Market Dynamics: The global amyloidosis market is poised to experience a robust revenue Compound Annual Growth Rate (CAGR) throughout the forecast period. Factors driving market revenue growth include the continuous development and introduction of more advanced therapeutic drugs for amyloidosis, an increase in genetic susceptibility to amyloidosis among populations, growing awareness regarding amyloidosis and available treatment options, and a rise in personal healthcare spending and wellness initiatives. Additionally, the growth in revenue for amyloidosis treatment is attributed to an escalating demand for targeted therapies, ongoing investments and focus on Research & Development (R&D) of novel drugs and therapies, the launch of new and innovative drugs by major market players to address symptoms associated with amyloidosis, and increased expenditure on healthcare infrastructure development.

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Amyloidosis encompasses a group of rare disorders characterized by the formation of amyloids (protein aggregates) that fold incorrectly and accumulate in various organs, predominantly affecting the heart, kidneys, liver, soft tissue, peripheral nervous system, and gastrointestinal tract. It is a rare metabolic condition that disrupts organ and tissue function and structure, potentially leading to life-threatening illnesses. Amyloidosis occurs when amyloid protein accumulates in tissues and organs.

Factors Supporting Market Growth: Drivers: The primary driver for market expansion is the increasing popularity of biologics. Other factors fueling market growth include higher healthcare infrastructure spending, a growing geriatric population, and increased strategic collaborations among market competitors.

An additional variable contributing to profitable market growth is the combination of rising personal disposable income and increasing unmet demands for the treatment of this condition.

Restraints: In developed countries, awareness of amyloidosis is increasing; however, countries with inadequate medical infrastructure remain unaware of various types of transthyretin amyloidosis and their treatment options. For a long time, cardiac amyloidosis was misdiagnosed as heart failure and lacked effective therapy.

The lack of approved medications to treat the condition negatively impacts market growth. Amyloidosis is challenging to recognize and manage, leading to frequent misdiagnoses and delays in diagnosis, which increase the risk of irreversible damage such as nerve cell destruction, heart failure symptoms, constipation, and other complications. The high cost of therapies is a significant issue in the amyloidosis treatment market, placing financial burdens on patients in developing countries.

Limited awareness of the illness in several countries has resulted in incorrect medical advice and delays in receiving appropriate medical care. Furthermore, a key constraint on the growth of amyloidosis is the limited number of treatment trials and misinformation about this disorder.

Opportunities: Amyloidosis was long considered a rare disorder; however, recent diagnoses in numerous countries have revealed a growing proportion of amyloidosis patients with heart failure. Recent medical breakthroughs have benefited amyloidosis patients, and the market is expected to expand due to increasing incidences and the introduction of novel medications.

Key Market Trends and Innovations: In March 2022, Alexion, AstraZeneca's Rare Diseases division, signed an exclusive global collaboration and license agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a systemic condition that causes progressive heart failure and has a high rate of fatality within four years of diagnosis.

In December 2021, Pfizer Inc. released a post-hoc interim analysis indicating that treatment with VYNDAQEL (tafamidis meglumine)/VYNDAMAX (tafamidis) produced a clinically significant survival advantage for patients with transthyretin amyloid cardiomyopathy after five years (ATTR-CM). The study examined the ATTR-ACT Phase 3 Transthyretin Amyloid Cardiomyopathy Clinical Trial (ATTR-ACT) and its Long-Term Extension (LTE) study.

In December 2021, Ionis Pharmaceuticals, Inc. (Ionis) and AstraZeneca signed a new global development and commercialization agreement for eplontersen, formerly known as IONIS-TTR-LRX, an experimental ligand-conjugated antisense drug in Phase III clinical studies for amyloid transthyretin cardiomyopathy (ATTR-CM) and amyloid transthyretin polyneuropathy (ATTR-PN).

In May 2021, The Janssen Pharmaceutical Companies of Johnson & Johnson released updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of newly diagnosed light chain (AL) amyloidosis.

In September 2020, Corino Therapeutics, Inc. presented positive results from a proof-of-concept study of oral CRX-1008 in patients with hereditary leptomeningeal Transthyretin Amyloidosis (hATTR-leptomeningeal) at the XVII International Symposium on Amyloidosis.

Competitive Landscape: Organic and Inorganic Strategies Adopted: In June 2022, The FDA approved AMVUTTRATM (Vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months for the treatment of polyneuropathy associated with hereditary transthyretin-mediated (hATTR) amyloidosis in adults, according to Alnylam Pharmaceuticals, Inc.

In January 2022, The FDA granted Eplontersen Orphan Drug Designation (ODD) in the U.S. for the treatment of transthyretin-mediated amyloidosis.

In September 2021, Alexion exercised its option to purchase all of Caelum Biosciences' remaining interest in CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody for the treatment of light chain (AL) amyloidosis.

In July 2021, Alexion Pharmaceuticals, Inc. was acquired by AstraZeneca, marking AstraZeneca's entry into the field of rare disease medications.

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