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市場調查報告書

OpportunityAnalyzer:乾燥症(修格蘭氏症候群) (SS) - 機會分析與預測

OpportunityAnalyzer: Sjogren's Syndrome - Opportunity Analysis and Forecast to 2024

出版商 GlobalData 商品編碼 355157
出版日期 內容資訊 英文 209 Pages
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OpportunityAnalyzer:乾燥症(修格蘭氏症候群) (SS) - 機會分析與預測 OpportunityAnalyzer: Sjogren's Syndrome - Opportunity Analysis and Forecast to 2024
出版日期: 2015年12月19日 內容資訊: 英文 209 Pages
簡介

主要7國 (美國,法國,德國,義大利,西班牙,英國,日本) 的乾燥症(修格蘭氏症候群) (SS) 治療藥市場,預測將從2014年的11億1千萬美元,規模擴大到2024年22億2千萬美元,以年複合成長率 (CAGR) 7.2%的速度成長。

本報告提供乾燥症(修格蘭氏症候群) (SS) 的治療藥市場相關調查分析,提供您疾病概要,流行病學,目前治療選項,未滿足需求和機會,研究開發策略,開發平台評估等相關的系統性資訊。

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
  • 預後

第4章 流行病學

  • 疾病的背景
  • 危險因素和合併症
  • 全球趨勢
    • 主要7個國家
    • EU5個國家
    • 日本
  • 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
  • 乾燥症(修格蘭氏症候群) (SS) 的流行病學預測
    • 確診的患者數
    • 確診的患者數 (各年齡)
    • 確診的患者數 (性別)
    • 確診的患者數 (年齡標準化) 、等
  • 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
  • 非標籤藥物治療和藥物分類

第6章 未滿足需求評估與機會分析

第7章 研究開發 (R&D) 策略

  • 概要
  • 臨床試驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發中的潛力藥物
  • 創新的初期階段方法

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10年預測
    • 美國
    • EU5個國家
    • 日本

第10章 附錄

圖表

目錄
Product Code: GDHC048POA

Sjogren's syndrome (SS) is a slow progressing chronic autoimmune disease, which predominantly affects middle-aged women, and is characterized by lymphocytic infiltration of the exocrine glands, mainly the lacrimal and salivary glands, resulting in reduced secretory functions and ocular and oral dryness. The syndrome can also cause many systemic manifestations, targeting various organs of the body. Current treatment of patients with SS is challenging, with few effective therapeutic agents available. Due to the multi-factorial nature of SS, agents are required to treat glandular symptoms of the disease - mainly salivary and lachrymal - and also any extraglandular manifestations that may arise. However, many of the agents that are available either only treat the symptoms of the disease, are used off-label for the treatment of SS, or are considered ineffective in many patients.

The SS market is now set to enter a new phase with the potential approval of the first biologic agent for SS treatment.

Highlights

Key Questions Answered

  • The SS market is marked by the presence of a number of unmet needs. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the SS market?
  • The late-stage SS pipeline includes the biologic treatment Orencia (abatacept). Will this late-stage drug make a significant impact on the SS market? Will this drug reach peak sales by the end of the forecast period?
  • The current SS market is dominated by the use of off-label therapies. How will the approval of the first biologic agent for the treatment of SS change the drug treatment landscape? What are the key drivers and barriers to market growth?

Key Findings

  • The main driver of the expansion of the SS market will be the anticipated approval of the first biologic agent for the treatment of SS, Bristol-Myers Squibb's Orencia (abatacept).
  • Growth will also be driven by an increase in the prescribing of off-label biologic therapies for the treatment of SS, such as Genentech/Biogen's Rituxan (rituximab). However, this growth will be dampened by the anticipated entry of cheaper rituximab biosimilars.
  • Until the first biologic agent is approved for the treatment of SS, physicians will continue to have difficulty in gaining reimbursement for the use of off-label biologics in their patients, due to their expense and the lack of treatment guidelines to help payers in making reimbursement decisions.
  • A number of randomized controlled trials evaluating biologics in SS have failed, bringing into question the design of the clinical trials. It is believed that as more robust scoring systems and an accurate disease activity index are used in SS clinical trials, studies will be more capable of providing clinically relevant information, with an increased likelihood of detecting efficacy.

Scope

  • Overview of SS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized SS therapeutics market revenue, annual cost of therapy, and treatment usage pattern data from 2014 and forecast for 10 years to 2024.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications for the SS therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global SS 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

The report will enable you to -

  • 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 SS therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SS 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 SS therapeutics market from 2014-2024.
  • 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

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Diagnosis
  • 3.4. Prognosis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. 7MM Diagnosed Prevalent Cases
    • 4.3.2. 5EU Diagnosed Prevalent Cases
    • 4.3.3. Japan Diagnosed Prevalent Cases
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast for SS (2014-2024)
    • 4.5.1. Diagnosed Prevalent Cases of SS
    • 4.5.2. Age-Specific Diagnosed Prevalent Cases of Primary SS
    • 4.5.3. Sex-Specific Diagnosed Prevalent Cases of Primary SS
    • 4.5.4. Age-Standardized Diagnosed Prevalence of Primary SS
    • 4.5.5. Ocular and Oral Manifestations
  • 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. General Preventative Measures
  • 5.2. Product Profiles - Major Brands, Cholinergic Agonists
    • 5.2.1. Salagen (Pilocarpine Hydrochloride)
    • 5.2.2. Evoxac (Cevimeline Hydrochloride)
  • 5.3. Off-Label Treatments and Drug Classes
    • 5.3.1. Tear and Saliva Substitutes
    • 5.3.2. Cyclosporine Ophthalmic Emulsion - Restasis, Ikervis, Papilock Mini
    • 5.3.3. Topical Ophthalmic Corticosteroids - Prednisolone, Fluorometholone, Loteprednol
    • 5.3.4. Antimalarial Agents - Hydroxychloroquine
    • 5.3.5. Other Systemic Immunosuppressive Therapies - Methotrexate, Azathioprine, Cyclophosphamide
    • 5.3.6. Systemic Corticosteroids - Prednisolone, Methylprednisolone
    • 5.3.7. Biologic Agents - Rituxan (Rituximab)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Sjogren's Syndrome Treatments with Improved Efficacy
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Earlier Sjogren's Syndrome Diagnosis
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Treatment Guidelines to Improve Patient Access to Therapies
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Improved Public and Patient Awareness of Sjogren's Syndrome
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity

7. Research and Development Strategies

  • 7.1. Overview
    • 7.1.1. Evaluation of Biologic Therapies Marketed for Other Autoimmune Diseases
    • 7.1.2. Inhibition of Immunological Mechanisms Involved in Sjogren's Syndrome
  • 7.2. Clinical Trial Design
    • 7.2.1. Patient Number
    • 7.2.2. Inclusion Criteria
    • 7.2.3. Efficacy Endpoints

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Orencia (Abatacept)
  • 8.3. Innovative Early-Stage Approaches

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top-Line Ten-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU
    • 9.4.3. Japan

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecast Methodology
    • 10.4.1. Percent Diagnosed Patients
    • 10.4.2. Percent Drug-Treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Launch and Patent Expiry Dates
    • 10.4.5. General Pricing Assumptions
    • 10.4.6. Individual Drug Assumptions
  • 10.5. Physicians and Specialists Included in This Study
  • 10.6. About the Authors
    • 10.6.1. Analyst
    • 10.6.2. Therapy Area Director
    • 10.6.3. Epidemiologist
    • 10.6.4. Global Director of Therapy Analysis and Epidemiology
    • 10.6.5. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Prevalence of Systemic Symptoms in Patients Diagnosed with Primary Sjogren's Syndrome
  • Table 2: Clinical Features of Sjogren's Syndrome
  • Table 3: Classification Criteria for Sjogren's Syndrome
  • Table 4: AECG Classification Criteria for Sjogren's Syndrome (2002)
  • Table 5: AECG Rules for Sjogren's Syndrome Classification (2002)
  • Table 6: ACR Criteria for Sjogren's Syndrome (2012)
  • Table 7: Japanese MHLW Criteria for the Diagnosis of Sjogren's Syndrome (1999)
  • Table 8: Risk Factors and Comorbidities for SS
  • Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Primary SS
  • Table 10: 7MM, Sources Used to Forecast the Oral and Ocular Manifestations of SS
  • Table 11: 7MM, Sources Not Used in the Epidemiological Analysis of SS
  • Table 12: Diagnosed Prevalent Cases of SS, Age ≥18 Years, Both Sexes, N, 2014-2024
  • Table 13: 7MM, Age-Specific Diagnosed Prevalent Cases of Primary SS, Age ≥18 Years, Both Sexes, N, 2014
  • Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of Primary SS, Age ≥18 Years, N, 2014
  • Table 15: Key Marketed Products for Sjogren's Syndrome, 7MM
  • Table 16: Product Profile - Salagen
  • Table 17: Incidence of Adverse Events ≥10% in Any Treatment Group
  • Table 18: Summary of the Frequency of Adverse Reactions Related to Salagen Treatment
  • Table 19: Salagen SWOT Analysis, 2015
  • Table 20: Product Profile - Evoxac
  • Table 21: Change in Patients' Assessment of Dry Mouth Between Baseline and Final Value*
  • Table 22: Effect of Evoxac on Salivary Flow at Clinical Trial End Point
  • Table 23: Incidence of Adverse Events Reported by ≥10% of Patients in Any Treatment Group (15mg and 30mg Evoxac Study), N (%)
  • Table 24: Incidence of Adverse Effects with Evoxac Treatment, N (%)
  • Table 25: Incidence of Adverse Events Reported by ≥10% of Patients in Any Treatment Group (30 and 60mg Evoxac Study), N (%)
  • Table 26: Evoxac SWOT Analysis, 2015
  • Table 27: Product Profile - Cyclosporine Ophthalmic Emulsion
  • Table 28: Cyclosporine Ophthalmic Emulsion SWOT Analysis, 2012
  • Table 29: Product Profile - Topical Ophthalmic Corticosteroids
  • Table 30: Efficacy of Systemic Immunosuppressive Therapy in Sjogren's Syndrome Clinical Trials
  • Table 31: Topical Corticosteroids SWOT Analysis, 2015
  • Table 32: Product Profile - Hydroxychloroquine
  • Table 33: Antimalarial Therapy SWOT Analysis, 2015
  • Table 34: Major Systemic Immunosuppressive Therapies Used to Treat Patients with SS
  • Table 35: Product Profile - Systemic Immunosuppressive Therapies
  • Table 36: Efficacy of Systemic Immunosuppressant Drugs in Sjogren's Syndrome Clinical Trials
  • Table 37: Systemic Immunosuppressive Therapy SWOT Analysis, 2015
  • Table 38: Product Profile - Systemic Corticosteroids
  • Table 39: Systemic Corticosteroids SWOT Analysis, 2015
  • Table 40: Product Profile - Rituxan
  • Table 41: Efficacy of Rituxan in Sjogren's Syndrome Clinical Trials
  • Table 42: Rituxan SWOT Analysis, 2015
  • Table 43: Unmet Need in Sjogren's Syndrome
  • Table 44: Mechanism of Action of Pipeline Products for Sjogren's Syndrome, 7MM
  • Table 45: Late-Stage Pipeline Products for Sjogren's Syndrome, 7MM
  • Table 46: Product Profile - Orencia
  • Table 47: Summary of Orencia Efficacy in Primary SS Patients (Open-Label Pilot Study)
  • Table 48: Orencia SWOT Analysis, 2014
  • Table 49: Early-Stage Pipeline Products for Sjogren's Syndrome, 7MM
  • Table 50: Clinical Benchmark of Key Pipeline Drug - Sjogren's Syndrome Treatments
  • Table 51: Commercial Benchmark of Key Pipeline Drug - Sjogren's Syndrome Treatments
  • Table 52: Top-Line Sales Forecasts ($m) for the Sjogren's Syndrome Market in the 7MM, 2014-2024
  • Table 53: Key Events Impacting Sales for the Sjogren's Syndrome Market, 2014-2024
  • Table 54: Sjogren's Syndrome Market - Drivers and Barriers, 2014-2024
  • Table 55: Launch Dates in the Sjogren's Syndrome Market, 2014-2024
  • Table 56: Patent Expiry Dates in the Sjogren's Syndrome Market, 2014-2024
  • Table 57: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Diagnosed Prevalence Rate of SS in the 7MM, 2014
  • Figure 2: Case Flow Map for Primary SS: US, Germany, Italy, UK, and Japan
  • Figure 3: Case Flow Map for Primary SS: France and Spain
  • Figure 4: 7MM, Diagnosed Prevalent Cases of Primary SS, Age ≥18 Years, Both Sexes, N, Selected Years, 2014-2024
  • Figure 5: 7MM, Diagnosed Prevalent Cases of Secondary SS, Age ≥18 Years, Both Sexes, N, Selected Years, 2014-2024
  • Figure 6: 7MM Diagnosed Prevalent Cases of SS, Age ≥18 Years, Both Sexes, N, Selected Years, 2014-2024
  • Figure 7: 7MM, Age-Specific Diagnosed Prevalent Cases of Primary SS, Age ≥18 Years, Both Sexes, N, 2014
  • Figure 8: 7MM, Sex-Specific Diagnosed Prevalent Cases of Primary SS, Age ≥18 Years, N, 2014
  • Figure 9: 7MM, Age-Standardized Diagnosed Prevalence of Primary SS, Age ≥18 Years , 2014
  • Figure 10: 7MM, Ocular and Oral Manifestations of SS in the Diagnosed Prevalent Cases of SS, Age ≥18 Years , 2014
  • Figure 11: Competitive Assessment of the Late-Stage Pipeline Agent Orencia for Sjogren's Syndrome
  • Figure 12: Sales for the Sjogren's Syndrome Market in the 7MM, 2014-2024
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