表紙
市場調查報告書

全球克隆氏症市場:到2027年的預測和分析

Crohn's Disease Forecast and Market Analysis to 2027

出版商 Datamonitor Healthcare 商品編碼 945701
出版日期 內容資訊 英文 73 Pages
商品交期: 最快1-2個工作天內
價格
全球克隆氏症市場:到2027年的預測和分析 Crohn's Disease Forecast and Market Analysis to 2027
出版日期: 2020年06月09日內容資訊: 英文 73 Pages
簡介

2018年,全球克隆氏症(CD)患者數量為610萬,預計到2027年將增加到650萬。儘管CD療法價格昂貴並且在配方中排名較高,但是所有主要的CD療法品牌都將在未來10年內到期專利,這將導致生物仿製藥的出現,尤其是在歐洲市場。產品的傳播有望增加。當前正在開發的CD治療劑包括口服Janus激□抑製劑(JAK),例如filgotinib和Rinvoq,而未來的挑戰包括與生物療法,常規療法和瘺管不相容的患者。這包括與未得到充分治療的患者打交道。

該報告調查了CD治療的全球市場,概述了疾病,治療和流行病學,市場上的藥物,正在投放的藥物以及重要的法規發展。提供有關許可和資產收購協議,臨床試驗狀態,藥物評估模型,市場動態以及未來趨勢的信息。

內容

概述

疾病背景

  • 定義
  • 症狀
  • 患者分類

治療

  • ACG治療指南
  • ECCO治療指南
  • NICE治療指南

流行病學

  • 患病率方法

非處方藥

管道藥物

監管事務的主要動向

成功的可能性

許可協議和資產收購協議

臨床試驗狀態

  • 按狀態劃分的學生贊助商
  • 階段階段的發起人
  • 最近的動作

藥物評價模型

市場動態

未來趨勢

  • 儘管處方有限制,但新的管線藥物仍在擴大市場
  • 未來十年,主要品牌市場的生物仿製藥侵蝕將加劇

共識預測

最近的動向和分析師的觀點

未來的主要動向

無法滿足的需求

參考

  • 處方藥信息

附錄

目錄
Product Code: DMKC0216632

Overview

As specialty products, therapies for Crohn's disease (CD) can be expensive, and formulary positioning is paramount to product uptake. Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade. This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates. Biosimilar and generic competition will further undermine the likely premium pricing of newer drugs and pipeline products.

Over the next decade, all key marketed brands for CD will have faced patent expiry. Thus far, the European market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance compared to other countries. In the US, biosimilars will face challenges in usurping branded anti-tumor necrosis factor inhibitors (anti-TNFs), with adalimumab biosimilars not expected until 2023, substantial originator rebates, and exclusive contracting with payers. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence accumulates and long-term data support biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars and encourage uptake.

Nevertheless, the CD market is projected to expand, propelled by a growing patient caseload and the introduction of pipeline products. Datamonitor Healthcare estimates that in 2018, there were 6.1 million prevalent cases of CD worldwide, and forecasts that number to increase to 6.5 million prevalent cases by 2027.

The entry of novel drug classes will drive growth of the CD market, despite facing cost-related barriers to uptake. The pipeline holds distinct prospects that aim to treat non-responders, including the oral Janus kinase (JAK) inhibitors filgotinib and Rinvoq. These will be welcomed for their distinguished mechanisms of action, and their oral formulation will further offer unprecedented convenience in the CD treatment algorithm. Targeting global markets broadens their commercial potential as they are being investigated across the US, Japan, and Europe. Advantageously, over the forecast period, Rinvoq and filgotinib will not encounter the increasing biosimilar competition that will directly erode sales of already marketed drugs. On the other hand, newer premium-priced entrants will likely be relegated to later lines of therapy after cheaper conventional drugs and biosimilars.

Significant unmet needs include targeting inadequate responders to biologic and conventional therapies, as well as underserved patients with fistulas. In terms of clinical trials, active comparators and the endoscopic endpoints should be prioritized as there is a stark absence of head-to-head data and the field is moving towards endoscopic treatment goals. Additionally, new mechanisms of action and convenient oral therapies that are safe and effective are desirable. Pricing will be critical to secure favorable positioning in formularies and maximize commercial opportunities.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

DISEASE BACKGROUND

  • Definition
  • Symptoms
  • Patient segmentation

TREATMENT

  • ACG treatment guidelines
  • ECCO treatment guidelines
  • NICE treatment guidelines

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Part B Drugs At Home: Medicare Policy Responds To COVID-Driven Access Concerns
  • Alberta Is Second Canadian Province To Switch To Biosimilars
  • CHMP Positive On Pfizer's Adalimumab
  • Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar
  • Samsung Bioepis Gets US Adalimumab Nod

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Gilead Moves Into Microbiome In Deal With Second Genome
  • Beximco And Mylan Strike Biosimilars Deal
  • Asia Deal Watch: Mundipharma Will Sell Samsung Bioepis' Biosimilars In Taiwan, Hong Kong
  • AZ Gets IBD Drug Back From Allergan
  • Interview: AbiVax Equipped To Enter Anti-Inflammatory Market
  • AbbVie Will Use Allergan Revenue To Fund Combined Firm's Large R&D Pipeline

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Despite formulary constraints, novel pipeline drugs will expand the market
  • Biosimilar erosion of key brands will intensify over the next 10 years

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Stelara for Crohn's Disease (February 13, 2020)
  • PRV-6527 for Crohn's Disease (October 22, 2019)
  • Inflectra for Crohn's Disease (September 19, 2019)
  • Multiple Drugs for Crohn's Disease (June 25, 2019)
  • Mirikizumab for Crohn's Disease (May 21, 2019)
  • SensoReady Injector Pen for Crohn's Disease (April 9, 2019)

KEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of Crohn's disease, 2018-27
  • Figure 2: Overview of pipeline drugs for Crohn's disease in the US
  • Figure 3: Pipeline drugs for Crohn's disease, by company
  • Figure 4: Pipeline drugs for Crohn's disease, by drug type
  • Figure 5: Pipeline drugs for Crohn's disease, by classification
  • Figure 6: Probability of success in the Crohn's disease pipeline
  • Figure 7: Clinical trials in Crohn's disease
  • Figure 8: Top 10 drugs for clinical trials in Crohn's disease
  • Figure 9: Top 10 companies for clinical trials in Crohn's disease
  • Figure 10: Trial locations in Crohn's disease
  • Figure 11: Crohn's disease trials status
  • Figure 12: Crohn's disease trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for Crohn's disease
  • Figure 14: Market dynamics in Crohn's disease
  • Figure 15: Future trends in Crohn's disease
  • Figure 16: Stelara for Crohn's Disease (February 13, 2020): Phase IIIb - STARDUST
  • Figure 17: PRV-6527 for Crohn's Disease (October 22, 2019): Phase IIa - PRINCE Study (PoC)
  • Figure 18: Mirikizumab for Crohn's Disease (May 21, 2019): Phase II - SERENITY
  • Figure 19: Key upcoming events in Crohn's disease
  • Figure 20: Unmet needs in Crohn's disease

LIST OF TABLES

  • Table 1: American College of Gastroenterology working definitions of CD activity
  • Table 2: 2018 ACG recommendations for mild-to-moderately severe disease/low-risk disease
  • Table 3: 2018 ACG recommendations for moderate-to-severe disease/moderate-to-high-risk disease
  • Table 4: 2018 ACG recommendations for severe/fulminant disease
  • Table 5: 2020 ECCO treatment guidelines for induction of remission of mild-to-moderate disease
  • Table 6: 2020 ECCO treatment guidelines for induction of remission of moderate-to-severe disease
  • Table 7: 2020 ECCO treatment guidelines for maintenance of remission
  • Table 8: 2019 NICE treatment guidelines for induction of remission
  • Table 9: 2019 NICE treatment guidelines for induction of remission
  • Table 10: 2019 NICE treatment guidelines for maintenance of remission
  • Table 11: Prevalent cases of Crohn's disease, 2018-27
  • Table 12: Marketed drugs for Crohn's Disease
  • Table 13: Pipeline drugs for Crohn's disease
  • Table 14: Historical global sales, by drug ($m), 2015-19
  • Table 15: Forecasted global sales, by drug ($m), 2020-24
  • Table 16: Stelara for Crohn's Disease (February 13, 2020)
  • Table 17: PRV-6527 for Crohn's Disease (October 22, 2019)
  • Table 18: Inflectra for Crohn's Disease (September 19, 2019)
  • Table 19: Multiple Drugs for Crohn's Disease (June 25, 2019)
  • Table 20: Mirikizumab for Crohn's Disease (May 21, 2019)
  • Table 21: SensoReady Injector Pen for Crohn's Disease (April 9, 2019)