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Market Spotlight: Waldenström Macroglobulinemia (WM)

  • ID: 4462162
  • Report
  • 38 pages
  • Datamonitor Healthcare
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This Market Spotlight report covers the Waldenström 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:
  • The author estimates that in 2017, there were approximately 5,330 incident cases of Waldenström 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 mid-to-late-stage development for WM focus on targets such as the PI3K/AKT pathway, proteasome, and Bruton’s tyrosine kinase. These drugs are administered via the oral, intravenous, and subcutaneous routes.
  • An expected CHMP supplemental filing opinion for Imbruvica is the only high-impact upcoming event in the WM space. The overall likelihood of approval of a Phase I hematologic cancer asset is 10.1%, and the average probability a drug advances from Phase III is 57.7%. 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 two 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 96% of trials in Phase I–II, and only 4% 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.
  • Clinical trial activity in the WM space is dominated by completed trials. Takeda has the highest number of completed clinical trials for WM, with 11 trials. Takeda also leads industry sponsors with the highest number of overall clinical trials for WM, followed by Celgene
Note: Product cover images may vary from those shown
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OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT
  • Chemotherapy
  • Targeted drugs
  • Biological therapy or immunotherapy
  • Plasmapheresis
  • Stem cell transplantation (SCT)
EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION
  • Calquence for WM (June 3, 2018)
  • Imbruvica for WM (June 1, 2018)
KEY UPCOMING EVENTS

KEY REGULATORY EVENTS
  • AbbVie Adds Rituxan To Imbruvica's Label For WM Indication
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
BIBLIOGRAPHY
  • Prescription information
APPENDIX

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

LIST OF TABLES
Table 1: Incident cases of WM, 2017–26
Table 2: Incident cases of WM, by gender, 2017
Table 3: Marketed drugs for WM
Table 4: Pipeline drugs for WM in the US
Table 5: Calquence for WM (June 3, 2018)
Table 6: Imbruvica for WM (June 1, 2018)
Table 7: Historical global sales, by drug ($m), 2014–18
Table 8: Forecasted global sales, by drug ($m), 2019–23
Note: Product cover images may vary from those shown
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