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 2019, there were 179.8 million prevalent cases of attention deficit hyperactivity disorder (ADHD) in people aged 5–44 years worldwide, and forecasts that number to increase to 189.0 million prevalent cases by 2028.
- The worldwide prevalence of ADHD among children aged 5–19 years is estimated to be 5.29%, while the prevalence among adults aged 20–44 years is estimated to be 2.80%.
- 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 three drugs in the NDA/BLA stage.
- Therapies in development for ADHD focus on a wide variety of targets. The majority of pipeline drugs for ADHD are administered via the oral route, with one drug being tested in a transdermal formulation.
- High-impact upcoming events for drugs in the ADHD space comprise topline Phase IIa trial results for LSD microdose program, topline Phase III trial results for centanafadine, pivotal efficacy study results for KP484, estimated PDUFA dates for AR19 and KP415, and an expected patent expiration for Adzenys XR-ODT.
- The overall likelihood of approval of a Phase I ADHD asset is 11.8%, and the average probability a drug advances from Phase III is 73.7%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.3 years in the overall psychiatry space.
- 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% of trials 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 European 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 159 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
21 PIPELINE DRUGS
27 RECENT EVENTS AND ANALYST OPINION
27 SPN-812 for ADHD (December 22, 2020)
28 ABV-1504 for ADHD (November 9, 2020)
29 SPN-812 for ADHD (November 9, 2020)
30 AR19 for ADHD (October 8, 2020)
31 AR19 for ADHD (October 6, 2020)
32 AR19 for ADHD (September 10, 2020)
33 Centanafadine for ADHD (June 11, 2020)
35 SPN-810 for ADHD (February 25, 2020)
36 SPN-810 for ADHD (December 9, 2019)
39 KEY UPCOMING EVENTS
40 KEY REGULATORY EVENTS
40 Keeping Track: US FDA Clears Another Novel ADHD Drug; Submissions Blossom
40 Keeping Track: US FDA Approves Azstarys For ADHD
40 Noven Submits New Drug Application For Dextroamphetamine Transdermal System
40 Supernus Removes Reference To Lab Move In SPN-812 NDA
40 Setbacks For Supernus
41 ADHD Advisory Committee Wants FDA-Defined Standards Before Clearing Abuse-Deterrent Stimulant Label
41 Gaming For Attention: FDA Grants De Novo For Novel ADHD Treatment
42 PROBABILITY OF SUCCESS
43 REVENUE OPPORTUNITY
45 CLINICAL TRIAL LANDSCAPE
46 Sponsors by status
47 Sponsors by phase
48 Recent events
49 BIBLIOGRAPHY
51 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of ADHD, 2019–28
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: SPN-812 for ADHD (December 22, 2020): Phase III – P306 (Adults)
33 Figure 7: AR19 for ADHD (September 10, 2020): Phase III – AR19.004
35 Figure 8: Centanafadine for ADHD (June 11, 2020): Phase III – 405-201-00013, Phase III – 405-201-00014 (Sustained-release)
36 Figure 9: SPN-810 for ADHD (February 25, 2020): Phase III – CHIME 2 (Pediatric)
38 Figure 10: SPN-810 for ADHD (December 9, 2019): Phase III – CHIME 1 (Pediatric)
39 Figure 11: Key upcoming events in ADHD
42 Figure 12: Probability of success in the ADHD pipeline
45 Figure 13: Clinical trials in ADHD
45 Figure 14: Top 10 drugs for clinical trials in ADHD
46 Figure 15: Top 10 companies for clinical trials in ADHD
46 Figure 16: Trial locations in ADHD
47 Figure 17: ADHD trials status
48 Figure 18: ADHD trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of ADHD, 2019–28
15 Table 2: Marketed drugs for ADHD
23 Table 3: Pipeline drugs for ADHD in the US
27 Table 4: SPN-812 for ADHD (December 22, 2020)
29 Table 5: ABV-1504 for ADHD (November 9, 2020)
30 Table 6: SPN-812 for ADHD (November 9, 2020)
31 Table 7: AR19 for ADHD (October 8, 2020)
32 Table 8: AR19 for ADHD (October 6, 2020)
33 Table 9: AR19 for ADHD (September 10, 2020)
34 Table 10: Centanafadine for ADHD (June 11, 2020)
35 Table 11: SPN-810 for ADHD (February 25, 2020)
36 Table 12: SPN-810 for ADHD (December 9, 2019)
43 Table 13: Historical global sales, by drug ($m), 2016–20
44 Table 14: Forecasted global sales, by drug ($m), 2021–25
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