Gen-Probe Incorporated Product Pipeline Analysis

SUMMARY

Gen-Probe Incorporated Product Pipeline Analysis

Summary

This report is an insightful source for data, analysis and strategic insights into a Gen-Probe Incorporated's pipeline and investigational products. The report also provides details on clinical trials covering trial phase, description, investigator information, primary and secondary end-points and trial results for products in development.

Scope

• Details of development stage by sector and equipment type.
• Pipeline products grouped by therapy area, development stage and trial phase.
• Detailed information on clinical trials covering trial phase, description, investigator .nformation, primary and secondary end-points and trial results.
• Trial updates, trial start and end dates, patient numbers and the trials primary outcome measures, secondary outcome measures.
• Product updates covering estimated approval dates and estimated launch dates.
• Descriptions of novel technologies relating to pipeline products of the company.
• Patents and patent applications covered for the product.
• News updates on key events relating to the product and its development.

Reasons to buy

• A single source to fulfill competitor information relating to products in development.
• Identify pipeline products that are potential competitor to your product lines.
Understand a company's strategic position by accessing detailed independent intelligence on its product pipeline.
• Access clinical trial information to map trial results and plan targeted marketing activities.
• Take corrective measures on your own development programs and R&D initiatives based on regulatory events of competitor product pipelines.
• Identification of potential investment opportunities.
• Build up knowledge base for potential distribution and marketing partners.
• Helps avoid patent infringement.
• Timelines from concept to market lets you keep track of market potential build for a new product.
Assess a company's future growth by determining its pipeline depth, for probable acquisition opportunities.

TABLE OF CONTENTS

1 Table of Contents 3
1.1 List of Tables 7
1.2 List of Figures 8
2 Company Snapshot 9
2.1 Key Information 9
2.2 Company Overview 9
2.3 Financial Performance 9
2.4 Industry Outlook -- In Vitro Diagnostics 9
3 Business Description 10
3.1 Business Overview 10
3.2 Clinical Diagnostics and Blood Screening products 10
3.2.1 Overview 10
3.2.2 Financials 10
3.2.3 Market View 10
3.2.4 Key Strategies 11
3.3 Major Products and Services 11
3.3.1 Overview 11
4 History 12
5 BUSINESS STRATEGY 16
5.1 Mission Statement 16
5.2 Strategy 16
5.3 Corporate Social Responsibility 16
5.3.1 Overview 16
6 VALUE CHAIN ANALYSIS 17
6.1 Manufacturing 17
6.1.1 In House Manufacturing 17
6.1.2 Outsourcing 17
6.2 Product Development 18
6.2.1 Regulatory Approvals 18
6.2.2 Clinical Trials 18
6.2.3 Research and Development 18
6.3 Sales and Marketing 18
6.3.1 Partnerships and Alliances 18
6.3.2 Licensing Agreements 19
7 Competitors 20
8 Share Holding Structure 21
9 Key Employees 22
10 Key Employee Biographies 23
11 Company Statement 24
12 Locations And Subsidiaries 29
12.1 Head Office 29
13 Recent Developments 30
13.1 Strategy And Business Planning 30
13.1.1 Jun 17, 2008: 3M Ends Staph-Screening Partnership With Gen-Probe 30
13.1.2 Apr 30, 2007: Gen-Probe And 3M Collaborate To Develop Rapid Molecular Tests 30
13.2 Financial Announcements 30
13.2.1 Jul 31, 2008: Gen-Probe Declares 2Q 2008 Results 30
13.2.2 Apr 28, 2008: Gen-Probe Declares Q1 2008 Results 32
13.2.3 Apr 10, 2008: Gen-Probe To Declare Q1 2008 Results 34
13.2.4 Oct 30, 2007: Gen-Probe Reports Q3 2007 Results 34
13.2.5 Aug 01, 2007: Gen-Probe Declares Q2 2007 Results 36
13.2.6 May 01, 2007: Gen-Probe Declares Q1 2007 Results 38
13.2.7 Feb 13, 2007: Gen-Probe Declares Q4 2006 Results 39
13.2.8 Feb 13, 2007: Gen-Probe Declares Q4 2007 Results 41
13.3 Corporate Communications 43
13.3.1 May 19, 2008: Gen-Probe Elects New Board Member 43
13.3.2 Feb 11, 2008: Gen-Probe Appoints President 43
13.3.3 Feb 11, 2008: Gen-Probe Appoints COO 44
13.3.4 Nov 19, 2007: Gen-Probe Appoints VP, Operations 44
13.3.5 Sep 20, 2007: Gen-Probe Elects New Board Member 44
13.3.6 Feb 13, 2007: Gen-Probe COO To Join 44
13.4 Product News 44
13.4.1 Aug 13, 2008: FDA Grants Full Approval Of PROCLEIX ULTRIO Blood Screening Assay 44
13.4.2 May 28, 2008: Gen-Probe Launches In Europe CE-Marked APTIMA HPV Assay For Detection Of Human Papillomavirus 45
13.4.3 Apr 01, 2008: Gen-Probe Begins US Clinical Study Of Molecular Test For Human Papillomavirus 45
13.4.4 Mar 19, 2008: New Study Backs Use Of Gene-Based Urine Test In Prostate Cancer 46
13.4.5 Feb 21, 2008: Gen-Probe Submits US Regulatory Application For Additional Approval Of PROCLEIX 46
13.4.6 Apr 30, 2007: 3M, Gen-Probe Form Collaboration To Develop Rapid Molecular Tests To Combat Healthcare-Associated Infections 46
13.4.7 Mar 29, 2007: Promising Data On Molecular Research Test For Prostate Cancer Published In Peer-Reviewed Journal UROLOGY 47
13.4.8 Jan 29, 2007: Gen-Probe Reports Positive Regulatory Progress for PROCLEIX ULTRIO Blood Screening Assay on the TIGRIS System 47
13.4.9 Nov 22, 2006: New, Highly Specific Gene-Based Test For Prostate Cancer Introduced In Europe 47
13.4.10 Feb 25, 2005: Gen-Probe Signs Agreement With Roche To Purchase Products For APTIMA Human Papillomavirus Assay 48
13.5 Product Approvals 48
13.5.1 Aug 13, 2008: FDA Grants Full Approval Of PROCLEIX ULTRIO Blood Screening Assay 48
13.6 Clinical Trials 48
13.6.1 Apr 01, 2008: Gen-Probe Begins US Clinical Study Of Molecular Test For Human Papillomavirus 48
13.6.2 Mar 19, 2008: New Study Backs Use Of Gene-Based Urine Test In Prostate Cancer 49
14 Gen-Probe Incorporated Pipeline Products 50
14.1 Gen-Probe Incorporated Product Pipeline Analysis 50
14.1.1 Gen-Probe Incorporated Pipeline Products By Equipment Type 50
14.1.2 Gen-Probe Incorporated Pipeline Products By Development Stage 52
14.1.3 Gen-Probe Incorporated Pipeline Products By Therapy Area 53
14.1.4 Gen-Probe Incorporated Pipeline Products By Clinical Trials 53
14.1.5 Gen-Probe Incorporated Pipeline Products By News Summary 54
14.2 APTIMA HPV Assay 55
14.2.1 Product Description 55
14.2.2 Product Status 55
14.2.3 Clinical Trials 55
14.2.4 Product Milestone 56
14.3 PROGENSA PCA3 Assay 56
14.3.1 Product Description 56
14.3.2 Product Status 57
14.3.3 Clinical Trials 57
14.3.4 Product Milestone 57
14.4 Panther System 58
14.4.1 Product Description 58
14.4.2 Product Status 58
14.5 PROCLEIX ULTRIO assay for hepatitis B virus 59
14.5.1 Product Description 59
14.5.2 Product Status 59
14.5.3 Product Milestone 59
14.6 Methicillin-resistant Staphylococcus aureus nucleic acid test 60
14.6.1 Product Description 60
14.6.2 Product Status 60
14.6.3 Product Milestone 60
15 Appendix 62
15.1 Methodology 62
15.1.1 Coverage 62
15.1.2 Secondary Research 63
15.1.3 Primary Research 63
15.1.4 Expert Panel Validation 64
15.2 Contact Us 64
15.3 About Global Markets Direct 64
15.4 Disclaimer 64

1.1 List of Tables
Table 1: Gen-Probe Incorporated,Key Facts, 2007 9
Table 2: Gen-Probe Incorporated, Share Holding Structure 21
Table 3: Gen-Probe Incorporated, Key Employees, 2007 22
Table 4: Gen-Probe Incorporated Pipeline Products by Equipment Type 51
Table 5: Gen-Probe Incorporated Pipeline Products By Development Stage 52
Table 6: Gen-Probe Incorporated Pipeline Products By Therapy Area 53
Table 7: Gen-Probe Incorporated Pipeline Products By Clinical Trials 53
Table 8: Gen-Probe Incorporated Pipeline Products By News Summaries 54

1.2 List of Figures
Figure 1: Gen-Probe Incorporated, Value Chain Analysis 17
Figure 2: Gen-Probe Incorporated Pipeline Products By Equipment Type 50
Figure 3: Gen-Probe Incorporated Pipeline Products By Equipment Type 51
Figure 4: Gen-Probe Incorporated Pipeline Products By Development Stage 52
Figure 5: Gen-Probe Incorporated Pipeline Products By News Summary 54
Figure 6: Global Markets Direct Methodology 62