확장성 심근병증 치료제 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The dilated cardiomyopathy therapeutic market size stands at USD 381.55 million in 2025 and is forecast to reach USD 489.23 million by 2030, progressing at a 4.23% CAGR over the period.

Demand rises as precision medicine converges with legacy heart-failure pharmacology, giving drug developers clear targets that promise disease-modifying benefit rather than symptom relief alone. SGLT-2 inhibitors, originally diabetes agents, now improve cardiovascular survival in dilated cardiomyopathy, signalling a shift toward metabolic modulation. Simultaneously, genetic profiling is carving rare but lucrative sub-segments that reward high-value therapeutics able to match specific molecular defects. Regulators are supporting this evolution with orphan-drug incentives, yet clinicians still rely on ACE inhibitors and beta-blockers as the therapeutic backbone, underscoring the market's blend of established volume products and high-margin precision assets.

Global Dilated Cardiomyopathy Therapeutic Market Trends and Insights

Rising Global Prevalence of Cardiovascular Diseases

Heart-failure prevalence climbed from 25.43 million cases in 1990 to 55.50 million in 2021, increasing the downstream pool of dilated cardiomyopathy patients who survive acute ischemic events yet progress to chronic ventricular dysfunction. Emerging economies accelerate this burden as urban lifestyles raise hypertension, obesity and metabolic syndrome rates. Longevity gains compound incidence because improved acute care keeps vulnerable myocardium alive long enough to decompensate. Clinicians therefore encounter broader phenotypic variation, urging tailored therapy bundles that move beyond one-size-fits-all protocols. Drug makers recognise the opportunity to segment on comorbid metabolic status, offering combination regimens that synchronise neuro-hormonal blockade with metabolic re-programming. Collectively, disease prevalence and survivorship extend the addressable base for the dilated cardiomyopathy therapeutic market.

Growing Awareness and Early Diagnosis of Dilated Cardiomyopathy

The 2024 European Society of Cardiology criteria for nondilated left ventricular cardiomyopathy enable intervention before overt chamber enlargement, potentially expanding the treatable cohort by 30-40%. Cardiac MRI and strain echocardiography detect subclinical fibrosis, guiding earlier drug initiation. Familial screening programmes uncover mutation carriers decades before symptoms, while consumer genetics platforms seed patient self-referral to specialised clinics. These diagnostic shifts pull therapeutic demand forward in the disease timeline, creating longer treatment windows per patient. Early-stage intervention also boosts response rates, bolstering real-world-evidence packages that facilitate reimbursement. Consequently, drug developers integrate biomarker-based enrichment into clinical trials, accelerating time-to-proof and sharpening market positioning.

High Treatment Costs and Reimbursement Barriers

Mavacamten lists near USD 300,000 annually, while single-dose gene therapies could top USD 1 million, deterring uptake even in insured populations. Payers demand longitudinal outcome data before broad coverage, yet such evidence matures years after launch, delaying revenue inflection. Emerging economies rely on out-of-pocket spending, restricting access to affluent urban consumers and truncating volume growth. Advanced therapies also require serial imaging, genomics and biomarker surveillance, piling ancillary costs onto health systems. Manufacturers are therefore piloting outcomes-based contracts and instalment payment models, yet pricing scepticism persists and tempers the expansion pace of the dilated cardiomyopathy therapeutic market.

Other drivers and restraints analyzed in the detailed report include:

1. Technological Advances in Heart Failure Pharmacotherapy
2. Increasing Adoption of Precision Medicine and Genetic Testing
3. Stringent Regulatory Requirements and Prolonged Approval Timelines

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Current prescriptions continue to lean on ACE inhibitors, yet their 34.65% share in 2024 is gradually eroding as SGLT-2 inhibitors scale fast on a 6.54% CAGR trajectory, bolstered by robust mortality-reduction data. Neuro-hormonal agents retain guideline primacy, but metabolic re-programming introduces a novel disease-modification layer that resonates with cardiologists treating multi-morbid patients. Development pipelines now spotlight cardiac myosin inhibitors and sarcomere modulators targeting contractile mechanics directly; mavacamten set the precedent, and aficamten follows with REMS refinement. Cell-based therapies such as Deramiocel deliver regenerative cues, whereas ARNi products bridge traditional and emerging paradigms by enhancing natriuretic signalling. This breadth of mechanistic diversity enlarges therapeutic armamentarium and supports a complex competitive mosaic for the dilated cardiomyopathy therapeutic market.

Second-generation SGLT-2 assets pursue once-weekly dosing to heighten adherence. Meanwhile, research into mitochondrial modulators seeks to correct energy deficits intrinsic to dilated myocardium. Combination packs that blend neuro-hormonal blockade with metabolic agents are in early trials, foreshadowing fixed-dose formulations that may dominate future prescriptions. Pricing strategies pivot on additive benefit demonstrated in head-to-head trials, an arena where precision-stratified sub-studies confer advantage. The result is a highly segmented yet synergistic product landscape that gives clinicians flexible algorithms while challenging payers to reconcile overlapping indications across chronic comorbidities.

Oral formulations remain the most widely used owing to convenience and familiarity. However, growth momentum is shifting toward device-enabled delivery platforms that supply consistent mechanical or electrical support and circumvent adherence barriers. Leadless left-ventricular pacing, conduction-system pacing and cardiac contractility modulation exemplify minimally invasive implants that augment pharmacotherapy. The 2025 ACC/AHA appropriate-use criteria list 335 clinical scenarios guiding when and how to combine drugs with hardware, reflecting the sophisticated decision tree now facing electrophysiologists [JACC.ORG]. Subcutaneous infusion pumps for novel biologics are also progressing through feasibility studies, promising sustained exposure while avoiding hospital infusion suites.

Digital ecosystems tethered to implants stream haemodynamic data into cloud analytics, permitting algorithm-driven dose adjustment of concomitant oral agents. This closed-loop paradigm blurs the boundary between drug and device markets and invites joint ventures between med-tech and pharmaceutical firms. Though initial capital outlay is high, value-based contracting frameworks linking reimbursement to reduced hospitalisation are emerging, creating economic headroom for premium technologies and expanding total spending within the dilated cardiomyopathy therapeutic market.

The Dilated Cardiomyopathy Therapeutic Market Report is Segmented by Drug Class (ACE Inhibitors, Beta-Blockers, and More), Route of Administration (Oral, Intravenous, and More), Disease Etiology (Genetic/Familial, Idiopathic, and More), End User (Hospitals, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America anchors the dilated cardiomyopathy therapeutic market with 42.43% of global revenue in 2024, underpinned by mature reimbursement systems and guideline leadership that endorses rapid uptake of novel classes. The region's high prevalence of obesity and hypertension sustains a broad pharmacological base, while well-funded academic centres spearhead gene-therapy trials attracting inward investment. Convergence of payer pressure and outcomes-based contracts is gradually shifting economic risk onto manufacturers, yet premium drugs still win adoption where real-world data verify hospitalisation reductions.

Europe follows with steady single-digit growth, supported by cross-border reference pricing and the European Medicines Agency's rolling-review pathway that accelerates authorisation for breakthrough therapies. Country-level heterogeneity persists-Germany embraces device integration swiftly whereas Southern Europe remains price-sensitive-yet guideline harmonisation maintains consistent clinical practice. The dilated cardiomyopathy therapeutic market benefits from strong patient-advocacy networks in the United Kingdom, Netherlands and Scandinavia, which facilitate registry-driven evidence gathering that convinces public payers to reimburse high-cost precision agents.

Asia-Pacific, growing at 5.45% CAGR, is reshaping the global outlook as China's heart-failure prevalence rises faster than the world average and governments boost cardiovascular budgets. Japan's super-aged demographic fuels device uptake, while India's emerging middle class diversifies demand beyond public tertiary hospitals into private cardiology chains. Regulatory agencies in China and South Korea are launching real-time review pilots to shorten approval lag behind the US and EU, promising earlier revenue capture for multinational sponsors. Nonetheless, variable insurance coverage and price caps compel tiered-pricing models that preserve volume while protecting global list pricing integrity within the dilated cardiomyopathy therapeutic market.

1. AstraZeneca
2. Pfizer
3. Novartis
4. Bristol Myers Squibb (Incl. MyoKardia)
5. Capricor Therapeutics
6. Zensun (Shanghai) Sci-Tech Co. Ltd.
7. Tenaya Therapeutics Inc.
8. t2cure
9. Vericel
10. Ionis Pharmaceuticals
11. Rocket Pharmaceuticals Inc.
12. BridgeBio Pharma Inc.
13. Eli Lilly and Company
14. Johnson & Johnson
15. Merck
16. Abbott Laboratories
17. Medtronic
18. Renovacor Inc.
19. CellProthera SA

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global Prevalence of Cardiovascular Diseases
  • 4.2.2 Growing Awareness and Early Diagnosis of Dilated Cardiomyopathy
  • 4.2.3 Technological Advances in Heart Failure Pharmacotherapy
  • 4.2.4 Increasing Adoption of Precision Medicine and Genetic Testing
  • 4.2.5 Robust Pipeline of Novel Therapies and Regulatory Support
  • 4.2.6 Expanding Healthcare Expenditure in Emerging Economies
• 4.3 Market Restraints
  • 4.3.1 High Treatment Costs and Reimbursement Barriers
  • 4.3.2 Stringent Regulatory Requirements and Prolonged Approval Timelines
  • 4.3.3 Safety Concerns and Adverse Effects of Polypharmacy
  • 4.3.4 Limited Access to Advanced Therapies in Low- And Middle-Income Regions
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat Of New Entrants
  • 4.5.2 Bargaining Power Of Buyers/Consumers
  • 4.5.3 Bargaining Power Of Suppliers
  • 4.5.4 Threat Of Substitute Products
  • 4.5.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Drug Class
  • 5.1.1 ACE Inhibitors
  • 5.1.2 Beta-Blockers
  • 5.1.3 Angiotensin II Receptor Blockers
  • 5.1.4 Aldosterone Antagonists
  • 5.1.5 Angiotensin Receptor-Neprilysin Inhibitors (ARNi)
  • 5.1.6 SGLT-2 Inhibitors
  • 5.1.7 Other / Emerging (Gene, Cell, Myosin Modulators)
• 5.2 By Route Of Administration
  • 5.2.1 Oral
  • 5.2.2 Intravenous
  • 5.2.3 Subcutaneous
  • 5.2.4 Implantable / Device-Mediated
• 5.3 By Disease Etiology
  • 5.3.1 Genetic / Familial
  • 5.3.2 Idiopathic
  • 5.3.3 Ischemic
  • 5.3.4 Toxin-Induced (Alcohol, Chemotherapy, Etc.)
  • 5.3.5 Infectious / Inflammatory
  • 5.3.6 Endocrine / Metabolic
  • 5.3.7 Other Diseases
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Cardiology Clinics
  • 5.4.3 Research & Academic Institutes
  • 5.4.4 Other End Users
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 AstraZeneca PLC
  • 6.3.2 Pfizer Inc.
  • 6.3.3 Novartis AG
  • 6.3.4 Bristol Myers Squibb (Incl. MyoKardia)
  • 6.3.5 Capricor Therapeutics Inc.
  • 6.3.6 Zensun (Shanghai) Sci-Tech Co. Ltd.
  • 6.3.7 Tenaya Therapeutics Inc.
  • 6.3.8 t2cure GmbH
  • 6.3.9 Vericel Corporation
  • 6.3.10 Ionis Pharmaceuticals Inc.
  • 6.3.11 Rocket Pharmaceuticals Inc.
  • 6.3.12 BridgeBio Pharma Inc.
  • 6.3.13 Eli Lilly And Company
  • 6.3.14 Johnson & Johnson (Janssen)
  • 6.3.15 Merck & Co. Inc.
  • 6.3.16 Abbott Laboratories
  • 6.3.17 Medtronic PLC
  • 6.3.18 Renovacor Inc.
  • 6.3.19 CellProthera SA

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment