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世界のADHD治療薬市場:特許失効の一方で、診断基準の拡張・成人有病者の増大に伴って成長し続ける市場

ADHD Therapeutics to 2020 - Broadened Diagnostic Criteria and Growing Adult Prevalence to Drive Market Growth despite Patent Expirations

発行 GBI Research 商品コード 310993
出版日 ページ情報 英文 91 Pages
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世界のADHD治療薬市場:特許失効の一方で、診断基準の拡張・成人有病者の増大に伴って成長し続ける市場 ADHD Therapeutics to 2020 - Broadened Diagnostic Criteria and Growing Adult Prevalence to Drive Market Growth despite Patent Expirations
出版日: 2014年07月31日 ページ情報: 英文 91 Pages
概要

近年、ADHD(注意欠陥・多動性障害)の診断基準が拡張・緩和されたことにより、成人でもADHDと診断される人々が増加してきました。米国の成人の4.1%がADHDを発症し、そのうちの41.3%が重篤な患者で治療的介入が必要である、と推計されています。現在のADHD治療薬市場はジェネリック医薬品であふれかえっており、もともとは即放性(IR)だった薬剤を徐放性(ER)として利用している場合がほとんどです。しかし、大半の薬剤は乱用の危険性が伴います。また、刺激薬の利用が適さない患者むけに、非刺激性の治療薬の開発も進められています。今後は、新薬の承認よりも、診断率の上昇・有病者数の増加を背景にADHD治療薬の市場は拡大していくものと思われ、2020年までの年平均成長率(CAGR)は4.8%、同年の市場規模は94億米ドルと推計されています。

当レポートでは、世界各国における注意欠陥・多動性障害(ADHD)治療法の関連市場について分析し、疾患の概要や主な治療パターン、上市済み製品の概要(安全性・効能など)、現在開発中の治療薬のパイプライン情報、全世界および主要国における市場動向の見通し(今後8年間の予測値)、資本取引・事業提携の動きなどを調査しております。

第1章 目次

第2章 イントロダクション

  • 疾患の概要
  • 症状
  • 疫学
  • 病因
  • 病態生理
    • 診断基準スケール
    • DSM-5のADHDに対する基準
    • ICD-10の多動性障害に対する基準
  • 治療法
    • 治療アルゴリズム

第3章 上市済み製品

  • 刺激薬
    • Adderall XR (Shire)
    • Concerta (Janssen Pharmaceuticals)
    • Daytrana (Noven Pharmaceuticals)
    • Focalin XR (Novartis)
    • Ritalin LA (Novartis)
    • Provigil (Teva Pharmaceutical)
    • Quillivant XR (Pfizer Pharmaceuticals)
    • Vyvanse (Shire)
  • 刺激薬以外
    • Strattera (Eli Lilly)
    • Intuniv (Shire)
    • Kapvay (Concordia Pharmaceuticals)
  • 効能・安全性の比較分析

第4章 ADHD向けパイプライン製品

  • 概要
  • パイプライン製品の作動メカニズム
  • 治験
    • 損耗率
    • 治験期間
    • 治験の規模
    • 治験関連指標の比較分析
    • SHP465 (Shire)
    • NT-0202 (Neos Therapeutics)
    • Edivoxetine (Eli Lilly)
    • NWP09 (Pfizer)
    • NT-0102 (Neos Therapeutics)
    • メタドキシンのER(延長放出) (Alcobra)
    • SPN-812 (Supernus Pharmaceuticals)
    • デキストロアンフェタミンの経皮投与 (Noven Pharmaceuticals)
  • 効能・安全性の比較分析

第5章 市場の将来予測

  • 世界市場
  • 北米
    • 治療法の利用パターン
    • 年間治療費
    • 市場規模
  • 欧州主要5ヶ国(EU5)
  • 日本
  • 市場促進・抑制要因

第6章 資本取引と戦略的市場再編

  • 概要
  • 共同開発契約

第7章 付録

図表一覧

目次
Product Code: GBIHC337MR

GBI Research has released the pharma report, "ADHD Therapeutics to 2020 - Broadened Diagnostic Criteria and Growing Adult Prevalence to Drive Market Growth despite Patent Expirations" Changes in diagnostic criteria have reduced the symptom threshold for diagnosis and finally bring the acceptance of adult ADHD to the clinical setting, enabling those previously unable to obtain a diagnosis to be diagnosed for ADHD treatment. In the case of adult ADHD, 4.1% of US adults are believed to suffer from ADHD, 41.3% of these cases are classified as severe and would be eligible for therapeutic intervention.

The current ADHD therapeutics market is flooded with generics and dominated by the use of Extended-Release (ER) stimulant drugs which have superseded short-acting, Immediate-Release (IR) formulations. With dose titration per patient, ER stimulants are usually effective in 70-90% of patients. However, all stimulants apart from Vyvanse come with potential for abuse. Non-stimulants are used for those who are poor-responders, have poor cardiac history or prefer non-stimulant medication however their efficacy is lacking in comparison. Currently, 10% of adult patients are using a combination of ER and IR treatment for an additional duration, representing an unmet need within this growing ADHD segment.

The current developmental pipeline addresses these gaps in the market, with three potential non-stimulants entering the market during the forecast period and SHP465, which aims to address the unmet need in the adult ADHD segment with its tailored duration of action. In spite of anticipated drug approvals, patents expirations and increased generic competition will cause ACoT to remain fairly static and even decrease across some nations.

As a result, the global market is not expected to be driven by drug approvals, but primarily by a growing prevalence, increase in rates of diagnosis, and therefore eligible treatment population. Global market revenues are forecast to rise at a CAGR of 4.8% to $9.4 billion by 2020.

Scope

The report analyzes the incidence of ADHD, current options for its treatment, pipeline, market forecasts and deals surrounding ADHD therapeutics.The report covers and includes -

  • A brief introduction into ADHD, symptoms, diagnosis, epidemiology, etiology, pathophysiology, economic implications of their treatment and the current treatment options for the condition.
  • An analysis of the currently marketed ADHD drugs, including recent sales figures, safety and efficacy data of the drugs and a discussion of the likely performance of each drug within the forecast period.
  • Comprehensive reviews of the pipeline for ADHD drugs, including individual analysis of a number of late-stage pipeline drugs that have the potential to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule type and mechanism of action.
  • Additional statistical analysis of clinical trial duration, size and attrition rate by phase and mechanism of action.
  • An in-depth, multi-scenario forecast model for the ADHD drugs market in the US, Canada, UK, France, Germany, Italy, Spain and Japan. Each model is based on the anticipated performance of both marketed drugs and any expected to be approved within the forecast period, and takes into account drug cost, patent expiration, efficacy, safety and likely prescription volumes.
  • A detailed discussion of drivers and barriers for the ADHD market
  • An in-depth analysis of licensing and co-development deals involving drugs indicated in ADHD, including an in-depth outline of key deals.

Reasons to buy

  • The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to -
  • Understand the key signaling pathways and molecular targets currently under investigation in drug development for ADHD.
  • Gain an in-depth view of the current status of the ADHD therapeutics pipeline, including the most common molecule types and molecular targets in development.
  • Observe trends in clinical trial duration and size amongst clinical phases and mechanisms of action, and use the clinical trial attrition rate analysis to assess the risk profiles of current and/or future developmental programs for ADHD therapeutics.
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the ADHD therapeutics market.
  • Analyze current and past deals surrounding ADHD therapeutics, including their value, year of deal and in-depth details of key deals within the ADHD market.

Abstract

The Attention-Deficit Hyperactivity Disorder (ADHD) therapeutics market value will rise from $6.9 billion in 2013 to $9.9 billion by 2020, with broadening diagnostic criteria a key driver of growth, according to business intelligence provider GBI Research.

The company's latest report* states that this increase, which represents a Compound Annual Growth Rate (CAGR) of 5.3% and relates to eight major markets (the US, the UK, France, Germany, Spain, Italy, Japan and Canada), will occur fastest in Japan, due to its high ADHD prevalence.

Despite the stigma attached to mental health conditions, this country will witness a more impressive ADHD treatment market CAGR of 15.7%.

Dale Prior, Analyst for GBI Research, says: "ADHD prevalence will rise steadily across the major markets, from approximately 15 million cases in 2013 to just over 18 million by 2020. However, diagnosis rates are particularly low outside of the US, as the disorder is still treated with considerable skepticism.

"Debate remains about the fear of under- or over-diagnosis, the causes and legitimacy of ADHD as a condition, and the skew towards greater prevalence in the US. Research has suggested that ADHD is just as prevalent in other countries as in the US, but it is significantly more recognized in this market."

Prior notes that this trend is expected to change over the coming decade, due largely to an increased recognition of adult ADHD.

The fifth edition of The Diagnostic and Statistical Manual of Mental Disorders, which was published in 2013, broadened the diagnostic criteria for ADHD, recognizing that impairment from symptoms of the disorder may develop in later life.

Prior comments: "These developments herald the final acceptance of adult ADHD in a clinical setting and mean that many people who met the 'partial remission' criteria will now meet the full criteria, leading to an increase in diagnosis.

"However, the continuing reluctance of many patients to seek treatment for mental health conditions will be a barrier to ADHD diagnosis rates, and consequently to any further market growth."

ADHD therapeutics to 2020 - Broadened Diagnostic Criteria and Growing Adult Prevalence to Drive Market Growth despite Patent Expirations

This report provides analysis of the currently marketed Attention-Deficit Hyperactivity Disorder (ADHD) drugs, including recent sales figures and safety and efficacy data, across eight major markets (8MM: the US, Canada, UK, France, Germany, Italy, Spain and Japan). It also provides comprehensive reviews of the ADHD drugs pipeline and in-depth, multi-scenario forecasts for ADHD therapeutics in the 8MM up to 2018.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Disease Introduction
  • 2.2. Symptoms
  • 2.3. Epidemiology
  • 2.4. Etiology
  • 2.5. Pathophysiology
    • 2.5.1. Diagnosis Rating Scales
    • 2.5.2. DSM-5 Criteria for ADHD
    • 2.5.3. ICD-10 Criteria for Hyperkinetic Disorder
  • 2.6. Treatment
    • 2.6.1. Treatment Algorithm

3. Marketed Products

  • 3.1. Stimulant Drugs
    • 3.1.1. Adderall XR - Shire
    • 3.1.2. Concerta - Janssen Pharmaceuticals
    • 3.1.3. Daytrana - Noven Pharmaceuticals
    • 3.1.4. Focalin XR - Novartis
    • 3.1.5. Ritalin LA - Novartis
    • 3.1.6. Provigil - Teva Pharmaceutical
    • 3.1.7. Quillivant XR- Pfizer Pharmaceuticals
    • 3.1.8. Vyvanse - Shire
  • 3.2. Non-stimulant Drugs
    • 3.2.1. Strattera - Eli Lilly
    • 3.2.2. Intuniv - Shire
    • 3.2.3. Kapvay - Concordia Pharmaceuticals
  • 3.3. Comparative Efficacy and Safety

4. ADHD Pipeline

  • 4.1. Overview
  • 4.2. Mechanisms of Action in the Pipeline
  • 4.3. Clinical Trials
    • 4.3.1. Attrition Rate
    • 4.3.2. Clinical Trial Duration
    • 4.3.3. Clinical Trial Size
    • 4.3.4. Comparative Clinical Trial Metrics Analysis
    • 4.3.5. SHP465 - Shire
    • 4.3.6. NT-0202 - Neos Therapeutics
    • 4.3.7. Edivoxetine - Eli Lilly
    • 4.3.8. NWP09 - Pfizer
    • 4.3.9. NT-0102 - Neos Therapeutics
    • 4.3.10. Metadoxine ER - Alcobra
    • 4.3.11. SPN-812 - Supernus Pharmaceuticals
    • 4.3.12. Dextroamphetamine Transdermal - Noven Pharmaceuticals
  • 4.4. Comparative Efficacy and Safety

5. Market Forecast to 2020

  • 5.1. Global Market
  • 5.2. North America
    • 5.2.1. Treatment Usage Patterns
    • 5.2.2. Annual Cost of Treatment
    • 5.2.3. Market Size
  • 5.3. Leading Five EU Countries (EU5)
    • 5.3.1. Treatment Usage Patterns
    • 5.3.2. Annual Cost of Treatment
    • 5.3.3. Market Size
  • 5.4. Japan
    • 5.4.1. Treatment Usage Patterns
    • 5.4.2. Annual Cost of Treatment
    • 5.4.3. Market Size
  • 5.5. Drivers and Barriers
    • 5.5.1. Drivers
    • 5.5.2. Barriers

6. Deals and Strategic Consolidations

  • 6.1. Overview
  • 6.2. Co-development Deals

7. Appendix

  • 7.1. Market Definition
  • 7.2. Abbreviations
  • 7.3. References
  • 7.4. Research Methodology
    • 7.4.1. Secondary Research
    • 7.4.2. Marketed Product Profiles
    • 7.4.3. Late-Stage Pipeline Candidates
    • 7.4.4. Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
    • 7.4.5. Product Competitiveness Framework
    • 7.4.6. Pipeline Analysis
    • 7.4.7. Forecasting Model
    • 7.4.8. Deals Data Analysis
  • 7.5. Contact Us
  • 7.6. Disclaimer

List of Tables

  • Table 1: Common Assessment Scales Used to Aid ADHD Diagnosis
  • Table 2: DSM-5 Criteria for Attention Deficit Hyperactivity Disorder
  • Table 3: ICD-10 Criteria for Attention Deficit Hyperactivity Disorder
  • Table 4: ADHD Therapeutics Market, Global, Pipeline, Discovery, 2014
  • Table 5: ADHD Therapeutics Market, Global, Pipeline, Preclinical, 2014
  • Table 6: ADHD Therapeutics Market, Global, Pipeline, Phase I, 2014
  • Table 7: ADHD Therapeutics Market, Global, Pipeline, Phase II, 2014
  • Table 8: ADHD Therapeutics Market, Global, Pipeline, Phase III, 2014
  • Table 9: ADHD Theapeutics Market, Global, Pipeline, Pre-Registration, 2014
  • Table 10: ADHD Therapeutics Market, Global, Market Forecast, 2013-2020
  • Table 11: ADHD Therapeutics Market, US, Market Forecast, 2013-2020
  • Table 12: ADHD Therapeutics Market, Canada, Market Forecast, 2013-2020
  • Table 13: ADHD Therapeutics Market, UK, Market Forecast, 2013-2020
  • Table 14: ADHD Therapeutics Market, France, Market Forecast, 2013-2020
  • Table 15: ADHD Therapeutics Market, Germany, Market Forecast, 2013-2020
  • Table 16: ADHD Therapeutics Market, Italy, Market Forecast, 2013-2020
  • Table 17: ADHD Therapeutics Market, Spain, Market Forecast, 2013-2020
  • Table 18: ADHD Therapeutics Market, Japan, Market Forecast, 2013-2020

List of Figures

  • Figure 1: ADHD Treatment Algorithm
  • Figure 2: ADHD Therapeutics Market, Marketed Products, Heat Map, 2013
  • Figure 3: ADHD Therapeutics Market, Global, Pipeline (%), 2013
  • Figure 4: ADHD Therapeutics Market, Global, Pipeline Distribution by Mechanism of Action and Program Type, 2013
  • Figure 5: ADHD Therapeutics Market, Global, Pipeline Distribution by Mechanism of Action (Tier 1) and Stage of Development, 2013
  • Figure 6: ADHD Therapeutics Market, Global, Pipeline Distribution by Mechanism of Action (Tier 2) and Stage of Development, 2013
  • Figure 7: ADHD Therapeutics Market, Global, Pipeline, Attrition Rate (%), 2013
  • Figure 8: ADHD Therapeutics Market, Global, Attrition Rate by Mechanism of Action (%), 2013
  • Figure 9: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Duration (months), 2013
  • Figure 10: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Duration by Mechanism (months), 2013
  • Figure 11: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Size, 2013
  • Figure 12: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Size per Product by Mechanism of Action, 2013
  • Figure 13: ADHD Therapeutics Market, Global, Pipeline, Size by Clinical Trial by Mechanism of Action, 2013
  • Figure 14: ADHD Therapeutics Market, Global, Pipeline, Mechanism of Action Heat Map, 2013
  • Figure 15: ADHD Therapeutics Market, Global, Sales Forecast for Edivoxetine ($m), 2016-2020
  • Figure 16: ADHD Therapeutics Market, Global, Sales Forecast for Metadoxine ER ($m), 2017-2020
  • Figure 17: ADHD Therapeutics Market, Global, Sales Forecast for SPN-812 ($m), 2019-2020
  • Figure 18: ADHD Therapeutics Market, Promising Pipeline Molecules, Heat Map
  • Figure 19: ADHD Therapeutics Market, Marketed Products, Heat Map, 2013
  • Figure 20: ADHD Therapeutics Market, Global, Treatment Patterns (million), 2013-2020
  • Figure 21: ADHD Therapeutics Market, Global, Market Size ($bn), 2013-2020
  • Figure 22: ADHD Therapeutics Market, Global, 2013-2020
  • Figure 23: ADHD Therapeutics Market, North America, Treatment Patterns, 2013-2020
  • Figure 24: ADHD Therapeutics Market, North America, Annual Cost of Treatment ($), 2013-2020
  • Figure 25: ADHD Therapeutics Market, North America, Market Size ($m), 2013-2020
  • Figure 26: ADHD Therapeutics Market, Top Five EU Countries, Treatment Patterns, 2013-2020
  • Figure 27: ADHD Therapeutics Market, Top Five EU Countries, Annual Cost of Treatment ($), 2013-2020
  • Figure 28: ADHD Therapeutics Market, Top Five EU Countries, Market Size ($m), 2013-2020
  • Figure 29: ADHD Therapeutics Market, Japan, 2013-2020
  • Figure 30: ADHD Therapeutics Market, Global, Major Licensing Deals by Year and Value, 2006-2014
  • Figure 31: ADHD Therapeutics Market, Global, Major Licensing Deals, 2006-2014
  • Figure 32: ADHD Therapeutics Market, Global, Major Co-developments Distribution, 2006-2014
  • Figure 33: ADHD Therapeutics Market, Global, Major Co-developments by Year and Phase, 2006-2014
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