Amyloidosis Therapeutics Market Forecast 2035: Growth Fueled by Drug Pipeline Advancements and Rising Rare Disease Awareness | Transparency Market Research, Inc

Amyloidosis therapeutics market was valued at US$ 2.7 billion in 2024 and is projected to grow at a CAGR of 8.2% from 2025 to 2035, reaching more than US$ 6.3 billion by 2035.

The market expansion is being fueled by a combination of increased disease awareness, improved treatment options, and significant investments in drug discovery. As pharmaceutical companies and biotechnology firms continue to introduce novel therapies, the industry is poised for rapid advancements that will improve patient outcomes and expand treatment accessibility.

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The Amyloidosis Therapeutics Market is set to experience significant growth in the coming years, driven by the increasing prevalence of amyloidosis, advancements in drug development, and rising investments in research and development (R&D). Amyloidosis is a serious condition in which abnormal proteins, known as amyloids, accumulate in organs and tissues, leading to dysfunction. While it remains a rare disease, improved diagnostic capabilities and growing awareness are enabling early detection and better treatment options.

Key Market Growth Drivers and Emerging Trends

Increasing Prevalence of Amyloidosis Driving Market Expansion

The growing number of light-chain amyloidosis (AL) cases and other amyloidosis-related conditions is a major factor behind the rising demand for therapeutic solutions. With enhanced diagnostic capabilities, healthcare professionals can now detect amyloidosis earlier, leading to a higher number of diagnosed cases and an increasing need for specialized treatments.

According to Immix Biopharma (2023), the estimated U.S. prevalence of relapsed or refractory amyloidosis cases was 29,712. Additionally, data from the Council of Health Insurance suggests that around 4,000 new cases of AL amyloidosis are diagnosed annually in the U.S., primarily affecting individuals between 50 and 65 years old, though cases have been recorded in younger adults as well.

As healthcare professionals become more adept at identifying symptoms and more patients seek treatment, the demand for innovative therapies is rising. Additionally, patient advocacy groups and research funding organizations are playing a crucial role in promoting disease awareness and driving research efforts aimed at finding more effective treatments.

Rising Investments in Research and Development (R&D) Fueling Innovation

The amyloidosis therapeutics market is benefiting from significant R&D investments by pharmaceutical companies, government institutions, and biotech firms. These investments are driving advancements in novel drug formulations, improved diagnostic tools, and personalized therapies, with an emphasis on targeting amyloidosis at the molecular level.

Recent Advancements in Amyloidosis Drug Development:

November 2024 - Intellia Therapeutics, Inc. announced positive clinical trial data for Nexiguran Ziclumeran, a one-time treatment for ATTR amyloidosis, developed as part of a collaboration with Regeneron.

December 2023 - The FDA approved WAINUA (eplontersen), a polyneuropathy treatment for hereditary transthyretin-mediated amyloidosis (hATTR-PN), developed by Ionis Pharmaceuticals, Inc. and AstraZeneca. WAINUA is notable for being the first approved self-administered amyloidosis treatment, making treatment more convenient for patients.

October 2024 - Alnylam Pharmaceuticals, Inc. submitted a supplemental New Drug Application (sNDA) for Vutrisiran, an RNA interference (RNAi) therapeutic for ATTR amyloidosis with cardiomyopathy (ATTR-CM).

The industry's focus on monoclonal antibodies (mAbs), RNAi therapeutics, and transthyretin stabilizers is expected to reshape amyloidosis treatment in the coming decade. These developments highlight the growing commitment of pharmaceutical companies to finding targeted and effective therapies.

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Analysis of Key Players in the Amyloidosis Treatment Market

Leading companies are actively partnering with hospitals, specialty clinics, long-term care facilities, and research institutes to enhance amyloidosis drug development and expand distribution.

Key Market Players:

Pfizer Inc., Johnson & Johnson Services, Inc., GSK plc, Takeda Pharmaceutical Company Limited, Amgen Inc., Bristol-Myers Squibb Company, Alnylam Pharmaceuticals, Inc., AstraZeneca, BridgeBio Inc., Ionis Pharmaceuticals, Attralus, Inc., Eisai Co., Ltd.

Market Segmentation and Key Growth Areas

Drug Type

Monoclonal Antibodies, Proteasome Inhibitors, Immunomodulators, Corticosteroids, Alkylating Agents, Transthyretin stabilizers, Others (RNA Interference Therapeutics, Non-Steroid Anti-inflammatory Drugs, etc.)

Indication

AL (Primary) Amyloidosis, AA (Secondary) Amyloidosis, Familial ATTR Amyloidosis

Distribution Channel

Hospital Pharmacies, Retail Pharmacies, Online Pharmacies

Regional Outlook: North America Leading the Market

North America dominates the amyloidosis therapeutics market, driven by advanced healthcare infrastructure, high disease awareness, and strong R&D investments. The presence of major pharmaceutical companies like Pfizer, Alnylam Pharmaceuticals, and Johnson & Johnson accelerates drug innovation, particularly in monoclonal antibodies and RNA interference (RNAi) therapeutics. Regulatory support from the FDA, including orphan drug designations and expedited approvals, further boosts market growth.

Key developments include the FDA's acceptance of Alnylam Pharmaceuticals' sNDA for Vutrisiran (November 2024) and orphan drug designation for Attralus' AT-02. Additionally, growing awareness and patient advocacy efforts improve early diagnosis and treatment adoption. Despite challenges like high costs and healthcare disparities, North America is expected to maintain its leadership through continued innovation and expanding access to advanced therapies.

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Future Outlook:

The amyloidosis therapeutics market is on track for robust growth, with a projected value exceeding US$ 6.3 billion by 2035. Advances in monoclonal antibodies, RNAi-based therapies, and transthyretin stabilizers will continue to shape treatment strategies, improving outcomes for patients worldwide.

As pharmaceutical companies accelerate drug development, regulatory agencies grant fast-track approvals, and patient advocacy groups drive awareness, the industry is moving toward a future of more accessible, effective, and personalized amyloidosis treatments. With continued innovation and investment, amyloidosis patients will have greater hope for improved quality of life in the years to come.

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