Amyloidosis Therapeutics Market to Reach US$ 8.20 Bn by 2032, Reports Persistence Market Research

The global amyloidosis therapeutics market has emerged as a rapidly evolving segment of the rare disease treatment landscape, underpinned by advancements in diagnostic technologies and novel therapeutic developments. Valued at US$ 5.17 billion in 2025, the market is projected to reach US$ 8.20 billion by 2032, reflecting a compound annual growth rate (CAGR) of 6.8% during the forecast period (2025-2032). Amyloidosis, a disorder characterized by the accumulation of misfolded amyloid proteins in various organs, remains a life-threatening condition if left untreated. It encompasses several subtypes, including AL (primary), AA (secondary), hereditary (familial), and wild-type (senile) amyloidosis, each presenting unique diagnostic and therapeutic challenges.

The growing recognition of amyloidosis as a significant cause of cardiac, renal, and neurological morbidity has propelled healthcare systems to invest in early diagnosis, personalized medicine, and novel treatment platforms. North America is anticipated to dominate the global market, accounting for nearly 47% of total revenue in 2025, owing to its strong clinical infrastructure, access to innovative therapies, and active patient registries. The chemotherapy segment remains the leading therapeutic category, contributing around 33% of the market share, driven by its role in managing AL amyloidosis through plasma cell-targeted regimens.

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Collectively, the expansion of research pipelines, growing prevalence of transthyretin-mediated amyloidosis (ATTR), and greater clinical awareness are reshaping the treatment ecosystem, ushering in an era of precision therapeutics for this complex condition.

Key Highlights from the Report

• The chemotherapy segment dominates the market with a 33% share in 2025.
• Hospitals & clinics account for 51% of market share, leading the end-user segment.
• Rising prevalence and awareness of amyloidosis drive sustained market growth.
• Immunosuppressive therapies such as dexamethasone and lenalidomide gain traction in combination regimens.
• Home care and telemedicine models are rapidly expanding, particularly in North America and Europe.
• North America leads globally with a projected 47% market share in 2025.

Market Segmentation
By Treatment Type

The amyloidosis therapeutics market is segmented primarily by treatment type, with chemotherapy standing as the leading segment, representing approximately 33% of global revenue in 2025. Chemotherapy plays a crucial role in treating AL (primary) amyloidosis, where misfolded immunoglobulin light chains form amyloid fibrils that deposit in major organs such as the heart and kidneys. High-dose melphalan combined with autologous stem cell transplant (ASCT) remains a cornerstone therapy, while newer agents such as bortezomib and daratumumab are transforming clinical outcomes.

The immunosuppressive drugs segment is poised for the fastest growth through 2032, as therapies such as lenalidomide, pomalidomide, and dexamethasone are increasingly used to control abnormal plasma cell proliferation and reduce inflammation. Furthermore, the approval of monoclonal antibodies targeting specific amyloid precursors has strengthened this category, leading to more targeted and tolerable treatment options.

By End-User

Based on end-user, the hospitals & clinics segment holds a commanding 51% share of the market in 2025. Hospitals serve as the primary sites for diagnosis and management, given the need for advanced imaging, biopsies, and laboratory-based protein analysis. Multidisciplinary teams involving hematologists, cardiologists, nephrologists, and neurologists are essential in delivering comprehensive care. Renowned centers such as Mayo Clinic (U.S.), Vienna General Hospital (Austria), and the National Amyloidosis Centre (U.K.) exemplify integrated approaches to diagnosis, treatment, and follow-up.

Meanwhile, the home care settings segment is expanding rapidly, particularly in developed markets. The proliferation of telemedicine, remote monitoring, and hospital-community partnerships enables patients-especially those with chronic or cardiac amyloidosis-to receive continued care outside traditional hospital environments. This trend enhances patient adherence, quality of life, and long-term outcomes while alleviating healthcare costs.

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Regional Insights
North America

North America remains the largest and most mature market for amyloidosis therapeutics, accounting for approximately 47% of the global share in 2025. The region benefits from advanced healthcare infrastructure, early adoption of novel drugs, and robust R&D initiatives. The approval of innovative therapies such as Amvuttra® (vutrisiran) and Acoramidis (Attruby) has expanded therapeutic choices for patients with transthyretin amyloidosis (ATTR-CM).

The U.S. continues to lead the region, supported by government-backed reimbursement programs, precision medicine initiatives, and strong participation in clinical trials. Additionally, AI-driven diagnostic solutions-such as Ultromics' EchoGo Amyloidosis-are revolutionizing early detection through non-invasive imaging. Canada's Amyloidosis Program of Calgary (APC) also stands out for its patient education, multidisciplinary care models, and community-based engagement.

Europe

The European amyloidosis therapeutics market exhibits solid growth, supported by strong clinical networks, government funding for rare diseases, and streamlined drug approval mechanisms. Major European economies-Germany, France, Italy, and the U.K.-form the core of this growth. The U.K.'s National Amyloidosis Centre, tracking over 6,400 patients, is a model of coordinated care and clinical excellence.

Recent approvals such as Vyndaqel (tafamidis), Amvuttra (vutrisiran), and Beyonttra (acoramidis) have strengthened the region's treatment arsenal. Germany, in particular, demonstrates one of the fastest-growing national markets, driven by 12 university hospitals treating over 10,000 amyloidosis patients. The country's regulatory body, G-BA, continues to improve access to high-value therapeutics through proactive reimbursement strategies.

Asia Pacific

The Asia Pacific market is experiencing accelerated expansion, propelled by healthcare modernization, improved disease recognition, and supportive regulatory reforms. Japan and China are leading the charge through advanced diagnostics, public health initiatives, and inclusion of amyloidosis in national rare disease frameworks. Japan's adoption of cardiac PYP scans for early diagnosis and China's National Medical Products Administration (NMPA) approval of Darzalex Faspro (daratumumab) underscore this progress.

Increased participation in global clinical trials, along with investments from multinational pharmaceutical firms, has positioned the region as a key hub for innovation. As patient registries expand and novel therapies gain reimbursement, the Asia Pacific market is expected to achieve one of the highest growth rates globally through 2032.

Market Drivers

The most influential driver shaping the amyloidosis therapeutics market is the advancement of diagnostic technologies that enable earlier and more accurate detection. Historically, amyloidosis was underdiagnosed due to its nonspecific symptoms, which mimic those of more common diseases. Innovations in cardiac MRI, echocardiography, and nuclear imaging-combined with AI-based analytical systems-now allow clinicians to identify disease subtypes and initiate treatment before irreversible organ damage occurs.

Additionally, growing disease awareness, patient advocacy, and specialized clinical centers have significantly improved diagnostic rates. The proliferation of personalized therapies-particularly gene-silencing drugs, transthyretin stabilizers, and immunotherapies-has expanded treatment options for both AL and ATTR subtypes. Global collaboration among research institutions and biotechnology companies continues to accelerate innovation and clinical accessibility.

Market Restraints

Despite its promising growth trajectory, the amyloidosis therapeutics market faces substantial economic and operational constraints. Foremost among these is the high cost of treatment, which limits patient accessibility and strains healthcare budgets. Drugs such as tafamidis and patisiran can cost between US$ 200,000 and US$ 500,000 annually per patient, creating disparities in access even in well-funded healthcare systems.

Moreover, the complexity of diagnostic procedures-including biopsies, genetic testing, and advanced imaging-further increases the burden on healthcare infrastructure. In emerging economies, limited diagnostic capabilities and low disease awareness result in delayed diagnosis and suboptimal treatment outcomes. Reimbursement challenges, particularly in markets without established rare disease policies, remain another critical hurdle that could impede long-term adoption.

Market Opportunities

The evolving integration of artificial intelligence (AI) in amyloidosis diagnostics represents one of the most transformative opportunities in this market. AI-enabled platforms leveraging deep-learning convolutional neural networks (CNNs) have demonstrated exceptional accuracy in identifying early-stage cardiac amyloidosis (CA). For example, a collaborative European-Asian study involving 16,000 patients confirmed AI's ability to detect CA from scintigraphy scans with near-expert precision.

These technologies not only enhance diagnostic efficiency but also facilitate risk stratification, treatment planning, and prognostic assessment. In parallel, the emergence of RNA interference (RNAi) and gene-editing therapies is expanding the frontier of amyloidosis treatment. Pharmaceutical companies are investing heavily in these domains, while regulatory bodies are supporting accelerated approval pathways for orphan drugs. The convergence of AI, genomics, and precision medicine could therefore unlock a new era of patient-specific, outcome-driven therapies in amyloidosis care.

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Company Insights

The competitive landscape of the amyloidosis therapeutics market is highly dynamic, comprising leading multinational pharmaceutical firms and specialized biotechnology innovators. Key players focus on expanding their therapeutic pipelines, forming strategic alliances, and securing regulatory approvals for next-generation treatments.

• Pfizer Inc.
• Johnson & Johnson Services, Inc. (Janssen Pharmaceuticals)
• GSK plc
• Takeda Pharmaceutical Company Limited
• Amgen Inc.
• Bristol-Myers Squibb Company
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Merck KGaA
• Sanofi S.A.
• Alnylam Pharmaceuticals, Inc.

Market Segmentation

By Treatment

Chemotherapy
Immunosuppressive Drugs
Transplantation
Supportive Care
Surgery
Others

By End-user

Hospitals & Clinics
Home Care
Ambulatory Surgical Centers
Others

By Region

North America
Europe
Asia Pacific
South Asia and Oceania
Latin America
Middle East and Africa

Recent Developments

March 2025 - Alnylam Pharmaceuticals received U.S. FDA approval for AMVUTTRA® (vutrisiran), a subcutaneous RNAi therapy for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adults.

February 2025 - The European Commission granted marketing authorization for acoramidis (BeyonttraTM) to treat wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.

These developments exemplify the industry's commitment to addressing unmet clinical needs through breakthrough science and rapid commercialization of advanced therapeutics.

Conclusion

The global amyloidosis therapeutics market is at a transformative juncture, fueled by scientific innovation, patient-centric care models, and technological integration. The combination of early diagnostics, AI-driven insights, and precision therapeutics is reshaping the treatment paradigm for a condition once considered untreatable. Despite significant cost barriers and diagnostic complexities, the market's long-term trajectory remains strongly positive, with opportunities emerging from gene-based therapies and data-driven healthcare solutions.

As leading pharmaceutical companies continue to expand their pipelines and healthcare systems adopt holistic treatment approaches, the amyloidosis therapeutics market is set to evolve into a multi-billion-dollar ecosystem defined by innovation, collaboration, and improved patient outcomes. By 2032, the integration of AI, genomics, and personalized medicine will likely redefine the global standard of care for amyloidosis, ushering in a new era of hope for patients worldwide.

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