Next-Gen Treatments Fuel Expansion of Amyloidosis Therapeutics Market
The global amyloidosis therapeutics market is poised for robust growth, with a projected market value reaching US$ 8.20 billion by 2032, up from US$ 5.17 billion in 2025. This expansion represents a compound annual growth rate (CAGR) of 6.8% between 2025 and 2032. The market is being driven by the rising prevalence of amyloidosis, advances in diagnostic technologies, and the increasing availability of targeted and personalized therapies that improve survival outcomes and quality of life.
Understanding Amyloidosis and Market Drivers
Amyloidosis is a rare but serious condition caused by the buildup of amyloid proteins in various organs such as the heart, kidneys, liver, and nervous system. There are several forms of the disease, including AL (primary), AA (secondary), hereditary (familial), wild-type (senile), and localized amyloidosis. If left untreated, the condition can lead to organ failure and severe complications. Early diagnosis and proper subtype classification are critical for effective treatment.
The increasing incidence of amyloidosis globally—fueled by aging populations, chronic inflammatory diseases, and improved diagnostic awareness—has prompted pharmaceutical and biotech companies to invest heavily in therapeutic research and development. Improved patient outcomes are being achieved through early disease recognition and the use of targeted drugs tailored to specific types of amyloidosis.
Chemotherapy Segment to Maintain Market Leadership
By treatment type, the chemotherapy segment is expected to maintain its dominance, accounting for approximately 33% of the market share in 2025. Chemotherapy remains the cornerstone of treatment for AL amyloidosis, where abnormal plasma cells produce amyloidogenic light chains. Standard regimens include high-dose melphalan combined with autologous stem cell transplant (ASCT) and newer combinations incorporating proteasome inhibitors such as bortezomib and immunomodulatory drugs.
Additionally, the immunosuppressive drugs segment is emerging as the fastest-growing segment. Agents such as dexamethasone, lenalidomide, and pomalidomide have become vital in suppressing harmful plasma cells and managing inflammation, especially when used in combination therapies.
Hospitals & Clinics Remain the Primary End-User
Hospitals and clinics are projected to remain the dominant end-user segment, accounting for around 51% of the market in 2025. These facilities are best equipped to conduct the complex diagnostic and treatment regimens required for managing amyloidosis. Advanced imaging tools, organ biopsies, chemotherapy administration, and stem cell transplants are typically centralized within these institutions. Notable centers like the Mayo Clinic and Vienna General Hospital are leading examples of specialized care hubs.
However, the home care segment is gaining momentum, particularly in North America and Europe. This growth is driven by remote monitoring technologies, telehealth consultations, and collaborations between hospitals and community-based care providers. This model offers personalized, continuous care for patients with chronic or advanced stages of amyloidosis.
Technological Advancements Driving Early Diagnosis
One of the major growth drivers in the amyloidosis therapeutics market is the advancement of diagnostic technologies, which facilitate early disease detection. Cardiac Amyloidosis (CA), a particularly aggressive form, often mimics other heart diseases, delaying diagnosis. The use of advanced imaging modalities—such as cardiac MRI, echocardiography, and nuclear imaging with radiotracers—has significantly improved the accuracy of early diagnosis.
Artificial Intelligence (AI) is playing an increasingly critical role in diagnostics. Deep-learning algorithms, especially convolutional neural networks (CNNs), have been integrated with imaging tools to identify early signs of cardiac amyloidosis. AI-driven scintigraphy analysis can match the diagnostic accuracy of medical experts and provide prognostic insights. For example, MedUni Vienna’s AI system—trained on data from over 16,000 patients across Europe and Asia—can automatically detect CA using scintigraphy imaging data.
High Treatment Costs Pose a Challenge
Despite advancements in diagnostics and therapeutics, the high cost of treatment remains a significant barrier. Amyloidosis drugs such as tafamidis (Vyndaqel/Vyndamax), patisiran, and vutrisiran can cost between US$ 200,000 and US$ 500,000 annually per patient. These costs place a strain on healthcare systems, insurance providers, and patients, particularly in low- and middle-income countries.
In the United States, tafamidis is priced at about US$ 225,000 per year. Studies have shown that a price reduction of more than 90% would be necessary to meet cost-effectiveness thresholds. Similarly, gene-silencing therapies like patisiran and inotersen, priced at around US$ 450,000 annually, remain inaccessible to many patients.
North America Leads the Global Market
North America is projected to lead the amyloidosis therapeutics market in 2025, with an estimated 47% share. The region benefits from a well-established healthcare system, increased disease awareness, and robust investment in R&D. The recent FDA approval of Alnylam's Amvuttra (vutrisiran) for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the emergence of AI-powered diagnostic tools like EchoGo Amyloidosis have further bolstered market growth.
In the U.S., companies such as BridgeBio have introduced cost-effective treatment alternatives like Acoramidis (Attruby), priced at US$ 18,759 per 28-day supply, challenging the dominance of higher-cost therapies. Canada’s Amyloidosis Program of Calgary (APC) has also emerged as a center of excellence, offering comprehensive, multidisciplinary care and research opportunities.
Europe Strengthens Position Through Regulatory Support
Europe is experiencing notable growth in the amyloidosis therapeutics space, with countries like Germany, the UK, France, and Italy leading adoption. The European Medicines Agency has approved multiple therapies, including tafamidis, vutrisiran, and acoramidis. The UK’s National Amyloidosis Centre continues to play a crucial role, tracking and managing over 6,400 patients.
Germany, in particular, is poised for significant expansion due to its strong commitment to rare disease treatment. With more than 10,500 amyloidosis patients monitored in 2023 and favorable reimbursement policies from the Federal Joint Committee (G-BA), the country is emerging as a major treatment hub.
Asia Pacific Emerges as a Growth Hotspot
The Asia Pacific region is showing rapid market growth, driven by expanding healthcare access, regulatory innovation, and increased awareness. Countries like Japan and China are leading the way. Japan has implemented widespread cardiac PYP scanning for early detection of cardiac amyloidosis. Accelerated drug approvals and growing adoption of RNA-based therapies are enhancing treatment outcomes.
In China, amyloidosis has been included in the National Rare Disease List, and the National Medical Products Administration (NMPA) has streamlined its orphan drug approval pathways. The approval of Darzalex Faspro (daratumumab) for AL amyloidosis highlights China's commitment to expanding treatment options.
Competitive Landscape and Key Developments
The global amyloidosis therapeutics market is highly competitive, featuring major pharmaceutical giants alongside emerging biotech innovators. Leading players include Pfizer Inc., Johnson & Johnson (Janssen), GSK plc, Takeda Pharmaceutical Company, Amgen Inc., Bristol-Myers Squibb, Novartis AG, F. Hoffmann-La Roche Ltd, Merck KGaA, and Sanofi. Biotech firms like Alnylam Pharmaceuticals and Ionis Pharmaceuticals are also gaining market share through RNA-targeted therapies and gene-silencing technologies.
Recent developments include:
-
In March 2025, Alnylam Pharmaceuticals received FDA approval for AMVUTTRA® (vutrisiran) for ATTR-CM.
-
In February 2025, the European Commission granted marketing authorization to acoramidis (Beyonttra™) for wild-type and variant ATTR-CM.
-
BridgeBio’s Acoramidis received FDA approval in late 2024 and is positioned as a more cost-effective alternative to tafamidis.
Outlook and Future Opportunities
Looking ahead, the global amyloidosis therapeutics market will continue to benefit from innovations in AI, targeted drug development, and personalized medicine. Continued investment in clinical trials, regulatory reforms, and international collaborations are expected to reduce diagnosis time, improve treatment access, and ultimately improve patient outcomes.
Despite the high treatment costs, increasing government and private sector initiatives, combined with a growing emphasis on early diagnosis and patient education, will support the long-term growth of this critical therapeutic segment. As awareness spreads and technology advances, the amyloidosis therapeutics market is on course to transform from a niche specialty field into a robust and competitive healthcare domain by 2032.
Read Related Reports:
Esophageal Atresia Treatment Market
Comments
Post a Comment