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Votrient (Renal Cell Carcinoma) – Analysis and Forecasts to 2022
Published March 2012
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Votrient (Renal Cell Carcinoma) – Analysis and Forecasts to 2022
Reference Code: GDHC0011RCCDVR
The Renal Cell Carcinoma (RCC) Disease Therapeutics
Market
Publication Date: March 2012
GlobalData’s analysis suggests that the combined RCC market
in the US, EU-5 (the UK, France, Germany, Italy and Spain)
and Japan was worth c. $x billion in 2010 and is likely to grow
to c. $xx billion by 2022 at a Compound Annual Growth Rate
(CAGR) of x%. The worldwide oncology market in 2010 was c.
$xx billion and it is expected to grow further at a CAGR of
around xx% - xx%.
Votrient (pazopanib) Therapeutic Market
Votrient is a product of GlaxoSmithKline (GSK), the UK based
global pharmaceutical company. It is a potent and selective
multi–targeted receptor tyrosine kinase inhibitor. Votrient
received its first US Food and Drug Administration (FDA)
approval and EU approval for the treatment of advanced renal
cell carcinoma in October 2009 and June 2010 respectively. It
is expected to be approved in Japan for the treatment of
advanced RCC in 2014. Based on the estimated primary
completion date of the trial, the drug is expected to be approved
for the adjuvant treatment of RCC in 2017. Votrient is also
under trials for ovarian cancer and age-related macular
degeneration. It is expected to get approval in 2012, for the
treatment of soft-tissue sarcoma.Votrient currently faces
competition mainly from Pfizer’s Sutent, Genentech/Roche’s
Avastin and Onyx/Bayer’s Nexavar in the treatment of RCC.
Pfizer’s Inlyta which entered the RCC market in 2012 is also
supposed to pose strong competition to Votrient. The entry of
late stage pipeline drugs such as AVEO’s tivozanib and Active
Biotech’s Anyara is expected to further increase the
competition. The global sales of Votrient in RCC are expected
to increase at a CAGR of xx% during 2010 to 2021.
Oncology, Worldwide, Market Size Forecasts ($bn),
2005–2015
Source: GlobalData
RCC, Global, Market Size Forecasts ($bn), 2010–2022
Source: GlobalData
Votrient, Renal Cell Carcinoma, Global, Sales Estimates
($m), 2009–2022
Source: GlobalData
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Votrient (Renal Cell Carcinoma) – Analysis and Forecasts to 2022
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1 Table of contents
1 Table of contents ................................................................................................................................... 2
1.1 List of Tables .................................................................................................................................. 4
1.2 List of Figures ................................................................................................................................. 5
2 Introduction ........................................................................................................................................... 6
2.1 RCC 6
2.1.1 Types of Renal Cell Carcinoma ............................................................................................. 6
2.2 RCC Market .................................................................................................................................... 7
2.3 Epidemiology .................................................................................................................................. 7
2.4 Pathophysiology ............................................................................................................................10
2.5 Etiology ..........................................................................................................................................10
2.5.1 Cigarette Smoking ................................................................................................................10
2.5.2 Obesity .................................................................................................................................11
2.5.3 Acquired Cystic Disease .......................................................................................................11
2.5.4 Hypertension ........................................................................................................................11
2.5.5 Family History of Kidney Cancer ..........................................................................................11
2.5.6 High Blood Pressure .............................................................................................................11
2.5.7 Usage of Certain Medicines ..................................................................................................11
2.5.8 Advanced Kidney Disease ....................................................................................................11
2.5.9 Gender and Race .................................................................................................................11
2.5.10 Genetic and Hereditary Risk Factors ....................................................................................12
2.5.11 Symptoms .............................................................................................................................12
2.5.12 Diagnosis ..............................................................................................................................12
2.6 GlobalData Pipeline Report Guidance ...........................................................................................15
3 RCC Disease: Market Characterization ................................................................................................16
3.1 RCC Disease Market .....................................................................................................................16
3.2 RCC Disease Market Forecasts and CAGR ..................................................................................16
3.3 Drivers for the RCC Disease Market ..............................................................................................16
3.3.1 High Incidence ......................................................................................................................17
3.3.2 High Prevalence ...................................................................................................................18
3.3.3 Emergence of Targeted Therapies .......................................................................................18
3.3.4 Large Unmet Need ...............................................................................................................18
3.4 Tumor-Node-Metastases (TNM) Classification of RCC .................................................................19
3.4.1 Staging .................................................................................................................................19
3.4.2 Grading .................................................................................................................................21
3.4.3 Prognosis..............................................................................................................................21
3.5 Treatment Options in RCC ............................................................................................................22
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3.5.1 Surgery .................................................................................................................................22
3.5.2 Radiation therapy .................................................................................................................23
3.5.3 Chemotherapy ......................................................................................................................23
3.5.4 Targeted Therapies ..............................................................................................................23
3.5.5 Tyrosine Kinase Inhibitors ....................................................................................................25
3.5.6 Mammalian Target of Rapamycin (mTOR) Inhibitor .............................................................25
3.5.7 Vascular Endothelial Growth Factor (VEGF) Inhibitor ..........................................................26
3.5.8 Treatment by Stage ..............................................................................................................26
3.6 Classification of Patients with RCC ................................................................................................29
4 Votrient (pazopanib) .............................................................................................................................30
4.1 Introduction ....................................................................................................................................30
4.2 Mechanism of Action .....................................................................................................................30
4.3 Clinical Studies ..............................................................................................................................30
4.4 Factors Affecting Sales of Votrient .................................................................................................31
4.4.1 High Efficacy .........................................................................................................................31
4.4.2 NICE’s Approval in the UK....................................................................................................31
4.4.3 Increasing Competition .........................................................................................................31
4.4.4 Approval for Adjuvant Therapy .............................................................................................32
4.5 Drug Evaluation .............................................................................................................................32
4.5.1 Drug Risk Benefit Score .......................................................................................................32
4.5.2 Intensity of Competition ........................................................................................................33
4.6 Sales Forecasts .............................................................................................................................34
4.6.1 Target Patient Pool of Votrient ..............................................................................................34
4.6.2 Dosing ..................................................................................................................................34
4.6.3 Market Penetration ...............................................................................................................35
4.6.4 Annual Cost of Therapy ........................................................................................................35
4.6.5 Sales Projections of Votrient .................................................................................................36
5 RCC Market: Appendix .........................................................................................................................45
5.1 Market Definitions ..........................................................................................................................45
5.2 Abberiviations ................................................................................................................................45
5.3 Research Methodology ..................................................................................................................46
5.3.1 Coverage ..............................................................................................................................46
5.3.2 Secondary Research ............................................................................................................46
5.3.3 Forecasting ...........................................................................................................................46
5.3.4 Number of Patients Approved to Take the Drug ...................................................................47
5.3.5 Net Penetration of Drug ........................................................................................................47
5.3.6 Net Annual Dosing ................................................................................................................47
5.3.7 Annual Cost of Therapy ........................................................................................................47
5.4 Drug Sales Estimates Model..........................................................................................................48
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5.5 Disclaimer ......................................................................................................................................48
5.6 Sources .........................................................................................................................................48
1.1 List of Tables
Table 1: RCC, Incidences and Mortality, 2008-2030 ................................................................................... 9
Table 2: RCC, TNM Classification .............................................................................................................19
Table 3: RCC, Fuhrman grading system ....................................................................................................21
Table 4: RCC, Treatment Guidelines .........................................................................................................22
Table 5: Votrient, Renal Cell Carcinoma, Phase III Clinical Study Results ................................................31
Table 6: Renal Cell Carcinoma, Votrient, Drug Risk Benefit Score ............................................................32
Table 7: Votrient, Renal Cell Carcinoma, Global, Annual Cost of Therapy ($), 2011 .................................35
Table 8: Votrient, Renal Cell Carcinoma, Global, Sales Estimates ($m), 2009–2022 ................................36
Table 9: Votrient, Renal Cell Carcinoma, The US, Sales Estimates ($m), 2009–2022 ..............................37
Table 10: Votrient, Renal Cell Carcinoma, The UK, Sales Estimates ($m), 2010–2022 ............................38
Table 11: Votrient, Renal Cell Carcinoma, France, Sales Estimates ($m), 2010-2022 ..............................39
Table 12: Votrient, Renal Cell Carcinoma, Germany, Sales Estimates ($m), 2010-2022 ..........................40
Table 13: Votrient, Renal Cell Carcinoma, Italy, Sales Estimates ($m), 2010–2022 ..................................41
Table 14: Votrient, Renal Cell Carcinoma, Spain, Sales Estimates ($m), 2010–2022 ...............................42
Table 15: Votrient, Renal Cell Carcinoma, Japan, Sales Estimates ($m), 2014–2022 ..............................43
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1.2 List of Figures
Figure 1: Worldwide Incidence and Mortality Distribution of Top 20 Cancers (%), 2010 ............................. 8
Figure 2: Total number of cigarettes consumed, The US, 1976-2006 ........................................................10
Figure 3: RCC, Global, Market Size Forecasts ($bn), 2010–2022 .............................................................16
Figure 4: RCC, Global, Incidence (in million), 2008-2030 .........................................................................17
Figure 5: Oncology, Worldwide, Incidence (in million), 2008-2030 ..........................................................17
Figure 6: RCC, Marketed drug targets ......................................................................................................24
Figure 7: RCC, Surgical Management .....................................................................................................27
Figure 8: Treatment Algorithm for Metastatic Renal Cell Carcinoma .......................................................28
Figure 9: Classification of Patients with RCC .............................................................................................29
Figure 10: Renal Cell Carcinoma, Votrient, Drug Model Diagram ..............................................................34
Figure 11: Votrient, Renal Cell Carcinoma, Global, Sales Estimates ($m), 2009–2022 .............................36
Figure 12: Votrient, Renal Cell Carcinoma, The US, Sales Estimates ($m), 2009–2022 ...........................37
Figure 13: Votrient, Renal Cell Carcinoma, The UK, Sales Estimates ($m), 2010–2022 ...........................38
Figure 14: Votrient, Renal Cell Carcinoma, France, Sales Estimates ($m), 2010-2022 .............................39
Figure 15: Votrient, Renal Cell Carcinoma, Germany, Sales Estimates ($m), 2010–2022 ........................40
Figure 16: Votrient, Renal Cell Carcinoma, Italy, Sales Estimates ($m), 2010–2022 ................................41
Figure 17: Votrient, Renal Cell Carcinoma, Spain, Sales Estimates ($m), 2010–2022 ..............................42
Figure 18: Votrient, Renal Cell Carcinoma, Japan, Sales Estimates ($m), 2014–2022 .............................43
Figure 19: Votrient, Renal Cell Carcinoma, Global, Sales Distribution by Country (%), 2021 ....................44
Figure 20: Patients Approved for the Drug .................................................................................................47
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2 Introduction
2.1 RCC
Renal cell carcinoma (RCC) is classified under Code C-64 according to International Classification of
Disease (ICD-10) and is a cancer that develops in the lining of renal tubules, also called as renal cell
cancer or renal cell adenocarcinoma.RCC is most common type of kidney cancer and about 9 out of 10
kidney cancers are renal cell carcinomas. RCC is the 15th most common cancer (by incidence) and ninth
most common cancer in women accounting for 2-3% of all adult malignancies. RCC accounts for 80 to
85% of primary malignant renal tumors. Transitional cell carcinoma, Wilms' tumor (most often in children),
and sarcoma are the less common primary renal cell tumors known. Male to female incidence ratio is 3:2
and people affected are usually between 50 to 70 years of age.
In RCC malignant cancer cells are found in the lining of the tubules in the kidney. Cancer originating in the
ureter or the renal pelvis is different from RCC. Symptoms usually appear very late, when the tumor may
already become large and metastatic. Most metastatic sites include lymph nodes, lungs, adrenal glands,
liver, and bone. Renal cell cancer is also called renal adenocarcinoma or hypernephroma.
2.1.1 Types of Renal Cell Carcinoma
According to ACS (American Cancer Society) based on microscopic findings RCC has several subtypes
2.1.1.1 Clear cell renal cell carcinoma
This is the most common form of renal cell carcinoma. About 7 out of 10 people with renal cell carcinoma
have this kind of cancer. The cells that make up clear cell RCC look very pale or clear under a
microscope.
2.1.1.2 Papillary renal cell carcinoma
This is the second most common subtype about 1 one out of 10 RCC cases. These cancers form little
finger-like projections (called papillae) in some, if not most, of the tumor. This subtype is also called
chromophilic as the cancer cells look pink under a microscope when stained with certain dyes.
2.1.1.3 Chromophobe renal cell carcinoma
This subtype accounts for about 5% (5 cases in 100) of RCCs. The cells of these cancers are also pale,
like the clear cells, however comparatively these cells are much larger and have other distinguishing
features as well.
2.1.1.4 Collecting duct renal cell carcinoma
Very rare subtype and formation of irregular tubes by the cancer cells is the major distinguishing feature.
2.1.1.5 Unclassified renal cell carcinoma
Renal cell cancers are labelled as unclassified when they do not into any of the other categories or
because there is more than one type of cell present. According to WHO RCC can be classified by three
major histological subtypes:
• Clear cell (cRCC, 80-90%)
• Papillary (pRCC, 10-15%)
• Chromophobe (chRCC, 4-5%)
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2.6 GlobalData Pipeline Report Guidance
The report comprises:
A snapshot that includes the global RCC market forecasts from 2010 to 2022. It includes global
Votrient sales forecasts from 2009 to 2022.
Chapter 1 includes the RCC incidences and mortality in major countries. It also discusses various risk
factors associated with RCC and smoking consumption trends in the US.
Chapter 2 includes the RCC market forecasts and drivers for the RCC market.
Chapter 3 includes the Tumor Node Metastases (TNM) classification of RCC.
Chapter 4 gives a comprehensive Assessment of Votrient in RCC Market wherein promising results
of clinical trials, mode of mechanism, and toxicity profile of the drug are discussed. It includes
Votrient sales forecasts in different countries based on standard pricing of Votrient and standardized
market penetration.
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3 RCC Disease: Market Characterization
3.1 RCC Disease Market
3.2 RCC Disease Market Forecasts and CAGR
3.3 Drivers for the RCC Disease Market
Figure 3: RCC, Global, Market Size Forecasts ($bn), 2010–2022
Source: GlobalData
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3.3.1 High Incidence
Figure 4: RCC, Global, Incidence (in million), 2008-2030
Source: GlobalData
Figure 5: Oncology, Worldwide, Incidence (in million), 2008-2030
Source: GlobalData
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3.3.2 High Prevalence
3.3.3 Emergence of Targeted Therapies
3.3.4 Large Unmet Need
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3.4 Tumor-Node-Metastases (TNM) Classification of RCC
3.4.1 Staging
Table 2: RCC, TNM Classification
Stages Primary Tumor (T) Regional Lymph Node (N) Distant Metastasis (M)
Primary Tumor (T)
Regional Lymph Node (N)
Distant Metastasis (M)
Source: GlobalData, American Joint Committee on Cancer
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3.4.2 Grading
Table 3: RCC, Fuhrman grading system
Grading System (G1-G3) Definition
Source: GlobalData, American Joint Committee on Cancer
3.4.3 Prognosis
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5 RCC Market: Appendix
5.1 Market Definitions The Global RCC Market: The global RCC market includes the market for the treatment of renal cell
carcinoma in seven countries namely the US, the UK, Germany, France, Spain, Italy and Japan.
The Worldwide Oncology Market: The worldwide oncology market includes the market for the treatment
of all cancers in the major countries of the world.
5.2 Abberiviations
RCC: Renal Cell Carcinoma
CAGR: Compound Annual Growth Rate
TNM: Tumor Node Metastases
VEGF: Vascular Endothelial Growth Factor
EGFR: Epidermal Growth Factor Receptor
FDA: Food and Drug Administration
NICE: National Institute for Health and Clinical Excellence
IV: Intravenous
PFS: Progression Free Survival
OS: Overall Survival
RR: Response Rate
VEGFR: vascular endothelial growth factor receptor
PDGFR: platelet derived growth factor receptor
FGFR: fibroblast growth factor receptor
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5.3 Research Methodology
GlobalData’s dedicated research and analysis teams consist of experienced professionals with a pedigree
in marketing and market research, consulting backgrounds in the pharmaceutical industry and advanced
statistical expertise.
GlobalData adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and the
Society of Competitive Intelligence Professionals (www.scip.org). All GlobalData databases are
continuously updated and revised. The following research methodology is followed for all databases and
reports.
5.3.1 Coverage
The objective of updating GlobalData’s coverage is to ensure that it represents the most up to date vision
of the industry possible.
The drug coverage is based on few key factors such as drug’s importance as a treatment option,
sales/sales potential, innovation, market dynamics and media attention.
GlobalData aims to cover all major marketed and late stage pipeline drugs for a particular indication. The
indications which are of particular interest or making the news are prioritized. The scope is to cover the
market and drug sales in seven major countries namely the US, the UK, Germany, France, Spain, Italy
and Japan.
5.3.2 Secondary Research
The research process begins with exhaustive secondary research on internal and external sources, being
carried out to source qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, investor presentations and SEC Filings.
Industry trade journals, scientific journals and other technical literature;
Internal and external proprietary databases.
Relevant patent and regulatory databases.
National government documents, statistical databases and market reports;
Procedure registries.
News articles, press releases and web–casts specific to the companies operating in the market.
5.3.3 Forecasting
GlobalData uses a comprehensive epidemiology-based treatment flow model that uses drug risk benefit
score and competition intensity to forecast sales of a drug for a particular therapeutic indication.
GlobalData reports cover seven major geographies, namely the US, the UK, Germany, France, Spain,
Italy and Japan. The forecasting model used at GlobalData gathers data from various secondary sources.
The drug sales are calculated as the product of number of patients who are taking the drug and annual
cost of therapy.
Annual Drug Sales = Number of patient taking the drug * Annual cost of therapy
The number of patients taking the drug can be calculated as below
Number of patients taking the drug = Drug Market Penetration * Number of Patients approved to take the
drug
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5.3.4 Number of Patients Approved to Take the Drug
For finding the number of patients approved to take the drug, patient groups are formed based on the
functional classification of the disease. Based on this, the overall patients with a disease can be
categorized into multiple patient groups. The patient groups, who are not approved to take the drug, are
excluded to get the number of patients approved to take drug.
5.3.5 Net Penetration of Drug
After calculating the number of patients approved to take drug, different treatment options available for
patients in each patient group are evaluated. The market penetration of the drug will be driven by the
potency of the drug, along with its side effect profile and, suitability of alternative treatment options. Drug
risk benefit score quantifies efficacy, side effect profile and dosing convenience. The market penetration
of a drug in a particular patient group in the forecasting period, is determined by the following factors.
All the available drugs in the patient group.
The launch and expiration of drugs during the forecasting period.
The potency of the drug along with its side effect profile and suitability of alternative treatment
options.
An analogous forecasting methodology is used to account for the introduction of new products, the patent
expiries of branded products and the subsequent introduction of generics.
5.3.6 Net Annual Dosing
Annual dosing of the drug is calculated by multiplying the recommended dosage of the drug with the
treatment regimen.
5.3.7 Annual Cost of Therapy
The annual cost of therapy is the product of net annual dosing and the price per unit of the drug.
Annual Cost of Therapy = Net Annual Dosing * Price per Unit of Drug.
Figure 20: Patients Approved for the Drug
Source: GlobalData
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5.4 Drug Sales Estimates Model
Drug sales reports are supported by a comprehensive patient based model, which provides detailed
information on key inputs including prevalence rates, market penetration, and annual cost of therapy. The
model also includes a unique methodology to evaluate a drug based on its efficacy, safety and other
parameters, which are key determiners of a drug’s success, and evaluates potential competition that the
drug might face during its lifecycle. The drug model also has an inbuilt interactive tool to allow users to
input their own assumptions such as market penetration and annual cost of therapy to arrive at their own
estimates of sales. This model is available as a part of subscription to GlobalData's Pharma eTrack.
5.5 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.
5.6 Sources
www.gsk.com
www.votrient.com
Globocan (http://globocan.iarc.fr/)
Journal of Clinical Oncology website (http://jco.ascopubs.org/)
American Cancer Society (http://www.cancer.org/)
American Urological Association (http://www.auanet.org/content/homepage/homepage.cfm)
European Association of Urology (http://www.uroweb.org/)
Cancer Journal of Clinicians (http://caonline.amcancersoc.org/)
Cancer Research UK (http://www.cancerresearchuk.org/)
RxList (http://www.rxlist.com)
http://jnci.oxfordjournals.org
www.clinicaltrials.gov
www.ncbi.nlm.nih.gov
http://www.rxusa.com/cgi-bin2/db/db.cgi
British National Formulary, March 2011
http://medicprix.sante.gouv.fr/medicprix/detailPresentation.do?idPresentation=568618parameter=affi
cherPresDetail
http://www.parcelmed.de/p6639677_nexavar-200-mg-filmtabletten.html
http://farmaco.agenziafarmaco.it/index.php?SCHEDA_CONF=yes
Spain Drug Price List
http://www.genome.jp/kusuri/japic_med/show/00054545