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市場調查報告書

OpportunityAnalyzer:泛自閉症障礙(ASD)- 機會分析與預測

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

出版商 GlobalData 商品編碼 297502
出版日期 內容資訊 英文 214 Pages
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OpportunityAnalyzer:泛自閉症障礙(ASD)- 機會分析與預測 OpportunityAnalyzer: Autism Spectrum Disorder - Opportunity Analysis and Forecasts to 2018
出版日期: 2014年03月12日 內容資訊: 英文 214 Pages
簡介

泛自閉症障礙(ASD)的治療藥市場,現在是2個認證核可藥(抗精神病藥)獨佔的狀態。也有多數非適應症使用的其他藥劑。ASD因為常常好發於幼兒,需要針對兒童族群的安全有效的藥物。

本報告提供ASD的治療藥市場相關調查分析、疾病概要、流行病學、目前治療選項、未滿足需求分析、機會分析、研究開發策略、開發平台評估等,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理生理學
  • 症狀
  • 診斷

第4章 流行病學

  • 疾病的背景
  • 風險因素和共生病症
    • 妊娠中服用特定藥物提高兒童的ASD風險
    • 妊娠併發症提高ASD的風險
    • 一等親血緣者的精神疾病家族病史為ASD的強力預測因素
    • 母親年齡的上升與父親年齡的上升比較ASD的風險提高
    • 男孩比女孩容易ASD發病
    • 精神神經疾病在自閉症患者中常見
  • 全球趨勢
    • 美國
    • EU5個國家
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的前提條件與手法:患病數量
  • 流行病學預測
    • 受診斷的患病數量
    • 受診斷的患病數量:各年齡
    • 受診斷的患病數量:性別
    • 受診斷的得病率:年齡標準化
    • 受診斷的患病數量:各子類型
  • 議論
    • 流行病學預測的考察
    • 分析的限制
    • 分析的優勢

第5章 目前治療選項

  • 概要
  • 產品簡介:領導品牌

第6章 未滿足需求評估與機會分析

  • 概要
  • 未滿足需求分析
  • 機會分析

第7章 研究開發(R&D)策略

  • 概要
  • 患者適合性製劑
  • EU-AIMS
  • 臨床試驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發中的有前途藥物
  • 創新的初期階段的方法

第9章 開發平台評估分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • 銷售額的5年預測
    • 美國
    • EU5個國家

第10章 附錄

圖表

目錄
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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