NSCLC Therapeutics in Asia-Pacific Markets to 2019 Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool GBI Research Report Guidance GBI Research Report Guidance Chapter two provides an overview of the disease, its symptoms, etiology, pathophysiology, diagnosis, classification, epidemiology, prognosis, staging and treatment options. Chapter three provides a detailed profiling and comparative heat map analysis in terms of safety and efficacy for currently marketed products in the NSCLC market. Chapter four presents a detailed pipeline analysis for the disease, including individual product profiles, a comparative efficacy and safety profile heat map analysis of the most promising pipeline products as well as analyses on the distribution of molecule types across the NSCLC developmental pipeline, the molecular targets of pipeline mAbs and the developmental program types. In addition, detailed analyses of the clinical trial failure rates, the clinical trial durations by phase and clinical trial sizes, by participant numbers. Chapter five provides market forecasts for countries across the globe, with special attention given to the APAC countries: India, Australia, China and Japan. The multiple scenario forecasts take into account a range of factors that are likely to vary and provide a clear perspective on the level of the potential degree of variance in the market sizes. Chapter six covers the major deals that have taken place in the disease market in recent years. Coverage includes co-development deals and licensing agreements, which are segmented on the basis of geography and total value. A concomitant analysis of the licensing deal values for products by molecule types and molecular targets is also provided. © GBI Research. This is a licensed product and is not to be photocopied GBIHC326MR / Published MAR 2014 Page 2 Executive Summary Modest growth is driven by Executive Summary the increasing incidence Non-Small Cell Lung Cancer Therapeutics Market to Witness Modest Growth over Forecast Period population and expected launch of premium-priced The launch of premium-priced targeted therapies has changed the Non-Small Cell Lung Cancer (NSCLC) pipeline molecules. 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 $XX billion in 2012 to $XX billion by 2019, in Asia-Pacific (APAC). In 2012, Japan and China had respective shares of XX% and XX% in the NSCLC market of APAC. India and Australia had much lower shares of XX% and XX% respectively. An aging population and increasing number of NSCLC incident cases, especially in China and India, drive the growth in the market. The expected launches of premium-priced novel antibodies and immunotherapies in the first and second lines of therapies, targeting both Non-Squamous NSCLC (NOS NSCLC) and Squamous NSCLC (S NSCLC) patients, widen the eligible treatment population, maximize the patient share and ultimately drive market growth. In spite of many expected drug launches, without the risk of generic erosion of currently entrenched therapies, growth is expected to be marginal due to the dominant generic penetration of a few NSCLC drugs in India. A complex and lengthy regulatory pathway and limited reimbursement from national insurance programs, in China, as well as regular price cuts, in Japan, also limit growth in the APAC market. Non-Small Cell Lung Cancer Therapeutics, Asia-Pacific, Market Size ($bn), 2012 and 2019 Market size ($bn)size Market 2012 2019 China India Japan Australia Source: GBI Research Proprietary Marketed Products Database © GBI Research. This is a licensed product and is not to be photocopied GBIHC326MR / Published MAR 2014 Page 3 Table of Contents 1 Table of Contents 1 Table of Contents ................................................................................................................................. 6 1.1 List of Tables ............................................................................................................................. 8 1.2 List of Figures............................................................................................................................ 8 2 Introduction........................................................................................................................................10 2.1 Symptoms ...............................................................................................................................10 2.2 Etiology ...................................................................................................................................11 2.3 Pathophysiology ......................................................................................................................12 2.4 Co-morbidities and Complications ............................................................................................12 2.5 Diagnosis .................................................................................................................................13 2.5.1 Physical Examination........................................................................................................13 2.5.2 Sputum Cytology ..............................................................................................................13 2.5.3 Imaging Tests...................................................................................................................13 2.5.4 Biopsy ..............................................................................................................................14 2.6 Classification............................................................................................................................15 2.6.1 Adenocarcinoma ..............................................................................................................15 2.6.2 Squamous Cell Carcinoma ................................................................................................15 2.6.3 Large Cell Carcinoma ........................................................................................................15 2.7 Epidemiology ...........................................................................................................................15 2.8 Prognosis and Disease Staging ..................................................................................................16 2.8.1 Staging ............................................................................................................................16 2.9 Treatment Options ..................................................................................................................18 2.9.1 Surgery and Radiation Therapy .........................................................................................18 2.9.2 Pharmacological ..............................................................................................................18 2.9.3 Treatment Algorithms and Prescribing Habits ...................................................................20 3 Marketed Products .............................................................................................................................23 3.1 Therapeutic Landscape ............................................................................................................24 3.1.1 Alimta (pemetrexed disodium) – Eli Lilly and Company ......................................................24 3.1.2 Abraxane (nab-paclitaxel) – Celgene .................................................................................26 3.1.3 Iressa (gefitinib) – AstraZeneca .........................................................................................28 3.1.4 Tarceva (erlotinib hydrochloride) – F. Hoffmann-La Roche .................................................29 3.1.5 Xalkori (crizotinib) – Pfizer ................................................................................................31 3.1.6 Avastin (bevacizumab) – F. Hoffmann-La Roche ................................................................32 3.1.7 Gilotrif (afatinib) – Boehringer Ingelheim ..........................................................................34 3.2 Comparative Efficacy and Safety...............................................................................................34 4 Pipeline Products ................................................................................................................................37 4.1 Overall Pipeline........................................................................................................................37 4.2 Pipeline Analysis by Molecule Type ..........................................................................................39 4.3 Pipeline Analysis by Mechanism of Action ................................................................................41 4.4 Clinical Trials ............................................................................................................................44 4.4.1 Failure Rate .....................................................................................................................44 4.4.2 Patient Enrollment and Clinical Trial Size ...........................................................................46 4.4.3 Duration ..........................................................................................................................48