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Amyotrophic Lateral Sclerosis Market Outlook: Expanding Therapeutic Pipeline and Novel Drug Launches Propel Growth Throughout Forecast Period (2025-2034) | DelveInsight
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The global incidence of ALS is on the rise, with nearly new cases diagnosed annually in the United States alone. The total prevalent cases of ALS in the 7MM comprised nearly in 2023 which are estimated to reach 75K by 2034. This increase in prevalence is fueling demand for effective treatments and driving market growth.
RADICAVA has proven to be a successful treatment for ALS. Approval of oral RADICAVA in the United States and its approval in Japan in December 2022 have enhanced patient compliance.
Advancements in diagnostic technologies and treatment methodologies are improving patient outcomes. The development of personalized medicine and targeted therapies is enhancing the efficacy of ALS treatments, contributing to market expansion.
Some of the drugs in the pipeline include (AB Sciences), (Neurosense Therapeutics), (Revalesio), (Neuvivo), (MediciNova), (Brainstorm-Cell Therapeutics' MSC-NTF cells), (Prilenia Therapeutics), and others.
Currently, available drugs for the treatment of ALS include , (oral suspension), (IV and oral suspension/ORS), and . Approved symptomatic therapies comprise , , and , along with supportive medications such as anti-epileptic drugs, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), diuretics, selective serotonin reuptake inhibitors (SSRIs), and various antidepressants.
Following the approval of , sales of the RADICAVA franchise rebounded significantly, reversing the previous decline in IV RADICAVA usage. The oral formulation was rapidly adopted in both the United States and Japan .
experienced rapid market adoption in the U.S. between 2022 and 2023. However, after the failed to meet its primary endpoints, upheld its earlier commitment to withdraw the drug. Consequently, RELYVRIO was officially discontinued on , following consultations with the and .
The anticipated launches of emerging therapies such as (InFlectis BioScience), (Ionis/Otsuka Pharmaceuticals), (MediciNova), (AB Science), (BrainStorm Cell Therapeutics), (Clene Nanomedicine), (Neuvivo), and (Ceres Brain Therapeutics, early-stage) are expected to expand the ALS market in the coming years, supported by a rising number of diagnosed cases.
Additionally, , a novel drug combination developed through , received from the U.S. FDA in 2023 and for a Phase I clinical trial in 2024. The therapy aims to slow disease progression, alleviate ALS symptoms, and extend patient survival.
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Some of the ALS drugs in clinical trials include (AB Sciences), (Neurosense Therapeutics), (Revalesio), (InFlectis BioScience), (Neuvivo), (MediciNova), (Brainstorm-Cell Therapeutics' MSC-NTF cells), (Prilenia Therapeutics), (CERES Brain Therapeutics), and others.
is an oral tyrosine kinase inhibitor that regulates the activity of mast cells and macrophages, key immune cells, by selectively targeting a small subset of kinases. Notably, at therapeutic doses, it avoids inhibiting kinases linked to toxicity. The drug is currently undergoing a Phase III confirmatory trial for the treatment of amyotrophic lateral sclerosis (ALS).
is a novel combination of two FDA-approved drugs, ciprofloxacin and celecoxib, formulated at unique doses to work synergistically in slowing the progression of ALS. The therapy has received Orphan Drug Designation (ODD) from both the US FDA and EMA, and NeuroSense is advancing it through regulatory pathways while preparing for a pivotal Phase III trial. Following favorable feedback from the FDA, the company plans to initiate a multinational Phase III study in the second half of 2025.
is a creatine prodrug formulated within a patented composition of matter, representing an innovative drug design. It is currently in a Phase I clinical trial for the treatment of adult patients with ALS.
The anticipated launch of these emerging therapies are poised to transform the ALS market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ALS market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
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Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, leading to the gradual loss of muscle control. In ALS, the motor neurons responsible for transmitting signals from the brain to the muscles degenerate and die, resulting in muscle weakness, atrophy, and eventual paralysis. Over time, individuals with ALS lose the ability to speak, swallow, and breathe independently, while cognitive function typically remains intact. Although the exact cause of ALS is not fully understood, a combination of genetic and environmental factors is believed to contribute to its development.
The ALS epidemiology section provides insights into the historical and current amyotrophic lateral sclerosis patient pool and forecasted trends for the leading markets. In the US, among mutation-specific cases of ALS in 2024, including , and others such as accounted for the largest proportion, representing approximately of cases.
The ALS market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:
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report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ALS companies, including among others.
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