NEWS: 公告在東京證券交易所JASDAQ標準市場新上市

表紙
市場調查報告書

疾病分析:類風濕性關節炎 (RA)

Disease Analysis: Rheumatoid Arthritis

出版商 Datamonitor Healthcare 商品編碼 980117
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
疾病分析:類風濕性關節炎 (RA) Disease Analysis: Rheumatoid Arthritis
出版日期: 2020年12月18日內容資訊: 英文 84 Pages
簡介

預計2018年,全球類風濕性關節炎 (RA)的患病人數達到2,590萬件,至2027年增加到2,860萬件。

本報告類風濕性關節炎 (RA) 調查分析,主要的上市藥、開發平台藥物,成功的可能性,臨床試驗,未來趨勢,未滿足需求等相關的系統性資訊。

目錄

內容

概要

疾病的背景

  • 定義
  • 患者的分類

治療

  • ACR治療指南
  • EULAR治療指南

流行病學

上市藥

開發平台藥物

主要的法規活動

成功的可能性

授權、資產取得交易

臨床試驗形勢

  • 贊助商:各狀態
  • 贊助商:各階段
  • 最近的事件

醫藥品評估模式

  • 生物學的 DMARDs
  • 非生物學的 DMARDs

市場動態

未來趨勢

  • 生物相似藥的普及,品牌逆風
  • 抗TNF級依然具優勢
  • JAK抑制劑級的擴大抑制
  • 新的開發中產品

共識的預測

最近的事件和分析師的見解

今後主要的事件

未滿足需求

  • 達到寬解的有效的藥
  • 標靶治療
  • 藥高價
  • 抗性高,安全的藥

參考文件

附錄

目錄
Product Code: DMKC0210967

Overview:

The rheumatoid arthritis (RA) market will decline slightly over the 2020-29 forecast period, with sales in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK) ending at $19.2bn in 2029, and decreasing at an overall compound annual growth rate (CAGR) of -0.6%. Revenues in this market will peak at $22.3bn in 2025 due to increasing disease prevalence, uptake of new targeted drugs, and the anticipated launch of pipeline drugs, before decreasing as a whole due to biosimilar and generic erosion.

Latest key takeaways

The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition. The EU market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance of biosimilars compared to other countries. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence builds, with long-term data supporting biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars and encourage uptake.

Nevertheless, as the RA caseload enlarges and several pipeline drugs launch, this will provide impetus for market growth. Datamonitor Healthcare estimates that in 2018, there were 25.9 million prevalent cases of RA worldwide, and expects that number to increase to 28.6 million prevalent cases by 2027.

As multi-billion-dollar products, Humira and Enbrel represent the best-selling brands in the market, and their stronghold will continue. In the US, biosimilars will face challenges in usurping branded anti-TNF drugs, with adalimumab biosimilars not expected to enter until 2023, etanercept biosimilars held in patent litigation, substantial originator rebates, and exclusive contracting with payers.

Gilead's Jyseleca is the latest addition to the oral JAK inhibitor class, following Rinvoq's US launch in September 2019. AbbVie is positioning Rinvoq as a follow-on product from Humira, supported by an extensive global pivotal trial program, and AbbVie has demonstrated Rinvoq's superiority in head-to-head trials with gold-standard Humira. AbbVie's experience and presence in the RA market will foster success for the drug, despite its third-to-market status.

Although the JAK inhibitors are differentiated by their convenient oral administration, the class has been associated with venous thromboembolic event (VTE) concerns, and this stigma may fuel hesitancies towards using these products. Despite AbbVie releasing data showing that the rate of VTEs associated with Rinvoq treatment was in line with the background rate for RA patients, the FDA included a black box warning for the safety issue. Furthermore, the drugs are premium-priced, and the entry of generic tofacitinib will not only erode market share from Xeljanz, but also from Olumiant, Rinvoq, and Jyseleca.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

  • ACR treatment guidelines
  • EULAR treatment guidelines

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Shaking Off US Rebuff, Gilead And Galapagos Get Filgotinib Green Lights In EU And Japan
  • Cadila Pharma Adds To Indian Biosimilars With Adalimumab
  • Lupin And Mylan Launch Etanercept In Germany
  • Gilead's RA Hopeful Filgotinib Hit By Complete Response Letter
  • Cadila Pharma Launches Rituximab And Teriparatide Biosimilars In India
  • FDA Approves Mylan's Humira Biosimilar
  • Japan Approves First Humira Biosimilar
  • Sandoz' Ziextenzo And Riximyo Cleared In Canada
  • Teva And Celltrion Gain Arthritis Advantage On Rituximab
  • Pfizer Has Eyes On EU Rituximab Market Following EC Approval
  • Mylan And Lupin Get EU Etanercept Nod
  • Celltrion Eyes 'Competitive Edge' With Adalimumab Filing
  • Celltrion Launches Remsima SC In UK
  • Pfizer's Ruxience Rituximab Biosimilar Gets CHMP Nod
  • Pfizer Will Not Launch EU Adalimumab
  • EU Approvals: Rinvoq Cleared For RA
  • CHMP Positive On Pfizer's Adalimumab
  • Amgen Gets US Infliximab Nod

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Jubilant Obtains Americas Rights To Navidea's RA Diagnostic Agent
  • Beximco And Mylan Strike Biosimilars Deal
  • Mundipharma Will Sell Samsung Bioepis' Biosimilars In Taiwan, Hong Kong
  • Deals Shaping The Medical Industry, January 2020

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent Events

DRUG ASSESSMENT MODEL

  • Biologic DMARDs
  • Non-biologic DMARDs

MARKET DYNAMICS

FUTURE TRENDS

  • Brands will face headwinds as the RA market is penetrated by more biosimilars
  • Spearheaded by Humira and Enbrel, the anti-TNF class will remain dominant, despite pressure from biosimilars
  • Expansion of the JAK inhibitor class will be dampened by the entry of generic tofacitinib and safety concerns
  • New pipeline products will be relegated to later lines of therapy

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Piclidenoson for Rheumatoid Arthritis (October 6, 2020)
  • Jyseleca for Rheumatoid Arthritis (August 18, 2020)
  • ABBV-3373 for Rheumatoid Arthritis (June 10, 2020)
  • Rinvoq for Rheumatoid Arthritis (June 6, 2020)
  • Multiple Drugs for Rheumatoid Arthritis (June 25, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

  • Therapies are clinically comparable
  • Pricing and insurance coverage drive prescribing

UNMET NEEDS

  • There is critical unmet need for effective drugs that achieve remission
  • Unmet need exists for targeted treatments applied with a stratified medicine approach
  • With RA patients being treated with costly specialty drugs, more affordable treatments are needed
  • Better tolerated, safer drugs are desired

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: 2015 ACR treatment algorithm for patients with symptomatic early RA
  • Figure 2: 2015 ACR treatment algorithm for patients with established RA
  • Figure 3: 2015 ACR recommendations for patients with single TNFi failure in established RA
  • Figure 4: 2015 ACR recommendations for patients with single non-TNF biologic failure in established RA
  • Figure 5: Trends in prevalent cases of rheumatoid arthritis, 2018-27
  • Figure 6: Overview of pipeline drugs for rheumatoid arthritis in the US
  • Figure 7: Pipeline drugs for rheumatoid arthritis, by company
  • Figure 8: Pipeline drugs for rheumatoid arthritis, by drug type
  • Figure 9: Pipeline drugs for rheumatoid arthritis, by classification
  • Figure 10: Probability of success in the rheumatoid arthritis pipeline
  • Figure 11: Clinical trials in rheumatoid arthritis
  • Figure 12: Top 10 drugs for clinical trials in rheumatoid arthritis
  • Figure 13: Top 10 companies for clinical trials in rheumatoid arthritis
  • Figure 14: Trial locations in rheumatoid arthritis
  • Figure 15: Rheumatoid arthritis trials status
  • Figure 16: Rheumatoid arthritis trials sponsors, by phase
  • Figure 17: Datamonitor Healthcare's drug assessment summary for rheumatoid arthritis
  • Figure 18: Market dynamics in rheumatoid arthritis
  • Figure 19: Future trends in rheumatoid arthritis
  • Figure 20: ABBV-3373 for Rheumatoid Arthritis (June 10, 2020): Phase II - M16-560
  • Figure 21: Rinvoq for Rheumatoid Arthritis (June 6, 2020): Phase III - SELECT-CHOICE
  • Figure 22: Key upcoming events in rheumatoid arthritis

LIST OF TABLES

  • Table 1: 2015 ACR recommendations for patients with symptomatic early RA
  • Table 2: 2015 ACR recommendations for patients with established RA
  • Table 3: 2016 EULAR recommendations for the management of RA
  • Table 4: Prevalent cases of rheumatoid arthritis, 2018-27
  • Table 5: Marketed drugs for rheumatoid arthritis
  • Table 6: Pipeline drugs for rheumatoid arthritis in the US
  • Table 7: Historical global sales, by drug ($m), 2015-19
  • Table 8: Forecasted global sales, by drug ($m), 2020-24
  • Table 9: Piclidenoson for Rheumatoid Arthritis (October 6, 2020)
  • Table 10: Jyseleca for Rheumatoid Arthritis (August 18, 2020)
  • Table 11: ABBV-3373 for Rheumatoid Arthritis (June 10, 2020)
  • Table 12: Rinvoq for Rheumatoid Arthritis (June 6, 2020)
  • Table 13: Multiple Drugs for Rheumatoid Arthritis (June 25, 2019)