rencarex (renal cell carcinoma)- analysis and …transitional cell carcinoma, wilms' tumor...

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Rencarex (Renal Cell Carcinoma) – Analysis and Forecasts to

2022

Published: March 2012

© GlobalData. This report is a licensed product and is not to be photocopied

Rencarex (Renal Cell Carcinoma)- Analysis and Forecasts to 2022

Reference Code: GDHC0004RCCDVR Publication Date: March 2012

The Renal Cell Carcinoma (RCC) Disease Therapeutics

Market

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%.

Rencarex Therapeutic Market

Rencarex (girentuximab), a product of Wilex AG

pharmaceuticals, is a chimeric monoclonal targeted antibody. It

is currently in Phase III clinical trial (ARISER) as an adjuvant

therapy for patients with non-metastatic clear cell renal cell

cancer (RCC) at high risk of relapse after surgery. It is expected

to get approval in 2014 in the US and EU. Till date, no drug

has been approved by the FDA or EMEA for the adjuvant

therapy of non-metastatic clear cell RCC. However, Rencarex is

likely to face competition from Sutent and Votrient which are

expected to get approval for adjuvant therapy in 2017 in the US

and EU. The sales of Rencarex are expected to increase at a

CAGR of xx% from 2014 to 2022.

Oncology, Worldwide , Market Size Forecasts ($bn),

2005–2015

Source: GlobalData

RCC, Global, Market Size Forecasts ($bn), 2010–2022

Source: GlobalData

Rencarex, RCC, Global Sales Forecast ($m), 2014–2022

Source: GlobalData

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1 Table of contents

1 Table of contents ................................................................................................................................... 2 1.1 List of Tables .................................................................................................................................. 3 1.2 List of Figures ................................................................................................................................. 4

2 Introduction ........................................................................................................................................... 5 2.1 RCC 5

2.1.1 Types of Renal Cell Carcinoma ............................................................................................. 5 2.2 RCC Market .................................................................................................................................... 6 2.3 Epidemiology .................................................................................................................................. 6 2.4 Pathophysiology ............................................................................................................................. 9 2.5 Etiology ........................................................................................................................................... 9

2.5.1 Cigarette Smoking ................................................................................................................. 9 2.5.2 Obesity .................................................................................................................................10 2.5.3 Acquired Cystic Disease .......................................................................................................10 2.5.4 Hypertension ........................................................................................................................10 2.5.5 Family History of Kidney Cancer ..........................................................................................10 2.5.6 High Blood Pressure .............................................................................................................10 2.5.7 Usage of Certain Medicines ..................................................................................................10 2.5.8 Advanced Kidney Disease ....................................................................................................10 2.5.9 Gender and Race .................................................................................................................10 2.5.10 Genetic and Hereditary Risk Factors ....................................................................................11 2.5.11 Symptoms .............................................................................................................................11 2.5.12 Diagnosis ..............................................................................................................................12

2.6 GlobalData Report Guidance .........................................................................................................14 3 RCC Disease: Market Characterization ................................................................................................15

3.1 RCC Disease Market .....................................................................................................................15 3.2 RCC Disease Market Forecasts and CAGR ..................................................................................15 3.1 Drivers for the RCC Disease Market ..............................................................................................15

3.1.1 High Incidence ......................................................................................................................16 3.1.2 High Prevalence ...................................................................................................................17 3.1.3 Emergence of Targeted Therapies .......................................................................................17 3.1.4 Large Unmet Need ...............................................................................................................17

3.2 Tumor-Node-Metastases (TNM) Classification of RCC .................................................................18 3.2.1 Staging .................................................................................................................................18 3.2.2 Grading .................................................................................................................................19 3.2.3 Prognosis..............................................................................................................................19

3.3 Treatment Options in RCC ............................................................................................................20 3.3.1 Surgery .................................................................................................................................20 3.3.2 Radiation therapy .................................................................................................................21 3.3.3 Chemotherapy ......................................................................................................................21 3.3.4 Targeted Therapies ..............................................................................................................21 3.3.5 Tyrosine Kinase Inhibitors ....................................................................................................22 3.3.6 Mammalian Target of Rapamycin (mTOR) Inhibitor .............................................................22 3.3.7 Vascular Endothelial Growth Factor (VEGF) Inhibitor ..........................................................23 3.3.8 Treatment by Stage ..............................................................................................................23

3.4 Classification of Patients with RCC ................................................................................................25 4 Rencarex ..............................................................................................................................................26

4.1 Introduction ....................................................................................................................................26 4.2 Mechanism of Action .....................................................................................................................26 4.3 Clinical Studies ..............................................................................................................................26

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4.4 Factors Affecting Sales of Rencarex ..............................................................................................27 4.4.1 High Efficacy .........................................................................................................................27 4.4.2 Excellent Safety Profile .........................................................................................................27 4.4.3 Large Unmet Need ...............................................................................................................27 4.4.4 Orphan Drug Status ..............................................................................................................27

4.5 Drug Evaluation .............................................................................................................................28 4.5.1 Drug Risk Benefit Score .......................................................................................................28 4.5.2 Intensity of Competition ........................................................................................................28

4.6 Sales Forecasts .............................................................................................................................29 4.6.1 Target Patient Pool of Rencarex ...........................................................................................29 4.6.2 Dosing ..................................................................................................................................29 4.6.3 Market Penetration ...............................................................................................................30 4.6.4 Annual Cost of Therapy ........................................................................................................30 4.6.5 Sales Projections of Rencarex ..............................................................................................31

5 RCC Market: Appendix .........................................................................................................................39 5.1 Market Definitions ..........................................................................................................................39 5.2 Abberiviations ................................................................................................................................39 5.3 Research Methodology ..................................................................................................................39

5.3.1 Coverage ..............................................................................................................................39 5.3.2 Secondary Research ............................................................................................................39 5.3.3 Forecasting ...........................................................................................................................40 5.3.4 Number of Patients Approved to Take the Drug ...................................................................40 5.3.5 Net Penetration of Drug ........................................................................................................40 5.3.6 Net Annual Dosing ................................................................................................................41 5.3.7 Annual Cost of Therapy ........................................................................................................41

5.4 Drug Sales Estimates Model..........................................................................................................41 5.5 Disclaimer ......................................................................................................................................41 5.6 Sources .........................................................................................................................................41

1.1 List of Tables

Table 1: RCC, Incidences and Mortality, 2008-2030 ................................................................................... 8 Table 2: RCC, TNM Classification .............................................................................................................18 Table 3: RCC, Fuhrman grading system ....................................................................................................19 Table 4: RCC, Treatment Guidelines .........................................................................................................20 Table 5: Rencarex, Renal Cell Carcinoma, Phase II Clinical Study Results ..............................................27 Table 6: Rencarex, Renal Cell Carcinoma, Global, Sales Estimates ($m), 2014–2022 .............................31 Table 7: Rencarex, Renal Cell Carcinoma, The US, Sales Estimates ($m), 2014–2022 ...........................32 Table 8: Rencarex, Renal Cell Carcinoma, The UK, Sales Estimates ($m), 2014–2022 ...........................33 Table 9: Rencarex, Renal Cell Carcinoma, France, Sales Estimates ($m), 2014–2022 ............................34 Table 10: Rencarex, Renal Cell Carcinoma, Germany, Sales Estimates ($m), 2014–2022.......................35 Table 11: Rencarex, Renal Cell Carcinoma, Italy, Sales Estimates ($m), 2014–2022 ...............................36 Table 12: Rencarex, Renal Cell Carcinoma, Spain, Sales Estimates ($m), 2014–2022 ............................37

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1.2 List of Figures

Figure 1: Worldwide Incidence and Mortality Distribution of Top 20 Cancers (%), 2010 ............................. 7 Figure 2: Total number of cigarettes consumed, The US, 1976-2006 ......................................................... 9 Figure 3: RCC, Global, Market Size Forecasts ($bn), 2010–2022 .............................................................15 Figure 4: RCC, Global, Incidence (in million), 2008-2030 .........................................................................16 Figure 5: Oncology, Worldwide, Incidence (in million), 2008-2030 ..........................................................16 Figure 6: Classification of Patients with RCC .............................................................................................25 Figure 7: Renal Cell Carcinoma, Rencarex, Drug Model Diagram .............................................................29 Figure 8: Rencarex, Renal Cell Carcinoma, Global, Sales Estimates ($m), 2014–2022 ............................31 Figure 9: Rencarex, Renal Cell Carcinoma, The US, Sales Estimates ($m), 2014–2022 ..........................32 Figure 10: Rencarex, Renal Cell Carcinoma, The UK, Sales Estimates ($m), 2014–2022 ........................33 Figure 11: Rencarex, Renal Cell Carcinoma, France, Sales Estimates ($m), 2014-2022 ..........................34 Figure 12: Rencarex, Renal Cell Carcinoma, Germany, Sales Estimates ($m), 2014–2022 .....................35 Figure 13: Rencarex, Renal Cell Carcinoma, Italy, Sales Estimates ($m), 2014–2022 .............................36 Figure 14: Rencarex, Renal Cell Carcinoma, Spain, Sales Estimates ($m), 2014–2022 ...........................37 Figure 15: Rencarex, Renal Cell Carcinoma, Global, Sales Distribution by Country (%), 2022 .................38 Figure 16: Patients Approved for the Drug .................................................................................................40

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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 Report Guidance

The report comprises:

A snapshot that includes the global RCC market forecasts from 2010 to 2022. It includes the Global

Rencarex sales forecasts from 2014 to 2022.

Chapter 1 includes the RCC incidences and mortality in major countries. It also discusses various risk

factors associated with RCC.

Chapter 2 includes the RCC market forecasts and drivers for the RCC market.

Chapter 3 includes the Tumor Node Metastases (TNM) classification of RCC in the US, EU-5 and

Japan.

Chapter 4 gives a comprehensive Assessment of Rencarex in RCC Market wherein promising results

of clinical trials, mode of mechanism and toxicity profile of the drug are discussed. It includes

Rencarex’s sales forecasts in different countries based on standard pricing of Rencarex 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

3.1 Drivers for the RCC Disease Market

Figure 3: RCC, Global, Market Size Forecasts ($bn), 2010–2022

Source: GlobalData

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3.1.1 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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3.1.2 High Prevalence

3.1.3 Emergence of Targeted Therapies

3.1.4 Large Unmet Need

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3.2 Tumor-Node-Metastases (TNM) Classification of RCC

3.2.1 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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3.2.1.1 Stage I

3.2.1.2 Stage IA

3.2.1.3 Stage IB

3.2.2 Grading

Table 3: RCC, Fuhrman grading system

Grading System (G1-G3) Definition

Source: GlobalData, American Joint Committee on Cancer

3.2.3 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

mRCC: Metastatic Renal Cell Carcinoma

TNM: Tumor, Nodes, Metastasis

GIST: Gastrointestinal Stromal Tumor

NSCLC: Non Small Cell Lung Cancer

CAGR: Compounded Annual Growth Rate

FDA: Food and Drug Administration

NICE: National Institute for Health and Clinical Excellence

VEGFR: Vascular Epidermal Growth Factor Receptor

PDGFR: Platelet Derived Epidermal Growth Factor Receptor

RTK: Receptor Tyrosine Kinase

IFNα: Interferon Alfa

PFS: Progression Free Survival

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

potential of the drug and its innovation potential.

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.

http://www.mrs.org.uk/

http://www.scip.org/

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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

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.

Figure 16: Patients Approved for the Drug

Source: GlobalData

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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.

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

Pfizer Pharmaceuticals website (http://www.pfizer.com/home/)

Annual reports of Pfizer Pharmaceuticals

American Association of Urology (http://www.auanet.org/)

European Association of Urology (http:/www.uroweb.org/)

Globocan (http://www-dep.iarc.fr/)

Cancer Journal of Clinicians (http://caonline.amcancersoc.org/)

Cancer Research UK (http://caonline.amcancersoc.org/)

American Cancer Society (www.cancer.org/)

http://jnci.oxfordjournals.org

www.fda.gov

http://www.clinicaltrials.gov/

www.rxlist.com

http://jnci.oxfordjournals.org/

http://www.rxlist.com/

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