DUBLIN--(BUSINESS WIRE)--The "Market Spotlight: Waldenström Macroglobulinemia (WM)" report has been added to ResearchAndMarkets.com's offering.
This 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
- The author estimates that in 2017, there were approximately 5,330 incident cases of Waldenstrm 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, Bruton's tyrosine kinase, and cluster of differentiation 20. These drugs are administered via the oral, intravenous, and subcutaneous routes.
- The overall likelihood of approval of a Phase I hematologic cancer asset is 10.7%, and the average probability a drug advances from Phase III is 57.6%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.2 years in the overall oncology space.
- There have been only two licensing and asset acquisition deals involving WM drugs during 2013-18. The $50m collaboration agreement in 2014 between Genmab and Novartis, pursuant to which Novartis intends to transition Arzerra for the treatment of certain CLL indications, was the largest deal during the period.
- The clinical trials distribution 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 clinical trials for WM, followed by Celgene.
Topics Covered
OVERVIEW
KEY TAKEAWAYS
DISEASE BACKGROUND
TREATMENT
Chemotherapy
Targeted drugs
Biological therapy or immunotherapy
Plasmapheresis
Stem cell transplantation (SCT)
EPIDEMIOLOGY
MARKETED DRUGS
Approvals by country
PIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
Calquence for WM (June 3, 2018)
Imbruvica for WM (June 1, 2018)
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: Probability of success in the WM pipeline
Figure 10: Licensing and asset acquisition deals in WM, 2013-18
Figure 11: Parent patents in WM
Figure 12: Clinical trials in WM
Figure 13: Top 10 drugs for clinical trials in WM
Figure 14: Top 10 companies for clinical trials in WM
Figure 15: Trial locations in WM
Figure 16: WM trials status
Figure 17: 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: Approvals by country for WM
Table 5: Pipeline drugs for WM in the US
Table 6: Calquence for WM (June 3, 2018)
Table 7: Imbruvica for WM (June 1, 2018)
Table 8: Historical global sales, by drug ($m), 2013-17
Table 9: Forecasted global sales, by drug ($m), 2018-22
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