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市場調查報告書
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997332

病情分析:偏頭痛

Disease Analysis: Migraine

出版日期: | 出版商: Datamonitor Healthcare | 英文 72 Pages | 商品交期: 最快1-2個工作天內

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  • 全貌
  • 簡介
  • 目錄
簡介

偏頭痛是一種常見的,令人困擾的反覆發作的神經病,其特徵是嚴重的頭痛,噁心,嘔吐和其他症狀,持續數小時至數天,甚至可能持續很長時間。偏頭痛的患病率在城市地區和女性中較高。偏頭痛的病因尚不完全清楚,但遺傳學和生活方式都與偏頭痛的進展和偏頭痛的嚴重程度有關。偏頭痛的常見合併症包括精神狀態,如焦慮和抑鬱。

據估計,偏頭痛將在2019年廣泛傳播,全球將有5.546億年齡在20歲及以上的成年人,到2028年,這一數字預計將增至6.198億。

偏頭痛領域中批准的大多數藥物靶向5-羥色胺受體5HT家族。大多數非處方藥是通過口服途徑給藥的,很少有產品可以通過靜脈內,鼻內,肌內,皮內,關節內,膀胱內,直腸,舌下,經粘膜和皮下獲得。

正在為偏頭痛開發的藥物集中在各種各樣的靶標上。約有一半的偏頭痛藥物是通過口服途徑給藥的,其餘的是鼻內,吸入,皮下,局部,透皮,舌下和經粘膜製劑。

本報告探討了偏頭痛市場,並概述了該疾病,並概述了市場,流行病學,藥物開發趨勢,臨床試驗趨勢和未來趨勢。

目錄

內容

概述

  • 最新要點

疾病背景

  • 沒有先兆的偏頭痛
  • 帶有先兆的偏頭痛

治療

  • 止痛藥
  • NSAID
  • 血清素激動劑
  • CGRP抑製劑
  • 偏頭痛的預防

流行病學

  • 患病率調查方法

非處方藥

管道醫學

重大監管事件

  • Lasmiditan是歐盟最新的藥物之一
  • Impel Neuro Pharma提交了INP104 NDA
  • 丹參生物電子獲得FDA突破性指定的神經刺激藥,用於治療慢性偏頭痛
  • PK研究Qtrypta錯誤
  • CefalyTouts的首款OTC兩用eTNS偏頭痛設備
  • Cipla獲得CGT批准與美國偏頭痛競爭對手競爭
  • Biohaven獲得Nurtec和ODT的批准
  • 雷迪博士的Elyxyb獲得美國NDA批准 FDA對Rizaport做出回應
  • 英國NICE扭轉了Ajovy的拒絕態度,並為偏頭痛提供了緩解
  • 最新的EMA建議允許Shionogi並拒絕禮來公司。
  • Nurtec ODT,Biohaven的口服CGRP抑製劑在美國獲批用於急性偏頭痛
  • 定價有助於Lundbeck的Vyepti在緩慢增長的CGRP市場中
  • Triptan開關給澳大利亞的OTC市場帶來希望

成功的可能性

許可和資產收購交易

  • Biohaven授予Sosei CGRP選擇性受體拮抗劑的全球使用權
  • 禮來與Daiichi Pharmaceutical合作開發了日本的galcanezumab
  • Biohaven與Royalty Pharma達成高達4.5億美元的交易

臨床試驗情況

  • 按狀態贊助
  • 分階段贊助
  • 最近事件

藥物評估模型

  • 急性偏頭痛
  • 預防慢性和暫時性偏頭痛

市場動態

趨勢

  • HCP中的品牌意識有助於增長
  • 口服CGRP預防偏頭痛具有最大的商業潛力

共識預測

最近發生的事件和分析師的觀點

  • Qtrypta偏頭痛(2020年10月21日)
  • Qtrypta偏頭痛(2020年9月30日)
  • Reyvow偏頭痛(2020年9月11日)
  • STS101偏頭痛(2020年9月10日)
  • 偏頭痛的Atogepant(2020年7月29日)
  • Trudhesa偏頭痛(2020年6月10日)
  • AXS-07偏頭痛(2020年4月6日)
  • 偏頭痛的Nurtec ODT(2020年3月30日)

即將發生的重大事件

未滿足的需求

參考

  • 處方信息

附錄

數字列表

表列表

目錄
Product Code: DMKC0223228

Disease Background:

Migraine is a common, disabling, and recurring complex neurological disorder with a genetic component, affecting adults throughout their lifespans. It is characterized by episodic headaches that throb, intensify, and cause or co-occur with nausea, vomiting, and abnormal sensory sensitivities. Migraines can occur without warning or be preceded by symptoms such as fatigue, mood change, and changes in appetite and digestion. Both positive symptoms of migraine, such as geometric patterns or flashing lights, and negative symptoms, such as vision impairment, have gradual onset and resolve completely. Migraine episodes can last from a few hours to a few days

Latest key takeaways

Datamonitor Healthcare estimates that in 2019, there were 554.6 million prevalent cases of migraine in adults aged 20 years and older worldwide, and forecasts that number to increase to 619.8 million prevalent cases by 2028.

The majority of approved drugs in the migraine space target the serotonin 5-HT family of receptors. Most marketed drugs are administered via the oral route, with a smaller number of products being available in intravenous, intranasal, intramuscular, intradermal, intraarticular, intravesical, rectal, sublingual, oral transmucosal, and subcutaneous formulations.

Drugs in development for migraine focus on a wide variety of targets. Approximately half of the drugs in development for migraine are administered via the oral route, with the remainder being intranasal, inhaled, subcutaneous, topical, transdermal, sublingual, and oral transmucosal formulations.

High-impact upcoming events for drugs in the migraine space include topline Phase IIIb trial results for Vyepti, an estimated sNDA PDUFA date for Nurtec ODT, an NDA PDUFA date for atogepant, and topline Phase III results for zavegepant.

The overall likelihood of approval of a Phase I migraine and other headaches asset is 15.1%, and the average probability a drug advances from Phase III is 90.5%. Drugs, on average, take 7.8 years from Phase I to approval, compared to 10.0 years in the overall neurology space.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for migraine have been in the early and mid-phases of development, with 54% of trials in Phase I-II, and 46% in Phase III-IV.

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

While clinical performance is important in driving a product's success in migraine, the overriding differentiation between products, and the CGRP inhibitors in particular, is market access. The CGRP biologics used for migraine prophylaxis are not highly differentiated based on efficacy, and so physicians typically choose brands based on patients' insurance coverage. In the current market, this has posed a high barrier to the newest entrants such as Vyepti (eptinezumab), but developers will continue to negotiate for formulary placement, which will expand coverage over time.

The gepants are oral small molecule CGRP receptor antagonists used for abortive migraine treatment. While traditional triptans are still considered the gold-standard treatments for acute migraine and are usually utilized at first line, alternative options are needed for patients who have contraindications, who cannot tolerate side effects, or whose migraine is not well controlled by triptans. Currently, triptans are contraindicated for patients with cardiovascular conditions, which comprises 20% of migraineurs.

Botox (onabotulinumtoxinA) has had favorable market access positioning given that patients must fail two to three drug classes (including Botox) before the initiation of CGRP biologics. However, payers have recently started to approve the earlier use of CGRP preventives, given mounting supportive evidence and broader labeling covering both chronic and episodic migraine; in comparison, Botox is limited only to those with the chronic form of the disease.

The first three anti-CGRP antibodies - Aimovig (erenumab), Emgality (galcanezumab), and Ajovy (fremanezumab) - entered the US market in 2018 as preventive treatments, and all have demonstrated similar efficacy in clinical trials, typically reducing the number of headache days of migraineurs by half or more. The CGRP class in general is well tolerated, works relatively quickly, and has proven to be effective in the prevention of both episodic migraine and chronic migraine.

In addition to clinical needs, focusing on the actions of both the migraine patient and the diagnosing physician remains a significant barrier to effective treatment. The understanding of migraine has evolved significantly over the years and yet there is still a need for consistency between guidelines, which may partly contribute to the underdiagnosis and undertreatment of migraine patients worldwide.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Migraine without aura
  • Migraine with aura

TREATMENT

  • Analgesics
  • NSAIDs
  • Serotonergic drugs
  • CGRP inhibitors
  • Prophylactic agents for migraine

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Granules' Third OTC ANDA In A Year
  • UK Funding Nod For Novartis Migraine Drug After Bumpy Ride
  • Lasmiditan Is Among Latest EU Filings
  • Impel NeuroPharma Submits NDA For INP104
  • Salvia BioElectronics Receives FDA Breakthrough Designation For Neurostimulator To Treat Chronic Migraine
  • PK Studies Trip Qtrypta
  • Cefaly Touts First OTC Dual-Purpose eTNS Migraine Device
  • Cipla Gets CGT Nod For US Migranal Rival
  • Biohaven Goes All In On ODT With Nurtec
  • Dr Reddy's Elyxyb Receives US Approval For Its NDA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Biohaven Licenses Global Rights To Selected Sosei CGRP Receptor Antagonists
  • Lilly Links With Daiichi For Galcanezumab In Japan
  • Biohaven To Receive Up To $450m In Deal With Royalty Pharma

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Acute migraine
  • Chronic and episodic migraine prevention

MARKET DYNAMICS

FUTURE TRENDS

  • Brand awareness among HCPs will contribute to growth
  • Oral CGRPs for migraine prophylaxis have the greatest commercial potential

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • STS101 for Migraine (March 1, 2021)
  • Qtrypta for Migraine (October 21, 2020)
  • Qtrypta for Migraine (September 30, 2020)
  • Reyvow for Migraine (September 11, 2020)
  • STS101 for Migraine (September 10, 2020)
  • Atogepant for Migraine (July 29, 2020)
  • Trudhesa for Migraine (June 10, 2020)

KEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of migraine, 2019-28
  • Figure 2: Overview of pipeline drugs for migraine in the US
  • Figure 3: Pipeline drugs for migraine, by company
  • Figure 4: Pipeline drugs for migraine, by drug type
  • Figure 5: Pipeline drugs for migraine, by classification
  • Figure 6: Probability of success in the migraine and other headaches pipeline
  • Figure 7: Clinical trials in migraine
  • Figure 8: Top 10 drugs for clinical trials in migraine
  • Figure 9: Top 10 companies for clinical trials in migraine
  • Figure 10: Trial locations in migraine
  • Figure 11: Migraine trials status
  • Figure 12: Migraine trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for migraine
  • Figure 14: Market dynamics in migraine
  • Figure 15: Future trends in migraine
  • Figure 16: STS101 for Migraine (March 1, 2021): Phase III - EMERGE
  • Figure 17: Reyvow for Migraine (September 11, 2020): Phase III - CENTURION (>4 Migraine Attacks)
  • Figure 18: STS101 for Migraine (September 10, 2020): Phase III - EMERGE
  • Figure 19: Atogepant for Migraine (July 29, 2020): Phase III - ADVANCE
  • Figure 20: Trudhesa for Migraine (June 10, 2020): Phase III - STOP-301
  • Figure 21: Key upcoming events in migraine

LIST OF TABLES

  • Table 1: Prevalent cases of migraine, 2019-28
  • Table 2: Prevalence proportions of migraine, 2019-28
  • Table 3: Marketed drugs for migraine
  • Table 4: Pipeline drugs for migraine in the US
  • Table 5: Historical global sales, by drug ($m), 2016-20
  • Table 6: Forecasted global sales, by drug ($m), 2021-25
  • Table 7: STS101 for Migraine (March 1, 2021)
  • Table 8: Qtrypta for Migraine (October 21, 2020)
  • Table 9: Qtrypta for Migraine (September 30, 2020)
  • Table 10: Reyvow for Migraine (September 11, 2020)
  • Table 11: STS101 for Migraine (September 10, 2020)
  • Table 12: Atogepant for Migraine (July 29, 2020)
  • Table 13: Trudhesa for Migraine (June 10, 2020)