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市場調查報告書

亞太地區的非小細胞肺癌(NSCLC)治療藥市場:聚焦扁平表皮癌症的未開發領域的個體化療法,治療池的擴張

NSCLC Therapeutics in Asia-Pacific Markets to 2019 - Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool

出版商 GBI Research 商品編碼 297631
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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亞太地區的非小細胞肺癌(NSCLC)治療藥市場:聚焦扁平表皮癌症的未開發領域的個體化療法,治療池的擴張 NSCLC Therapeutics in Asia-Pacific Markets to 2019 - Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool
出版日期: 2014年03月14日 內容資訊: 英文
簡介

亞太地區(APAC)的非小細胞肺癌(NSCLC)治療藥的市場規模,2012年達到了18億美元之後,以年複合成長率6.3%成長,預計2019年擴大到29億美元。NSCLC的發病率上升,及潛力治療藥物(新抗體、免疫疾病療法的第一、第二線的高級藥)的上市前景等,為市場成長的主要原因。同時,印度國內的基本醫藥品藥價上限設定,及學名藥的市場支配,中國的藥價抑制預測等,可能妨礙今後的市場成長。

本報告提供亞太地區各國的非小細胞肺癌(NSCLC)治療方法的相關市場相關分析、疾病概要和主要的治療模式、已上市產品概要(安全性、功效等)、現在正在開發的治療藥的平台資訊、地區整體及主要國的市場趨勢預測(今後8年的預測值)、資本交易、產業聯盟的動向等調查,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

  • 症狀
  • 病因
  • 病理生理學
  • 共生病症/併發症
  • 診斷
    • 健康檢查
    • 痰液細胞學檢查
    • 影像檢查
    • 切片檢查
  • 分類
    • 腺癌症
    • 扁平表皮癌症
    • 大細胞癌症
  • 流行病學
  • 預測和分期
    • 癌症分期(分期診斷)
  • 治療選擇
    • 手術及放射治療
    • 藥物治療
    • 治療的研究和處方的趨勢

第3章 已上市產品

  • 治療環境
    • Alimta (pemetrexed disodium):Eli Lilly and Company
    • Abraxane (nab-paclitaxel):Celgene
    • Iressa (gefitinib):AstraZeneca
    • Tarceva (erlotinib hydrochloride): F. Hoffmann-La Roche
    • Xalkori (crizotinib):Pfizer
    • Avastin (bevacizumab):F. Hoffmann-La Roche
    • Gilotrif (afatinib):Boehringer Ingelheim
  • 功效、安全性比較分析

第4章 開發中產品

  • 開發平台的整體情形
  • 各分子種類的開發平台
  • 各行動機制的平台
  • 臨床實驗
    • 失敗率
    • 參加的患者數和臨床實驗的規模
    • 臨床實驗的期間
  • 開發平台上有前途的醫藥品候補
    • Ramucirumab (IMC-1121B):Eli Lilly and Company
    • Necitumumab (IMC-11F8):Eli Lilly and Company
    • Onartuzumab (MetMab):F. Hoffmann-La Roche
    • Ganetespib (STA-9090):Synta
    • Nintedanib (BIBF1120):Boehringer Ingelheim
    • Dacomitinib (PF-00299804):Pfizer
    • LDK378:Novartis
    • Yervoy (ipilimumab):Bristol-Myers Squibb
    • Nivolumab (BMS-936558/ONO-4538):Bristol Myers Squibb

第5章 市場未來預測(今後6年份)

  • 各地區市場趨勢
    • 亞太地區各國
    • 印度
    • 澳洲
    • 中國
    • 日本
  • 市場促進、阻礙因素
    • 推動市場要素
    • 市場阻礙因素

第6章 資本交易與策略性的市場重組

  • 主要的共同開發交易(共5件)
  • 主要的許可證交易(共4件)

第7章 附錄

圖表一覽

目錄
Product Code: GBIHC326MR

GBI Research, the leading business intelligence provider, has released its latest research, "NSCLC Therapeutics in Asia-Pacific Markets to 2019 - Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool", which provides in-depth insights into the Non-Small Cell Lung Cancer (NSCLC) indication. The report provides an estimation of the market size for 2012 along with market forecasts until 2019 for the Asia-Pacific (APAC) region, covering Australia, China, India and Japan. It also covers disease epidemiology, treatment algorithms, treatment patterns, clinical trial analysis (including failure rates), pipeline analysis, and analysis of deals relevant to NSCLC. The NSCLC market in the APAC region is estimated to have been worth $1.8 billion in 2012 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 6.3% to reach $2.9 billion by 2019. The key drivers for this growth include an aging population, an increasing number of NSCLC incident cases and the expected launch of promising therapies. The launch of premium-priced novel antibodies and immunotherapies in the first and second lines of therapy, including Boehringer Ingelheim's Gilotrif, Eli Lilly's necitumumab, Bristol-Myers Squibb's Yervoy (ipilimumab) and nivolumab, Pfizer's dacomitinib and Novartis's LDK378 are set to drive the market during the forecast period. However, the recent implementation of a price ceiling on essential drugs,dominance of generic drugs in India and expected pricing restrictions in China could curtail the NSCLC market in APAC countries.

Scope

The report analyzes treatment usage patterns, market characterization, pipeline analysis and key licensing and co-development deals in Australia, China, India and Japan. It includes -

  • A brief introduction to NSCLC, including the disease's pathogenesis, etiology, diagnosis and treatment algorithms
  • In-depth analysis of currently marketed drugs for NSCLC, including analysis of their safety, efficacy, treatment patterns and strengths and weaknesses, as well as a heat map comparing them in terms of safety and efficacy
  • A comprehensive review of the pipeline for NSCLC, including individual analysis of a number of late-stage pipeline drugs likely to enter the market during the forecast period, analyzed on the basis of phase distribution, molecule type, program type, mechanisms of action and molecular target
  • Additional in-depth analysis of pipeline drug clinical trials, by Phase, trial size, trial duration and program failure rate, for each molecule type
  • Multi-scenario forecast data of the market to 2019, taking into account how the market may 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
  • Discussion of the drivers of and barriers to market growth
  • In-depth analysis of all licensing and co-development deals that have occurred in the NSCLC market since 2006

Reasons to buy

  • The report will enhance your decision-making capability by allowing you to -
  • Understand the NSCLC pipeline and the factors that indicate that it is becoming more innovative
  • Observe detailed profiles for promising pipeline products and gain insights into how they are likely to compete in the market and who their main competitors will be
  • Follow the trends in NSCLC clinical trial size and duration in relation to industry averages
  • Assess the potential risk of future developmental programs for NSCLC therapeutics, depending on the mechanism of action, by considering the recorded clinical trial failure rates
  • Observe the potential growth patterns expected for the NSCLC market over the forecast period
  • Identify which countries are expected to contribute the most to this growth and devise a more effectively tailored country strategy through the understanding of key drivers and barriers in the NSCLC market
  • Accelerate and strengthen your market position by identifying key companies for strategic partnerships

Abstract

Non-Small Cell Lung Cancer Therapeutics Market to Witness Modest Growth over Forecast Period

The launch of premium-priced targeted therapies has changed the Non-Small Cell Lung Cancer (NSCLC) treatment paradigm and elevated the NSCLC market during the past decade. This growth is expected to continue at a moderate pace during the forecast period, culminating in growth from $1.8 billion in 2012 to $2.9 billion by 2019, in Asia-Pacific (APAC). In 2012, Japan and China had respective shares of 48.5% and 41.5% in the NSCLC market of APAC. India and Australia had much lower shares of 4.1% and 5.9% respectively.

An aging population and increasing number of NSCLC incident cases, especially in China and India, drive the growth in the market. The expected launches of premium-priced novel antibodies and immunotherapies in the first and second lines of therapies, targeting both Non-Squamous NSCLC (NOS NSCLC) and Squamous NSCLC (S NSCLC) patients, widen the eligible treatment population, maximize the patient share and ultimately drive market growth. In spite of many expected drug launches, without the risk of generic erosion of currently entrenched therapies, growth is expected to be marginal due to the dominant generic penetration of a few NSCLC drugs in India. A complex and lengthy regulatory pathway and limited reimbursement from national insurance programs, in China, as well as regular price cuts, in Japan, also limit growth in the APAC market.

Advent of New Targeted Therapies and Improved Diagnostics Revolutionized Non-Small Cell Lung Cancer Treatment Paradigm

A multitude of targeted agents have been explored in the treatment of advanced NSCLC in the last few years. The launch of targeted drugs has shifted the NSCLC treatment landscape away from cytotoxic chemotherapies towards targeted biomarker-driven therapies. Thus far, the broad classes of agents that have been implemented in clinical practice include antagonists of the Epidermal Growth Factor Receptor (EGFR) and Hepatocyte Growth Factor Receptor (HGFR), Vascular Endothelial Growth Factor (VEGF)-directed therapies, and inhibitors of Anaplastic Lymphoma Kinase (ALK).

In the last decade, five targeted therapies have been approved by the US Food and Drug Administration (FDA) for the treatment of NSCLC: Iressa (gefitinib) in 2002, Tarceva (erlotinib) in 2003, Avastin (bevacizumab) in 2006, Xalkori (crizotinib) in 2011 and Gilotrif (afatinib) in 2012. All of these drugs are also marketed in APAC regions, except Gilotrif, which is currently in the pre-registration phase in Japan. The launch of Iressa by AstraZeneca and Tarceva by F. Hoffmann-La Roche Ltd (Roche) has greatly increased the treatment options available to NSCLC patients that harbor specific EGFR mutations. The last entrant, Gilotrif (afatinib), has the potential to overcome the resistance developed to the first-generation EGFR inhibitors: Iressa and Tarceva. So far, Avastin is the only approved VEGF-targeted agent. Anti-angiogenic Avastin has shown landmark improvements in survival when added to standard doublet cytotoxic therapy. Pfizer's Xalkori is the only approved targeted agent that addresses the treatment needs of the sub-set of NSCLC patients that harbor ALK mutations.

Advancement in the diagnostic patterns will also improve the treatment of NSCLC. New biomarkers include the recently approved companion diagnostics: Abbott's Vysis ALK Break-Apart FISH Probe Kit and Pfizer's Xalkori, for the detection of rearrangements involving the ALK gene; the cobras EGFR Mutation Test and Tarceva, for the detection of specific mutations of the EGFR gene; and Qiagen's therascreen EGFR RGQ PCR Kit and Boehringer Ingelheim's Gilotrif, for the diagnosis of specific substitutive mutations of EGFR.

However, all of the approved targeted therapies in the current therapeutic landscape are not approved for NSCLC patients with squamous histology. A significant unmet need exists for therapies that can extend overall survival, with an improved safety profile over gemcitabine, the current standard of care for this patient population.

Robust Pipeline with Promising Late-Stage Molecules to Cater to Unmet Need in Squamous Non-Small Cell Lung Cancer Patients

The pipeline for NSCLC is very strong, with a total of 290 active pipeline molecules in development, either as monotherapies or in combination with chemotherapy. The majority of pipeline candidates being investigated are for the treatment of stage IV advanced disease, either as first-line or second-line therapies. Only a few of these promising pipeline molecules are likely to grab part of the patient population of existing NSCLC therapeutics, and only a few have the potential to increase the treatment population.

Promising candidates in the late-stage clinical trials include second-generation Tyrosine-Kinase Inhibitors (TKIs) such as, Pfizer's dacomitinib and Boehringer Ingelheim's Gilotrif, which is currently a pre-registration drug in Japan, for EGFR-positive patients. In contrast to the currently marketed EGFR inhibitor Tarceva, these second-generation TKIs are effective against both mutant EGFR and wild-type EGFR. Novartis's LDK378 is another promising second-generation TKI targeting ALK-positive patients. A necitumumab by Eli Lilly (Lilly) is in development as a first-line targeted therapy for NSCLC patients with squamous histology. In addition to this, Lilly is also evaluating a second-generation VEGF receptor antibody, ramucirumab, in the second-line setting for patients with squamous histology. Apart from these targeted therapies, the Phase III immunotherapy Yervoy of Bristol-Myers Squibb (BMS) also targets patients with squamous histology. These pipeline molecules targeting patients with squamous histology are expected to gain a rapid uptake due to the absence of marketed drugs that target patients with squamous histology.

Additional promising immunotherapies include BMS's nivolumab, which indicated its improved efficacy for treatment of NSCLC regardless of EGFR mutational status and the MAGE-A3 vaccine therapy of GlaxoSmithKline (GSK) as an adjuvant treatment for EGFR-mutant patients. In addition to pipeline candidates for EGFR- and ALK-mutant patients, early-stage emerging targeted therapies are in development for patients with specific biomarkers or mutations, such as KRAS, ROS1, DDR2, and Fibroblast Growth Factor Receptor 1. Overall, the focus of the NSCLC development pipeline trends towards targeting niche patient populations defined by biomarkers or histology.

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Symptoms
  • 2.2. Etiology
  • 2.3. Pathophysiology
  • 2.4. Co-morbidities and Complications
  • 2.5. Diagnosis
    • 2.5.1. Physical Examination
    • 2.5.2. Sputum Cytology
    • 2.5.3. Imaging Tests
    • 2.5.4. Biopsy
  • 2.6. Classification
    • 2.6.1. Adenocarcinoma
    • 2.6.2. Squamous Cell Carcinoma
    • 2.6.3. Large Cell Carcinoma
  • 2.7. Epidemiology
  • 2.8. Prognosis and Disease Staging
    • 2.8.1. Staging
  • 2.9. Treatment Options
    • 2.9.1. Surgery and Radiation Therapy
    • 2.9.2. Pharmacological
    • 2.9.3. Treatment Algorithms and Prescribing Habits

3. Marketed Products

  • 3.1. Therapeutic Landscape
    • 3.1.1. Alimta (pemetrexed disodium) - Eli Lilly and Company
    • 3.1.2. Abraxane (nab-paclitaxel) - Celgene
    • 3.1.3. Iressa (gefitinib) - AstraZeneca
    • 3.1.4. Tarceva (erlotinib hydrochloride) - F. Hoffmann-La Roche
    • 3.1.5. Xalkori (crizotinib) - Pfizer
    • 3.1.6. Avastin (bevacizumab) - F. Hoffmann-La Roche
    • 3.1.7. Gilotrif (afatinib) - Boehringer Ingelheim
  • 3.2. Comparative Efficacy and Safety

4. Pipeline Products

  • 4.1. Overall Pipeline
  • 4.2. Pipeline Analysis by Molecule Type
  • 4.3. Pipeline Analysis by Mechanism of Action
  • 4.4. Clinical Trials
    • 4.4.1. Failure Rate
    • 4.4.2. Patient Enrollment and Clinical Trial Size
    • 4.4.3. Duration
  • 4.5. Promising Drug Candidates in the Pipeline
    • 4.5.1. Ramucirumab (IMC-1121B) - Eli Lilly and Company
    • 4.5.2. Necitumumab (IMC-11F8) - Eli Lilly and Company
    • 4.5.3. Onartuzumab (MetMab) - F. Hoffmann-La Roche
    • 4.5.4. Ganetespib (STA-9090) - Synta
    • 4.5.5. Nintedanib (BIBF1120) - Boehringer Ingelheim
    • 4.5.6. Dacomitinib (PF-00299804) - Pfizer
    • 4.5.7. LDK378 - Novartis
    • 4.5.8. Yervoy (ipilimumab) - Bristol-Myers Squibb
    • 4.5.9. Nivolumab (BMS-936558/ONO-4538) - Bristol Myers Squibb

5. Market Forecast to 2019

  • 5.1. Geographical Markets
    • 5.1.1. APAC Market
    • 5.1.2. India
    • 5.1.3. Australia
    • 5.1.4. China
    • 5.1.5. Japan
  • 5.2. Drivers and Barriers for the Disease Market
    • 5.2.1. Drivers
    • 5.2.2. Barriers

6. Deals and Strategic Consolidations

  • 6.1. Major Co-development Deals
    • 6.1.1. OxOnc Enters Co-development Agreement with Pfizer for Crizotinib
    • 6.1.2. SFJ Pharma Enters Co-development Agreement with Pfizer for Dacomitinib
    • 6.1.3. Merck Enters Co-development Agreement with Endocyte for Cancer Drug
    • 6.1.4. Roche Enters Co-development Agreement with Clovis
    • 6.1.5. Abbott Laboratories Enters Co-development Agreement with GlaxoSmithKline
  • 6.2. Major Licensing Deals
    • 6.2.1. Chugai Enters Licensing Agreement with Roche for Onartuzumab and Lebrikizumab
    • 6.2.2. Azaya Enters Licensing Agreement with CANbridge Life Sciences for ATI-1123
    • 6.2.3. Merck Expands Licensing Agreement with Biomira
    • 6.2.4. Clovis Enters Licensing Agreement with Avila Therapeutics

7. Appendix

  • 7.1. All Pipeline Drugs by Phase
    • 7.1.1. Discovery
    • 7.1.2. Preclinical
    • 7.1.3. IND-filed
    • 7.1.4. Phase I
    • 7.1.5. Phase II
    • 7.1.6. Phase III
    • 7.1.7. Undisclosed
  • 7.2. Market Forecasts to 2019
    • 7.2.1. APAC
    • 7.2.2. India
    • 7.2.3. Australia
    • 7.2.4. China
    • 7.2.5. Japan
  • 7.3. Market Definitions
  • 7.4. Abbreviations
  • 7.5. Bibliography
  • 7.6. Research Methodology
    • 7.6.1. Coverage
    • 7.6.2. Secondary Research
    • 7.6.3. Primary Research
    • 7.6.4. Therapeutic Landscape
    • 7.6.5. Geographical Landscape
    • 7.6.6. Pipeline Analysis
  • 7.7. Expert Panel Validation
  • 7.8. Contact Us
  • 7.9. Disclaimer

List of Tables

  • Table 1: Non-Small Cell Lung Cancer Market, Common Symptoms of Non-Small Cell Lung Cancer
  • Table 2: Non-Small Cell Lung Cancer Market, Risk Factors of Non-Small Cell Lung Cancer Market
  • Table 3: Non-Small Cell Lung Cancer Market, American Joint Committee on Cancer's Tumor Node Metastasis Staging System, 2010
  • Table 4: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Discovery), 2013
  • Table 5: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Preclinical), 2013
  • Table 6: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (IND-filed), 2013
  • Table 7: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase I), 2013
  • Table 8: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase II), 2013
  • Table 9: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Phase III), 2013
  • Table 10: Non-Small Cell Lung Cancer Market, Global, Pharmaceutical Pipeline (Undisclosed), 2013
  • Table 11: Non-Small Cell Lung Cancer Market, Asia-Pacific, Market Forecast, 2012-2019
  • Table 12: Non-Small Cell Lung Cancer Market, India, Market Forecast, 2012-2019
  • Table 13: Non-Small Cell Lung Cancer Market, Australia, Market Forecast, 2012-2019
  • Table 14: Non-Small Cell Lung Cancer Market, China, Market Forecast, 2012-2019
  • Table 15: Non-Small Cell Lung Cancer Market, Japan, Market Forecast, 2012-2019

List of Figures

  • Figure 1: Non-Small Cell Lung Cancer Market, Asia-Pacific, Distribution of Prevalence Population, 2012-2019
  • Figure 2: Non-Small Cell Lung Cancer Market, Treatment Algorithm for Early and Advanced Localized Tumors Stages IIIA and IIIB, 2013
  • Figure 3: Non-Small Cell Lung Cancer Market, Treatment Algorithm for Early and Advanced Localized Tumors Stages IIIA and IIIB, 2013
  • Figure 4: Non-Small Cell Lung Cancer Market, Treatment Algorithm for Advanced Metastatic Tumors, 2013
  • Figure 5: Non-Small Cell Lung Cancer Market, Global, Annual Sales, 2012
  • Figure 6: Non-Small Cell Lung Cancer Market, Global, Alimta (pemetrexed disodium) Annual Sales ($bn), 2004-2012
  • Figure 7: Non-Small Cell Lung Cancer Market, Global, Abraxane (nab-paclitaxel) Annual Sales ($m), 2009-2012
  • Figure 8: Non-Small Cell Lung Cancer Market, Global, Iressa (gefitinib) Annual Sales ($m), 2005-2012
  • Figure 9: Non-Small Cell Lung Cancer Market, Global, Tarceva (erlotinib) Annual Sales ($bn), 2006-2012
  • Figure 10: Non-Small Cell Lung Cancer Market, Global, Xalkori (crizotinib) Annual Sales ($m), 2012-2013
  • Figure 11: Non-Small Cell Lung Cancer Market, Global, Avastin (bevacizumab) Annual Sales ($bn), 2006-2012
  • Figure 12: Non-Small Cell Lung Cancer Market, Global, Comparative Safety and Efficacy of Marketed Products (Heat Map), 2013
  • Figure 13: Non-Small Cell Lung Cancer Market, Global, Pipeline by Stage of Development, Program Type and Route of Administration, 2013
  • Figure 14: Non-Small Cell Lung Cancer Market, Global, Pipeline by Molecule Type and Stage of Development, 2013
  • Figure 15: Non-Small Cell Lung Cancer Market, Global, Pipeline by Mechanism of Action, 2013
  • Figure 16: Non-Small Cell Lung Cancer Market, Global, Pipeline by Mechanism of Action, Molecule Type and Stage of Development (Number), 2013
  • Figure 17: Non-Small Cell Lung Cancer Market, Global, Clinical Trial Failure Rate (%), 2013
  • Figure 18: Non-Small Cell Lung Cancer Market, Global, Clinical Trial Size (Participants), 2013
  • Figure 19: Non-Small Cell Lung Cancer Market, Global, Pipeline Clinical Trial Duration (months), 2013
  • Figure 20: Non-Small Cell Lung Cancer Market, Asia-Pacific, Market Size, 2012-2019
  • Figure 21: Non-Small Cell Lung Cancer Market, India, Market Size, 2012-2019
  • Figure 22: Non-Small Cell Lung Cancer Market, Australia, Market Size, 2012-2019
  • Figure 23: Non-Small Cell Lung Cancer Market, China, Market Size, 2012-2019
  • Figure 24: Non-Small Cell Lung Cancer Market, Japan, Market Size, 2012-2019
  • Figure 25: Non-Small Cell Lung Cancer Market, Global Deals by Value, Year and Stage of Development, 2006-2013
  • Figure 26: Non-Small Cell Lung Cancer Market, Global, Deals by Phase, Molecule Type and Mechanism of Action, 2006-2013
  • Figure 27: Non-Small Cell Lung Cancer Market, Global, Co-development Deals by Geography, 2006-2013
  • Figure 28: Non-Small Cell Lung Cancer Market, Global, Licensing Deals by Geography, 2006-2013
  • Figure 29: GBI Research Market Forecasting Model (Example)
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