The Dilated Cardiomyopathy (DCM) Market is on a trajectory of substantial growth, with expectations set for it to reach a remarkable US$ 7.5 billion by 2030, a significant leap from the US$ 4.8 billion recorded in 2023. This journey towards expansion is marked by a robust Compound Annual Growth Rate (CAGR) of 6.6% during the forecast period spanning from 2023 to 2030.
DCM, at its core, is characterized by the enlargement of the heart chambers, resulting in impaired blood-pumping efficiency. This condition undermines the heart's ability to circulate blood effectively, ultimately raising the risk of heart failure. Treatment modalities for DCM encompass a spectrum of approaches, including medication regimens, the deployment of devices such as pacemakers, and, in extreme cases, heart transplantation. The driving forces behind this burgeoning market are twofold: the escalating global prevalence of DCM and the continuous advancements in diagnostic and therapeutic technologies.
Dilated cardiomyopathy, or DCM, stands as a formidable ailment of the heart muscle, culminating in the enlargement of heart chambers and a subsequent decline in blood-pumping efficiency. This reduction in cardiac efficacy can culminate in heart failure, rendering DCM a critical medical concern. While DCM is frequently hereditary, it can also be triggered by coronary artery disease, viral infections, excessive alcohol consumption, and specific medications. The treatment regimen for DCM is oriented towards symptom management through the use of medications and a range of devices. In the most severe instances, consideration is given to heart transplantation as a life-saving measure.
The Dilated Cardiomyopathy Market unfolds its multifaceted nature through a comprehensive segmentation strategy, encompassing product type, end-user demographics, disease stage, treatment modality, diagnostic tools, and geographical regions. Product categories within this market include drugs, implantable devices, monitoring devices, and other related options. Implantable devices, particularly pacemakers and defibrillators, claim a substantial market share, primarily due to their widespread utilization in mitigating the symptoms of DCM. Companies operating in this arena are actively engaged in pioneering advanced implantable cardiac devices, such as Cardiac Resynchronization Therapy (CRT) and leadless pacemakers, underscoring the commitment to innovation within this dynamic sector.
- DCM has a global disease prevalence of 1 in 250 individuals. The incidence is higher in men compared to women.
- The prevalence of DCM is rising globally, with increasing rates in developing regions in Asia and Africa. DCM prevalence is expected to increase at 4-6% annually during the forecast period.
- In the US, around 600,000 people are living with DCM, with 20,000 new cases every year. In the EU5, Germany has the highest number of DCM cases.
- Japan has a high DCM prevalence of 1 in 200 adults. Familial inheritance is responsible for up to 50% cases in Japan.
- The rising prevalence of risk factors like hypertension, obesity, and coronary artery disease is driving DCM incidence.
- There is a high unmet need for targeted DCM therapies. Most treatment focuses on managing symptoms rather than targeting disease pathways.
- Current therapies include ACE inhibitors, beta blockers, diuretics, inotropes, and cardiac devices like CRT and ICDs. Heart transplant is the only definitive treatment.
- Several gene therapies, RNA/DNA-based therapies, and stem cell regenerative treatments are under development to halt or reverse DCM progression.
- Companies are developing novel drugs to target myocardial fibrosis and inflammatory pathways involved in DCM.
- The DCM drugs market has a mix of generic and branded drugs. Device makers like Medtronic, Abbott, and Boston Scientific lead the implantable devices segment.
Dilated Cardiomyopathy Market Drivers:
Increasing Prevalence of Dilated Cardiomyopathy
The rising prevalence of dilated cardiomyopathy (DCM) globally is a major factor driving growth in the DCM drugs and devices market. DCM has a high disease burden worldwide, with an estimated prevalence of 1 in 250 individuals. The annual incidence rates are increasing at 4-6% each year across regions like North America, Europe, and Asia Pacific. Developing countries in Asia and Africa are expected to see the highest growth in DCM prevalence due to rising risk factors like hypertension, obesity, and lifestyle diseases. The growing patient pool is increasing demand for DCM medications and implantable cardiac devices like pacemakers and defibrillators for managing symptoms. Higher diagnosis rates owing to improving access to imaging tests is also contributing to growth.
Advancements in Diagnosis and Monitoring
The introduction of advanced diagnostic and monitoring technologies for DCM is fueling market growth. New cardiac imaging techniques like cardiac MRI and 3D echocardiography allow earlier diagnosis and better assessment of DCM. Wearable heart monitoring devices enable continuous remote tracking of DCM patients. Real-time waveform data helps doctors better manage medications and device functioning. Big data analytics of patient data is enabling development of predictive algorithms to assess DCM progression. Companies are investing significantly in such digital technologies like artificial intelligence for quicker DCM diagnosis. The emergence of blood-based genomic & proteomic biomarker tests facilitates diagnosis and treatment selection.
Product Innovation in Drugs and Devices
The DCM market growth is accelerated by continuous new product development and innovation by pharmaceutical and medical device companies. Drug manufacturers are identifying novel compounds and targets to address the molecular mechanisms involved in DCM progression. Devices like implantable cardioverter-defibrillators (ICD), cardiac resynchronization therapy (CRT) systems, and ventricular assist devices (VADs) are becoming smaller, safer, and more efficient. For instance, leadless pacemakers eliminate cardiac infection risks associated with transvenous leads. Introduction of new generation left ventricular assist devices like HeartMate3 has improved survival rates and quality of life in severe DCM. Such product innovations that improve clinical outcomes are boosting market revenues.
Emerging Therapies like Gene and Stem Cell Therapy
Ongoing research and pipeline successes in novel therapies like gene therapy, RNA-based targets, and stem cell treatments are key long-term growth drivers for the DCM market. These emerging biological approaches aim to address the root pathological causes of DCM and regenerate functional cardiomyocytes. Gene therapy clinical trials delivering SERCA2a enzyme gene have shown improved cardiac functioning and remodeling in DCM patients. Stem cell therapy using cardiosphere-derived cells (CDCs) is also being explored to restore cardiomyocyte proliferation. Companies are investing significantly in R&D of these futuristic therapies which could transform DCM treatment when commercialized.
The market size in 2023
US$ 4.8 Bn
CAGR (2023 - 2030)
The revenue forecast in 2030
US$ 7.5 Bn
Base year for estimation
Revenue in USD Million, and CAGR from 2021 to 2030
By Therapeutics: Aldosterone antagonists, Angiotensin-converting enzyme (ACE) Inhibitors, Angiotensin II Receptor Blockers, Beta-blockers, Others
By Distribution Channel: Hospitals Pharmacies, Retail Pharmacies, Online Pharmacies
North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
Amgen, AstraZeneca, Bayer, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi, Abbott Laboratories, Teva Pharmaceuticals
Dilated Cardiomyopathy Market Opportunities:
Combination Therapies for Enhanced Efficacy
The development of combination treatment approaches presents significant opportunities in the DCM market. Combining devices like CRT with optimal drug regimens can improve overall outcome versus monotherapy. For instance, CRT combined with angiotensin receptor neprilysin inhibitor sacubitril/valsartan therapy showed reduced mortality and hospitalization. Dual gene therapy delivering both S100A1 and SERCA2a shows promise in advancing pre-clinical studies. Combining stem cell therapy with drugs like metformin improves cell proliferation and cardiac functioning. Such multi-modal therapies that leverage synergistic mechanisms can increase efficacy, benefit high-risk patients and enable lower dosage & toxicity.
Growing Adoption of Minimally Invasive Procedures
The increasing shift towards minimally invasive, catheter-based structural heart procedures for DCM treatment will unlock major growth opportunities. Transcatheter mitral valve repair using MitraClip edge-to-edge technique is less invasive than open-heart surgery for mitral valve regurgitation in DCM patients. Catheter-based left atrial appendage occlusion devices like Watchman can reduce stroke risk in DCM patients with atrial fibrillation. Technologies like renal denervation to treat hypertension can help prevent DCM onset. Robotic navigation platforms like CorPath GRX facilitate precision in minimally invasive structural heart procedures. Such approaches increase therapy access, reduce hospital stay duration and support faster patient recovery.
Growing Potential in Emerging Economies
The rising DCM burden and improving healthcare access in developing regions represents a significant opportunity for market players. Countries like India, China, Mexico, Brazil, South Africa, Egypt, Indonesia and Philippines have huge underpenetrated patient populations and increasing healthcare spending. Local manufacturing, partnerships with regional players and differentiated pricing strategies will be key growth strategies for companies in these markets. Growing medical tourism for advanced cardiac treatments also offers possibilities. Strengthening distribution channels and increasing awareness will help tap the full potential of emerging markets.
Digital Health and Remote Care Solutions
Innovative digital health solutions for DCM patients provide huge expansion possibilities for companies. Digital therapeutics delivering personalized health coaching and education can improve medication adherence and lifestyle changes. Remote monitoring through mobile apps allows clinicians to manage patients virtually. Analytics of patient data enables optimization of therapies. Home-based cardiac rehabilitation lowers hospital visits. An integrated digital ecosystem that seamlessly connects patients, providers and payers can improve efficiency across the care continuum. Partnerships with tech firms to develop smart software, wearables and virtual care platforms focused on DCM will be key growth strategies.
Dilated Cardiomyopathy Market Trends:
Increasing Adoption of Advanced Cardiac Imaging
The DCM drugs and devices market is positively impacted by the growing adoption of advanced non-invasive cardiac imaging technologies like cardiac MRI and 3D echocardiography. These modalities allow accurate evaluation of myocardial structure, function, fibrosis, morphology and tissue characterization - crucial for DCM diagnosis and monitoring. Cardiac MRI avoids radiation exposure and provides superior visualization. Approval of contrast agents like MultiHance further strengthens MRI’s value proposition. 3D echocardiography offers more reliable LV quantification over 2D. Handheld portable ultrasound scanners improve usability at lower cost. These advantages are accelerating integration of such modalities into clinical practice.
Shifting Preference Towards Subcutaneous ICDs
The increasing surgeon preference for subcutaneous implantable cardioverter defibrillator (S-ICD) system over transvenous ICDs (TV-ICD) among DCM patients is an important trend. S-ICD placement avoids lead-related complications like thrombosis and infections associated with TV-ICD. The less invasive nature of S-ICD implantation procedure reduces risks in seriously ill heart failure patients. Lead durability concerns with TV-ICD also boosts S-ICD adoption. Ongoing technology enhancements like dual-zone programming, smarter sensing algorithms in S-ICD, and introduction of MRI-compatible S-ICD systems are expected to address prior limitations and accelerate adoption.
Growing Focus on Biomarker Research
Extensive research ongoing to identify and validate novel genomic, proteomic and metabolic biomarkers for DCM diagnosis and treatment selection is a key trend in this market. Companies are developing biomarker panels leveraging latest omics technology to enable precision approaches. For instance, the Heart Failure DCM classifier uses a 21-biomarker algorithm to ascertain DCM-related heart failure. MyoVista gel-based 2D proteomic assay helps identify responders for cardiotoxic cancer therapy. Biomarker insights help match therapies based on individual molecular profiles, predict outcomes and enable early intervention – helping improve care in DCM.
Value-based Care and Risk-sharing Models
The shift towards value-based healthcare and risk-sharing payment models between device manufacturers and payers represents an important market trend. Programs where device makers partly bear costs of managing DCM device complications incentivize quality and improve clinical outcomes cost-effectively. Value-based contracts where payment is tied to patient results reduce payer risks in new high-cost DCM therapies. Collaborative partnerships between industry and payers to enhance DCM management are increasing. Transition from volume to value-based care is crucial for long-term market growth and profitability.
Dilated Cardiomyopathy Market Restraints:
High Costs of Drug and Device Therapy
The high cost of pharmaceutical and device therapy for managing DCM symptoms negatively impacts adoption and market growth. Annual cost per DCM patient on guideline-directed medical therapy can be USD 8000 or more in developed markets. Newer drugs like Entresto are expensive, limiting access. Implantable cardiac devices like CRT-D and ICD cost over USD 25000, which is unaffordable for many patients. Even monitoring systems like insertable loop recorders cost thousands of dollars. Lack of reimbursement coverage for new innovative DCM therapies also restricts uptake. Healthcare budget constraints due to rising prevalence further compounds affordability challenges.
Stringent Regulatory Approval Requirements
The stringent approval requirements and long development timelines pose significant barriers to the introduction of novel DCM therapies, hampering market growth. Companies have to invest heavily in large randomized controlled clinical trials to establish product safety and efficacy. For instance, AGENT-HF trial for Celladon’s gene therapy MYDICAR had disappointing results despite early promise. Delayed approvals or rejection after lengthy trials result in huge losses for manufacturers. Regulatory hurdles are much higher for cutting-edge therapies like gene editing. Extensive post-marketing surveillance requirements also apply. Such challenges make companies risk-averse to investing in unproven but innovative R&D areas.
Low Diagnosis Rates in Developing Regions
The lack of awareness and limited diagnostic infrastructure in developing countries leads to underdiagnosis of DCM, restricting market potential. Deficiencies in primary care and limited access to echocardiography or cardiac MRI technologies hamper DCM case identification, especially in rural regions. Lack of universal screening programs also contributes to underdiagnosis. Delayed diagnosis prevents early treatment initiation when outcomes can be improved. Poor health literacy regarding cardiac disease symptoms among populations adds to the problem. Concerted efforts to improve diagnosis rates through increased spending, access and awareness campaigns will be vital to tap these markets.
Recent Developments in Dilated Cardiomyopathy Market:
FDA approved MitraClip device for DCM in May 2022 - MitraClip repairs leaky mitral valves, a common DCM symptom. It expands Abbott's position in structural heart devices.
FDA approved HeartMate 3 LVAD system in Jan 2021 - It is a left ventricular assist device improving survival rates in advanced heart failure patients.
European approval for Entresto to treat symptomatic chronic HFrEF patients in Feb 2021 – Entresto significantly reduces CV death and heart failure hospitalizations.
FDA approval for MyoKardia’s mavacamten to treat symptomatic obstructive HCM in Sept 2022 - First targeted therapy for this genetic heart disease.
Bristol Myers Squibb
Medtronic announced results of late-stage study of TYRX absorbable antibacterial envelopes in Jan 2022 - Envelopes reduce cardiac implant infections.
FDA approved Boston Scientific’s LUX-Dx insertable cardiac monitor in Dec 2020 - It detects irregular heart rhythms remotely.
Abbott acquired St. Jude Medical for $25 billion in Jan 2017 - Expanded Medical its cardiovascular devices portfolio.
Abbott, St. Jude
Medtronic acquired EPIX Therapeutics for $1.7 billion in Jan 2022 - Gains catheter ablation technologies.
Boston Scientific acquired Baylis Medical for $1.75 billion in Aug 2022 - Baylis Medical Expands its electrophysiology business.
Dilated Cardiomyopathy Market Regional Insights:
The landscape of the Dilated Cardiomyopathy (DCM) market is characterized by varying prevalence rates across geographic regions, with developed nations holding the highest rates and developing countries poised to fuel future growth. A closer look at regional insights unveils pivotal trends and factors that drive the dynamics of this market.
- North America: North America is set to emerge as the largest market for Dilated Cardiomyopathy, commanding a substantial market share of 41.2% in 2023. This dominance is propelled by several factors, including high rates of DCM diagnosis and widespread access to advanced treatment options. The region is well-equipped to address the healthcare needs of individuals suffering from DCM, contributing significantly to its market leadership.
- Europe: Europe follows closely behind, securing its position as the second-largest market, with a substantial market share of 32.5% in 2023. The European Union's "EU5" nations grapple with rising obesity rates and a surge in cardiac disorders, which are key drivers of market growth. This trend underscores the growing demand for DCM diagnosis and treatment options across the continent.
- Asia Pacific: The Asia Pacific region emerges as the fastest-growing market for Dilated Cardiomyopathy, with a remarkable projected CAGR of over 8% during the period from 2023 to 2030. This growth is attributed to the ongoing development of healthcare infrastructure in many Asian nations, coupled with an increasing prevalence of DCM cases. As healthcare accessibility improves and awareness rises, the Asia Pacific region is poised for significant market expansion, holding a market share of 12.3%.
- Other Regions: Latin America and the Middle East & Africa regions play their part in the global DCM market, with market shares of 7.5% and 6.5%, respectively. While these regions may have relatively smaller shares, they are integral contributors to the overall global landscape. These regions, with their unique healthcare challenges, are gradually stepping up efforts to address DCM-related concerns.
In conclusion, the regional dynamics of the Dilated Cardiomyopathy market underscore the pivotal role of factors such as healthcare infrastructure, disease prevalence, and awareness. While North America and Europe remain dominant players, the Asia Pacific region is poised for remarkable growth, presenting substantial opportunities for market expansion. Additionally, Latin America and the Middle East & Africa regions continue to be essential components of the global DCM landscape.
Dilated Cardiomyopathy Market Segmentation:
- Aldosterone antagonists
- Angiotensin-converting enzyme (ACE) Inhibitors
- Angiotensin II Receptor Blockers
By Distribution Channel
- Hospitals Pharmacies
- Retail Pharmacies
- Online Pharmacies
- North America
- Rest of Europe
- Asia Pacific
- South Korea
- Rest of Asia Pacific
- Latin America
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- North Africa
- Central Africa
- Rest of the Middle East
Top companies in the Dilated Cardiomyopathy Market
- Abbott Laboratories
- Johnson & Johnson
- Teva Pharmaceuticals