Lung cancer is currently is the most common cause of death from cancer worldwide. Of total lung cancer incident cases, approximately 85% are the non-small cell lung cancer (NSCLC) subtype. NSCLC patients are usually diagnosed in the later stages of the disease, with poor prognosis. Historically, treatment options for advanced-stage NSCLC patients have been dominated by chemotherapy. However, the launch of targeted therapies such as Iressa (gefitinib) in 2003, Tarceva (erlotinib) in 2004, and Xalkori (crizotinib) in 2011, has shifted the treatment landscape towards personalized medicine.
For the purposes of this report, GlobalData considers the Global NSCLC market to include NSCLC-specific drug sales in the 8MM (US, 5EU [France, Germany Italy, Spain, and the UK], Japan, and China). The current market across these countries is dominated by the sale of major chemotherapy regimens, anti-angiogenic agents and targeted therapies for patients with EGFR+ and ALK+ NSCLC. GlobalData estimated that the Global NSCLC market was valued at $6.2b in 2015. The NSCLC therapeutics market is expected to grow at a positive CAGR of 15.7%, reaching 26.71b in the 8MM by 2025.
The growth of the NSCLC market during the forecast period will be driven partly by increasing incident cases of NSCLC in the US, 5EU, Japan, and China, as the population ages. In addition, the launch of premium-priced immuno-oncology (I/O) and targeted pipeline agents will drive the uptake of new therapies and prolong the duration of treatment in the first-line and beyond. The increased used of branded I/O therapies, such as Keytruda, Opdivo, and Tecentriq will be the primary driver of growth during the forecast period. The projected increase in mutation testing rate during the forecast period coupled with the launch of new generation EGFR and ALK TKIs, and BRAF inhibitors will significantly promote the sales of the targeted therapies, Tagrisso, Alecensa, and Tafinlar + Mekinist.
Key Questions Answered
- Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the NSCLC marketplace. Will the leading pipeline agents fulfil these unmet needs during the forecast period (2015-2025)?
- What research and development (R&D) strategies will companies leverage to compete in the future NSCLC marketplace?
- Which pipeline products are poised to make a major clinical and commercial impact?
- What clinical and commercial factors are likely to influence NSCLC drug uptake in the 8MM?
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- The increasing incorporation of premium-priced immune checkpoint inhibitor immunotherapies into the NSCLC treatment algorithm, particularly in the first-line setting, will be one major driver. Collectively, immunotherapies will reach $17.5B in sales by 2025, accounting for roughly 65% of total sales in the NSCLC market. Of the $17.5B total, Keytruda, Opdivo, and Tecentriq are projected to contribute $5.2B, $5.5B, and $2.8B, respectively.
- The increasing incidence of NSCLC in the 8MM will also drive growth. China, in particular, will see its NSCLC incident cases increase dramatically over the forecast period, at an Annual Growth Rate (AGR) of 4.7%. Overall, across the 8MM, the incidence of NSCLC is expected to increase at an AGR of 3.1% from 2015-2025. This increase, coupled with an anticipated increase in branded therapy prescriptions in China, will drive the growth of both the Chinese and global NSCLC markets over the forecast period.
- Patent expiration of several blockbuster drugs, including Tarceva and Alimta, and the uptake of generics will limit growth. GlobalData expects sales of the patented drug in the 8MM to decrease from $783M in 2015 to $18M by 2025. In addition, sales of Alimta will decrease from $2.1B in 2015 to $54M in 2025.
- An increasing emphasis on cost-consciousness is anticipated over the forecast period, which will limit premium pricing opportunities for developers of NSCLC pipeline agents. GlobalData expects this era of austerity and healthcare reform to make it increasingly more difficult for pharmaceutical companies to gain reimbursement approval for their new NSCLC therapies.
- Overview of NSCLC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Topline NSCLC drug market revenue from 2015-2025, annual cost of therapy (ACOT), and major product sales in 17 patient segments during the forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, opportunities, R&D strategies, and clinical trial mapping for the NSCLC market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- 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.
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The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- 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 NSCLC market in the 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
1 Table of Contents 10
1.1 List of Tables 14
1.2 List of Figures 26
2 Introduction 30
2.1 Catalyst 30
2.2 Related Reports 30
2.3 Upcoming Related Reports 31
3 Disease Overview 32
3.1 Etiology and Pathophysiology 32
3.2 Classification or Staging Systems 36
3.3 Symptoms 39
3.4 Prognosis 40
3.5 Quality of Life 42
4 Epidemiology 43
4.1 Disease Background 43
4.2 Risk Factors and Comorbidities 44
4.3 Global Trends 46
4.4 Forecast Methodology 49
4.5 Epidemiological Forecast for NSCLC (2015-2025) - Base Forecast 72
4.6 Epidemiological Forecast for NSCLC (2015-2025) - Alternate Forecast 86
4.7 Discussion 89
5 Disease Management 92
5.1 Diagnosis and Treatment Overview 92
5.2 US 102
5.3 France 103
5.4 Germany 104
5.5 Italy 105
5.6 Spain 106
5.7 UK 107
5.8 Japan 108
5.9 China 109
6 Competitive Assessment 110
6.1 Overview 110
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