PharmaPoint: Colorectal Cancer - Global Drug Forecast and Market Analysis to 2023


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GlobalData

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PharmaPoint: Colorectal Cancer - Global Drug Forecast and Market Analysis to 2023

Summary

Colorectal cancer (CRC) is the second leading cause of mortality among cancer patients in the world and is the third most diagnosed cancer globally, and thus represents a huge burden on healthcare systems. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the colorectal cancer market, with coverage of multiple settings of the disease including neoadjuvant/adjuvant, first-, second-, third-line KRAS wild-type and mutation-positive, and fourth-line metastatic. In terms of targeted treatments, the metastatic CRC treatment landscape is mature, including the branded treatments Avastin (bevacizumab), Erbitux (cetuximab), and Vectibix (panitumumab), treatments that have extended the survival of metastatic patients compared to chemotherapy-only regimens. However, high unmet needs remain for the extension of survival of metastatic patients, and particularly those with KRAS mutation-positive disease, for whom the epidermal growth factor receptor (EGFR) inhibitors Erbitux and Vectibix are not recommended. The CRC market is expected to grow due to the incorporation of five late-stage pipeline agents during the forecast period, including Mologens MGN1703, Eli Lillys Cyramza, and Boehringer Ingelheims nintedanib. Furthermore, GlobalData expects the label extension of Stivarga as a first-line adjuvant treatment for metastatic CRC patients with resected liver metastases. Ultimately, however, GlobalData expects unmet needs to remain unfulfilled by these pipeline agents, and anticipates that novel, innovative approaches, such as those targeting BRAF mutation-positive disease and immune checkpoint inhibitors, will provide the best opportunity for substantial improvement in the prognosis of advanced CRC patients.

Highlights

Key Questions Answered

- What are the corporate strategies being used by drug makers?
- How is the disease management evolving? What is the impact for drug manufacturers?
- What opportunities remain after the launch of pipeline agents?
- How large are the metastatic KRAS wild-type and mutation-positive CRC markets for branded agents, and which are growing the fastest?
- What exciting, innovative approaches are being investigated in CRC? Which immunotherapies are of interest to the CRC market?
- What do KOLs think about the latest therapies and drug development strategies?

Key Findings

- By 2023, the end of the forecast period, GlobalData projects CRC sales to rise to $8.11 billion in the 8MM, at a moderate Compound Annual Growth Rate (CAGR) of 4.9%. Major drivers of the growth of the CRC market over the forecast period include increasing CRC incident cases, the launch of premium-priced adjuvant and maintenance treatments for first-line metastatic disease, and the launch of pipeline agents for later-line CRC.
- Roches anti-angiogenesis drug Avastin has been the best-selling brand in CRC for many years, and, after label extension in the second-line continuation setting, is set to remain the market leader across the forecast period. However, competition in this drug class is expected to become more intense, especially in the second-line metastatic setting, as Sanofi/Regenerons Zaltrap and Eli Lillys pipeline agent Cyramza (ramucirumab) garner uptake across the major markets.
- GlobalData expects the next surge of anti-angiogenesis drugs to be focused on the anti-Ang2 inhibitor class. This class is likely to be led by Roches dual anti-VEGF/Ang2 inhibiting antibody vanucizumab (RO5520985; RG7221). Roche is currently investigating vanucizumab head-to-head against Avastin in a randomized Phase II study. If this agent is successful in a large, pivotal study, GlobalData anticipates vanucizumab to become a key part of Roches strategy to overcome biosimilar erosion of Avastin towards the end of the forecast period.
- Interviewed KOLs are enthusiastic about early-stage innovative approaches targeting metastatic CRC patients with BRAF and KRAS mutation-positive disease, and immune checkpoint inhibitors such as the anti-PD1/PDL1 drugs. With Big Pharma taking a leading role, GlobalData expects the targeted, biomarker-driven approach for the treatment of metastatic CRC to become a significant R&D strategy for developers during and beyond the forecast period.

Scope

- Overview of colorectal cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized Colorectal cancer therapeutics market revenue, annual cost of therapy, and treatment usage patterns in eight patient segments, forecast from 2013 to 2023.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, remaining commercial opportunities, and current and future players for the colorectal cancer therapeutics market.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for different lines of therapy. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global colorectal cancer therapeutics 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 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 colorectal cancer therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global colorectal cancer therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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.
and Diagnosis 65
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 68
5.1.3 Clinical Practice 72
5.2 US 78
5.2.1 Screening and Diagnosis 80
5.2.2 Clinical Practice 81
5.3 France 83
5.3.1 Screening and Diagnosis 85
5.3.2 Clinical Practice 85
5.4 Germany 87
5.4.1 Screening and Diagnosis 89
5.4.2 Clinical Practice 89
5.5 Italy 91
5.5.1 Screening and Diagnosis 93
5.5.2 Clinical Practice 93
5.6 Spain 95
5.6.1 Screening and Diagnosis 97
5.6.2 Clinical Practice 97
5.7 UK 99
5.7.1 Screening and Diagnosis 101
5.7.2 Clinical Practice 101
5.8 Japan 103
5.8.1 Screening and Diagnosis 105
5.8.2 Clinical Practice 105
5.9 China 107
5.9.1 Screening and Diagnosis 108
5.9.2 Clinical Practice 108
6 Competitive Assessment 110
6.1 Overview 110
6.2 Product Profiles Major Brands 111
6.2.1 Avastin (Bevacizumab) 111
6.2.2 Erbitux (Cetuximab) 117
6.2.3 Vectibix (Panitumumab) 122
6.2.4 Stivarga (Regorafenib) 126
6.2.5 Zaltrap (Ziv-Aflibrcept) 131
6.2.6 Lonsurf (TAS-102) 135
6.2.7 TS-1 (Tegafur, Gimeracil, Oteracil) 140
6.2.8 Xeloda (Capecitabine) 144
7 Unmet Need and Opportunity 148
7.1 Overview 148
7.2 Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients 149
7.2.1 Unmet Need 149
7.2.2 Gap Analysis 151
7.2.3 Opportunity 151
7.3 Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients 153
7.3.1 Unmet Need 153
7.3.2 Gap Analysis 154
7.3.3 Opportunity 154
7.4 Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease 155
7.4.1 Unmet Need 155
7.4.2 Gap Analysis 156
7.4.3 Opportunity 156
7.5 Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients 157
7.5.1 Unmet Need 157
7.5.2 Gap Analysis 157
7.5.3 Opportunity 158
8 Pipeline Assessment 159
8.1 Overview 159
8.2 Promising Drugs in Clinical Development 160
8.2.1 Cyramza (Ramucirumab) 161
8.2.2 Imprime PGG 167
8.2.3 MGN1703 173
8.2.4 Nintedanib (BIBF-1120) 179
8.3 Promising Approaches in Early-Stage Development 184
8.3.1 Anti-Angiopoietin-2 Inhibitors 184
8.3.2 Strategies for BRAF Mutation-Positive Disease 186
8.3.3 Strategies for KRAS-Mutation Positive Disease 192
8.3.4 Immune Checkpoint Inhibitors 196
9 Current and Future Players 201
9.1 Overview 201
9.2 Trends in Corporate Strategy 205
9.3 Company Profiles 207
9.3.1 Roche/Genentech 207
9.3.2 Sanofi 211
9.3.3 Eli Lilly and Company 214
9.3.4 Merck KGaA 217
9.3.5 Bayer 220
9.3.6 Taiho Pharmaceutical 223
10 Market Outlook 226
10.1 Global Markets 226
10.1.1 Forecast 226
10.1.2 Drivers and Barriers - Global Issues 230
10.2 United States 233
10.2.1 Forecast 233
10.2.2 Key Events 237
10.2.3 Drivers and Barriers 237
10.3 France 240
10.3.1 Forecast 240
10.3.2 Key Events 244
10.3.3 Drivers and Barriers 244
10.4 Germany 247
10.4.1 Forecast 247
10.4.2 Key Events 251
10.4.3 Drivers and Barriers 251
10.5 Italy 253
10.5.1 Forecast 253
10.5.2 Key Events 257
10.5.3 Drivers and Barriers 257
10.6 Spain 259
10.6.1 Forecast 259
10.6.2 Key Events 263
10.6.3 Drivers and Barriers 263
10.7 United Kingdom 265
10.7.1 Forecast 265
10.7.2 Key Events 269
10.7.3 Drivers and Barriers 269
10.8 Japan 272
10.8.1 Forecast 272
10.8.2 Key Events 276
10.8.3 Drivers and Barriers 276
10.9 China 278
10.9.1 Forecast 278
10.9.2 Key Events 282
10.9.3 Drivers and Barriers 282
11 Appendix 286
11.1 Bibliography 286
11.2 Abbreviations 322
11.3 Methodology 329
11.4 Forecasting Methodology 329
11.4.1 Diagnosed Colorectal Cancer Patients 329
11.4.2 Percent Drug-Treated Patients 330
11.4.3 Drugs Included in Each Therapeutic Class 330
11.4.4 Launch and Patent Expiration Dates 331
11.4.5 General Pricing Assumptions 332
11.4.6 Average Body Weight and Surface Area Across the 8MM 333
11.4.7 Individual Drug Assumptions 333
11.4.8 Generic Erosion 339
11.4.9 Pricing of Pipeline Agents 339
11.5 Primary Research - KOLs Interviewed for this Report 340
11.6 Primary Research - Prescriber Survey 342
11.7 About the Authors 343
11.7.1 Analyst 343
11.7.2 Epidemiologist 343
11.7.3 Global Head of Healthcare 344
11.8 About GlobalData 345
11.9 Disclaimer 345

1.1 List of Tables
Table 1: TNM and Staging Classification System for CRC 29
Table 2: Symptoms of Colorectal Cancer 30
Table 3: Risk Factors and Comorbidities for CRC 33
Table 4: 8MM, Five-Year Relative Survival 37
Table 5: 8MM, Sources of CRC Incidence Data 40
Table 6: 8MM, Sources of CRC Diagnosed Five-Year Prevalent Cases Data 42
Table 7: 8MM, Sources of CRC Cancer Stage at Diagnosis Data 43
Table 8: 8MM, Diagnosed Incident Cases of CRC, Both Sexes, Ages