DUBLIN--(BUSINESS WIRE)--The "Market Spotlight: Amyotrophic Lateral Sclerosis (ALS)" report has been added to Research and Markets' offering.
This Market Spotlight report covers the Amyotrophic Lateral Sclerosis (ALS) market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- The author estimates that in 2016, there were 46,080 incident cases of amyotrophic lateral sclerosis (ALS) in adults aged 40 years and older worldwide, and forecasts that number to increase to 54,750 incident cases by 2025.
- Oceania and Europe are estimated to have the highest disease incidence (2.33 and 2.16 cases per 100,000 people, respectively), while Asia and Africa have the lowest incidence (0.62 and 0.89 cases per 100,000 people, respectively).
- The majority of industry-sponsored drugs in active clinical development for ALS are in Phase II. Therapies in mid- and late-stage development for ALS focus on targets such as the fibroblast growth factor receptor, platelet derived growth factor receptor, KIT/c-KIT, mitochondria, superoxide dismutase 1, mitochondrial electron transport chain, and troponin. Among these therapies, Masitinib (masitinib mesylate) is the most clinically advanced drug for ALS. Approximately one third of the drugs in mid-to-late-stage development are administered via the oral route, with the remainder including intravenous, subcutaneous, intrathecal, and intramuscular formulations.
- Mitsubishi's Radicava (edaravone), Concordia's Rilutek (riluzole), and Corestem's Neuronata-R are the only marketed drugs available for ALS. Radicava gained US Food and Drug Administration (FDA) approval in 2017 after trial data demonstrated that it slows decline in the loss of physical function in ALS patients.
- High impact upcoming events for drugs in the ALS space include topline Phase I/II and Phase III trial results for IONIS-SOD1Rx, Masitinib, and Tirasemtiv, as well as a Committee for Medicinal Products for Human Use (CHMP) opinion regarding Masitinib's filing.
- There were 17 licensing and asset acquisition activities involving ALS drugs during 2012-17. The $784m strategic collaboration agreement between Biogen and Ionis to develop drugs for the treatment of neurological disorders was the largest deal during this period.
- The majority of drugs used for the treatment of ALS are prescribed off-label, making it difficult to estimate the current value of the ALS market.
- The distribution of clinical trials across Phase I-IV indicates that the majority of drugs are in the early and mid-phases of development, with 81% of trials in Phase I-II, and only 19% in Phase III-IV.
- The US has a substantial lead in the number of ALS clinical trials globally, yet forecasted incident cases are lower in North America as compared to Europe and Asia. France and the UK lead the major EU markets, while Japan has the top spot in Asia, where incident cases of ALS are highest.
- Clinical trial activity in the ALS space is dominated by completed trials, with only 13% of trials currently ongoing. Biogen and Otsuka have the highest number of completed clinical trials for ALS with 10 each.
- Biogen and Otsuka also have the highest numbers of Phase I trials, while the greatest number of trials are in Phase II across the majority of industry sponsors
Key Topics Covered:
1 Key Takeaways
2 Disease Background
5 Pipeline Drugs
6 Marketed Drugs
7 Key Upcoming Events
8 Licensing And Asset Acquisition Deals
9 Parent Patents
10 Revenue Opportunity
11 Clinical Trial Landscape
For more information about this report visit https://www.researchandmarkets.com/research/gbs3qv/market_spotlight