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 II. 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 12.4%, and the average probability a drug advances from Phase III is 84.6%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 8.8 years in the overall psychiatry space.
- There have been 19 licensing and asset acquisition deals 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 during the period.
- 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 154 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
21 PIPELINE DRUGS
27 RECENT EVENTS AND ANALYST OPINION
27 AEVI-001 for ADHD (January 02, 2019)
28 SPN-812 for ADHD (December 20, 2018)
29 SPN-812 for ADHD (December 06, 2018)
31 Dasotraline for ADHD (August 31, 2018)
32 KP415 for ADHD (July 9, 2018)
35 KEY UPCOMING EVENTS
36 KEY REGULATORY EVENTS
36 CDER Novel Agent CRLs Mount With Rebuffs Of Dasotraline, Waylivra
36 Sunovion Must Regroup After Setback With Dasotraline In ADHD
36 Ironshore’s Jornay PM Approved As First ADHD Stimulant For Nighttime Dosing
36 Ironshore Refiles ADHD Treatment HLD200
37 PROBABILITY OF SUCCESS
38 LICENSING AND ASSET ACQUISITION DEALS
38 Tris Adds Two ADHD Drugs In NextWave Buyout
39 PARENT PATENTS
40 REVENUE OPPORTUNITY
42 CLINICAL TRIAL LANDSCAPE
43 Sponsors by status
44 Sponsors by phase
45 Recent events
46 BIBLIOGRAPHY
47 Prescription information
49 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of ADHD, 2017–26
21 Figure 2: Overview of pipeline drugs for ADHD in the US
21 Figure 3: Pipeline drugs for ADHD, by company
22 Figure 4: Pipeline drugs for ADHD, by drug type
22 Figure 5: Pipeline drugs for ADHD, by classification
28 Figure 6: 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)
29 Figure 7: SPN-812 for ADHD (December 20, 2018): Phase III – P302 (Low Dose Adolescents)
31 Figure 8: SPN-812 for ADHD (December 06, 2018): Phase III – P301 (Low Dose Children), Phase III – P303 (High Dose Children)
34 Figure 9: KP415 for ADHD (July 9, 2018): Phase III – Children (KP415.E01)
35 Figure 10: Key upcoming events in ADHD
37 Figure 11: Probability of success in the ADHD pipeline
38 Figure 12: Licensing and asset acquisition deals in ADHD, 2014–19
39 Figure 13: Parent patents in ADHD
42 Figure 14: Clinical trials in ADHD
42 Figure 15: Top 10 drugs for clinical trials in ADHD
43 Figure 16: Top 10 companies for clinical trials in ADHD
43 Figure 17: Trial locations in ADHD
44 Figure 18: ADHD trials status
45 Figure 19: ADHD trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of ADHD, 2017–26
15 Table 2: Marketed drugs for ADHD
23 Table 3: Pipeline drugs for ADHD in the US
27 Table 4: AEVI-001 for ADHD (January 02, 2019)
28 Table 5: SPN-812 for ADHD (December 20, 2018)
30 Table 6: SPN-812 for ADHD (December 06, 2018)
32 Table 7: Dasotraline for ADHD (August 31, 2018)
33 Table 8: KP415 for ADHD (July 9, 2018)
40 Table 9: Historical global sales, by drug ($m), 2013–17
41 Table 10: Forecasted global sales, by drug ($m), 2019–23
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