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The Report contains:
Report Introduction
DelveInsight’s “Autism Spectrum
Disorder (ASD) - Market Insights,
Epidemiology & Market Forecast-2027”
Report provides an overview of the
disease and market size of Autism
Spectrum Disorder for the seven major
The report provides the understanding of the markets i.e., the United States, EU5
epidemiology and changing market dynamics (France, Germany, Italy, Spain, UK) and
Japan.
of the Autism Spectrum Disorder (ASD) in the The Report covers the overview,
7 major pharmaceutical markets for the treatment practice & Autism Spectrum
Disorder forecasted epidemiology
period 2016-2027 from 2018 to 2027, segmented by
seven major markets.
✓ The report helps in developing business strategies by ❖ Key Products and Key Players
❖ Market Drivers and Barriers
understanding trends shaping and driving the global Autism
❖ Company Collaborations
Spectrum Disorder market
❖ Unmet Needs
DelveInsight | Page |3
Epidemiology Insights
ASD refers to a group of neurodevelopmental conditions defined by impairment in three areas: social interaction,
communication or use of verbal and non-verbal language, and a stereotyped, restricted or repetitive pattern of
behavior, interests and activities. In 2013, the American Psychiatric Association merged four distinct autism
diagnoses into one umbrella diagnosis of autism spectrum disorder (ASD). They included autistic disorder,
childhood disintegrative disorder (CDD), pervasive developmental disorder-not otherwise specified (PDD-NOS)
and Asperger syndrome.
Symptoms of ASD start to appear during the first three years of life. The exact cause of autism spectrum disorder
(ASD) is currently unknown, however it’s a complex condition that may occur as a result of genetic predisposition,
environmental or unknown factors.
ASD occurs in all racial, ethnic, and socioeconomic groups, but is about 4 times more common among boys than
among girls.
• As per DelveInsight estimates, the total prevalent cases of Autism Spectrum Disorder in 7 major markets
was found to be 6,545,050 in 2016
• Among all the countries, United States accounts for the highest number of prevalent cases of ASD, with
around 3,734,939 cases in 2016
• Among the European countries, UK had the highest prevalent population of Autism Spectrum Disorder with
655,612 cases, followed by Italy which had prevalent population of 357,235 in 2016. On the other hand,
Germany had the lowest prevalent population of 90,333 cases in 2016
• As per the DSM diagnostic subtype criteria of Autism Spectrum, in 2016, there were highest cases of Autistic
disorder with 1,777,831 cases followed by Pervasive Development Disorder with 1,718,072 cases in the
United States
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Epidemiology Segmentation-7MM
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Children Adult
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Gender Specific Diagnosed Prevalent Cases of Autism Spectrum Disorder in the United States
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Male: 0-17 yrs Male: 18 & above Female: 0-17 yrs Female: 18 & above
Subtype Specific Diagnosed Prevalent Cases of Autism Spectrum Disorder in the United States
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Year
Autistic Disorder Pervasive Development Disoder- not otherwise specified
Asperger Disorder Childhood Disintegrative Disorder
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Market Insights
The therapeutic market for Autism Spectrum Disorder in seven major markets was found to be USD 2510.2
million in 2016 as per DelveInsight assessments, for the study period (2016-2027).
2016 2027
US EU5 JP US EU5 JP
54% 55%
Among EU5 countries, United Kingdom had the highest market size with USD 255.21 million, while Germany
had the lowest market size of ASD with USD 35.16 million in 2016.
Today, most medicines prescribed to ease autism’s disabling symptoms are used “off label”. These off-label
medicines are generally prescribed to relieve signs and symptoms associated with ASD and are not
definitive cure for ASD. The drugs commonly prescribed to ASD patients include antipsychotics
antidepressants, selective-serotonin reuptake inhibitors, stimulants, anticonvulsants, antihypertensives, CNS
depressants and others. Many alternative and complementary therapies can also be used, however there
is no research to show that they are effective. Some of these therapies include behavior and
communication therapies, education therapies, family therapies, creative therapies (art therapy or music
therapy), sensory-based therapies, special diets, chelation therapy and acupuncture.
DelveInsight | Page |8
Risperidone (Johnson and Johnson) and Aripiprazole (Otsuka Pharmaceuticals) are the only two
antipsychotics that are FDA-approved for the treatment of irritability in ASD. However, these also have
significant drawbacks and limitations. Not all people respond to these therapies, symptoms often return
when the drug is discontinued, and they doesn’t improve many of the core behaviors associated with
autism.
Market Size of Autism The market size is expected Despite remarkable advances in the
Spectrum Disorder in the to increase at a CAGR of knowledge of autism made in the past
7MM was found to be USD XX% during the study decade, the treatment of core
2510.2 million in 2016 period symptoms remains a major challenge
in ASD.
Also, the diagnosis and management of ASD, however is quite a challenge. No pharmacological treatment
currently exists to help improve the challenges that individuals may experience with social skills, repetitive
behaviors, restrictive interests and communication. These core symptoms of ASD may be persistent and
difficult to overcome.
To counter the current unmet needs of the market and to provide better treatment options for ASD, various
research studies have focused on developing novel treatments for ASD treatment. Thus, various
experimental studies are undergoing to find promising therapies for the ASD treatment.
Overall, increase in the awareness for the condition, shifts in the criteria for diagnosing autism and the
launch of upcoming therapies will significantly shift the ASD market during the forecast period (2018-2027).
DelveInsight | Page |9
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Year
D e l v e I n s i g h t | P a g e | 10
Drugs Uptake
Market Size by Therapies
Currently, there is no cure for ASD and most medicines are prescribed to ease autism’s disabling symptoms
and are used “off label”. Only two drugs, Riperidone and Apipripazole are FDA approved, however, these
are associated with certain side effects, leaving behind many opportunities for ASD therapeutic market.
Many players are such as Roche, Neurochlore/Servier, Nobelpharma, Johnson and Johnson, Yamo
Pharmaceuticals, Curemark etc. are involved in developing therapies for the treatment of ASD. Therapies
such as Balovaptan (Roche), Bumetanide (Neurochlore/ Servier), L1-79 (Yamo Pharmaceuticals), CM-AT
(Curemark) etc. are under-development for the treatment of ASD.
Balovaptan is a vasopressin receptor antagonist (VRA) for individuals with autism. The drug is under Phase
III stage of development by Roche. Recently, in January 2018, Balovaptan was granted Breakthrough
Therapy Designation by US FDA. The drug is under development for both children and adults with ASD and
is expected to get launched in the market by 2021. The drug is estimated to hold the highest market share
during the forecast period.
CM-AT is under development by Curemark and is in Phase III stage for the treatment of Autism in children.
The drug candidate has received Fast Track Designation for Autism and the company has also begun rolling
NDA submission of CM-AT for the treatment of Autism.
L1-79 is a novel therapy currently in Phase II stage of development by Yamo Pharmaceuticals for the
treatment of the core symptoms of Autism Spectrum Disorder in both children and adults. It has also
received Fast Track Designation by FDA. Previous experience with open-label administration of L1-79 in
patients with autism demonstrated that L1-79 is a well-tolerated.
Bumetanide is under development by Neurochlore/ Servier and is under Phase III stage of development.
The drug is under development for children. Results have shown that Bumetanide constitutes a successful
strategy to treat ASD with several advantages over the 2 FDA approved drugs (Risperdal and Apiriprazole)
endowed with side effects. The drug is expected to hold decent market share during the forecast period.
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2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
List of Tables
Table 1: Single gene disorders with the high rate of autism 18
Table 2: Changes in the diagnostic criteria for the PDDs in the DSM-5 (adapted from Ozonoff) 32
Table 3: Differential diagnosis of language disorders 34
Table 4: Severity Levels of Autism Spectrum Disorder 36
Table 5: Severity Levels of Autism Spectrum Disorder 37
Table 6: Organisation and delivery of care 43
Table 7: NICE Guideline, Core Autism Features 43
Table 8: 7MM Total Diagnosed Prevalent Cases of Autism Spectrum Disorder (2016-2027) 50
Table 9: Diagnosed Prevalent Cases of ASD in the United States (2016-2027) 53
Table 10: Gender Specific Diagnosed Prevalent Cases of ASD in the United States (2016-2027) 54
Table 11: Subtype-Specific Diagnosed Prevalent Cases of ASD in the United States (2016-
2027) 55
Table 12: Diagnosed Prevalent Cases of Autism Spectrum Disorder in Germany (2016-2027) 57
Table 13: Gender Specific Diagnosed Prevalent Cases of ASD in Germany (2016-2027) 58
Table 14: Subtype-Specific Diagnosed Prevalent Cases of ASD in Germany (2016-2027) 59
Table 15: Diagnosed Prevalent Cases of Autism Spectrum Disorder in France (2016-2027) 61
Table 16: Gender Specific Diagnosed Prevalent Cases of ASD in France (2016-2027) 62
Table 17: Subtype-Specific Diagnosed Prevalent Cases of ASD in France (2016-2027) 63
Table 18: Diagnosed Prevalent Cases of ASD in Italy (2016-2027) 65
Table 19: Gender Specific Diagnosed Prevalent Cases of ASD in Italy (2016-2027) 66
Table 20: Subtype-Specific Diagnosed Prevalent Cases of ASD in Italy (2016-2027) 67
Table 21: Diagnosed Prevalent Cases of ASD in Spain (2016-2027) 69
Table 22: Gender Specific Diagnosed Prevalent Cases of ASD in Spain (2016-2027) 70
Table 23: Subtype-Specific Diagnosed Prevalent Cases of ASD in Spain (2016-2027) 71
Table 24: Diagnosed Prevalent Cases of ASD in the United Kingdom (2016-2027) 73
Table 25: Gender Specific Diagnosed Prevalent Cases of ASD in the United Kingdom (2016-
2027) 74
Table 26: Subtype-Specific Diagnosed Prevalent Cases of ASD in the United Kingdom (2016-
2027) 75
Table 27: Diagnosed Prevalent Cases of ASD in Japan (2016-2027) 77
Table 28: Gender Specific Diagnosed Prevalent Cases of ASD in Japan (2016-2027) 78
Table 29: Subtype-Specific Diagnosed Prevalent Cases of ASD in Japan (2016-2027) 79
Table 30: Essential characteristics of effective interventions for children with autism
spectrum disorder 83
Table 31: Consensus recommendations of pharmacological treatment of co-occurring
conditions and symptoms in children and adults with ASD 88
Table 32: Recommendations 91
D e l v e I n s i g h t | P a g e | 17
List of Figures
Figure 1: Types of Autism Spectrum Disorder 11
Figure 2: Converging Mechanisms of Autism Spectrum Disorder 21
Figure 3: Types of Autism Spectrum Disorder 47
Figure 4: 7MM Total Diagnosed Prevalent Cases of Autism Spectrum Disorder (2016-2027) 50
Figure 5: Diagnosed Prevalent Cases of ASD in the United States (2016-2027) 53
Figure 6: Gender Specific Diagnosed Prevalent Cases of ASD in the United States (2016-2027) 54
Figure 7: Subtype-Specific Diagnosed Prevalent Cases of ASD in the United States (2016-2027) 55
Figure 8: Diagnosed Prevalent Cases of Autism Spectrum Disorder in Germany (2016-2027) 57
Figure 9: Gender Specific Diagnosed Prevalent Cases of ASD in Germany (2016-2027) 58
Figure 10: Subtype-Specific Diagnosed Prevalent Cases of ASD in Germany (2016-2027) 59
Figure 11: Diagnosed Prevalent Cases of Autism Spectrum Disorder in France (2016-2027) 61
Figure 12: Gender Specific Diagnosed Prevalent Cases of ASD in France (2016-2027) 62
Figure 13: Subtype-Specific Diagnosed Prevalent Cases of ASD in France (2016-2027) 63
Figure 14: Diagnosed Prevalent Cases of ASD in Italy (2016-2027) 65
Figure 15: Gender Specific Diagnosed Prevalent Cases of ASD in Italy (2016-2027) 66
Figure 16: Subtype-Specific Diagnosed Prevalent Cases of ASD in Italy (2016-2027) 67
Figure 17: Diagnosed Prevalent Cases of ASD in Spain (2016-2027) 69
Figure 18: Gender Specific Diagnosed Prevalent Cases of ASD in Spain (2016-2027) 70
Figure 19: Subtype-Specific Diagnosed Prevalent Cases of ASD in Spain (2016-2027) 71
Figure 20: Diagnosed Prevalent Cases of ASD in the United Kingdom (2016-2027) 73
Figure 21: Gender Specific Diagnosed Prevalent Cases of ASD in the United Kingdom (2016-
2027) 74
Figure 22: Subtype-Specific Diagnosed Prevalent Cases of ASD in the United Kingdom (2016-
2027) 75
Figure 23: Diagnosed Prevalent Cases of ASD in Japan (2016-2027) 77
Figure 24: Gender Specific Diagnosed Prevalent Cases of ASD in Japan (2016-2027) 78
Figure 25: Subtype-Specific Diagnosed Prevalent Cases of ASD in Japan (2016-2027) 79
Figure 26: Unmet Needs for Autism Spectrum Disorder 94
Figure 27: 7 Major Market Size of Autism Spectrum Disorder in USD Million (2016-2027) 122
Figure 28: United States Market Size of Autism Spectrum Disorder in USD Millions (2016-2027) 127
Figure 29: United States Market Size of ASD by Therapies in USD Million (2016-2027) 128
Figure 30: Germany Market Size of Autism Spectrum Disorder in USD Millions (2016-2027) 132
Figure 31: Germany Market Size of ASD by Therapies in USD Million (2016-2027) 133
Figure 32: France Market Size of Autism Spectrum Disorder in USD Millions (2016-2027) 135
Figure 33: France Market Size of ASD by Therapies in USD Million (2016-2027) 136
Figure 34: Italy Market Size of Autism Spectrum Disorder in USD Millions (2016-2027) 138
Figure 35: Italy Market Size of ASD by Therapies in USD Million (2016-2027) 139
D e l v e I n s i g h t | P a g e | 19
Figure 36: Spain Market Size of Autism Spectrum Disorder in USD Millions (2016-2027) 141
Figure 37: Spain Market Size of ASD by Therapies in USD Million (2016-2027) 142
Figure 38: United Kingdom Market Size of Autism Spectrum Disorder in USD Millions (2016-
2027) 144
Figure 39: UK Market Size of ASD by Therapies in USD Million (2016-2027) 145
Figure 40: Japan Market Size of Autism Spectrum Disorder in USD Millions (2016-2027) 148
Figure 41: Japan Market Size of ASD by Therapies in USD Million (2016-2027) 149
Figure 42: Market Drivers 151
Figure 43:Market Barriers 152
D e l v e I n s i g h t | P a g e | 20
Appendix
Report Methodology
DelveInsight is a premier source for pharmaceutical and biotechnology sector analysis, delivering
exclusive, trusted commercial insight into industry performance through its proprietary platform.
DelveInsight’s reports are continuously updated and revised. The following research methodology
is followed for all databases and reports.
Coverage
The objective of updating DelveInsight coverage is to ensure that it represents the most up to date
vision of the industry possible. The DelveInsight is a fully-integrated solution for comprehensive
intelligence on various pharmaceutical products, both in-market and in pipeline, across the globe.
Sources Used
Secondary Research
The secondary research on internal and external sources is being carried out to source qualitative
and quantitative information relating to each market. The secondary research sources that are
typically referred to include, but are not limited to:
• Company websites, annual reports, financial reports, broker reports, investor
presentations and SEC Filings Industry trade journals and other literature
• Internal and external proprietary databases
• National government documents, statistical databases and market reports
• News articles, press releases and web-casts specific to the companies operating in the
market
Primary Research
DelveInsight conducts primary research by interacting with the healthcare professionals, doctors,
industry’s experts and industry participants and commentators in order to validate its data and
analysis. The discussion provides first-hand information on the market size, market trends, growth
trends, competitive landscape, future outlook, for example.
• It helps in validating and strengthening the secondary research findings
• It further develops the Analysis Team’s expertise and market understanding
• An interactive one-stop, fully integrated business intelligence (BI) platform, catering the
need of the global pharmaceuticals market, across all the value chains
• The comprehensive integration allows for the seamless comparison of the market
dynamics, helps strategic planning and decision making to stay competitive in the global
pharmaceuticals industry
• We help our clients to find answers relevant to business decision-making, including
potential market opportunities, competitor assessments and business environmental
D e l v e I n s i g h t | P a g e | 21
Forecast Methodology
DelveInsight Reports are prepared considering different epidemiology and market factors, keeping
past and current trends in focus. Our forecasting models are prepared based on
the Hybrid approach, where we use both top to bottom and bottom to top approaches and
analyze different factors and parameters to forecast the numbers.
We develop a deep understanding by doing systemic literature research for Epidemiological data
around different geographies. We prepare the forecast model based on different data sources,
considering past and current trends from different factors such as Improvements in survival and
disease therapy, Unmet need, Risk of disease by gender and age group, population size, diagnose
trends, treatment factors and others.
Our Market Forecast model consider factors such as unmet medical need, drug competitor factor,
patient compliance, product price, Marketed drugs- calibration based on actual sales and their
impact in different geographies, emerging drugs and their impact, Novel Agents Analysis based on
their results, therapeutic potential, regulatory success, launch dates, etc., market challenges,
drivers and barriers, and other factors.
Our major sources are company annual reports, scientific literature, epidemiology studies
conducted by different agencies, Pub-Med Articles, country specific government released
population sources and others. To keep up with current market trends, we try to take doctors,
KOLs and industry experts’ opinion through secondary as well as primary research to come with
the actual market size.
DelveInsight Capabilities
DelveInsight Consulting Services collaborate with Biotech & Pharmaceutical companies, Venture
Capitalist, R&D units & API manufacturers to help them in critical business decisions, building
commercial excellence and growing businesses in an increasingly competitive and challenging
environment.
Competitive Intelligence
Conference/Congress
Intelligence
Market/BD
Assessment Studies
R&D
Analytics
Forecasting
Primary CI
DelveInsight delivers strategic CI Inputs to clients for monitoring competition and staying ahead via
our expertise in gathering industry intelligence, leading to better decision making.
1
Our in-depth insights helps market research and business development teams of global bio-Pharma
companies in understanding the market, identifying and targeting the untapped opportunities. 2
DelveInsight’s forecasting through epidemiology-based and unit-based methodologies help create
flexible and robust models to accommodate key inputs for effective market forecasting. 3
DelveInsight’s CI team has supported many global clients by delivering CI projects with high-quality
insights, helping improve their business processes, combining primary and secondary research
methods and validating information to provide un-biased insights. 4
DelveInsight’s subject matter experts help deliver high-quality insights, supporting clients in key
decisions like prioritizing indications, analyzing clinical trials, & analyzing the patents & publications. 5
Our in-house conference/congress intelligence experts gather information from various websites
of congresses and analyze the data to map the KOLs attending the congresses, to effectively plan 6
congresses etc. and provide our un-biased analysis.
D e l v e I n s i g h t | P a g e | 23
Report Price
Autism Spectrum Disorder (ASD)
USD 6250
Single User License
USD 9500
2-3 Users License
USD 12500
Site License
USD 18750
Corporate License
D e l v e I n s i g h t | P a g e | 24
Disclaimer
All Rights Reserved.
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system or transmitted in any form by any means, electronic,
mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, DelveInsight.
As such DelveInsight can accept no liability whatever for actions taken based on any information
that may subsequently prove to be incorrect.
About DelveInsight
DelveInsight is a Business Consultant company and serve as a Knowledge partner across the value
chain of Pharmaceutical Industry. With the use of proprietary databases and analytical models,
DelveInsight provides cutting-edge market and pipeline analysis and API intelligence across all
therapy areas to the Pharma and biotech sector, helping clients to quantify market events and
evaluate their impact on the valuation of products, portfolios and companies. Additional
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