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市場調查報告書

到2020年的類風濕性關節炎治療藥市場:市場於飽和狀態平靜成長

Rheumatoid Arthritis Market to 2020 - A Crowded Market Characterized by Modest Growth

出版商 GBI Research 商品編碼 326289
出版日期 內容資訊 英文 139 Pages
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到2020年的類風濕性關節炎治療藥市場:市場於飽和狀態平靜成長 Rheumatoid Arthritis Market to 2020 - A Crowded Market Characterized by Modest Growth
出版日期: 2014年12月31日 內容資訊: 英文 139 Pages
簡介

緩解疾病抗風濕藥 (DMARDs) 市場,從2013年的566億美元,2020年擴大到807億美元規模,預計以年複合成長率5.2%成長。

本報告提供類風濕性關節炎治療藥市場相關調查分析、市場概要、上市產品、開發中產品、市場預測、交易和策略性整合等相關的系統性資訊。

第1章 目錄

第2章 簡介

  • 疾病概要
  • 症狀
  • 病因
  • 病理生理學
  • 診斷
  • 流行病學
  • 共生病症和併發症
  • 疾病的進展
  • 藥物療法研究
  • 治療的選項
  • 其他非生技藥品
  • 生物學的緩解疾病抗風濕藥
  • 測量治療效果的疾病評分法

第3章 上市產品

  • 概要
  • 小分子緩解疾病抗風濕藥
  • 生物學的緩解疾病抗風濕藥
  • 未滿足需求

第4章 開發平台形勢

  • 概要
  • 開發平台分佈:各開發階段、分子類型、給藥途徑、新穎性
  • 開發平台分佈:各作用機制

第5章 臨床試驗分析

第6章 市場預測

  • 地區市場
  • 全球市場
  • 北美
  • 歐洲主要5個國家
  • 日本
  • 推動因素與阻礙

第7章 交易與策略性整合

  • 許可證
  • 共同開發

第8章 附錄

圖表

目錄
Product Code: GBIHC354MR

Executive Summary

Increasingly Crowded Market for Second-Line Therapies Improving Treatment Options for Moderate-to-Severe Rheumatoid Arthritis Patients

Rheumatoid Arthritis (RA) is a chronic, progressive and currently incurable autoimmune disease that primarily affects joints. It is characterized by synovial inflammation and gradual bone erosion over many years, and disease progression results in stiffness and pain, especially in the hands and feet, which hinders patient mobility. Without treatment, the disease leads to joint destruction and disability. Prior to 1998, treatment options were limited to small-molecule disease-modifying therapies, such as Methotrexate (MTX), sulfasalazine and anti-malarials. However, while MTX is efficacious in controlling RA symptoms in a large percentage of patients, approximately 33% are unresponsive to these first-line drugs. The approval of revolutionary biological therapies, including Enbrel, Remicade and Humira, for the treatment of RA patients that are refractory to MTX has triggered unparalleled growth in the market. Globally, there are at least 12 biological therapies, including monoclonal antibodies (mAb), biosimilars and therapeutic proteins, competing as second-line therapies for this sub-population. Over the past 16 years, the therapeutic market for RA has become extremely competitive as a result of the high number of new drug approvals. Competition for Tumor Necrosis Factor Alpha (TNF-a) inhibitors is particularly fierce, and now dominates the treatment market for RA patients who are refractory to first-line Disease Modifying Anti-Rheumatic Drugs (DMARD). In 2013, three TNF-a targeting mAbs, Humira (adalimumab), Remicade (infliximab) and Enbrel (etanercept), were ranked among the top-10 best-selling drugs in the world, with global revenues of $11.1 billion, $9.9 billion and $8.9 billion respectively, reflecting their groundbreaking clinical and commercial success. Despite this, 30% of RA patients fail to achieve clinical responses when treated with TNF-a inhibitors (Rubbert-Roth and Finckh, 2009). However, patients who are unresponsive to TNF-a inhibitors can also be medicated with the cytokine modulators Rituxan and Xeljanz. Thus, the extensive range of available therapies is addressing the need for efficacious therapies for a broad spectrum of RA patients.

Modest Rate of Market Growth Expected between 2013 and 2020

The market for disease-modifying RA therapeutics is expected to increase from $56.6 billion in 2013 to $80.7 billion in 2020, at a Compound Annual Growth Rate (CAGR) of 5.2%. First-line DMARDs are expected to remain stagnant, as the late-stage pipeline predominantly constitutes second-line therapies. The high number of clinically and commercially strong products in the current market represents a barrier for the market infiltration of such emerging therapies. In the EU market, the patent expiration of blockbuster drugs from 2015 is expected to cause a strong uptake of biosimilars. However, uncertainty over the regulatory guidelines that govern the approval pathway of biosimilars into the US, the largest RA market across the eight key territories, may not measurably affect the pricing of the currently marketed drugs.

Scope

The report covers and includes -

  • A brief introduction to RA, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
  • Detailed analysis of the drugs currently marketed for this indication: MTX, Remicade, Humira, Enbrel, Rituxan, Orencia, Simponi, Cimzia and Xeljanz, including key characteristics such as safety and efficacy, clinical trial outcomes, tolerability, dosing, administration, historical sales, price, and overall competitive strength, as well as a comprehensive heat map comparison
  • Detailed analysis of the pipeline for RA by stage of development, molecule type, program type, mechanism of action, and molecular target, as well as analysis of recent clinical trials by enrollment, duration, failure rate, and promising late-stage pipeline molecules
  • Forecasts for the RA market, including epidemiology, treatment usage pattern, pricing, and market size for the 2013-2020 period, for which data are presented at country level with further analysis of key market drivers and barriers
  • Major deals that have taken place in the global RA market since 2006, analyzing licensing and co-development agreements by stage of development, year, molecule type, mechanism of action and value; network graphs of these deals are also included

Reasons to buy

  • Primarily, the report will allow clients to gain a strong understanding of RA, helping to identify and clarify market opportunities and the competitive environment. It will also allow you to -
  • Understand the RA pipeline and the key trends in the current product development landscape
  • Observe detailed profiles for the promising pipeline products, including revenue forecasts, and gain an insight into how they are likely to compete in the market, and what their main competitors will be
  • Follow the trends in RA clinical trial size and duration in relation to industry averages and assess the potential risk of future developmental programs for RA therapeutics, depending on the mechanism of action, by considering the recorded clinical trial failure rates
  • Observe the potential growth patterns expected for the RA market over the forecast period, and identify which countries are expected to make the biggest contribution to this growth

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. Etiology
  • 2.4. Pathophysiology
  • 2.5. Diagnosis
    • 2.5.1. Physical Examination
    • 2.5.2. Blood Tests
    • 2.5.3. 1987 Rheumatoid Arthritis Classification
    • 2.5.4. The 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis
  • 2.6. Epidemiology
  • 2.7. Co-morbidities and Complications
  • 2.8. Disease Progression
  • 2.9. Pharmacotherapy Algorithm
  • 2.10. Treatment Options
    • 2.10.1. Pharmacological
    • 2.10.2. Methotrexate
    • 2.10.3. Plaquenil (hydroxychloroquine)
    • 2.10.4. Arava (leflunomide)
    • 2.10.5. Azulfidine, Salazopyrin (sulfasalazine)
    • 2.10.6. Neoral (cyclosporine)
    • 2.10.7. Prograf (tacrolimus)
    • 2.10.8. Xeljanz (tofacitinib)
  • 2.11. Other Non-biologics
    • 2.11.1. Non-steroidal Anti-inflammatory Drugs
    • 2.11.2. Painkillers
    • 2.11.3. Glucocorticoids
  • 2.12. Biologic Disease-Modifying Anti-rheumatic Drugs
    • 2.12.1. Tumor Necrosis Factor Alpha Inhibitors
    • 2.12.2. Interleukin Inhibitors
    • 2.12.3. Other Biologics that Target B- and T-Cell Antigens
  • 2.13. Disease Scoring Methods for Measuring Treatment Efficacy
    • 2.13.1. Radiographic Progression
    • 2.13.2. Clinical Disease Activity Index and Simplified Disease Activity Index
    • 2.13.3. Disease Activity Score-28
    • 2.13.4. American College of Rheumatology
    • 2.13.5. Health Assessment Questionnaire

3. Marketed Products

  • 3.1. Overview
  • 3.2. Small-Molecule Disease-Modifying Anti-rheumatic Drugs
    • 3.2.1. Methotrexate-Based Products
    • 3.2.2. Xeljanz (tofacitinib) - Pfizer
  • 3.3. Biologic Disease-Modifying Anti-rheumatic Drugs
    • 3.3.1. Remicade (infliximab) - Johnson and Johnson, Merck
    • 3.3.2. Remsima - infliximab biosimilar
    • 3.3.3. Humira (adalimumab) - Abbvie
    • 3.3.4. Enbrel (etanercept) - Amgen, Pfizer and Takeda Pharmaceutical
    • 3.3.5. Rituxan (rituximab) - Genentech (Roche), Biogen IDEC
    • 3.3.6. Reditux (Non-comparable Biologic of Rituxan)
    • 3.3.7. AcellBia (rituximab biosimilar)
    • 3.3.8. Orencia (abatacept) - Bristol-Myers Squibb
    • 3.3.9. Simponi (golimumab) - Johnson and Johnson, Merck
    • 3.3.10. Cimzia (certolizumab pegol) - UCB
    • 3.3.11. Kineret (anakinra) - Swedish Orphan Biovitrum
    • 3.3.12. Actemra (tocilizumab) - Roche
    • 3.3.13. Comparative Safety and Efficacy
  • 3.4. Unmet Need

4. Pipeline Landscape

  • 4.1. Overview
  • 4.2. Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty
  • 4.3. Pipeline Distribution by Mechanism of Action
    • 4.3.1. Cytokine Inhibitors
    • 4.3.2. B- and T-cells
    • 4.3.3. Intracellular kinases

5. Clinical Trial Analysis

  • 5.1. Overall Attrition Rate
  • 5.2. Attrition Rate by Phase, Molecule Type and Method of Administration
  • 5.3. Average Clinical Trial Size by Molecule Type
  • 5.4. Average Clinical Trial Size by Mechanism of Action
  • 5.5. Average Clinical Trial Duration per Molecule Type by Product
  • 5.6. Average Clinical Trial Duration per Mechanism of Action by Product
  • 5.7. Primary and Secondary End Points
  • 5.8. Summary
  • 5.9. Promising Pipeline Drugs
    • 5.9.1. Phase III Programs
    • 5.9.2. Phase II Programs
  • 5.10. Comparative Heat Map

6. Market Forecasts to 2020

  • 6.1. Geographical Markets
  • 6.2. Global Market
    • 6.2.1. Treatment Usage Patterns
    • 6.2.2. Market Size
  • 6.3. North America
    • 6.3.1. Treatment Usage Patterns
    • 6.3.2. Annual Cost of Therapy
    • 6.3.3. Market Size
  • 6.4. Top-Five EU Markets
    • 6.4.1. Treatment Usage Patterns
    • 6.4.2. Annual Cost of Therapy
    • 6.4.3. Market Size
  • 6.5. Japan
    • 6.5.1. Treatment Usage Patterns
    • 6.5.2. Annual Cost of Therapy
    • 6.5.3. Market Size
  • 6.6. Drivers and Barriers of Rheumatoid Arthritis Therapeutic Market
    • 6.6.1. Drivers
    • 6.6.2. Barriers

7. Deals and Strategic Consolidations

  • 7.1. Licensing agreements
    • 7.1.1. Deal Values by Therapeutic Molecule Types
    • 7.1.2. Deal Values by Therapeutic mechanism of administration
    • 7.1.3. AstraZeneca Enters into Licensing Agreement with Rigel Pharma for fostamatinib disodium
    • 7.1.4. Alder Biopharmaceuticals Enters into Licensing Deal with Bristol-Myers Squibb Company Alder Biopharmaceuticals for Clazakizumab
    • 7.1.5. Janssen Biotech enters into a licensing deal with Astellas Pharma for Peficitinib
    • 7.1.6. Ablynx enters into a licensing deal with Abbvie for the Nanobody ALX-006
  • 7.2. Co-development
    • 7.2.1. Deal Values by Therapeutic Molecule Types and Phase
    • 7.2.2. Deal Values by Therapeutic mechanism of administration and Phase
    • 7.2.3. GlaxoSmithKline enters into Global Agreement with Archemix
    • 7.2.4. Abbott Laboratories Enters into Global Collaboration with Galapagos for filgotinib
    • 7.2.5. Chroma Therapeutics Enters into a Co-development Agreement with GlaxoSmithKline

8. Appendix

  • 8.1. All Pipeline Drugs by Phase of Development
    • 8.1.1. Discovery
    • 8.1.2. Preclinical
    • 8.1.3. IND-CTA Filed
    • 8.1.4. Phase I
    • 8.1.5. Phase II
    • 8.1.6. Phase III
  • 8.2. Market Forecasts to 2020
  • 8.3. Abbreviations
  • 8.4. References
    • 8.4.1. References for Error! Reference source not found.
    • 8.4.2. References for Figure 32
  • 8.5. Research Methodology
    • 8.5.1. Secondary Research
    • 8.5.2. Marketed Product Profiles
    • 8.5.3. Late-Stage Pipeline Candidates
    • 8.5.4. Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
    • 8.5.5. Pipeline Analysis
    • 8.5.6. Forecasting Model
    • 8.5.7. Deals Data Analysis
  • 8.6. Contact Us
  • 8.7. Disclaimer

List of Tables

  • Table 1: 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis
  • Table 2: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Discovery Phase, 2014
  • Table 3: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014
  • Table 4: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, IND/CTA-Filed Phase, 2014
  • Table 5: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Phase I, 2014
  • Table 6: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Phase II, 2014
  • Table 7: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Phase III, 2014
  • Table 8: Rheumatoid Arthritis, Therapeutics Market, Global, Market Forecast, 2013-2020
  • Table 9: Rheumatoid Arthritis, Therapeutics Market, US, Market Forecast, 2013-2020
  • Table 10: Rheumatoid Arthritis, Therapeutics Market, Canada, Market Forecast, 2013-2020
  • Table 11: Rheumatoid Arthritis, Therapeutics Market, UK, Market Forecast, 2013-2020
  • Table 12: Rheumatoid Arthritis, Therapeutics Market, Germany, Market Forecast, 2013-2020
  • Table 13: Rheumatoid Arthritis, Therapeutics Market, France, Market Forecast, 2013-2020
  • Table 14: Rheumatoid Arthritis, Therapeutics Market, Italy, Market Forecast, 2013-2020
  • Table 15: Rheumatoid Arthritis, Therapeutics Market, Spain, Market Forecast, 2013-2020
  • Table 16: Rheumatoid Arthritis, Therapeutics Market, Japan, Market Forecast, 2013-2020
  • Table 17: Abbreviations

List of Figures

  • Figure 1: American College of Rheumatology Treatment Guidelines, 2012
  • Figure 2: Rheumatoid Arthritis Market, Global, Annual Sales of Remicade ($bn), 2008-2013
  • Figure 3: Rheumatoid Arthritis Market, Global, Annual Sales of Humira ($bn), 2008-2013
  • Figure 4: Rheumatoid Arthritis Market, Global, Annual Sales of Enbrel ($bn), 2008-2013
  • Figure 5: Rheumatoid Arthritis Market, Global, Annual Sales of Rituxan ($bn), 2008-2013
  • Figure 6: Rheumatoid Arthritis Market, Global, Annual Sales of Orencia ($m), 2008-2013
  • Figure 7: Rheumatoid Arthritis Market, Global, Annual Sales of Simponi ($m), 2008-2013
  • Figure 8: Rheumatoid Arthritis Market, Global, Annual Sales of Cimzia ($m), 2008-2013
  • Figure 9: Rheumatoid Arthritis Market, Global, Annual Sales of Actemra ($m), 2008-2013
  • Figure 10: Comparative Efficacy and Safety of Marketed Products
  • Figure 11: Rheumatoid Arthritis Market, Global, Pipeline, 2014
  • Figure 12: Rheumatoid Arthritis Market, Global, Pipeline by Mechanism of Action, 2014
  • Figure 13: Rheumatoid Arthritis Market, Global, Pipeline, Cytokine Inhibitors, 2014
  • Figure 14: Rheumatoid Arthritis Market, Global, Pipeline, Inhibitors of B and T cells, 2014
  • Figure 15: Rheumatoid Arthritis Market, Global, Pipeline, Intracellular Kinase Inhibitors, 2014
  • Figure 16: Rheumatoid Arthritis, Global, Clinical Trial Failure Rate, 2006-2014
  • Figure 17: Rheumatoid Arthritis, Global, Clinical Trial Failure Rate, 2006-2014
  • Figure 18: Rheumatoid Arthritis, Global, Clinical Trial Failure Rate, 2006-2014
  • Figure 19: Rheumatoid Arthritis Market, Global, Pipeline, Recruitment Size by Molecule Type by Product, 2006-2014
  • Figure 20: Rheumatoid Arthritis Market, Global, Pipeline, Recruitment Size by Molecule Type by Trial, 2006-2014
  • Figure 21: Rheumatoid Arthritis Market, Global, Pipeline, Recruitment Size by Mechanism of Action by Product, 2006-2014
  • Figure 22: Rheumatoid Arthritis Market, Global, Pipeline, Recruitment Size by Mechanism of Action by Trial, 2006-2014
  • Figure 23: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Duration by Molecule Type by Product (months), 2006-2014
  • Figure 24: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Duration by Mechanism of Action by Product (months), 2006-2014
  • Figure 25: Rheumatoid Arthritis Market, Global, Frequency of Primary End points Measured in Clinical Trials, 2006-2014
  • Figure 26: Rheumatoid Arthritis Market, Global, Sales Projection of Baricitinib, 2016-2020
  • Figure 27: Rheumatoid Arthritis Market, Global, Sales Projection of BOW-015, 2015-2020
  • Figure 28: Rheumatoid Arthritis Market, Global, Sales Projection of TuNEX, 2016-2020
  • Figure 29: Rheumatoid Arthritis Market, Global, Sales Projection of Sarilumab, 2015-2020
  • Figure 30: Rheumatoid Arthritis Market, Global, Sales Projection of Secukinumab, 2015-2020
  • Figure 31: Rheumatoid Arthritis Market, Global, Sales Projection of Sirukumab, 2017-2020
  • Figure 32: Comparative Efficacy and Safety of Pipeline Programs
  • Figure 33: Rheumatoid Market, Global, Market Size, 2013-2020
  • Figure 34: Rheumatoid Market, Global, Market Size, 2013-2020
  • Figure 35: Rheumatoid Market, North America, Treatment Usage Patterns, 2013-2020
  • Figure 36: Rheumatoid Market, North America, Annual Cost of Therapy, 2013-2020
  • Figure 37: Rheumatoid Market, North America, Market Size, 2013-2020
  • Figure 38: Rheumatoid Market, Five EU Countries, Treatment Usage Patterns, 2013-2020
  • Figure 39: Rheumatoid Market, Five EU Countries, Annual Cost of Therapy, 2013-2020
  • Figure 40: Rheumatoid Market, Five EU Countries, Market Size, 2013-2020
  • Figure 41: Rheumatoid Market, Japan, Treatment Usage Patterns, 2013-2020
  • Figure 42: Rheumatoid Market, Japan, Annual Cost of Therapy, 2013-2020
  • Figure 43: Rheumatoid Market, Japan, Market Size, 2013-2020
  • Figure 44: Rheumatoid Arthritis Market, Global, Licensing Deals, 2006-2014
  • Figure 45: Rheumatoid Arthritis Market, Global, Licensing Deals, 2006-2014
  • Figure 46: Rheumatoid Arthritis Market, Global, Licensing Deals, 2006-2014
  • Figure 47: Rheumatoid Arthritis Market, Global, Co-development Deals, 2006-2014
  • Figure 48: Rheumatoid Arthritis Market, Global, Co-development Deals, 2006-2014
  • Figure 49: Rheumatoid Arthritis Market, Global, Co-development Deals, 2006-2014
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