Amyloidosis Market Outlook 2025-2035:
The seven major amyloidosis market have reached USD 5,949.5 million in 2024. An upbeat industry forecast suggests that the 7MM will reach USD 23,542.9 million within the next 11 years, i.e., between 2025-2035, showing a growth rate (CAGR) of 13.32%. Forging a path through diagnostic and therapeutic borders, the market is supported by wider acceptance of non-invasive and minimally invasive avenues for diagnosis and treatment, continuing to build the prospect of economic status achievements for patients due to lessening of risk and shortening of recovery time. More advanced diagnostic procedures such as cardiac magnetic resonance imaging and nuclear imaging (for example, technetium-labeled bone scans), allow clinicians to diagnose amyloidosis early and accurately, without invasive biopsy procedures. These methods have a design that allows them to reach much higher sensitivity and specificity, especially in differentiating among the various classes of amyloidosis, thus enabling targeted treatment of each patient’s needs.
Advances in Early Detection and Diagnostic Technologies: Driving the Amyloidosis Market
Modern advancement in diagnosis and treatment concerning technologies is transforming the amyloidosis market, greatly enhancing the management of pathologies and patient outcomes. Cutting-edge imaging modalities-such as cardiac magnetic resonance imaging (MRI) with late gadolinium enhancement or technetium-labeled scintigraphy -present a very accurate and non-invasive visualization of amyloid deposits, particularly in the heart. Such techniques allow very early detection and, thus, the differentiation of disturbs in amyloidosis subtypes-important for the effective management of diseases. With the advent of molecular diagnostics arising through next-generation sequencing (NGS) and mass spectrometry-based proteomics now growing in popularity, there has been less genetic mutation identification linked to hereditary amyloidosis, as well as characterization of the amyloid fibril types. These advances help to formulate personalized treatment plans by determining the exact aetiology of the disease, which can be, for example, amyloidosis caused by transthyretin (ATTR) or light chain (AL). The integration of AI into diagnostic workflows is changing the accuracy with which imaging can be interpreted, yielding automated classification of each type of amyloidosis. AI can also aid in monitoring disease progression and predicting treatment response, further lessening reliance on invasive biopsy and subjective evaluation. Treatments through RNA interference therapies, such as patisiran and vutrisiran, antisense oligonucleotides, and transthyretin stabilizers such as tafamidis offer selective, less invasive means of treatment. These target treatments address the molecular mechanisms of amyloidosis-related diseases, with lesser side effects than TV-chemotherapy through the combination intended to reduce production of amyloid. Other types of advancement include the usage of biomarker-based blood tests and wearables that can assist in real-time monitoring of disease progression and therapy’s effectiveness. Such technologies allow patients to be empowered with actionable insights toward them, especially in the remote, underserved regions that afford less hospital-based care/less convenient visits that could have otherwise delayed interventions. The telemedicine is making it possible to expand access to specialized care by means of remote consultations, virtual diagnostics, and personalized treatment recommendations. Remote patients get timely and effective treatment due to these results in the diagnosis and therapy. In short, combined technologies for diagnostics and therapy are increasing precision and access and advancing the efficiency with which management in amyloidosis occurs, likely leading to improved long-term outcomes and satisfaction of patients.
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Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion
The amyloidosis market is expanding thanks to the development of new therapies and improved pharmacological treatments. New therapeutic agents are being developed in order to address the underlying causes of amyloid fibril formation and deposition, offering the most effective and highly targeted ways for disease management. Emerging drugs show more efficacy with minimum side effects and greater patient acceptability in satisfying the specific molecular pathways caused by different types of amyloidosis. Such biological therapy researches have advanced particularly in cases of moderate to severe amyloidosis caused by chronic inflammatory diseases. Monoclonal antibodies targeting such relevant inflammatory mediators like interleukin-1 and interleukin-6 are explored to reduce the processes involved with inflammation that could lead to amyloid deposition. The therapies not only reduce the progression of organ damage but also help the patient lead a better quality of life. Drug delivery system advancements include the use of liposomal formulations, nanoparticle-based carriers, and hydrogels, which ensure localized and sustained drug delivery. These technologies will enhance the concentration of the drugs at the target sites, thus reducing systemic exposure and adverse effects, hence more effective and safer treatments. Complementary treatment approaches include immunomodulators and treatments aimed at rebalancing the physiological condition in the body. These therapies, by modulating the immune system, can, at best prevent further amyloid accumulation. This also includes probing probiotics with a view towards enhancing gut and systemic health that could be supplemented as an auxiliary measure for management of amyloidosis. Such combination therapies consisting of innovative mechanism drugs, like anti-inflammatory agents (or RNA interference drugs) given along with stabilizers such as tafamidis appear to address many of the problematic pathophysiological issues associated with amyloidosis. These combinations prove to be exceptionally effective in the treatment of multivisceral cases. Furthermore, non-invasive pharmaceutical breakthroughs, including agents that break biofilm and better oral or subcutaneous formulations, are being especially well adopted because of their ease of use and patient-friendly design. Thus, these therapies stress convenience and compliance, which enhances the clinical outcomes and patient satisfaction. The ongoing integration of advanced pharmacological and therapeutic strategies is revolutionizing the amyloidosis market, offering the potential for more effective treatments and better management of this challenging disease.
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Marketed Therapies in Amyloidosis Market
Amvuttra (Vutrisiran): Alnylam Pharmaceuticals
Amvuttra (vutrisiran) is an RNA interference (RNAi) therapy developed by Alnylam Pharmaceuticals to treat hereditary transthyretin-mediated (hATTR) amyloidosis. By reducing transthyretin (TTR) protein production, it targets the underlying cause of amyloid deposition and is administered as a subcutaneous injection every three months.
Tegsedi (Inotersen): Akcea Therapeutics/Ionis Pharmaceuticals
Tegsedi (Inotersen) is an RNA-targeted therapeutic used to treat hereditary transthyretin-mediated amyloidosis (hATTR) in adults. It works by reducing the production of transthyretin (TTR) protein, thereby slowing the progression of the disease and alleviating symptoms associated with amyloid deposits.
Onpattro (Patisiran): Alnylam Pharmaceuticals
Onpattro (Patisiran) is an RNA interference (RNAi) therapy approved for adults with hereditary transthyretin-mediated amyloidosis (hATTR). It targets and silences the transthyretin (TTR) gene, reducing the production of abnormal TTR protein that leads to amyloid fibril deposits, helping to alleviate neuropathy symptoms and enhance patients’ quality of life.
Emerging Therapies in Amyloidosis Market
NEOD 001: Prothena
NEOD-001 is a monoclonal antibody in development by Prothena aimed at targeting amyloid deposits in patients with light-chain amyloidosis (AL amyloidosis). It works by binding to soluble amyloid fibrils, helping to mitigate the toxic effects of amyloid accumulation and potentially improving organ function and patient outcomes. However, its development was halted following unsatisfactory results in clinical trials.
ZN d5: Zentalis Pharmaceuticals
ZN-d5 is an experimental drug being developed for the treatment of amyloidosis, specifically targeting transthyretin (ATTR) amyloidosis. Its mechanism aims to stabilize the transthyretin protein, preventing its misfolding and the formation of amyloid fibrils, thus helping to stop the progression of organ damage caused by the disease.
Drug Name | Company Name | MOA | ROA |
NEOD 001 | Prothena | Amyloid fibril protein AL inhibitors | Intravenous |
ZN d5 | Zentalis Pharmaceuticals | Proto-oncogene protein c-bcl-2 inhibitors | Oral |
Detailed list of emerging therapies in Amyloidosis is provided in the final report…
Leading Companies in the Amyloidosis Market:
The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Several key companies in the global amyloidosis market are leading the way in creating integrated platforms to improve the management of the condition. Some of the major players include Alnylam Pharmaceuticals, Akcea Therapeutics, Ionis Pharmaceuticals, Zentalis Pharmaceuticals, Pfizer, and others. These companies are fostering innovation in the amyloidosis market by investing in ongoing research, developing diagnostic tools, and broadening their product portfolios to address the increasing demand for amyloidosis treatments.
In November 2024, the U.S. Food and Drug Administration approved Attruby (acoramidis) for the treatment of adults with cardiomyopathy, a condition affecting the heart muscle, caused by wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM). This approval aims to reduce deaths and hospitalizations related to heart complications associated with the disease.
Key Players in Amyloidosis Market:
The key players in the Amyloidosis market who are in different phases of developing different therapies are Alnylam Pharmaceuticals, Akcea Therapeutics, Ionis Pharmaceuticals, Zentalis Pharmaceuticals, Pfizer, Janssen Biotech, Prothena, Sorrento Therapeutics, Attralus, Caelum Biosciences, and Others.
Regional Analysis:
The primary markets for amyloidosis include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. IMARC projections indicate that the United States not only has the largest patient population for amyloidosis but also represents the largest market for its treatment. Recent innovations in treatments for amyloidosis have led to the development of novel therapies, including advanced biologics, gene therapies, and small molecule drugs, designed to target the root causes of the disease more precisely. These treatments focus on stabilizing amyloidogenic proteins, preventing amyloid fibril formation, and reducing organ damage, offering significant improvements in disease management with fewer side effects. Drugs targeting transthyretin (TTR) stabilization, such as tafamidis, and RNA interference (RNAi) therapies like patisiran and vutrisiran, have shown promise in halting disease progression and improving patient outcomes.
Recent advancements in diagnostic technologies, including high-resolution imaging and biomarker-based tests, have enabled earlier and more accurate identification of amyloidosis and its severity. These innovations facilitate personalized treatment strategies, ensuring timely and effective interventions with minimal adverse effects. The growth of the amyloidosis market is being driven by several key factors, including the approval of new treatment guidelines, greater investment in research and development, and improved collaboration between pharmaceutical companies, diagnostic technology providers, and research institutions. Artificial intelligence (AI)-powered diagnostic tools and telemedicine platforms are expanding access to high-quality care, even in remote and underserved areas, making state-of-the-art treatments more widely available. Regions like North America and Europe remain at the forefront of innovation in both treatment and diagnostic solutions, propelling the global amyloidosis market toward continued growth and improving the quality of care for patients worldwide.
Recent Developments in Amyloidosis Market:
· In October 2024, the Amyloidosis Research Consortium (ARC) introduced its Clinical Fellowship Program, aimed at advancing the education and professional development of future amyloidosis specialists. The program seeks to expand the number of physicians capable of delivering expert care and driving scientific progress in the diagnosis and treatment of this rare and complex disease.
· In December 2023, the U.S. Food and Drug Administration (FDA) approved WAINUA (eplontersen), developed by AstraZeneca and Ionis, for the treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis in adults, also known as hATTR-PN or ATTRv-PN. WAINUA (eplontersen) is a Ligand-Conjugated Antisense therapy that works by targeting and blocking RNA in liver cells, preventing the production of transthyretin (TTR) protein and halting its accumulation.
Key information covered in the report.
Base Year: 2024
Historical Period: 2019-2024
Market Forecast: 2025-2035
Countries Covered
- United States
- Germany
- France
- United Kingdom
- Italy
- Spain
- Japan
Analysis Covered Across Each Country
- Historical, current, and future epidemiology scenario
- Historical, current, and future performance of the Amyloidosis market
- Historical, current, and future performance of various therapeutic categories in the market
- Sales of various drugs across the Amyloidosis market
- Reimbursement scenario in the market
- In-market and pipeline drugs
Competitive Landscape:
This report offers a comprehensive analysis of current Amyloidosis marketed drugs and late-stage pipeline drugs.
In-Market Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
Late-Stage Pipeline Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
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