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, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, 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 route, with the remainder being available in intravenous and subcutaneous formulations.
- The largest proportion 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 parsaclisib; topline Phase II/III trial results for TG-1303 and umbralisib; topline Phase III trial results for Venclexta, Imbruvica, and Calquence; and an expected CHMP opinion as well as an estimated PDUFA date for KTE-X19.
- The overall likelihood of approval of a Phase I hematologic asset is 10%, and the average probability a drug advances from Phase III is 59.6%. Drugs, on average, take 8.9 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been four licensing and asset acquisition deals involving MCL drugs during 2015–20. 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. France and Germany lead the major European markets, while South Korea has the top spot in Asia.
- Johnson & Johnson has the highest number of completed clinical trials for MCL, with 13 trials. Johnson & Johnson leads industry sponsors with the highest overall number of clinical trials for MCL, 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 KTE-X19 for MCL (December 9, 2019)
27 Copiktra for MCL (July 25, 2019)
28 Copiktra for MCL (March 6, 2019)
29 Revlimid for MCL (February 27, 2019)
30 Zevalin for MCL (January 17, 2019)
31 Brukinsa for MCL (December 1, 2018)
33 Brukinsa for MCL (December 1, 2018)
36 KEY UPCOMING EVENTS
37 KEY REGULATORY EVENTS
37 Brukinsa Sprints To Accelerated Approval For MCL
37 Accord Gets EMA Support For Arsenic Trioxide
38 PROBABILITY OF SUCCESS
39 LICENSING AND ASSET ACQUISITION DEALS
39 Deals Shaping The Medical Industry, January 2020
39 Deals Shaping The Medical Industry, April 2019
41 PARENT PATENTS
42 REVENUE OPPORTUNITY
43 CLINICAL TRIAL LANDSCAPE
44 Sponsors by status
45 Sponsors by phase
46 Kite Readies A Second CAR-T For Filing As CD19 Competition Grows
47 BIBLIOGRAPHY
48 Prescription information
49 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: KTE-X19 for MCL (December 9, 2019): Phase II – ZUMA-2 (r/r MCL)
33 Figure 8: Brukinsa for MCL (December 1, 2018): Phase II – China
35 Figure 9: Brukinsa for MCL (December 1, 2018): Phase I/II – B-Cell Malignancies (Australia)
36 Figure 10: Key upcoming events in MCL
38 Figure 11: Probability of success in the MCL pipeline
39 Figure 12: Licensing and asset acquisition deals in MCL, 2015–20
41 Figure 13: Parent patents in MCL
43 Figure 14: Clinical trials in MCL
43 Figure 15: Top 10 drugs for clinical trials in MCL
44 Figure 16: Top 10 companies for clinical trials in MCL
44 Figure 17: Trial locations in MCL
45 Figure 18: MCL trials status
46 Figure 19: 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: KTE-X19 for MCL (December 9, 2019)
28 Table 6: Copiktra for MCL (July 25, 2019)
29 Table 7: Copiktra for MCL (March 6, 2019)
30 Table 8: Revlimid for MCL (February 27, 2019)
31 Table 9: Zevalin for MCL (January 17, 2019)
32 Table 10: Brukinsa for MCL (December 1, 2018)
34 Table 11: Brukinsa for MCL (December 1, 2018)
42 Table 12: Historical global sales, by drug ($m), 2014–18
42 Table 13: Forecasted global sales, by drug ($m), 2020–24
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