Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder that impacts an individual ability to focus, self-control, and perform other skills important in daily life. ADHD is caused due to biochemical, connectivity, and the structural difference in the mind. Symptoms of Attention Deficit Hyperactivity Disorder (ADHD) mostly advances over a period and vary according to the type of causing factor and according to the age group of the person. The common symptoms in patient population are trouble at work, low self-esteem and substance abuse or ADHD, low-stress tolerance level, mood swings, and many more. Further, based on symptoms, ADHD is classified into three key categories including the predominantly inattentive, predominantly hyperactive-impulsive, and combined type. ADHD is diagnosed using a comprehensive evaluation of the patient’s mental and behavioral condition. Various treatment options are pharmacological treatment, educational interventions & other behavioral therapies, and EEG biofeedback therapies, physicians could reduce the disorder symptoms and their effects on the individual health.
The global attention deficit hyperactivity disorder (ADHD) market is expected to grow with increasing pharmaceutical R&D spending, growing healthcare expenditure, accelerating economic growth, unmet treatment needs, and mounting occurrence of ADHD. Key trends and developments of this market include progressing drugs under pipeline, high demand for dual therapy, and rising preference for EEG biofeedback therapy. However, there are some factors that can hinder the growth of the market including Medical complications of existing drug therapies, high domination of the generic pharmaceutical market, and strict government protocols
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Report Segmentation
Global ADHD Market
By Geography By Drug Class
Distribution
Channel
North America
Europe
Asia Pacific
Latin America
Middle East and
Africa
By Drug type
Methylphenidates
Amphetamines
Dopaminergic /
Noradrenergic
Agents
Adrenergic Receptor
Agonists
Stimulant Drug
Non-Stimulant Drug
Hospital Pharmacy
Retail Pharmacy
Specialty Clinics
E-Commerce
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Table of Content
1. Global ADHD Market Overview..………………………………………………………………………………………..................................................................06
a. Market size Disease forecast and Key Findings(2019-2028)
2. Market Growth Drivers………………………………………………………………………………………………………...........................................................08
a. Increasing diagnosis and treatment rates
b. Launch of new drugs in US targeting unmet needs
c. Approved treatments in Japan for ADHD
d. Other Drivers
3. Epidemiology Populations………………………………………………………………………………………………………………………….…………….........14
a. Total Prevalent Cases of ADHD
b. Total Prevalent Cases of Pediatric ADHD
c. Total Prevalent Cases of Pediatric ADHD Symptoms
d. Total Prevalent Cases of ADHD by Comorbid conditions
e. Diagnosed and Drug Treated Prevalent Cases of ADHD
4. ADHD Disease Market Segmentation…………………………………………………………………………………………………………………………………….21
a. Drugs Type
i. Stimulant Drug
ii. Non-Stimulant Drug
b. Drug Class
i. Methylphenidates
ii. Amphetamines
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Table of Content
iii. Dopaminergic / Noradrenergic Agents
iv. iv. Adrenergic Receptor Agonists
v. Clonidine
v. Bupropion
b. By Geographic Region
i. Current treatment used for ADHD by region
ii. Region-specific treatment practices (US, EU and Japan)
c. By Distribution Channel
i. Distribution Channel Value for Hospital Pharmacy, Retail Pharmacy, Specialty Clinics and E-Commerce
5. ADHD Drug Market Share by Region and therapies……………………………………………………………………………………………………………………..25
a. Market share by current therapy
b. Market Sales and Patient Share by Region (US, EU and Japan)
c. Key Findings
6. Competitive Landscape……………………………………………………………………………………………………………………………………………………….31
a. Top performing companies by sales
b. Insights & Forecast (2019-2028)
7. Key Company Profiles………………………………………………………………………………………………………………………………………………………34
a. Eli Lilly Company overview, Product & Services, Strategies & Financials
b. Johnson & Johnson Company, Product & Services, Strategies & Financials
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Table of Content
c. Pfizer Company, Product & Services, Strategies & Financials
d. Novartis Company, Product & Services, Strategies & Financials
e. Highland Therapeutics Inc., Product & Services, Strategies & Financials
f. Noven Pharmaceuticals Inc., Product & Services, Strategies & Financials
g. Teva Pharmaceutical, Product & Services, Strategies & Financials
h. NEOS Therapeutics, Product & Services, Strategies & Financials
i. Shire, Product & Services, Strategies & Financials
j. Mallinckrodt, Product & Services, Strategies & Financials
8. Access and Reimbursement Scenario………………………………………………………………………………………………………………………………….49
a. Region-Specific Reimbursement Scenario
b. Key Market Access Consideration in ADHD by region
9. Factors Driving Future Growth…………………………………………………………………………………………………………………………………………..53
a. Emerging Therapies for ADHD
b. Analysis of Clinic Development Programs for ADHD
c. Early Phase Pipeline Analysis (notable developments for ADHD)
d. Future focus of development for ADHD
10. Conclusion………………………………………………………………………………………………………………………………………………………………….59
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Global ADHD Market Overview - Market Size
The overall ADHD market will experience sizable growth over the forecast period, increasing from $14 billion in 2019 to
over xx billion in 2028 with a CAGR of xx
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
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Global ADHD Market Size (In Billions) (2019-2028)
Key Findings
The overall ADHD market will experience sizable growth
over the forecast period, increasing from $10.5 billion in
2017 to over xx billion in 2027 with a CAGR of xx
This growth is primarily due to increasing diagnosis and
treatment rates in all markets under study as a result of a
lower barrier to diagnosis of adult ADHD from growing use
of the updated DSM-5 criteria
We expect the market to continue to grow at a rate of over
xx% annually, driven primarily by the release of key
treatment guidance, new drug launches in the US and
increasing drug availability in other regions, and increasing
physician education
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Market Growth Drivers
Growth
Drivers
Lisdexamfetamine in Japan
Launch of three new drugs in US
Increase in incidence and advancements in
medical field of ADHD
Increase in diagnosis and treatment
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Market Growth Drivers
Increase in diagnosis and treatment rates
The primary driver of the growth of ADHD market is the increase in diagnosis and treatment rates of adult ADHD in both US
and EU
The lower barrier to diagnosis with the continued adoption of the DSM-5 with increase in physician awareness and
education in US are the factors driving the market over forecast period
Launch of medications approved for the adult population and guidance providing adult treatment pathway will result in
modest growth
Drug treated adult ADHD population is expected to grow from over 3.7 million patients across the G7 in 2017 to over 6.9
million patients in 2027
Increase in diagnosis and drug treatment rates in paediatric population is expected to have modest market growth through
2027
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Market Growth Drivers
The launch of three new drugs in the United States
In US, the launch of three new therapies during the forecast period, including a methylphenidate formulation with a unique
dosing pattern and other nonstimulant drugs with lower abuse risk is expected to lead in market expansion
Molindone, seeking approval for IA in ADHD, has the potential to be the first therapy to niche population, and together with
the high cost associated with newly launched branded drugs in market, it is expected to add xx Million in US sales in 2028.
Combined, it is anticipated nearly $xx billion in 2028 sales from the launch of these three new therapies in the US
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Market Growth Drivers
Lisdexamfetamine in Japan
Japan historically had xx approved therapies available for treatment of ADHD
With the expected launch of lisdexamfetamine in this market in 2019 and interviewed experts’ expectation to prioritize its
use in the adult population, lisdexamfetamine to be responsible for xx of the Japanese market in 2028
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Market Growth Drivers
Increase in incidence and advancements in medical field of ADHD
The growing incidence of ADHD due to rough impact of unstable lifestyles and additives in children’s diet across the world
is fundamentally driving the market growth as there is no treatment to for this disorder
Increase number of research in neurosciences, expanding focus of biotechnology and pharmaceutical companies into
developing innovative therapeutics for ADHD is driving the development of the global ADHD therapeutics market
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Total prevalent cases of adult ADHD (2019-2028) (In’000)
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US 12,556 xx xx xx xx xx xx xx xx xx
Europe 8,759 xx xx xx xx xx xx xx xx xx
France xx xx xx xx xx xx xx xx xx xx
Germany xx xx xx xx xx xx xx xx xx xx
Italy xx xx xx xx xx xx xx xx xx xx
Spain xx xx xx xx xx xx xx xx xx xx
UK xx xx xx xx xx xx xx xx xx xx
Japan xx xx xx xx xx xx xx xx xx xx
Major-
Markets Total
xx xx xx xx xx xx xx xx xx xx
Note: Numbers reflect rounding. Estimates include males and females aged 20 or older
Total prevalent cases of adult ADHD in US and EU is 12,556 and 8,759 in 2019 and projected to increase by xx in 2028
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Total prevalent cases of pediatric ADHD (2019-2028) (In’000)
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US 8,246 xx xx xx xx xx xx xx xx xx
Europe 4,117 xx xx xx xx xx xx xx xx xx
France xx xx xx xx xx xx xx xx xx xx
Germany xx xx xx xx xx xx xx xx xx xx
Italy xx xx xx xx xx xx xx xx xx xx
Spain xx xx xx xx xx xx xx xx xx xx
UK xx xx xx xx xx xx xx xx xx xx
Japan xx xx xx xx xx xx xx xx xx xx
Major-
Markets Total
xx xx xx xx xx xx xx xx xx xx
Total prevalent cases of adult ADHD in US and EU is 8,246 and 4,117 in 2019 and projected to increase xx by 2028
Note: Numbers reflect rounding. Estimates include males and females aged 19 or younger
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Total prevalent cases of pediatric ADHD Symptoms (2019-2028) (In’000)
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US 11,671 xx xx xx xx xx xx xx xx xx
Europe 9,689 xx xx xx xx xx xx xx xx xx
France xx xx xx xx xx xx xx xx xx xx
Germany xx xx xx xx xx xx xx xx xx xx
Italy xx xx xx xx xx xx xx xx xx xx
Spain xx xx xx xx xx xx xx xx xx xx
UK xx xx xx xx xx xx xx xx xx xx
Japan xx xx xx xx xx xx xx xx xx xx
Major-
Markets Total
xx xx xx xx xx xx xx xx xx xx
Total prevalent cases of adult ADHD in US and EU is 11,671 and 9,689 in 2019 and projected to increase xx by 2028
Note: Numbers reflect rounding. Estimates include males and females of all ages
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Prevalent cases of pediatric ADHD by comorbid ODD (2019-2028) (In’000)
US EU France Germany Italy Spain UK Japan
Hyperactive-impulsive
only type with ODD
631 307 81 73 27 51 76 122
Hyperactive-impulsive
only type with no ODD
xx xx xx xx xx xx xx xx
Inattentive type with
ODD
xx xx xx xx xx xx xx xx
Inattentive type with no
ODD
xx xx xx xx xx xx xx xx
Combined type with
ODD
xx xx xx xx xx xx xx xx
Combined type with no
ODD
xx xx xx xx xx xx xx xx
Note: Numbers reflect rounding. Estimates include males and females of all ages
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Diagnosed cases of adult ADHD: (2019-2028) (In’000)
Note: Numbers reflect rounding. Estimates include males and females of all ages
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US 5,545 xx xx xx xx xx xx xx xx xx
France xx xx xx xx xx xx xx xx xx xx
Germany xx xx xx xx xx xx xx xx xx xx
Italy xx xx xx xx xx xx xx xx xx xx
Spain xx xx xx xx xx xx xx xx xx xx
UK xx xx xx xx xx xx xx xx xx xx
Japan xx xx xx xx xx xx xx xx xx xx
Major-
Markets Total
xx xx xx xx xx xx xx xx xx xx
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Drug-treated prevalent cases of adult ADHD: (2019-2028) (In’000)
Note: Numbers reflect rounding. Estimates include males and females of all ages
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US 3,379 xx xx xx xx xx xx xx xx xx
France xx xx xx xx xx xx xx xx xx xx
Germany xx xx xx xx xx xx xx xx xx xx
Italy xx xx xx xx xx xx xx xx xx xx
Spain xx xx xx xx xx xx xx xx xx xx
UK xx xx xx xx xx xx xx xx xx xx
Japan xx xx xx xx xx xx xx xx xx xx
Major-
Markets Total
xx xx xx xx xx xx xx xx xx xx
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ADHD Market size by drug type, (2019-2028)
Attention deficit hyperactivity disorder (ADHD) market Size, by
drug type (2019-2028)
Drug Type Insights
By type of drug, the market has been segmented into stimulant
and non-stimulant drugs. Stimulant drugs include Amphetamine,
Methylphenidate, Lisdexamfetamine, Dexmethylphenidate.
Non-stimulant drugs include Atomoxetine, Guanfacine,
Clonidine, and Bupropion
The stimulant segment accounted for the largest share in the
ADHD market in 2019 and is expected to maintain its
dominance throughout the forecast period
Non-stimulants are expected to exhibit the fastest growth rate
during the forecast period due to their long-lasting effect
compared to stimulants; he fact that these drugs present no risk
of substance abuse is also a key factor in boosting segment
growth
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ADHD Market by geographic regional summary
Region
In terms of regions, the global attention deficit hyperactivity disorder (ADHD) market is categorized as Asia Pacific, Europe, North
America, Middle East & Africa, and Latin America. North America dominates the segment with more than xx% market share in 2019. The
presence of major players in the region and increasing number of collaborations among them is enhancing market penetration.
Additionally, rise in the number of product launches and boosting product development are among the factors boosting the growth of
the market in North America. Surging number of drug prescriptions in the region is also the factor fueling the growth of the market
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ADHD Market by distribution channel
Distribution Channel: Value in USD Millions
On the basis of distribution channels, the market is divided into hospitals pharmacy, retail pharmacy, specialty clinics, and e-
commerce. Retail pharmacy dominates the segment with maximum revenue share and market share of more than 50%. Surging
number of prescriptions is one of the major factors propelling the growth of the retail pharmacy distribution channel. Additionally,
increasing care initiatives of patient is also fueling the growth of the sub-segment. ADHD patients prefer purchasing drugs from
retail pharmacy stores over hospitals
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Major market sales of ADHD drug class
Major Market Sales of ADHD Drug Classes and Total Patient Share: 2019-2028
We anticipate that methylphenidates will
become the market-share leader in 2028 as a
result of growth within this drug class in the
U.S. market. Growth of this class in the US is
driven primarily by the launch of a new
methylphenidate agent within our forecast
period, methylphenidate PM (Jornay PM) in
2019
This formulation has the potential to partially
address a current unmet need in ADHD
treatment, but with the number of
methylphenidate formulations currently
available including many that are generically
available
Market sales of Amphetamines is also
increasing from 2019-2028
Key Insights
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Major market sales of ADHD drugs in major pharma markets
Major Market Sales of ADHD Drug Classes in major pharma markets: 2019-2028
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US
Methylphenidates 3960 4257 xx xx xx xx xx xx xx xx
Amphetamines 52 56 xx xx xx xx xx xx xx xx
Dopamenergic 608 584 xx xx xx xx xx xx xx xx
Adrenergic receptor 75 101 xx xx xx xx xx xx xx xx
Europe
Methylphenidates 158 165 xx xx xx xx xx xx xx xx
Amphetamines 64 69 xx xx xx xx xx xx xx xx
Dopamenergic 137 138 xx xx xx xx xx xx xx xx
Adrenergic receptor 42 44 xx xx xx xx xx xx xx xx
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Major market sales of ADHD drugs in major pharma markets
Major Market Sales of ADHD Drug Classes in major pharma markets: 2019-2028
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
France
Methylphenidates 19 19 xx xx xx xx xx xx xx xx
Amphetamines 0 0 xx xx xx xx xx xx xx xx
Dopamenergic 7.8 8 xx xx xx xx xx xx xx xx
Adrenergic receptor 2.4 2.6 xx xx xx xx xx xx xx xx
Germany
Methylphenidates 36 36.8 xx xx xx xx xx xx xx xx
Amphetamines 0 0 xx xx xx xx xx xx xx xx
Dopamenergic 41 37.4 xx xx xx xx xx xx xx xx
Adrenergic receptor 14.1 14.5 xx xx xx xx xx xx xx xx
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Major market sales of ADHD drugs in major pharma markets
Major Market Sales of ADHD Drug Classes in major pharma markets: 2019-2028
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
Italy
Methylphenidates 8.7 9.2 xx xx xx xx xx xx xx xx
Amphetamines 0 0 xx xx xx xx xx xx xx xx
Dopamenergic 20 20.5 xx xx xx xx xx xx xx xx
Adrenergic receptor 7.2 7.6 xx xx xx xx xx xx xx xx
Spain
Methylphenidates 35.1 36.7 xx xx xx xx xx xx xx xx
Amphetamines 0 0 xx xx xx xx xx xx xx xx
Dopamenergic 41 41.1 xx xx xx xx xx xx xx xx
Adrenergic receptor 13 13.4 xx xx xx xx xx xx xx xx
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Major market sales of ADHD drugs in major pharma markets
Major Market Sales of ADHD Drug Classes in major pharma markets: 2019-2028
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
UK
Methylphenidates 59.3 62.9 xx xx xx xx xx xx xx xx
Amphetamines 19 21.7 xx xx xx xx xx xx xx xx
Dopamenergic 27.3 30.4 xx xx xx xx xx xx xx xx
Adrenergic receptor 5.2 6 xx xx xx xx xx xx xx xx
Japan
Methylphenidates 109.2 112.5 xx xx xx xx xx xx xx xx
Amphetamines 11.5 23.1 xx xx xx xx xx xx xx xx
Dopamenergic 153.2 152.8 xx xx xx xx xx xx xx xx
Adrenergic receptor 18.6 19.2 xx xx xx xx xx xx xx xx
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Highlights
Pfizer recently received the U.S. Food &
Drugs Administration (FDA) approval for a
chewable tablet named Quillichew ER
which is used for the treatment of ADHD
patient who are aged 6 years and above
Lupin launched a generic version of Kapvay
in the United States as an expansion
strategy of its product line for ADHD
treatment in February 2018
Dasotraline launched in 2020 for the
treatment of ADHD in paediatric patients
Key players of ADHD market, as per market share
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Insights and forecast
Analysis
Market share for all the major pharma
markets are analyzed and forecasted for
2028 year
As per the forecast, J&J will lead the ADHD
market with xx Bn
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Johnson & Johnson
Company Name
Johnson & Johnson
Year of establishment
Jan 1886, US
Headquarter
New Brunswick, New Jersey, US
Revenue
$79.23 Bn
Website
www.jnj.in
Company Overview
Concerta, a long-acting formulation of the older
ADHD drug Ritalin, is a popular ADHD treatment
by J&J
Worldwide sales of Concerta rose 42% annually
to $206 million, but the drug accounted for less
than 3% of Johnson & Johnson's pharmaceutical
unit's top line
Concerta already faces generic competition, but
the FDA only deemed one generic version, from
Actavis/Allergan, to be equivalent to J&J's version
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Johnson & Johnson
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
The company is profiled for the financial year ended, 2028
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Johnson & Johnson
Company Name
Johnson & Johnson
Year of establishment
Jan 1886, US
Headquarter
New Brunswick, New Jersey, US
Revenue
$79.23 Bn
Website
www.jnj.in
Company Overview
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Eli Lilly and Co.
Company Name
Eli Lilly and Co.
Year of establishment
Headquarters
Revenue
Website
Company Overview
Content
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Eli Lilly
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
The company is profiled for the financial year ended, 2028
Content
Sample
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Pfizer
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
The company is profiled for the financial year ended, 2028
Content
Sample
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Access and reimbursement scenario: Region specific
Reimbursement for prescription healthcare products and services is done by private companies that operate insurance plans
Commercial insurance remains the largest and most lucrative system, providing healthcare coverage to more than 170 million
people
Drug manufacturers often engage in complex pricing and formulary negotiations with numerous health plans offered by
manufacturers
Public scrutiny on the high cost of branded medications in the US has grown, prompting some manufacturers to launch drugs at
below market prices
The physicians’ ability to prescribe
brands is more controlled, because of
variety of generic versions available in
the US
Despite the variety of generics available,
physicians encounter difficulties with
reimbursement as a downstream consequence of
individual variability in response to drugs
U.S. experts experience prior authorization
and step-therapy requirements in the
prescription of ADHD treatments
General Reimbursement Environment: US
Key Market Access Considerations in ADHD: US
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Access and reimbursement scenario: Region specific
Nationalized statutory healthcare system to cover OOP expense
Use of drug controlled by wide range of national, regional, budgets and funding channels
Region specific HTA has become essential for pricing and reimbursement
Use of cost containment strategies like reference pricing, limits on reimbursement, MEA’s
EU5 countries operates a unique market access requirements HTA scale and processes with stakeholders
A social perspective is followed while undertaking a HTA to support fiscal benefits of new medicines
Availability of various drugs hinders
access in EU
Availability of drugs such as methylphenidate
only reimbursed for children and not adults
Long waiting times to access treatment
General Reimbursement Environment: EU
Key Market Access Considerations in ADHD: EU
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Access and reimbursement scenario: Region specific
Japan operates a highly developed healthcare infrastructure that offers universal coverage under the NHI system.
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Japanese physicians have few therapies
available to prescribe for ADHD
treatment, while Methylphenidate IR use
severely restricted
No availability of generic drug
has lead to a considerable
patient OOP cost for adult
patients
Medical expenses for children are free or
largely subsidized while most adult patients
use a public fund for psychiatric rehabilitation
General Reimbursement Environment: Japan
Key Market Access Considerations in ADHD: Japan
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Emerging therapies for ADHD
Emerging therapies launching in existing drug classes will have to
differentiate themselves on efficacy and tolerability measures.
Supernus Pharmaceuticals’ molindone and Aevi’s fasoracetam are
targeting subpopulations of the ADHD market where they would be
first-to-market solutions, in order to avoid competition
Promising ADHD therapies in development have encountered late-
phase issues preventing further activity
In 2015, a Phase II/III trial for Eli Lilly’s edivoxetine in ADHD in children
was terminated, and no further news about development of the drug
has appeared on Eli Lilly’s pipeline
Drug US France Germany Italy UK Japan
Jornay PM 2019 xx xx xx xx xx
Viloxazine 2020 xx xx xx xx xx
Molindone 2021 xx xx xx xx xx
XX xx xx xx xx xx
Estimated Launch Dates Of Key Emerging Therapies For
The Treatment Of ADHD
Abuse/misuse or overdose with prescription medications, have led to
the development of new ADHD therapies, focused on nonscheduled
ADHD therapies, with five nonstimulants in late-phase development
Notable Developments Among Key Emerging Therapies for
ADHD
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Analysis of Clinic Development Programs for ADHD
Jornay PM
Jornay PM demonstrated
robust efficacy at
reducing ADHD
symptoms in children
Despite positive efficacy
results, late-phase trials
have yielded a mixed
message of tolerability.
Insomnia is one of the
intrusive side effects
The FDA has approved
Jornay PM, which
indicates tolerability
issues didn’t outweigh
the benefits of immediate
strong efficacy profile
• KemPharm expects to
file KP-484 via the
505(b)(2) regulatory
pathway and to use
pharmacokinetic and
human abuse liability
study results for KP-415,
drug similar to KP-484, to
expedite the filing of an
NDA for KP-484 in the
first half of 2020
• KemPharm expects to
begin a Phase III efficacy
study for KP-484 in the
United States in 2019
• Molindone is being
investigated for
adjunctive use to treat IA
in ADHD in four Phase III
trials in children and
adolescents
• Molindone was
previously available in
the United States for the
treatment of
schizophrenia, eventually
banned due to side
effects
• The drug burden should
be minimal with the
addition of the ER form of
the Molindone
• Otsuka is investing in a
comprehensive Phase III
program for adults with
ADHD, including an
open-ended tolerability
trial
• In Phase II testing,
AISRS will increase
centanafadine’s chances
of being accurately in
adult population
• Otsuka has selected
atomoxetine as the active
comparator in order to
add credibility to the
performance of
centanafadine
•Dasotraline’s safety and
efficacy data in children
aged 6-12 can be
extrapolated to the aged 13-
17 adolescent population,
but with a trial failure in the
adult population
• Sunovion is only
investigating the drug in
adult patients for BED,
which typically begins in
young adulthood (DSM-
5) while dasotraline is
one of the few drugs
being developed for adult
ADHD in addition to
pediatric ADHD
KP-484 Molindone Centanafadine Dasotraline
Methylphenidates Dopaminergic/Noradrenergic Agent
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Analysis of Clinic Development Programs for ADHD
• Three doses demonstrated
improvements on both the
ADHD-RS-5 hyperactivity and
inattention subscales compared
with placebo which is an
important sign of efficacy
• Viloxazine was previously
available for antidepressant use
in Europe, indicating the agent
had an acceptable safety profile,
Phase III and IIb results report
notable rates of decreased
appetite
• Atomoxetine showed efficacy
over placebo using the ADHD-
RS-IV still has a perception
among clinicians of lower efficacy
compared with stimulants in
practice
• Aevi found an eight-gene subset
predictive of response, which
accounts for approximately 8-
10% of pediatric ADHD patients
• Fasoracetam’s ability to
demonstrate robust clinical
efficacy in the mGluR-enriched
population in the SAGA trial
failed. As a result, Its anticipated
fasoracetam will not meet the
primary end point in Part B of the
ASCEND trials
• Aevi selected the ADHD-RS-5
scale as the primary end point in
all trials, However, this scale
failed to meet the end point in the
SAGA trial
Viloxazine Fasoracetam
Adrenergic Receptor Agonists Glutamate receptor modules
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Early-phase pipeline for ADHD
Phase II compounds in development for ADHD
NLS-1 by
NLS Pharma
OPC-64005 by
Lundbeck
HLD-100 by
Highland
Therapeutics
Dexamphetami
ne by
Noven Pharma
TS-141 by
Taisho Pharma
CX-717 by
RespireRx
Pharma
xx
xx
xx
xx
xx
xx
Phase I compounds in development for ADHD
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Future focus of development for ADHD
Nonstimulant agents are the primary focus of development
Companies are focusing early-phase development efforts on nonstimulant drugs for ADHD, presumably due to the better
safety/tolerability profile associated with these agents that have a lower risk of abuse/misuse or overdose than stimulants. NLS
Pharma and Lundbeck/Otsuka are developing monoamine reuptake inhibitors (NLS-1, a CR formulation of mazindol, and
OPC-64005, respectively) while RespireRx (formerly Cortex Pharmaceuticals) is investigating the use of an ampakine
compound for the treatment of a variety of disorders including ADHD. This shift in the pipeline from stimulants to alternative
drug classes indicates the psychostimulant market is saturated and new treatment advances will come from outside the class
Adult ADHD is a focus for early-phase development
Following in the footsteps of Shire’s Mydayis and capitalizing on increasing awareness of adult ADHD by lowering the DSM-5
diagnostic criteria for adults with the disorder, several early-phase therapies are only in trials of adult patients (NLS-1, POC-
64005, CX-717). Based on our epidemiology, the potential size of the adult ADHD population is larger than the pediatric
population, and, by increasing diagnosis and treatment rates through continuing education, NLS Pharma, Lundbeck/Otsuka,
and RespireRx have an opportunity to capitalize on this population by appealing to adult patients with treatment solutions
tailored to their age demographic
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ADHD market is globally evolving owing with government playing a more
proactive role in containing the disease and reformulation of marketed drugs
Global use of ADHD medications rose threefold from 2010 to 2020, whereas global spending (U.S. xx in 2010) rose ninefold,
adjusting for inflation. Per capita gross domestic product (GDP) robustly predicted use across countries, but the United States,
EU have showed significantly higher-than-predicted use
Use and spending grew in both developed and developing countries, but spending growth was concentrated in developed
countries, which adopted more costly, long-acting formulations. Promoting optimal prescription and monitoring should be a
priority
The use of medication for the treatment of attention deficit disorders, such as Attention Deficit Hyperactive Disorder (ADHD), is
growing. The recent recognition of ADHD as a condition that can also afflict adults has provided a boom to the industry, and
health care reform has enabled more children to access behavioral health services, resulting in more patients being able to
have their ADHD identified and treated
With the growing prevalence of attention deficit hyperactivity disorder across the world, the ADHD market is witnessing an
increase in the number of government initiatives to promote the awareness of the disease and to fund drug development in the
area mental health therapeutics
For instance, in 2016, the US Department of Health and Human Services (HHS) donated USD 3,454 Mn to the Substance Abuse
and Mental Health Services Administration (SAMHSA) to address the needs of people with mental illnesses
Such rising government support to help people with ADHD will drive market growth during the forecast period