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市場調查報告書

主要已開發國家的胰臟腺癌症治療藥市場:初期階段的開發中產品的廣泛新目標及實際影響度的極限

Pancreatic Adenocarcinoma Therapeutics in Major Developed Markets to 2019 - Early Stage Pipeline Shows Diversity of Novel Targets though Commercial Impact Remains Distant

出版商 GBI Research 商品編碼 299448
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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主要已開發國家的胰臟腺癌症治療藥市場:初期階段的開發中產品的廣泛新目標及實際影響度的極限 Pancreatic Adenocarcinoma Therapeutics in Major Developed Markets to 2019 - Early Stage Pipeline Shows Diversity of Novel Targets though Commercial Impact Remains Distant
出版日期: 2014年04月14日 內容資訊: 英文
簡介

全球的胰臟腺癌症治療藥市場,2012年達到8億5600萬美元,預計2019年達到12億美元的規模。在各種領域累積小變化--新藥的認證,得病率的上升,及診斷方法的改善,接受藥物治療患者數的增加結果等--為市場成長的要素。

本報告提供全球主要已開發國家(美國、英國、法國、德國、義大利、西班牙、日本、加拿大)的胰臟腺癌症治療藥的市場相關分析、疾病概要和目前主要治療方法、現在已上市、臨床實驗中主要的治療藥的概要與臨床實驗的進展、全球及各國的市場趨勢預測(今後7年份)、主要的推動及阻礙市場要素、市場最新趨勢(資本交易、共同開發等)、今後的市場方向性等調查,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

  • 疾病概要:胰臟腺癌症
  • 流行病學
    • 遺傳性疾病
    • 體細胞突然變異
  • 症狀
  • 風險要素
    • 抽煙
    • 胰炎與其他疾病
    • 肥胖
    • 感染疾病
  • 診斷
  • 治療流程
    • 外科手術
    • 放射治療
    • 化療
    • 胰臟癌症的化療研究

第3章 已上市產品

  • 已認證產品
    • Gemcitabine
    • IV Fluorouracil
    • Tarceva
    • Abraxane
    • Teysuno/TS-1
  • 非標籤藥物(保險不適用)產品
    • Xeloda
    • Eloxatin
  • 已上市產品相關的議論

第4章 產品平台

  • 開發平台概要
  • 各相(階段)、投藥法、分子類型、目標分子的平台概要
  • 藥物開發的主要趨勢:胰臟癌症開發平台相關
    • 藥物遞輸的改善
    • 標靶治療
    • 免疫疾病療法
  • 臨床實驗的期間、規模
  • 臨床實驗的失敗率
  • 臨床實驗相關討論
  • 開發平台上的有前途的候補藥
    • Masivet/Kinavet (US)(AB Science)
    • Glufosfamide(Eleison Pharmaceuticals Incorporated)
    • Tertomotide(Kael-GemVax Co., Ltd)
    • TH-302(Threshold Pharmaceuticals)
    • HyperAcute Pancreas(NewLink Genetics Corporation)
    • MM-398(Merrimack Pharmaceuticals Inc.)
  • 開發平台相關討論

第5章 市場預測

  • 簡介
  • 全球市場
  • 北美
    • 治療藥的使用模式
    • 年度治療費用
    • 市場規模
  • 歐洲主要5個國家
  • 日本
  • 推動及阻礙市場要素
    • 推動市場要素
    • 阻礙市場要素

第6章 資本交易

  • 授權合約(共4件)
  • 共同開發契約(1件)

第7章 附錄

圖表一覽

目錄
Product Code: GBIHC327MR

GBI Research, the leading business intelligence provider, has released its latest research,‘Pancreatic Adenocarcinoma Therapeutics in Major Developed Markets to 2019 - Early Stage Pipeline Shows Diversity of Novel Targets though Commercial Impact Remains Distant’, which provides in-depth analysis of pancreatic adenocarcinoma market within the eight major developed markets of the US, UK, France, Germany, Italy, Spain, Japan and Canada. The report provides an estimation of the market size for 2012, along with market forecasts to 2019. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth analysis of the pipeline, and deal analysis.

The global pancreatic adenocarcinoma therapeutics market is expected to grow from approximately $856m in 2012 to $1.2 billion in 2019, with growth driven by small changes in multiple factors. These include the impact of the drugs approved in the forecast period, but also the increase in the prevalence of the disease and minor improvements in diagnostics that result in more patients being eligible for pharmacological.

Scope

  • A brief introduction to pancreatic adenocarcinoma, including the disease's pathogenesis, risk factors, diagnosis, staging and treatment algorithms for each stage.
  • In-depth analysis of drugs available for the treatment of pancreatic adenocarcinoma, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map comparing the drugs in terms of safety and efficacy.
  • Comprehensive review of the pipeline for pancreatic adenocarcinoma therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets, program type.
  • Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action.
  • Multi-scenario forecast data of the market to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Japan, Germany, the UK, France, Italy and Spain.
  • Discussion of the drivers and barriers for market growth.
  • Discussion of the licensing and co-development deals landscape in pancreatic adenocarcinoma, Includes an analysis of licensing deals by stage of development, molecule type and mechanism of action. Also includes an analysis of both licensing and co-development deals by year and value and network maps of licensing and co-development deals.

Reasons to buy

  • Understand the vast scope and diversity of the pipeline, including which molecule types and mechanisms of action are prominent.
  • Observe the trends in clinical trial duration and size amongst clinical Phases, between molecule types and mechanisms of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for pancreatic adenocarcinoma therapeutics.
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the pancreatic adenocarcinoma therapeutics market.

Abstract

Poor Disease Prognosis Due to Lack of Effective Treatment Options

The current Pancreatic Cancer (PC) therapeutics market is very limited, with only four drugs approved for the treatment of the disease. These are the generics gemcitabine and fluorouracil (5-FU) and the patented drugs Tarceva, by Genentech and Roche, and Abraxane, by Celgene. Abraxane was approved by the US Food and Drug Administration (FDA) in September 2013 and by the European Medicines Agency (EMA) in January 2014 (FDA, 2013).

Since 1997, the standard of care in the treatment of advanced PC (approximately 80% of patients are diagnosed with advanced disease) has been gemcitabine therapy, either as a monotherapy or in combination. In combination, gemcitabine is often prescribed with off-label drugs that cause minor improvements in progression-free survival, and trends towards (although not statistically significant) OS - for example, Xeloda and Eloxatin. Either in combination or as a monotherapy, average Overall Survival (OS) with gemcitabine-based therapy is six months, while the five-year survival rate is less than 5%. The recently approved Abraxane has been shown, when in combination with gemcitabine, to increase OS to 8.5 months (Von Hoff et al, 2011). The FOLFIRINOX regimen, which uses a combination of folinic acid, 5-FU, irinotecan and oxaliplatin, has been shown to increase OS in advanced PC patients to 11 months, but only in those with a good performance status.

Even with Abraxane's and the FOLFIRINOX regimen's recent improvements in survival demonstrated with Abraxane and FOLFIRINOX, prognosis and survival chances are still substantially worse in PC than for other leading causes of cancer-related deaths, such as breast and lung cancer. There are noticeable gaps in treatment development, namely a lack of diagnostic tools and a lack of patient subset analysis and targeted therapies. As such, the marketed products are expected to remain dominated by gemcitabine and the off-label use of other chemotoxic agents, throughout the 2014-2020 forecast period.

Forecast Drug Approvals to Result in Limited Market Growth and Minimal Change in Disease Prognosis

GBI Research expects that three drugs will be approved in the forecast period: Threshold's TH-302, Merrimack's MM-398 and NewLink Genetic's HyperAcute Pancreas. TH-302 is indicated for the first-line treatment of patients with advanced PC. MM-398 is a second-line treatment in advanced PC patients that have failed prior gemcitabine therapy. HyperAcute Pancreas is an adjuvant therapy in combination with gemcitabine in patients with resectable early-stage disease. All of these drug candidates have demonstrated significant improvements in progression-free survival and OS in clinical trials, compared with gemcitabine monotherapy (or best standard of care in the case of MM-398). However, the market penetration and subsequent impact on revenues of each of these drugs is expected to be limited.

TH-302 has demonstrated a small increase in OS of 2.3 months, in comparison with gemcitabine monotherapy, but is estimated to cost between $8,000 and $15,000, depending on geography. The result is a high cost-to-benefit ratio, which GBI Research believes will limit its sales, particularly in Europe and Japan, where reimbursement agencies place significant emphasis on the cost-effectiveness of drugs. The main limitations for HyperAcute Pancreas and MM-398 will be cohort size as very few patients are eligible for surgical resection or second-line therapy.

In conclusion, the global PC therapeutics market is expected to grow from approximately $856m in 2012 to $1.2 billion in 2019, with growth driven by small changes in multiple factors. These include the impact of the drugs approved in the forecast period, but also the increase in the prevalence of the disease and minor improvements in diagnostics that result in more patients being eligible for pharmacological treatment.

Wealth of Novel Products and Attrition Rate of 77% Hoped to Deliver Successful Drug

The drugs expected to be approved in the forecast period are expected to have little impact on the PC market, with a continued need for more targeted therapies. Potential targeted therapies that have previously been analyzed in clinical trials include vascular endothelial growth factor receptors and epidermal growth factor receptors, but with limited success. Numerous novel targets are being analyzed in the current developmental pipeline, many of which have not been investigated in a clinical setting before. These include insulin-like growth factor receptors, members of the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) signaling pathway (KRAS is mutated in 90% of PCs) and signals leading to the development of a dense surrounding stroma, which is characteristic of pancreatic tumors. Such a high variation in molecular targets, the majority of which are in the Preclinical of the Phase I stage of development, and an attrition rate of 77% support the suggestion that there will be an influx of targeted therapies beyond the forecast period.

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Overview
    • 2.1.1. Pancreatic Neuroendocrine Tumors
  • 2.2. Pathophysiology
    • 2.2.1. Inherited Disease
    • 2.2.2. Somatic Mutations
  • 2.3. Signs and Symptoms
  • 2.4. Risk Factors
    • 2.4.1. Smoking
    • 2.4.2. Pancreatitis and Other Medical Conditions
    • 2.4.3. Obesity
    • 2.4.4. Infections
  • 2.5. Diagnosis
  • 2.6. Treatment Algorithm
    • 2.6.1. Surgery
    • 2.6.2. Radiation Therapy
    • 2.6.3. Chemotherapy
    • 2.6.4. Algorithm of Chemotherapeutic Treatment for Pancreatic Cancer

3. Marketed Products

  • 3.1. Approved Products
    • 3.1.1. Gemcitabine
    • 3.1.2. IV Fluorouracil
    • 3.1.3. Tarceva
    • 3.1.4. Abraxane
    • 3.1.5. Teysuno/TS-1
  • 3.2. Off-Label Products
    • 3.2.1. Xeloda
    • 3.2.2. Eloxatin
  • 3.3. Marketed Products - Discussion

4. Product Pipeline

  • 4.1. Pipeline Overview
  • 4.2. Overview of Pipeline by Phase, Route of Administration, Molecule Type and Molecular Target
  • 4.3. Key Trends in Drug Development within the Pancreatic Cancer Pipeline
    • 4.3.1. Enhancing Drug Delivery
    • 4.3.2. Targeted Therapies
    • 4.3.3. Immunotherapy
  • 4.4. Clinical Trial Duration and Size
  • 4.5. Clinical Trial Failure Rate
  • 4.6. Clinical Trial Discussion
  • 4.7. Promising Drug Candidates in Pipeline
    • 4.7.1. Masivet/Kinavet (US) - AB Science
    • 4.7.2. Glufosfamide - Eleison Pharmaceuticals Incorporated
    • 4.7.3. Tertomotide - Kael-GemVax Co., Ltd
    • 4.7.4. TH-302 - Threshold Pharmaceuticals
    • 4.7.5. HyperAcute Pancreas - NewLink Genetics Corporation
    • 4.7.6. MM-398 - Merrimack Pharmaceuticals Inc.
  • 4.8. Pipeline Discussion

5. Market Forecast

  • 5.1. Introduction
  • 5.2. Global Market
  • 5.3. North America
    • 5.3.1. Treatment Usage Patterns
    • 5.3.2. Annual Cost of Therapy
    • 5.3.3. Market Size
  • 5.4. Top Five European Countries
    • 5.4.1. Treatment Usage Patterns
  • 5.5. Annual Cost of Therapy
  • 5.6. Market Size
  • 5.7. Japan
    • 5.7.1. Treatment Usage Patterns
    • 5.7.2. Annual Cost of Therapy
    • 5.7.3. Market Size
  • 5.8. Drivers and Barriers
    • 5.8.1. Drivers
    • 5.8.2. Barriers

6. Deals

  • 6.1. Licensing Deals
    • 6.1.1. Clavis Enters Licensing and Development Agreement with Clovis
    • 6.1.2. Baxter Enters Licensing Agreement with Onconova for Rigosertib
    • 6.1.3. Lorus Therapeutics Enters Into Licensing Agreement with Zor Pharma
    • 6.1.4. Novogen Enters Into Licensing Agreement with Marshall Edwards For NV-196 And NV-143
  • 6.2. Co-Development Deals
    • 6.2.1. Merck Serono Enters Into Co-Development Agreement with Threshold Pharma for TH-302

7. Appendix

  • 7.1. All Pipeline Drugs by Phase
    • 7.1.1. Discovery
    • 7.1.2. Preclinical
    • 7.1.3. IND/CTA-Filed
    • 7.1.4. Phase I
    • 7.1.5. Phase II
    • 7.1.6. Phase III
    • 7.1.7. Pre-Registration
  • 7.2. Market Forecasts to 2019
    • 7.2.1. Global
    • 7.2.2. US
    • 7.2.3. Canada
    • 7.2.4. UK
    • 7.2.5. France
    • 7.2.6. Germany
    • 7.2.7. Italy
    • 7.2.8. Spain
    • 7.2.9. Japan
  • 7.3. Abbreviations
  • 7.4. References
  • 7.5. Methodology
  • 7.6. Secondary Research
  • 7.7. Contact Us
  • 7.8. Disclaimer

List of Tables

  • Table 1: Pancreatic Cancer Therapeutics, Inherited Cancer Syndromes Associated with an Increased Risk of Pancreatic Cancer
  • Table 2: Pancreatic Cancer Therapeutics, Common Mutations in Pancreatic Cancer
  • Table 3: Pancreatic Cancer Therapeutics, Tumor Staging in Pancreatic Cancer
  • Table 4: Pancreatic Cancer Therapeutics, ECOG Performance Status Scores and Description
  • Table 5: Pancreatic Cancer Therapeutics, Common Endpoints in Oncology Clinical Trials and their Description
  • Table 6: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy
  • Table 7: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy
  • Table 8: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Eloxatin
  • Table 9: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Cisplatin
  • Table 10: Pancreatic Cancer Therapeutics, Typical Dosing of Teysuno based on Body Surface Area (BSA) of Patient
  • Table 11: Pancreatic Cancer Therapeutics, Adverse Events Associated with Gemcitabine Monotherapy, Teysuno Monotherapy, and with their Combination
  • Table 12: Pancreatic Cancer Therapeutics, Improvements in Overall Survival with Gemcitabine Drug Combinations
  • Table 13: Pancreatic Cancer Therapeutics, Key Molecular Targets of the Developmental Pipeline
  • Table 14: Pancreatic Cancer Therapeutics, Global, Average Clinical Trial Duration (months)
  • Table 15: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Masivet
  • Table 16: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with TH-302
  • Table 17: Pancreatic Cancer Therapeutics, Top Five European Markets, Europe Age-Standardized Incidence Rates of Pancreatic Cancer, 2008
  • Table 18: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Discovery Phase
  • Table 19: Pancreatic Cancer Therapeutics, Developmental Pipeline, Preclinical Phase
  • Table 20: Pancreatic Cancer Therapeutics, Developmental Pipeline, IND/CTA-Filed Phase
  • Table 21: Pancreatic Cancer Therapeutics, Developmental Pipeline, Phase I
  • Table 22: Pancreatic Cancer Therapeutics, Developmental Pipeline, Phase II I
  • Table 23: Pancreatic Cancer Therapeutics, Developmental Pipeline, Phase III
  • Table 24: Pancreatic Cancer Therapeutics, Global, Developmental Pipeline, Pre-Registration
  • Table 25: Pancreatic Cancer Therapeutics, Global, Market Forecast, 2012-2019
  • Table 26: Pancreatic Cancer Therapeutics, US, Market Forecast, 2012-2019
  • Table 27: Pancreatic Cancer Therapeutics, Canada, Market Forecast, 2012-2019
  • Table 28: Pancreatic Cancer Therapeutics, UK, Market Forecast, 2012-2019
  • Table 29: Pancreatic Cancer Therapeutics, France, Market Forecast, 2012-2019
  • Table 30: Pancreatic Cancer Therapeutics, Germany, Market Forecast, 2012-2019
  • Table 31: Pancreatic Cancer Therapeutics, Italy, Market Forecast, 2012-2019
  • Table 32: Pancreatic Cancer Therapeutics, Spain, Market Forecast, 2012-2019
  • Table 33: Pancreatic Cancer Therapeutics, Japan, Market Forecast, 2012-2019
  • Table 34: Pancreatic Cancer Therapeutics, Abbreviations

List of Figures

  • Figure 1: Pancreatic Cancer Therapeutics, Global, World-Age Standardized Incidence Rates (rate per 100,000), 2008
  • Figure 2: Pancreatic Cancer Therapeutics, Efficacy Results For Key Parameters - Marketed Products
  • Figure 3: Pancreatic Cancer Therapeutics, Safety Results for Key Parameters - Marketed Products
  • Figure 4: Pancreatic Cancer Therapeutics, Global, Pipeline Distribution by Stage, Program Type and Route of Administration
  • Figure 5: Pancreatic Cancer Therapeutics, Global, Pipeline by Molecule Type and Mechanism of Action
  • Figure 6: Pancreatic Cancer Therapeutics, Global, Pipeline by Molecular Target
  • Figure 7: Pancreatic Cancer Therapeutics, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2013
  • Figure 8: Pancreatic Cancer Therapeutics, Global, Clinical Trial Sizes by Phase and Molecule Type, 2006-2013
  • Figure 9: Pancreatic Cancer Therapeutics, Global, Clinical Trial Failure Rate and Reasons for Failure, 2006-2013
  • Figure 10: Pancreatic Cancer Therapeutics, Cross Analysis of Clinical Trial Failure Rate, Duration and Size by Molecule Type and Phase, Global, 2006-2013
  • Figure 11: Pancreatic Cancer Therapeutics, Global, Estimated Sales of TH-302 ($m), 2017-2019
  • Figure 12: Pancreatic Cancer Therapeutics, Global, Estimated Sales of HyperAcute Pancreas ($m), 2015-2019
  • Figure 13: Pancreatic Cancer Therapeutics, Global, Estimated Sales of MM-398 ($m), 2016-2019
  • Figure 14: Pancreatic Cancer Therapeutics, Efficacy Results for Key Parameters - Pipeline Products
  • Figure 15: Pancreatic Cancer Therapeutics, Safety results for Key Parameters - Pipeline Products
  • Figure 16: Pancreatic Cancer Therapeutics, Product Competitiveness Framework in First-line treatment in Metastatic Disease - Efficacy
  • Figure 17: Pancreatic Cancer Therapeutics, Product Competitiveness Framework in First-line treatment in Metastatic Disease - Safety Parameters
  • Figure 18: Pancreatic Cancer Therapeutics Market, Global, Treatment Patterns and Market Revenues ($m), 2012-2019
  • Figure 19: Pancreatic Cancer Therapeutics, US and Canada, Treatment Usage Patterns, 2012-2019
  • Figure 20: Pancreatic Cancer Therapeutics, US and Canada, Annual Cost of Therapy ($), 2012-2019
  • Figure 21: Pancreatic Cancer Therapeutics Market, US and Canada, Market Revenues ($m), 2012-2019
  • Figure 22: Pancreatic Cancer Therapeutics, Top Five European Markets, Treatment Usage Patterns, 2012-2013
  • Figure 23: Pancreatic Cancer Therapeutics, Top Five European Markets, Annual Cost of Therapy ($), 2012-2019
  • Figure 24: Pancreatic Cancer Therapeutics, Top Five European Markets, Market Revenues ($m), 2012-2019
  • Figure 25: Pancreatic Cancer Therapeutics, Japan, Treatment Usage Patterns, 2012-2019
  • Figure 26: Pancreatic Cancer Therapeutics, Japan, Annual Cost of Therapy ($), 2012-2019
  • Figure 27: Pancreatic Cancer Therapeutics, Japan, Market Size ($m), 2012-2019
  • Figure 28: Pancreatic Cancer Therapeutics, Global, Licensing Deals by Region, Value ($m) and Year, 2006-2013
  • Figure 29: Pancreatic Cancer Therapeutics, Global, Licensing Deals by Phase, Value ($m) and Molecule Type, 2006-2013
  • Figure 30: Pancreatic Cancer Therapeutics, Global, Co-Development Deals by Region, Value ($m) and Year, 2006-2013
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