表紙
市場調查報告書

熱門市場分析:失眠症

Market Spotlight: Insomnia

出版商 Datamonitor Healthcare 商品編碼 594580
出版日期 內容資訊 英文 42 Pages
商品交期: 最快1-2個工作天內
價格
熱門市場分析:失眠症 Market Spotlight: Insomnia
出版日期: 2019年11月26日內容資訊: 英文 42 Pages
簡介

本報告提供失眠症的治療藥市場相關分析,提供疾病概要和患者數的轉變·預測,目前的主要治療方法及臨床實驗·認證情形,失眠症治療藥市場趨勢預測 (今後10年份),資本交易的動向,現在開發中臨床實驗的進展等調查。

分析的要點

疾病的背景情況

  • 失眠症的分類

治療方法

  • 非醫學的療法
  • 醫學的療法

流行病學

已上市醫藥品

  • 各國的認證情形

開發平台上的醫藥品

法規當局近幾年的主要動向 (1件)

授權合約·資產收購交易

母體專利

商機

臨床實驗形勢

  • 贊助商數:各狀態
  • 贊助商數:各期

相關分析

  • 處方藥的資訊

附錄

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目錄
Product Code: DMKC0181437

This Market Spotlight report covers the insomnia market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, key upcoming events and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

Datamonitor Healthcare estimates that in 2017, there were 1.7 billion prevalent cases of insomnia worldwide, and forecasts that number to increase to 1.9 billion prevalent cases by

2026. It is estimated that Asia had the largest number of prevalent cases in 2017 (675.7 million cases). The approved drugs in the insomnia space target GABA-A receptor, hypocretin/orexin receptor, melatonin receptor, histamine H1 receptor, and potassium channels. The majority of marketed drugs are administered via the oral route, with the remainder being available in sublingual, oral transmucosal, or intravenous formulations.

The largest proportion of industry-sponsored drugs in active clinical development for insomnia are in Phase III, with two drugs in the NDA/BLA phase.

Therapies in mid-to-late-stage development for insomnia focus on targets such as melatonin receptor, hypocretin/orexin receptor, GABA-A receptor, GABA receptors, histamine H1 receptor, serotonin 5-HT1 receptor, and serotonin 5-HT2B receptor. All of the pipeline drugs for insomnia are administered via the oral route.

High-impact upcoming events in the insomnia space comprise an expected PDUFA date for lemborexant, an expected approval decision for ZolpiMist, topline Phase III trial results for daridorexant, and an estimated patent expiration for Belsomra.

The overall likelihood of approval of a Phase I insomnia asset is 17.6%, and the average probability a drug advances from Phase III is 66.7%. Drugs, on average, take 8.0 years from Phase I to approval, compared to 9.8 years in the overall neurology space.

There have been 22 licensing and asset acquisition deals involving insomnia drugs during 2014-19. The largest deal was the $150.8m agreement in August 2016 between Shionogi and Lupin's Japanese subsidiary, Kyowa, for the transfer of marketing rights of Shionogi's 21 long-listed drugs to Kyowa.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for insomnia have been in the early and mid-phases of development, with 59% of trials in Phase I-II, and 41% in Phase III-IV.

The US has a substantial lead in the number of insomnia clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.

Clinical trial activity in the insomnia space is dominated by completed trials. Takeda has the highest number of completed clinical trials for insomnia, with 65 trials.

Takeda leads the industry sponsors with the highest overall number of clinical trials for insomnia, followed by Merck & Co.

TABLE OF CONTENTS

CONTENTS

6 OVERVIEW

7 KEY TAKEAWAYS

8 DISEASE BACKGROUND

8 Insomnia subtypes

9 TREATMENT

9 Non-medical treatments

9 Medical treatments

12 EPIDEMIOLOGY

15 MARKETED DRUGS

18 PIPELINE DRUGS

23 RECENT EVENTS AND ANALYST OPINION

23 Hetlioz for Insomnia (August 16, 2019)

24 Seltorexant for Insomnia (June 24, 2019)

26 Lemborexant for Insomnia (October 17, 2018)

29 KEY UPCOMING EVENTS

30 KEY REGULATORY EVENTS

30 New Zealand Switches Melatonin From Prescription To OTC Status

30 US FDA Converges With Other Regulators On Insomnia Drug Warnings, But Broader Safety Disagreements Persist

30 German Melatonin Denial Is 'Further Blow' To PUMA Scheme

31 PROBABILITY OF SUCCESS

32 LICENSING AND ASSET ACQUISITION DEALS

32 Eisai Buys Out Global Rights To Lemborexant

33 PARENT PATENTS

34 REVENUE OPPORTUNITY

35 CLINICAL TRIAL LANDSCAPE

36 Sponsors by status

37 Sponsors by phase

38 Recent events

39 BIBLIOGRAPHY

39 Prescription information

41 APPENDIX

LIST OF FIGURES

  • 14 Figure 1: Trends in prevalent cases of insomnia, 2017-26
  • 18 Figure 2: Overview of pipeline drugs for insomnia in the US
  • 18 Figure 3: Pipeline drugs for insomnia, by company
  • 19 Figure 4: Pipeline drugs for insomnia, by drug type
  • 19 Figure 5: Pipeline drugs for insomnia, by classification
  • 26 Figure 6: Seltorexant for Insomnia (June 24, 2019): Phase IIb - Dose Finding
  • 28 Figure 7: Lemborexant for Insomnia (October 17, 2018): Phase III - SUNRISE 2
  • 29 Figure 8: Key upcoming events in insomnia
  • 31 Figure 9: Probability of success in the insomnia pipeline
  • 32 Figure 10: Licensing and asset acquisition deals in insomnia, 2014-19
  • 33 Figure 11: Parent patents in insomnia
  • 35 Figure 12: Clinical trials in insomnia
  • 35 Figure 13: Top 10 drugs for clinical trials in insomnia
  • 36 Figure 14: Top 10 companies for clinical trials in insomnia
  • 36 Figure 15: Trial locations in insomnia
  • 37 Figure 16: Insomnia trials status
  • 38 Figure 17: Insomnia trials sponsors, by phase

LIST OF TABLES

  • 13 Table 1: Prevalent cases of insomnia, 2017-26
  • 16 Table 2: Marketed drugs for insomnia
  • 20 Table 3: Pipeline drugs for insomnia in the US
  • 23 Table 4: Hetlioz for Insomnia (August 16, 2019)
  • 25 Table 5: Seltorexant for Insomnia (June 24, 2019)
  • 27 Table 6: Lemborexant for Insomnia (October 17, 2018)
  • 34 Table 7: Historical global sales, by drug ($m), 2014-18
  • 34 Table 8: Forecasted global sales, by drug ($m), 2019-23