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 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 8.5%, and the average probability a drug advances from Phase III is 58.4%. 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 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. France leads the major European markets, while China has the top spot in Asia.
- 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, closely followed by Bristol Myers Squibb.
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 Proteasome inhibitors
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 Kite Strikes CAR-T Access & Discount Deal For Tecartus In England
35 InnoCare’s Yinuokai Among Latest China Approvals
35 Krka, Accord, And Xeris Pick Up European Nods
35 Kite’s Tecartus PRIMEd For EU Market With CHMP Nod
36 Gilead/Kite Gain Second CAR-T Approval With Tecartus, Price On Par With Their First
37 PROBABILITY OF SUCCESS
38 REVENUE OPPORTUNITY
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
43 Recent events
45 BIBLIOGRAPHY
47 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 hematologic 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 ($m), 2016–20
39 Table 11: Forecasted global sales, by drug ($m), 2021–25
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