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市場調查報告書

疾病分析:類風濕性關節炎

Disease Analysis: Rheumatoid Arthritis

出版商 Datamonitor Healthcare 商品編碼 923381
出版日期 內容資訊 英文 82 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 Disease Analysis: Rheumatoid Arthritis
出版日期: 2020年05月22日內容資訊: 英文 82 Pages
簡介

EU的類風濕關節炎市場正面臨著生物仿製藥的進入,和其他國家相比,EU的上市速度和認識速度都在加速,只要支持生物仿製藥功效和安全性的長期數據得到國際認可,生物仿製藥今後可望日益普及。同時醫生和患者由於信賴並習慣生物相似藥,更會擴大攝取量。

本報告提供類風濕性關節炎的相關調查,彙整疾病的背景和患者趨勢,治療指南,藥物趨勢,臨床實驗趨勢,未來趨勢等相關資訊。

概要

疾病的背景

  • 定義
  • 患者市場區隔

治療

  • ACR治療指南
  • EULAR治療指南

流行病學

  • 罹患方法

上市完畢藥物

開發平台藥物

主要的法規活動

成功概率

授權與資產收購交易

臨床實驗趨勢

藥物評估模式

市場趨勢

未來趨勢

共識預測

近幾年的活動和分析師的見解

今後的活動

關鍵意見領袖的意見

  • 未滿足需求

參考文獻

附錄

目錄
Product Code: DMKC0210967

Latest key takeaways

The rheumatoid arthritis (RA) market will experience increasing attrition due to biosimilar competition. The EU market has taken the brunt of*biosimilar erosion, with earlier launches and more acceptance 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 Janus kinase (JAK) inhibitors 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-TNFs, 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 filgotinib will launch as 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.*Rinvoq*is supported by an extensive global pivotal trial program, and AbbVie has demonstrated its 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 filgotinib. The JAK*inhibitors are not expected to*supplant the leading anti-TNF class.

TABLE OF CONTENTS

CONTENTS

7 OVERVIEW

7 Latest key takeaways

8 DISEASE BACKGROUND

8 Definition

8 Patient segmentation

9 TREATMENT

9 ACR treatment guidelines

11 EULAR treatment guidelines

14 EPIDEMIOLOGY

14 Prevalence methodology

17 MARKETED DRUGS

27 PIPELINE DRUGS

38 KEY REGULATORY EVENTS

38 Pfizer Has Eyes On EU Rituximab Market Following EC Approval

38 Mylan And Lupin Get EU Etanercept Nod

38 Celltrion Eyes 'Competitive Edge' With Adalimumab Filing

38 Celltrion Launches Remsima SC In UK

39 Pfizer's Ruxience Rituximab Biosimilar Gets CHMP Nod

39 Pfizer Will Not Launch EU Adalimumab

39 EU Approvals: Rinvoq Cleared For RA

39 CHMP Positive On Pfizer's Adalimumab

40 Amgen Gets US Infliximab Nod

40 Pfizer's FDA-Approved Adalimumab Faces Four-Year Wait

40 Celltrion Pushes 'Biobetters' Concept With Remsima SC

41 Bio-Thera Solutions Has China's First Adalimumab Biosimilar

41 EMA Recommends Caution For Pfizer's Xeljanz

41 Celltrion Will Sell World's First Subcutaneous Infliximab Directly In Europe

41 AbbVie's Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

42 Europe's Biotechs Gathering Steam With Filgotinib Filing

42 Samsung Bioepis Gets US Adalimumab Nod

42 Nichi-Iko Looks To File For Interchangeable Infliximab In US Next Year

43 PROBABILITY OF SUCCESS

44 LICENSING AND ASSET ACQUISITION DEALS

44 Beximco And Mylan Strike Biosimilars Deal

44 Mundipharma Will Sell Samsung Bioepis' Biosimilars In Taiwan, Hong Kong

44 Deals Shaping The Medical Industry, January 2020

44 CC-Pharming And iBio Expand Chinese Rituximab Venture

44 $5bn Galapagos Deal Won't Be Last For Gilead, Says O'Day

46 CLINICAL TRIAL LANDSCAPE

48 Celltrion Begins US Phase III For Infliximab SC, Aims For 2022 Launch

49 Start-Up Spotlight: SetPoint Develops Vagus Nerve Stimulation To Treat Crohn's Disease And Rheumatoid Arthritis

49 Interview: Abivax Equipped To Enter Anti-Inflammatory Market

49 GSK's Otilimab Goes Head-To-Head To Crack Rheumatoid Arthritis

49 Gilead To File Filgotinib For RA in 2019, Earlier Than Forecast

50 Celltrion Reports Positive Rheumatoid Arthritis Data From Subcutaneous Infliximab

50 AbbVie Ups The Ante For Upadacitinib At EULAR

51 DRUG ASSESSMENT MODEL

53 MARKET DYNAMICS

54 FUTURE TRENDS

54 Brands will face headwinds as the RA market is penetrated by more biosimilars

54 Spearheaded by Humira and Enbrel, the anti-TNF class will remain dominant, despite pressure from biosimilars

54 Expansion of the JAK inhibitor class will be dampened by the entry of generic tofacitinib and safety concerns

56 CONSENSUS FORECASTS

61 RECENT EVENTS AND ANALYST OPINION

61 Multiple Drugs for Rheumatoid Arthritis (June 25, 2019)

61 Filgotinib for Rheumatoid Arthritis (March 28, 2019)

63 Filgotinib for Rheumatoid Arthritis (March 28, 2019)

65 Xeljanz / Xeljanz XR for Rheumatoid Arthritis (February 19, 2019)

66 Biosimilar Rituximab (Amgen) for Rheumatoid Arthritis (January 24, 2019)

67 AVT-02 for Rheumatoid Arthritis (November 19, 2018)

68 Otilimab for Rheumatoid Arthritis (October 23, 2018)

70 Hyrimoz for Rheumatoid Arthritis (October 22, 2018)

71 Otilimab for Rheumatoid Arthritis (October 21, 2018)

74 KEY UPCOMING EVENTS

75 KEY OPINION LEADER INSIGHTS

75 Therapies are clinically comparable

75 Pricing and insurance coverage drive prescribing

76 UNMET NEEDS

76 There is critical unmet need for effective drugs that achieve remission

76 Unmet need exists for targeted treatments applied with a stratified medicine

76 With RA patients being treated with costly specialty drugs, more affordable treatments are needed

77 Better tolerated, safer drugs are desired

78 BIBLIOGRAPHY

79 Prescription information

81 APPENDIX

LIST OF FIGURES

  • 16 Figure 1: Trends in prevalent cases of rheumatoid arthritis, 2018-27
  • 27 Figure 2: Overview of pipeline drugs for rheumatoid arthritis in the US
  • 27 Figure 3: Pipeline drugs for rheumatoid arthritis, by company
  • 28 Figure 4: Pipeline drugs for rheumatoid arthritis, by drug type
  • 28 Figure 5: Pipeline drugs for rheumatoid arthritis, by classification
  • 43 Figure 6: Probability of success in the rheumatoid arthritis pipeline
  • 46 Figure 7: Clinical trials in rheumatoid arthritis
  • 46 Figure 8: Top 10 drugs for clinical trials in rheumatoid arthritis
  • 47 Figure 9: Top 10 companies for clinical trials in rheumatoid arthritis
  • 47 Figure 10: Trial locations in rheumatoid arthritis
  • 48 Figure 11: Rheumatoid arthritis trials status
  • 48 Figure 12: Rheumatoid arthritis trials sponsors, by phase
  • 51 Figure 13: Datamonitor Healthcare's drug assessment summary for rheumatoid arthritis
  • 53 Figure 14: Market dynamics in rheumatoid arthritis
  • 54 Figure 15: Future trends in rheumatoid arthritis
  • 63 Figure 16: Filgotinib for Rheumatoid Arthritis (March 28, 2019): Phase III - FINCH 3
  • 65 Figure 17: Filgotinib for Rheumatoid Arthritis (March 28, 2019): Phase III - FINCH 1
  • 70 Figure 18: Otilimab for Rheumatoid Arthritis (October 23, 2018): Phase IIa - 205180
  • 73 Figure 19: Otilimab for Rheumatoid Arthritis (October 21, 2018): Phase IIb - BAROQUE (w/Methotrexate)
  • 74 Figure 20: Key upcoming events in rheumatoid arthritis

LIST OF TABLES

  • 9 Table 1: 2015 ACR recommendations for patients with symptomatic early RA
  • 10 Table 2: 2015 ACR recommendations for patients with established RA
  • 12 Table 3: 2016 EULAR recommendations for the management of RA
  • 15 Table 4: Prevalent cases of rheumatoid arthritis, 2018-27
  • 18 Table 5: Marketed drugs for rheumatoid arthritis
  • 29 Table 6: Pipeline drugs for rheumatoid arthritis in the US
  • 57 Table 7: Historical global sales, by drug ($m), 2014-18
  • 59 Table 8: Forecasted global sales, by drug ($m), 2020-24
  • 61 Table 9: Multiple Drugs for Rheumatoid Arthritis (June 25, 2019)
  • 62 Table 10: Filgotinib for Rheumatoid Arthritis (March 28, 2019)
  • 64 Table 11: Filgotinib for Rheumatoid Arthritis (March 28, 2019)
  • 66 Table 12: Xeljanz / Xeljanz XR for Rheumatoid Arthritis (February 19, 2019)
  • 67 Table 13: Biosimilar Rituximab (Amgen) for Rheumatoid Arthritis (January 24, 2019)
  • 68 Table 14: AVT-02 for Rheumatoid Arthritis (November 19, 2018)
  • 69 Table 15: Otilimab for Rheumatoid Arthritis (October 23, 2018)
  • 71 Table 16: Hyrimoz for Rheumatoid Arthritis (October 22, 2018)
  • 72 Table 17: Otilimab for Rheumatoid Arthritis (October 21, 2018)