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.
- 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
- Targeted drugs
- Biological therapy or immunotherapy
- Stem cell transplantation (SCT)
RECENT EVENTS AND ANALYST OPINION
- Brukinsa for WM (December 16, 2019)
- Mavorixafor for WM (July 17, 2019)
KEY REGULATORY EVENTS
- Janssen's Imbruvica Leads CLL Market Expansion In Europe
PROBABILITY OF SUCCESS
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
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: Brukinsa for WM (December 16, 2019): Phase III - ASPEN (vs. Ibrutinib)
- Figure 8: Probability of success in the WM pipeline
- Figure 9: Parent patents in WM
- Figure 10: Clinical trials in WM
- Figure 11: Top 10 drugs for clinical trials in WM
- Figure 12: Top 10 companies for clinical trials in WM
- Figure 13: Trial locations in WM
- Figure 14: WM trials status
- Figure 15: 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: Brukinsa for WM (December 16, 2019)
- Table 6: Mavorixafor for WM (July 17, 2019)
- Table 7: Historical global sales, by drug ($m), 2014-18
- Table 8: Forecasted global sales, by drug ($m), 2020-24