Market Spotlight: Amyotrophic Lateral Sclerosis (ALS)
|出版日||ページ情報||英文 46 Pages
|注目市場の分析：筋萎縮性側索硬化症 (ALS) Market Spotlight: Amyotrophic Lateral Sclerosis (ALS)|
|出版日: 2019年10月15日||ページ情報: 英文 46 Pages||
世界の40歳以上の人口における筋萎縮性側索硬化症 (ALS) の発症事例数は、2016年の46,080件から、2025年までに54,750件へ増加すると予測されています。
当レポートでは、世界の筋萎縮性側索硬化症 (ALS) の市場を調査し、疾患の背景・概要、有病者数の10ヵ年予測、パイプライン薬および上市済み薬剤の概要、臨床試験の状況、ライセンシング・資産買収などの主要取引の動向、特許情報、主要薬剤の収益予測などをまとめています。
Amyotrophic lateral sclerosis (ALS) is a fatal late-onset neurodegenerative disorder characterized by progressive muscular paralysis. It leads to damage of the upper and lower motor neurons present in the corticospinal tracts, brainstem, primary motor cortex, and spinal cord. The first onset of symptoms is generally seen in patients aged 50-65 years. Common symptoms reported by patients with ALS include muscle twitching, weakness, and cramping, which subsequently lead to muscle impairment. Furthermore, patients in the final stages of ALS will develop symptoms of dysphagia and dyspnea.
Datamonitor Healthcare estimates that in 2017, there were 47,190 incident cases of amyotrophic lateral sclerosis (ALS) in adults aged 40 years and older worldwide, and forecasts that number to increase to 56,070 incident cases by
2026. 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).
Italfarmaco's Tiglutik, Mitsubishi Tanabe's Radicava, Advanz's Rilutek, and Corestem's Neuronata-R are the only marketed drugs available for ALS. These drugs are administered via the intravenous and oral routes.
The greatest proportion of industry-sponsored drugs in active clinical development for ALS are in Phase II, with only one drug in the NDA/BLA phase.
Therapies in active clinical development for ALS focus on a wide variety of targets. The most popular method of administration is the oral route.
High-impact upcoming events for drugs in the ALS space comprise topline Phase III trial results for NurOwn, Simdax, Arimoclomol, and IONIS-SOD1Rx, and an expected PDUFA date for Exservan.
The overall likelihood of approval of a Phase I ALS asset is 6.7%, and the average probability a drug advances from Phase III is 42.9%. ALS drugs, on average, take 7.8 years from Phase I to approval, compared to 9.8 years in the overall neurology space.
There have been 27 licensing and asset acquisition deals involving ALS drugs during 2014-19. The $1,225m exclusive collaboration and license agreement signed in October 2018 between Denali and Sanofi to develop and commercialize products containing receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitors for neurological indications such as Alzheimer's disease, ALS, and multiple sclerosis was the largest deal.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for ALS have been in the early and midphases 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. The UK leads the major EU markets, while Japan has the top spot in Asia.
Clinical trial activity in the ALS space is dominated by completed trials. Otsuka/Avanir have the highest number of completed clinical trials for ALS, with 11 trials.
Biogen leads industry sponsors with the highest overall number of clinical trials for ALS