PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009 : Market Research Report

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009

Published by: Barnett Educational Services

Published: Jun. 1, 2008 - 400 Pages

Section 1: R&D Spending: Pharmaceuticals; Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2012P (EvaluatePharma); R&D Spending by Research-Based Pharmaceutical Companies, 1980-2007; R&D Investments by Research-Based Pharmaceutical Companies, 1975-2007; Industry-wide and Government R&D Spending, 1980-2007; Booz Allen Hamilton Study on R&D Spending; Analysis of Top 20 Companies by 2007 Pharma R&D Spend (EvaluatePharma); Total PhRMA R&D as a Percent of Sales, 1985-2007; Domestic U.S. R&D and R&D Abroad, 1985-2007; Domestic U.S. Sales and Sales Abroad, 1985-2007; Growth in Domestic U.S. R&D and R&D Abroad, 1970-2007; R&D Spending at Top 50 Pharmaceutical Companies in 2007; Productivity as Measured by R&D Spending per NME Approval “Deeply Flawed”; Various Measures of New Drug/Biologic R&D Productivity; Global R&D Spending per Global New Active Substance (NAS) Launch, 1995-2007; Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2008 Analysis; An Analysis of Pharma and Biotech Industry R&D Spending Growth Through 2008; Pharma M&A Activity in 2007; R&D Spending by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2006; Domestic U.S. Scientific, Professional, and Technical R&D Personnel by R&D Function,; Domestic R&D by Function, Ethical Pharmaceuticals, PhRMA Member Companies, 2006; Domestic R&D and R&D Abroad for Human-Use and Veterinary-Use Pharmaceuticals,; Domestic R&D by Origin of Product (Licensed-in vs. Self-originated), PhRMA Member Companies, 2006; Phase 4 Postmarketing Research to Top $12 Billion in 2007—Cutting Edge; U.S. Government (NIH) Funding for Medical/Clinical Research, 1995-2008; Growth in Domestic U.S. Sales and Sales Abroad, Ethical Pharmaceuticals, 1970-2007; Sales by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2006; A New Look at the Global Pharmaceutical Market: North America Sets Pace in 2007 Pharma Sales; Contribution to Drug Market by Age of Drug; Top 20 Companies by Worldwide Prescription Drugs Sales in 2006/2007 (EvaluatePharma); An Analysis of Worldwide Prescription and OTC Sales by Technology (2002-2012):; Two in Ten New Drugs Recoup Costs—New Study (EvaluatePharma); An Analysis of the Sales Potential of New Drugs Approved in 2006 and 2007 (EvaluatePharma); Few Drug Launches Vastly Successful—IMS Health; Biologic Drugs/Vaccine Sales to 2011E; The Future Pharma R&D Model: The New PharmaCo Threat; An Analysis of the U.S. Pharma Market: U.S. Prescription Drug Sales in 2007; Your Own Lab—Oh, and a Home Mortgage; Want To Help Reduce Healthcare Costs? Then Smoke and Overeat!; Pharma Behind Networking and Mining/Oil Production Among Most Profitable U.S. Industries; Global and US Sales Growth of Branded Drugs by Therapeutic Category, 2004-2011E; Therapeutic Categories: Drug Sales as a Percentage of Worldwide Market, 2007 vs. 2012P; Pharma Companies: Drug Sales as Percentage of Worldwide Market, 2007 vs. 2012P; The Future of Pharma: Adjusting the Pharma R&D Model; Assessing Patent Risk: Industry and Company-specific Exposure to Generics, 2006-2011E; Biomarker Market to $12.8bn by 2012; U.S. Generic Drug Market Outlook to 2012; Prescription Drugs Represent 10% of Health Care Dollar Spent—CMS Analysis; U.S. Disease Foundation Investment in Biopharma R&D Rises; New Global Pharma Outsourcing Market Model to 2011; A May 2008 Update to the Goldman Sachs Global R&D Outsourcing Model; EDC Spending to Top $500 Million in 2009—Health Industry Insights; The CRO Contribution to Drug Development: A 2005 Assessment; Percentage of Development Budget Outsourced, As Average by Phase Across Therapeutic Areas; Sources of Clinical Trial Funding, 2001-2007P; Breakdown of Government vs. Industry-Sponsored Clinical Trials; Biopharmaceuticals; Top 100 Biotech Companies by 2007 R&D Spending; R&D Spending at Selected Leading Biotechnology Companies, 2007A-2012E; Biotech Industry Benchmarks from E&Y; Biotech R&D Spending to 2009E; Biologics and Biotech R&D: An Analysis of PhRMA Member Companies, 2006; mAb Sales Growth to Dwarf Small Molecules; Financial Markets Continue to Fuel Biotech’s R&D Efforts; Does Biotech Have the Pharma Flu?; An Analysis of Global Biologics/Biotech Market: Worldwide Sales for Top Products and Top Product Classes in 2007
Section 2: Products in Development: Pharmaceuticals; Worldwide Drugs in the Pipeline by Therapeutic Category as of January 2008 (IMS Health); Top 50 Drug Companies by Number of Drug Products in Development as of January 2008 (IMS Health); Top 50 Drug Companies by Number of Drug Products in Development as of March 2008 (Pharmaprojects); A Snapshot of the Pharma R&D Pipeline, Number of Projects by Development Phase, 1998-2008; An Analysis of the Drug and Biotech Pipeline by Development Phase, Technology, Therapeutic Category, and Strategy (EvaluatePharma); Pipeline Expansion Accelerates; A 2008 Analysis of the Mid- and Late-Stage R&D Pipeline: Size, Developer Type, Indications, and Success Rates; Wall Street No Longer Impressed by Pipeline; Top 20 Most Valuable R&D Projects (Ranked by Net Present Value); Biotechs Responsible for 65% of Recent FDA New Drug Approvals—New Study; Valuing Company R&D Pipelines based on NPV Analysis: Top R&D Spenders; Measures of Pharma Industry’s New Drug Output: NME/NAS Submissions to FDA and EMEA, 1995-2007; Active Clinical Drug Development Programs Worldwide by Phase, April 2008; An Analysis of New US Clinical Trial Starts for Drugs as Measured by Commercial IND Submissions to FDA, 2007; Global New Active Substance Product Launches, 2007; An Analysis of U.S.-based Clinical Trial Activity for Drugs as Measured by Active INDs at Year-End 2007; Top Therapeutic Categories by Number of Projects in Development as of March 2008 (Pharmaprojects); Number of Drugs in Preclinical Testing, 1995-2008 (Pharmaprojects); Top Therapeutic Drug Categories Worldwide by Number of Projects in Development as of January 2008; Drug R&D Projects: Top Ten Areas of Research, 2007; The Late-Stage Pipeline: A 2008 Assessment; Did the Molecular Bulge Begin Shifting in Late 2007?; Proportion of Top Pharma and Biotech Company Pipelines In-Licensed: A 2008 Assessment; Number of Companies in Pharma R&D on Rise, 1997-2007; The R&D Pipeline for Antibody-Derived Therapies, 2006-2012; The Future Pharma R&D Model: The NewPharmaCo Threat; The Pipeline and the New Realities of Drug Development; Pharma/Biotech Dealmaking: A 2008 Analysis; Dealmaking Trends: Can Prices Continue to Grow?; Pharma and Biotech Company Pipelines: An Assessment of “Replacement Power,” 2007; An Assessment of Pharma Industry Pipelines: Anticipated Launches to 2011e; New Cancer Therapeutics and Vaccines Entering Clinical Study, 1993-2006; Number of Annual New Drug Launches Projected for 62 Selected Companies in Lehman Universe, 2001-2011e; The Pharmaceutical Pipeline: A December 2007 Analysis; An Assessment of Oncology Market and Pipeline; Novartis Looks to Build on New Growth Cycle in Pharmaceuticals in 2008; Tufts CSDD Study on the Value of Follow-on Drugs and Indications; Roche Moves Ahead to Further Expand Innovation Capacity and Personalized Medicine Focus; More than 2,700 Drugs in US Clinical Development; Finding Biomarkers as Difficult as Finding New Drugs—Roche’s Humer; Merck Updates Its “Plan to Win” and New Operating Model; FDA Clears First Molecular Test to Profile Genetic Activity; Genetic Tests Could Accompany One in Five R&D Drugs Within Next Decade—Medco; Pfizer Acclerates and Refocuses Its Pipeline; Lilly Unveils Transformation Plan to Focus on Personalized Medicine; GSK Highlights R&D Pipeline and CEDDs Model, Looks to Biopharm and Asia; Bristol-Myers Squibb: Evolving to the “Next Generation BioPharma Model”; Incremental R&D: A 2004 Study; PhRMA’s Medicines in Clinical Development Series; Embryonic Stem Cells to Enter Clinical Trials in 2008?; Leading Pharmaceutical Company R&D Profiles; Development Pipelines of Selected Leading Drug Companies: Number of Products by Stage of Development, March 2008; Large and Small/Mid-Tier Pharmas Relying on Each Other for Growth; New Drug Clinical Trial Starts Surge at Top 10 Companies in 2003-2005 Period; AIDS Vaccine R&D Setback; FDA Reviewers Being Pressured into Approval Indecision—Vasella and Hassan; International Patenting of Pharmaceuticals and Biotechnology, 2004-2006: Top Innovators; Innovating Beyond Pharma’s Patent “Black Hole”; Biopharmaceuticals; Number of Biotechnology R&D Projects by Therapeutic Area, 2007; Biotech Company Development Pipelines: Number of Development Projects by Phase of Development, March 2008; Biotech Filling Pharma’s Pipeline Gaps, But With Blockbusters?; An Assessment of the Biotech Pipeline; Biological Drugs: A Study of Additional Indications Approved Postlaunch in the US; Genetics, Genomics, Proteomics, and Now Epigenetics; Vaccines Entering Clinical Development Rise Only Modestly in 1990-2005; Target Organism Types for Vaccines Studied, 1990-2005; Number of Vaccines in Clinical Trials by Phase of Development; Clinical Phase Transition Probabilities for Vaccines Entering Clinical Study, 1990-2005; Development Project Pipelines for 19 Selected Leading Biotech Companies by Therapeutic Categories, March 2008
Section 3: Drug Development Costs/Complexity, Development Time, and Success Rates: Costs/Complexity; Recent Estimates of the Cost of Developing New Drugs, 2008; Measures of Clinical Trial Costs and Complexity, 2005-2007 (TTC); Mean Cost per Patient in Clinical Trials, 2005-2007; Clinical Trial Complexity by Trial Phase, 2005-2007; Measures of Clinical Trial Costs, 2005-2007 (TTC); Indices of US Clinical Trial Costs per Patient, 2005-2007 (TTC); Measures of Clinical Study Complexity, 2005-2007 (TTC); Biomedical Research and Development Price Index, 1980-2013; Selected Health Care Inflation Data, 1998-2007; New Drug Development Spending and Costs: A 2008 Analysis; Avandia, Vytorin, and Surrogate Endpoints; An Analysis of Site Performance within a Clinical Study and its Effect on Cost; Lilly Moves Relationships with Successful Sites to the Next Level; The Effects of Growing Clinical Trial Protocol Complexity: A 2008 Analysis; Study-Related Burdens vs. Compensation for Clinical Trial Sites, 2000-2005; An Analysis of Ways to Reduce Central Recruitment Costs; US Clinical Site Profitability: A 2007 Assessment; EDC Adoption in Clinical Trials: A 2008 Analysis; The FDA Amendments Act of 2007: An Analysis of Possible Effects on Phase 4 Clinical Trials and the CRO Market Opportunity; Segmentation of US Clinical Trials by Therapeutic Area (TTC); Industry Postmarketing Study Commitments: A 2007 Study; Where Today’s Clinical Trials Are Being Conducted: A Study of New FDA-Regulated Studies in 2007; Active Clinical Trials by Phase and Country/Region: A 2008 Analysis; Number of Clinical Trials Initiated Annually for U.S. Submissions: FDA Estimates; Analysis of Paying Clinical Study Subjects; Clinical Trials Move Abroad: Chasing Patients; The Globalization of Clinical Trials: Number of Recruiting Studies by Country; Patient Recruitment Metrics at Pfizer; Demographics of Clinical Trial Populations: A Look at NIH Trials, 2007; Aggregate Enrollment Data for All Extramural and Intramural Research Protocols in FY2006 by Race and Gender; Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2007; Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2006; Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2005; Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2004; Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2003; Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2002; A 2007 Assessment of the Clinical Trial Experience: Volunteer Experiences, Study Enrollment,; Consent Form Comprehension, and Study Dropout Rates; Emerging Markets Not a Solution to Rising R&D Costs—Vasella; US Clinical Trial Sites Rate Sponsors: A 2007 Assessment; The Case for New Drugs and Better Predictive Biomarkers; A 2007 Assessment of the Site Management Organization Space; Assessing the Cost to Develop a New Biotech Product; Pre-Approval Cash Outlays and Time Costs per Approved New Biopharmaceutical; Pre-Approval Cash Outlays per Approved New Molecule; Pre-Approval Capitalized Cost per Approved New Molecule: Biotech vs. Pharma; Capitalized Preclinical and Clinical Period Costs per Investigational Biopharmaceutical Compound; Medical Imaging Emerges in Clinical Trials: A 2007 Assessment; Estimating the Cost of New Drug Development: Is It Really $802 Million; Achieving High Performance in Pharmaceuticals: Reversing the R&D Productivity Decline; R&D Productivity Challenge: Spend vs. Value (Sales); Average Number of Patients per Trial, by Phase and Therapeutic Area: A 2006 Assessment; Finding Biomarkers as Difficult as Finding New Drugs—Roche’s Humer; The Global Clinical Trial Landscape: A 2006 Assessment; Emerging Markets’ Cost and Enrollment Advantages: India and China vs. US; Clinical Sites in ROW Represent 20% of Sites Under US INDs; The Cost of Attrition in Drug Development; Addressing the Investigator Shortfall; Clinical Research Offshoring: A Country Attractiveness Index for Clinical Trials; Various Clinical Trial Metrics: Number of Sites, Patients per Phase; Estimates of Nonclinical Study Costs and Durations; Clinical and Total R&D Costs by Therapeutic Category; The Price of Innovation: New Estimates on Drug Development Costs; Tufts Center for the Study of Drug Development Estimate of Cost to Develop a New Drug; The Costs of Drug Development: The Public Citizen Rebuttal; DiMasi Rebuttal to Public Citizen Critique; The Phase I Clinical Study Market: A 2007 Assessment; The Phase IIIb/IV Market: A 2006 Assessment; The Central Laboratory Market: A 2006 Assessment; Top Disqualification Categories for Study Candidates Sourced by Data-Based Patient Recruitment Strategies; Clinical Trial Recruitment Best Practices and Performance Benchmarks: The Wise Investments Survey; The Impact of Internet-based Clinical Trials on the Efficiency of Data Entry, Monitoring, and Data Management: A 2006 Case Study; Development Time; Analysis of U.S. New Drug Development Process by Average Time to; New Drug Development Times: A 2007 Analysis; Cancer Therapy Development Times vs. Other Drugs: A 2007 Study; Development Phase Lengths for Selected Therapeutic Categories; Development Phase Lengths and Attrition Rates for Selected Therapeutic Categories; The FDA’s Fast Track Program: Effect on Review Time and Approval Success; Delays in Study Enrollment Timelines: A 2007 Assessment; Biopharmaceutical Development Times: A 2007 Analysis; Top Factors Causing Clinical Study Delays: A 2007 Survey; The FDA on Study Initiation Delays; The Speed Demons of Drug Development: Achieving Revenue Gains and Cost Savings; Emerging Markets’ Cost and Enrollment Advantages: India vs. China vs. U.S; Development Times for Biotech vs. Drug Products: A 2006 Study; Time Consumed by Various Clinical Trial Activities; Study Sites’ Perception on Reasons for Study Delays; Clinical and Approval Timelines for Drugs Approved 1984-2004; Are Development Times for Pharmaceutical Companies Increasing or Decreasing?; Clinical and Approval Timelines for Biopharmaceuticals Approved in the US, 1996-2005; Total Development Times for Drug and Biopharmaceutical Products, 1985-2004; The FDA’s Fast Track Program: Its Utilization and Impact on Drug Development Times: An April 2006 Update; The Effects of CRO Usage on Drug Development Times; Quantifying the Time Used in Key Clinical Study Activities: A 2006 Assessment; The Duration of Clinical Trials by Phase and Therapeutic Area: A 2004 Study; Pharmaceutical Development Phases: A Duration and Success Rate Analysis; Various New Drug Development Metrics; The FDA’s Fast Track Program: A 2005 Analysis; The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade After Passage of PDUFA; Success Rates; A 2008 Analysis of Approval Success Rates by Product Type and Novelty; A 2008 Analysis of the Mid- and Late-Stage R&D Pipeline: Size, Developer Type, Indications, and Success Rates; The Pipeline and the New Realities of Drug Development; Development Attrition Rates for Selected Therapeutic Categories; Emerging Success Rates for New Cancer Therapies, 1990-2006; Almost Nothing Getting Through FDA Now—Wyeths’s Ruffolo; Smaller Companies and Biotechs More Reluctant to Discontinue R&D Projects—Pazdur; FDA Approvals and Phase III Failures: Pharma vs. Biotech; Attrition Rates in Drug Development Phases; An Analysis of Late-Stage Success Rates: Biotech Products versus Pharmaceuticals; Probability of Success to Market for New Active Substances by Origin: Self-Originated vs. Licensed-in; Kola on Emerging Attrition Rate Trends, 2007; Estimates of Drug Success Rates: Unprecedented vs. Precedented Molecules; Major Culprits in Drug Approvals and Late-Stage Trial Delays; Comparative Success Rates for Biotech vs. Drug Products: A 2006 Study; Fastest Pharma Firms Kill Development Projects Sooner; FDA Reviewers Being Pressured into Approval Indecision—Vasella and Hassan; Emerging FDA Approval Standard Creating Monopolies—Wyeth’s Essner; New Drug Success Rates at Top 10 Pharma Companies: A 2006 Study; Success to Market Rates for New Active Substances: Comparison of Chemical Entities and Biotech Products; New Postapproval Requirements Less Harmful to Pharma R&D Than New Preapproval Burdens—Analysis; Can the Pharmaceutical Industry Reduce Attrition Rates?; Drug Success Rates: A 2003 Assessment; Drews on Pharma Industry Productivity and Strategic Trends in the Drug Industry
Section 4: Regulatory/FDA Statistics: INDs; Number of IND Submissions, 1982-2007; Breakdown of Drug Divisions’ Active IND Review Workload as of Year-End 2007; Number of Active INDs at the Close of the Calendar Year, 1983-2007; Breakdown of CDER Divisions’ Workload by INDs Received in 2007; CDER Holds on Commercial IND Submissions, 1990-2006; Clinical Holds on Commercial IND Submissions by Division, 2006; NDAs; Number of NDAs Pending at the Close of the Calendar Year, 1983-2007; Breakdown of Drug Divisions’ Pending NDA Review Workload, Year-End 2007; Breakdown of Drug Divisions’ Workload by NDAs Received in Fiscal Year 2007; Breakdown of Divisions’ Workload by Pending NDA Supplements, Year-End 2007; CDER Refusal-to-File (RTF) Actions by Year, 1994-2007; Key Drug Submission and Approval Statistics, 1993-2007; Number of NME Approvals and Approval Times, 1984-2007; NME Review Time Ranges, 1995-2007; Priority/Standard NME Review Gap, 1995-2007 (in months); Median Approval Times for All NMEs by Calendar Year, 1986-2007; Average NME Review Times in Months by CDER Division, 2005, 2006, and 2007; Average NME Review Times in Months by CDER Division, 1993-2004; Number of NDAs and NMEs Approved by Year, 1983-2007; NMEs Approved Based on Therapeutic Potential, 1985-2007; Percent of All Approved NDAs Receiving Priority Review Status, 1994-2007; CDER’s Priority NME Approvals by Class of Drug, 1994-2007; CDER-Wide First Action Performance for FY05, FY06, and FY07 User Fee Cohorts of NDAs, Resubmissions, Effectiveness Supplements, and Manufacturing Supplements; A 2008 Analysis of CDER First-Cycle Review Outcome Trends for NDAs, FY1996-FY2007; An Analysis of Review Cycles to Approval for New Drugs; Mean Review Cycle Times for Approved Priority/Standard NDAs in the FY2000-FY2006 Submission Cohorts; FDA: Refusing Few NDAs, but Delaying More Clinical Trials; FDA “Barely Hanging On”—Hutt; A Closer Look at the FDA’s 50 Fastest Drug Approvals, 1963-2007; Median Approval Times for Priority and Standard NDAs, 1993-2006; Median Approval Times for Priority and Standard NMEs, 1993-2006; Guardrails, Not Speedbumps, for FDA Drug Approval Process—FDA’s Von Eschenbach; A Comparison of FDA vs. EMEA Drug Approval Times, 2000-2005; “Risk Averse” FDA? A Look at What’s Being Approved; U.S. New Drug Approvals of 2007: NDA Review Times by Drug; U.S. New Drug Approvals of 2006: NDA Review Times by Drug; U.S. New Drug Approvals of 2005: NDA Review Times by Drug; U.S. New Drug Approvals of 2004: NDA Review Times by Drug; U.S. New Drug Approvals of 2003: NDA Review Times by Drug; U.S. New Drug Approvals of 2002: NDA Review Times by Drug; U.S. New Drug Approvals of 2001: NDA Review Times by Drug; U.S. New Drug Approvals of 2000: NDA Review Times by Drug; U.S. New Drug Approvals of 1999: NDA Review Times by Drug; U.S. New Drug Approvals of 1998: NDA Review Times by Drug; U.S. New Drug Approvals of 1997: NDA Review Time for Each Drug; U.S. New Drug Approvals of 1996: NDA Review Time for Each Drug; U.S. New Drug Approvals of 1995: NDA Review Time for Each Drug; U.S. New Drug Approvals of 1994: NDA Review Time for Each Drug; U.S. New Drug Approvals of 1993: NDA Review Time for Each Drug; U.S. New Drug Approvals of 1990, 1991, and 1992: NDA Review Times for Each Drug; New Analysis on Factors Associated with First-Cycle Approvals; An Analysis of FDA’s Fast Track Initiative, 2008; Remembering the Good Old Delays; Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved in 2007; New Postapproval Requirements Less Harmful to Pharma R&D Than New Preapproval Burdens—Analysis; Safety-Based Drug Marketing Withdrawals in the United States, 1980-2008; CDER Safety-Based Drug Withdrawals: Pre-PDUFA vs. PDUFA Era, 1971-2007; Drugs Cleared New User-Fee Review Deadlines More Likely to Present Safety Issues?; Molecular “Nose” to Sniff Out Drug Safety Issues Earlier?; Faster FDA Drug Approval Times and Drug Withdrawals: A 2005 Analysis; Pediatric Study Costs and Complexity Levels Grow, 2000-2006; Orphan Drug Activity Continues to Hit Record Levels in 2007; Is FDA Failing to Use Advisory Committees?; NDAs Approved Under CDER’s Accelerated Approval Program, 1992-September 2007; Biologics; Summary of CBER Actions in 2007; Summary of CBER Actions in 2006; Summary of CBER Actions in 2005; Summary of CBER Actions in 2004; Summary of CBER Actions in 2003; Summary of CBER Actions in 2002; Summary of CBER Actions in 2001; Summary of CBER Actions in 2000; Orphan Drugs; Orphan Drug Designation and Approval Statistics, 1990-2007; Cumulative Growth of Orphan Drugs, 1984-2007; Orphan Drug Approval Times vs. Approval Times of Other Drugs, 1993-2007; Orphan Drug and Biologic Approvals, 1993-2007; Orphan Drug and Biologic Approvals in 1990, 1991, and 1992; Over-the-Counter Drugs; Rate of Rx-to-OTC Switches per Year, 1951-2007; Generic Drugs; Generic Drug Approval Times: Median Time to Approval 1993 to 2007; Pending ANDAs Continue to Surge at FDA, 2000-2007; Mean and Median ANDA/AADA Review Times, 1995-2007; Annual ANDA and AADA Submission and Approval Statistics, 1995-2007; CDER Clinical Site Inspection Results, FY1997-FY2007
Section 5: International Statistics: European Union; R&D Spending in Europe’s Pharmaceutical Industry, 1980-2007; Mean EMEA Review Time for Human Drugs Submitted Under the EC’s Centralized Procedure, 2007; Cancer, Anti-Infective, and Neurology Drugs Dominate New Centralized Submissions to EMEA in 2007; Marketing Authorization Applications Rise to Record Levels at the EMEA; An Analysis of the Mutual Recognition Procedure, 2007; UK R&D and Clinical Trials to Plummet After Drug Pricing Scheme Scapped; Comparison of FDA vs. EMEA Drug Approval Times, 2000-2005; United Kingdom; Pharmaceutical Industry R&D Investment in the UK, 1989-2006; The MHRA’s Clinical Trials Work (by CTX submissions), 2006/2007; MHRA’s New Active Substances Assessed and Mean Assessment Times, 1993-2007; Japan; Pharmaceutical R&D Expenditures in Japan, 1985-2006 (in bill. Yen); Annual Number of New Chemical Entities Approved in Japan, 1983-2007; Number of INDs for Investigational New Drugs Submitted in Japan, 1990-2006; Success Rates of New Drug Development in Japan, 2002-2006; R&D Expenditures of 20 Leading Japanese Pharmaceutical Manufacturers, 2003-2006; Number of Prescription Drug Manufacture and Import Approvals Granted in Japan, 1985-2006; Median NDA Approval Trends in Japan by Year of Submission, 1996-2005; Number of Drugs in Development in Japan by Pipeline Stage and Disease/Therapeutic Category, 2008; Addressing Japan’s “Drug Lag”; Germany; Pharmaceutical R&D Expenditures by German Drug Industry, 1999-2006; Number of New Chemical Entities Approved in Germany, 1988-2006; Canada; Canadian Drugs Directorate New Active Substance (NAS) Approval Times, 1993-2007; R&D Spending by Canadian Drug (Rx&D Member) Companies, 1984-2006; New Drug Submission (NDS) Approval Times in Canada, 1997-2007; Latin America; Global Clinical Trials: A Focus on Latin America; Will Pharma Stop Drug Launches in the UK?; Orphan Drugs Get Closer Look; Global; Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2008 Analysis; Clinical Research Market in Central and Eastern Europe: A 2007 Assessment; Russia’s Clincial Trials Market Heats Up; Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2012P; Trends in Worldwide R&D Expenditure, 1993-2008P; Global New Active Substance Product Launches, 2007; Russia’s Clinical Trials Market: A 2007 Assessment; India’s Clinical Research Market: A 2006 Assessment; India to Need 50,000 Clinical Trial Pros by 2010?; Unprecedented Chinese Government Investment to Boost Innovative Drug Development; China’s R&D Goal: $10B by 2010; China as a Site for Clinical Trials: A 2005 Assessment; Western Drugs Hard Sell in China?; Singapore as Hub for Clinical Trials in Asia; Clinical Trials: Does East Cost Least?; Estimated Clinical Trial Applications Submitted per Year in Various European Countries; Clinical Trials in Spain, 1994-2000; Regulatory Approval Times, 1998-2004: US, Japan, and EU

Abstract

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009 is packed with more cutting-edge and proprietary intelligence and analyses not available anywhere else--for example:

New proprietary analyses on US clinical trial starts, now segmented for the first time by therapeutic category, as well as overall active clinical trials, also segmented by therapeutic category. See how quickly the numbers of active clinical trials are growing, and precisely which therapeutic areas are driving this growth.
An all-new and comprehensive analysis of clinical research offshoring in which we provide the first definitive analysis of the countries in which pharma companies are now locating their new clinical trials (based on new studies initiated in 2007).

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PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2008/2009

Table of Contents

Abstract