Global Bladder Cancer Therapeutics Industry

  • October 2010
  • -
  • Global Industry Analysts

This report analyzes the worldwide markets for Bladder Cancer Therapeutics in US$ Million. The report provides separate comprehensive analytics for US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2007 through 2015. A six-year historic analysis is also provided for these markets. The report profiles 62 companies including many key and niche players such as Affitech A/S, Allergan, Inc., Allos Therapeutics, Inc., Astellas Pharma, Inc., Astrazeneca Plc, AVI BioPharma, Inc., BioCancell Therapeutics, Inc., Bioniche Life Sciences, Inc., Bristol-Myers Squibb Company, Celldex Therapeutics, Inc., Cytavis BioPharma GMBH, Eli Lilly and Company, Endo Pharmaceuticals Holdings, Inc., ENKAM Pharmaceuticals A/S, F. Hoffmann-La Roche Ltd., Halozyme Therapeutics, Inc., Laboratoires Pierre Fabre SA, NatImmune A/S, Oncogenex Pharmaceuticals, Inc., OncoTherapy Science, Inc., Sanofi-Aventis, Spectrum Pharmaceuticals, Inc., Telormedix SA, and Viventia Biotechnologies, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

Table Of Contents


BLADDER CANCER THERAPEUTICS MCP-6020
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-3
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Introduction II-1
Bladder Cancer Growing at an Alarming Rate II-1
Bladder Cancer Statistics II-1
Table 1: Worldwide Incidence of Bladder Cancer by Select
Countries/Region (2003 and 2013): US, Europe, and Japan (In
'000s) (includes corresponding Graph/Chart) II-1

Table 2: Worldwide Incidence and Mortality Rates of Select
Cancer Types in Males: 2007 (includes corresponding
Graph/Chart) II-2

Table 3: Incidence and Mortality Rates of Select Cancer Types
in Industrialized Countries: 2007 (includes corresponding
Graph/Chart) II-3

Table 4: Incidence and Mortality Rates of Select Cancer Types
in Developing Markets: 2007 (includes corresponding
Graph/Chart) II-4
Recurrent Nature: A Major Cause of Concern II-4
Bladder Cancer: The Most Costly Cancer To Treat II-5
Generics Characterize Bladder Cancer Market II-5
Existing Drug Therapies Lack in Assuring Long Term Survival Rate II-5
Approved Intravesical Agents for Bladder Cancer II-6
Bladder Cancer Demands New Therapeutics to Fill the Void II-6
Table 5: Number of Pipeline Drugs by Select Cancer Types
(includes corresponding Graph/Chart) II-7
What the Future Holds? II-7
Table 6: World Market for Bladder Cancer Therapeutics (2008):
Percentage Share Breakdown of Total Number of Drugs by
Development Stage (includes corresponding Graph/Chart) II-7
Emerging Therapeutic Options for Superficial Bladder Cancer II-8
Table 7: EOquin Penetration Rate in the US for the Years
2011 through 2015 (includes corresponding Graph/Chart) II-8

Table 8: US Market for EOquin: Annual Revenue Projections
for the Years 2011 through 2015 in US$ Million (includes
corresponding Graph/Chart) II-9
Registration Process for New Drugs: A Review II-9
Competitive Landscape II-9
Leading Therapeutics in Global Bladder Cancer Market II-10
Select Companies Involved in Late-Stage Bladder Cancer
Clinical Trials II-10
Select Companies Involved in Phase-II Clinical Trials II-11
Select Companies Involved in Phase-I Clinical Trials II-11
Select Companies Involved in Pre-clinical Stage II-11
Current and Future Analysis II-12

2. MAJOR TRENDS and ISSUES II-13
Cigarette Smoking and Carcinogenic Substances: The Major Culprits II-13
Men at High Risk than Women II-13
New Therapeutics for Elderly Population: Need of the Hour II-13
Lasers for Bladder Cancer Treatment: An Evolving Approach II-14
Photodynamic Therapy (PDT) Holds Potential II-14
SonoPhoto Dynamic Therapy - A New Treatment for Non-Invasive
Bladder Cancer II-14

3. BLADDER CANCER TREATMENT II-15
Non-Invasive (Superficial) Bladder Cancer Treatment II-15
Treatment Options and Potential Side Effects II-15
Surgery II-15
Immunotherapy II-16
Intravesical Chemotherapy II-16
Invasive Bladder Cancer Treatment II-17
Treatment Options, and Potential Side Effects II-17
Surgery II-17
Cystectomy II-17
Partial Cystectomy - A Part of Bladder is Removed II-17
Radical Cystectomy - Entire Bladder is Removed II-18
Side Effects of Removing the Bladder II-18
What’s the Solution if the Bladder Is Removed? II-18
Reconstructive Surgery II-18
Continent Urinary Diversion or Ileal Loop Diversion II-18
Neobladder II-19
Radiotherapy II-19
Systemic Chemotherapy II-20
Metastatic Bladder Cancer II-20
Palliative Treatment II-20
Other Treatment Options II-21
Targeted Therapy II-21
Gene Therapy II-21
Chemoprevention II-21
Chemoradiotherapy II-21
Photodynamic Therapy (PDT) II-21
Complementary Therapies II-21

4. MAJOR BLADDER CANCER DRUGS II-22
A Quick Market Primer II-22
Leading Bladder Cancer Therapeutics II-22
Select Bladder Cancer Therapeutics in Pipeline: 2009 II-23
Approved Bladder Cancer Drugs II-24
Thiotepa II-24
Adriamycin (Doxorubican hydrochloride) II-24
Methotrexate II-24
Vinblastine II-24
Epirubicin II-24
Mitomycin C II-25
Mitoxzantrone II-25
Oxaliplatin II-25
IL2 (Aldesleukin) and Interferon into the Bladder II-25
Keyhole Limpet Haemocyanin (KLH) II-25
Platinol-AQ (Cisplatin) II-25
Gemzar (Gemcitabine) II-26
OncoTICE/TICE BCG II-26
PACISâ„¢ BCG II-26
Valstar (valrubicin) II-26
Late-Stage Pipeline Drugs II-27
EOquin (Apaziquone) II-27
Urocidin (MCC) II-28
Larotaxel (XRP-9881) II-28
Javlor® (Vinflunine) II-28
4-HPR (Fenretinide) II-29
Pipeline Analysis of Other Potential Drugs II-29
BEXIDEM [On-Hold] II-29
BC-819 [Phase IIb] II-29
CDX-1307 [Phase I] II-30
Chemophase® [Phase I/IIa] II-30
PDX [Pralatrexate] [Phase II] II-30
OGX-427 [Phase I] II-30
OGX-011 [Phase II] II-30
Celebrex (Celecoxib) [Phase IIb/III] II-31
TMX-101 [Pre-Clinical Stage] II-31
AGSPSCA [Phase Ib] II-31
Iressa with Gemzar [Phase II] II-31
MDR09521[Development Stage] II-32
siRNA ALPHAGEN [Development Stage] II-32

5. AN OVERVIEW OF BLADDER CANCER II-33
Cancer - An Insight II-33
Factors Causing Cancer Ranked in Order of Impact II-33
Cancer Diagnosis II-34
Treatment Strategies for Cancer II-34
Progressing RandD Efforts to Innovate Drug Delivery for Cancer
Treatment II-34
The Human Bladder: A Urine Storing Organ II-35
Bladder Cancer - Introduction II-35
Classification of Bladder Cancer II-35
Non-Invasive Cancer II-35
Invasive Cancer II-35
Types of Bladder Cancer II-36
Transitional Cell Carcinoma/Urothelial Carcinoma II-36
Squamous Cell Carcinoma II-36
Adenocarcinoma II-36
Table 9: US Prevalence of Bladder Cancer by Type (includes
corresponding Graph/Chart) II-36
Major Risk Factors II-37
Controllable Risk Factors II-37
Uncontrollable Risk Factors II-37
Symptoms and Diagnosis II-38
Symptoms II-38
Diagnosis II-38
General Diagnostic Tests II-39
Blood Tests II-39
Physical Examination II-39
Urine Test II-39
Prescribed Procedure to Locate Bladder Cancer II-39
Cytoscopy and Biopsy II-39
Intravenous Pyelogram (IVP) II-39
Ultrasound Scanning II-39
Test/Procedures to Confirm Cancer Penetration II-40
CT Scan II-40
Radioisotope Bone Scan II-40
Staging and Grading of Bladder Cancer: Crucial for Treatment II-40
Staging II-40
Grading II-41

6. RESEARCH and DEVELOPMENT II-42
Variations in PSCA Gene Increase Risk of Bladder Cancer II-42
Genetic Analysis for Assaying Bladder Cancer Recurrence II-42
Selenium Allays the Risk of Bladder Cancer II-43
Individuals with Common Genome Variants at Increased Risk of
Developing Bladder Cancer II-43
New Studies Reveal Correlation Between Coffee and Bladder Cancer II-43
Raw Cruciferous Vegetables Alleviates the Risk of Bladder Cancer II-44
Broccoli Sprouts a Super-Food to Prevent Bladder Cancer II-44
Well Water Counts to the Risk Factors for the Bladder cancer II-44
Frankincense Oil: Potentially a Future Aid for Bladder Cancer II-44
SRC Gene Suppresses Bladder Cancer Metastases II-45

7. FDA APPROVALS AND FILINGS II-46
Allos Therapeutics Obtains FDA Orphan Drug Designation for
Pralatrexate II-46
Aeterna Zentaris Secures FDA Approval for IND Application of
AEZS-108 II-46
Biocancell Obtains FDA Clearance to Continue Clinical Trial
for BC-819 II-46
Bioniche to Commence Additional Phase III Clinical Trial of
Urocidinâ„¢ II-46
Bioniche Obtains FDA Approval for Phase III Trial of Urocidin II-47
FDA Grants Fast Track Designation for Apaziquone (EOquin®) II-47
Indevus Receives FDA Nod for Valstar II-48
Biocancell Obtains FDA Approval of BC-819 for Phase IIb
Clinical Trail II-48

8. RECENT INDUSTRY ACTIVITY II-49
MDRNA Takes Over Cequent Pharmaceuticals II-49
MDRNA Changes Name to Marina Biotech II-49
Telormedix Commences Phase I/II clinical Trial for TMX-101 II-49
Spectrum and Handok Ink Joint Marketing Agreement for
Apaziquone in Korea II-50
MDRNA Expands and Extends Collaboration with VPC II-50
Endo Pharmaceuticals Acquires Indevus Pharmaceuticals II-50
Affitech Merges with Pharmexa II-51
Takeda America Holdings Acquires IDM Pharma II-51
Schering-Plough Merges with Merck II-51
Cell Genesys Merges with BioSante Pharmaceuticals II-51
Celldex Therapeutics Acquires CuraGen II-51
EMEA Grants Orphan Medicinal Product Designation for Pralatrexate II-52
Endo Pharmaceuticals Obtains License for Urocidin II-52
CHMP Issues Positive Opinion on JAVLOR® to Treat Metastatic
Bladder Cancer II-52
BioCis Pharma Initiates Phase I Clinical Trial of ProtoCureâ„¢ II-53
Sonus Pharmaceuticals Acquires OncoGenex Technologies II-53
Callisto Merges with Celldex Therapeutics II-53
Allergan and Spectrum Pharmaceuticals Collaborate for Apaziquone II-53
Pro-Pharmaceuticals and BioCancell Collaborate to Administer
siRNA for H19 Genes Destruction in Cancerous Cells II-54
AVANT Adopts New Identity as Celldex Therapeutics II-54
Lorus Therapeutics Receives New Patent for LOR-2040, Leukemia
Drug II-55
Spectrum Pharmaceuticals Obtains Canadian Authorities Approval
for Phase III Clinical Trial of EOquin II-55
NCCN Obtains Grant to Evaluate Cetuximab Efficacy in Bladder
Cancer II-55
Allos Therapeutics Commences Phase II Trials for Pralatrexate II-56
Halozyme Announces Status Update of Chemophase® Phase I/IIa
Clinical Trial II-56
Spectrum Pharmaceuticals Establishes New Company in Canada II-56
China Medical Technologies Acquires FISH Business II-56
Peregrine Acquires Global License for Anti-Angiogenesis
Technology II-57
Bristol-Myers Terminates Partnership with Pierre Fabre II-57

9. FOCUS ON SELECT GLOBAL PLAYERS II-58
Affitech A/S (Denmark) II-58
Allergan, Inc. (USA) II-58
Allos Therapeutics, Inc. (USA) II-59
Astellas Pharma, Inc. (Japan) II-59
Astrazeneca Plc. (UK) II-59
AVI BioPharma, Inc. (USA) II-60
BioCancell Therapeutics, Inc. (Israel) II-60
Bioniche Life Sciences, Inc. (Canada) II-61
Bristol-Myers Squibb Company (USA) II-61
Celldex Therapeutics, Inc. (USA) II-62
Cytavis BioPharma GmbH (Germany) II-62
Eli Lilly and Company (USA) II-63
Endo Pharmaceuticals Holdings, Inc. (USA) II-63
ENKAM Pharmaceuticals A/S (Denmark) II-64
F. Hoffmann-La Roche Ltd. (Switzerland) II-64
Halozyme Therapeutics, Inc. (USA) II-64
Laboratoires Pierre Fabre SA (France) II-65
NatImmune A/S (Denmark) II-65
Oncogenex Pharmaceuticals, Inc. (USA) II-66
OncoTherapy Science, Inc. (Japan) II-66
Sanofi-Aventis (France) II-66
Spectrum Pharmaceuticals, Inc. (USA) II-67
Telormedix SA (Switzerland) II-67
Viventia Biotechnologies, Inc. (Canada) II-68

10. GLOBAL MARKET PERSPECTIVE II-69
Table 10: World Recent Past, Current and Future Analysis for
Bladder Cancer Therapeutics by Geographic Region - US, Japan,
Europe, and Rest of World Markets Independently Analyzed by
Annual Revenues in US$ Million for the Years 2007 through 2015
(includes corresponding Graph/Chart) II-69

Table 11: World Historic Review for Bladder Cancer
Therapeutics by Geographic Region - US, Japan, Europe, and
Rest of World Markets Independently Analyzed by Annual
Revenues in US$ Million for the Years 2001 through 2006
(includes corresponding Graph/Chart) II-70

Table 12: World 11-Year Perspective for Bladder Cancer
Therapeutics by Geographic Region - Percentage Breakdown of
Revenues for US, Japan, Europe, and Rest of World Markets for
the Years 2005, 2010 and 2015 (includes corresponding
Graph/Chart) II-71


III. MARKET

1. UNITED STATES III-1
A.Market Analysis III-1
Bladder Cancer and Prevalence - A Recapitulation of Facts III-1
Mortality Rates Higher in African Americans III-2
Table 13: Incidence of Bladder Cancer Among African
Americans (Males): Percentage Share Breakdown by Select
Cancer/Type or Site and Gender for the Year 2007 (includes
corresponding Graph/Chart) III-2
Bladder Cancer - A Costly Urologic Condition III-3
Table 14: Urologic Disease Costs in the US: 2006 (includes
corresponding Graph/Chart) III-3
US Bladder Cancer Statistics III-3
Table 15: Bladder Cancer Prevalence and Mortality in the US
by Gender: Percentage Share Breakdown for 2009 III-3

Table 16: Bladder Cancer Incidence in the US by Gender:
Percentage Share Breakdown for 2008 III-3
FDA Approval III-4
Strategic Corporate Developments III-6
Select Players III-12
Allergan, Inc. III-12
Allos Therapeutics, Inc. III-13
AVI BioPharma, Inc. III-13
Bristol-Myers Squibb Company III-14
Celldex Therapeutics, Inc. III-14
Eli Lilly and Company III-15
Endo Pharmaceuticals Holdings, Inc. III-15
Halozyme Therapeutics, Inc. III-16
Marina Biotech, Inc. III-16
Oncogenex Pharmaceuticals, Inc. III-17
Peplin, Inc. III-17
Polyphenon Pharma III-17
Spectrum Pharmaceuticals, Inc. III-18
B.Market Analytics III-18
Table 17: US Recent Past, Current and Future Analysis for
Bladder Cancer Therapeutics - Annual Revenues in US$ Million
for the Years 2007 through 2015 (includes corresponding
Graph/Chart) III-18

Table 18: US Historic Review for Bladder Cancer Therapeutics -
Annual Revenues in US$ Million for the Years 2001 through
2006 (includes corresponding Graph/Chart) III-19

2. JAPAN III-20
A.Market Analysis III-20
Current and Future Analysis III-20
Select Players III-20
alphaGEN, Co., Ltd III-20
Astellas Pharma, Inc. III-20
Nippon Kayaku Co., Ltd III-20
OncoTherapy Science, Inc. III-21
B.Market Analytics III-22
Table 19: Japanese Recent Past, Current and Future Analysis
for Bladder Cancer Therapeutics - Annual Revenues in US$
Million for the Years 2007 through 2015 (includes
corresponding Graph/Chart) III-22

Table 20: Japanese Historic Review for Bladder Cancer
Therapeutics - Annual Revenues in US$ Million for the Years
2001 through 2006 (includes corresponding Graph/Chart) III-22

3. EUROPE III-23
A.Market Analysis III-23
Current and Future Analysis III-23
Bladder Cancer - Prevalence III-23
Table 21: Bladder Cancer Incidence in Europe by Region
(2006) for Germany, Italy, Spain, France, The UK,
Scandinavia, and Benelux (includes corresponding
Graph/Chart) III-23

Table 22: Bladder Cancer Mortality in Europe by Region
(2006) for Germany, Italy, the UK, Spain, France, Benelux,
and Scandinavia (includes corresponding Graph/Chart) III-24
Europe Lacks RandD Innovation in Bladder Cancer Market III-24
Focus on Select Regional Market III-24
United Kingdom III-24
Bladder Cancer Prevalence - A Review III-24
Bladder Cancer Statistics in the UK III-25
Table 23: Incidence, Mortality, and Five-Year Survival
Rate of Bladder Cancer in UK by Gender: 2006 III-25

Table 24: Bladder Cancer Incidence by Region (2006) for
England, Wales, Scotland, and Northern Ireland (includes
corresponding Graph/Chart) III-25

Table 25: Age-Specific Incidence of Bladder Cancer by
Gender: 2006 (includes corresponding Graph/Chart) III-25

Table 26: Number of Bladder Cancer Deaths in the UK
(2007): Breakdown by Region - England, Wales, Scotland,
and Northern Ireland (includes corresponding Graph/Chart) III-26

Table 27: Age-Specific Bladder Cancer Mortality Rate in UK
Males: Breakdown by Age Group for 2007 (includes
corresponding Graph/Chart) III-26

Table 28: Age-Specific Bladder Cancer Mortality Rate in UK
Females: Breakdown by Age Group for 2007 (includes
corresponding Graph/Chart) III-26
Strategic Corporate Developments III-26
Select Players III-28
Affitech A/S (Denmark) III-28
Astrazeneca PLC (UK) III-28
BioCis Pharma Ltd (Finland) III-29
Cambridge Laboratories Ltd. (UK) III-29
curasan AG (Germany) III-29
Cytavis BioPharma GmbH (Germany) III-29
ENKAM Pharmaceuticals A/S (Denmark) III-30
F. Hoffmann-La Roche Ltd. (Switzerland) III-30
Laboratoires Pierre Fabre SA (France) III-30
NatImmune A/S (Denmark) III-31
Sanofi-Aventis (France) III-31
Telormedix SA (Switzerland) III-32
B.Market Analytics III-33
Table 29: European Recent Past, Current and Future Analysis
for Bladder Cancer Therapeutics - Annual Revenues in US$
Million for the Years 2007 through 2015 (includes
corresponding Graph/Chart) III-33

Table 30: European Historic Review for Bladder Cancer
Therapeutics - Annual Revenues in US$ Million for the Years
2001 through 2006 (includes corresponding Graph/Chart) III-33

4. REST OF WORLD III-34
A.Market Analysis III-34
Current and Future Analysis III-34
Select Markets III-34
Canada III-34
Bladder Cancer Treatment III-34
Bladder Cancer Statistics III-34
Table 31: Bladder Cancer New Cases in Canada: Percentage
Share Breakdown by Gender for 2009 III-34
Table 32: Bladder Cancer Mortality in Canada: Percentage
Share Breakdown by Gender for 2009 III-35

Table 33: New Cases of Cancer Among Canadian Females by
Type: Percentage Share Breakdown for 2009 (includes
corresponding Graph/Chart) III-35

Table 34: Cancer Mortality Among Canadian Females by
Cancer Type: Percentage Share Breakdown for 2009
(includes corresponding Graph/Chart) III-36

Table 35: New Cases of Cancer Among Canadian Males by
Type: Percentage Share Breakdown for 2009 (includes
corresponding Graph/Chart) III-36

Table 36: Cancer Mortality among Canadian Males by Cancer
Type: Percentage Share Breakdown for 2009 (includes
corresponding Graph/Chart) III-37
Asia-Pacific III-37
China III-37
India III-37
Australia III-37
Women at Increased Risk Over Men in Australia - A New
Finding III-37
Table 37: Number of Deaths Due to Bladder Cancer:
Breakdown by Age Group for the Year 2006 (includes
corresponding Graph/Chart) III-38

Table 38: Age-Standardized Mortality Rate Due to Bladder
Cancer in Australia: Breakdown by Age Group for the Year
2006 (includes corresponding Graph/Chart) III-38

Table 39: Number of Deaths Due to Bladder Cancer
(Males): Breakdown by Age Group for the Year 2006
(includes corresponding Graph/Chart) III-39

Table 40: Number of Deaths Due to Bladder Cancer
(Females): Breakdown by Age Group for the Year 2006
(includes corresponding Graph/Chart) III-39
South Africa - Prevalence III-40
FDA Approval III-40
Strategic Corporate Developments III-40
Select Players III-42
BioCancell Therapeutics, Inc. (Israel) III-42
Bioniche Life Sciences, Inc. (Canada) III-42
China Medical Technologies Inc. (China) III-43
Lorus Therapeutics, Inc. (Canada) III-43
PharmaGap, Inc. (Canada) III-43
Viventia Biotechnologies, Inc. (Canada) III-43
B.Market Analytics III-44
Table 41: Rest of World Recent Past, Current and Future
Analysis for Bladder Cancer Therapeutics - Annual Revenues
in US$ Million for the Years 2007 through 2015 (includes
corresponding Graph/Chart) III-44

Table 42: Rest of World Historic Review for Bladder Cancer
Therapeutics - Annual Revenues in US$ Million for the Years
2001 through 2006 (includes corresponding Graph/Chart) III-45


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 62 (including Divisions/Subsidiaries - 67)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 28
Canada 6
Japan 8
Europe 21
France 3
Germany 4
The United Kingdom 4
Spain 1
Rest of Europe 9
Asia-Pacific (Excluding Japan) 2
Middle-East 2
------------------------------------------

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