The global AL amyloidosis diagnostic market comprises biopsy, imaging tests, and laboratory tests which help detect the presence of amyloid deposits in organs and tissues. AL amyloidosis diagnostic has gained prominence due to the rising burden of amyloidosis. Biopsy which involves extracting a small sample of organs and tissues for microscopic examination remains the gold standard test for verifying amyloid deposits. Further, imaging modalities such as magnetic resonance imaging (MRI) are utilized to analyze organ damage in amyloidosis. Laboratory tests such as immunoassays help detect amyloid proteins like immunoglobulin light chains and serum protein electrophoresis aid in management and treatment of amyloidosis.
The AL amyloidosis diagnostic market is estimated to be valued at USD 1.068 billion in 2024 and is expected to reach USD 1.693 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.8% from 2024 to 2031.
Key players operating in the AL amyloidosis diagnostic are Pfizer Inc., GlaxoSmithKline plc, Prothena Corporation plc, Alnylam Pharmaceuticals Inc., and Ionis Pharmaceuticals Inc. These players are engaged in developing novel therapies and partnering with other pharmaceutical companies for drug approvals and distribution across regions.
The growing R&D for biomarkers and development of advanced diagnostic tools present key opportunities in the market. Moreover, collaborations between companies and research institutes for commercializing diagnostic tests in emerging economies of Asia Pacific and Latin America will aid the global expansion of the AL Amyloidosis Diagnostic Market.
Market Drivers
The increasing prevalence of amyloidosis owing to aging population across the globe acts as a primary driver. As per estimates, around 8-12 cases per million people are diagnosed with amyloidosis annually. Amyloidosis is often underdiagnosed due to non-specific symptoms in early stages. Advanced diagnostic tests are helping in early and accurate diagnosis thus driving the market growth. Growing awareness about amyloidosis and supportive government initiatives are some other factors fueling the AL amyloidosis diagnostic market.
Market Restrains
High cost of advanced diagnostic devices and procedures may hinder widespread adoption, especially in low to middle-income countries. Limited awareness among primary physicians poses challenges in identifying patients and referring them to amyloidosis specialists for confirmatory diagnosis. Stringent regulatory landscape and lengthy product approval timelines remain impediments for pharmaceutical players to commercialize novel therapies.
Segment Analysis
The AL amyloidosis diagnostic market is segmented into biopsy testing, blood testing, urine testing, genetic testing and others. Biopsy testing holds the largest market share as it is considered the gold standard test for AL amyloidosis diagnosis. It involves extracting a small tissue sample from organs affected by amyloid deposits like heart, kidney, liver and gastrointestinal tract. Special staining techniques of these tissue samples examined under a microscope can confirm the presence of amyloid fibrils and determine the type of amyloid involved.
Blood testing segment is growing rapidly due to increasing preference for minimally invasive diagnostic techniques. Serum and immunofixation electrophoresis tests help detect abnormal amounts of immunoglobulin light chains in the blood, which are biomarkers of AL amyloidosis. Urine testing for detecting Bence Jones proteins through urine electrophoresis is also gaining significance. Genetic testing through DNA sequencing facilitates early diagnosis by identifying gene mutations associated with AL amyloidosis.
Global Analysis
North America dominates the global AL amyloidosis diagnostic market majorly due to rising incidence of amyloidosis, increasing research activities and availability of advanced diagnostic technologies. The Asia Pacific region is expected to witness the highest growth during the forecast period due to growing healthcare expenditure, rising awareness about amyloidosis and expanding diagnostic infrastructure across emerging countries. Developing nations in Latin America and Middle East & Africa are also projected to provide lucrative opportunities for market players on account of improving access to healthcare facilities and diagnostic services.
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Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. (https://www.linkedin.com/in/ravina-pandya-1a3984191)
