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 pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
- Description
- Contents
This Market Spotlight report covers the Attention Deficit Hyperactivity Disorder (ADHD) market, comprising key pipeline and marketed 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 2016, there were 175.1 million prevalent cases of attention deficit hyperactivity disorder (ADHD) in people aged 5–44 years worldwide, and forecasts that number to increase to 185.5 million prevalent cases by 2025.
- 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%.
- The majority of approved drugs in the ADHD space target dopamine, dopamine reuptake, norepinephrine (noradrenaline), norepinephrine (noradrenaline) reuptake/transporter, and alpha 2 adrenergic receptor. The majority of approved therapies are administered via the oral route, however, a few products are available in topical and intranasal formulations.
- The majority of industry-sponsored drugs in active clinical development for ADHD are in Phase II, with only two drugs in NDA/BLA phase.
- Therapies in mid-to-late stage development for ADHD focus on a wide variety of targets. All the pipeline drugs in mid-to-latestage development for ADHD are administered via the oral route.
- High-impact upcoming events for drugs in the ADHD space include topline Phase II and Phase III trial results, pivotal efficacy study results, expected patent expirations, as well as the FDA’s decision on NDAs.
- The overall likelihood of approval of a Phase I ADHD asset is 13.5%, and the average probability a drug advances from Phase III is 84.6%. Drugs, on average, take 8.7 years from Phase I to approval in ADHD as well as the overall psychiatry space.
- There were 16 licensing and asset acquisition deal agreements during 2013–18. 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.
- Vyvanse’s sales have ranked highest among the drugs in the ADHD space during 2013–17, and are forecast to remain the highest during the forecast period (2018–22).
- The clinical trials distribution across Phase I–IV indicates that the majority of trials for ADHD have been in late phases of development, with 46% of trials in Phase I–II, and 54% in Phase III–IV.
- 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. Shire has the highest number of completed clinical trials for ADHD, with 148 trials.
- Shire 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 ADHD Subtypes
9 TREATMENT
9 Non-pharmacological therapy
9 Pharmacological therapy
11 EPIDEMIOLOGY
14 MARKETED DRUGS
21 Approvals by country
26 PIPELINE DRUGS
35 RECENT EVENTS AND ANALYST OPINION
35 KP415 for ADHD (July 9, 2018)
36 NLS-1 for ADHD (May 31, 2017)
37 Benjorna for ADHD (May 23, 2017)
38 NLS-1 for ADHD (May 16, 2017)
40 AEVI-001 for ADHD (April 20, 2017)
42 Dasotraline for ADHD (April 12, 2017)
43 AEVI-001 for ADHD (March 20, 2017)
45 MDX for ADHD (January 17, 2017)
47 Dasotraline for ADHD (January 13, 2017)
48 MDX for ADHD (January 9, 2017)
50 KEY UPCOMING EVENTS
51 PROBABILITY OF SUCCESS
52 LICENSING AND ASSET ACQUISITION DEALS
53 PARENT PATENTS
54 REVENUE OPPORTUNITY
56 CLINICAL TRIAL LANDSCAPE
57 Sponsors by status
58 Sponsors by phase
59 Recent events
61 BIBLIOGRAPHY
62 Prescription information
64 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of ADHD, 2016–25
26 Figure 2: Pipeline drugs for ADHD in the US
26 Figure 3: Pipeline drugs for ADHD, by company
27 Figure 4: Pipeline drugs for ADHD, by drug type
27 Figure 5: Pipeline drugs for ADHD, by classification
36 Figure 6: KP415 for ADHD (July 9, 2018): Phase III – Children (KP415.E01)
37 Figure 7: NLS-1 for ADHD (May 31, 2017): Phase IIb – NLS-1 (Adults)
40 Figure 8: NLS-1 for ADHD (May 16, 2017): Phase IIb – NLS-1 (Adults)
42 Figure 9: AEVI-001 for ADHD (April 20, 2017): Phase II/III – SAGA (mGluR+ Adolescents Aged 12-17)
43 Figure 10: Dasotraline for ADHD (April 12, 2017): Phase III – Study 305
45 Figure 11: AEVI-001 for ADHD (March 20, 2017): Phase II/III – SAGA (mGluR+ Adolescents Aged 12-17)
47 Figure 12: MDX for ADHD (January 17, 2017): Phase III – MEASURE
48 Figure 13: Dasotraline for ADHD (January 13, 2017): Phase III – Study 301
50 Figure 14: Key upcoming events in ADHD
51 Figure 15: Probability of success in the ADHD pipeline
52 Figure 16: Licensing and asset acquisition deals in ADHD
53 Figure 17: Parent patents in ADHD
56 Figure 18: Clinical trials in ADHD
56 Figure 19: Top 10 drugs for clinical trials in ADHD
57 Figure 20: Top 10 companies for clinical trials in ADHD
57 Figure 21: Trial locations in ADHD
58 Figure 22: ADHD trials status
59 Figure 23: ADHD trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of ADHD, 2016–25
15 Table 2: Marketed drugs for ADHD
22 Table 3: Approvals by country for ADHD
28 Table 4: Pipeline drugs for ADHD in the US
35 Table 5: KP415 for ADHD (July 9, 2018)
36 Table 6: NLS-1 for ADHD (May 31, 2017)
38 Table 7: Benjorna for ADHD (May 23, 2017)
39 Table 8: NLS-1 for ADHD (May 16, 2017)
41 Table 9: AEVI-001 for ADHD (April 20, 2017)
42 Table 10: Dasotraline for ADHD (April 12, 2017)
44 Table 11: AEVI-001 for ADHD (March 20, 2017)
46 Table 12: MDX for ADHD (January 17, 2017)
47 Table 13: Dasotraline for ADHD (January 13, 2017)
49 Table 14: MDX for ADHD (January 9, 2017)
54 Table 15: Historical global sales, by drug ($m), 2013–17
55 Table 16: Forecasted global sales, by drug ($m), 2018–22
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