Study Forecasts Uptick in ALS Prevalence in Coming Decades

Using registry data from the Piemonte and Valle d'Aosta region of Italy (PARALS), a newly published study in Annals of Clinical and Translational Neurology reported that the global prevalence of amyotrophic lateral sclerosis (ALS) is projected to increase significantly by 2040, mainly driven by incidence associated with population aging and gradual improvements in survival. Overall, these findings underscored the potential need for public health policies to promptly allocate resources to ensure the necessary care for patients with ALS.^1,2

In this study, researchers explored trends of incidence, survival, and prevalence of ALS between 2005 to 2019 from the PARALS registry (n = 3294) and then estimated those trends into future years up to 2040. Based on the observed projections, findings suggest that the prevalence of ALS is expected to increase to other countries, with a median rise of 24.9% from 2024 to 2040 and 55.6% from last available estimates to 2040; however, the authors noted that the impact might differ based on the size of the population.

"This study provides critical foresight for clinicians and health systems, giving them the opportunity to respond proactively – rather than reactively – to an increasing number of people living with ALS. Many clinics are struggling with current demand and limited resources, so these projections can help them anticipate future needs, identify areas where they will need to build capacity, and then implement targeted interventions to support the growing number of people who will need care," co-author Kuldip Dave, PhD, senior vice president of research at the ALS Association, told NeurologyLive^® in a recent interview.

By the end of the study period, results showed that the number of prevalent cases in Italy increased from 350 at baseline to 468. Notably, the crude prevalence rate rose steadily, starting at 7.92 per 100,000 population on December 31, 2005, and reaching 10.55 per 100,000 population on December 31, 2019, with an annual increment of 0.182 points (P = .000008). Incidence ranged from 3.21 in 2005 to 3.61 in 2019, without exhibiting a linear trend during the interval (P = .461). In addition, the median survival increased from 2.47 to 3.42 years during the same period, corresponding to an annual increment of 0.06 years (P = .0000002).

Through application of the same annual increase up to 2040, authors reported that the median survival is predicted to reach 3.72 years in 2024 and 4.67 years in 2040. Researchers noted that because of the aging population in Piemonte and Valle d'Aosta, the incidence rate is projected to change from 3.61 per 100,000 person-years in 2019 to 3.36 in 2024 and 3.82 by 2040. As a result, the prevalence of ALS in these regions is anticipated to increase, reaching 11.70 per 100,000 population in 2024 and 15.72 by 2040, corresponding to an estimated 654.5 patients living with ALS as of December 31, 2024.

READ MORE: Clene to Submit Application for CNM-Au8 as Potential ALS Treatment

“People are living longer with ALS thanks to advances in care and treatment. More people are gaining access to multidisciplinary care, which we know extends survival and improves quality of life. Greater awareness is also helping people be diagnosed with ALS earlier and begin treatment with appropriate approved therapies as soon as possible, when they are more likely to provide benefit,” Dave said.

In Italy, researchers reported that the incidence rate of ALS is expected to increase nationwide, from 3.01 per 100 000 person-years in 2019 to 3.19 per 100 000 person-years in 2024 and 3.78 per 100,000 person-years by 2040. Applying the survival increase observed in the PARALS register, results suggested that the prevalence rate is projected to rise from 10.28 per 100,000 population in 2019 to 11.54 per 100,000 population in 2024 and 15.91 per 10,000 population by 2040.

Looking at other countries, authors noted that the prevalence of ALS in the United States is projected to increase from 9.10 per 100,000 population in 2018 to 9.68 in 2024, reaching 11.21 by 2040. Researchers also considered the potential effect of edaravone (Radicava ORS; Mitsubishi Tanabe Pharma America), where the prevalence could further increase to 12.01 per 100,000 population. Similarly, in Japan, ALS prevalence in 2009 was 9.90 per 100,000 population and factoring in the effect of edaravone, the prevalence could further rise to 15.32 per 100,000 population.

“Knowing that the number of people living with ALS is set to rise dramatically over the next 15 years, it’s important for clinicians and health systems to start looking now for opportunities to build clinical efficiencies and capacity,” Dave added. “This could include strategically implementing technologies like telehealth and remote patient monitoring or developing models for mobile or pop-up ALS clinics that can bring ALS care directly to the people who need it. It will also be essential to expand the ALS workforce and enhance professional education and awareness of ALS among health care professionals.”

To account for differences across countries and regions, researchers developed a free online tool where researchers and physicians can input their own data for projections, even for countries not included in the original study. Authors noted that default values based on ALS survival and incidence estimates from the PARALS register are also provided in the model.

“Knowing the challenges clinicians and health systems will face as patient volumes increase, the ALS Association is committed to improving access to multidisciplinary care nationwide and supports capacity building initiatives through programs like our Trial Capacity Grant Program,Hoffman ALS Clinic Development, and Clinic Capacity Awards Programs,” Dave told NeurologyLive.

REFERENCES
1. Vasta R, Callegaro S, Canosa A, et al. Amyotrophic Lateral Sclerosis Prevalence Projection in 2040: A Less Rare Disease. Ann Clin Transl Neurol. Published online October 14, 2025. doi:10.1002/acn3.70226
2. New ALS Association Co-Authored Study Projects Dramatic Increase in Prevalence by 2040. News release. ALS Association. November 5, 2025. Accessed November 17, 2025. https://www.als.org/stories-news/new-als-association-co-authored-study-projects-dramatic-increase-prevalence-2040