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 highest proportion of industry-sponsored drugs in active clinical development for ALL are in Phase I, with only two drugs in the NDA/BLA phase.
• 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 oral and intramuscular formulations.
• High-impact upcoming events for drugs in the ALL space comprise topline Phase II trial results for Sarclisa, an estimated supplemental approval for Blincyto, and an expected PDUFA date for Tecartus.
• The overall likelihood of approval of a Phase I hematologic asset is 8.6%, and the average probability a drug advances from Phase III is 59.1%. 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 ALL have been in the early and midphases of development, with 92% of trials in Phase I–II, and only 8% 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 47 trials.
• Novartis also leads industry sponsors with the highest overall number of clinical trials for ALL.