Driven by accelerating diagnosis of ATTR cardiomyopathy, sustained reliance on cost-effective chemotherapy, and rapid uptake of disease-modifying therapies in North America, the global amyloidosis therapeutics market is on a strong growth trajectory, expanding by 2033, as imaging-led case identification, regulatory fast-tracking, and broader reimbursement convert rare-disease innovation into routine clinical care worldwide.
Chicago, Jan. 21, 2026 (GLOBE NEWSWIRE) — The global amyloidosis therapeutics market was valued at 2.95 billion in 2024 and is expected to reach US$ 6.37 billion by 2033, growing at a CAGR of 9.20% from 2025 to 2033.
Burgeoning diagnostic awareness is reshaping the global amyloidosis therapeutics market each year. AL amyloidosis still leads in incidence, with almost 18,000 new diagnoses worldwide in 2023, including 4,200 in the United States, yet the fastest absolute patient growth is in transthyretin (ATTR) cardiomyopathy.
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Echocardiography registries in North America and Japan now capture 11,700 fresh ATTR-CM cases each year, boosted by routine technetium-pyrophosphate scans. Overall, roughly 220,000 systemic amyloidosis cases are under active management in accredited centers at the start of 2024, fueling demand for disease-modifying drugs and supportive agents such as loop diuretics. China and Brazil, which once treated fewer than 3,000 patients a year, added 6,400 new treatment starts after reimbursement expansions in 2023.
Amyloidosis Therapeutics Stabilize on Five Core Compounds Despite Regional Manufacturing Disruptions
Five disease-modifying compounds anchor current therapy in the Amyloidosis therapeutics market. Pfizer shipped 2.3 million capsules of tafamidis in 2023, covering around 36,000 patient-years, and its Freiburg plant added a second change in February 2024 to clear back-orders from Italy and South Korea.
Alnylam followed with 13,400 vials of patisiran and 29,600 syringes of vutrisiran; French access logs show 26,300 of those syringes utilized in cardiology clinics. Ionis/Akcea kept 5,800 patients on inotersen, while Johnson & Johnson delivered 41,000 subcutaneous doses of daratumumab for relapsed AL cases. The only notable supply pinch this year involves Takeda’s bortezomib: a lyophilizer outage in Osaka removed 190,000 vials from inventory, forcing allocation in seven Asia-Pacific markets. North American inventory fully normalized by mid-April.
Diagnostic Throughput Becomes the Demand Engine of the ATTR-CM Therapeutics Market
The most powerful growth lever in the 2024 amyloidosis therapeutics market is the surge in transthyretin-cardiomyopathy (ATTR-CM) detection, propelled by technetium-99m pyrophosphate (PYP) and DPD bone scintigraphy. US Medicare claims logged 47,860 cardiac PYP scans during calendar 2023, an incremental 18,460 procedures over two years, while Japan’s National Health Insurance processed 12,300 analogous reimbursements.
At Cleveland Clinic, a new “rapid-rule-in” protocol screened 2,140 symptomatic heart-failure patients and confirmed ATTR-CM in 480 of them, quadrupling the center’s 2020 baseline. Across Europe, the Royal Free London, University Hospital Würzburg, and Policlinico San Matteo collectively ran 9,700 DPD scans, identifying 2,660 novel cases. Diagnostic throughput is rising further: Bracco’s CardioMIBI generator added 6,000 monthly doses in March, and GE HealthCare deployed eleven extra Discovery NM/CT 870 scanners into community hospitals. This imaging capacity directly swells the treatable population, making consistent radiopharmaceutical supply a strategic concern for every tafamidis and RNAi franchise.
Therapy uptake is tracking the diagnostic wave almost in real time. Pfizer shipped 2.3 million tafamidis meglumine capsules in 2023, enough for 36,000 patient-years, yet internal demand models built on V-Valuate claims predict 53,000 treated patients by December 2024. Meanwhile, Alnylam documented 13,400 patisiran vials and 29,600 vutrisiran syringes released globally, with 4,080 units routed into newly diagnosed Japanese cardiology clinics alone. US integrated health systems such as Kaiser Permanente recorded 740 fresh tafamidis starts in first-quarter 2024, compared with 460 in the same period last year; 310 of those initiations came directly from nuclear-scan referrals. Brazil’s SUS reimbursement change triggered 1,250 therapy enrollments within six months, underscoring how imaging access can unlock drug budgets. Collectively, nuclear scintigraphy has expanded the actively managed ATTR-CM cohort to roughly 220,000 worldwide, creating sustained, quantifiable pull-through for stabilizers, silencers, and forthcoming gene-editing agents inside the amyloidosis therapeutics market.
Generic Chemotherapy Sustains Amyloidosis Treatment at Population Scale
Chemotherapy remains the backbone of the market because it gives reproducible hematologic responses across the broadest patient pool at manageable costs and with well-documented safety profiles. In 2023, more than 28,000 newly diagnosed AL amyloidosis patients worldwide began induction with bortezomib-cyclophosphamide-dexamethasone, and 17,400 proceeded to second-line regimens containing daratumumab without discontinuing core cytotoxic agents.
These numbers dwarf uptake for RNA interference drugs, which collectively served fewer than 8,000 light-chain cases. Generic availability of bortezomib, melphalan, and cyclophosphamide keeps drug acquisition spending below forty million dollars per ten thousand treated patients, whereas tafamidis or patisiran courses reach ten times that figure. Furthermore, hematologists have four decades of dose-modification algorithms to guide frail or renally impaired individuals, giving chemotherapy an advantage over newer modalities that lack long-term surveillance data. This combination of scale, affordability, and clinical familiarity positions chemotherapy as the default therapeutic type when initial treatment decisions are made.
North America Anchors Global Amyloidosis Revenues with Fast Diagnosis and Fast Uptake
North America anchors the amyloidosis therapeutics market because its clinical ecosystem converts rare-disease innovation into routine care faster than any other region. The United States alone logged roughly 4,200 newly diagnosed AL cases and 11,700 transthyretin-cardiomyopathy confirmations in 2023, numbers supported by 47,860 Medicare-reimbursed technetium PYP scans and 38,200 commercial TTR genotypes. Those patients gain rapid access to high-value drugs: Pfizer dispensed about 2.3 million tafamidis capsules for U.S. use last year, while Alnylam delivered 18,700 patisiran doses through 160 infusion suites.
Regulatory velocity is equally important; the FDA assigned Breakthrough or Fast-Track status to six amyloidosis assets between January 2022 and March 2024, shaving as much as fourteen months off review clocks. Payer policy keeps uptake strong, Medicare’s permanent J-code for tafamidis and bundled DRG 835 anchor predictable reimbursement, and eleven Blue Cross plans now cover vutrisiran without step edits. Layer on 57 active North-American clinical trials and a US$ 4.5-trillion health-expenditure base, and the region decisively sustains more than forty-five percent of global therapeutic revenues.
Amyloidosis Therapeutic Market Major Players:
- Astra Zeneca
- Alnylam Pharmaceuticals, Inc.
- Amgen Inc.
- Bristol-Myers Squibb Company
- F. Hoffmann-La Roche Ltd
- GSK plc.
- Takeda Pharmaceutical Company Limited
- Sanofi, Pfizer Inc.
- Johnson & Johnson Services, Inc.
- Merck KGaA
- Novartis AG
- Ionis Pharmaceuticals
- Other Prominent Players
Key Market Segmentation:
By Therapy Type
- Chemotherapy
- Stem Cell Transplantation
- Targeted Therapy
- Supportive Care & Surgery
- Others
By Route of Administration
- Oral
- Intravenous
- Subcutaneous
By Indication
- AL Amyloidosis
- ATTR Amyloidosis
- AA Amyloidosis
- Wild-Type ATTR
By End User
- Hospitals & Clinics
- Ambulatory Surgical Centers
- Home Care Settings
- Others
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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