市場調查報告書

潰瘍性結腸炎市場:預測分析

Ulcerative Colitis Market and Forecast Analysis

出版商 Datamonitor Healthcare 商品編碼 939975
出版日期 內容資訊 英文 84 Pages
商品交期: 最快1-2個工作天內
價格
潰瘍性結腸炎市場:預測分析 Ulcerative Colitis Market and Forecast Analysis
出版日期: 2020年05月07日內容資訊: 英文 84 Pages
簡介

作為特殊的製品,潰瘍性結腸炎(UC)治療可能會花費高額費用、處方定位對於製品的攝取至關重要。因為重要的合約使得支付者優先考慮Humira和Remicade等免疫學藥物。這對於無法在數量與折扣上競爭的市場新進入者是很難以跨越的障礙。生物仿製藥和非專利藥的競爭將進一步破壞新的Pipeline藥物的價格。

本報告中,分析了全球潰瘍性結腸炎治療藥的臨床試驗情勢與市場動向預測,並提供了疾病的概要與流行病學的預測,現在的主要治療藥 (已上市/Pipeline製品) 及臨床試驗的進行狀況,現在未滿足的需求及將來的市場機會,專家對於臨床試驗/市場走向相關的見解等情報。

目次

概要

  • 最新要點

疾病的背景

  • 定義
  • 患者的市場劃分

治療

  • ACG治療指導方針
  • ECCO治療指導方針
  • NICE治療指導方針

流行病學

  • 有病率的調查方法

市售藥物

Pipeline藥物

主要法規事例

  • EU:Pfizer警告醫師關於Xeljanz引起血栓的危險性
  • 對Pfizer的阿達木單抗CHMP呈陽性
  • EMA勸告謹慎使用Pfizer的Xeljanz
  • 追蹤:Vertex的Trikafta加速獲得美國的許可; AZ的Farxiga、J&J的Stelara、GSK的Zejula的新的適應症
  • AbbVie的Humira後戰略獲得Rinvoq的許可持續具體化
  • Samsung Bioepis取得美國的Adalimumab許可
  • 血塊的疑慮促進EU限制了Pfizer的Xeljanz

成功的機率

執照與資產收購交易

  • 從AstraZeneca、Allergan 取回IBD藥
  • Celgene收購完成,Bristol面對重大里程碑
  • Medtech的協議:BI、Inflammasome 有關視網膜疾病的炎症工作、武田藥品與Prometheus挑戰IBD
  • 收購Encycle使得Zealand獲得第一筆外部資產
  • 武田藥品進行IBD治療與採用診斷的Prometheus
  • 因Amgen以134億美金收購Otezla、Bristol/Celgene 合併將在年底結束
  • 訪問:為了進入抗炎症劑市場而準備的AbiVax
  • Roche 免疫學技術交涉中

臨床實驗的情勢

  • 地位別贊助者
  • 階段別贊助者
  • 最新事例

藥物評價模型

市場力學

將來動向

  • 新的Pipeline製品將使得UC市場更加多樣化
  • 因為UC市場已被生物仿製藥與非專利藥浸透、品牌將會面臨逆風狀態

共識決測法預測

最新事例與分析師見解

  • 潰瘍性結腸炎的Inflectra(2019年9月19日)
  • IMU-838對於潰瘍性結腸炎(2019年9月5日)
  • 潰瘍性結腸炎的Kappaproct(2019年8月27日)
  • Brilacidin(局部)對於潰瘍性結腸炎(2019年7月22日)
  • 潰瘍性結腸炎治療的複數藥品(2019年6月25日)
  • 潰瘍性結腸炎用SensoReady注射針(2019年4月9日)
  • 潰瘍性結腸炎的Entyvio(2019年3月9日)
  • Etrasimod對於潰瘍性結腸炎(2019年1月7日)
  • 潰瘍性結腸炎的Rinvoq(2018年10月23日)
  • 潰瘍性結腸炎的Stelara(2018年10月9日)

關於今後

未滿足需求

參考文獻

  • 處方箋情報

附錄

目錄
Product Code: DMKC5435

Latest key takeaways

As specialty products, therapies for ulcerative colitis (UC) 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 and pipeline products.

Pivotal upcoming events in the forecast period include the entries of biosimilar adalimumab and generic tofacitinib. Biosimilar adalimumab will enter the US market from 2023, while generic tofacitinib is expected to enter the US market at the end of 2025. Notably, generics have fewer barriers to entry than biosimilars due to numerous factors, including their less complex nature and long-standing familiarity, which facilitates much faster and stronger erosion of branded sales.

Nevertheless, the UC 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 12.6 million prevalent cases of UC worldwide, and forecasts that number to increase to 13.5 million prevalent cases by 2027. The UC pipeline holds multiple novel prospects in terms of distinct mechanisms of action and biologics with more convenient formulations. The market will welcome sphingosine 1-phosphate (S1P) receptor modulators etrasimod and Zeposia, interleukin-23 (IL-23) modulator mirikizumab, and toll-like receptor 9 modulator Kappaproct. There has been a positive response to Xeljanz as the first, novel oral drug competing with biologics for UC, and other companies have recognized this opportunity to provide ease of administration with oral etrasimod, Zeposia, and Rinvoq. Once these products reach the market, they will provide more options for UC patients beyond the established, non-oral anti-TNF class, which is currently the mainstay of treatment. It is likely that these novel products will initially compete at later lines of therapy after the anti-TNF inhibitors, given the latter's enduring stronghold at the first line of biologic therapy.

Although the anti-TNF class are the cornerstone of treatment, ~10-30% of patients are non-responders to initial treatment and ~23-46% of patients lose response over time. Additionally, the class has black box warnings for the risk of serious infections and malignancy. These drugs are favored due to long-standing physician familiarity and prioritization in formularies, however, they do not satisfy persisting unmet needs in the UC market.

Critical unmet needs and opportunities include demonstrating strong efficacy to treat inadequate responders, clinically balanced drugs that offer both efficacy and safety, producing superior data over anti-TNF inhibitors and available drugs in the same class through head-to-head trials, and competitive pricing, which is essential to facilitate better positioning in the treatment algorithm.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

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

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • EU: Pfizer Warns Doctors About Blood Clot Risk With Xeljanz
  • CHMP Positive On Pfizer's Adalimumab
  • EMA Recommends Caution For Pfizer's Xeljanz
  • Keeping Track: Vertex's Trikafta Speeds To US Approval; New Indications For AZ's Farxiga, J&J's Stelara, GSK's Zejula
  • AbbVie's Post-Humira Strategy Continues Taking Shape With Rinvoq Approval
  • Samsung Bioepis Gets US Adalimumab Nod
  • Blood Clot Concerns Prompt EU Restrictions For Pfizer's Xeljanz

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • AZ Gets IBD Drug Back From Allergan
  • With Celgene Acquisition Closed, Bristol Faces Major Milestones
  • Pacts In Medtech: BI, Inflammasome Work On Retinal Disease; Takeda And Prometheus Take On IBD
  • Buying Encycle Gives Zealand Its First External Asset
  • Takeda Taps Prometheus For IBD Therapies And Diagnostics
  • Amgen's $13.4bn Otezla Buy Helps Bristol/Celgene Merger Close By Year-End
  • Interview: AbiVax Equipped To Enter Anti-Inflammatory Market
  • Roche Dealmakers On The Immunology Technology They're Shopping For

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Novel pipeline products are poised to diversify the UC market
  • Brands will face headwinds as the UC market is penetrated by biosimilars and generics

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Inflectra for Ulcerative Colitis (September 19, 2019)
  • IMU-838 for Ulcerative Colitis (September 5, 2019)
  • Kappaproct for Ulcerative Colitis (August 27, 2019)
  • Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
  • Multiple Drugs for Ulcerative Colitis (June 25, 2019)
  • SensoReady Injector Pen for Ulcerative Colitis (April 9, 2019)
  • Entyvio for Ulcerative Colitis (March 9, 2019)
  • Etrasimod for Ulcerative Colitis (January 7, 2019)
  • Rinvoq for Ulcerative Colitis (October 23, 2018)
  • Stelara for Ulcerative Colitis (October 9, 2018)

KEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: UC disease extent
  • Figure 2: Trends in Prevalent Cases of Ulcerative Colitis, 2018-27
  • Figure 3: Overview of pipeline drugs for UC in the US
  • Figure 4: Pipeline drugs for UC, by company
  • Figure 5: Pipeline drugs for UC, by drug type
  • Figure 6: Pipeline drugs for UC, by classification
  • Figure 7: Probability of success in the UC pipeline
  • Figure 8: Clinical trials in UC
  • Figure 9: Top 10 drugs for clinical trials in UC
  • Figure 10: Top 10 companies for clinical trials in UC
  • Figure 11: Trial locations in UC
  • Figure 12: UC trials status
  • Figure 13: UC trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for UC
  • Figure 15: Market dynamics in UC
  • Figure 16: Future trends in UC
  • Figure 17: Kappaproct for Ulcerative Colitis (August 27, 2019): Phase IIb - CONDUCT
  • Figure 18: Entyvio for Ulcerative Colitis (March 9, 2019): Phase IIIb - VARSITY (vs. Adalimumab SC)
  • Figure 19: Etrasimod for Ulcerative Colitis (January 7, 2019): Phase II - OASIS Extension
  • Figure 20: Rinvoq for Ulcerative Colitis (October 23, 2018): Phase IIb/III - U-ACHIEVE
  • Figure 21: Stelara for Ulcerative Colitis (October 9, 2018): Phase III - UNIFI
  • Figure 22: Key upcoming events in UC
  • Figure 23: Unmet needs in UC

LIST OF TABLES

  • Table 1: American College of Gastroenterology UC activity index
  • Table 2: 2019 ACG recommendations for induction of remission in patients with mildly active UC
  • Table 3: 2019 ACG recommendations for maintenance of remission in patients with previously mildly active UC
  • Table 4: 2019 ACG recommendations for induction of remission in patients with moderately to severely active UC
  • Table 5: 2019 ACG recommendations for maintenance of remission in patients with previously moderately to severely active UC
  • Table 6: 2019 ACG recommendations for hospitalized patients with acute severe UC
  • Table 7: 2017 ECCO treatment guidelines for proctitis
  • Table 8: 2017 ECCO treatment guidelines for left-sided UC
  • Table 9: 2017 ECCO treatment guidelines for extensive UC
  • Table 10: 2017 ECCO treatment guidelines for severe UC
  • Table 11: 2017 ECCO treatment guidelines for maintenance of remission
  • Table 12: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctitis
  • Table 13: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctosigmoiditis and left-sided UC
  • Table 14: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate extensive UC
  • Table 15: 2019 NICE treatment guidelines regarding biologics and JAK inhibitors for moderate-severely active UC for all extents of disease
  • Table 16: 2019 NICE treatment guidelines for acute severe UC for all extents of disease
  • Table 17: 2019 NICE treatment guidelines for maintaining remission
  • Table 18: Prevalent cases of ulcerative colitis, 2018-27
  • Table 19: Marketed drugs for ulcerative colitis
  • Table 20: Pipeline drugs for ulcerative colitis
  • Table 21: Historical global sales, by drug ($m), 2015-19
  • Table 22: Forecasted global sales, by drug ($m), 2020-24
  • Table 23: Inflectra for Ulcerative Colitis (September 19, 2019)
  • Table 24: IMU-838 for Ulcerative Colitis (September 5, 2019)
  • Table 25: Kappaproct for Ulcerative Colitis (August 27, 2019)
  • Table 26: Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
  • Table 27: Multiple Drugs for Ulcerative Colitis (June 25, 2019)
  • Table 28: SensoReady Injector Pen for Ulcerative Colitis (April 9, 2019)
  • Table 29: Entyvio for Ulcerative Colitis (March 9, 2019)
  • Table 30: Etrasimod for Ulcerative Colitis (January 7, 2019)
  • Table 31: Rinvoq for Ulcerative Colitis (October 23, 2018)
  • Table 32: Stelara for Ulcerative Colitis (October 9, 2018)