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 121,800 incident cases of acute lymphoblastic leukemia (ALL) worldwide, and expects that number to increase to 131,900 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 a few select products being available in oral and intramuscular formulations.
- Industry-sponsored drugs in active clinical development for ALL are spread evenly across Phase I and Phase II, with only one drug in Phase III.
- Therapies in mid-to-late-stage development for ALL focus on a wide variety of targets. The majority of pipeline drugs in mid-tolate-stage development are administered via the intravenous route, with the remainder being tested in oral formulations.
- The overall likelihood of approval of a Phase I hematologic asset is 10.1%, and the average probability a drug advances from Phase III is 57.7%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been 40 licensing and asset acquisition deals involving ALL drugs during 2014–19. The $1,220m strategic collaboration agreement signed in 2018 between Fate Therapeutics and Ono Pharmaceutical for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates 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.
- Clinical trial activity in the ALL space is dominated by completed trials. 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
20 PIPELINE DRUGS
28 RECENT EVENTS AND ANALYST OPINION
28 Yescarta for ALL (June 1, 2019)
29 Copiktra for ALL (March 6, 2019)
30 Marqibo for ALL (January 17, 2019)
31 AFM11 for ALL (December 3, 2018)
32 Yescarta for ALL (December 3, 2018)
33 AUTO3 for ALL (December 2, 2018)
35 Xpovio for ALL (December 1, 2018)
35 AFM11 for ALL (October 8, 2018)
36 ERY-ASP for ALL (June 24, 2018)
37 Yescarta for ALL (June 4, 2018)
39 Blincyto for ALL (March 7, 2018)
40 Blincyto for ALL (March 5, 2018)
43 KEY REGULATORY EVENTS
43 Japan Approvals Include World-First For Skyrizi, Kymriah As Asia’s First CAR-T
43 Measuring ‘Minimal Residual Disease’ With NGS
44 PROBABILITY OF SUCCESS
45 LICENSING AND ASSET ACQUISITION DEALS
45 CASI Acquires Global Rights To Juventas’ Anti-CD19 Therapy
45 Fate, Ono Partner On Two Stem Cell CAR-T Therapies
47 PARENT PATENTS
48 REVENUE OPPORTUNITY
50 CLINICAL TRIAL LANDSCAPE
51 Sponsors by status
52 Sponsors by phase
53 Recent events
55 Prescription information
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
21 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: Yescarta for ALL (June 1, 2019): Phase I/II – ZUMA-3 (Adults)
33 Figure 7: Yescarta for ALL (December 3, 2018): Phase I/II – ZUMA-3 (Adults)
39 Figure 8: Yescarta for ALL (June 4, 2018): Phase I/II – ZUMA-3 (Adults)
44 Figure 9: Probability of success in the ALL pipeline
45 Figure 10: Licensing and asset acquisition deals in ALL, 2014–19
47 Figure 11: Parent patents in ALL
50 Figure 12: Clinical trials in ALL
50 Figure 13: Top 10 drugs for clinical trials in ALL
51 Figure 14: Top 10 companies for clinical trials in OIC
51 Figure 15: ALL trials sponsors by status
52 Figure 16: ALL trials sponsors by status
53 Figure 17: 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
28 Table 4: Yescarta for ALL (June 1, 2019)
29 Table 5: Copiktra for ALL (March 6, 2019)
30 Table 6: Marqibo for ALL (January 17, 2019)
31 Table 7: AFM11 for ALL (December 3, 2018)
32 Table 8: Yescarta for ALL (December 3, 2018)
34 Table 9: AUTO3 for ALL (December 2, 2018)
35 Table 10: Xpovio for ALL (December 1, 2018)
36 Table 11: AFM11 for ALL (October 8, 2018)
37 Table 12: ERY-ASP for ALL (June 24, 2018)
38 Table 13: Yescarta for ALL (June 4, 2018)
39 Table 14: Blincyto for ALL (March 7, 2018)
41 Table 15: Blincyto for ALL (March 5, 2018)
48 Table 16: Historical global sales, by drug ($m), 2014–18
49 Table 17: Forecasted global sales, by drug ($m), 2019–23
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