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Oncology Reports


Lung Cancer Therapeutics Market Outlook and Pipeline Analysis

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Single-User License: $1395 | Departmental/Site License: $3250 | Company-Wide License: $4850

Publication Date: November 2009

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With over 50% of all non-small cell lung cancer (NSCLC) patients diagnosed at the advanced stages of the disease, and 95% of all small-cell lung cancer (SCLC) patients unsuitable for surgical resection, drug therapy plays a vital role in the management of lung cancer. Such high level of unmet need ensures the lung cancer market is an attractive commercial opportunity for new drug development.

Lung Cancer Therapeutics Market & Pipeline Analysis supports the process of successful product development and commercialization within the pharmaceutical/biopharmaceutical lung cancer market by addressing the following key areas:

  • Epidemiology of lung cancer
  • Current lung cancer treatments
  • Analysis of current lung cancer therapeutics
  • Unmet needs within the lung cancer market
  • Research and development (R&D) approaches towards lung cancer
  • Pipeline analysis of key lung cancer candidates
  • Forecast sales of key pipeline lung cancer candidates

 

The report also analyzes the market status and potential for the following key lung cancer therapies:

  • Sanofi-Aventis’ Taxotere (docetaxel)
  • Eli-Lilly’s Gemzar (gemcitabine)
  • Eli-Lilly’s Alimta (pemetrexed)
  • GlaxoSmithKline’s Hycamtin (topotecan) (SCLC therapeutic)
  • OSI Pharmaceuticals/Roche’s Tarceva (erlotinib)
  • AstraZeneca’s Iressa (gefitinib)
  • Roche’s Avastin (bevazicumab)


and the market potential for the following key late-clinical stage developmental candidates:

  • Opaxio
  • Erbitux (line extensions)
  • Zactima
  • Picoplatin

 

This in-depth, quality report delivers:

  • An assessment of the lung market potential, including identification of unmet needs, commercial opportunities, and key trends in R&D
  • Analysis of the lung cancer pipeline with in-depth clinical and commercial assessment of key Phase III candidates
  • Seven major pharmaceutical market sales forecasts to 2015 for key pipeline candidates incorporating product events

 

Report highlights include:

  • Arrowhead has identified 70 drugs in the late-stage lung cancer pipeline. Collectively, key late-phase products have a forecast sales potential of up to $5651m by 2015 in the seven major pharmaceutical markets.
  • Molecular targeted therapies (MTTs) are the focus of R&D in lung cancer. Of the MTTs in late-phase development, Erbitux (cetuximab; ImClone /Bristol-Myers Squibb/Merck KGaA) is forecast to achieve the highest level of sales, with $1000m by 2015.
  • Arrowhead forecasts AstraZeneca’s Iressa (gefitinib) will overcome its disappointing start in the NSCLC arena following positive results of two recent Phase III trials. Iressa will go on to compete well with Roche’s Avastin and OSI Pharma/Roche’s Tarceva (erlotinib).

 

Purchasing this report will enable you to:

  • Assess opportunities and risks influencing R&D in lung cancer, unmet needs in the treatment of the disease, and trends in current development
  • Identify  key lung cancer products in late-phase development based on sales forecasts to 2015 to maximize your product’s commercial potential
  • Gain an impartial perspective of the strategies used between competing companies involved in the lung cancer pipeline to enhance your product’s performance

 

Table of Contents

 

1    EXECUTIVE SUMMARY
1.1      Scope of Lung Cancer Therapeutics: Market Trends and R&D Insights
1.2      Methodology of Lung Cancer Therapeutics: Market Trends and R&D Insights
1.3      Lung Cancer Epidemiology Trends
1.4      Current Therapeutic Treatments of Lung Cancer
1.5      Unmet Needs of Lung Cancer
1.6      Research and Development (R&D) Trends
1.7      Pipeline Analysis


2    LUNG CANCER: DISEASE BACKGROUND
2.1       An Introduction to Lung Cancer
2.2       An Overview of Non Small Cell Lung Cancer (NSCLC)
2.2.1    Squamous Cell Carcinoma
2.2.2    Adenocarcinoma
2.3       Large Cell Carcinoma
2.4       Staging of NSCLC
2.5       Small Cell Lung Cancer (SCLC)
2.6       Staging of SCLC
2.7        Lung Cancer Risk Factors
2.7.1    Smoking
2.7.2    Radon Gas
2.7.3    Asbestos
2.7.4    Personal or Family History of Lung Cancer
2.7.5     Age
2.8        Lung Cancer Symptoms
2.9        Diagnosis of Lung Cancer
2.10      Prognosis of Lung Cancer


3    EPIDEMIOLOGICAL AND FINANCIAL IMPACT OF CANCER
3.1        Epidemiology of Lung Cancer in the Seven Major Markets
3.1.1     Obama’s Family Smoking and Tobacco Control Act: How will this Influence the Lung Cancer Market?
3.2        The Financial Impact of Lung Cancer
3.3        Would a Lung Cancer Screening Program Impact Patient Survivorship and Reduce the Financial Cost of the Disease?


4    CURRENT LUNG CANCER MANAGEMENT CONTROVERSIES
4.1        An Introduction to the Management of Lung Cancer
4.2        An Overview to the Surgical Resection of Lung Cancer
4.3        An Overview of Radiation Therapy for Lung Cancer
4.4        An Overview of Chemotherapy for Lung Cancer
4.4.1     Overview of the Chemotherapeutic Management of NSCLC
4.4.2     Overview of the Chemotherapeutic Management of SCLC
4.5         First-Line Cytotoxic Management of Lung Cancer
4.5.1      Sanofi-Aventis’ Taxotere (docetaxol)
4.5.2      Eli-Lilly’s Gemzar (gemcitabine)
4.5.3      Eli Lilly’s Alimta (pemetrexed)
4.6         Second- and Third-Line Cytotoxic Management of Lung Cancer
4.6.1      Sanofi-Aventis’ Taxotere (docetaxel)
4.6.2      Eli Lilly’s Alimta (pemetrexed)
4.6.3      GlaxoSmithKline’s Hycamtin (topotecan)
4.7          Molecular Targeted Therapies (MTTs) Used in the Management of NSCLC
4.7.1      Roche’s Avastin (bevacizumab)
4.7.2      OSI Pharmaceuticals/ Roche’s Tarceva (erlotinib)
4.7.3      AstraZeneca’s Iressa (gefitinib)
4.8          Neo-adjuvant and Adjuvant Lung Cancer Chemotherapy
4.8.1      Adjuvant Lung Cancer Chemotherapy
4.8.2      Neo-adjuvant Lung Cancer Chemotherapy


5    ANALYSIS OF THE LUNG CANCER THERAPEUTICS MARKET
5.1          First-Line Therapies
5.2          Key Branded Cytotoxic Therapies
5.3          SWOT Analysis: Taxotere
5.4          SWOT Analysis: Alimta
5.5          SWOT Analysis: Gemzar
5.6          SWOT Analysis: Hycamtin
5.7          Key Molecular-Targeted Therapies (MTTs)
5.7.1       Avastin
5.7.1.1    SWOT Analysis: Avastin
5.7.2       Tarceva
5.7.2.1    SWOT Analysis: Tarceva
5.7.3       Iressa
5.7.3.1    SWOT Analysis: Iressa


6    UNMET NEEDS IN THE LUNG CANCER THERAPEUTIC MARKET
6.1           Unmet Needs in the Lung Cancer Market
6.2           Five-year Survival Rates Remain Static
6.3           Extensive-Stage SCLC Specific Agent
6.4           First-line Agents that Prevent Disease Relapse
6.5           First-line Agents with Favorable Toxicity Profiles
6.6           Elderly Lung Cancer Patients are Underserved
6.7           Effective Second-Line Agents
6.8           Bronchioalveolar Carcinoma Patients are Underserved
6.9           Stage IIIA Specific Agent
6.10         Development of a Cost-Effective Lung Cancer Screening Program
6.11         Development of a Chemo-Preventative


7    LUNG CANCER RESEARCH AND DEVELOPMENT (R&D) TRENDS
7.1           An Introduction to Oncology Clinical Trials
7.2           Issues Surrounding the Design of Lung Cancer Clinical Trials
7.2.1        Patient Selection
7.2.2        Trial Duration
7.2.3        Trial Comparator Drug Choice
7.2.4        Adjuvant and Neo-adjuvant Trial Design
7.3           An Introduction to Oncology Clinical Trial Endpoints
7.3.1        Survival Rates
7.3.2        Tumor Response Rates
7.3.3        Time to Tumor Progression
7.3.4        Quality of Life
7.3.5        Adverse Effects
7.3.6        Oncology Vaccine Endpoints
7.4           Emerging Lung Cancer Biomarkers May Aid R&D Direction
7.4.1        NSCLC Biomarkers
7.4.2        SCLC Biomarkers


8    LUNG CANCER PIPELINE ANALYSIS
8.1           Introduction to the Lung Cancer Therapeutics Pipeline
8.2           ImClone/Bristol-Myers Squibb/Merck KGaA’s Erbitux (cetuximab)
8.2.1        Erbitux’s FLEX Trial Results
8.2.2        Erbitux’s Commercialization Potential
8.3           Cell Therapeutics’ Opaxio (polyglutamate paclitaxel)
8.3.1        Opaxio’s STELLAR Trial Results
8.3.2        Opaxio’s Commercialization Potential
8.4           AstraZeneca’s Zactima (vandetanib)
8.4.1        Zactima ZODIAC Trial Results
8.4.2        Zactima’s Commercialization Potential
8.5           Poniard Pharmaceuticals’ Picoplatin
8.5.1        Picoplatin’s Trial Results
8.5.2        Picoplatin’s Commercialization Potential
8.6           Financial Forecast of the Therapeutic Lung Cancer Market


TABLES

Table 1:    Lung Cancer Incidence Forecast in 2009 and 2019 in the Seven Major Markets
Table 2:    Worldwide Branded Therapeutics Indicated for Lung Cancer Revenues ($million) 2007, 2008 and H2- 2009
Table 3:    AJCC TNM Staging System of NSCLC
Table 4:    AJCC TNM Staging System of NSCLC
Table 5:    Veterans Administration Lung Study Group (VALG) Staging of SCLC
Table 6:    Lung Cancer Diagnosis and Five-Year Survival Rate by Disease Stage
Table 7:    NSCLC Five-year Survival Rate by Disease Stage in the US and Across Europe
Table 8:    Diagnosis and Survival Rate for Untreated and Treated SCLC Patients by Disease Stage
Table 9:    Crude Incidence Rate of Lung Cancer by Gender (per 100,000) in the Seven Major Markets, 2009
Table 10:  Lung Cancer Incidence Forecast in Males in the Seven Major Markets, 2008-2019
Table 11:  Lung Cancer Incidence Forecast in Females in the Seven Major Markets, 2008-2019
Table 12:  Lung Cancer Incidence Forecast in the Seven Major Markets, 2008-2019
Table 13:  NSCLC Incidence Forecast in the Seven Major Markets, 2008-2019
Table 14:  Stage-Specific Incidence of NSCLC in 2009
Table 15:  SCLC Incidence Forecast in the Seven Major Markets, 2008-2019
Table 16:  Stage-Specific Incidence of SCLC in the Seven Major Markets, 2009
Table 17:  Cytotoxics Used in Lung Cancer by Generic Name, Brand Name, Company and Line-Setting
Table 18:  Worldwide Branded Cytotoxic Lung Cancer Therapeutics Revenues ($million) 2007, 2008 and H2- 2009
Table 19:  Branded Lung Cancer Cytotoxic Agents’ US Patent Approval and Expiry Dates
Table 20:  SWOT Analysis of Taxotere
Table 21:  SWOT Analysis of Alimta
Table 22:  SWOT Analysis of Gemzar
Table 23:  SWOT Analysis of Hycamtin
Table 24:  Worldwide Branded MTT NSCLC Therapeutics Revenues ($million) 2007, 2008 and H2- 2009
Table 25:  Branded Lung Cancer MTT Agents US Patent Approval and Expiry Dates
Table 26:  SWOT Analysis of Avastin
Table 27:  SWOT Analysis of Tarceva
Table 28:  SWOT Analysis of Iressa
Table 29:  Lung Cancer Diagnosis and Five-Year Survival by Disease Stage
Table 30:  Key Phase III Clinical Trials Involving Elderly Advanced NSCLC Patients
Table 31:  Late-Stage NSCLC Therapeutic Pipeline, Aug 2009
Table 32:  Late-Stage SCLC Therapeutic Pipeline, Aug 2009
Table 33:  STELLAR-3 and STELLAR-4 Survival Data
Table 34:  Worldwide Lung Cancer Therapeutic Forecast Sales ($million), 2008-2015


FIGURES

Figure 1:   Lung Cancer Incidence Forecast in 2009 and 2019 in the Seven Major Markets
Figure 2:   Clinical Unmet Needs in the Lung Cancer Therapeutic Market
Figure 3:   The Anatomy of the Human Respiratory System
Figure 4:    Lung Cancer Incidence Forecast in the Seven Major Markets, 2008-2019
Figure 5:   NSCLC Incidence Forecast in the Seven Major Markets, 2008-2019
Figure 6:   Stage-Specific Incidence of NSCLC in 2009
Figure 7:   SCLC Incidence Forecast in the Seven Major Markets, 2008-2019
Figure 8:   Stage-Specific Incidence of SCLC in the Seven Major Markets, 2009
Figure 9:   NCCN Recommendations for the Chemotherapeutic Management of PS 0-2 Stage IV or Relapsed NSCL
Figure 10: NCCN Recommendations for the Chemotherapeutic Management of PS0-2 Limited (in excess T1-2, N0) and Extensive Stage SCLC

 

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