The U.S. amyloidosis treatment market is projected to experience substantial growth over the next decade, driven by rising prevalence, early diagnosis, and the introduction of next-generation therapies. From an estimated USD 1.04 billion in 2025, the market is expected to reach USD 2.38 billion by 2035, registering a compound annual growth rate (CAGR) of 8.4%.
Market Overview
Amyloidosis, a rare disorder characterized by abnormal protein deposition in organs, affects approximately 40,000–50,000 individuals in the U.S., with cardiac and neurological manifestations accounting for over 65% of cases. Historically underdiagnosed, enhanced imaging, biomarker assays, and growing clinical awareness are expected to increase the treated patient pool by nearly 6–7% annually.
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The market is divided across three major therapeutic segments:
AL Amyloidosis Therapies – Chemotherapy and immunomodulators targeting plasma cell dyscrasias.
ATTR Amyloidosis Therapies – Transthyretin stabilizers and RNA-based silencing agents.
Emerging Biologics – Monoclonal antibodies, fibril-disrupting agents, and gene-modifying therapies.
In 2025, AL therapies account for approximately 35% of the market (USD 364 million), ATTR therapies 50% (USD 520 million), and emerging biologics 15% (USD 156 million). By 2035, the share of ATTR therapies is projected to rise to 55% (USD 1.31 billion), while emerging biologics increase to 22% (USD 524 million), reflecting their growing clinical adoption.
Key Market Drivers
1. RNA-Based and Targeted Therapies
The introduction of RNA interference (RNAi) and gene-silencing therapies has transformed treatment strategies for ATTR amyloidosis. The ATTR therapy segment is forecasted to grow from USD 520 million in 2025 to USD 1.31 billion by 2035, representing a CAGR of 9%. This segment’s expansion is largely driven by higher adoption among patients with cardiomyopathy and neuropathy.
2. Increasing Diagnosis Rates
Advances in non-invasive diagnostics, including cardiac scintigraphy, advanced echocardiography, and biomarker testing, have reduced time-to-diagnosis from an average of 24 months to 12 months. Early detection is expected to increase the number of patients initiating treatment from approximately 12,000 in 2025 to 22,500 by 2035, supporting market expansion.
3. Aging Population
The U.S. population over 65 is expected to increase from 56 million in 2025 to 71 million in 2035, driving higher prevalence of wild-type ATTR amyloidosis. This demographic shift is projected to contribute 35–40% of new therapy demand over the decade.
Treatment Delivery Channels
Hospitals and Specialty Clinics: In 2025, these account for 70% of revenue. Adoption remains high due to complex treatment protocols and multidisciplinary management.
Homecare and Outpatient Settings: Projected to grow from USD 312 million in 2025 to USD 780 million by 2035, reflecting the shift toward convenient oral therapies and long-term monitoring solutions.
Segment Growth Projections (2025–2035)
| Segment | 2025 Revenue (USD Million) | 2035 Revenue (USD Million) | CAGR (%) |
|---|---|---|---|
| AL Therapies | 364 | 545 | 4.5 |
| ATTR Therapies | 520 | 1,310 | 9.0 |
| Emerging Biologics | 156 | 524 | 11.0 |
| Total | 1,040 | 2,379 | 8.4 |
Competitive Landscape
The U.S. market is dominated by both global pharmaceutical companies and innovative biotech firms. Current trends indicate:
RNAi-based therapies will capture nearly 55% of ATTR revenue by 2035.
Emerging biologics are expected to triple in market value, accounting for 22% of total revenue.
Chemotherapy-based AL treatments will continue steady growth but will decline in market share from 35% to 23% due to targeted therapies.
Challenges
Despite strong growth, the market faces several hurdles:
High therapy costs, averaging USD 200,000–400,000 per patient annually for advanced RNAi or monoclonal antibody treatments.
Insurance and reimbursement barriers, particularly for rare and combination therapies.
Limited specialist availability, leading to geographic treatment disparities.
Forecast Summary
Patient Population Growth: From 12,000 treated patients in 2025 to 22,500 by 2035.
Market Expansion: USD 1.04 billion to USD 2.38 billion.
Highest-Growth Segment: Emerging biologics (CAGR 11%).
Dominant Revenue Segment: ATTR therapies (55% of total revenue by 2035).
Primary Drivers: RNA-based therapies, early diagnosis, and aging population.
Conclusion
The U.S. amyloidosis treatment market is set for strong, data-driven growth through 2035. With nearly 2.5x revenue expansion, increasing adoption of advanced therapeutics, and improved patient access through diagnostic and care advancements, the market is poised to deliver significant clinical and commercial impact. Companies investing in RNA-based therapies, protein stabilizers, and biologics are expected to benefit the most, while patients will experience earlier intervention, improved outcomes, and expanded treatment options.
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