cyramza (colorectal cancer) – forecast …the following figure illustrates the global sales for...
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REFERENCE CODE GDHC476DFR | PUBLICAT ION DATE NOVEMBER 2014
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
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CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
Table below presents the key metrics of Cyramza
for colorectal cancer (CRC) in the eight major
pharmaceutical markets (8MM) (US, France,
Germany, Italy, Spain, UK, Japan, and China)
during the forecast period from 2013–2023.
Cyramza: Key Metrics in the 7MM and China for Colorectal Cancer, 2013-2023
Key events (2013-2023) Level of Impact
Launch of Cyramza (ramucirumab) in the second-line Avastin pre-treated metastatic setting in 2016
↑↑
2023 Market Sales
US $ 130.5m
5EU $ 39.9m
Japan $ 23.9m
Total $194.3m Source: GlobalData 7MM= US, France, Germany, Italy, Spain, the UK, Japan and China 5EU = France, Germany, Italy, Spain, and the UK
Sales for Cyramza in the Colorectal Cancer Market
GlobalData estimates that sales of Cyramza for
CRC markets were $25.2 million in the year 2016
when it will be launched. By 2023, the end of the
forecast period, GlobalData projects Cyramza
sales at $194.3 million in the 8MM.
Major drivers of the growth of Cyramza in the CRC
market over the forecast period include:
Eli Lilly’s experience commercializing oncology
products.
Demonstrated statistically significant efficacy
benefit with FOLFIRI compared to FOLFIRI
alone in a Phase III study.
Prescribed with FOLFIRI, a common second-
line chemotherapy regimen.
Has demonstrated single-agent activity in
another GI cancer (gastric cancer), a disease
where Avastin failed to demonstrate clinical
benefit.
Major barriers to the growth of Cyramza in the
CRC market will include:
Not being investigated as a single-agent in
CRC.
Restrictive eligible patient population of Avastin
+ FOLFOX pre-treated patients only.
Lack of available clinical data.
The following figure illustrates the global sales for
Cyramza in the CRC markets by region during the
forecast period.
Sales for Cyramza by Region, 2023
67%
21%
12%
2023Total: $194.3m
US
5EU
Japan
Source: GlobalData
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CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
What Do the Physicians Think?
Key Opinion Leaders (KOLs) do not expect results
from the FIRE-3 study comparing Erbitux and
Avastin in the first-line KRAS wild-type metastatic
setting to have a major impact on prescribing
behavior.
“I am not sure [the results from the FIRE-3 study]
are going to make a huge difference. I think, in
practice at least, in the US, for patients who are
KRAS wild-type, the choice of Erbitux vs. Avastin
has really been something that the physician has
chosen on their own. I think there are some
physicians who really like to use Erbitux, and use it
up front, and other people who always prescribed
Avastin and either don’t use Erbitux at all or really
use it more at a later stage.”
US Key Opinion Leader
“Avastin is the standard of care for both KRAS
wild-type and KRAS mutated patients. This is the
perception right now for the US as a whole. There
are pockets, perhaps, where people probably are
moving to Erbitux plus FOLFIRI, but I would say
majority is still Avastin frontline.”
US Key Opinion Leader
“The reason for using Avastin as a first-line
treatment is due to the side-effect profile compared
to Erbitux, rather than the efficacy. The side effect
of most concern with Erbitux is the rash.”
US Key Opinion Leader
Interviewed KOLs expect Zaltrap and Cyramza
(ramucirumab) to struggle to garner much uptake
in the second-line metastatic setting.
“In second-line [setting] you have Avastin, Zaltrap,
and now, [potentially,] ramucirumab. For
ramucirumab, to be honest, I think it will come
down to what the survival data looks like. If it’s only
as good as or worse than the other two, then,
being the third player to join the party, I don’t think
it has much chance of becoming a standard of
care…”
OUS Key Opinion Leader
“In my view there is no probable advantage [of
Zaltrap] over Avastin continuation, and [in my
experience] there seems to be more side effects
with Zaltrap than Avastin; so I really don’t prefer to
use Zaltrap at this time.”
US Key Opinion Leader
Interviewed experts reported high unmet need for
targeted treatments for KRAS and BRAF mutation-
positive CRC patients.
“Unmet needs in overall survival are greater for
KRAS mutated patients. We need to have new
drugs to try to increase overall survival in this
population. [Overall], I think now we need to have a
different strategy for KRAS and for BRAF patients.
It’s important to have different strategy.”
OUS Key Opinion Leader
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CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
Executive Summary
“BRAF mutant-positive colorectal cancer patients
are a subset with very poor prognosis; most
patients really have a very rapid and progressive
course and it is a pretty nasty disease. But, I think
his is probably the area where in the area of
targeted therapies we may see perhaps the most
exciting developments in the next few years for
colorectal cancer”
US Key Opinion Leader
Interviewed KOLs are excited about the potential of
kinase inhibitor combinations, such as BRAF/MEK
with EGFR inhibitors for BRAF mutation-positive
disease, and the immune checkpoint inhibitors,
such as the anti-PD1/PDL1 antibodies.
“The high level question is the comparison
between the doublet BRAF/EGFR combinations to
some of the potential triplet BRAF/MEK/EGFR or
BRAF/PI3K/EGFR combinations. If they are
tolerable, I really think that those triplets are going
to be the better way to go. I am hopeful we could
see some, potentially, really exciting advances in
the ‘oncogene-addiction’ treatment category.”
US Key Opinion Leader
“The PD1 and PDL1 inhibitors are exciting, and so
far, in CRC, they have only been tested in a very
small number of patients. But I think there is
enough there to warrant the [further] exploration of
this space in colorectal cancer. It remains to be
seen what happens, but I know there is a lot of
excitement about that.”
US Key Opinion Leader
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Table of Contents
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
1 Table of Contents
1 Table of Contents ....................................................................................................................... 5
1.1 List of Tables ...................................................................................................................... 8
1.2 List of Figures ..................................................................................................................... 8
2 Introduction ................................................................................................................................. 9
2.1 Catalyst ............................................................................................................................... 9
2.2 Related Reports ................................................................................................................ 10
2.3 Upcoming Related Reports ............................................................................................... 11
3 Disease Overview ..................................................................................................................... 12
3.1 Etiology and Pathophysiology ........................................................................................... 12
3.1.1 Etiology ......................................................................................................................... 12
3.1.2 Pathophysiology ............................................................................................................ 14
3.2 Clinical Staging ................................................................................................................. 15
3.3 Symptoms ......................................................................................................................... 16
4 Disease Management ............................................................................................................... 18
4.1 Diagnosis and Treatment Overview .................................................................................. 18
4.1.1 Screening and Diagnosis .............................................................................................. 18
4.1.2 Treatment Guidelines and Leading Prescribed Drugs ................................................... 21
4.1.3 Clinical Practice ............................................................................................................. 25
5 Competitive Assessment .......................................................................................................... 32
5.1 Overview ........................................................................................................................... 32
6 Unmet Need and Opportunity ................................................................................................... 34
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Table of Contents
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
6.1 Overview ........................................................................................................................... 34
6.2 Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients ......... 35
6.2.1 Unmet Need .................................................................................................................. 35
6.2.2 Gap Analysis ................................................................................................................. 37
6.2.3 Opportunity ................................................................................................................... 37
6.3 Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients ............................... 39
6.3.1 Unmet Need .................................................................................................................. 39
6.3.2 Gap Analysis ................................................................................................................. 40
6.3.3 Opportunity ................................................................................................................... 40
6.4 Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease .................. 41
6.4.1 Unmet Need .................................................................................................................. 41
6.4.2 Gap Analysis ................................................................................................................. 42
6.4.3 Opportunity ................................................................................................................... 42
6.5 Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients ............................. 43
6.5.1 Unmet Need .................................................................................................................. 43
6.5.2 Gap Analysis ................................................................................................................. 43
6.5.3 Opportunity ................................................................................................................... 44
7 Pipeline Assessment................................................................................................................. 45
7.1 Overview ........................................................................................................................... 45
7.2 Promising Drugs in Clinical Development .......................................................................... 46
8 Cyramza (Ramucirumab) .......................................................................................................... 48
8.1 Overview ........................................................................................................................... 48
8.2 Efficacy ............................................................................................................................. 51
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Table of Contents
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
8.3 Safety ............................................................................................................................... 51
8.4 Dosing and Formulation .................................................................................................... 51
8.5 Potential Clinical and Commercial Positioning................................................................... 52
8.6 SWOT Analysis ................................................................................................................. 53
8.7 Forecast ............................................................................................................................ 54
9 Appendix................................................................................................................................... 55
9.1 Bibliography ...................................................................................................................... 55
9.2 Abbreviations .................................................................................................................... 60
9.3 Methodology ..................................................................................................................... 64
9.4 Forecasting Methodology .................................................................................................. 64
9.4.1 Diagnosed Colorectal Cancer Patients .......................................................................... 64
9.4.2 Percent Drug-Treated Patients ...................................................................................... 65
9.4.3 General Pricing Assumptions ........................................................................................ 65
9.4.4 Average Body Weight and Surface Area Across the 8MM ............................................. 66
9.4.5 Generic Erosion ............................................................................................................ 66
9.4.6 Pricing of Pipeline Agents.............................................................................................. 66
9.5 Primary Research – KOLs Interviewed for this Report ...................................................... 67
9.6 Primary Research – Prescriber Survey ............................................................................. 69
9.7 About the Authors ............................................................................................................. 70
9.7.1 Analyst .......................................................................................................................... 70
9.7.2 Global Head of Healthcare ............................................................................................ 71
9.8 About GlobalData .............................................................................................................. 72
9.9 Disclaimer ......................................................................................................................... 72
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Table of Contents
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
1.1 List of Tables
Table 1: TNM and Staging Classification System for CRC ......................................................................... 16
Table 2: Symptoms of Colorectal Cancer .................................................................................................. 17
Table 3: Treatment Guidelines for CRC ..................................................................................................... 22
Table 4: Most-Prescribed Neoadjuvant/Adjuvant Regimens for Early-Stage CRC in the Global Markets,
2013............................................................................................................................................ 23
Table 5: Most Prescribed Targeted Therapies for Metastatic CRC by Segment in the Global Markets, 2013
................................................................................................................................................... 24
Table 6: Leading Treatments for CRC, 2014 ............................................................................................. 33
Table 7: Unmet Need and Opportunity in CRC .......................................................................................... 35
Table 8: Product Profile – Cyramza ........................................................................................................... 50
Table 9: Cyramza SWOT Analysis, 2014 .................................................................................................. 53
Table 10: Global Sales Forecasts ($m) for Cyramza, 2013-2023 ................................................................. 54
Table 11: Average Body Weight and Surface Area Across the 8MM ............................................................ 66
Table 12: High-Prescribing Physicians (non-KOLs) Surveyed, By Country .................................................. 69
1.2 List of Figures
Figure 1: CRC – Phase III Pipeline ............................................................................................................. 46
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023................................ 47
Figure 3: Clinical and Commercial Positioning of Cyramza ......................................................................... 52
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CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
Introduction
2 Introduction
2.1 Catalyst
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. Despite robust screening programs across most of the 8MM (US, France,
Germany, Italy, Spain, UK, Japan, and China), a significant proportion (10-20%) of patients are
diagnosed with stage IV metastatic disease and correspondingly poor prognoses, compared to
resectable early-stage disease. 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 Mologen’s MGN1703, Eli Lilly’s Cyramza (ramucirumab), and
Boehringer Ingelheim’s nintedanib. These pipeline agents will be utilized across different segments
of the metastatic population, from the first-line maintenance setting (MGN1703) to the second- and
later-line settings (Cyramza and nintedanib). Furthermore, GlobalData expects the label extension
of Stivarga as a first-line adjuvant treatment for metastatic CRC patients with resected liver
metastases. Stivarga is currently approved for the smaller third- or fourth-line, chemotherapy, and
targeted-treatment refractive settings. 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.
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CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
Introduction
2.2 Related Reports
GlobalData (2014). HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis
to 2023, September 2014, GDHC86PIDR
GlobalData (2014). Non-Hodgkin’s B-Cell Lymphoma – Opportunity Analysis and Forecast to
2018, August 2014, GDHC035POA
GlobalData (2014). Chronic Lymphocytic Leukemia (CLL) – Opportunity Analysis and
Forecasts to 2018, June 2014, GDHC017POA
GlobalData (2014). Non-Small Cell Lung Cancer (NSCLC) – Global Drug Forecast and Market
Analysis to 2022 – Event-Driven Update, April 2014, GDHC002EPIDR
GlobalData (2014). Pancreatic Cancer – Opportunity Analysis and Forecasts to 2017, March
2014, GDHC016POA
GlobalData (2013). Bladder Cancer – Opportunity Analysis and Forecasts to 2017, December
2013, GDHC014POA
GlobalData (2014). Colorectal Cancer – Global Drug Forecast and Market Analysis to 2023,
November 2014, GDHC95PIDR
GlobalData (2014). Colorectal Cancer – US Drug Forecast and Market Analysis to 2023,
November 2014, GDHC257CFR
GlobalData (2014). Colorectal Cancer – 5EU Drug Forecast and Market Analysis to 2023,
November 2014, GDHC258CFR
GlobalData (2014). Colorectal Cancer – Japan Drug Forecast and Market Analysis to 2023,
November 2014, GDHC259CFR
GlobalData (2014). Colorectal Cancer – China Drug Forecast and Market Analysis to 2023,
November 2014, GDHC260CFR
GlobalData. Avastin (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC469DFR
GlobalData. Erbitux (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC470DFR
Cyramza (Colorectal Cancer) – Forecast and Market Analysis to 2023 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
Introduction
GlobalData. Vectibix (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC471DFR
GlobalData. Stivarga (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC472DFR
GlobalData. Zaltrap (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC473DFR
GlobalData. TS-1 (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC474DFR
GlobalData. Lonsurf (Colorectal Cancer) – Forecast and Market Analysis to 2023, November
2014, GDHC475DFR
GlobalData. Imprime PGG (Colorectal Cancer) – Forecast and Market Analysis to 2023,
November 2014, GDHC477DFR
GlobalData. MGN1703 (Colorectal Cancer) – Forecast and Market Analysis to 2023,
November 2014, GDHC478DFR
GlobalData. Nintedanib (Colorectal Cancer) – Forecast and Market Analysis to 2023,
November 2014, GDHC479DFR
GlobalData. Colorectal Cancer – Current and Future Players, November 2014,
GDHC1039FPR
2.3 Upcoming Related Reports
GlobalData (2014). HER2-Negative Breast Cancer – Global Drug Forecast and Market
Analysis to 2023
GlobalData (2014). Malignant Melanoma – Global Drug Forecast and Market Analysis to 2023
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Appendix
CYRAMZA (COLORECTAL CANCER) – FORECAST AND MARKET ANALYSIS TO 2023
9.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India and Singapore.
9.9 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior
permission of the publisher, GlobalData.