Market Spotlight: Acute Lymphoblastic Leukemia (ALL)
Market Spotlight: Acute Lymphoblastic Leukemia (ALL)
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This Market Spotlight report covers the Acute Lymphoblastic Leukemia (ALL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, 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 Acute Lymphoblastic Leukemia (ALL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, 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 2018, there were 86,600 incident cases of acute lymphoblastic leukemia (ALL) worldwide, and expects that number to increase to 93,500 incident cases by 2027.
- Approved drugs in the ALL space focus on a wide variety of targets. The majority of these therapies are administered via the intravenous route, with the remaining products being available in oral and intramuscular formulations.
- The vast majority of industry-sponsored drugs in active clinical development for ALL are evenly spread across Phase I and Phase II, with only one drug in Phase III.
- Therapies in development for ALL focus on a wide variety of targets. The majority of pipeline drugs in development are administered via the intravenous route, with the remainder being tested as oral formulations.
- The only high-impact upcoming event for drugs in the ALL space is topline Phase II trial results for Sarclisa. The overall likelihood of approval of a Phase I hematologic asset is 8.3%, and the average probability a drug advances from Phase III is 58.5%. Drugs, on average, take 9.6 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 ALL have been in the early and midphases of development, with 93% of trials in Phase I–II, and only 7% in Phase III–IV.
- The US has a substantial lead in the number of ALL clinical trials globally. France leads the major European markets, while China has the top spot in Asia.
- Novartis has the highest number of completed clinical trials for ALL, with 36 trials. Novartis also leads industry sponsors with the highest overall number of clinical trials for ALL.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Definition
8 Patient segmentation
9 Symptoms
9 Risk factors
9 Diagnosis
11 TREATMENT
11 Chemotherapy
11 Corticosteroids
11 TKI therapy
11 Immunotherapy
12 Radiation therapy
12 Stem cell transplant
13 EPIDEMIOLOGY
16 MARKETED DRUGS
20 PIPELINE DRUGS
28 RECENT EVENTS AND ANALYST OPINION
28 Tecartus for ALL (June 4, 2021)
29 Tecartus for ALL (May 19, 2021)
31 KEY UPCOMING EVENTS
32 KEY REGULATORY EVENTS
32 Accord Receives CHMP Endorsements For Dasatinib
32 Xspray Pharma’s Dasynoc Under FDA Review
32 First Academic Sponsor On EMA’s PRIME Pledges Cheaper CAR-Ts
33 US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals
33 Gilead/Kite’s Tecartus Moves Into Leukemia With Second US Indication
34 Jazz’s Rylaze Gets Fast Review, But No PRV
34 Zolgensma, Kymriah First Korean Approvals Under New Biologics Law
35 Oncology Submissions From Hutchmed, Takeda And Shorla
35 CAR-T Therapies Roll On
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Laurus Labs Buys Into Indian CAR-T Start-Up
37 Autolus On The Rise After Big Backing From Blackstone
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
15 Figure 1: Trends in incident cases of ALL, 2018–27
20 Figure 2: Overview of pipeline drugs for ALL in the US
20 Figure 3: Pipeline drugs for ALL, by company
21 Figure 4: Pipeline drugs for ALL, by drug type
21 Figure 5: Pipeline drugs for ALL, by classification
29 Figure 6: Tecartus for ALL (June 4, 2021): Phase I/II – ZUMA-3 (r/r Adults)
31 Figure 7: Key upcoming events in ALL
36 Figure 8: Probability of success in the hematologic pipeline
40 Figure 9: Clinical trials in ALL
40 Figure 10: Top 10 drugs for clinical trials in ALL
41 Figure 11: Top 10 companies for clinical trials in ALL
41 Figure 12: Trial locations in ALL
42 Figure 13: ALL trials status
43 Figure 14: ALL trials sponsors, by phase
LIST OF TABLES
14 Table 1: Incident cases of ALL, 2018–27
17 Table 2: Marketed drugs for ALL
22 Table 3: Pipeline drugs for ALL in the US
28 Table 4: Tecartus for ALL (June 4, 2021)
30 Table 5: Tecartus for ALL (May 19, 2021)
38 Table 6: Historical global sales, by drug ($m), 2016–20
39 Table 7: Forecasted global sales, by drug ($m), 2022–26
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