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OpportunityAnalyzer:自閉症スペクトラム障害(ASD)- 機会分析と予測

OpportunityAnalyzer: Autism Spectrum Disorder - Opportunity Analysis and Forecasts to 2018

発行 GlobalData 商品コード 297502
出版日 ページ情報 英文 214 Pages
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OpportunityAnalyzer:自閉症スペクトラム障害(ASD)- 機会分析と予測 OpportunityAnalyzer: Autism Spectrum Disorder - Opportunity Analysis and Forecasts to 2018
出版日: 2014年03月12日 ページ情報: 英文 214 Pages
概要

自閉症スペクトラム障害(ASD)の治療薬市場は、現在、2つの承認薬(ともに抗精神病薬)が独占している状態です。適応外使用のその他の薬剤も多数あります。ASDは幼児で明らかになることが多いため、小児集団に対する安全で有効性のある薬が必要とされています。

当レポートでは、ASDの治療薬市場について調査分析し、疾患の概要、疫学、現在の治療選択肢、アンメットニーズ分析、機会分析、研究開発戦略、パイプライン評価などを提供して、概略以下の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因・病態生理
  • 症状
  • 診断

第4章 疫学

  • 疾患の背景
  • リスク因子と併存疾患
    • 妊娠中の特定の薬剤の服用は子供のASDリスクを高める
    • 妊娠合併症はASDのリスクを高める
    • 一等親血縁者の精神疾患の家族歴はASDの強力な予測因子
    • 母性年齢の上昇は父親年齢の上昇と比較してASDのリスクを上げる
    • 男児は女児よりもASDを発症しやすい
    • 精神神経疾患は自閉症患者に高頻度に見られる
  • 世界の動向
    • 米国
    • EU5ヶ国
  • 予測手法
    • 利用した情報源
    • 利用しなかった情報源
    • 予測の前提条件と手法:有病件数
  • 疫学予測
    • 診断された有病件数
    • 診断された有病件数:年齢別
    • 診断された有病件数:性別
    • 診断された有病率:年齢標準化
    • 診断された有病件数:サブタイプ別
  • 議論
    • 疫学予測の考察
    • 分析の限界
    • 分析の強み

第5章 現在の治療選択肢

  • 概要
  • 製品プロファイル:主要ブランド

第6章 アンメットニーズ評価と機会分析

  • 概要
  • アンメットニーズ分析
  • 機会分析

第7章 研究開発(R&D)戦略

  • 概要
  • 患者適合性製剤
  • EU-AIMS
  • 臨床試験設計

第8章 パイプライン評価

  • 概要
  • 臨床開発中の有望薬
  • 革新的な初期段階のアプローチ

第9章 パイプライン評価分析

  • 主要パイプライン薬の臨床ベンチマーク
  • 主要パイプライン薬の商業ベンチマーク
  • 競合評価
  • 売上の5ヶ年予測
    • 米国
    • EU5ヶ国

第10章 付録

図表

目次
Product Code: GDHC009POA

Autism Spectrum Disorders (ASD) is a chronically underserved market currently dominated by the two approved drugs, both of which are antipsychotics. There is off-label use of a multitude of other drugs which target different core and non-core symptoms of ASD. Since this disorder can first become apparent in very young children there is a need for medications which are safe and effective in the pediatric population. The ASD market is expected to grow remain relatively flat between 2012 and 2018, which is predominantly due to various drug patent expiration, and the introduction of novel therapies in the US and EU countries is not anticipated to offset this expected decline in the market. The new treatments will target some key unmet needs but opportunities will remain for drugs which can effectively target any of the many core and non-core symptoms of ASD, as well as offering an improved safety profile over currently used drugs.

Highlights

Key Questions Answered

  • The ASD market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the ASD market?
  • The late-stage ASD pipeline is filled with diverse therapies and novel routes of administration. Which drug will have a significant impact on the ASD market. Which of these drugs will have the highest CAGR, and why?
  • The current ASD market is dominated by antipsychotics, many of which are used off-label. How will the introduction of numerous first-in-class drugs change the treatment landscape? How will the drug treatment rates change over the next five years? What are the key drivers and barriers to this change?

Key Findings

  • The main driver of the ASD market will be the introduction of first-in-class drugs which target core ASD symptoms, which will increase the market size following their uptake. The introduction of another antipsychotic will strengthen the market growth.
  • An additional driver for the ASD market is the assignment of orphan drug status to several ASDs drugs.
  • The biggest barrier for growth in the ASD market will be patent expiration of marketed and pipeline drugs, with rapid genericization expected in some markets.
  • Significant opportunities remain for further drug development in the ASD market due to the large unmet need for novel safe and efficacious drugs for the pediatric population.

Scope

  • Overview of ASD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized ASD therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for six years to 2018.
  • Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the ASD therapeutics market.
  • Pipeline analysis: focus on the five late-stage pipeline ASD drugs discussing emerging trends as well as overview of earlier phase drugs.
  • Analysis of the current and future market competition in the global ASD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global uveitis therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global uveitis therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global ASD therapeutics market from 2012-2018.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
    • 3.2.1. Core Symptoms
    • 3.2.2. Associated Non-Core Symptoms
  • 3.3. Diagnosis
    • 3.3.1. DSM-IV and DSM-V
    • 3.3.2. ICD-10 Diagnosis
    • 3.3.3. Diagnostic Tests

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
    • 4.2.1. Intake of certain drugs during pregnancy increases the risk of ASD in children
    • 4.2.2. Gestational complications elevate the risk of ASD
    • 4.2.3. Familial history of psychiatric disorders in first-degree relatives is a strong predictor of ASD
    • 4.2.4. Increasing maternal age raises the risk of ASD compared with increasing paternal age
    • 4.2.5. Boys are more likely to develop ASD than girls
    • 4.2.6. Neuropsychiatric disorders are highly prevalent in autistic patients
  • 4.3. Global Trends
    • 4.3.1. US
    • 4.3.2. 5EU
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods, Prevalent Cases
  • 4.5. Epidemiological Forecast for ASD (2012-2022)
    • 4.5.1. Diagnosed Prevalent Cases of ASD
    • 4.5.2. Age-Specific Diagnosed Prevalent Cases of ASD
    • 4.5.3. Sex-Specific Diagnosed Prevalent Cases of ASD
    • 4.5.4. Age-Standardized Diagnosed Prevalence of ASD
    • 4.5.5. Diagnosed Prevalent Cases of ASD by Subtype
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
    • 5.1.1. Psychotropic Medication
  • 5.2. Product Profiles - Major Brands
    • 5.2.1. Risperidone
    • 5.2.2. Abilify (aripiprazole)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Lack of Efficacious Therapies for the Core ASD Symptoms
    • 6.2.2. More approved treatment options for the associated non-core symptoms of ASD
    • 6.2.3. Improved early diagnosis in high-functioning autistic children
    • 6.2.4. Poor Diagnosis of Autistic Females and Adult Males
    • 6.2.5. Diagnostic Biomarkers for ASD
  • 6.3. Opportunity Analysis
    • 6.3.1. Development of Alternative Antipsychotic Drugs for ASD
    • 6.3.2. Label Expansion of Other CNS Drugs
    • 6.3.3. Treatments to Improve Language Skills
    • 6.3.4. Treatments Targeting Sleep Problems, Sensory Overload, and Anxiety
    • 6.3.5. Medications Suitable for Young Autistic Children

7. Research and Development Strategies

  • 7.1. Overview
    • 7.1.1. Correcting an Excitation-Inhibition Imbalance at the Synapse
    • 7.1.2. The Oxytocin-Vasopressin Pathway
    • 7.1.3. Alternative Therapies and Digestive Aids
  • 7.2. Patient-Compatible Drug Formulations
  • 7.3. EU-AIMS
  • 7.4. Clinical Trial Design
    • 7.4.1. Diagnosis and Relevant Inclusion Criteria
    • 7.4.2. Current Clinical Trial Design
    • 7.4.3. Recruiting Trial Participants

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. CM-AT
    • 8.2.2. Latuda
    • 8.2.3. Serelsa/AT-001
    • 8.2.4. Namenda
    • 8.2.5. RG-7314
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. NMDAR Modulation
    • 8.3.2. TSO
    • 8.3.3. Syntocinon
    • 8.3.4. Stem Cell Therapy

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmarking of Key ASD Pipeline Drugs
  • 9.2. Commercial Benchmarking of Key ASD Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Five-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed and Drug-Treated Autistic Patients
    • 10.4.2. Drugs Included in Each Therapeutic Class
    • 10.4.3. Key Launch and Patent Expiry Dates
    • 10.4.4. General Pricing Assumptions
    • 10.4.5. Individual Drug Assumptions
    • 10.4.6. Generic Erosion
    • 10.4..7 Drug Dosage Assumptions
  • 10.5. Physicians and Specialists Included in This Study
  • 10.6. About the Authors
    • 10.6.1. Authors
    • 10.6.2. Epidemiologist
    • 10.6.3. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Associated Non-Core symptoms associated with ASD
  • Table 2: Major Differences in the Autism Diagnostic Criteria Between the DSM-IV and the DSM-V
  • Table 3: Comparison Between the DSM-IV/DSM-IV-TR and the ICD-10 for Different ASDs
  • Table 4: Risk Factors and Comorbidities Associated with ASD
  • Table 5: Sources of Diagnosed Prevalence Data Used in the Epidemiological Forecast for ASD and Its Subtypes
  • Table 6: 6MM, Diagnosed Prevalent Cases of ASD, Boys and Girls, Ages 0-19 Years, N, Selected Years, 2012-2022
  • Table 7: 6MM, Diagnosed Prevalent Cases of ASD, by Age, Boys and Girls, N (Row %), 2012
  • Table 8: 6MM, Diagnosed Prevalent Cases of ASD, by Sex, Ages 0-19 Years, N, Row (%), 2012
  • Table 9: 6MM, Diagnosed Prevalent Cases of ASD, by Subtype, N (%), 2012
  • Table 10: Current Treatment Options for ASD
  • Table 11: Product Profile - Risperidone
  • Table 12: Risperidone SWOT Analysis, 2014
  • Table 13: Product Profile - Abilify
  • Table 14: Abilify SWOT Analysis, 2014
  • Table 15: Overall Unmet Needs - Current Level of Attainment
  • Table 16: Late-Stage ASD Pipeline, 2014
  • Table 17: Product Profile - CM-AT
  • Table 18: CM-AT SWOT Analysis, 2014
  • Table 19: Product Profile - Latuda
  • Table 20: Latuda SWOT Analysis, 2014
  • Table 21: Product Profile - Serelsa/ AT-001
  • Table 22: Serelsa/AT-001 SWOT Analysis, 2014
  • Table 23: Product Profile - Namenda
  • Table 24: Namenda SWOT Analysis, 2014
  • Table 25: Product Profile - RG-7314
  • Table 26: RG-7314 SWOT Analysis, 2014
  • Table 27: Early-Stage ASD Pipeline, 2014
  • Table 28: Clinical Benchmarking of Key ASD Pipeline Drugs, 2012-2018
  • Table 29: Commercial Benchmarking of Key ASD Pipeline Drugs, 2012-2018
  • Table 30: Top-Line Sales Forecasts ($m) for the ASD Market 2012-2018
  • Table 31: Country-Specific CAGRs for the Key ASD Drugs, 2012-2018
  • Table 32: Key Events Impacting Sales for ASD, 2012-2018
  • Table 33: ASD Market - Drivers and Barriers, 2012-2018
  • Table 34: Key Launch and Patent Expiry Dates in the ASD Market, 2012-2018
  • Table 35: Children's Average Weights (kg), 6MM

List of Figures

  • Figure 1: Core and Non-Core Symptoms of ASD and Their Interrelationships.
  • Figure 2: Total Prevalence of ASD, Age Eight Years, Boys and Girls, 2000-2008
  • Figure 3: 6MM, Prevalent Cases of Diagnosed ASD, Ages 0-19 Years, Boys and Girls, N, 2012-2022
  • Figure 4: 6MM, Diagnosed Prevalent Cases of Diagnosed ASD, by Age, Boys and Girls, N, 2012
  • Figure 5: 6MM, Diagnosed Prevalent Cases of ASD, by Sex, Ages 0-19 Years, N, 2012
  • Figure 6: 6MM, Age-Standardized Diagnosed Prevalence (%) of ASD, Ages 0-19 Years, Boys and Girls, 2012
  • Figure 7: 5EU, Diagnosed Prevalent Cases of ASD, by Subtypes, Ages 0-19 Years, Boys and Girls, N, 2012
  • Figure 8: ASD treatment Overview
  • Figure 9: Competitive Assessment of the Key Late-Stage Pipeline ASD Drugs, 2012-2018
  • Figure 10: Shifting Distribution of Global Drug Sales in ASD Market, 2012-2018
  • Figure 11: Market Share for ASD Drugs by Region, 5EU and 6MM, 2012 and 2018
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