Amyloidosis Therapeutics Market Poised to Expand from $5.17B in 2025 to $8.20B by 2032

The global amyloidosis therapeutics market is projected to experience robust expansion over the next decade, reflecting growing disease awareness, advancements in diagnostics, and the introduction of innovative therapies. The market size is estimated at US$ 5.17 billion in 2025 and is expected to reach US$ 8.20 billion by 2032, expanding at a compound annual growth rate (CAGR) of 6.8% during the forecast period (2025-2032). This steady growth is supported by technological innovations, early disease detection, and a rising focus on personalized medicine.

Amyloidosis refers to a group of rare diseases caused by the buildup of amyloid proteins in various organs, such as the heart, kidneys, and liver. Types of amyloidosis include AL (primary), AA (secondary), hereditary (familial), wild-type (senile), and localized amyloidosis, each associated with different pathophysiological profiles. Early detection and subtype identification are crucial as untreated amyloidosis can result in severe organ failure and mortality.

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Key Industry Highlights

The amyloidosis therapeutics market is witnessing a transition toward targeted therapies and personalized medicine. The chemotherapy segment is expected to dominate in 2025, accounting for approximately 33% of the total market share. In terms of end-users, hospitals and clinics are projected to lead the segment, representing about 51% of global demand.

Increasing prevalence and awareness of amyloidosis, coupled with advancements in immunotherapy, stem cell transplants, and AI-powered diagnostics, are key market accelerators. Immunosuppressive and immunomodulatory drugs such as dexamethasone, lenalidomide, and pomalidomide have demonstrated strong efficacy in reducing plasma cell abnormalities. Additionally, the homecare segment is growing rapidly, particularly across North America and Europe, where telemedicine and remote patient management are enhancing access to treatment.

Market Dynamics

Driver - Advancements in Diagnostic Technologies Enable Early Detection

One of the primary drivers for the amyloidosis therapeutics market is the rapid improvement in diagnostic tools, facilitating earlier and more accurate detection of amyloid deposits. Techniques such as echocardiography, cardiac MRI, nuclear imaging, and AI-based diagnostics have significantly improved the ability to identify cardiac amyloidosis (CA) at early stages. Early diagnosis remains critical as delayed treatment leads to poor prognosis and higher mortality rates.

Modern imaging technologies and AI-powered algorithms are now capable of differentiating amyloidosis subtypes, providing clinicians with precise insights for targeted interventions. This has led to more personalized and effective treatment regimens, significantly improving patient outcomes.

Restraint - High Treatment Costs and Limited Accessibility

Despite advancements in therapy, the high cost of amyloidosis drugs remains a major limiting factor for market growth. Disease-modifying treatments such as tafamidis, patisiran, and vutrisiran can cost between US$ 200,000 and US$ 500,000 annually, limiting accessibility, especially in low- and middle-income countries. Even in advanced healthcare markets like the U.S., pricing concerns have prompted discussions around reimbursement frameworks and cost-effectiveness analyses.

A recent evaluation of tafamidis revealed that a price reduction of over 90% would be necessary for it to meet standard U.S. value-based care thresholds. These cost challenges are influencing payer decisions, particularly in markets with constrained healthcare budgets.

Opportunity - Integration of Artificial Intelligence in Diagnosis and Treatment

Artificial Intelligence (AI) is emerging as a transformative opportunity in the amyloidosis therapeutics market. AI algorithms, particularly deep-learning convolutional neural networks (CNNs), are showing remarkable potential in enhancing diagnostic accuracy. AI-powered systems can identify high-risk patients through echocardiography, MRI, and nuclear imaging, providing early warnings of cardiac involvement.

A notable example includes a study led by MedUni Vienna, which developed an AI system capable of detecting cardiac amyloidosis from scintigraphy data with precision comparable to expert cardiologists. The model, trained on data from 16,000 patients across multiple institutions, demonstrated a strong correlation with patient outcomes, predicting a twofold increase in mortality risk and a 17-fold higher likelihood of heart failure among positive cases.

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Category-Wise Analysis

Treatment Insights

The chemotherapy segment is expected to dominate the global market in 2025 with an estimated 33% market share. Chemotherapy remains a cornerstone of treatment for AL amyloidosis, where abnormal plasma cells produce amyloidogenic light chains. High-dose melphalan combined with autologous stem cell transplantation (ASCT) continues to be a preferred approach. Proteasome inhibitors like bortezomib and immunomodulatory agents have improved survival rates significantly.

The immunosuppressive drug segment is projected to be the fastest-growing, supported by the efficacy of corticosteroids and IMiDs such as lenalidomide and pomalidomide. These drugs are commonly used in combination with proteasome inhibitors and monoclonal antibodies like daratumumab, which received FDA approval in 2021 for AL amyloidosis.

End-user Insights

Hospitals and clinics dominate the end-user segment, representing approximately 51% of global demand in 2025. These facilities offer advanced diagnostic equipment and specialized care for amyloidosis patients, often requiring multidisciplinary teams of hematologists, cardiologists, and nephrologists. Prominent institutions such as Mayo Clinic, National Amyloidosis Centre (UK), and Vienna General Hospital have established integrated care frameworks for complex cases.

The homecare segment is expanding, particularly in North America and Europe, as telemedicine and remote monitoring solutions enable patients to manage chronic amyloidosis effectively outside hospital settings. Collaborations between hospitals and homecare providers are creating sustainable treatment pathways that enhance convenience and reduce costs.

Regional Insights

North America

North America is projected to hold a dominant 47% market share in 2025. The region's growth is driven by the presence of advanced healthcare systems, widespread disease awareness, and high R&D investments. The approval of novel therapies such as Amvuttra (vutrisiran) and Acoramidis (Attruby) has expanded treatment options for transthyretin amyloidosis (ATTR).

The U.S. continues to lead innovation in diagnostics and clinical trials, supported by the FDA's proactive regulatory environment. Institutions such as the Amyloidosis Program of Calgary and the Mayo Clinic are pioneering patient-centric care models, integrating AI-based diagnostics and remote patient management systems.

Europe

Europe remains a critical market, driven by strong regulatory support, increasing disease awareness, and a well-established healthcare network. Major countries such as Germany, the UK, France, and Italy are spearheading growth through extensive research programs and early adoption of approved drugs including tafamidis, vutrisiran, and acoramidis.

Germany is projected to be the fastest-growing European market, with over 10,500 monitored amyloidosis patients across its university hospitals as of 2023. The Federal Joint Committee (G-BA) ensures that innovative therapies gain timely access, promoting a competitive and research-driven landscape.

Asia Pacific

The Asia Pacific region is witnessing accelerated growth due to expanding healthcare infrastructure, favorable government policies, and growing clinical research activities. Countries such as China and Japan are leading this expansion. Japan's adoption of advanced imaging technologies, including cardiac PYP scans, has substantially improved early amyloidosis detection rates.

China's inclusion of amyloidosis in its National Rare Disease List and the NMPA's expedited approval of therapies such as Darzalex Faspro (daratumumab) for AL amyloidosis have further boosted market prospects. These developments underscore the region's emergence as a hub for rare disease therapeutics.

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Competitive Landscape

The amyloidosis therapeutics market is moderately consolidated, with major players focusing on R&D, strategic alliances, and geographic expansion to strengthen their positions. Key participants include:

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

These companies are heavily investing in RNA-based therapies, monoclonal antibodies, and TTR-stabilizing drugs. Strategic collaborations and acquisitions are becoming common as firms seek to expand their therapeutic pipelines and market reach.

Recent Developments

March 2025: Alnylam Pharmaceuticals received FDA approval for AMVUTTRA® (vutrisiran) for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

February 2025: The European Commission granted marketing authorization for acoramidis (BeyonttraTM) for wild-type and variant transthyretin amyloidosis in adults with cardiomyopathy.

November 2024: BridgeBio Pharma launched Acoramidis (Attruby) in the U.S. as a cost-effective oral TTR stabilizer, priced at US$ 18,759 per 28-day supply, significantly lower than tafamidis.

2024: Ultromics received FDA clearance for EchoGo Amyloidosis, an AI-enabled echocardiography solution for early disease detection.

Future Outlook

The future of the amyloidosis therapeutics market is highly promising, marked by the integration of AI, gene therapy, and RNA-based technologies into clinical practice. Increasing focus on precision medicine, along with continued regulatory support and R&D funding, will drive innovation and accessibility.

While high drug costs remain a constraint, the entry of new competitors and generic versions post-patent expiry is expected to gradually lower prices. Furthermore, partnerships between academic institutions, biotech startups, and pharmaceutical giants are anticipated to accelerate drug development pipelines.

By 2032, the global amyloidosis therapeutics market is projected to exceed US$ 8.20 billion, supported by improved diagnostic tools, digital health integration, and the rising global commitment to managing rare diseases. As awareness expands and therapeutic options diversify, amyloidosis treatment is entering a new era of innovation, precision, and patient-centric care.

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