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.
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 III trial results for Venclexta, Imbruvica, and Calquence, as well as an expected PDUFA date for pirtobrutinib.
- The overall likelihood of approval of a Phase I MCL asset is 8.7%, and the average probability a drug advances from Phase III is 40%. Drugs, on average, take 5.8 years from Phase I to approval, compared to 9.8 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.
- Bristol Myers Squibb has the highest number of completed clinical trials for MCL, with 30 trials.
- Bristol Myers Squibb leads industry sponsors with the highest overall number of clinical trials for MCL, closely followed by Roche
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 (June 3, 2022)
27 Multiple Drugs for MCL (April 15, 2022)
28 Imbruvica for MCL (April 8, 2021)
30 KEY UPCOMING EVENTS
31 KEY REGULATORY EVENTS
31 Next-Generation BTK Inhibitor Among New Filings At EMA
31 Fresenius And Aurobindo Among Fresh Velcade Challengers In US
31 Lilly’s Non-Covalent BTK Inhibitor Pirtobrutinib
31 Lenalidomide Launch Kicks Off A Year Of Revlimid Competition
32 Incyte Pulls Parsaclisib Files As FDA Takes Foot Off Accelerator
32 Incyte Bids For Broad Parsaclisib Lymphoma Label
33 Scottish Funding Wins for Kite’s CAR-T Tecartus & Five Other Products
34 PROBABILITY OF SUCCESS
35 REVENUE OPPORTUNITY
37 CLINICAL TRIAL LANDSCAPE
38 Sponsors by status
39 Sponsors by phase
40 Recent events
41 BIBLIOGRAPHY
43 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
27 Figure 7: Imbruvica for MCL (June 3, 2022): Phase III – SHINE
30 Figure 8: Key upcoming events in MCL
34 Figure 9: Probability of success in the MCL pipeline
37 Figure 10: Clinical trials in MCL
37 Figure 11: Top 10 drugs for clinical trials in MCL
38 Figure 12: Top 10 companies for clinical trials in MCL
38 Figure 13: Trial locations in MCL
39 Figure 14: MCL trials status
40 Figure 15: 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 (June 3, 2022)
28 Table 6: Multiple Drugs for MCL (April 15, 2022)
29 Table 7: Imbruvica for MCL (April 8, 2021)
35 Table 8: Historical global sales, by drug ($m), 2017–21
36 Table 9: Forecasted global sales, by drug ($m), 2022–26
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