Non-Small Cell Lung Cancer Therapeutics in Asia-Pacific Markets to 2023 – Launch of Premium Targeted Therapies and Increasing Prevalence to Drive the Market

Non-Small Cell Lung Cancer (NSCLC) is the most common cancer and the leading cause of cancer-related mortality globally. There were more than 1.8 million newly diagnosed lung cancer cases in 2012, accounting for 13% of the total number of cancer cases. This figure has been gradually rising with increased smoking and the growing elderly population. Lung cancer is a leading cause of death worldwide, accounting for 1.69 million deaths in 2015. 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 grow, the prevalence of lung cancer is anticipated to increase, 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 therefore shifting 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, while patients harboring activating mutations in EGFR or ALK can be prescribed targeted therapies such as Tarceva, Iressa, Gilotrif, Conmana, Xalkori, Alecensa and Zykadia.

Opdivo and Keytruda are mAbs, immune checkpoint inhibitors targeted towards programmed cell death (PD) 1, and are recent market entrants. The former gained approval for treating advanced or metastatic squamous NSCLC in Japan in 2015 and in Australia and South Korea in 2016, and the latter gained approval in Japan in 2016 for the first- and second-line treatment of patients with PD-L1-positive unresectable advanced/recurrent NSCLC. Tagrisso and Olita – EGFR inhibitors that targeted towards EGFR T790M – are also recent market entrants, with the former gaining approval in Japan, Australia and South Korea, and the latter approved in South Korea in 2016 for advanced or metastatic patients with EGFR T790M mutation-positive metastatic NSCLC.

There are currently limited options for patients with squamous cell histology or other detectable molecular characteristics besides EFGR and ALK mutations. A therapy that targets mutant KRAS – abemaciclib – is being developed in the pipeline.

Scope

The NSCLC Asia-Pacific market will be valued at $6.2 billion in 2023, growing from $3 billion in 2016 at a CAGR of 10.8%.

– How will immunotherapies such as atezolizumab contribute to 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 limited treatment options 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 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 period, 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 the 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

1 Table of Contents 5

1.1 List of Tables 8

1.2 List of Figures 8

2 Introduction 11

2.1 Disease Introduction 11

2.2 Epidemiology 12

2.3 Symptoms 13

2.4 Etiology and Pathophysiology 14

2.4.1 Adenocarcinoma 15

2.4.2 Squamous-Cell Carcinoma 18

2.4.3 Large-Cell Carcinoma 20

2.4.4 Immunotherapy 21

2.5 Diagnosis 21

2.6 Prognosis 24

2.7 Treatment Guidelines and Options 24

2.7.1 Treatment Algorithm 25

2.7.2 First-Line Treatment 26

2.7.3 Maintenance Therapy 28

2.7.4 Second-Line Treatment 29

2.7.5 Third-Line Therapy 30

2.7.6 Adjuvant Therapy 30

3 Marketed Products 31

3.1 Overview 31

3.2 Chemotherapies 31

3.2.1 Alimta (pemetrexed) - Eli Lilly 31

3.2.2 Abraxane (paclitaxel) - Celgene 32

3.3 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors 33

3.3.1 Tarceva (erlotinib) - Roche 33

3.3.2 Iressa (gefitinib) - AstraZeneca 34

3.3.3 Gilotrif/Giotrif/Xovoltib (afatinib) - Boehringer Ingelheim 35

3.3.4 Tagrisso (osimertinib/AZD-9291) - AstraZeneca 36

3.3.5 Olita (olmutinib) - Hanmi Pharmaceuticals 37

3.3.6 Conmana (icotinib) - Betta Pharmaceuticals 38

3.4 Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors 39

3.4.1 Xalkori (crizotinib) - Pfizer 39

3.4.2 Alecensa (alectinib) - Roche 39

3.4.3 Zykadia (ceritinib/LDK378) - Novartis 40

3.5 Programmed Cell Death Protein 1/Programmed Death Ligand 1 Immune Checkpoint Inhibitors 41

3.5.1 Opdivo (nivolumab) - Bristol-Myers Squibb 41

3.5.2 Keytruda (pembrolizumab) - Merck & Co 42

3.6 Other 43

3.6.1 Avastin (bevacizumab) - Roche 43

3.6.2 Cyramza (Ramucirumab) - Eli Lilly 44

3.6.3 Ofev/Vargatef (Nintedanib) - Boehringer Ingelheim 44

3.7 Conclusion 45

3.8 Comparative Efficacy and Safety of Marketed Products 46

4 Pipeline Analysis 50

4.1 Overview 50

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 51

4.3 Pipeline by Molecular Target 53

4.4 Promising Pipeline Candidates 55

4.4.1 Yervoy (Ipilimumab) - Bristol-Myers Squibb 55

4.4.2 Tecentriq (Atezolizumab) - Roche 57

4.4.3 Necitumumab - Eli Lilly 59

4.4.4 Durvalumab plus Tremelimumab (MEDI-4736/MEDI-1123) - MedImmune 60

4.4.5 Veliparib - AbbVie 62

4.4.6 Vaxira - Recombio 63

4.4.7 Abemaciclib - Eli Lilly 64

4.4.8 Dacomitinib - Pfizer 65

4.4.9 Ensartinib (X-396) - Xcovery 67

4.4.10 Anlotinib (AL-3818) - Jiangsu Chia-Tai Tianqing 68

4.4.11 CimaVax-EGF (BVNSCLC-001) - Bioven 69

4.4.12 Brigatinib (AP-26113) - Ariad Pharmaceuticals 69

4.4.13 Naquotinib Mesylate (ASP8273) - Astellas Pharma 70

4.4.14 Plinabulin - BeyondSpring Pharma 71

4.4.15 Fruquintinib (HMPL-013) - Hutchison MediPharma 72

4.4.16 Famitinib (SHR-1020) - Jiangsu Hengrui Medicine 72

4.4.17 Vandetanib (ZD 6474) - Genzyme 73

4.4.18 Aitan (Apatinib) - Jiangsu Hengrui Medicine 73

4.5 Comparative Efficacy and Safety of Pipeline Products 74

4.6 Product Competitiveness Framework 76

5 Clinical Trial Analysis 79

5.1 Failure Rate 79

5.1.1 Overall Failure Rate 79

5.1.2 Failure Rate by Phase and Molecule Type 80

5.1.3 Failure Rate by Phase and Molecular Target 81

5.2 Clinical Trial Size 82

5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 82

5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 83

5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 84

5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 85

5.3 Clinical Trial Duration 86

5.3.1 Trial Duration by Molecule Type and Stage of Development 86

5.3.2 Trial Duration by Molecular Target and Stage of Development 87

5.4 Summary of Clinical Trial Metrics 88

6 Multi-scenario Forecast 90

6.1 Overview 90

6.2 Asia-Pacific Market 90

6.3 India 92

6.3.1 Treatment Usage Patterns 92

6.3.2 Annual Cost of Therapy 93

6.3.3 Market Size 94

6.4 China 95

6.4.1 Treatment Usage Patterns 95

6.4.2 Annual Cost of Therapy 96

6.4.3 Market Size 97

6.5 Australia 98

6.5.1 Treatment Usage Patterns 98

6.5.2 Annual Cost of Therapy 98

6.5.3 Market Size 99

6.6 South Korea 100

6.6.1 Treatment Usage Patterns 100

6.6.2 Annual Cost of Therapy 101

6.6.3 Market Size 102

6.7 Japan 103

6.7.1 Treatment Usage Patterns 103

6.7.2 Annual Cost of Therapy 104

6.7.3 Market Size 104

7 Drivers and Barriers 106

7.1 Drivers 106

7.1.1 Increasing Pollution and Passive Smoking to Drive the Incidence 106

7.1.2 Increasing Elderly Population and Incidence of NSCLC 106

7.1.3 The Availability of Novel First- and Second-Line Therapy Options in Pipeline 106

7.1.4 Increase in Mutation Testing to Drive Market Growth 106

7.1.5 Diversified Healthcare Reform to Boost Market Growth 107

7.1.6 Diversified Health Insurance System to Help Nurture Growth 107

7.2 Barriers 107

7.2.1 Patent Expiration of Branded Therapies to Affect NSCLC Market Growth 107

7.2.2 High Prices of Therapeutics to Slow Down Market Growth 107

7.2.3 Lack of Reimbursement and Penetration of Generic Drugs to Hinder Market Growth in China and India 108

7.2.4 Drug Pricing Reforms 108

8 Deals and Strategic Consolidations 109

8.1 Licensing Deals 109

8.1.1 Deals by Region and Value 109

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 110

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 111

8.1.4 Key Licensing Deals 114

8.2 Co-development Deals 117

8.2.1 Deals by Region and Value 117

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 117

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 118

8.2.4 Key Co-development Deals 121

9 Appendix 124

9.1 All Pipeline Drugs by Stage of Development 124

9.1.1 Discovery 124

9.1.2 Preclinical 125

9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 131

9.1.4 Phase I 132

9.1.5 Phase II 137

9.1.6 Phase III 143

9.1.7 Pre-registration 144

9.2 Summary of Multi-scenario Market Forecasts to 2023 144

9.2.1 Asia-Pacific 144

9.2.2 India 144

9.2.3 China 145

9.2.4 Australia 145

9.2.5 South Korea 146

9.2.6 Japan 146

9.3 Bibliography 146

9.4 Abbreviations 154

9.5 Research Methodology 156

9.5.1 Secondary Research 157

9.5.2 Marketed Product Profiles 157

9.5.3 Late-Stage Pipeline Candidates 158

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 158

9.5.5 Product Competitiveness Framework 158

9.5.6 Pipeline Analysis 158

9.5.7 Forecasting Model 159

9.5.8 Deals Data Analysis 160

9.6 Contact Us 160

9.7 Disclaimer 161

List of Tables

1.1 List of Tables

Table 1: NSCLC Therapeutics Market, Tumor Node Metastasis Classification 23

Table 2: NSCLC Therapeutics Market, Eastern Co-operative Oncology Group Criteria 24

Table 3: NSCLC Therapeutics Market, Treatment Options 26

Table 4: NSCLC Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006-2016 116

Table 5: NSCLC Therapeutics Market, Global, Co-development Deals Value, 2006-2016 123

Table 6: NSCLC Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 124

Table 7: NSCLC Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017 125

Table 8: Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2017 131

Table 9: NSCLC Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 132

Table 10: NSCLC Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 137

Table 11: NSCLC Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 143

Table 12: NSCLC Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017 144

Table 13: NSCLC Therapeutics Market, APAC, Market Forecast, 2016-2023 144

Table 14: NSCLC Therapeutics Market, India, Market Forecast, 2016-2023 144

Table 15: NSCLC Therapeutics Market, China, Market Forecast, 2016-2023 145

Table 16: NSCLC Therapeutics Market, Australia, Market Forecast, 2016-2023 145

Table 17: NSCLC Therapeutics Market, South Korea, Market Forecast, 2016-2023 146

Table 18: NSCLC Therapeutics Market, Japan, Market Forecast, 2016-2023 146

List of Figures

1.2 List of Figures

Figure 1: NSCLC Therapeutics Market, Australia, Age-Specific Incidence Rate (per 100,000), 2000-2012 13

Figure 2: NSCLC Therapeutics Market, Global, Molecular Characteristic Frequency (%) 15

Figure 3: NSCLC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for First-line Treatment 47

Figure 4: NSCLC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Maintenance Therapy 48

Figure 5: NSCLC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for Treatment of Second-line Treatment 49

Figure 6: NSCLC Therapeutics Market, Global, Pipeline, 2017 52

Figure 7: NSCLC Therapeutics Market, Global, Pipeline by Molecular Target, 2017 54

Figure 8: NSCLC Therapeutics Market, Pipeline by Molecular Target and Stage of Development, 2017 55

Figure 9: NSCLC Therapeutics Market, APAC, Ipilimumab Forecast ($m), 2019-2023 57

Figure 10: NSCLC Therapeutics Market, APAC, Atezolizumab Forecast ($m), 2020-2023 59

Figure 11: NSCLC Therapeutics Market, APAC, Necitumumab Forecast ($m), 2019-2023 60

Figure 12: NSCLC Therapeutics Market, APAC, Durvalumab plus Tremelimumab Forecast ($m), 2020-2023 61

Figure 13: NSCLC Therapeutics Market, APAC, Veliparib Forecast ($m), 2019-2023 63

Figure 14: NSCLC Therapeutics Market, APAC, Vaxira Forecast ($m), 2019-2023 64

Figure 15: NSCLC Therapeutics Market, APAC, Abemaciclib Forecast ($m), 2020-2023 65

Figure 16: NSCLC Therapeutics Market, APAC, Dacomitinib Forecast ($m), 2019-2023 67

Figure 17: NSCLC Therapeutics Market, APAC, Ensartinib Forecast ($m), 2022-2023 68

Figure 18: NSCLC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for First-line Treatment 74

Figure 19: NSCLC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Second-line Treatment 75

Figure 20: NSCLC Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for Third-line Treatment 76

Figure 21: NSCLC Therapeutics Market, Competitor Matrix for NSCLC Marketed and Pipeline First-Line Products, 2017 77

Figure 22: NSCLC Therapeutics Market, Competitor Matrix for NSCLC Marketed and Pipeline Second-Line Products, 2017 78

Figure 23: NSCLC Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 80

Figure 24: NSCLC Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 81

Figure 25: NSCLC Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 82

Figure 26: NSCLC Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 83

Figure 27: NSCLC Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 84

Figure 28: NSCLC Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 85

Figure 29: NSCLC Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 86

Figure 30: NSCLC Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 87

Figure 31: NSCLC Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 88

Figure 32: NSCLC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 88

Figure 33: NSCLC Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 89

Figure 34: NSCLC Therapeutics Market, APAC, Treatment Patterns (‘000), 2016-2023 91

Figure 35: NSCLC Therapeutics Market, APAC, Market Size ($bn), 2016-2023 92

Figure 36: NSCLC Therapeutics Market, India, Treatment Patterns (‘000), 2016-2023 93

Figure 37: NSCLC Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 94

Figure 38: NSCLC Therapeutics Market, India, Market Size ($m), 2016-2023 94

Figure 39: NSCLC Therapeutics Market, China, Treatment Patterns (‘000), 2016-2023 96

Figure 40: NSCLC Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 97

Figure 41: NSCLC Therapeutics Market, China, Market Size ($bn), 2016-2023 97

Figure 42: NSCLC Therapeutics Market, Australia, Treatment Patterns (‘000), 2016-2023 98

Figure 43: NSCLC Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 99

Figure 44: NSCLC Therapeutics Market, Australia, Market Size ($m), 2016-2023 100

Figure 45: NSCLC Therapeutics Market, South Korea, Treatment Patterns (‘000), 2016-2023 101

Figure 46: NSCLC Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 102

Figure 47: NSCLC Therapeutics Market, South Korea, Market Size ($m), 2016-2023 102

Figure 48: NSCLC Therapeutics Market, Japan, Treatment Patterns (‘000), 2016-2023 103

Figure 49: NSCLC Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 104

Figure 50: NSCLC Therapeutics Market, Japan, Market Size ($bn), 2016-2023 105

Figure 51: NSCLC Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 110

Figure 52: NSCLC Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 111

Figure 53: NSCLC Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 112

Figure 54: NSCLC Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2016 113

Figure 55: NSCLC Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2016 114

Figure 56: NSCLC Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2016 117

Figure 57: NSCLC Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2016 118

Figure 58: NSCLC Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016 119

Figure 59: NSCLC Therapeutics Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006-2016 120

Figure 60: NSCLC Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2016 121

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