Cardiac Amyloidosis Market Size (7MM) is Anticipated to Sustain a Steady CAGR During the Forecast Period 2024-2034 | DelveInsight

DelveInsight's "Cardiac Amyloidosis Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Cardiac Amyloidosis, historical and forecasted epidemiology, and the Cardiac Amyloidosis Market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from Cardiac Amyloidosis Market Report
• The Cardiac Amyloidosis market is anticipated to sustain a steady CAGR during the forecast period 2024-2034, chiefly propelled by advancements in diagnostic techniques, heightened disease awareness, and a growing number of reported cases.
• Cardiac amyloidosis remains a substantially underdiagnosed disease; improved awareness and advances in imaging over the past two decades have improved its noninvasive diagnosis.
• In 2023, the United States held a significant share of the overall 7MM cardiac amyloidosis market, primarily attributed to the country's higher disease prevalence and the elevated cost of available treatments.
• Analysis found the prevalence of cardiac amyloidosis to be approximately 20.1% in Spain.
• The majority of cases were transthyretin-related amyloidosis (ATTR-CM), accounting for approximately 84.6% of cases, while cardiac light-chain amyloidosis (AL-CM) represented approximately 2.2% of total cases.
• A notably higher prevalence was observed in men compared to women, with prevalence among men at approximately 60.1%.
• Prevalence was found to increase with advancing age: 1% (40-49 years), 2% (50-59 years), 9% (60-69 years), 21% (70-79 years), and 26% (80 years or older), a statistically significant trend (p < 0.01).
• The Cardiac Amyloidosis Companies include Pfizer, Alnylam Pharmaceuticals, Alexion Pharmaceuticals, Eidos Therapeutics, Ionis Pharmaceuticals, AstraZeneca, and others.
• Promising Cardiac Amyloidosis Therapies include Vutrisiran, Acoramidis, Eplontersen, and others.

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Recent Developments in the Cardiac Amyloidosis Market
• In January 2025, Life Molecular Imaging secured Fast Track Designation from the US FDA for its amyloid PET radiotracer, used to visualize cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.

What is Cardiac Amyloidosis?
Amyloidosis refers to the extracellular deposition of fibrils composed of low molecular weight subunits of various serum proteins, which can occur in a variety of organs, with involvement of the heart, kidney, liver, and autonomic nervous system most often responsible for observed morbidity and mortality. Cardiac amyloidosis is a disorder caused by amyloid fibril deposition in the extracellular space of the heart; among the different types, nearly all cases of clinical cardiac amyloidosis (>95%) are caused by light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). Cardiac involvement in amyloidosis typically presents with heart failure symptoms and signs with prominent features of right ventricular failure, including lower extremity oedema, jugular vein distention, hepatic congestion, ascites, and dyspnoea. Risk factors include age older than 40, male gender, family history, and other diseases such as multiple myeloma, while symptoms include congestive heart failure, heart rhythm abnormalities, lightheadedness, dizziness, palpitations, shortness of breath, fatigue, and vascular disease, among others.

Cardiac Amyloidosis Epidemiology Segmentation in the 7MM
• Total Prevalent Cases of Cardiac Amyloidosis
• Diagnosed Prevalent Cases of Cardiac Amyloidosis
• Cases segmented by Gender, Age, and Etiology

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Cardiac Amyloidosis Approved Therapies
• VYNDAQEL and VYNDAMAX (tafamidis meglumine/tafamidis): Pfizer
VYNDAQEL and VYNDAMAX are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM. Both are oral transthyretin stabilizers that selectively bind to transthyretin, stabilizing the tetramer of the transthyretin transport protein and slowing the formation of amyloid that causes ATTR-CM. VYNDAQEL was granted Orphan Drug Designation for ATTR-CM in the EU and US in 2012 and in Japan in 2018; the FDA granted it Fast Track (June 2017) and Breakthrough Therapy (May 2018) designations, followed by Priority Review for its NDA in November 2018. In May 2019, the US FDA approved VYNDAQEL and VYNDAMAX for the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. In March 2019, Japan's Ministry of Health, Labour and Welfare approved VYNDAQEL under the SAKIGAKE designation for wild-type and variant ATTR-CM, with regulatory submissions to the EMA under review.

Cardiac Amyloidosis Pipeline Analysis
• Vutrisiran: Alnylam Pharmaceuticals
Vutrisiran is an investigational RNAi therapeutic in development for transthyretin-mediated (ATTR) amyloidosis, encompassing both hereditary (hATTR) and wild-type (wtATTR) forms. It inhibits hepatic production of disease-causing transthyretin (TTR) protein, reducing blood TTR levels, and is currently being evaluated in a Phase III study in patients with transthyretin amyloidosis with cardiomyopathy.

• Acoramidis: Alexion Pharmaceuticals/Eidos Therapeutics/Bridgebio
Acoramidis is an investigational, oral, small molecule; Alexion holds an exclusive license to develop and commercialize it in Japan, where it is being evaluated in a Phase III study of ALXN2060 in Japanese participants with symptomatic ATTR-CM. In December 2023, BridgeBio submitted an NDA for acoramidis to the US FDA for the treatment of ATTR-CM.

• Eplontersen: Ionis Pharmaceuticals/AstraZeneca
Eplontersen is a ligand-conjugated antisense (LICA) investigational medicine designed to reduce production of transthyretin (TTR) protein to treat all types of ATTR, a systemic, progressive, and fatal disease. Designed as a monthly self-administered subcutaneous injection, it is currently in Phase III development for Transthyretin Amyloid Cardiomyopathy.

Cardiac Amyloidosis Companies
Pfizer, Alnylam Pharmaceuticals, Alexion Pharmaceuticals, Eidos Therapeutics, Ionis Pharmaceuticals, AstraZeneca, and others

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Cardiac Amyloidosis Market Outlook
The cardiac amyloidosis therapeutics market is expected to increase due to major drivers such as the rising prevalent population, technological advancements, and upcoming therapies during the forecast period 2024-2034. Diagnosis involves clinical evaluation, blood tests, imaging (echocardiography, MRI/CT), endomyocardial biopsy, and nuclear scans, with genetic testing identifying hereditary forms; a comprehensive, multidisciplinary approach is essential for accurate identification and timely intervention.

Treatment requires a two-pronged approach: for ATTR, stabilization of transthyretin with TTR stabilizers (tafamidis) or liver protein alteration with TTR silencers (patisiran/inotersen) is used, while AL is addressed with chemotherapy or stem cell transplant targeting abnormal plasma cells; symptomatic relief includes diuretics, salt reduction, blood thinners, and, in severe cases, heart transplantation. The existing market is characterized by less competition with limited players including Pfizer, though several companies including Alnylam Pharmaceuticals, Alexion Pharmaceuticals, Eidos Therapeutics, Ionis Pharmaceuticals, and AstraZeneca are developing mid-late stage assets, and with the expected approval of these therapies during the forecast period, the overall therapeutic market is likely to witness a rise at a significant CAGR. In 2023, the United States held a significant share of the overall 7MM market, a dominance projected to persist, especially with the potential early introduction of new products.

Scope of the Cardiac Amyloidosis Market Report
• Study Period: 2020-2034
• Coverage: 7MM (United States, EU4, United Kingdom, and Japan)
• Cardiac Amyloidosis Companies: Pfizer, Alnylam Pharmaceuticals, Alexion Pharmaceuticals, Eidos Therapeutics, Ionis Pharmaceuticals, AstraZeneca, and others
• Cardiac Amyloidosis Therapies: VYNDAQEL, VYNDAMAX, Vutrisiran, Acoramidis, Eplontersen, and others
• Cardiac Amyloidosis Therapeutic Assessment: Cardiac Amyloidosis current marketed and emerging therapies
• Cardiac Amyloidosis Market Dynamics: Cardiac Amyloidosis market drivers and market barriers
• Cardiac Amyloidosis Market Access and Reimbursement, physician perspectives, and prescription patterns

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Table of Contents
1. Key Insights
2. Report Introduction
3. Cardiac Amyloidosis Market Overview at a Glance
4. Epidemiology and Market Methodology
5. Executive Summary
6. Cardiac Amyloidosis Key Events
7. Disease Background and Overview: Cardiac Amyloidosis
8. Epidemiology and Patient Population
9. Patient Journey
10. Marketed Therapies
11. Emerging Therapies
12. Cardiac Amyloidosis: Seven Major Market Analysis
13. Key Opinion Leaders' Views
14. Unmet Needs
15. SWOT Analysis
16. Cardiac Amyloidosis Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

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