The Transthyretin Amyloid Cardiomyopathy (ATTR-CM) market is experiencing transformative growth, led by next-generation therapeutics, increasing diagnosis rates, and strong regulatory momentum. Once considered underdiagnosed and undertreated, ATTR-CM is now at the center of groundbreaking drug innovations that are expanding access and improving outcomes.

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Market Size & Growth Projections

The ATTR-CM treatment market was estimated at around USD 10.36 billion in 2024 and is expected to grow to more than USD 35 billion by 2029. Forecasts suggest an annual growth rate exceeding 28%, with some estimates reaching over USD 20 billion by 2033. Increasing patient awareness, expanding screening efforts, and new FDA approvals are accelerating this growth across both hereditary and wild-type ATTR-CM subtypes.

Core Market Drivers

1. Rising Global Aging Population
ATTR-CM predominantly affects individuals over 60, with cases increasing due to longer life expectancies and improved diagnostic imaging. As a result, detection is becoming more routine in cardiology settings, especially in developed markets like the U.S. and Japan.

2. Breakthrough Therapeutics: Stabilizers & RNAi Drugs
Tafamidis (Pfizer) remains a key player in the market. However, recent approvals of Acoramidis (BridgeBio Pharma) and Vutrisiran (Alnylam Pharmaceuticals) have introduced competitive therapies with improved efficacy, affordability, and administration profiles. Vutrisiran, an RNAi-based therapy, has shown up to 30% reduction in mortality and major cardiovascular events in clinical trials.

3. Enhanced Regulatory Pathways
ATTR-CM therapeutics have benefited from orphan drug designations and fast-track reviews in the U.S., EU, and Japan. This has accelerated the clinical pipeline and led to quicker patient access, especially in cases involving life-threatening cardiac amyloidosis.

4. Technological Advancements in Diagnosis
Improved cardiac imaging (echocardiography, nuclear scans, and MRI) and biomarker screening are boosting early diagnosis and making patients eligible for treatment before severe heart failure occurs.

5. Pipeline Maturity and Biotech Collaborations
The ATTR-CM pipeline is rich with antisense oligonucleotides, small interfering RNAs (siRNAs), and protein stabilizers. Pharmaceutical collaborations between biotech innovators and global players are facilitating multi-modal treatment approaches.

Regional Analysis

United States
The U.S. remains the global leader in ATTR-CM treatment adoption. FDA approvals for both Amvuttra (Vutrisiran) and Acoramidis are creating strong competition. Vutrisiran, administered subcutaneously quarterly, has gained traction due to ease of use and high patient adherence. Early U.S. sales of Acoramidis exceeded USD 36 million within a single quarter well above expectations. The U.S. market is projected to grow at a CAGR above 28% through 2030.

Japan
Japan’s ATTR-CM market is expanding rapidly due to its aging population and strong healthcare infrastructure. Diagnostic outreach by cardiologists and growing awareness in elderly care settings have improved case detection. Japan is a prime market for new approvals, especially stabilizers like Acoramidis and upcoming RNA therapies supported by collaborative trials between Japanese and global biopharma companies.

Competitive Landscape

Leading players in the ATTR-CM treatment space include:

• Pfizer (Tafamidis/Vyndamax)
  
  

• Alnylam Pharmaceuticals (Amvuttra/Vutrisiran)
  
  

• BridgeBio Pharma (Acoramidis/Attruby)
  
  

• Ionis Pharmaceuticals and AstraZeneca (Eplontersen/Wainua)
  
  

• Prothena Corporation
  
  

• Intellia Therapeutics (CRISPR-based candidates in early pipeline)
  
  

Each company is innovating in distinct therapeutic areas ranging from gene silencers to stabilizers with several exploring combination therapies for optimized outcomes.

Recent Developments

• Amvuttra Approval for ATTR-CM (U.S., 2025): A significant milestone, this approval expands treatment options beyond tafamidis, offering quarterly subcutaneous injections instead of daily oral administration.
  
  

• Acoramidis U.S. Launch: With positive head-to-head trial data vs. tafamidis and improved tolerability, it’s expected to capture significant market share.
  
  

• Vutrisiran Global Expansion: New trials underway in Europe and Asia indicate possible near-future regulatory approvals beyond the U.S.
  
  

Challenges

• High Cost of Therapy: Annual costs can exceed USD 450,000, making affordability a challenge despite clinical efficacy. Even with competition, reimbursement issues persist in some healthcare systems.
  
  

• Diagnosis Gap: Many patients, especially with wild-type ATTR-CM, remain undiagnosed or misdiagnosed due to symptom overlap with common heart failure.
  
  

• Therapy Differentiation: Physicians and payers must weigh long-term clinical outcome data to guide product choices among new therapies.

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Opportunities

• Early Combination Therapy Trials: Using RNAi alongside stabilizers could potentially halt disease progression faster than monotherapy.
  
  

• Emerging Markets: Countries with aging populations and improving healthcare access (e.g., South Korea, Germany) are likely to see increased diagnosis and treatment uptake.
  
  

• Biosimilar Development: As exclusivity periods end, biosimilars could improve affordability and expand access globally.
  
  

Outlook

With a robust clinical pipeline, improved diagnostics, and expanding healthcare access, the ATTR-CM market is projected to more than triple by the end of this decade. The U.S. and Japan will lead growth due to regulatory agility, aging demographics, and therapeutic innovation. New entrants and continued competition between gene-silencing and stabilizer therapies will shape the competitive landscape.

Conclusion

The ATTR-CM market is no longer niche it’s fast becoming a core segment within the broader rare cardiovascular disease space. With gene therapy innovations, improved awareness, and multi-billion-dollar commercial potential, stakeholders across biotech, pharma, and clinical practice have an opportunity to reshape the standard of care for a previously overlooked patient population. Companies that combine clinical efficacy with accessibility and early intervention strategies will dominate the future of ATTR-CM treatment.