicamtiv (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 pump blood to meet the body's needs adequately, MYK-491 is intended to increase myosin-actin engagement, thereby targeting the biomechanical defects underlying disease and improving cardiac contractility.
Currently, the company is conducting a Phase II study in patients with genetically dilated cardiomyopathy. Additionally, danicamtiv is also being investigated in patients with systolic dysfunction and atrial fibrillation.
Drug Class Insights
Dilated cardiomyopathy is characterized by the enlargement (dilation) of the heart's left ventricle, impairing its ability to pump blood efficiently. Some of the drug classes commonly used in the management of dilated cardiomyopathy include ACE inhibitors, angiotensin receptor blockers, beta-blockers, and others.
Hyperpolarization-activated cyclic nucleotide-gated channels play a crucial role in the generation of pacemaker currents in the sinoatrial node of the heart. These channels, specifically contribute to the IF current, which regulates the spontaneous depolarization of SA node cells, ultimately influencing heart rate in patients with dilated cardiomyopathy. Based on this mechanism of action Amgen's CORLANOR is US FDA-approved for treating stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients aged 6 months to 18 years old.
ACE inhibitors or ARB are used in the treatment of heart failure with reduced ejection fraction and are suggested for patients affected with dilated cardiomyopathy. Aldosterone receptor blockade with spironolactone or eplerenone is also 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 been 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.
Furthermore, 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.
Continued in report...
Currently, the treatment pattern of dilated cardiomyopathy 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, and 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 chemistry, particularly potassium loss.
Key players Bristol Myers Squibb, Berlin Cures, Cumberland Pharmaceuticals, Rocket Pharmaceuticals, Solid Biosciences, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat dilated cardiomyopathy
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Berlin Cures BC007 is expected to enter the US market by 2028 and is projected to have a slow-medium uptake during the forecast period.
Further detailed analysis of emerging therapies drug uptake in the report...
Dilated Cardiomyopathy Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for dilated cardiomyopathy.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on dilated cardiomyopathy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Washington, Johns Hopkins University School of Medicine, University Heart Centre Hamburg, Germany, Careggi University Hospital, Italy, and the Royal Brompton Hospital, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or dilated cardiomyopathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
According to our primary research analysis, various ACE inhibitors, and ARB therapies are available in the market and prescribed for symptomatic relief and managing heart-related complications however, no therapy has yet been approved to address dilated cardiomyopathy in adults. Surgical options, such as heart transplant, are considered the gold standard treatment for end-stage dilated cardiomyopathy when medical therapy is no longer effective and the patient's quality of life is significantly impacted. However, as with any surgical procedure, heart transplantation has potential risks and side effects. For example, the body's immune system may still recognize the transplanted heart as foreign tissue and attempt to reject it.
The current pipeline contains adeno-associated virus gene therapy therapies, BAG3 protein replacements, and several small molecules that target different pathways in dilated cardiomyopathy. The entry of these drugs will provide different options relating to patient-specific needs based on the severity of dilated cardiomyopathy.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
The current treatment regime for dilated cardiomyopathy in the US has high costs of treatment that affect the affordability and access of drugs to patients. The reimbursement challenges related to medical care and treatment for individuals with dilated cardiomyopathy can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care.
Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. There is financial assistance available from both governments and pharmaceutical companies to help people who cannot afford the cost of their medications and to expand the coverage.
The CORLANOR (ivabradine) Patient Support Program, launched by the Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen, aims to provide qualifying patients with free access to Amgen medications. Eligible commercially insured patients with dilated cardiomyopathy can pay as little as USD 20 per month through the CORLANOR (ivabradine) Copay Card Program.
Similarly, the HealthWell Foundation estimates that patients in the United States will spend an average of USD 2,520 during the 12-month grant period for this disease area. However, the HealthWell fund can assist with premium payments. Medicare supplemental policies can assist with cost-sharing for many aspects of your healthcare, and a HealthWell Foundation grant to cover premiums may be preferable to treatment-specific cost-sharing.
Further details will be provided in the report.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Dilated cardiomyopathy report insights
Dilated cardiomyopathy report key strengths
Dilated cardiomyopathy report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies