Pharmaceutical Research and Development (R&D) - Increasing Efficiency through Information Technology and Externalization

Summary

GBI Research’s pharma report, “Pharmaceutical Research and Development (R&D) - Increasing Efficency Through Information Technology and Externalization” provides key data, information and analysis on major pharmaceutical R&D practices at the global level in order to improve its efficiency and effectiveness. This pharmaceutical and healthcare report provides comprehensive insight into the major challenges in the current pharmaceutical R&D landscape. It analyzes key measures and practices (mergers and acquisitions, R&D restructuring, outsourcing and active lifecycle management) adopted by the pharmaceutical industry to tackle these challenges and improve the R&D efficiency. The report substantiates the analysis with various case studies to study the effect of measure post-implementation. The report also provides an analytical insight into the potential solutions that have tremendous potential to improve the future pharmaceutical and biotech R&D productivity.

The pharmaceutical industry has witnessed a significant decline in R&D productivity over the past few years, which has become a matter of concern among the key stakeholders in the industry, particularly the pharmaceutical companies. While the R&D expenditure of the industry has steadily increased, the output has been declining. The increase in the number of late-stage development failures is costing the pharmaceutical industry dearly. In addition, the stringent regulatory mechanisms on the pricing and reimbursement of approved drugs have added to the pressure. Pharmaceutical companies have tried many ways to improve the R&D efficiency which include the acquisitions of small biotechnology and pharmaceutical companies, R&D restructuring, outsourcing and better lifecycle management of their existing drugs in the market. However, there has been limited success achieved to date.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts.

Scope

The report analyses the key measures adopted to improve the R&D efficiency in the pharmaceutical and biotech industry along with the major challenges that have led to a decrease in the R&D productivity over the last decade. The scope of the report includes:
- Major challenges in the current pharmaceutical R&D landscape.
- Key solutions adopted by the pharmaceutical industry to improve the R&D productivity which include strategic mergers and acquisitions, R&D restructuring, outsourcing and active lifecycle management.
- More than 25 examples and case studies explaining each solution and its impact on the R&D productivity in a short and long term.
- Qualitative analysis of the major potential solutions that can improve the R&D productivity in the future.

Reasons to buy

The report will enhance your decision making. It will allow you to:
- Identify the key R&D challenges in the industry and its impact on your company's R&D productivity.
- Understand the three different focus areas of improving R&D efficiency and select the one best suited to the company’s long term business strategy.
- Develop more efficient and effective solutions by identifying the implementation issues from the case studies and examples covered for each solution.
- Ensure sustainable R&D growth by identifying long term potential solutions to improve R&D efficiency.
- Create an integrated and agile R&D organization through the understanding of key technologies and other external partners in improving the R&D efficiency in future.
- Optimize R&D efforts by identifying the key areas with maximum revenue potential in future.

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 8
2.1 GBI Research Report Guidance 8
3 Current Challenges in the Pharmaceutical R&D – Declining ROI and Stringent Pricing and Reimbursements are Major Impediments 9
3.1 Declining Return on Investment on R&D 9
3.1.1 Increasing R&D Costs against Declining NME/BLA (New Molecular Entities/Biologic License Application) Approvals in the Last 15 Years (1995–2009) 9
3.1.2 R&D Costs Increase against Revenue Growth for the Top 10 Pharma Companies 10
3.2 Adverse Pricing and Reimbursement Regime for New Drugs 11
3.2.1 Pressure to Curb Healthcare Costs Driving the Increased Adoption of Stringent Pricing Mechanisms 11
3.2.2 Economic Evaluations Gaining Importance as a Key Parameter for Reimbursement Decisions 12
3.3 Generic Competition and Increasing Number of Patent Challenges 14
4 Major Steps Taken by Pharmaceutical Companies to Improve R&D Efficiency – Significant but Ineffective 16
4.1 R&D Components to Concentrate on Increasing Efficiency 16
4.1.1 Decrease Cost – Short Term Solution 17
4.1.2 Improve Returns from the Same Level of Output – Limited Success Potential Solution 17
4.1.3 Increased Output (Number of Drugs) – Long Term Solution 17
4.1.4 Combining Multiple Strategies for Optimum Results 18
4.2 Strategic Consolidations 18
4.2.1 Top Five Major Industry Consolidations in the Last Decade 19
4.3 Restructuring the R&D 24
4.3.1 GlaxoSmithKline – Realigning Focus to Vaccines, Consumer Healthcare and Emerging Markets 25
4.3.2 Pfizer – Redefining the Research Focus and Outsourcing the Rest 26
4.3.3 AstraZeneca – Consolidating R&D Facilities with Narrowed Therapeutic Focus 27
4.3.4 Sanofi-Aventis – Combining Workforce Consolidation with Externalization to Safeguard Future Revenues 28
4.4 Outsourcing R&D to Low Cost Countries – Particularly the Early Stage Research 28
4.4.1 Role of CROs in Providing Cost Efficiencies 29
4.4.2 Drug Discovery Research Outsourcing –Focus on India and China 34
4.5 Better Lifecycle Management of Existing Drugs 40
4.5.1 Indication Expansion 40
4.5.2 Extended/Controlled Release Versions 45
4.5.3 New Formulations 50
4.6 Critical Path Initiative 54
5 Potential Solutions – Information Technology and External Collaborations to Play a Key Role in Reviving R&D Prospects 56
5.1 Solving the Root of the Problem – Improving Discovery Research 57
5.1.1 Failure Rates in Phase I/II/III 57
5.1.2 Improving Drug Discovery Process 61
5.1.3 Improving Clinical Trials Design 62
5.2 Information Technology – Key Success Factor in Optimizing R&D Costs 66
5.2.1 Effective Data Management Is Critical For R&D Productivity 66
5.2.2 Technology Support Inevitable For Personalized Medicine: The Future Class of Medicines 69
5.2.3 Paperless Clinical Trials – A Billion Dollar Saving Potential 70
5.3 Network R&D – Involving External Partners to Complement Internal R&D Capabilities 72
5.4 R&D Hive-off 74
5.4.1 AstraZeneca’s Alberio 74
5.4.2 Sanofi-Aventis’ Novexel 75
5.5 Establishing Focus on Niche Markets 75
6 Conclusion 76
7 Appendix 77
7.1 Market Definitions 77
7.2 Abbreviations 77
7.3 Research Methodology 79
7.3.1 Coverage 80
7.3.2 Secondary Research 80
7.3.3 Primary Research 80
7.3.4 Expert Panel Validation 81
7.4 Contact Us 81
7.5 Disclaimer 81
7.6 Sources 81