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Market Spotlight: Mantle Cell Lymphoma

  • Report

  • 51 Pages
  • April 2021
  • Region: Global
  • Citeline
  • ID: 4846135
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, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.

Key Takeaways

  • The publisher 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 or intravenous route, with one product also being available in a subcutaneous formulation.
  • The majority of industry-sponsored drugs in active clinical development for MCL are in Phase II. 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/III trial results for Ukoniq, and topline Phase III trial results for Venclexta, Imbruvica, and Calquence.
  • The overall likelihood of approval of a Phase I hematologic asset is 8.6%, and the average probability a drug advances from Phase III is 59.1%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
  • 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 91% of trials in Phase I–II, and only 9% in Phase III–IV.
  • The US has a substantial lead in the number of MCL clinical trials globally. France leads the major European markets, while China has the top spot in Asia.
  • Clinical trial activity in the MCL space is dominated by completed trials. Johnson & Johnson has the highest number of completed clinical trials for MCL, with 16 trials.
  • Johnson & Johnson leads industry sponsors with the highest overall number of clinical trials for MCL, followed by Bristol Myers Squibb.

Table of Contents

OVERVIEWKEY TAKEAWAYS
DISEASE BACKGROUND
  • Disease definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis

TREATMENT
  • Targeted therapies
  • Chemotherapies
  • Steroids
  • Immunomodulators
  • Radiation therapy
  • Proteasome inhibitors
  • Stem cell transplantation

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
  • Cirmtuzumab for MCL (December 7, 2020)
  • Parsaclisib for MCL (December 6, 2020)
  • Breyanzi for MCL (December 5, 2020)
  • Pirtobrutinib for MCL (December 5, 2020)
  • Tecartus for MCL (December 9, 2019)
  • Pirtobrutinib for MCL (December 8, 2019)

KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
  • Kite Strikes CAR-T Access & Discount Deal For Tecartus In England
  • InnoCare's Yinuokai Among Latest China Approvals
  • Krka, Accord And Xeris Pick Up European Nods
  • Kite’s Tecartus PRIMEd For EU Market With CHMP Nod
  • Gilead/Kite Gain Second CAR-T Approval With Tecartus, Price On Par With Their First

PROBABILITY OF SUCCESSREVENUE OPPORTUNITY
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
  • Daiichi's Novel EZH Candidate Progresses In New Consortium Trial
  • Incyte, TG's PI3K Inhibitors Show Safety Advantage In Indolent NHL
  • LOXO-305 Comes Out Swinging In Battle Of BTK Inhibitors

BIBLIOGRAPHYAPPENDIX
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: Cirmtuzumab for MCL (December 7, 2020): Phase Ib/II - CIRLL Study
Figure 8: Breyanzi for MCL (December 5, 2020): Phase I - TRANSCEND
Figure 9: Pirtobrutinib for MCL (December 5, 2020): Phase I/II - BRUIN
Figure 10: Tecartus for MCL (December 9, 2019): Phase II - ZUMA-2 (r/r MCL)
Figure 11: Key upcoming events in MCL
Figure 12: Probability of success in the hematologic pipeline
Figure 13: Clinical trials in MCL
Figure 14: Top 10 drugs for clinical trials in MCL
Figure 15: Top 10 companies for clinical trials in MCL
Figure 16: Trial locations in MCL
Figure 17: MCL trials status
Figure 18: 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: Cirmtuzumab for MCL (December 7, 2020)
Table 6: Parsaclisib for MCL (December 6, 2020)
Table 7: Breyanzi for MCL (December 5, 2020)
Table 8: Pirtobrutinib for MCL (December 5, 2020)
Table 9: Tecartus for MCL (December 9, 2019)
Table 10: Pirtobrutinib for MCL (December 8, 2019)
Table 11: Historical global sales, by drug ($m), 2016–20
Table 12: Forecasted global sales, by drug ($m), 2021–25