PharmaPoint: Non-Small Cell Lung Cancer - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update


#210566

390pages

GlobalData

$ 10995

In Stock

PharmaPoint: Non-Small Cell Lung Cancer - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

Summary

Non-Small Cell Lung Cancer (NSCLC) is the most common lung cancer, and the second-most common cancer in men and women. Historically, the treatment paradigm has centered around chemotherapy. However, the launch of targeted therapies for patients with specific biomarkers has begun to fragment the NSCLC treatment landscape into smaller niche patient populations. Over the forecast period, this trend will continue with the launch of multiple new drugs in several new drug classes to address the high unmet need among NSCLC patients, and provide new treatment options for previously underserved populations.

This Event-Driven Update was published in response to major events that occurred during the first quarter of 2014 that will result in the failure of several premium-priced agents to launch in the US and global markets during the forecast period. These agents include Pfizers dacomitinib and Boehringer Ingelheims nintedanib in the US, and Roches MetMab (onartuzumab) and GSKs MAGE-A3 immunotherapy in the global markets.

Highlights

Key Questions Answered

- The NSCLC market will become increasingly crowded during the forecast. How will the first and second lines of therapy be impacted by the launch of new therapies?
- How will the failure of dacomitinib and nintedanib to launch in the US affect global market growth? What effect will the failure to launch of MetMab (onartuzumab) and the MAGE-A3 immunotherapy in the nine major markets have on global market dynamics?
- How will the increasing stratification of patient populations by biomarkers affect the treatment landscape?
- The unmet needs of NSCLC patients are relatively high. What unmet needs will be addressed by the launch of new treatment options during the forecast period? What unmet needs will remain?
- How will Alimta, Avastin, Iressa and Tarceva patent expirations affect overall market growth during the forecast?
- How will increasing cost consciousness among European reimbursement authorities affect market growth in the 5EU?

Key Findings

- Launch of emerging pipeline therapies will result in more patients receiving premium-priced drugs in the first and second lines of therapy, and market growth in the US and Japan. However, the US and nine major markets will be negatively affected by the failure of premium-priced agents including dacomitinib, nintedanib, MetMab and MAGE-A3 to launch during the forecast period.
- Despite the launch of remaining premium-priced therapies such as Eli Lillys necitumumab and BMS nivolumab, the NSCLC market will shrink in the 5EU. This will be primarily due to the reduction in number of new premium-priced agents that will launch as well as the loss of patent protection for most of the major branded therapies as well as increasing cost pressures from European reimbursement authorities.
- The Indian and Chinese markets will continue to be difficult to penetrate. Many emerging pipeline therapies will not launch in these markets, especially expensive biologic therapies. Generic competition, regulatory hurdles and high cost of therapies will be major barriers to growth in these markets.
- BMSs nivolumab will emerge as the overall market leader in 2022, launching first in the second-line segment in 2015 and expanding into the first-line segment in 2019. Uptake will be driven by the drugs promising clinical efficacy in both squamous and non-squamous patients and strong safety profile.
- After Iressa and Tarceva lose patent protection in 2019 and 2020, respectively, Boehriger Ingelheims Gilotrif (afatinib) will emerge as the leading therapy for EGFR-positive patients. Gilotrifs market position will be driven by high uptake in the second-line segment.
- Pfizers Xalkori will lose ALK-positive patient share to Novartis ceritinib (LDK378) in the second-line segment. However, Xalkori will continue to be the patient share leader in the more lucrative first line setting and will maintain the overall sales leadership over LDK378 throughout the forecast.

Scope

- Overview of NSCLC, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized NSCLC therapeutics market revenue, annual cost of therapy and treatment usage pattern data by patient segment forecast from 2012 to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the NSCLC therapeutics market.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for different lines of therapy. The most promising 13 candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global NSCLC market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop business strategies by understanding the trends shaping and driving the global NSCLC therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global NSCLC therapeutics market in 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.
- Forecast drug sales in the global NSCLC therapeutics market from 2012-2022.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.
idemiology Forecast (2012-2022) 70
4.4.1 Incident/Prevalent Cases of NSCLC 70
4.4.2 Age-Specific Incident Cases of NSCLC 72
4.4.3 Sex-Specific Incident Cases of NSCLC 73
4.4.4 Age-Standardized Incidence Rates of NSCLC 75
4.4.5 Segmentation of NSCLC Incident Cases 76
4.5 Discussion 84
4.5.1 Limitations of the Analysis 85
4.5.2 Strengths of the Analysis 86
5 Disease Management 87
5.1 Treatment Overview 87
5.1.1 Diagnosis 88
5.1.2 Clinical Staging 89
5.1.3 Screening and Early Detection 91
5.1.4 Localized Procedures and Therapies 92
5.1.5 Systemic Chemotherapy 93
5.1.6 Targeted Therapy 93
5.2 US 96
5.2.1 Diagnosis 96
5.2.2 Clinical Practice 96
5.3 France 98
5.3.1 Diagnosis 98
5.3.2 Clinical Practice 99
5.4 Germany 100
5.4.1 Diagnosis 100
5.4.2 Clinical Practice 101
5.5 Italy 103
5.5.1 Diagnosis 103
5.5.2 Clinical Practice 104
5.6 Spain 105
5.6.1 Diagnosis 105
5.6.2 Clinical Practice 105
5.7 UK 106
5.7.1 Diagnosis 106
5.7.2 Clinical Practice 107
5.8 Japan 108
5.8.1 Diagnosis 108
5.8.2 Clinical Practice 109
5.9 China 110
5.9.1 Diagnosis 110
5.9.2 Clinical Practice 111
5.10 India 112
5.10.1 Diagnosis 112
5.10.2 Clinical Practice 112
6 Competitive Assessment 115
6.1 Overview 115
6.2 Strategic Competitor Assessment 116
6.3 Product Profiles - Major Brands, Chemotherapies 118
6.3.1 Alimta (pemetrexed disodium) 118
6.3.2 Abraxane (nab-paclitaxel) 123
6.4 Product Profiles - Major Brands, Targeted Therapies 127
6.4.1 Avastin (bevacizumab) 127
6.4.2 Gilotrif (afatinib) 132
6.4.3 Iressa (gefitinib) 138
6.4.4 Tarceva (erlotinib hydrochloride) 143
6.4.5 Xalkori (crizotinib) 149
7 Opportunity and Unmet Need 156
7.1 Overview 156
7.2 Improved Overall Survival and Less Toxicity 157
7.3 Treatments for Patients with Acquired TKI Resistance 158
7.4 Better Treatment Options for Squamous Patients 158
7.5 Preventing Relapse or Recurrence 159
7.6 More Efficacious Second-Line Therapies 159
7.7 Increased Availability of Mutation Testing 160
7.8 More Cost-Effective Therapies 160
7.9 Unmet Needs Gap Analysis 161
8 Pipeline Assessment 165
8.1 Overview 165
8.2 Clinical Trial Mapping 165
8.2.1 Clinical Trials by Country 165
8.3 Clinical Trials by Phase and Trial Status 167
8.4 Promising Drugs in Clinical Development 168
8.4.1 Onartuzumab (MetMab) 172
8.4.2 Necitumumab (IMC-11F8) 177
8.4.3 Ramucirumab (IMC-1121B) 183
8.4.4 Custirsen (OGX-011) 188
8.4.5 Ganetespib (STA-9090) 194
8.4.6 Nintedanib (BIBF1120) 201
8.4.7 Dacomitinib (PF-00299804) 206
8.4.8 LDK378 (ceritinib) 211
8.4.9 Yervoy (ipilimumab) 217
8.4.10 Nivolumab (BMS936558) 222
8.4.11 MPDL3280A (RG7446) 230
8.4.12 GSK1572932A (MAGE-A3 Cancer Immunotherapy) 233
8.4.13 Halaven (eribulin mesylate) 237
9 Current and Future Players 243
9.1 Overview 243
9.2 Trends in Corporate Strategy 245
9.3 Company Profiles 246
9.3.1 Roche/Genentech 246
9.3.2 Pfizer 249
9.3.3 Bristol-Myers Squibb 251
9.3.4 Eli Lilly 254
9.3.5 Boehringer Ingelheim 257
9.3.6 Novartis 259
10 Market Outlook 261
10.1 Global Markets 261
10.1.1 Forecast 261
10.1.2 Drivers and Barriers - Global Issues 265
10.2 United States 269
10.2.1 Forecast 269
10.2.2 Key Events 273
10.2.3 Drivers and Barriers 274
10.3 France 277
10.3.1 Forecast 277
10.3.2 Key Events 281
10.3.3 Drivers and Barriers 282
10.4 Germany 284
10.4.1 Forecast 284
10.4.2 Key Events 288
10.4.3 Drivers and Barriers 289
10.5 Italy 291
10.5.1 Forecast 291
10.5.2 Key Events 295
10.5.3 Drivers and Barriers 295
10.6 Spain 297
10.6.1 Forecast 297
10.6.2 Key Events 300
10.6.3 Drivers and Barriers 301
10.7 United Kingdom 302
10.7.1 Forecast 302
10.7.2 Key Events 306
10.7.3 Drivers and Barriers 307
10.8 Japan 309
10.8.1 Forecast 309
10.8.2 Key Events 313
10.8.3 Drivers and Barriers 313
10.9 China 316
10.9.1 Forecast 316
10.9.2 Key Events 320
10.9.3 Drivers and Barriers 320
10.10 India 323
10.10.1 Forecast 323
10.10.2 Key Events 327
10.10.3 Drivers and Barriers 327
11 Appendix 329
11.1 Bibliography 329
11.2 Abbreviations 360
11.3 Methodology 365
11.4 Forecasting Methodology 365
11.4.1 Number of NSCLC Patients Currently Seeking Treatment 365
11.4.2 Percent Drug-Treated Patients 366
11.4.3 Drugs Included in Each Therapeutic Class 366
11.4.4 Launch and Patent Expiry Dates 367
11.4.5 General Pricing Assumptions 368
11.4.6 Individual Drug Assumptions 371
11.4.7 Generic Erosion 381
11.4.8 Pricing of Pipeline Agents 381
11.5 Physicians and Specialists Included in This Study 383
11.6 Survey of Prescribing Physicians 385
11.7 About the Authors 386
11.7.1 Authors 386
11.7.2 Epidemiologists 387
11.7.3 Global Head of Healthcare 388
11.8 About GlobalData 389
11.9 Disclaimer 389

1.1 List of Tables
Table 1: Symptoms of NSCLC 30
Table 2: Risk Factors and Comorbidities for Lung Cancer 33
Table 3: 9MM, Age-Standardized (World) Smoking Prevalence, Men and Women, 2006 and 2009 40
Table 4: 9MM, Sources of NSCLC Incidence Data 61
Table 5: 9MM, Incident Cases of NSCLC, Men and Women Ages