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Market Spotlight: Mantle Cell Lymphoma

  • ID: 4846135
  • Report
  • 49 pages
  • Datamonitor Healthcare
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This Market Spotlight report covers the Mantle Cell Lymphoma (MCL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, 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 14,030 incident cases of mantle cell lymphoma (MCL) worldwide, and forecasts that number to increase to 18,010 incident cases by 2026.
  • It is estimated that the majority of diagnosed cases were male in 2017.
  • The incidence of MCL is highest among older individuals aged 60+ years. Approved drugs in the MCL space focus on a wide variety of targets. The majority of these drugs are administered via the oral route, with the remainder being available in intravenous and subcutaneous formulations.
  • The majority of industry-sponsored drugs in active clinical development for MCL are in Phase II, with only one drug in the NDA/BLA phase.
  • Therapies in active clinical development for MCL focus on a wide variety of targets. These drugs are administered via the oral and intravenous routes.
  • High-impact upcoming events for drugs in the MCL space comprise topline Phase II trial results for KTE-X19 and INCB50465, topline Phase II/III trial results for TG-1303 and TGR-1202, topline Phase III trial results for Imbruvica, and an estimated PDUFA date for Zanubrutinib.
  • The overall likelihood of approval of a Phase I hematologic asset is 9.6%, and the average probability a drug advances from Phase III is 58.3%. 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 five licensing and asset acquisition deals involving MCL drugs during 2014–19. The largest deal was the $391.5m strategic collaboration and licensing agreement between Innovent and Incyte in 2018 to develop and commercialize Incyte’s pemigatinib, itacitinib, and parsaclisib for hematology and oncology indications in China.
  • The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for MCL have been in the early and mid-phases of development, with 90% of trials in Phase I–II, and only 10% in Phase III–IV.
  • The US has a substantial lead in the number of MCL clinical trials globally. Germany leads the major EU markets, while South Korea has the top spot in Asia.
  • Takeda and Novartis have the highest number of completed clinical trials for MCL, with 12 trials each.
  • Johnson & Johnson leads industry sponsors with the highest overall number of clinical trials for MCL, followed by Celgene.
Note: Product cover images may vary from those shown
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OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND
  • Disease definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis
TREATMENT
  • Targeted therapies
  • Chemotherapies
  • Steroids
  • Immunomodulators
  • Radiation therapy
  • Proteasome inhibitors
  • Stem cell transplantation
EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

Copiktra for MCL (July 25, 2019)
  • Copiktra for MCL (March 6, 2019)
  • Revlimid for MCL (February 27, 2019)
  • Zevalin for MCL (January 17, 2019)
  • Zanubrutinib for MCL (December 1, 2018)
  • Zanubrutinib for MCL (December 1, 2018)
  • Venclexta for MCL (March 29, 2018)
KEY UPCOMING EVENTS

KEY REGULATORY EVENTS
  • BeiGene Wins Breakthrough Status For Zanubrutinib With Assist From Chinese Data
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Deals Shaping The Medical Industry, April 2019
PARENT PATENTS

REVENUE OPPORTUNITY

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

LIST OF FIGURES
Figure 1: Global trends in incident cases of MCL, 2017–26
Figure 2: Global incident cases of MCL, by age, 2017
Figure 3: Overview of pipeline drugs for MCL in the US
Figure 4: Pipeline drugs for MCL, by company
Figure 5: Pipeline drugs for MCL, by drug type
Figure 6: Pipeline drugs for MCL, by classification
Figure 7: Zanubrutinib for MCL (December 1, 2018): Phase II - China
Figure 8: Zanubrutinib for MCL (December 1, 2018): Phase I/II - B-Cell Malignancies (Australia)
Figure 9: Venclexta for MCL (March 29, 2018): Phase II - AIM
Figure 10: Key upcoming events in MCL
Figure 11: Probability of success in the MCL pipeline
Figure 12: Licensing and asset acquisition deals in MCL, 2014–19
Figure 13: Parent patents in MCL
Figure 14: Clinical trials in MCL
Figure 15: Top 10 drugs for clinical trials in MCL
Figure 16: Top 10 companies for clinical trials in MCL
Figure 17: Trial locations in MCL
Figure 18: MCL trials status
Figure 19: MCL trials sponsors, by phase

LIST OF TABLES
Table 1: Global incident cases of MCL, 2017–26
Table 2: Global incident cases of MCL, by gender, 2017
Table 3: Marketed drugs for MCL
Table 4: Pipeline drugs for MCL in the US
Table 5: Copiktra for MCL (July 25, 2019)
Table 6: Copiktra for MCL (March 6, 2019)
Table 7: Revlimid for MCL (February 27, 2019)
Table 8: Zevalin for MCL (January 17, 2019)
Table 9: Zanubrutinib for MCL (December 1, 2018)
Table 10: Zanubrutinib for MCL (December 1, 2018)
Table 11: Venclexta for MCL (March 29, 2018)
Table 12: Historical global sales, by drug ($m), 2014–18
Table 13: Forecasted global sales, by drug ($m), 2019–23
Note: Product cover images may vary from those shown
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