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市場調查報告書

市場焦點:華氏巨球蛋白血症 (WM)

Market Spotlight: Waldenstrom Macroglobulinemia (WM)

出版商 Datamonitor Healthcare 商品編碼 603917
出版日期 內容資訊 英文 36 Pages
商品交期: 最快1-2個工作天內
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市場焦點:華氏巨球蛋白血症 (WM) Market Spotlight: Waldenstrom Macroglobulinemia (WM)
出版日期: 2019年12月05日內容資訊: 英文 36 Pages
簡介

本報告提供全球華氏巨球蛋白血症 (WM) 治療藥市場相關調查分析,提供主要的開發平台·上市藥,臨床實驗,專利資訊,10年的盛行率預測,專利·取得交易等系統性資訊。

要點

疾病的背景

治療

  • 化療
  • 標靶治療
  • 生物學的療法/免疫療法
  • 血漿替換
  • 幹細胞移植 (SCT)

流行病學

上市藥

開發平台藥物

專利·資產取得交易

本源專利

商機

臨床實驗形勢

參考文獻

附錄

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目錄
Product Code: DMKC0183867

This Market Spotlight report covers the Waldenstrom Macroglobulinemia market, comprising key marketed and pipeline drugs, probability of success, clinical trials, recent events and analyst opinion, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

Datamonitor Healthcare estimates that in 2017, there were approximately 5,330 incident cases of Waldenstrom macroglobulinemia (WM) in people aged 40 years and over worldwide, and forecasts that number to increase to 6,920 incident cases by

2026. It is estimated that the majority of diagnosed cases worldwide were in males in

2017. Worldwide, the incidence of WM is highest among individuals aged 60-79 years.

Imbruvica, a small molecule tyrosine kinase inhibitor, is the only drug approved by the FDA for WM.

The majority of industry-sponsored drugs in active clinical development for WM are in Phase II, with only one drug in Phase III. Therapies in development for WM focus on targets such as p110 delta/PIK3CD, PI3K/AKT pathway, proteasome, and Bruton's tyrosine kinase. These drugs are administered via the oral, intravenous, and subcutaneous routes.

The overall likelihood of approval of a Phase I hematologic cancer asset is 9.9%, and the average probability a drug advances from Phase III is 59.4%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.

There have been three licensing and asset acquisition deals involving WM drugs during 2014-19. The collaboration agreement signed in 2014 between Genmab and Novartis for $50m, pursuant to which Genmab agreed for a conditional transfer of the Arzerra (ofatumumab) collaboration with GlaxoSmithKline to Novartis in oncology indications, was the largest deal.

The distribution of clinical trials across Phase I-IV indicates that almost all trials for WM have been in the early and mid-phases of development, with 95% of trials in Phase I-II, and only 5% in Phase III-IV.

The US has a substantial lead in the number of WM clinical trials globally. The UK and France lead the major EU markets, while China has the top spot in Asia.

Takeda has the highest number of completed clinical trials for WM, with 11 trials. Bristol-Myers Squibb and Takeda lead industry sponsors with the highest overall number of clinical trials for WM, followed by Johnson & Johnson.

TABLE OF CONTENTS

CONTENTS

5 OVERVIEW

6 KEY TAKEAWAYS

7 DISEASE BACKGROUND

8 TREATMENT

8 Chemotherapy

8 Targeted drugs

8 Biological therapy or immunotherapy

9 Plasmapheresis

9 Stem cell transplantation (SCT)

10 EPIDEMIOLOGY

15 MARKETED DRUGS

17 PIPELINE DRUGS

21 RECENT EVENTS AND ANALYST OPINION

21 Mavorixafor for WM (July 17, 2019)

21 Calquence for WM (June 3, 2018)

23 Imbruvica for WM (June 1, 2018)

26 KEY REGULATORY EVENTS

26 Janssen's Imbruvica Leads CLL Market Expansion In Europe

27 PROBABILITY OF SUCCESS

28 LICENSING AND ASSET ACQUISITION DEALS

29 PARENT PATENTS

30 CLINICAL TRIAL LANDSCAPE

31 Sponsors by status

32 Sponsors by phase

34 BIBLIOGRAPHY

34 Prescription information

35 APPENDIX

LIST OF FIGURES

  • 12 Figure 1: Trends in incident cases of WM, 2017-26
  • 14 Figure 2: Incident cases of WM, by age, 2017
  • 17 Figure 3: Overview of pipeline drugs for WM in the US
  • 17 Figure 4: Pipeline drugs for WM, by company
  • 18 Figure 5: Pipeline drugs for WM, by drug type
  • 18 Figure 6: Pipeline drugs for WM, by classification
  • 23 Figure 7: Calquence for WM (June 3, 2018): Phase I/II - ACE-WM-001
  • 25 Figure 8: Imbruvica for WM (June 1, 2018): Phase III - INNOVATE (w/Rituximab)
  • 27 Figure 9: Probability of success in the WM pipeline
  • 28 Figure 10: Licensing and asset acquisition deals in WM, 2014-19
  • 29 Figure 11: Parent patents in WM
  • 30 Figure 12: Clinical trials in WM
  • 30 Figure 13: Top 10 drugs for clinical trials in WM
  • 31 Figure 14: Top 10 companies for clinical trials in WM
  • 31 Figure 15: Trial locations in WM
  • 32 Figure 16: WM trials status
  • 33 Figure 17: WM trials sponsors, by phase

LIST OF TABLES

  • 11 Table 1: Incident cases of WM, 2017-26
  • 13 Table 2: Incident cases of WM, by gender, 2017
  • 16 Table 3: Marketed drugs for WM
  • 19 Table 4: Pipeline drugs for WM in the US
  • 21 Table 5: Mavorixafor for WM (July 17, 2019)
  • 22 Table 6: Calquence for WM (June 3, 2018)
  • 24 Table 7: Imbruvica for WM (June 1, 2018)
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