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 I/II and Phase III trial results, pivotal efficacy study results, estimated PDUFA dates, and an expected patent expiration.
- The overall likelihood of approval of a Phase I ADHD asset is 11.1%, and the average probability a drug advances from Phase III is 73.7%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 8.9 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
20 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 Centanafadine for ADHD (June 11, 2020)
27 SPN-810 for ADHD (February 25, 2020)
28 SPN-810 for ADHD (December 9, 2019)
30 SPN-810 for ADHD (November 5, 2019)
32 Multiple Drugs for ADHD (September 4, 2019)
33 Vafidemstat for ADHD (April 25, 2019)
35 Monarch eTNS system for ADHD (April 19, 2019)
37 SPN-812 for ADHD (March 28, 2019)
40 KEY UPCOMING EVENTS
41 KEY REGULATORY EVENTS
41 Gaming For Attention: FDA Grants De Novo For Novel ADHD Treatment
41 Lannett Rolls Out US Adderall XR Rival
41 KemPharm Seeks Clearance Of D-Methylphenidate Prodrug
41 Supernus ADHD NDA Repurposes Old European Antidepressant
43 PROBABILITY OF SUCCESS
44 LICENSING AND ASSET ACQUISITION DEALS
44 Teijin Gains Japanese Rights To NeuroSigma’s Monarch eTNS Device For ADHD
44 KemPharm Offloads Two ADHD Candidates To Gurnet Point
45 REVENUE OPPORTUNITY
47 CLINICAL TRIAL LANDSCAPE
48 Sponsors by status
49 Sponsors by phase
50 Recent events
52 BIBLIOGRAPHY
53 Prescription information
55 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of ADHD, 2019–28
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: Centanafadine for ADHD (June 11, 2020): Phase III – 405-201-00013, Phase III – 405-201-00014 (Sustained-release)
28 Figure 7: SPN-810 for ADHD (February 25, 2020): Phase III – CHIME 2 (Pediatric)
30 Figure 8: SPN-810 for ADHD (December 9, 2019): Phase III – CHIME 1 (Pediatric)
32 Figure 9: SPN-810 for ADHD (November 5, 2019): Phase III – CHIME 1 (Pediatric)
35 Figure 10: Vafidemstat for ADHD (April 25, 2019): Phase IIa – REIMAGINE (Spain)
39 Figure 11: SPN-812 for ADHD (March 28, 2019): Phase III – P304 (High Dose Adolescents)
40 Figure 12: Key upcoming events in ADHD
43 Figure 13: Probability of success in the ADHD pipeline
47 Figure 14: Clinical trials in ADHD
47 Figure 15: Top 10 drugs for clinical trials in ADHD
48 Figure 16: Top 10 companies for clinical trials in ADHD
48 Figure 17: Trial locations in ADHD
49 Figure 18: ADHD trials status
50 Figure 19: ADHD trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of ADHD, 2019–28
15 Table 2: Marketed drugs for ADHD
22 Table 3: Pipeline drugs for ADHD in the US
26 Table 4: Centanafadine for ADHD (June 11, 2020)
27 Table 5: SPN-810 for ADHD (February 25, 2020)
28 Table 6: SPN-810 for ADHD (December 9, 2019)
31 Table 7: SPN-810 for ADHD (November 5, 2019)
33 Table 8: Multiple Drugs for ADHD (September 4, 2019)
34 Table 9: Vafidemstat for ADHD (April 25, 2019)
36 Table 10: Monarch eTNS system for ADHD (April 19, 2019)
38 Table 11: SPN-812 for ADHD (March 28, 2019)
45 Table 12: Historical global sales, by drug ($m), 2015–19
46 Table 13: Forecasted global sales, by drug ($m), 2020–24
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