Amyloidosis Clinical Market to Reach USD 7.2 Billion by 2034

Sub-headline: Rising prevalence of systemic amyloidosis, increased clinical trial activity, and the emergence of RNA-based and monoclonal antibody therapies are fueling global market growth.

Pune, India, November 7, 2025 - The Global Amyloidosis Clinical Market is projected to grow from USD 3.1 billion in 2024 to approximately USD 7.2 billion by 2034, registering a CAGR of 8.7% during the forecast period (2025-2034), according to Exactitude Consultancy. The growth is driven by advancements in disease-specific treatment options, growing diagnostic awareness, and increased patient participation in clinical research programs for rare diseases.

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Key Takeaways
• Market Size (2024): USD 3.1 Billion
• Forecast (2034): USD 7.2 Billion
• CAGR (2025-2034): 8.7%
• Key Segments: Type, Treatment, Distribution Channel, and Region
• Leading Companies: Pfizer Inc., Alnylam Pharmaceuticals, Ionis Pharmaceuticals, Janssen Biotech (Johnson & Johnson), Prothena Corporation, Alexion Pharmaceuticals (AstraZeneca), and Eidos Therapeutics

Market Story
Amyloidosis is a rare yet life-threatening disorder caused by abnormal amyloid protein deposition in organs and tissues. With limited awareness historically, the condition is now gaining recognition due to improved diagnostic technologies such as mass spectrometry, immunohistochemistry, and next-generation sequencing (NGS).

Pharmaceutical research has entered a breakthrough phase, focusing on TTR-targeted RNA therapies, monoclonal antibodies, and small-molecule stabilizers. Notable approvals-such as Pfizer's Vyndaqel/Vyndamax and Alnylam's Onpattro and Amvuttra-have transformed treatment paradigms, while several candidates are progressing through late-stage clinical trials.

Increasing collaborations between biotech firms and academic centers are accelerating clinical pipelines, especially for AL, ATTR, and AA amyloidosis subtypes. Moreover, patient registries and advocacy groups are playing a vital role in enhancing trial recruitment and post-market evidence generation.

Market Segmentation
By Type:
AL (Primary) Amyloidosis, AA (Secondary) Amyloidosis, Hereditary (ATTR) Amyloidosis, Wild-Type (Senile) Amyloidosis, Others

By Treatment:
Chemotherapy, Targeted Therapy (TTR Stabilizers, RNA Therapies), Stem Cell Transplant, Supportive Care

By Distribution Channel:
Hospital Pharmacies, Specialty Clinics, Retail Pharmacies, Online Pharmacies

By Region:
North America, Europe, Asia Pacific, Latin America, Middle East & Africa

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Recent Developments
• Pfizer Inc. expanded its clinical trials for Vyndaqel in early-stage cardiomyopathy, aiming to broaden label indications.
• Alnylam Pharmaceuticals announced Phase III results for Amvuttra showing sustained TTR reduction with quarterly dosing.
• Ionis Pharmaceuticals partnered with AstraZeneca to develop Eplontersen, a next-generation RNA therapeutic.
• Prothena Corporation initiated trials for its monoclonal antibody candidate PRX004 targeting amyloid deposits.
• Eidos Therapeutics (BridgeBio) advanced its oral stabilizer Acoramidis for ATTR cardiomyopathy into late-stage testing.

Expert Insight
"After decades of limited treatment, amyloidosis care is entering a golden era. RNA interference, gene-silencing, and antibody-based therapies are changing survival outcomes while clinical trial activity expands globally,"
- Lead Rare Diseases Analyst, Exactitude Consultancy.

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Market Drivers
• Breakthrough Therapies: RNA-based and TTR-targeted drugs revolutionize disease management.
• Increased Clinical Awareness: Improved diagnostics and referral networks enable early detection.
• Regulatory Incentives: Orphan drug designations and fast-track approvals encourage innovation.
• Rising Clinical Trials: Global expansion of amyloidosis studies supported by public-private partnerships.

Forecast & Regional Insights
North America dominates the market with over 45% revenue share in 2024, driven by strong R&D pipelines, patient advocacy initiatives, and advanced healthcare infrastructure. Europe follows with favorable reimbursement frameworks and growing adoption of RNA-based therapies. The Asia Pacific region is expected to witness the fastest CAGR of 9.4%, supported by improving diagnostic facilities and emerging biopharma investments in rare disease research.

Conclusion
The amyloidosis clinical market is poised for transformative growth as novel therapeutic platforms move from experimental to commercial stages. The next decade will see improved survival rates and broader treatment accessibility, turning a historically underserved condition into a key focus area for global biopharma innovation.

This report is also available in the following languages : Japanese (アミロイドーシス臨床市場), Korean (아밀로이드증 임상 시장), Chinese (淀粉样变性临床市场), French (Marché clinique de l'amylose), German (Klinischer Markt für Amyloidose), and Italian (Mercato clinico dell'amiloidosi), etc.

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