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市場調查報告書
商品編碼
1019936

哮喘:疾病分析

Disease Analysis: Asthma

出版日期: | 出版商: Datamonitor Healthcare | 英文 92 Pages | 商品交期: 最快1-2個工作天內

價格
  • 全貌
  • 簡介
  • 目錄
簡介

2018 年全球 44 歲以下人群哮喘患病人數估計約為 3.436 億,預計2027 年患病人數將增至 3.637 億。

2019 年宣佈的 GINA 治療策略包括重大變化,這些變化擾亂了輕度哮喘管理的基本實踐。 GINA2021 提出了使用吸入性皮質類固醇 (ICS)/福莫特羅作為單一維持和姑息治療 (SMART) ,有兩個方向承認使用基於ABA的緩和劑與ICS或ICS/長效Beta2受體激動劑(LABA)相結合的更傳統的方法。

短效支氣管擴張劑可以緩解患者的症狀,但仍存在嚴重惡化的風險。到 2020 年底,NAEPP 指南將進行類似的更新。雖然在哮喘領域獲批的藥物大部分是吸入性小分子藥物,但一些新獲批的藥物表明向注射用生物製劑發展的轉變。在哮喘領域,SABA和ICS聯合療法PT027的3期試驗的頂線結果有望成為未來的重要引爆器。

本報告調查哮喘並提供有關疾病背景、治療、流行病學、藥物和管道、臨床試驗、市場趨勢和預測的信息。

目錄

內容

概述

  • 最新要點

疾病背景

  • 含義
  • 患者細分

治療

  • 主要的藥物治療分為控制劑和緩解劑
  • 治療指南建議加強治療
  • 傳統上,SABA 一直是主要的救濟藥物。
  • 對照藥物主要是ICS和LABA
  • 可以考慮同時使用額外的治療
  • 嚴重哮喘的額外治療是高度個性化的
  • 顛覆傳統哮喘管理的新建議
  • GINA 2021 提供基於 SMART 的建議,傳統 SABA 追蹤 COVID-19 哮喘管理建議

流行病學

  • 流行率調查方法

製藥

管道醫學

重大監管事件

  • FDA 宣佈通用 lalet 目標日期
  • 範圍廣泛的尋求 Amgen/AZ teseperumab 的患者
  • AZ/Amgen 未能通過歐盟快速通道競購 Teze Permab
  • FDA 批准 Xolair 預裝注射器用於自我注射
  • Viatris 清除了美國 Symbicort 的障礙,但在與阿斯利康的重大專利糾紛中敗訴
  • AstraZeneca和Amgen尋求歐盟應對嚴重哮喘的快速通道
  • 13 種新藥通過 EMA 召集
  • Hikma 宣佈期待已久的美國先進競爭對手
  • Teva 試圖通過加拿大吸入器來簡化
  • Teva 完成《Digihaler Family》等。

成功的概率

許可和資產收購交易

  • Vectura 同意在推出 Hikma Advair 後以 9.85 億英鎊收購
  • Quercis Pharma 與西新英格蘭大學簽署全球許可協議
  • 中美加入Amneal-Iconovo Symbicort Alliance
  • Vectura 獲得 Pan-JAK 抑製劑的銷售,用於治療嚴重哮喘
  • 過敏治療邁出進入更廣泛疫苗領域的第一步
  • Lannett 與 Respirent 的 Flovent Diskus 競爭對手簽訂合同
  • Chiesi與呼吸類藥物在中國等地共同推廣Bayer

臨床試驗情況

  • 贊助商狀態
  • 按階段贊助
  • 近期活動

藥物評價模型

  • ICS
  • ICS/LABA
  • ICS/LABA/LAMA
  • 其他口語課
  • 生物製藥

市場動態

趨勢

  • 儘管處方有限,但較高的生物價格仍能賺更多錢
  • 隨著第一代產品在後續產品和仿製藥中失去份額,ICS/LABA 類繼續在患者份額中佔據主導地位。
  • 對 LAMA 在哮喘中的作用的懷疑可能會減緩三聯療法的應用

共識預測

最近的事件和分析師的意見

  • 右旋普拉克索治療哮喘(2021 年 5 月 17 日)
  • Bemrist Breezhaler 治療哮喘(2021 年 3 月 1 日)
  • Dupilumab 治療哮喘(2021 年 3 月 1 日)
  • Dupilumab 治療哮喘(2021 年 3 月 1 日)
  • Dupilumab 治療哮喘(2021 年 3 月 1 日)
  • Fasenra 治療哮喘(2021 年 3 月 1 日)
  • Fasenra 治療哮喘(2021 年 3 月 1 日)
  • 治療哮喘的 Nukara 凍乾粉劑(2021 年 3 月 1 日)
  • Tezeperumab 治療哮喘(2021 年 3 月 1 日)
  • Treregy Ellipta 治療哮喘(2021 年 3 月 1 日)
  • Zimbus 哮喘呼吸器(2021 年 3 月 1 日)
  • Tezepermab 治療哮喘(2021 年 2 月 26 日)
  • Tezeperumab 治療哮喘(2020 年 12 月 22 日)
  • Tezeperumab 治療哮喘(2020 年 11 月 10 日)
  • TD-8236 治療哮喘(2020 年 11 月 5 日)
  • GB001 用於哮喘(2020 年 10 月 13 日)
  • QAW039 哮喘(2019 年 12 月 16 日)
  • 哮喘 Reliforant(2019 年 12 月 2 日)

即將發生的重大事件

對主要意見 KOL 的見解

參考

附錄

圖列表

表列表

目錄
Product Code: DMKC0215933

Definition:

Asthma is a chronic respiratory condition characterized by recurrent wheezing, coughing, and breathlessness, which occur in acute events known as exacerbations. Often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections, these flare-ups can vary significantly in frequency and severity. Attacks consist of swelling of the lining of the bronchial tubes, which narrows airways and results in a reduction of airflow into and out of the lungs. Historically considered to be a single disease, asthma is now viewed more as an overlapping assemblage of individual phenotypes with various underlying pathophysiological processes leading to symptoms.

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were approximately 343.6 million prevalent cases of asthma in individuals aged up to 44 years worldwide, and forecasts that number to increase to 363.7 million prevalent cases by 2027.

The GINA treatment strategy released in 2019 included an important change disrupting a fundamental practice in mild asthma management. Treatment with a short-acting beta 2 agonist (SABA) alone is no longer the preferred treatment for adults and adolescents with asthma. GINA 2021 now has two tracks, one with the preferred approach, using an inhaled corticosteroid (ICS)/formoterol as a single maintenance and reliever therapy (SMART), and a second allowing the more traditional approach using a SABA-based reliever with ICS or ICS/long-acting beta 2 agonist (LABA) combination. While short-acting bronchodilators may provide symptom relief for patients, they remain at risk for severe exacerbations. In late 2020, a similar update was made to the NAEPP guidelines.

The majority of approved drugs in the asthma space are inhaled small molecules, while several newer approvals show a shift towards the development of injectable biologics.

Since its launch as the first fixed-dose combination (FDC) of an ICS and a LABA, GlaxoSmithKline's Advair has become a well-established gold-standard therapy in asthma. However, generic competition in Europe, and more recently in the US, marks the end of this successful history.

Tezepelumab is a first-in-class human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin (TSLP), an epithelial cytokine. Results from the Phase III NAVIGATOR trial show that tezepelumab significantly reduced the annualized asthma exacerbation rates versus placebo over 52 weeks by 56% in the overall population, and by 41% in patients with a baseline blood eosinophil count of <300 cells/弮L.

The convenience of pipeline ICS/LABA/LAMA triple FDC therapies will only marginally increase the overall use of the LAMA drug class as physicians remain skeptical about the role of LAMAs in asthma.

Key upcoming catalysts in asthma include topline results from Phase III studies for SABA/ICS combination PT027.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

  • Main pharmacological treatments are categorized as controllers or relievers
  • Treatment guidelines recommend step-up therapy
  • Reliever medications have traditionally consisted of SABAs
  • Controller medications have been dominated by ICSs and LABAs
  • Concomitant use of additional treatments may be considered
  • Add-on treatment for severe asthma has become highly personalized
  • New recommendations upend decades of routine asthma management
  • GINA 2021 now provides the preferred SMART-based track and the traditional SABA track
  • COVID-19 recommendations for asthma management

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • FDA Hands Lannett Goal Date On Generic Advair
  • Broad Population Sought For Amgen/AZ's Tezepelumab
  • AZ/Amgen Fail In EU Fast-Track Bid For Tezepelumab
  • FDA Approves Xolair Prefilled Syringe For Self-Injection
  • Viatris Clears US Symbicort Hurdle But Loses Key Patent Fight To AstraZeneca
  • AstraZeneca & Amgen Seek EU Fast-Track For Severe Asthma Drug
  • 13 New Drugs Pass Muster At The EMA
  • Hikma Launches Long-Awaited US Advair Rival
  • Teva Seeks To Simplify With Canadian Inhalers
  • Teva Completes 'Digihaler Family'
  • Perrigo's Albuterol Advantage Blunted By Recall
  • GSK's Trelegy Ellipta Is First Triple Combination Approved For Asthma In the US
  • US Albuterol Market Hots Up With Lupin ProAir Approval
  • Aurobindo's US Respiratory Filing Could Rival Teva's Qvar
  • Genentech Seeks Self-Administration Option For Xolair
  • Teva Launches ProAir Dry Powder Digital Inhaler
  • Novartis Triple Combo Enerzair Gets EU OK For Asthma
  • Japan Nods For Enerzair And Atectura For Asthma

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Vectura Agrees £958m Takeover Following Hikma Advair Launch
  • Quercis Pharma Signs Worldwide License Agreement With Western New England University
  • China And US Added to Amneal-Iconovo Symbicort Alliance
  • Vectura Reaps Value From Pan-JAK Inhibitor For Severe Asthma
  • Allergy Therapeutics Takes First Steps Into Broader Vaccine Field
  • Lannett Makes Deal For Respirent's Flovent Diskus Rival
  • Chiesi Gets Bayer To Co-Promote Respiratory Drugs In China
  • GSK Sells Lesser Consumer Brands With Little Fanfare As Part Of Major Plan For Global Lead
  • Yuhan Partners With GI Innovation On Next-Generation Allergy Treatment

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • ICSs
  • ICS/LABAs
  • ICS/LABA/LAMAs
  • Other oral classes
  • Biologics

MARKET DYNAMICS

FUTURE TRENDS

  • High biologic prices will translate to high revenues, despite restricted prescribing
  • The ICS/LABA class will remain dominant by patient share, as first-generation products lose share to follow-on products and generics
  • Skepticism regarding the role of LAMAs in asthma may blunt uptake of triple therapies

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Dexpramipexole for Asthma (May 17, 2021)
  • Bemrist Breezhaler for Asthma (March 1, 2021)
  • Dupixent for Asthma (March 1, 2021)
  • Dupixent for Asthma (March 1, 2021)
  • Dupixent for Asthma (March 1, 2021)
  • Fasenra for Asthma (March 1, 2021)
  • Fasenra for Asthma (March 1, 2021)
  • Nucala Lyophilized Powder Formulation for Asthma (March 1, 2021)
  • Tezepelumab for Asthma (March 1, 2021)
  • Trelegy Ellipta for Asthma (March 1, 2021)
  • Zimbus Breezhaler for Asthma (March 1, 2021)
  • Tezepelumab for Asthma (February 26, 2021)
  • Tezepelumab for Asthma (December 22, 2020)
  • Tezepelumab for Asthma (November 10, 2020)
  • TD-8236 for Asthma (November 5, 2020)
  • GB001 for Asthma (October 13, 2020)
  • QAW039 for Asthma (December 16, 2019)
  • Seliforant for Asthma (December 2, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of asthma, 2018-27
  • Figure 2: Overview of pipeline drugs for asthma in the US
  • Figure 3: Pipeline drugs for asthma, by company
  • Figure 4: Pipeline drugs for asthma, by drug type
  • Figure 5: Pipeline drugs for asthma, by classification
  • Figure 6: Probability of success in the asthma pipeline
  • Figure 7: Clinical trials in asthma
  • Figure 8: Top 10 drugs for clinical trials in asthma
  • Figure 9: Top 10 companies for clinical trials in asthma
  • Figure 10: Trial locations in asthma
  • Figure 11: Asthma trials status
  • Figure 12: Asthma trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for asthma
  • Figure 14: Market dynamics in asthma
  • Figure 15: Future trends in asthma
  • Figure 16: Dupixent for Asthma (March 1, 2021): Phase III - LIBERTY ASTHMA TRAVERSE (Long-Term Follow-Up)
  • Figure 17: Tezepelumab for Asthma (February 26, 2021): Phase III - NAVIGATOR
  • Figure 18: Tezepelumab for Asthma (December 22, 2020): Phase III - SOURCE
  • Figure 19: Tezepelumab for Asthma (November 10, 2020): Phase III - NAVIGATOR
  • Figure 20: GB001 for Asthma (October 13, 2020): Phase IIb - LEDA
  • Figure 21: QAW039 for Asthma (December 16, 2019): Phase III - LUSTER 1, Phase III - LUSTER 2
  • Figure 22: Seliforant for Asthma (December 2, 2019): Related Drug - Trial Data
  • Figure 23: Key upcoming events in asthma

LIST OF TABLES

  • Table 1: Patient severity in asthma
  • Table 2: GINA treatment recommendations for asthma: Track 1
  • Table 3: GINA treatment recommendations for asthma: Track 2
  • Table 4: NAEPP EPR-3 Guidelines and Focused Update
  • Table 5: Prevalent cases of asthma, 2018-27
  • Table 6: Marketed drugs for asthma
  • Table 7: Pipeline drugs for asthma in the US
  • Table 8: Historical global sales, by drug ($m), 2016-20
  • Table 9: Forecasted global sales, by drug ($m), 2021-25
  • Table 10: Dexpramipexole for Asthma (May 17, 2021)
  • Table 11: Bemrist Breezhaler for Asthma (March 1, 2021)
  • Table 12: Dupixent for Asthma (March 1, 2021)
  • Table 13: Dupixent for Asthma (March 1, 2021)
  • Table 14: Dupixent for Asthma (March 1, 2021)
  • Table 15: Fasenra for Asthma (March 1, 2021)
  • Table 16: Fasenra for Asthma (March 1, 2021)
  • Table 17: Nucala Lyophilized Powder Formulation for Asthma (March 1, 2021)
  • Table 18: Tezepelumab for Asthma (March 1, 2021)
  • Table 19: Trelegy Ellipta for Asthma (March 1, 2021)
  • Table 20: Zimbus Breezhaler for Asthma (March 1, 2021)
  • Table 21: Tezepelumab for Asthma (February 26, 2021)
  • Table 22: Tezepelumab for Asthma (December 22, 2020)
  • Table 23: Tezepelumab for Asthma (November 10, 2020)
  • Table 24: TD-8236 for Asthma (November 5, 2020)
  • Table 25: GB001 for Asthma (October 13, 2020)
  • Table 26: QAW039 for Asthma (December 16, 2019)
  • Table 27: Seliforant for Asthma (December 2, 2019)