Market Spotlight: Acute Lymphoblastic Leukemia (ALL)
Market Spotlight: Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL), also known as acute lymphocytic leukemia, is a rare blood cancer characterized by rapid proliferation and accumulation of immature lymphoid cells in the bone marrow, peripheral blood, and other organs.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
This Market Spotlight report covers the Acute Lymphoblastic Leukemia (ALL) market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, 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.
- 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 majority of industry-sponsored drugs in active clinical development for ALL are in Phase I, with two drugs 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.
- 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 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 32 licensing and asset acquisition deals involving ALL drugs during 2015–20. The $2,000m collaboration and license agreement signed in January 2020 between MorphoSys and Incyte to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody, MOR208 (tafasitamab), globally was the largest deal.
- 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 91% of trials in Phase I–II, and only 9% in Phase III–IV.
- The US has a substantial lead in the number of ALL clinical trials globally. France leads the major EU markets, while China has the top spot in Asia.
- Novartis has the highest number of completed clinical trials for ALL, with 41 trials.
- Novartis leads industry sponsors with the highest overall number of clinical trials for ALL.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Patient segmentation
9 Risk factors
11 TKI therapy
12 Radiation therapy
12 Stem cell transplant
16 MARKETED DRUGS
21 PIPELINE DRUGS
29 RECENT EVENTS AND ANALYST OPINION
29 Blincyto for ALL (December 10, 2019)
30 GC022 for ALL (December 7, 2019)
31 Blincyto for ALL (September 24, 2019)
32 Copiktra for ALL (July 25, 2019)
33 KTE-X19 for ALL (June 1, 2019)
35 Copiktra for ALL (March 6, 2019)
36 Marqibo for ALL (January 17, 2019)
37 AFM11 for ALL (December 3, 2018)
38 KTE-X19 for ALL (December 3, 2018)
39 AUTO3 for ALL (December 2, 2018)
41 Xpovio for ALL (December 1, 2018)
41 AFM11 for ALL (October 8, 2018)
43 KEY UPCOMING EVENTS
44 KEY REGULATORY EVENTS
44 Japan Approvals Include World-First For Skyrizi, Kymriah As Asia’s First CAR-T
45 PROBABILITY OF SUCCESS
46 LICENSING AND ASSET ACQUISITION DEALS
46 Pascal, Y-Biologics Ink Bispecific Collaboration For Leukemia
46 CASI Acquires Global Rights To Juventas’ Anti-CD19 Therapy
48 PARENT PATENTS
49 REVENUE OPPORTUNITY
51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
56 Prescription information
LIST OF FIGURES
15 Figure 1: Trends in incident cases of ALL, 2018–27
21 Figure 2: Overview of pipeline drugs for ALL in the US
21 Figure 3: Pipeline drugs for ALL, by company
22 Figure 4: Pipeline drugs for ALL, by drug type
22 Figure 5: Pipeline drugs for ALL, by classification
32 Figure 6: Blincyto for ALL (September 24, 2019): Phase III – Pediatric (1st Relapse)
35 Figure 7: KTE-X19 for ALL (June 1, 2019): Phase I/II – ZUMA-3 (r/r Adults)
39 Figure 8: KTE-X19 for ALL (December 3, 2018): Phase I/II – ZUMA-3 (r/r Adults)
43 Figure 9: Key upcoming events in ALL
45 Figure 10: Probability of success in the ALL pipeline
46 Figure 11: Licensing and asset acquisition deals in ALL, 2015–20
48 Figure 12: Parent patents in ALL
51 Figure 13: Clinical trials in ALL
51 Figure 14: Top 10 drugs for clinical trials in ALL
52 Figure 15: Top 10 companies for clinical trials in ALL
52 Figure 16: Trial locations in ALL
53 Figure 17: ALL trials sponsors by status
54 Figure 18: ALL trials sponsors, by phase
LIST OF TABLES
14 Table 1: Incident cases of ALL, 2018–27
17 Table 2: Marketed drugs for ALL
23 Table 3: Pipeline drugs for ALL in the US
29 Table 4: Blincyto for ALL (December 10, 2019)
30 Table 5: GC022 for ALL (December 7, 2019)
31 Table 6: Blincyto for ALL (September 24, 2019)
33 Table 7: Copiktra for ALL (July 25, 2019)
34 Table 8: KTE-X19 for ALL (June 1, 2019)
35 Table 9: Copiktra for ALL (March 6, 2019)
36 Table 10: Marqibo for ALL (January 17, 2019)
37 Table 11: AFM11 for ALL (December 3, 2018)
38 Table 12: KTE-X19 for ALL (December 3, 2018)
40 Table 13: AUTO3 for ALL (December 2, 2018)
41 Table 14: Xpovio for ALL (December 1, 2018)
42 Table 15: AFM11 for ALL (October 8, 2018)
49 Table 16: Historical global sales, by drug ($m), 2014–18
50 Table 17: Forecasted global sales, by drug ($m), 2020–24
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