Market Spotlight: Attention Deficit Hyperactivity Disorder (ADHD)
Market Spotlight: Attention Deficit Hyperactivity Disorder (ADHD)
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This Market Spotlight report covers the Attention Deficit Hyperactivity Disorder (ADHD) 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 prevalence 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 Attention Deficit Hyperactivity Disorder (ADHD) 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 prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare estimates that in 2017, there were 177.3 million prevalent cases of attention deficit hyperactivity disorder (ADHD) in people aged 5–44 years worldwide, and forecasts that number to increase to 187.4 million prevalent cases by 2026.
- Approved drugs in the ADHD space target dopamine, dopamine reuptake, norepinephrine (noradrenaline), norepinephrine (noradrenaline) reuptake/transporter, and the alpha 2 adrenergic receptor. The vast majority of approved therapies are administered via the oral route.
- The highest proportion of industry-sponsored drugs in active clinical development for ADHD are in Phase II, with only one drug in the NDA/BLA stage.
- Therapies in development for ADHD focus on a wide variety of targets. All pipeline drugs for ADHD are administered via the oral route.
- High-impact upcoming events for drugs in the ADHD space comprise topline Phase I/II and Phase III trial results, pivotal efficacy study results, an expected patent expiration, an estimated PDUFA date, and a meeting with the FDA.
- The overall likelihood of approval of a Phase I ADHD asset is 12.3%, and the average probability a drug advances from Phase III is 75%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 8.7 years in the overall psychiatry space.
- There have been 20 licensing and asset acquisition deals involving ADHD drugs during 2015–20. Impax Laboratories’ acquisition of certain assets related to generic products from Teva and Allergan in 2016 for $586m was the largest deal.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for ADHD have been in the late phases of development, with 53% in Phase III–IV, and 47% in Phase I–II.
- The US has a substantial lead in the number of ADHD clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the ADHD space is dominated by completed trials. Takeda has the highest number of completed clinical trials for ADHD, with 158 trials.
- Takeda leads industry sponsors with the highest overall number of clinical trials for ADHD, followed by Eli Lilly.
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Subtypes
9 TREATMENT
9 Non-pharmacological therapy
9 Pharmacological therapy
11 EPIDEMIOLOGY
14 MARKETED DRUGS
19 PIPELINE DRUGS
25 RECENT EVENTS AND ANALYST OPINION
25 SPN-810 for ADHD (December 9, 2019)
26 SPN-810 for ADHD (November 5, 2019)
28 Multiple Drugs for ADHD (September 04, 2019)
29 Vafidemstat for ADHD (April 25, 2019)
31 Monarch eTNS system for ADHD (April 19, 2019)
33 SPN-812 for ADHD (March 28, 2019)
35 AEVI-001 for ADHD (January 02, 2019)
36 SPN-812 for ADHD (December 20, 2018)
38 SPN-812 for ADHD (December 06, 2018)
40 Dasotraline for ADHD (August 31, 2018)
41 KP415 for ADHD (July 9, 2018)
44 KEY UPCOMING EVENTS
45 KEY REGULATORY EVENTS
45 Supernus ADHD NDA Repurposes Old European Antidepressant
45 NeuroSigma Monarch eTNS Becomes The First FDA-Cleared ADHD Device
45 Approval of Vyvanse for Pediatric ADHD in Japan
45 Adhansia XR Approval Boosts Purdue’s Move Away From Opioids
46 PROBABILITY OF SUCCESS
47 LICENSING AND ASSET ACQUISITION DEALS
47 Teijin Gains Japanese Rights To NeuroSigma’s Monarch eTNS Device For ADHD
47 KemPharm Offloads Two ADHD Candidates To Gurnet Point
48 Shionogi Licenses Akili’s Digital Medicine Candidates For ADHD, ASD
49 PARENT PATENTS
50 REVENUE OPPORTUNITY
52 CLINICAL TRIAL LANDSCAPE
53 Sponsors by status
54 Sponsors by phase
55 Recent events
56 BIBLIOGRAPHY
57 Prescription information
59 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of ADHD, 2017–26
19 Figure 2: Overview of pipeline drugs for ADHD in the US
19 Figure 3: Pipeline drugs for ADHD, by company
20 Figure 4: Pipeline drugs for ADHD, by drug type
20 Figure 5: Pipeline drugs for ADHD, by classification
26 Figure 6: SPN-810 for ADHD (December 9, 2019): Phase III – CHIME 1 (Pediatric)
28 Figure 7: SPN-810 for ADHD (November 5, 2019): Phase III – CHIME 1 (Pediatric)
31 Figure 8: Vafidemstat for ADHD (April 25, 2019): Phase IIa – REIMAGINE (Spain)
35 Figure 9: SPN-812 for ADHD (March 28, 2019): Phase III – P304 (High Dose Adolescents)
36 Figure 10: AEVI-001 for ADHD (January 02, 2019): Phase II – ASCEND Part A (w/ mGluR Mutations Ages 6-17 Years), Phase II – ASCEND Part B (w/o mGluR Mutations, Ages 6 to 17 Years)
38 Figure 11: SPN-812 for ADHD (December 20, 2018): Phase III – P302 (Low Dose Adolescents)
40 Figure 12: SPN-812 for ADHD (December 06, 2018): Phase III – P301 (Low Dose Children), Phase III – P303 (High Dose Children)
43 Figure 13: KP415 for ADHD (July 9, 2018): Phase III – Children (KP415.E01)
44 Figure 14: Key upcoming events in ADHD
46 Figure 15: Probability of success in the ADHD pipeline
47 Figure 16: Licensing and asset acquisition deals in ADHD, 2015–20
49 Figure 17: Parent patents in ADHD
52 Figure 18: Clinical trials in ADHD
52 Figure 19: Top 10 drugs for clinical trials in ADHD
53 Figure 20: Top 10 companies for clinical trials in ADHD
53 Figure 21: Trial locations in ADHD
54 Figure 22: ADHD trials status
55 Figure 23: ADHD trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of ADHD, 2017–26
15 Table 2: Marketed drugs for ADHD
21 Table 3: Pipeline drugs for ADHD in the US
25 Table 4: SPN-810 for ADHD (December 9, 2019)
27 Table 5: SPN-810 for ADHD (November 5, 2019)
29 Table 6: Multiple Drugs for ADHD (September 04, 2019)
30 Table 7: Vafidemstat for ADHD (April 25, 2019)
32 Table 8: Monarch eTNS system for ADHD (April 19, 2019)
34 Table 9: SPN-812 for ADHD (March 28, 2019)
36 Table 10: AEVI-001 for ADHD (January 02, 2019)
37 Table 11: SPN-812 for ADHD (December 20, 2018)
39 Table 12: SPN-812 for ADHD (December 06, 2018)
41 Table 13: Dasotraline for ADHD (August 31, 2018)
42 Table 14: KP415 for ADHD (July 9, 2018)
50 Table 15: Historical global sales, by drug ($m), 2014–18
51 Table 16: Forecasted global sales, by drug ($m), 2020–24
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