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注目市場の分析:筋萎縮性側索硬化症 (ALS)

Market Spotlight: Amyotrophic Lateral Sclerosis (ALS)

発行 Datamonitor Healthcare 商品コード 573557
出版日 ページ情報 英文 46 Pages
納期: 即日から翌営業日
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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
概要

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。

要点

疾患の背景

  • サブタイプ

治療

疫学

パイプライン薬

上市済み薬剤

  • 承認:国別

主な近い将来の動向

ライセンシング・資産買収などの取引

親特許

収益機会

臨床試験環境

  • スポンサー:ステイタス別
  • スポンサー:フェーズ別
  • 処方情報

付録

目次
Product Code: DMKC0178753

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.

Key Takeaways:

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

TABLE OF CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Subtypes

TREATMENT

  • Symptomatic treatments
  • Ventilatory management
  • Nutritional management
  • Disease-modifying therapies

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • Radicava for ALS (September 17, 2019)
  • IONIS-SOD1Rx for ALS (May 7, 2019)
  • Reldesemtiv for ALS (May 5, 2019)
  • Masitinib for ALS (May 28, 2018)
  • NP001 for ALS (April 26, 2018)
  • Multiple Drugs for ALS (April 20, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • US FDA Reassures ALS Patients In Final Development Guidance
  • Hello NMPA: New Drug Approvals, Online Database And More
  • Wanted: Orphan Drugs, Antivirals Dominate China's Latest Fast Track List
  • EMA Decides Fast-Track Fate Of Masitinib And Anthrax Antitoxin

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Mitsubishi Tanabe/Daiichi Sankyo Link For Edaravone In Brazil
  • Deals Shaping The Medical Industry, February 2019
  • Sanofi Stumps Up $125m To Access Denali RIPK1 Inhibitors

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in incident cases of ALS, 2017-26
  • Figure 2: Overview of pipeline drugs for ALS in the US
  • Figure 3: Pipeline drugs for ALS, by company
  • Figure 4: Pipeline drugs for ALS, by drug type
  • Figure 5: Pipeline drugs for ALS, by classification
  • Figure 6: IONIS-SOD1Rx for ALS (May 7, 2019): Phase I/II - 233AS101
  • Figure 7: Reldesemtiv for ALS (May 5, 2019): Phase II - FORTITUDE-ALS
  • Figure 8: NP001 for ALS (April 26, 2018): Phase II - North America
  • Figure 9: Multiple Drugs for ALS (April 20, 2018)
  • Figure 10: Key upcoming events in ALS
  • Figure 11: Probability of success in the ALS pipeline
  • Figure 12: Licensing and asset acquisition deals in ALS, 2014-19
  • Figure 13: Parent patents in ALS
  • Figure 14: Clinical trials in ALS
  • Figure 15: Top 10 drugs for clinical trials in ALS
  • Figure 16: Top 10 companies for clinical trials in ALS
  • Figure 17: Trial locations in ALS
  • Figure 18: ALS trials status
  • Figure 19: ALS trials sponsors, by phase

LIST OF TABLES

  • Table 1: Incident cases of ALS, 2017-26
  • Table 2: Incidence rates of ALS, 2017-26
  • Table 3: Marketed drugs for ALS
  • Table 4: Pipeline drugs for ALS in the US
  • Table 5: Radicava for ALS (September 17, 2019)
  • Table 6: IONIS-SOD1Rx for ALS (May 7, 2019)
  • Table 7: Reldesemtiv for ALS (May 5, 2019)
  • Table 8: Masitinib for ALS (May 28, 2018)
  • Table 9: NP001 for ALS (April 26, 2018)
  • Table 10: Multiple Drugs for ALS (April 20, 2018)
  • Table 11: Historical global sales, by drug ($m), 2014-18
  • Table 12: Forecasted global sales, by drug ($m), 2019-23
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