Cover Image
市場調查報告書

軸性脊椎關節炎 - 機會分析與至2023年的預測

OpportunityAnalyzer: Axial Spondyloarthritis - Opportunity Analysis and Forecast to 2024 - Event-Driven Update

出版商 GlobalData 商品編碼 341943
出版日期 內容資訊 英文 199 Pages
訂單完成後即時交付
價格
Back to Top
軸性脊椎關節炎 - 機會分析與至2023年的預測 OpportunityAnalyzer: Axial Spondyloarthritis - Opportunity Analysis and Forecast to 2024 - Event-Driven Update
出版日期: 2015年07月13日 內容資訊: 英文 199 Pages
簡介

軸性脊椎關節炎,是腰痛和伴隨僵硬的骶髂關節發炎的自體免疫疾病。美國,歐洲5國以及日本的7大市場上,由於診斷率的變化預計罹患率提高。抗TNF對於治療軸性脊椎關節炎的前兆和症狀有效,不過,該治療無效的患者沒有其他方法,留下龐大的未滿足需求。

本報告提供軸性脊椎關節炎的概要與2014∼2024年的市場收益、市場競爭、研究開發策略、開發平台分析、現在及未來市場預測等彙整資料。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因及病理學
  • 症狀

第4章 流行病學

  • 風險因素及並用疾病
  • 全球的趨勢
  • 預測方法
  • 流行病學的預測:基礎方案
  • 流行病學的預測:替代方案
  • 考察

第5章 目前治療方法

  • 概要
  • 產品簡介:主力品牌

第6章 未滿足需求評估與機會分析

  • 概要
  • 認識不足
  • 診斷標準與早期治療
  • 有新作用機制的藥物
  • Nr-axSpA的認識

第7章 研究開發策略

  • 概要
  • 臨床實驗設計

第8章 開發平台評估

  • 概要
  • 臨床開發的潛力產品
  • 開發中的追加藥物

第9章 開發平台價值分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業性基準
  • 競爭評估
  • 主要國家的5年預測

第10章 附錄

目錄
Product Code: GDHC012EPOA

Ankylosing Spondylitis (AS) is an autoimmune disease that causes inflammation of the sacroiliac joint accompanied by pain and stiffness of the lower back, which typically gets better with exercise. Ankylosis (fusion) of the spine is typically a late-stage complication and has been nicknamed "bamboo spine", due to its appearance on X-ray. It is now recognized that the pathological changes leading to ankylosis develop over time, and an early stage of the disease, known as non-radiographic axial spondyloarthritis (nr-axSpA) is characterized by the same symptoms of inflammatory back pain without radiographic changes observed by X-ray. Together, AS and nr-axSpA are known as axial spondyloarthritis (axSpA). AS and nr-axSpA affect roughly 1.3 million and 700,000 individuals, respectively, in the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) covered in this report and the prevalence is expected to grow mainly due to changes in diagnosis rates. The anti-TNFs have been effective in treating the signs and symptoms of axSpA, however, there is a lack of effective therapeutic classes, and no treatment options for patients who have failed anti-TNF therapy, representing a key unmet need and opportunities for drug developers.

Highlights

Key Questions Answered

  • What are the preferred anti-TNFs for and how will competition from pipeline agents and biosimilars affect sales? Are rheumatologists across the 7MM expected to prescribe biosimlars for axSpA?
  • Will there be strong uptake of pipeline agents and how will Novartis's Cosentyx, J&J's Stelara, and Celgene's Otezla be used in the clinic?
  • According to key opinion leaders (KOLs), what are the most important unmet needs in axSpA? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2024?
  • How will disease awareness change over the forecast period and will this affect diagnosis?
  • How is non-radiographic axial spondyloarthritis (nr-axSpA) treated and will the diagnosis and treatment change over the next decade? Which drugs are expected to gain label expansions into nr-axSpA?

Key Findings

  • Increased diagnosis and treatment are key drivers in the axSpA market.
  • Novartis's Cosentyx and J&J's Stelara will address the unmet need for drugs with novel MOAs and pose a threat to anti-TNFs, which are currently the only therapeutic class beyond NSAIDs.
  • Label expansions into AS and nr-axSpA are expected to be an increasingly popular life-cycle management strategy for pharmaceutical companies developing drugs that target the immune system.
  • Biosimilars are expected to change the landscape for axSpA and will create pricing pressure in the market.

Scope

  • Overview of axial spondyloarthritis (axSpA), including etiology, pathophysiology, symptoms, and current treatment recommendations.
  • Annualized axSpA market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024, segmented by ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, clinical trial design, and implications for the axSpA market for branded drugs and biosimilars.
  • Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically Novartis's IL-17 inhibitor, Cosentyx; J&J's IL-12/IL-23 inhibitor, Stelara; Celgene's novel PDE4 inhibitor, Otezla; and biosimilars.
  • Analysis of the current and future market competition in the global axSpA market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies for both AS and nr-axSpA . Insightful review of the key industry drivers, restraints and challenges.

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.
  • Develop business strategies by understanding the trends shaping and driving the axSpA market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global axSpA market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 axSpA 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
  • 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. Ankylosing Spondylitis
    • 3.2.2. Non-radiographic Axial Spondyloarthritis

4. Epidemiology

  • 4.1. Risk Factors and Comorbidities
  • 4.2. Global Trends
    • 4.2.1. US
    • 4.2.2. 5EU
    • 4.2.3. Japan
  • 4.3. Forecast Methodology
    • 4.3.1. Sources Used for Diagnosed Prevalence of AS
    • 4.3.2. Sources Used for Diagnosed Prevalence of Nr-axSpA
    • 4.3.3. Sources Used for the Prevalence of HLA-B27 Seropositivity in Diagnosed AS
    • 4.3.4. Sources Not Used
    • 4.3.5. Forecast Assumptions and Methods, Diagnosed Prevalent Cases of AS - Base Scenario
    • 4.3.6. Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Nr-axSpA - Base Scenario
    • 4.3.7. Forecast Assumptions and Methods, HLA-B27 Seropositivity in Diagnosed AS
    • 4.3.8. Forecast Assumptions and Methods, Diagnosed Prevalent Cases of AS - Alternative Scenario
    • 4.3.9. Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Nr-axSpA - Alternative Scenario
  • 4.4. Epidemiological Forecast for AS (2014-2024) - Base Scenario
    • 4.4.1. Diagnosed Prevalent Cases of AS
    • 4.4.2. Age-Specific Diagnosed Prevalent Cases of Ankylosing Spondylitis
    • 4.4.3. Sex-Specific Diagnosed Prevalent Cases of AS
    • 4.4.4. Age-Standardized Diagnosed Prevalence of AS
    • 4.4.5. Diagnosed Prevalent Cases of Nr-axSpA
    • 4.4.6. Prevalent Cases of HLA-B27 Seropositivity in Diagnosed AS Cases
  • 4.5. Epidemiological Forecast for AS (2014-2024) - Alternative Scenario
    • 4.5.1. Diagnosed Prevalent Cases of AS
    • 4.5.2. Diagnosed Prevalent Cases of Nr-axSpA
  • 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
  • 5.2. Product Profiles - Major Brands
    • 5.2.1. Enbrel (etanercept)
    • 5.2.2. Humira (adalimumab)
    • 5.2.3. Remicade (infliximab)
    • 5.2.4. Simponi (golimumab)
    • 5.2.5. Cimzia (certolizumab pegol)
    • 5.2.6. NSAIDs
    • 5.2.7. Biosimilars
    • 5.2.8. Other Therapies

6. Unmet Needs Assessment and Oppportunity Analysis

  • 6.1. Overview
  • 6.2. Lack of Awareness
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Standardization of Diagnosis and Early Treatment
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Drugs With Novel MOAs
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Recognition of Nr-axSpA
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Life-Cycle Management Strategies: Expansion from Key Autoimmune Indications
    • 7.1.2. Life-Cycle Management Strategies: Expansion into Nr-axSpA
    • 7.1.3. Development of New Formulations and Drug Delivery Methods
  • 7.2. Clinical Trial Design
    • 7.2.1. Ankylosing Spondylitis
    • 7.2.2. Non-radiographic Axial Spondyloarthritis
    • 7.2.3. Future Clinical Trials

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Cosentyx (Secukinumab)
    • 8.2.2. Stelara (ustekinumab)
    • 8.2.3. Otezla (apremilast)
  • 8.3. Additional Drugs in Development for AS

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmarking 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. Abbreviations
  • 10.2. Bibliography
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. 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
    • 10.4.7. Generic Erosion
    • 10.4.8. Pricing of Pipeline agents
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Author
    • 10.7.2. Therapy Area Director
    • 10.7.3. Epidemiologist
    • 10.7.4. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Clinical History Screening for AS
  • Table 2: Symptoms of AS
  • Table 3: Diagnostic Criteria for AS and Nr-axSpA
  • Table 4: Risk Factors and Comorbidities for AS
  • Table 5: Summary of the Global Reported Prevalence of AS
  • Table 6: Incidence of AS, Cases per 100,000 Population, 1935-1973, Rochester, Minnesota, US
  • Table 7: Annual Incidence of AS, Cases per 100,000 Population, 1980-1990, Finland
  • Table 8: 7MM, Sources of Diagnosed Prevalence Data for AS used in the Epidemiology Forecast
  • Table 9: 7MM, Sources of Diagnosed Prevalence Data for Nr-axSpA used in the Epidemiology Forecast
  • Table 10: 7MM, Sources of HLA-B27 Seropositivity Data in Diagnosed AS Cases used in the Epidemiology Forecast
  • Table 11: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ≥15 Years, Select Years, N, 2014-2024
  • Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of AS, Both Sexes, N (Row %), 2014
  • Table 13: 7MM, Sex-Specific Diagnosed Prevalent Cases of Ankylosing Spondylitis, Ages ≥15 Years, N (Row %), 2014
  • Table 14: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ≥15 Years, Select Years, N, 2014-2024
  • Table 15: 5EU and Japan, Prevalent Cases of HLA-B27 Seropositivity in Diagnosed AS Cases, Both Sexes, Ages ≥15 Years, Select Years, N, 2014-2024
  • Table 16: 5EU and Japan, HLA-B27 and Non-HLA-B27 Seropositivity Status Among Diagnosed AS Cases, Both Sexes, Ages ≥15 Years, N, 2014
  • Table 17: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ≥15 Years, Select Years, N, 2014-2024
  • Table 18: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ≥15 Years, Select Years, N, 2014-2024
  • Table 19: Leading Treatments for Ankylosing Spondylitis, 2015
  • Table 20: Drug Approvals for AS and Nr-axSpA Across the 7MM, July 2015
  • Table 21: Product Profile - Enbrel
  • Table 22: Enbrel SWOT Analysis, 2015
  • Table 23: Product Profile - Humira
  • Table 24: Humira SWOT Analysis, 2015
  • Table 25: Product Profile - Remicade
  • Table 26: Safety of Remicade in AS - the ASSERT trial
  • Table 27: Remicade SWOT Analysis, 2015
  • Table 28: Product Profile - Simponi
  • Table 29: Efficacy of Simponi in AS - the GO-RAISE Trial, Week 104
  • Table 30: Safety of Simponi in AS - the GO-RAISE Trial, Week 104
  • Table 31: Simponi SWOT Analysis, 2015
  • Table 32: Product Profile - Cimzia
  • Table 33: Safety of Cimzia in axSpA - the RAPID-axSpA Trial, Week 24
  • Table 34: Cimzia SWOT Analysis, 2015
  • Table 35: Product Profile - NSAIDs
  • Table 36: Evidence for a Disease-Modifying Effect of NSAIDs in axSpA
  • Table 37: NSAIDs SWOT Analysis, 2015
  • Table 38: Biosimilars Pipeline for axSpA, 2015
  • Table 39: Physician Uptake of Biosimilar Products for axSpA Across the 7MM, 2015
  • Table 40: Summary of Minor Therapeutic Drug Classes Used to Treat AS/Nr-axSpA, 2015
  • Table 41: Unmet Need and Opportunity in axSpA, 2015
  • Table 42: Modified New York Criteria for AS
  • Table 43: Criteria for AS Disease Activity
  • Table 44: Instruments Used for AS Clinical Trial Endpoints
  • Table 45: Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
  • Table 46: ASAS Criteria for axSpA
  • Table 47: Ankylosing Spondylitis - Late Stage Pipeline, July 2015
  • Table 48: Product Profile - Cosentyx
  • Table 49: Cosentyx Phase III Trial, MEASURE1: Week 16
  • Table 50: Cosentyx SWOT Analysis, 2015
  • Table 51: Product Profile - Stelara
  • Table 52: Stelara Phase II Trial, TOPAS: Week 24
  • Table 53: Stelara SWOT Analysis, 2015
  • Table 54: Product Profile - Otezla
  • Table 55: Otezla SWOT Analysis, 2015
  • Table 56: Early-Stage Pipeline Products in AS, May 2015
  • Table 57: Clinical Benchmark of Key Pipeline Drugs for Ankylosing Spondylitis
  • Table 58: Commercial Benchmark of Key Pipeline Drugs for Ankylosing Spondylitis
  • Table 59: Top-Line Sales Forecasts ($m) for axSpA, 2014-2024
  • Table 60: Top-Line Sales Forecasts ($m) by Indication, 2014-2024
  • Table 61: Key Events Impacting Sales for axSpA, 2014-2024
  • Table 62: Global AS/nr-axSpA Disease Market - Drivers and Barriers, 2014-2024
  • Table 63: Key Launch Dates
  • Table 64: Key Patent Expiries
  • Table 65: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country

List of Figures

  • Figure 1: Enthesitis and the Pathogenesis of Spondyloarthritis
  • Figure 2: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ≥15 Years, N, 2014-2024
  • Figure 3: 7MM, Age-Specific Diagnosed Prevalent Cases of AS, Both Sexes, N, 2014
  • Figure 4: 7MM, Sex-Specific Diagnosed Prevalent Cases of AS, Ages ≥15 Years, N, 2014
  • Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of AS, Cases per 100,000 Population, Men and Women, 2014
  • Figure 6: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ≥15 Years, N, 2014-2024
  • Figure 7: 5EU and Japan, Prevalent Cases of HLA-B27 Seropositivity in Diagnosed AS Cases, Both Sexes, Ages ≥15 Years, N, 2014-2024
  • Figure 8: 5EU and Japan, HLA-B27 and Non-HLA-B27 Seropositivity Status Among Diagnosed AS Cases, Both Sexes, Ages ≥15 Years, N, 2014
  • Figure 9: 7MM, Diagnosed Prevalent Cases of AS, Both Sexes, Ages ≥15 Years, N, 2014-2024
  • Figure 10: 7MM, Diagnosed Prevalent Cases of Nr-axSpA, Both Sexes, Ages ≥15 Years, N, 2014-2024
  • Figure 11: Biosimilar Prescribing Habits in axSpA Across the 7MM, 2015
  • Figure 12: Competitive Assessment of AS Pipeline Therapies, 2014-2024
  • Figure 13: Global Sales for axSpA by Region, 2014-2024
  • Figure 14: Global Sales for axSpA by Indication, 2014-2024
Back to Top