Amyloidosis Therapeutics Market Size, Share and Trends 2025 to 2034

Amyloidosis Therapeutics Market Size and Forecast 2025 to 2034

The global amyloidosis therapeutics market size accounted for USD 2.94 billion in 2024 and is predicted to increase from USD 3.18 billion in 2025 to approximately USD 6.45 billion by 2034, expanding at a CAGR of 8.18% from 2025 to 2034. The rising incidences of amyloidosis, increasing disposable incomes, favourable health insurance policies and rising patient awareness are the factors driving the growth of the amyloidosis therapeutics market.

Amyloidosis Therapeutics Market Key Takeaways

• North America dominated the global market with the highest share of 47% in 2024.
• Asia Pacific is estimated to expand at the fastest CAGR in the market between 2025 and 2034.
• By treatment, the chemotherapy segment held the largest market share in 2024.
• By treatment, the transplantation segment is anticipated to grow at a remarkable CAGR between 2025 and 2034.
• By end user, the hospitals and clinics segment dominated the market with the largest share in 2024
• By end user, the home care settings segment is anticipated to show fastest growth during the predicted timeframe

Artificial Intelligence (AI) in Amyloidosis Therapeutics 

Integration of artificial intelligence in amyloidosis therapeutics is improving treatment outcomes for patients by enhancing patient care and decision-making. AI algorithms can be applied for analysing medical images such as echocardiograms for early detection of cardiac amyloidosis. The mitigated misdiagnosis rates with improved accuracy of diagnostic procedures, ability for monitoring disease progression allowing time interventions for effective treatments, in patient stratification and for identification of  biomarkers are the potential applications of AI in amyloidosis therapeutics.
Furthermore, the potential for developing personalized treatment strategies and optimization of clinical trials with the implementation of AI as well as the approvals from regulatory agencies for use of AI technology in amyloidosis therapeutics drives the market expansion.

• For instance, in November 2024, Ultromics’ EchoGo Amyloidosis which is an AI-powered software-only medical device for early detection of Cardiac Amyloidosis received the U.S. FDA clearance making it the first device to be registered in the FDA’s Total Product Lifecycle Advisory Program (TAP) with marketing clearance.

U.S. Amyloidosis Therapeutics Market Size and Growth 2025 to 2034

The U.S. amyloidosis therapeutics market size was exhibited at USD 1.04 billion in 2024 and is projected to be worth around USD 2.31 billion by 2034, growing at a CAGR of 8.30% from 2025 to 2034.

North America dominated the global amyloidosis therapeutics market in 2024. The market dominance of this region can be attributed to the increased amyloidosis disease awareness, advanced healthcare infrastructure, presence of major pharmaceutical companies heavily investing and conducting R&D activities for developing innovative therapies, access to specialized treatment centres and the favourable regulatory environment.

U.S. Amyloidosis Therapeutics Market Trends

U.S. is leading the market in North America owing to the increasing number of clinical trials for developing amyloidosis therapies, increased investments in research and for training purposes, rising disposable incomes, favourable insurance programs, advancements in telehealth and home health monitoring services, improved collaboration activties and growing approvals for new treatments by the U.S. Food and Drug Administration (FDA).

Asia Pacific Amyloidosis Therapeutics Market Trends

Asia Pacific is anticipated to witness lucrative growth in the market during the forecast period. The rising cases of chronic disease, increased expenditure on healthcare, collaborations between pharmaceutical companies and healthcare providers, growing geriatric population, surge in R&D for effective treatments and active involvement of government bodies by developing initiatives with investments and for creating awareness among the population are the factors fostering the market growth of the region. Moreover, the increased focus of key countries including China, Japan, India, South Korea and Australia for advancing treatment of amyloidosis is boosting the region’s growth.

• For instance, in May 2023, Amrita Hospital, a leading hospital in South Asia launched the Amrita Amyloid Centre which is India’s first centre of excellence for evaluating and treating patients with suspected or established amyloidosis.

China Amyloidosis Therapeutics Market Trends

China is emerging as a key player in the Asia Pacific amyloidosis therapeutics market. The active involvement of the Chinese government for improving health outcomes, advancements in diagnostic capabilities and the large population base favour the market growth.

Europe Amyloidosis Therapeutics Market Trends

Europe is seen to be a significantly growing region in the market. The market growth of the region is driven by the increasing geriatric population, rising initiatives for supporting research activities for rare diseases and incentives for development of orphan drugs by governments, robust healthcare infrastructure, conduction of clinical trials, supportive regulatory frameworks, growing focus on increasing awareness through patient advocacy organizations and early diagnosis initiatives for timely interventions leading to better treatment outcomes for amyloidosis.

Key regional countries in Europe in amyloidosis therapeutics market which include Germany, France, Spain, Italy and the United Kingdom also called as EU4 when grouped together are majorly contributing to the market growth owing to the presence of advanced healthcare infrastructures, increased research activities and presence of huge patient populations.

• Germany’s growth in the amyloidosis therapeutics market is fuelled by the presence of major pharmaceutical companies developing novel therapies, access to cutting-edge facilities, enhanced diagnostic capabilities and rising awareness among healthcare professionals for treating and managing amyloidosis.

Market Overview

Amyloidosis is a rare, incurable disease which occurs due to the build-up of abnormal proteins called amyloid in the body. The disease affects the brain, heart, kidneys, spleen, nerves, liver and gastrointestinal tract. Amyloidosis therapeutics such as chemotherapy, immunotherapies and targeted drugs help with the symptoms of the disease and preventing amyloid accumulation in the body which can lead to organ failure.

The surge in research and development for innovative therapies, increased investments by pharmaceutical and  biotechnology companies as well as through government initiatives, growing number of amyloidosis treatment providing centers, genetic mutations associated with hereditary amyloidosis, advancements in diagnostics technologies, rising patient burden with underlying chronic inflammations leading to amyloid protein deposition, surging demand for effective immunotherapies and personalized medicine boost the market growth.

Furthermore, increased awareness and support programs, ongoing improvements and adoption of advanced healthcare infrastructure in various developing areas across the globe and supportive regulatory frameworks accelerating approvals and development of new treatment guidelines create opportunities for growth of the amyloidosis therapeutics market.

Amyloidosis Therapeutics Market Growth Factors

• Surging cases of amyloidosis: The growing incidence of amyloidosis across diverse demographics specifically in the aging population withy cardiac amyloidosis being the most prevalent creates the need for developing innovative therapies for effective management and treatment of patients with better outcomes and improved quality of life.
• Increased research and development activities: Companies, various investors and governments are actively investing and focusing on developing novel therapies such as RNA-based treatments like RNA interference (RNAi) therpaeutics, monoclonal antibodies, use of molecule inhibitors such as proteasome inhibitors and with gene editing tools like CRISPR. Additionally, the accelerated approval processes by regulatory bodies for providing effective treatments to patients’ fosters innovation and development of robust product pipelines.
• Rising collaborations: Several biopharmaceutical companies, investment firms, diagnostic technology providers, research institutions and hospitals are actively collaborating and heavily investing for developing advanced therapies and innovative drugs for the treatment and management of amyloidosis as well as for strengthening their global market presence.

Market Scope

Market Dynamics

Drivers

Advancements in Diagnostics Technologies

The ongoing advancements in diagnostic technologies allows early detection and timely interventions for treatment of amyloidosis allowing healthcare providers to make informed decisions with enhanced accuracy and efficiency leading to improved patient care and better disease management. Development of non-invasive imaging techniques such as cardiac magnetic resonance imaging (MRI) with late gadolinium enhancement (LGE) for evaluating disease severity and treatment response, bone scintigraphy using technetium-99m pyrophosphate (Tc-99m-PYP) for detection in early stages, PET imaging with amyloid-specific tracers for patient stratification and monitoring efficacy of treatment as well as applying multimodal approach with the combination of various imaging modalities such as echocardiography and MRI among others are reducing the need for invasive endomyocardial biopsies.

Furthermore, rising investments on research for identifying blood-based biomarkers for early detection and monitoring progression of disease as well as for promoting training and research programs for educating and creating awareness regarding the management and treatment of amyloidosis in the medical community significantly boosts the market growth.

Restraint

High costs and treatment inefficiencies

One of the major factors affecting the growth of the amyloidosis therapeutics market is the high treatment costs associated with the diagnosis and treatment. Furthermore, the high costs of newly launched drugs and therapies make them unaffordable for everyone. Lack of awareness among healthcare professionals and patients, disease misdiagnosis, limited clinical trials and poor medical infrastructure in underdeveloped countries as well as no availability of effective drugs leads to inefficiencies in treatment of amyloidosis conditions such as transthyretin amyloidosis (ATTR).

Opportunity

Addressing unmet medical needs

The growing need for addressing unmet medical requirements such as the early diagnosis of amyloidosis, development of effective treatment strategies for reversing organ damage, improving management of advanced cardiac involvement, validating guidelines for treatment of relapsed or refractory cases, optimizing clinical trial designs and enabling access to specialized care for patients will potentially create substantial opportunities for market growth. 

Additionally, the increased emphasis on developing novel therapeutic strategies, improving the functionality of diagnostic marker by enhancing their sensitivity and specificity, investigating combination therapies and creating awareness among patients and healthcare workers through campaigns can potentially help in addressing the unmet medical needs.

Treatment Insights

The chemotherapy segment accounted for the largest market share in 2024. Chemotherapy is usually given for primary amyloidosis (AL) for destroying abnormal plasma cells producing amyloid proteins. Drugs such as melphalan, bortezomib, cyclophosphamide and dexamethasone are extensively used as chemotherapy agents with combination of these drugs applied as a primary treatment approach for AL (amyloid light chain) amyloidosis which potentially decreases progression of disease and enhances patient survival rate by improving organ function.

Furthermore, the advancements in diagnostic technologies, increased emphasis on developing targeted therapies and combination regimens, growing adoption of chemotherapy treatments, established efficacy of chemotherapy backed by extensive research and rising incidence of amyloidosis amongst the geriatric population fosters the market growth.

The transplantation segment is anticipated to witness lucrative growth over the forecast period. Transplantation refers harvesting a patient’s own stem cells known as autologous stem cell transplantation (ASCT) for the management of light chain amyloidosis (AL) by targeting the underlying plasma cell dyscrasia for reducing the production of amyloidogenic light chains and improving overall survival rate for suitable patients.

The growth of this segment is driven by ongoing advancements in transplantation techniques and post-transplant management, growing success rates of stem cell transplants, increased awareness among healthcare providers and patients, rising investments for development of potential stem cell therapies and immunomodulator, early detection of amyloidosis allowing timely interventions for transplants and the increased adoption of specific types of implants such as kidney, liver and heart transplantation.

End User Insights

The hospitals & clinics segment held the largest market share in 2024. Hospitals and clinics are the principal providers of treatment for chronic disease like amyloidosis. They offer specialized care and are equipped with the infrastructure and expertise for accurately diagnosing amyloidosis. Furthermore, these healthcare facilities can provide a multidisciplinary approach by uniting specialists form different fields such as cardiologists, nephrologists, oncologists and haematologists for managing the several organ complications related with amyloidosis.

The availability of advanced diagnostic tools for effective management and early detection of amyloidosis in hospitals, growing patient awareness and the involvement of hospitals and clinics in clinical trials for developing innovative amyloidosis therapies are the factors fostering the market growth.

Additionally, pharmaceutical and biotechnology companies provide research grants and offer fellowship programs to experts in hospitals and researchers for training and creating awareness across the medical community as well as for creating new treatments for amyloidosis.

• For instance, in December 2024, Pfizer, a multinational pharmaceutical and biotechnology company, awarded a $80,000 grant to the Rutgers Robert Wood Johnson Medical School (RWJMS) for funding an Amyloidosis Fellowship which will support training cardiologists for diagnosing serious heart conditions at the Robert Wood Johnson University Hospital (RWJUH).

The home care settings segment is expected to show the fastest growth during the forecast period. The growth of this segment is driven by the convenience and availability of personalized treatments at home as well as the growing preference towards patient-focused care in a familiar environment boosting comfort and adherence to amyloidosis treatment plans. The growing emphasis on palliative care at home, especially in the geriatric population helps in preventing hospital readmissions and in improving the management of amyloidosis at home.

Additionally, the reduced costs compared to hospital care, advancements in remote monitoring technologies such as digital biomarkers and activity tracking devices, growing adoption of telemedicine, access to portable diagnostic tools and increased patient awareness about the available treatment options for managing amyloidosis are the factors fostering the market growth.

Amyloidosis Therapeutics Market Companies

• 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

Leader’s Announcements

• In March 2025, Ionis Pharmaceuticals Inc., announced the European Union’s approval for Ionis and AstraZeneca’s WAINZUA (eplontersen). Brett P. Monia, Chief Executive Officer, Ionis, said that, “Today’s approval of WAINZUA in Europe offers adults with hereditary transthyretin-mediated amyloidosis with polyneuropathy a new, self-administered treatment option that provides consistent suppression of transthyretin production and improves neuropathy impairment and quality of life. With approvals in North America, UK and now across the EU, we are proud of the continued progress as we and our partner, AstraZeneca, rapidly and effectively deliver WAINZUA to people around the world.”

Recent Developments

• In February 2025, Paradox Immunotherapeutics, a pharmaceutical company developing innovative antibody therapies, secured a $10 million investment in a financing round led by SymBiosis which is an investment firm concentrated on advancing biotherapeutics innovations for serious and life-threatening diseases. The funding will focus on advancing therapies for protein misfolding diseases and accelerating candidates for immunoglobulin light chain amyloidosis (AL amyloidosis) and leukocyte chemotactic factor 2 amyloidosis (LECT2).
• In July 2024, Kisunla which is a first-of-a-kind amyloid plaque removal therapy developed by Eli Lilly and Company for treatment of adults with early symptoms of Alzheimer’s disease and confirmed amyloid pathology received approval from the U.S. FDA.

Segments Covered in the Report

By Treatment

• Chemotherapy
• Immunosuppressive Drugs
• Transplantation
• Supportive Care
• Surgery
• Others

By End User

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Home Care Settings
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa