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 largest proportion of industry-sponsored drugs in active clinical development for ADHD are in Phase III. Therapies in mid-to-late-stage development for ADHD focus on a wide variety of targets. The majority of pipeline drugs in midto-late-stage development are administered via the oral route, with only one drug also being tested in intramuscular and subcutaneous formulations.
- High-impact upcoming events for drugs in the ADHD space comprise topline Phase III trial results, pivotal efficacy study results, an expected patent expiration, and a meeting with the FDA.
- The overall likelihood of approval of a Phase I ADHD asset is 12.9%, and the average probability a drug advances from Phase III is 78.6%. Drugs, on average, take 8.9 years from Phase I to approval, compared to 8.8 years in the overall psychiatry space.
- There have been 21 licensing and asset acquisition deals involving ADHD drugs during 2014–19. 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 54% in Phase III–IV, and 46% 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 157 trials.
- Takeda leads the industry sponsors with the highest number of clinical trials for ADHD, followed by Eli Lilly and Johnson & Johnson
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
20 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 Vafidemstat for ADHD (April 25, 2019)
27 Monarch eTNS system for ADHD (April 19, 2019)
29 SPN-812 for ADHD (March 28, 2019)
31 AEVI-001 for ADHD (January 02, 2019)
32 SPN-812 for ADHD (December 20, 2018)
34 SPN-812 for ADHD (December 06, 2018)
36 Dasotraline for ADHD (August 31, 2018)
37 KP415 for ADHD (July 9, 2018)
40 KEY UPCOMING EVENTS
41 KEY REGULATORY EVENTS
41 NeuroSigma Monarch eTNS Becomes The First FDA-Cleared ADHD Device
41 Approval of Vyvanse in Japan
41 Adhansia XR Approval Boosts Purdue’s Move Away From Opioids
41 CDER Novel Agent CRLs Mount With Rebuffs Of Dasotraline, Waylivra
41 Sunovion Must Regroup After Setback With Dasotraline In ADHD
42 Ironshore’s Jornay PM Approved As First ADHD Stimulant For Nighttime Dosing
42 Ironshore Refiles ADHD Treatment HLD200
43 PROBABILITY OF SUCCESS
44 LICENSING AND ASSET ACQUISITION DEALS
44 Shionogi Licenses Akili’s Digital Medicine Candidates For ADHD, ASD
44 Tris Adds Two ADHD Drugs In NextWave Buyout
46 PARENT PATENTS
47 REVENUE OPPORTUNITY
49 CLINICAL TRIAL LANDSCAPE
50 Sponsors by status
51 Sponsors by phase
52 Recent events
53 BIBLIOGRAPHY
54 Prescription information
56 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of ADHD, 2017–26
20 Figure 2: Overview of pipeline drugs for ADHD in the US
20 Figure 3: Pipeline drugs for ADHD, by company
21 Figure 4: Pipeline drugs for ADHD, by drug type
21 Figure 5: Pipeline drugs for ADHD, by classification
27 Figure 6: Vafidemstat for ADHD (April 25, 2019): Phase IIa – REIMAGINE (Spain)
31 Figure 7: SPN-812 for ADHD (March 28, 2019): Phase III – P304 (High Dose Adolescents)
32 Figure 8: 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)
34 Figure 9: SPN-812 for ADHD (December 20, 2018): Phase III – P302 (Low Dose Adolescents)
36 Figure 10: SPN-812 for ADHD (December 06, 2018): Phase III – P301 (Low Dose Children), Phase III – P303 (High Dose Children)
39 Figure 11: KP415 for ADHD (July 9, 2018): Phase III – Children (KP415.E01)
40 Figure 12: Key upcoming events in ADHD
43 Figure 13: Probability of success in the ADHD pipeline
44 Figure 14: Licensing and asset acquisition deals in ADHD, 2014–19
46 Figure 15: Parent patents in ADHD
49 Figure 16: Clinical trials in ADHD
49 Figure 17: Top 10 drugs for clinical trials in ADHD
50 Figure 18: Top 10 companies for clinical trials in ADHD
50 Figure 19: Trial locations in ADHD
51 Figure 20: ADHD trials status
52 Figure 21: ADHD trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of ADHD, 2017–26
15 Table 2: Marketed drugs for ADHD
22 Table 3: Pipeline drugs for ADHD in the US
26 Table 4: Vafidemstat for ADHD (April 25, 2019)
28 Table 5: Monarch eTNS system for ADHD (April 19, 2019)
30 Table 6: SPN-812 for ADHD (March 28, 2019)
32 Table 7: AEVI-001 for ADHD (January 02, 2019)
33 Table 8: SPN-812 for ADHD (December 20, 2018)
35 Table 9: SPN-812 for ADHD (December 06, 2018)
37 Table 10: Dasotraline for ADHD (August 31, 2018)
38 Table 11: KP415 for ADHD (July 9, 2018)
47 Table 12: Historical global sales, by drug ($m), 2014–18
48 Table 13: Forecasted global sales, by drug ($m), 2019–23
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