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Non-Small Cell Lung Cancer Therapeutics in Asia-Pacific Markets to 2022 - Launch of Premium Targeted Therapies and Increasing Prevalence to Drive the Market

Published: Apr 30, 2016 | Pages: 144 | Publisher: GBI Research | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Non-Small Cell Lung Cancer Therapeutics in Asia-Pacific Markets to 2022 - Launch of Premium Targeted Therapies and Increasing Prevalence to Drive the Market

Summary

Non-Small Cell Lung Cancer (NSCLC) is the most common cancer and cause of cancer-related mortality globally. There were more than 1.8 million newly diagnosed lung cancer cases in 2012 globally, accounting for 13% of the total number of cancer cases. Over half of the incident cases of NSCLC are diagnosed in patients over the age of 65 - a high-risk age range for lung cancer. As the aged population is projected to increase, the prevalence of lung cancer is anticipated to increase, thereby acting as a driver for revenue growth. The poor prognosis, particularly for patients with advanced disease, has created a pressing need for improved therapeutic options. The NSCLC market is undergoing a gradual change from a focus on generic chemotherapy regimens to a complex treatment landscape based on different NSCLC subtypes, and the presence of various molecular aberrations.

In the current market, patients with non-squamous histology can be treated with more efficacious therapies such as Alimta (pemetrexed), while patients harboring activating mutations in EGFR or ALK can be prescribed targeted therapies such as Tarceva, Iressa, Xalkori and Gilotrif. Opdivo (nivolumab) - a mAb immune checkpoint inhibitor targeted towards Programmed cell Death (PD) 1 - is a recent market entrant, gaining approval for treating advanced or metastatic squamous NSCLC patients in Japan in 2015 and in Australia in 2016. While the NSCLC developmental pipeline must aim to improve the outlook for all patients, there is currently a lack of options for patients with squamous cell histology or other detectable molecular characteristics besides EFGR and ALK mutations. Therapies that target mutant T790M and KRAS are being developed in the pipeline, with osimertinib, targeting T790M, gaining approval in Japan in 2016.

Scope

The NSCLC Asia-Pacific market will be valued at $4.9 billion in 2022, growing from $2.7 billion in 2015 at a CAGR of 8.7%.
  - How will immunotherapies such as Keytruda contribute to the growth?
  - What effect will patent expirations of currently branded therapies have on market value?
The NSCLC pipeline is large and diverse, with an increased presence of mAbs and targeted therapies.
  - What are the common targets and mechanisms of action of pipeline therapies?
  - Will the pipeline address unmet needs such as a lack of treatments for squamous cell patients?
  - What implications will the increased focus on targeted therapies have on the future of NSCLC treatment?
Numerous late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period.
  - How have the late-stage therapies performed in clinical trials?
  - How would the approval of rociletinib to treat T790M mutant patients affect the competitive landscape, with its competitor osimertinib (AZD-9291) already approved in Japan in 2016?
  - How would the approval of abemaciclib to treat KRAS mutant patients affect the competitive landscape, with no targeted therapy currently available to address this patient subset?
The market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.
  - How will the annual cost of therapy and market size vary between the five Asia-Pacific markets?
  - How could changes in risk factors such as population age, smoking habits and pollution influence the market?
Licensing deals are the most common form of strategic alliance in NSCLC, with total deal values ranging from under $10m to over $1 billion.
  - How do deal frequency and value compare between target families and molecule types?
  - What were the terms and conditions of key licensing deals?

Reasons to buy.

This report will allow you to - 
- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
- Visualize the composition of the NSCLC market in terms of dominant therapies for each patient subset along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the current market.
- Analyze the NSCLC pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
- Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
- Predict NSCLC market growth in the five Asia-Pacific markets with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as individual contributions of promising late-stage molecules to market growth.
- Identify commercial opportunities in the NSCLC deals landscape by analyzing trends in licensing and co-development deals.
 Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8

2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 11
2.3 Symptoms 12
2.4 Etiology and Pathophysiology 13
2.4.1 Adenocarcinoma 14
2.4.2 Squamous-Cell Carcinoma 16
2.4.3 Large-Cell Carcinoma 19
2.4.4 Immunotherapy 20
2.5 Diagnosis 20
2.6 Prognosis 23
2.7 Treatment Guidelines and Options 23
2.7.1 Treatment Algorithm 24
2.7.2 First-Line Treatment 25
2.7.3 Maintenance Therapy 26
2.7.4 Second-Line Treatment 27
2.7.5 Third-Line Therapy 28
2.7.6 Adjuvant Therapy 29

3 Marketed Products 30
3.1 Overview 30
3.2 Chemotherapies 30
3.2.1 Alimta (pemetrexed) - Eli Lilly 30
3.2.2 Abraxane (paclitaxel) - Celgene 31
3.3 Tarceva (erlotinib) - Roche 32
3.4 Iressa (gefitinib) - AstraZeneca 33
3.5 Gilotrif (afatinib) - Boehringer Ingelheim 34
3.6 Xalkori (crizotinib) - Pfizer 35
3.7 Avastin (bevacizumab) - Roche 36
3.8 Opdivo (nivolumab) - Bristol-Myers Squibb 37
3.9 Alecensa (alectinib) - Roche 38
3.10 Conclusion 39
3.11 Comparative Efficacy and Safety of Marketed Products 40

4 Pipeline Analysis 44
4.1 Overview 44
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 45
4.3 Pipeline by Molecular Target 46
4.4 Promising Pipeline Candidates 49
4.4.1 Ipilimumab - Bristol-Myers Squibb 49
4.4.2 Custirsen - OncoGenex 51
4.4.3 Atezolizumab - Roche 52
4.4.4 Necitumumab - Eli Lilly 54
4.4.5 Rociletinib - Clovis 55
4.4.6 Vaxira - Recombio 57
4.4.7 Keytruda - Merck 58
4.4.8 TG4010 - Transgene 60
4.4.9 Veliparib - AbbVie 61
4.4.10 Abemaciclib - Eli Lilly 63
4.4.11 Bavituximab - Peregrine Pharmaceuticals 64
4.4.12 Cyramza (Ramucirumab) - Eli Lilly 65
4.4.13 Zykadia (ceritinib/LDK378) - Novartis 67
4.4.14 Tagrisso (osimertinib/AZD-9291) - AstraZeneca 68
4.4.15 Dacomitinib - Pfizer 70
4.4.16 Selumetinib - AstraZeneca 71
4.5 Comparative Efficacy and Safety of Pipeline Products 72
4.6 Product Competitiveness Framework 73

5 Clinical Trial Analysis 75
5.1 Failure Rate 75
5.1.1 Overall Failure Rate 75
5.1.2 Failure Rate by Phase and Molecule Type 75
5.1.3 Failure Rate by Phase and Molecular Target 76
5.2 Clinical Trial Size 77
5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 78
5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 78
5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 79
5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 80
5.3 Clinical Trial Duration 81
5.3.1 Trial Duration by Molecule Type and Stage of Development 82
5.3.2 Trial Duration by Molecular Target and Stage of Development 82
5.4 Summary of Clinical Trial Metrics 83

6 Multi-scenario Forecast 85
6.1 Overview 85
6.2 Asia-Pacific Market 85
6.3 India 87
6.3.1 Treatment Usage Patterns 87
6.3.2 Annual Cost of Therapy 88
6.3.3 Market Size 89
6.4 China 90
6.4.1 Treatment Usage Patterns 90
6.4.2 Annual Cost of Therapy 91
6.4.3 Market Size 92
6.5 Australia 93
6.5.1 Treatment Usage Patterns 93
6.5.2 Annual Cost of Therapy 93
6.5.3 Market Size 94
6.6 South Korea 95
6.6.1 Treatment Usage Patterns 95
6.6.2 Annual Cost of Therapy 96
6.6.3 Market Size 97
6.7 Japan 98
6.7.1 Treatment Usage Patterns 98
6.7.2 Annual Cost of Therapy 99
6.7.3 Market Size 99

7 Market Dynamics (Drivers and Barriers) 101
7.1 Drivers 101
7.1.1 Increasing pollution and passive smoking to drive the incidence 101
7.1.2 Increasing Elderly Population and Incidence of NSCLC 101
7.1.3 The Availability of Novel First- and Second-Line Therapy Options in Pipeline 101
7.1.4 Increase in Mutation Testing to Drive Market Growth 101
7.1.5 Diversified Healthcare Reform to Boost Market Growth 102
7.1.6 Diversified Health Insurance System to Help Nurture Growth 102
7.2 Barriers 102
7.2.1 Patent Expiration of Branded Therapies to Affect NSCLC Market Growth 102
7.2.2 High Prices of Therapeutics to Slow Down Market Growth 102
7.2.3 Lack of Reimbursement and Penetration of Generic Drugs to Hinder Market Growth in China and India 103

8 Deals and Strategic Consolidations 104
8.1 Co-development Deals 104
8.1.1 Key Co-development Deals 106
8.2 Licensing Deals 107
8.2.1 Key Licensing Deals 111

9 Appendix 113
9.1 All Pipeline Drugs by Stage of Development 113
9.1.1 Discovery 113
9.1.2 Preclinical 114
9.1.3 Investigational New Drug/ Clinical Trial Authorization-filed 118
9.1.4 Phase I 119
9.1.5 Phase II 123
9.1.6 Phase III 128
9.1.7 Pre-registration 130
9.2 Summary of Multi-scenario Market Forecasts to 2022 130
9.2.1 Asia-Pacific 130
9.2.2 India 131
9.2.3 China 131
9.2.4 Australia 131
9.2.5 South Korea 132
9.2.6 Japan 132
9.3 References 132
9.4 Abbreviations 138
9.5 Research Methodology 140
9.5.1 Secondary Research 140
9.5.2 Marketed Product Profiles 141
9.5.3 Late-Stage Pipeline Candidates 141
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 141
9.5.5 Product Competitiveness Framework 141
9.5.6 Pipeline Analysis 142
9.5.7 Forecasting Model 143
9.5.8 Deals Data Analysis 144
9.6 Contact Us 144
9.7 Disclaimer 144
List of Tables
Table 1: NSCLC Therapeutics Market, Tumor Node Metastasis Classification 22
Table 2: NSCLC Therapeutics Market, Eastern Co-operative Oncology Group Criteria 23
Table 3: NSCLC Therapeutics Market, Treatment Options 24
Table 4: NSCLC Therapeutics Market, Global, All Pipeline Products, Discovery, 2015 113
Table 5: NSCLC Therapeutics Market, Global, All Pipeline Products, Preclinical, 2015 114
Table 6: NSCLC Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2015 118
Table 7: NSCLC Therapeutics Market, Global, All Pipeline Products, Phase I, 2015 119
Table 8: NSCLC Therapeutics Market, Global, All Pipeline Products, Phase II, 2015 123
Table 9: NSCLC Therapeutics Market, Global, All Pipeline Products, Phase III, 2015 128
Table 10: NSCLC Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2015 130
Table 11: NSCLC Therapeutics Market, APAC, Market Forecast, 2015-2022 130
Table 12: NSCLC Therapeutics Market, India, Market Forecast, 2015-2022 131
Table 13: NSCLC Therapeutics Market, China, Market Forecast, 2015-2022 131
Table 14: NSCLC Therapeutics Market, Australia, Market Forecast, 2015-2022 131
Table 15: NSCLC Therapeutics Market, South Korea, Market Forecast, 2015-2022 132
Table 16: NSCLC Therapeutics Market, Japan, Market Forecast, 2015-2022 132

List of Figures
Figure 1: NSCLC Therapeutics Market, Australia, Age-Specific Incidence Rate (100,000), 2000-2012 12
Figure 2: NSCLC Therapeutics Market, Global, Molecular Characteristic Frequency (%) 13
Figure 3: NSCLC Therapeutics Market, Market Heatmap, First-Line Products 41
Figure 4: NSCLC Therapeutics Market, Market Heatmap, Maintenance Products 42
Figure 5: NSCLC Therapeutics Market, Market Heatmap, Second-Line Products 43
Figure 6: NSCLC Therapeutics Market, Global, Pipeline, 2015 46
Figure 7: NSCLC Therapeutics Market, Global, Pipeline by Molecular Target, 2015 48
Figure 8: NSCLC Therapeutics Market, Pipeline by Molecular Target and Stage of Development 49
Figure 9: NSCLC Therapeutics Market, APAC, Ipilimumab Forecast ($m), 2017-2022 51
Figure 10: NSCLC Therapeutics Market, APAC, Custirsen Forecast ($m), 2019-2022 52
Figure 11: NSCLC Therapeutics Market, APAC, Atezolizumab Forecast ($m), 2017-2022 54
Figure 12: NSCLC Therapeutics Market, APAC, Necitumumab Forecast ($m), 2017-2022 55
Figure 13: NSCLC Therapeutics Market, APAC, Rociletinib Forecast ($m), 2018-2022 57
Figure 14: NSCLC Therapeutics Market, APAC, Vaxira Forecast ($m), 2019-2022 58
Figure 15: NSCLC Therapeutics Market, APAC, Keytruda Forecast ($m), 2017-2022 60
Figure 16: NSCLC Therapeutics Market, APAC, TG4010 Forecast ($m), 2021-2022 61
Figure 17: NSCLC Therapeutics Market, APAC, Veliparib Forecast ($m), 2019-2022 62
Figure 18: NSCLC Therapeutics Market, APAC, Abemaciclib Forecast ($m), 2019-2022 64
Figure 19: NSCLC Therapeutics Market, APAC, Bavituximab Forecast ($m), 2019-2022 65
Figure 20: NSCLC Therapeutics Market, APAC, Cyramza Forecast ($m), 2017-2022 67
Figure 21: NSCLC Therapeutics Market, APAC, Zykadia Forecast ($m), 2017-2022 68
Figure 22: NSCLC Therapeutics Market, APAC, Tagrisso Forecast ($m), 2016-2022 70
Figure 23: NSCLC Therapeutics Market, Pipeline Heatmap, First-Line Products 72
Figure 24: NSCLC Therapeutics Market, Pipeline Heatmap, Second-Line Products 73
Figure 25: NSCLC Therapeutics Market, Marketed and Pipeline Product Competitiveness Framework 74
Figure 26: NSCLC Therapeutics Market, Clinical Trial Attrition Rates (%) 75
Figure 27: NSCLC Therapeutics Market, Clinical Trial Attrition Rates by Molecule Type (%) 76
Figure 28: NSCLC Therapeutics Market, Clinical Trial Attrition Rates by Molecular Target (%) 77
Figure 29: NSCLC Therapeutics Market, Clinical Trial Size per Product by Molecule Type (participants) 78
Figure 30: NSCLC Therapeutics Market, Clinical Trial Size per Product Molecular Target (participants) 79
Figure 31: NSCLC Therapeutics Market, Clinical Trial Size per Individual Trial by Molecule Type (participants) 80
Figure 32: NSCLC Therapeutics Market, Clinical Trial Size per Individual Trial by Molecular Target (participants) 81
Figure 33: NSCLC Therapeutics Market, Clinical Trial Duration by Molecule Type (months) 82
Figure 34: NSCLC Therapeutics Market, Clinical Trial Duration by Molecular Target (months) 83
Figure 35: NSCLC Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecule Type 83
Figure 36: NSCLC Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecular Target 84
Figure 37: NSCLC Therapeutics Market, APAC, Treatment Patterns (‘000), 2015-2022 86
Figure 38: NSCLC Therapeutics Market, APAC, Market Size ($bn), 2015-2022 87
Figure 39: NSCLC Therapeutics Market, India, Treatment Patterns (‘000), 2015-2022 88
Figure 40: NSCLC Therapeutics Market, India, Annual Cost of Therapy ($), 2015-2022 89
Figure 41: NSCLC Therapeutics Market, India, Market Size ($m), 2015-2022 89
Figure 42: NSCLC Therapeutics Market, China, Treatment Patterns (‘000), 2015-2022 91
Figure 43: NSCLC Therapeutics Market, China, Annual Cost of Therapy ($), 2015-2022 92
Figure 44: NSCLC Therapeutics Market, China, Market Size ($bn), 2015-2022 92
Figure 45: NSCLC Therapeutics Market, Australia, Treatment Patterns (‘000), 2015-2022 93
Figure 46: NSCLC Therapeutics Market, Australia, Annual Cost of Therapy ($), 2015-2022 94
Figure 47: NSCLC Therapeutics Market, Australia, Market Size ($m), 2015-2022 95
Figure 48: NSCLC Therapeutics Market, South Korea, Treatment Patterns (‘000), 2015-2022 96
Figure 49: NSCLC Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2015-2022 97
Figure 50: NSCLC Therapeutics Market, South Korea, Market Size ($m), 2015-2022 97
Figure 51: NSCLC Therapeutics Market, Japan, Treatment Patterns (‘000), 2015-2022 98
Figure 52: NSCLC Therapeutics Market, Japan, Annual Cost of Therapy ($), 2015-2022 99
Figure 53: NSCLC Therapeutics Market, Japan, Market Size ($bn), 2015-2022 100
Figure 54: NSCLC Therapeutics Market, Co-development Deals by Territory, 2006-2015 104
Figure 55: NSCLC Therapeutics Market, Co-development Deals Overview, 2006-2015 105
Figure 56: NSCLC Therapeutics Market, Co-development by Molecule Type, 2006-2015 105
Figure 57: NSCLC Therapeutics Market, Co-development by Molecular Target, 2006-2015 106
Figure 58: NSCLC Therapeutics Market, Licensing Deals by Territory, 2006-2015 108
Figure 59: NSCLC Therapeutics Market, Licensing Deals Overview, 2006-2015 109
Figure 60: NSCLC Therapeutics Market, Licensing Deals by Molecule Type, 2006-2015 110
Figure 61: NSCLC Therapeutics Market, Licensing Deals by Molecular Target, 2006-2015 110 



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