Market Spotlight: Mantle Cell Lymphoma
Market Spotlight: Mantle Cell Lymphoma
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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
- Datamonitor Healthcare estimates that in 2021, there were approximately 15,700 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 are in males.
- 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 greatest proportion of industry-sponsored drugs in active clinical development for MCL are in Phase II, with one drug in the NDA/BLA stage.
- 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 MCL asset is 11.3%, and the average probability a drug advances from Phase III is 50%. Drugs, on average, take 5.8 years from Phase I to approval, compared to 9.7 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 94% of trials in Phase I–II, and only 6% 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.
- Roche has the highest number of completed clinical trials for MCL, with 30 trials. Bristol Myers Squibb and Roche lead industry sponsors with the highest overall number of clinical trials for MCL, followed by Johnson & Johnson.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Disease definition
8 Patient segmentation
8 Symptoms
8 Risk factors
9 Diagnosis
10 TREATMENT
10 Targeted therapies
10 Chemotherapies
10 Steroids
11 Immunomodulators
11 Radiation therapy
11 CAR T-cell therapy
11 Stem cell transplantation
12 EPIDEMIOLOGY
17 MARKETED DRUGS
20 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 Imbruvica for MCL (April 8, 2021)
26 Cirmtuzumab for MCL (December 7, 2020)
28 Parsaclisib for MCL (December 6, 2020)
29 Breyanzi for MCL (December 5, 2020)
31 Pirtobrutinib for MCL (December 5, 2020)
34 KEY UPCOMING EVENTS
35 KEY REGULATORY EVENTS
35 Lilly’s Non-Covalent BTK Inhibitor Pirtobrutinib
35 Lenalidomide Launch Kicks Off A Year Of Revlimid Competition
35 Incyte Pulls Parsaclisib Files As FDA Takes Foot Off Accelerator
36 Incyte Bids For Broad Parsaclisib Lymphoma Label
36 Scottish Funding Wins for Kite’s CAR-T Tecartus & Five Other Products
37 PROBABILITY OF SUCCESS
38 REVENUE OPPORTUNITY
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
44 BIBLIOGRAPHY
46 APPENDIX
LIST OF FIGURES
14 Figure 1: Global trends in incident cases of MCL, 2017–26
16 Figure 2: Global incident cases of MCL, by age, 2017
20 Figure 3: Overview of pipeline drugs for MCL in the US
20 Figure 4: Pipeline drugs for MCL, by company
21 Figure 5: Pipeline drugs for MCL, by drug type
21 Figure 6: Pipeline drugs for MCL, by classification
28 Figure 7: Cirmtuzumab for MCL (December 7, 2020): Phase Ib/II – CIRLL Study
31 Figure 8: Breyanzi for MCL (December 5, 2020): Phase I – TRANSCEND
33 Figure 9: Pirtobrutinib for MCL (December 5, 2020): Phase I/II – BRUIN
34 Figure 10: Key upcoming events in MCL
37 Figure 11: Probability of success in the MCL pipeline
40 Figure 12: Clinical trials in MCL
40 Figure 13: Top 10 drugs for clinical trials in MCL
41 Figure 14: Top 10 companies for clinical trials in MCL
41 Figure 15: Trial locations in MCL
42 Figure 16: MCL trials status
43 Figure 17: MCL trials sponsors, by phase
LIST OF TABLES
13 Table 1: Global incident cases of MCL, 2017–26
15 Table 2: Global incident cases of MCL, by gender, 2017
18 Table 3: Marketed drugs for MCL
22 Table 4: Pipeline drugs for MCL in the US
26 Table 5: Imbruvica for MCL (April 8, 2021)
27 Table 6: Cirmtuzumab for MCL (December 7, 2020)
29 Table 7: Parsaclisib for MCL (December 6, 2020)
30 Table 8: Breyanzi for MCL (December 5, 2020)
32 Table 9: Pirtobrutinib for MCL (December 5, 2020)
38 Table 10: Historical global sales, by drug ($m), 2017–21
39 Table 11: Forecasted global sales, by drug ($m), 2022–26
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