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PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2008/2009
Publication Date June 2008
Publisher Barnett International
Product Type Reference Manual
Pages 400
ISBN Number not applicable
Product Code BAR025
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Summary
Note: Please note that this product is also available as a package composed of a year Single-User Electronic Access (web access) and a harcopy for the price of GBP 605.00 equivalent of US$ 1,200.00. Should you wish to purchase the package version, please call customer services.
Now industry's most widely read reference on emerging pharma/biotech R&D trends worldwide, PAREXEL's Pharmaceutical R&D Statistical Sourcebook 2008/2009 features hundreds of all-new, real-world studies, analyses, articles, and data sets providing fresh insights into the developments reshaping pharma R&D and the industry itself.
- 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 2006). The results will surprise you.
Supported by thousands of graphs, illustrations, and analyses, PAREXEL'S Pharmaceutical R&D Statistical Sourcebook 2008/2009 provides the latest intelligence on every aspect of pharmaceutical development--from product discovery to R&D performance and productivity to time-to-market trends.
An invaluable resource for executives and managers working within or with the pharma and biotech industries, this 2007/2008 compendium puts real-world data sets at your fingertips for presentations, reports, business development efforts, meetings, and critical decision-making analyses:
- New R&D Spending Trends (U.S. and Global)
- International Statistics on Drug Development Output Industry-wide and Company-by-Company
- Emerging Data on the Worldwide and Company-specific R&D Pipelines and Product Launch Trends
- New Analyses on Drug Development Costs/Development Cycle Times/Attrition Rates
- Drug Approval Statistics Compiled from FDA, EMEA and other Key Regulatory Agencies
- International R&D Data from Key Global Markets
And in response to customer demand, the new 2008/2009 edition is once again available in electronic format. Gain instant access to the data, analyses, and benchmark provided in the hardcopy compendium on a fully searchable, hyperlinked and printable web-based edition!
From an in-depth an analysis on the realities of migrating clinical trials to developing nations to advances in clinical trial simulation and genomics to emerging trends in industry's product pipeline and product success rates to the new demographics of US clinical investigators and clinical trial populations, make sure that your meetings, reports, presentations, and decision-making are based on the very best and latest data available today!
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Content
- Section 1: R&D Spending
- Pharmaceuticals
- R&D Spending by Research-Based Pharmaceutical Companies, 1980-2006
- R&D Investments by Research-Based Pharmaceutical Companies, 1975-2006
- Industry-wide and Government R&D Spending, 1980-2006
- Biopharmaceutical Industry Investment in Research and Development, 1980-2006
- Biopharmaceutical R&D Expenditure and NIH Budget: 1995-2006
- Booz Allen Hamilton Study on R&D Spending
- Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2012P
- Global R&D Spending by World's Top 400 Pharma and Biotech Companies 2002-2012
- Total PhRMA R&D as a Percent of Sales, 1980-2006
- Domestic U S. R&D and R&D Abroad, 1980-2006
- Domestic U S. Sales and Sales Abroad, 1980-2006
- Growth in Domestic U S. R&D and R&D Abroad, 1970-2006
- R&D Spending at Top 50 Pharmaceutical Companies in 2006
- Productivity as Measured by R&D Spending per NME Approval "Deeply Flawed"
- Various Measures of New Drug/Biologic R&D Productivity
- Industry R&D Spending per NDA Submission in the U S , 1993-2006
- Industry R&D Spending per NDA Approval in U S, 1996-2006
- Industry R&D Spending per NME Submission to FDA, 1995-2006
- Industry R&D Spending per NME Approved in the U S , 1995-2006
- Global R&D Spending per Global New Active Substance (NAS) Launch, 1995-2006
- Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2006 Analysis
- Breakdown of World Pharma Market-2006 Sales
- Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2006
- Late-Stage Pipelines in US, EU, Japan, and ROW, 1997-2005
- Number of New Chemical Entities or Biological Entities by Country/Region of
- Originating Company: Europe, US, Japan, Others, 1990-2005
- U S , European, Canadian, Japanese and Australian Biotech: Global Activity Measures, 2005
- Top Pharma Companies: Global R&D, 2006 vs. 2005
- Pharma and Biotech Industry R&D Spending: A 2007 Estimate
- Pharma R&D Spending Accelerates into 2007
- R&D Spending by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2005
- Trends in Worldwide R&D Expenditure, 1993-2008p
- Regional Distribution of Total R&D Expenditure and R&D FTEs, 2004
- Global R&D Expenditure and FTEs by Stage of R&D, 2004
- Proportion of Total R&D Expenditure by Therapeutic Area, 2004
- Relevance of NIH R&D Spending to Pharma
- Domestic U S. Scientific, Professional, and Technical R&D Personnel by R&D Function,
- Ethical Pharmaceuticals, 2005
- Domestic R&D by Function, Ethical Pharmaceuticals, PhRMA Member Companies, 2005
- Domestic R&D and R&D Abroad for Human-Use and Veterinary-Use Pharmaceuticals,
- PhRMA Member Companies, 2005
- Domestic R&D by Type (Basic and Applied Research vs. Development), PhRMA Member Companies, 2003
- Domestic R&D by Origin of Product (Licensed-in vs. Self-originated), PhRMA Member Companies, 2005
- U S. Government (NIH) Funding for Medical/Clinical Research, 1995-2007E
- NIH Appropriations, 1995-2008P
- NIH Clinical Research and Clinical Trials Spending, 2003-2008P
- Estimates of Funding for Selected Diseases, Conditions, and Research Areas, 2003-2007E
- Growth in Domestic U S. Sales and Sales Abroad, Ethical Pharmaceuticals, 1970-2006
- Sales by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2005
- A New Look at the Global Pharmaceutical Market: North America Sets Pace in 2006 Pharma Sales
- Global Pharma Sales, 1998-2006
- Global Pharmaceutical Sales in 2006 by Region
- Leading Therapy Classes in 2006 Global Pharma Sales
- Global Pharma Sales in 2006-Leading Products
- Pharma Market Growth in Five Key Regions
- Contribution to Drug Market by Age of Drug
- Percentage Contribution to the Overall Market by Age of Drug, 2000-2010
- Targeted Oncology Therapies to Capture Majority of Cancer Drug Sales by 2015-Datamonitor
- Deloitte's Mulder on 2006 Survey of Pharma/Bio Firms
- Top 20 Pharma Companies: Global Drug Sales, 2006 vs. 2005
- Biologic Drugs/Vaccine Sales to 2010E
- An Analysis of the U S. Pharma Market: U S. Prescription Drug Sales in 2006
- Annual Growth Rate of U S. Prescription Pharmaceutical Market, 1994-2009P
- Top 10 Therapeutic Classes by U S. Prescription Sales, 2006
- Top 10 U S. Prescription Products by Sales, 2006
- Top 10 Pharma Companies by U S. Prescription Sales, 2006
- Specialty Drugs to Comprise 25% of U S. Prescription Market in 2006
- Total U S. Prescription and Specialty Drug Markets, 2003-2006E
- Modest Growth in Global Pharma Market, But Blockbusters Continue to Climb to 2007-IMS Health
- Pharma Behind Only Mining/Oil Production Among Most Profitable U S. Industries
- Global and US Sales Growth of Branded Drugs by Therapeutic Category, 2005-2010
- Global Drug Sales and Growth Forecasts in Major Therapeutic Areas: 2003-2010E
- US Sales and Growth Forecasts-Major Therapeutic Areas, 2003-2010E
- An Assessment of Conditions of Reimbursement for Prescription Drugs, 2002 vs. 2005
- Share of Global Top 100 Selling Drugs with Conditions Applied to Reimbursement, 2002 vs. 2005
- Pharma's Diabetes Opportunity Not Just in the West
- Oncology Drug Sales to Almost Double in Five Years-IMS Health
- Therapeutic Categories: Drug Sales as a Percentage of Worldwide Market, 2006 vs. 2011P
- Pharma Companies: Drug Sales as Percentage of Worldwide Market, 2006 vs. 2011P
- So How Do You Think Pharma Feels? Did a Song Every Treat Cancer?..........................25
- Assessing Patent Risk: Industry and Company-specific Exposure to Generics, 2006-2011E
- Percentage of US Market Over Time at Risk of Loss Through Patent Expiries, 1994-2011E
- U S. Pharma Sales in 2006E at Risk of Generic Competition in 2006-2011E as a
- Percentage of Pharma Sales at 13 Large Pharma Companies
- U S. Generic Drug Market Outlook to 2012
- 2006 U S. Sales of Drugs Losing Patent Protection, 2007-2012
- Percent Sales Vulnerable to Patent Expirations Through 2010: Selected Leading Companies
- U S. Healthcare Spending Nearly $2 Trillion in 2005
- Generics Accounted for Over Half of Pharma Sales in Major Markets-IMS Health
- Multiple Generics Needed to Drive Down Drug Prices-FDA Study
- $100 Billion in Brand Sales Exposed to Generics through 2011
- Why New-Engine Drugs Are Succeeding and Blockbuster Drugs Failing
- Prescription Drug Revenue Growth by Severity, 1990-2004
- Worldwide Prescription Drug Sales, Blockbusters vs. New-Engines (1990, 2004 actual)
- Worldwide Prescription Drug Sales, Blockbusters vs. New-Engines (2004 actual, 2012 projection)
- Forecast Sales and Growth Rates for the Top 10 Pharma Companies, 2003-2008
- Forecast Sales and Growth Rates for the Top 10 Pharma Companies Index, 2003-2008
- New Global Pharma Outsourcing Market Model to 2010
- The Goldman Sachs Global R&D Outsourcing Model
- A Contract Research Organization Market Size Model to 2010
- Biopharmaceutical Industry R&D Spending and Year-over-Year R&D Growth, 2001-2010E
- Development Spending by Phase, 2003-2010
- Outsourcing Penetration Assumptions, 2003-2010E
- CRO Market Size and YOY Growth by Phase, 2003-2010E
- Big Pharma Cash and "Knock Out" Premiums for Biotech Acquisitions
- The CRO Contribution to Drug Development: A 2005 Assessment
- Global Spending on Development and Clinical Outsourcing Services, 2001-2004
- Global Clinical Research Personnel, Pharma Companies vs. CROs, 2001-2004
- Clinical Study Activity Managed Worldwide by Major CROs, 2001-2004
- Days That Actual Submission Exceeded Projected Submission Data, Low vs. High CRO Usage Projects
- Mean Time to Four Pivotal Clinical Trial Milestones, Low vs. High CRO Usage Projects
- A Measure of Quality: Case Report Form Queries/Page Screen
- Percentage of Development Budget Outsourced, As Average by Phase Across Therapeutic Areas
- Percentage of Clinical Development Budget Outsourced, as Average Across Therapeutic Areas (by Phase, US)
- CROs Accelerate Drug Development-Pharma/Biotech Execs
- CROs, Academic Medical Centers, and the Future of Clinical Trials
- Trial Outsourcing Distribution
- Worldwide CRO Market, 2003-2008P
- Top Five CROs: Percentage of Market Share by Year, 1995-2005
- Biotech Deals Soar in Early 2007
- As Search for New Therapies Heats Up, Biotech and Pharma Lure More VC Money in 2006
- New Amgens Unlikely-Pisano
- Big Savings in Store with Generic Biologics-Express Scripts
- ...Not So Fast Says BIO
- Biopharmaceuticals
- Top 100 Biotech Companies by 2006 R&D Spending
- R&D Spending at Selected Leading Biotechnology Companies
- Biotech Industry Benchmarks from E&Y
- 2006 Financial Markets Continue to Fuel Biotech's R&D Efforts
- Total Equity Raised by Biotech, 1995-2006
- Biotech Drug Spending to Be 26% of Total Drug Spending by 2010-Express Scripts
- An Analysis of Global Biologics/Biotech Market: Worldwide Sales for Top Products and Top Product Classes in 2006
- Top-Selling Categories of Biologic Products, 2006
- Growth Rates of Top-Selling Classes of Biological Products, 2006
- Top 20 Selling Biologic Products Worldwide, 2006
- Section 2: Products in Development
- Top 50 Drug Companies by Number of Drug Products in Development as of March 2007 (Pharmaprojects)
- An Analysis of Year-over-Year R&D Pipeline Growth, 2004-2007
- Number of Drugs in Various Phases of Clinical Development, 2004-2007
- Number of Drugs in Various Phases of Clinical Development: Selected Top Pharmas, 2004-2007
- Number of Drugs in Various Phases of Clinical Development: Selected Large-Cap Biotechs, 2004-2007
- FDA Drug Approvals Indicate Pharma Shift to Specialty Care
- A Snapshot of the Pharma R&D Pipeline, Number of Projects by Development Phase, 1998-2007
- Worldwide Active R&D Projects in Development by Stage, 1998-2007
- The R&D Pipeline, 1998-2007
- A New Era of Pipeline Expansion Beginning?
- Drugs in Active Development, 1995-2007
- Global New Active Substance Product Launches, 2006
- An Analysis of New US Clinical Trial Starts for Drugs as Measured by Commercial IND Submissions to FDA, 2006
- New US Clinical Trial Starts for Drugs and Biologics/Biotechs, 1998-2006
- Breakdown of CDER Divisional Workload by INDs Received in 2006
- Segmentation of US Clinical Trial Starts for Drugs by Therapeutic Category, 2006
- An Analysis of U S -based Clinical Trial Activity for Drugs as Measured by Active INDs at Year-End 2006
- Breakdown of CDER Drug Divisions' IND Review Workload (Active as of Year-End 2006)
- Segmentation of US Clinical Trials for Drugs by Therapeutic Category, 2006
- R&D Projects by Therapeutic Category, April 2007
- Measures of Pharma Industry's New Drug Output: NME/NAS Submissions to FDA and EMEA, 1995-2006
- Annual Number of Marketing Applications for New Molecular Entities/New Active Substances
- Filed With the FDA and EMEA, 1995-2006
- New Molecular Entities in Development at Major Pharmas, 2004 vs. 2006
- U S. Clinical Development Pipeline by Phase, 1997-2006
- Number of Companies in Pharma R&D on Rise, 1997-2007
- Clinical Pipeline Grows 7% in 2006-IMS Health
- Up to 12 Blockbuster Launches in 2006/2007-IMS Health
- R&D Projects by Current Phase of Development and Technology
- R&D Project Counts by Current Phase of Development
- R&D Project Counts by Technology: Biotechnology and Conventional
- Claims of Pharma Innovation Productivity Crisis "Overblown"?
- Number of Clinical Trials Initiated Annually for U S. Submissions: FDA Estimates
- Proportion of Top Pharma and Biotech Company Pipelines In-Licensed: A 2007 Assessment
- Top 10 Pharma Companies by Pipeline Size: Percent of Pipelines In-Licensed
- Selected Leading Biotech Companies by Pipeline Size: Percent of Pipelines In-Licensed
- Garnier: Genomics Benefits Yet to Show
- Top Ten Therapeutic Categories for Drug R&D
- AZ's Patterson Questions Early-Stage Deals
- Hassan Calls Acquisition Prices "Breathtaking"
- R&D Failures and "Repositioning"
- Pricey Early-Stage Products Deals Are Sign of Desperation-GSK's Garnier
- Dealmaking Trends: Higher Prices, More Acquisitions
- Number of Preclinical/Phase I Deals with Upfronts Greater than $20m, 2000-2006
- Phase II Deals, 2001-2006
- Number of Phase III and NDA-Stage Deals with Upfronts Greater than $25m, 2000-2006
- Average Acquisition Values are Rising, 2000-2006
- Acquisitions Valued Between $150m and $2b, 2000-2007
- Biotech Therapeutic IPOs, 1999-2006
- Innovating Beyond Pharma's Patent "Black Hole"
- Industry "Black Hole": 28% of Aggregated Revenues Threatened by 2010+
- Bristol-Myers Squibb Innovation Plot
- Schering-Plough Innovation Plot
- Eli Lilly Innovation Plot
- Merck Innovation Plot
- Wyeth Innovation Plot
- Pfizer Innovation Plot
- Segmentation of U S. Clinical Trials by Therapeutic Category
- Analysis of Drug Pipelines: US, EU, Japan, and ROW, 1997-2005
- Late-Stage Pipelines in US, EU, Japan and ROW, 1997-2005
- The Mid- to Late-Stage Pharmaceutical Pipeline: A 2006 Analysis
- Number of NMEs in Industry's Late-Stage Pipeline (Phase II-Filed), 2002-2005
- Current Pipeline Status for Leading Pharma Companies, 2006-2011E
- Estimated Number of NME Launches, Adjusted for Industry Attrition Rates
- Number of Launches per Company (2006-2009E), Adjusted for Industry Attrition Rates
- IMS Health Count of Global NME Launches in Key Markets During 2006
- Pharma and Biotech Company Pipelines: An Assessment of "Replacement Power," 2006
- Large Pharma Replacement Power: 13 Major Companies
- Large Biotech Replacement Power: 7 Major Companies
- An Assessment of Pharma Industry Pipelines: Anticipated Launches to 2010e
- Industry Summary: Launches, Peak Sales, and NPV by Year
- Launch Expectations Over Time: Comparison of Lehman's 2004, 2005, and 2006 Estimates
- Number of Drugs in Development for Group of 38 Companies, 2002-2006
- Breakdown of R&D Portfolio by Size
- FDA Cancer Drug Approvals Rise Markedly in Last Decade
- Targeted Oncology Drugs Fill the Clinical Pipeline in 2006
- International Patenting of Pharmaceuticals and Biotechnology, 2004-2006: Top Innovators
- Ranking of Top 30 Pharma/Biotech Patentees, 2006
- Number of Annual New Drug Launches Projected for 45 Selected Companies in Lehman Universe, 2000-2010e
- Global Trends in Pharma/Biotech Product Licensing: A 2006 Assessment of 25 Leading Companies
- Number of Product Licensing Deals by the Top 25 Pharmaceutical Companies, 2000-2005
- Number of Product Licensing Deals by Top 25 Pharma Companies by Stage of Development, 2000-2005
- Biotech's Biological and Small Molecule Product Deals, 1995-2005
- Pharma-Biotech Licensing Deals by Therapeutic Category, 1996-2000 vs. 2001-2005
- Average Cost of In-Licensing Early-Stage vs. Late-Stage Products, 2000-2005
- Novartis Continues to Transform Drug Discovery and Development Model: A 2007 Update
- U S. Approvals for Top Pharma Companies, 2000-2006
- NMEs in Phase 3 or Registration/2005 Sales: 12 Leading Companies
- The DELPHI Initiative
- Early Stage Pipeline: PoC and Increasing Number of Early Clinical Trial Initiations
- The Novartis Clinical Pipeline, 1997-2006
- Novartis Clinical Pipeline by Phase and Therapeutic Area, 2006
- GlaxoSmithKline Touts R&D Pipeline, Expands CEDDs Model
- GSK's Late-Stage Pipeline
- GSK Phase 2 NCE Research Starts, 2001-2005
- Clinical and Filing Cycle Times, GSK vs. Peer Companies, 2001-2005
- GSK/Genmab Deal a Record Breaker?
- Wyeth Progress on Its R&D Productivity Model and Springboard Initiative
- The Wyeth R&D Productivity Model, 1990-2006
- Number of Wyeth NMEs by Stage of Development, 2001 vs. 2006
- Wyeth's Effort to Shift Global Patient Recruitment Mix, 2004-2007
- Myth Buster: Are Older Drugs Really Safer/Better Than New Drugs?
- Roche Adopts New R&D Model for Expanding Pipeline
- Roche's Current Functional R&D Model vs. New Disease Biology Area Model
- The Roche Pipeline
- Roche Phase 3 Success Rate, 1997-2005
- Stem Cell Research: A 2006 Assessment
- Stem Cell Market Share by Therapeutic Area, 2015E
- Merck Extends "Plan to Win" and Adopts New R&D Model
- Merck's R&D Pipeline, 2002 vs. 2006
- Merck First in Man to First Pivotal Dose Timelines: Merck vs. Major Companies
- FDA Clears First Molecular Test to Profile Genetic Activity
- Genetic Tests Could Accompany One in Five R&D Drugs Within Next Decade-Medco
- AstraZeneca Pushes Ahead with New Strategy to Strengthen Its R&D Pipeline
- AstraZeneca Pipeline by Phase, 2004-2006
- AstraZeneca's New Disease Area Focus
- Pfizer Shoots for Unprecedented New Drug Productivity Targets by 2011
- Growth in Pfizer NME Portfolio, 2000-2007
- Early Drug Candidate Attrition Rates at Pfizer, 1990-2005
- Pfizer Pharmaceutical Sciences Reorganization
- Small and Mid-Tier Pharmas Become Significant Factor in New Drug Innovation, 2001-2006
- Share of NME Approvals in the U S , 2001-2006
- Nature Trumps Man in Drug Development-So Far
- In-Sourced Drugs Dominate 2006 New Drug Approvals
- FDA Approvals of NMEs, 2005-2006
- Sourcing Innovation More Efficient for Pharma-Burrill
- Projects in Development Since 1999 for the European Pharma Companies: Novel Projects Only, 1999-2008E
- All Projects in Development Since 1999 for the European Pharma Companies:
- Novel Projects and Line Extentions, 1999-2008E
- Phase 3 Outlook for the Five Major European Pharma Companies, 1999-2008E
- Attrition Rates Used in Projections
- Average Duration of Projects in Phase 2 and 3 for Five Major European Pharma Companies
- Incremental R&D: A 2004 Study
- Share of Follow-on Drugs Reaching R&D Milestones at Time of First-in-Class Approval
- Share of Follow-on Drugs Reaching Clinical Milestones Prior to First-in-Class Reaching Same Milestone
- Effective Market Exclusivity for First-in-Class Drugs, 1970s-1998
- The Effect of Follow-on Approvals on Drug Prices
- FDA Therapeutic Ratings for Follow-on Drugs
- PhRMA's Medicines in Clinical Development Series
- Analysis of Drugs in Development to Treat Rare Illnesses, 2007
- Analysis of Drugs in Development for Neurological Disorders by Development
- Status and Indication, 2006
- Analysis of Drugs in Clinical Development for Cancer by Development Status
- and Indication, 2006
- Analysis of Drugs in U S. Clinical Development to Treat Mental Illnesses, 2006
- Analysis of Drugs in U S. Development for Heart Disease and Stroke, 2005
- Analysis of Drugs in U S. Development for AIDS and AIDS-Related Illnesses, 2005
- Analysis of Drugs in U S. Clinical Development for Diseases of Aging, 2005
- Analysis of Drugs in U S. Clinical Development to Treat Pediatric Illnesses, 2004
- Analysis of Drugs in U S. Clinical Development for Women by Development Status and Indication, 2004
- Analysis of Drugs and Vaccines in U S. Clinical Development for Infectious Diseases, 2004
- Leading Pharmaceutical Company R&D Profiles
- GlaxoSmithKline
- Pfizer
- Schering-Plough
- Bristol-Myers Squibb
- Biogen Idec
- Merck
- Astellas
- AstraZeneca
- Wyeth
- Johnson & Johnson
- Novartis
- Roche
- Sanofi-Aventis
- Eli Lilly
- Amgen
- Bayer Schering Pharma
- Abbott
- Biopharmaceuticals
- Biotech Product Approval News Expected to Increase in 2007
- Analysis of Biotechnology Medicines and Vaccines in U S. Development
- by Development Status and Product Class, 2006
- Vaccines Entering Clinical Development Rise Only Modestly in 1990-2005
- Number of Anti-Infective Vaccines Entering Clinical Study, 1990-2004
- 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
- Acceleration in the Biotech Development Pipeline
- Renaissance in Vaccines?
- Is Gene Therapy R&D Staging a Comeback?
- Gene Therapy: Focusing on the Promise, Underestimating the Challenges
- Stem Cell Therapies: The Latest to be Overhyped?
- Experts Warn Funding Needed So FDA Can Address Nanotechnology
- Drugmakers' "Arms Race" Spurs Biotech Deals in 2006
- Estimates of Biotech's Importance to Current R&D Pipeline
- Section 3: Drug Development Costs/Complexity, Development Time, and Success Rates
- Costs/Complexity
- Recent Estimates of the Cost of Developing New Drugs, 2007
- 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
- Measures of Clinical Trial Costs and Complexity, 2000-2006
- Mean Cost per Patient in Clinical Trials by Phase I-IV, 2000-2006
- Mean Cost per Patient in Clinical Trials by Therapeutic Area, Phase I-IV, 2000-2006
- Clinical Study Complexity by Trial Phase, Phase I-IV, Worldwide, 2000-2006
- Clinical Study Complexity by Therapeutic Area, Phase I-IV, Worldwide, 2000-2006
- Emerging Markets Not a Solution to Rising R&D Costs-Vasella
- Indexes of Clinical Study Complexity, 2000-2006
- Index of Clinical Study Complexity by Therapeutic Area, Phases I-IV, Worldwide, 2000-2006
- Index of Clinical Study Complexity by Trial Phase, Worldwide, 2000-2006
- Index of Worldwide Study Complexity by Year, Phases I-IV, 1995-2005
- Index of Clinical Study Complexity by Mean Medical Procedures per Patient,
- Clinical Trials Phases II-III, 2000-2005
- Index of Clinical Study Complexity, U S. vs. Western Europe, 2000-2006
- Index of Clinical Study Complexity by Year, Phases I-IV, 2000-2005
- Indexes of Clinical Trial Costs per Patient, 2000-2006
- Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, 2000-2006
- Index of Mean Cost per Patient in Clinical Trials by Year, 2000-2005
- Index of Mean Cost per Patient in Clinical Trials, U S. vs. Western Europe, Phase I-IV, 2000-2006
- Impact of Site Affiliation on Mean Cost per Patient in Clinical Trials, Phases I-IV, 2000-2006
- Index of Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2000-2006, Phase I-IV
- Relative Cost per Patient by Venue, U S. Only, Phase II-III, 1999-2005
- Is Regulation Pricing Some Drug Sponsors Out of Clinical Trials?
- Average Per-Patient Clinical Trial Costs: A 2006 Assessment
- Average Per-Patient Clinical Trial Cost Across Therapeutic Areas
- Mean Phase 1 Per-Patient Clinical Trial Costs, by Therapeutic Area, US
- Mean Phase 2 Per-Patient Clinical Trial Costs, by Therapeutic Area, US
- Mean Phase 3 Per-Patient Clinical Trial Costs, by Therapeutic Area, US
- Mean Phase 4 Per-Patient Clinical Trial Costs, by Therapeutic Area, US
- Average Number of Patients per Trial, by Phase and Therapeutic Area: A 2006 Assessment
- Mean Number of Patients per Trial: Phase 1 Studies, by Therapeutic Area
- Mean Number of Patients per Trial: Phase 2 Studies, by Therapeutic Area
- Mean Number of Patients per Trial: Phase 3 Studies, by Therapeutic Area
- Need for Cancer Trial Participants Outstripping Supply?
- Trial Participation Rates Flat Despite Recruitment Spending Increases-CenterWatch
- Achieving High Performance in Pharmaceuticals: Reversing the R&D Productivity Decline
- R&D Productivity Challenge: Spend vs. Value (Sales)
- Estimating the Cost of New Drug Development: Is It Really $802 Million
- Average Out-of-Pocket Clinical Costs for Investigational Compounds
- Average Phase Time and Clinical Capitalized Costs for Investigational Compounds
- Capitalized Preclinical, Clinical, and Total Cost per New Drug, in Millions of 2000 Dollars
- Probability of Market Entry, Durations, and Costs for New Drugs by Firm
- Probability of Market Entry, Durations, and Costs for New Drugs, by Disorder and Primary Indication
- Where Today's Clinical Trials Are Being Conducted: A Study of New FDA-Regulated Studies in 2006
- Number of Investigators Signing 1572s Annually for FDA-Regulated Clinical Trials, 1995-2006
- Number of Investigators Completing 1572s to Participate in FDA-Regulated Clinical Studies by Country
- The Global Clinical Trial Landscape: A 2006 Assessment
- Delays in Clinical Development, 1995-2005
- Investigators Actively Participating in FDA-Regulated Clinical Trials, US vs. Foreign, 1996-2006
- Distribution of Investigators Outside North America Actively Participating in FDA-Regulated Trials, 1996-2006
- Annual Growth in Clinical Investigators Participating in FDA-Regulated Clinical Trials by Select Countries, 1995-2006
- Growth in Clinical Investigators Participating in FDA-Regulated Trials for Selected Countries
- Global Turnover Among Active Investigators: "Drop Out" Investigators in US and Abroad by Level of Experience
- Clinical Study Cost Comparisons by Country
- Average Patient Enrollment Duration for Phase II and III Clinical Trials in Six Regions: Asia,
- Eastern Europe, Western Europe, Australia, South America, and US
- 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
- Demographics of Clinical Trial Populations: A Look at NIH Trials, 2006
- Aggregate Enrollment Data for All Extramural Research Protocols in FY2005, by Race
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2006
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 2000-2006
- Clinical Trial Enrollments for Selected NMEs Approved in 2006
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2005
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 2000-2005
- Clinical Trial Enrollments for Selected NMEs Approved in 2005
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2004
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 1999-2004
- Clinical Trial Enrollments for Selected NMEs Approved in 2004
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2003
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 1999-2003
- Clinical Trial Enrollments for Selected NMEs Approved in 2003
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2002
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 1998-2002
- Clinical Trial Enrollments for Selected NMEs Approved in 2002
- Addressing the Investigator Shortfall
- The Widening Gap: More New Investigators, But Many More Studies, 1981-2005
- Top Five Reasons Physicians Don't Refer Patients Into Clinical Trials
- Measures of Investigator Participation in Trials
- Number of Studies by Top 12 Pharma Countries by U S -Only and Non-U S. Sites
- Top 12 Pharma Companies as a Percentage of Total Industry Studies
- Top 15 Most Common Locations for Clinical Trials Outside the U S : Number of Studies
- Sponsored by Pharmas in Each Country
- Percentages and Numbers of Industry Studies and Offshore Locations
- Overall Patient Availability Score by Country
- Various Clinical Trial Metrics: Number of Sites, Patients per Phase
- Average Number of Sites by Phase
- Patients-per-Site Ratios by Phase
- Average Number of Patients by Phase
- Average Per-Patient Clinical Trial Cost by Phase
- Average Per-Patient Clinical Trial Cost by Therapeutic Area and Trial Phase
- Estimates of Nonclinical Study Costs and Durations
- Selected Health Care Inflation Data, 1998-2006
- The Case for New Drugs and Better Predictive Biomarkers
- Clinical and Total R&D Costs by Therapeutic Category
- Mean Clinical Phase Costs for Investigational New Drugs by Therapeutic Category
- Mean Clinical Cost per Approved New Drug by Therapeutic Category
- The Price of Innovation: New Estimates on Drug Development Costs
- Average Out-of-Pocket Clinical Period Costs for Investigational Compounds
- Average Phase Times and Clinical Period Capitalized Costs for Investigational Compounds
- Trends in Capitalized Preclinical, Clinical, and Total Cost per Approved New Drug
- Compound Annual Growth Rates in Out-of-Pocket and Capitalized Inflation-adjusted Cost per Approved New Drug
- Out-of-Pocket Clinical Period Phase Costs for Approved Compounds
- Out-of-Pocket and Capitalized Total Cost per Approved New Drug for New Drugs
- and for Improvements to Existing Drugs
- Tufts Center for the Study of Drug Development Estimate of Cost to Develop a New Drug
- Total Mean Costs to Develop a New Drug
- The Costs of Drug Development: The Public Citizen Rebuttal
- DiMasi Rebuttal to Public Citizen Critique
- Quantifying Savings from New Drug R&D Efficiencies
- Decreases in Capitalized Cost per Approved New Drug Resulting from Shorter Development and Review Times
- Decreases in Capitalized Clinical and Total Cost per Approved New Drug for
- Simultaneous Percentage Decreases in All Phase Lengths
- Decreases in Capitalized Clinical and Total Cost per Approved New Drug for 1-Year Reductions in Phase Length
- Decreases in Out-of-Pocket and Capitalized Clinical Cost per Approved
- New Drug Resulting from Shifting Failures from Phase II to Phase I
- Decreases in Out-of-Pocket and Capitalized Clinical Cost per Approved New Drug
- Resulting from Shifting Failures from Phase III/Regulatory Review to Phase II or Phase I
- Total Capitalized Cost Reductions from Increases in the Clinical Success Rate
- R&D Spending and Clinical Trial Industry Growth: A Look Ahead
- Growth of US Clinical Trials Industry, 2001-2007P
- US R&D Spending: Government-Sponsored vs. Industry-Sponsored R&D, 1996-2005E
- Pediatric Trials Sag in Recent Years
- The Phase I Clinical Study Market: A 2007 Assessment
- Phase I Still Stands Out: Projected Spending by Phase (U S. $ in billions)
- Spending on Various Drug Development Phases, 2005-2009P
- The Central Laboratory Market: A 2006 Assessment
- Projected Central Laboratory Market, 2004-2009
- 2005 Revenue from Companies with Central Laboratory Services
- Clinical Trial Laboratory Services Market Share
- The eClinical Trials Market: A 2006 Assessment
- Estimated EDC Solutions Market Size, 2001-2006P
- The Electronic Diaries Market in Clinical Trials: A 2006 Assessment
- Electronic Diary Adoption, 2003-2008
- Top Disqualification Categories for Study Candidates Sourced by Data-Based Patient Recruitment Strategies
- Top 5 Reasons for Study Candidate Disqualifications Across 18 Therapeutic Areas
- Top Disqualifications for Migraine
- Top Disqualifications for Depression
- Top Disqualifications for Anxiety
- Top Disqualifications for Asthma
- Top Disqualifications for Insomnia
- Top Disqualifications for Fibromyalgia
- Analysis of U S. Clinical Investigators by Specialty and Percentage of Trials Conducted by Experienced Clinical Investigators
- U S. Clinical Investigators by Medical Specialty
- Percentage of U S. Trials Conducted by Experienced Investigators, 1998-2002
- Segmentation of U S. Clinical Trials by Therapeutic Category
- Clinical Trial Recruitment Best Practices and Performance Benchmarks: The Wise Investments Survey
- Source of Enrollment Delays
- Enrollment Costs by Therapeutic Area
- Patient Recruitment Budget Allocations, US vs. Non-US Sites
- Performance Benchmarks
- Percent of Recruitment Resources Applied to Planning vs. Rescue Intervention
- Company Experiences based on When They Address Patient Recruitment Issues
- Patients Enrolled per Site per Month
- Average Months Delay per Trial Launched
- Typical Contracting Time Required by Practice Setting
- Reliance on Local & Central IRBs-Accuracy & Acceleration
- Sources of Enrolled Patients-Phase III
- Enrollment Impact of Recruitment Tactics
- European Clinical Sites Rate Drug Sponsors: A 2006 Assessment
- Highest Frequency as a Top 3 Rated Sponsor Across 28 Relationship Attributes
- Factor Most Often Causing Clinical Study Delays
- Quality of Study Initiation Process
- Quality of Ongoing Study Support
- Number of Clinical Trials Initiated Annually for U S. Submissions: FDA Estimates
- The Impact of Internet-based Clinical Trials on the Efficiency of Data Entry, Monitoring, and
- Data Management: A 2006 Case Study
- Cumulative Frequency for Data of Initial Entry to Last Form Modified by the Study Site
- Cumulative Frequency From the Day the Form Was Last Modified to CRA Review
- Cumulative Frequency From the Date of CRA Review to In-House Form Review
- Pharmacogenomics in Clinical Development: A 2005 Assessment
- Total Spending on Pharmacogenomic Activity in Clinical Development, 2000-2005P
- Incidence of Genetic Testing During Clinical Trials, 1999-2004
- Estimated Reduction in Drug Development Time from Pharmacogenomics
- Development Time
- Analysis of U S. New Drug Development Process by Average Time to
- Complete Each Phase of Product Development, 2007
- The Speed Demons of Drug Development: Achieving Revenue Gains and Cost Savings
- Fastest Development Companies: Median Clinical Development and Regulatory Cycle Times, 2000-2005
- Median Time from IND Filing to NDA Approval for Nine Therapeutic Areas, 2000-2005
- Median Clinical Development Time and Regulatory Cycle Times: All Companies vs. Fastest 10 Companies
- Standard Deviations and Coefficients of Variation for Drugs Approved Between 2000 and 2005
- Fastest vs. Slowest Firms: Percentage of Terminated Projects by Phase, 1994-2005
- Drugs of Fastest vs. Slowest Companies: Comparative Development and
- Regulatory Cycle Times and Revenue Advantage, 2000-2005
- Emerging Markets' Cost and Enrollment Advantages: India vs. China vs. U S
- Development Phase Lengths for Selected Therapeutic Categories
- Development Phase Lengths and Attrition Rates for Selected Therapeutic Categories
- Development Times for Biotech vs. Drug Products: A 2006 Study
- Clinical Development and Approval Times: Biopharmaceuticals vs. Drugs
- Time Consumed by Various Clinical Trial Activities
- Study Sites' Perception on Reasons for Study Delays
- Factor Most Often Causing Clinical Study Delays
- Clinical and Approval Timelines for Drugs Approved 1984-2004
- Clinical and Approval Phases for New Drugs, 1984-2004
- Mean Clinical Phase Times for Priority and Standard NCEs Approved, 1984-2004
- Mean FDA Approval Times for Standard and Priority NCEs, 1984-2004
- Mean Clinical Phase Times for NCEs Approved by Therapeutic Area, 1996-2004
- Mean Clinical and Approval Phase Lengths by Therapeutic Class, 2002-2004
- Share of NCE Approvals by Location of Original Marketing, 1987-2004
- Number of NCE Approvals, 1984-2004
- Development Time for New Molecular Entities First Launched Onto the World Market, 1997-2004
- Phase 2 and Phase 3 Development Times at Five Major European Pharma Companies
- Phase 2 Cycle Times Now Longer than Phase 3?
- Are Development Times for Pharmaceutical Companies Increasing or Decreasing?
- Sample of Development Times for 25 Drugs
- Pharmaceutical Development Times, by Category
- Total Post-IND Development Period, Clinical Trial Period, and
- Regulatory Review Periods, by Year of NDA Approval, 1992-2001
- Total Post-IND Development Period, Clinical Trial Period, and
- Regulatory Review Period, by Year of IND Filing, 1985-1995
- Clinical and Approval Timelines for Biopharmaceuticals Approved in the US, 1996-2005
- Comparison of Mean Clinical and Approval Phase Lengths for Biopharmaceuticals Approved,
- 1996-2000 vs. 2001-2005: All, Orphan, and Priority Biopharmaceuticals
- Comparison of Mean Clinical and Approval Phase Lengths for Biopharmaceuticals Approved,
- 1996-2000 vs. 2001-2005 for Top Therapeutic Categories: Oncology, Endocrine, and Immunology
- Total Development Times for Drug and Biopharmaceutical Products, 1985-2004
- Cumulative Fast Track Designations Granted by CDER and CBER, 2000-2006
- Fast-Track Designations by Disease Type, 2001-2005
- Reasons for Development Problems in Fast Track Programs
- Total Development and Approval Times by FDA Program
- Mean Development Times for Fast Track Products by Therapeutic Area, 1998-2005
- The Effects of CRO Usage on Drug Development Times
- Days that Actual Submission Exceeded Projected Submission Date, Low vs
- High CRO Usage Projects
- Mean Time to Four Pivotal Clinical Trial Milestones, Low vs. High CRO Usage Projects
- A Measure of Quality: Case Report Form Queries/Page Screen
- Quantifying the Time Used in Key Clinical Study Activities: A 2006 Assessment
- Percent of Site Personnel Time by Research Study Activity
- Site Personnel Time: Minutes/Activity for Common Study Activities
- Ten Most Time-consuming Activities
- Top Causes of Clinical Study Delays: A 2005 Assessment
- Top Causes of Clinical Study Delays: The Site Perspective, 2003 vs. 2005
- Distribution of Delays in Site Enrollment Timelines, 2001-2005
- How Has Sponsor Performance Changed in the Past Three Years in Several Areas?
- Who Reviewed the Informed Consent Form With You?
- The Duration of Clinical Trials by Phase and Therapeutic Area: A 2004 Study
- Clinical Trial Duration by Phase
- Phase I Clinical Trial Duration by Therapeutic Area
- Phase II Clinical Trial Duration by Therapeutic Area
- Phase III Clinical Trial Duration by Therapeutic Area
- Clinical Trial Components by Percent of Total Trial Timeline Consumed
- Pharmaceutical Development Phases: A Duration and Success Rate Analysis
- Phase I, II, and III Clinical Trial Durations by Successful and Failing Projects: Summary Descriptive Statistics
- Crude Probability of Success (and Phase Durations, in months) for Successful Drugs by
- Company Size, Type of Product, Dosage Form, and Therapeutic Category
- Crude Probability of Failure (and Phase Durations, in months) for Failing Drugs by
- Company Size, Type of Product, Dosage Form, and Therapeutic Category
- Various New Drug Development Metrics
- Number of NMEs First Marketed 1992-2003 and Their Mean Development Time
- Trends in Clinical Development Times: Various Milestones, 1997-2003
- Composite Median Cycle Times for NASs in Development, 1997-2003
- Development Times for All New Active Substances in R&D Between 2000 and 2002
- The FDA's Fast Track Program: A 2005 Analysis
- Drug Development Times
- Biological Product Development Times
- Fast Track Designation Requests
- Percent of Fast Track Designations and Approvals by Type of Product: Biological or Chemical
- Reasons for "Fast Fail"
- The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade After Passage of PDUFA
- Mean NCE Clinical, Approval, and Total Phase Lengths for NCEs Approved in 1999, 2000, and 2001
- Median Clinical and Approval Phases for New Chemical Entity Approvals in 1999, 2000, and 2001
- Mean Clinical and Approval Phases in Years for NCEs Approved in Each of Last Six Three-Year Periods
- Mean Clinical and Approval Phases for NCEs Grouped by Therapeutic Classes
- Mean Clinical Phases in Years for NCEs Grouped by Therapeutic Class in Each of
- the Last Three-Year Periods
- Mean Clinical, Approval, and Total Phases in Years for NCEs Approved in 1999-2001
- and Designated as Accelerated Approval, Fast Track Approval, or Both, Compared
- with Those for All Other NCEs and with Orphan Approvals
- Percentage of NCEs First Approved in the United States and Those with Various
- Periods of Prior Foreign Marketing
- Percentage of NCEs First Approved in the United States, and Those with One or
- More Years of Prior Foreign Marketing, in Each of the Last Five Three-Year Periods
- Biosimulation in Clinical Development: A Case Study Involving a Type 2 Diabetes Clinical Trial
- Change in Glucose Concentration During a 120-Minute Oral Glucose Tolerance Test
- in a Clinical Population and Virtual Patient Cohort
- Biopharmaceutical Development and Approval Times, 1982-2002
- Mean Clinical and Approval Phases for New Biopharmaceutical Approvals by Time Period
- Mean Clinical and Approval Phase Times for New Biopharmaceutical Approvals,
- 2000-2002, by FDA Review Center
- Mean Clinical and Approval Phase Times for New Biopharmaceutical Approvals,
- 2000-2002, by Product Type
- Approval Times for Priority and Standard New Drugs and Biopharmaceuticals Under PDUFA
- Mean Approval Times for Priority-Reviewed NCEs and New Biopharmaceuticals:
- FY1994-1997 vs. FY1998-2000
- Mean Approval Times for Standard-Reviewed NCEs and New Biopharmaceuticals:
- FY1994-FY1997 vs. FY1998-2000
- Mean Approval Time for Priority- and Standard-Reviewed NCEs: FY1998, FY1999, and FY2000
- Mean Approval Time for Priority- and Standard-Reviewed Biopharmaceuticals:
- FY1998, FY1999, and FY2000
- Mean NCE Approval Times: FY1998-FY2000
- Mean New Biopharmaceutical Approval Times: FY1998-FY2000
- Biopharmaceutical Development Times, 1982-2002
- Mean Clinical and Approval Times for Biopharmaceuticals, 1982-2002
- New Drug Development Times in the United States, 1963-1999
- Duration of US Clinical and Approval Phases for NCEs Approved in the US from 1963-1999
- Mean Length of Pre-human Testing Phases, Clinical Development Phases, and
- US Approval Phases for NCEs Approved in the US by Period of Approval
- Mean Length of Pre-human Testing Phases, Clinical Development Phases, and US Approval Phases
- for NCEs Approved in the US During 1990 to 1999 by Therapeutic Category
- Mean Clinical Development and US Approval Phases by FDA Therapeutic Rating for
- Four NCE Approval Periods, 1963-1999
- Success Rates for NCEs that have had an NDA Submitted by Period of NDA Submission
- Percent of NCEs First Tested in Humans Anywhere in the World by Period and Therapeutic Category
- Mean Clinical Phase Lengths by Therapeutic Class, 1990-1999
- Drug and Biopharmaceutical Clinical Development and FDA Approval Times: The Effects of PDUFA and FDAMA
- New Biopharmaceuticals: Mean Clinical, Approval, and Total Phases for
- Cohorts in Fiscal Years 1981 to 1998
- NCEs: Mean Clinical, Approval, and Total Phases for Cohorts in Fiscal Years 1981 to 1998
- CRO versus Sponsor Clinical Cycle Times
- A Study of Clinical Development Times, 1993-1998
- Mean Clinical and Approval Phases, 1984-1998
- Mean Clinical and Approval Phases for Priority versus Standard NCEs, 1996-1998
- Mean Clinical and Approval Phases by Therapeutic Class, 1996-1998
- Mean Clinical and Approval Phases for Various Drug Categories, 1993-1995 versus 1996-1998
- All Drugs
- Priority NCEs
- Standard NCEs
- Anesthetic/Analgesic NCEs
- Central Nervous System NCEs
- Cardiovascular NCEs
- Antineoplastic NCEs
- Antiinfective NCEs
- Endocrine NCEs
- Success Rates
- Development Attrition Rates for Selected Therapeutic Categories
- Development Attrition Rates for Selected Therapeutic Categories
- Kola on Emerging Attrition Rate Trends, 2007
- Estimates of Drug Success Rates: Unprecedented vs. Precedented Molecules
- 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
- Transition Probabilities for Clinical Phases: Biopharmaceuticals vs. Drugs
- Fastest Pharma Firms Kill Development Projects Sooner
- Fastest vs. Slowest Firms: Percentage of Terminated Projects by Phase, 1994-2005
- Genotype Biomarkers Save R&D Projects
- Improving Phase 2 Success Rates
- Increasing Source of Drug Attrition: Payers?
- Clinical Forecasting Tool Predicts Phase 3/Approval Success Rate with 78% Accuracy-Researchers
- Fail Fast Phenomenon is Failing Pharma-former Pharma Exec
- An Analysis of Late-Stage Success Rates: Biotech Products versus Pharmaceuticals
- Success Rates of Late-Stage Clinical Trials in Biotechnology, 1995-2006
- FDA Actions on Biotechnology Product Applications by Nature of Action, 1995-2006
- Probability of Success to Market for New Active Substances by Origin: Self-Originated vs. Licensed-in
- New Drug Success Rates at Top 10 Pharma Companies: A 2006 Study
- Phase Transition Probabilities for Self-Originated Drugs of Leading Firms
- Phase Transition Probabilities by Therapeutic Class for Relatively High Success Rate Classes
- Phase Transition Probabilities by Therapeutic Class for Relatively Low Success Rate Classes
- Clinical Approval Success Rates by Therapeutic Class
- Success to Market Rates for New Active Substances: Comparison of Chemical Entities and Biotech Products
- Probability of Success to Market for New Active Substances: Comparison of Therapeutic Areas
- New Postapproval Requirements Less Harmful to Pharma R&D Than New Preapproval Burdens-Analysis
- Can the Pharmaceutical Industry Reduce Attrition Rates?
- Success Rates by Therapeutic Area
- Success Rates from First-in-Man to Registration
- Success Rates by Stage of Development
- Reasons for Attrition
- Development-Phase Transition Probabilities in One-Year and Several-Year Time Spans: A European Study
- Probability of Getting Through a Phase
- Average Probability of Getting Through a Phase
- Forecast of Number of New Authorized and/or Marketed Products in Europe, 2000-2003
- Clinical Trial Attrition Rates for Licensed-In vs. Internal Candidates
- External Survivors Rule: Clinical Survival of Internally Developed vs. Licensed Compounds
- Comparative Success Rates of US Biopharmaceuticals and NCEs
- Comparative Approval Success Rates of US Biopharmaceutical Products and Drugs Entering Clinical Trials
- Drug Success Rates: A 2003 Assessment
- Probability of FDA Approval for New Drugs Entering a Clinical Phase by Therapeutic Category
- Distribution of Research Terminations by Therapeutic Category
- Probability of New Drugs Entering a Phase by Therapeutic Category
- Recombinant Protein Therapeutics: An Analysis of Success Rates
- U S. Approval Success Rates for rDNA Therapeutics
- Phase Transition Probabilities by Therapeutic Category for rDNA Products Entering Clinical Study
- Declining R&D Success Rates: A 2003 Assessment
- Phase 2 Attrition Rates Reach 80% Today?
- Phase 2 Clinical Trials: The New Emphasis in "Go/No Go" Decisions
- Characteristics of Phase IIa and Phase IIb Trials
- Design Rigor of Phase IIa and Phase IIb Trials
- Statistical Findings and Advancement Rates of Phase IIa and IIb Trials
- Percent of Phase IIa and IIb Product Candidates Advancing to Later-Stage Trials,
- Categorized by Rigor of Trial Design
- Drews on Pharma Industry Productivity and Strategic Trends in the Drug Industry
- Section 4: Regulatory/FDA Statistics
- INDs
- Number of IND Submissions, 1982-2006
- Breakdown of Drug Divisions' Active IND Review Workload as of Year-End 2006
- Number of Active INDs at the Close of the Calendar Year, 1983-2006
- Breakdown of CDER Divisions' Workload by INDs Received in 2006
- 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, 1983-2006
- Breakdown of Drug Divisions' Pending NDA Review Workload, Year-End 2006
- Breakdown of Drug Divisions' Workload by NDAs Received in Fiscal Year 2006
- Breakdown of Divisions' Workload by Pending NDA Supplements, Year-End 2006
- CDER Refusal-to-File (RTF) Actions by Year, 1994-2006
- Key Drug Submission and Approval Statistics, 1993-2006
- Number of NME Approvals and Approval Times, 1984-2006
- NME Review Time Ranges, 1995-2006
- Priority/Standard NME Review Gap, 1995-2006 (in months)
- Median Approval Times for All NMEs by Calendar Year, 1986-2006
- Average NME Review Times in Months by CDER Division, 2005 and 2006
- Average NME Review Times in Months by CDER Division, 1993-2004
- 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
- Number of NDAs and NMEs Approved by Year, 1983-2006
- NMEs Approved Based on Therapeutic Potential, 1985-2006
- Percent of All Approved NDAs Receiving Priority Review Status, 1994-2006
- CDER's Priority NME Approvals by Class of Drug, 1994-2005
- CDER-Wide First Action Performance for FY04, FY05, and FY06 User Fee Cohorts of NDAs,
- Resubmissions, Effectiveness Supplements, and Manufacturing Supplements
- A 2007 Analysis of CDER First-Cycle Review Outcome Trends for NDAs, FY1996-FY2006
- Percent of Original NDAs Approved in First Review Cycle by Submission Cohort, FY1996-FY2006
- Percent of Standard/Priority Original NDAs Approved in First Review Cycle
- by Submission Cohort, FY1997-FY2006
- Percent of Original NDAs Receiving Approvable, Not Approvable, and Withdrawal
- Actions, FY1997 to FY2006
- An Analysis of Review Cycles to Approval for New Drugs
- Summary Cycle to Approval Statistics for 2005- and 2006-Approved NMEs
- Distribution of Review Cycles to Approval, 2006 vs. 2005
- Benchmarking the Review Cycles for NMEs Approved in 2006
- Average Cycle Times for Approved NMEs, 2005 vs. 2006
- Mean Review Cycle Times for Approved Priority/Standard NDAs in the FY2000-FY2005 Submission Cohorts
- NME Approval Rate Estimates
- And Some Think It's User-Fee Deadlines That Put Too Much Pressure on the FDA?
- A Closer Look at the FDA's 50 Fastest Drug Approvals, 1963-2006
- A Comparison of FDA vs. EMEA Drug Approval Times, 2000-2005
- Mean Approval Times for New Substances Approved by EMEA and FDA, 2000-2005
- Time from Approval in First Market to Approval in Second Market
- EU vs. US Approval Time for Orphan Drugs
- 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
- Approval Cycle Percentage by Application Type
- First-Cycle Approval Rates for Self-Originated vs. In-licensed Products
- Percentage of Multi-Cycle Reviews by Sponsor Experience
- Approval Rate vs. Sponsor Type and Origin
- Key Deficiencies Cited in Action Letters
- Effect of End of Phase 2 Meetings on Approval Rate
- An Analysis of FDA's Fast Track Initiative, 2007
- Industry's Fast Track Designation Requests to CDER, FY1999-FY2006
- CDER's Fast Track Program Activity
- CBER's Fast Track Program Activity
- Remembering the Good Old Delays
- Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved in 2006
- Percent of NMEs Approved with Postmarketing Commitments, 2001-2005
- New Postapproval Requirements Less Harmful to Pharma R&D Than New Preapproval Burdens-Analysis
- Safety-Based Drug Marketing Withdrawals in the United States, 1980-2007
- CDER Safety-Based Drug Withdrawals: Pre-PDUFA vs. PDUFA Era, 1971-2007
- The IOM and the So-Called "Drug Safety Crisis": Where's the Science?
- Drug Safety: A Growing Patient/Regulatory Environment Disconnect?
- Myth Buster: Are Older Drugs Really Safer/Better Than New Drugs?
- When Do We Learn the Most About Drug Safety After Approval?
- Physicians Want Vioxx Back on Market, Believe FDA Approval Delays Hurt Patients
- Kessler on Drug Safety
- Faster FDA Drug Approval Times and Drug Withdrawals: A 2005 Analysis
- Drug Safety Withdrawals and Withdrawal Rates by Decade
- Rates of New Drug Approvals and Safety Based Withdrawals
- Median Approval Times for Safety Withdrawals vs. All Drugs by Decade
- Median Approval Times for Safety Withdrawals vs. All Drugs, by Therapeutic Class
- Distribution of Safety Withdrawals by Therapeutic Class, 1980-2005
- Pediatric Study Costs and Complexity Levels Grow, 2000-2006
- Orphan Drug Activity Continues to Hit Record Levels in 2006
- Orphan Drug Designation and Approval Statistics, 1990-2006
- Prevalence of Orphan Drugs in CDER's NME Approvals, 2001-2006
- Biologics
- Summary of CBER Actions in 2006
- Key CBER Review Statistics for 2006
- CBER's New Biological Product Approvals for 2006
- Summary of CBER Actions in 2005
- Key CBER Review Statistics for 2005
- CBER's New Biological Product Approvals for 2005
- Summary of CBER Actions in 2004
- Key CBER Review Statistics for 2004
- CBER's New Biological Product Approvals for 2004
- Summary of CBER Actions in 2003
- Key CBER Review Statistics for 2003
- CBER's New Biological Product Approvals for 2003
- Summary of CBER Actions in 2002
- Key CBER Review Statistics for 2002
- CBER's New Biological Product Approvals for 2002
- Summary of CBER Actions in 2001
- Key CBER Review Statistics for 2001
- CBER's New Biological Product Approvals for 2001
- Summary of CBER Actions in 2000
- Key CBER Review Statistics for 2000
- CBER's New Biological Product Approvals for 2000
- FDA vs. EMEA Biotech Product Approval Times: A 2004 Assessment
- Mean Approval Time for 18 Biopharmaceuticals Approved in the EU and US, 2000-2003
- Biotech Products on the US Market Top 280 in 2005, BIO
- CDER Median Approval Times for BLAs Approved in Calendar Year 2006
- Orphan Drugs
- Orphan Drug Designation and Approval Statistics, 1990-2006
- Cumulative Growth of Orphan Drugs, 1984-2006
- Orphan Drug Approval Times vs. Approval Times of Other Drugs, 1993-2006
- Orphan Drug and Biologic Approvals, 1993-2006
- Orphan Drug and Biologic Approvals in 1990, 1991, and 1992
- Over-the-Counter Drugs
- Rate of Rx-to-OTC Switches per Year, 1951-2006
- Generic Drugs
- Generic Drug Approval Times: Median Time to Approval 1993 to 2006
- Pending ANDAs Continue to Surge at FDA, 2000-2006
- Mean and Median ANDA/AADA Review Times, 1995-2006
- Annual ANDA and AADA Submission and Approval Statistics, 1995-2006
- CDER Clinical Site Inspection Results, FY1997-FY2006
- CDER Clinical Investigator Inspections, FY92-FY2006
- CDER Inspections of Foreign Clinical Investigators, FY91-FY2006
- Clinical Investigator Deficiency Categories, FY2006
- Inspection Results for Clinical Investigators, FY2006
- Section 5: International Statistics
- European Union
- R&D Spending in Europe's Pharmaceutical Industry, 1980-2006
- Pharmaceutical R&D Spending Within EFPIA Countries, 1990-2005
- Mean EMEA Review Time for Human Drugs Submitted Under the EC's Centralized Procedure, 2006
- Mean EMEA Processing Time for Human Medicinal Products, 1995-2006
- Mean Processing Times for Key Stages of Centralized Process, 1995-2006
- Cancer, Anti-Infective, and Cardiovascular Drugs Dominate New Centralized Submissions to EMEA in 2006
- Marketing Authorization Applications Rise to Records Levels at the EMEA
- Marketing Authorization Applications Undergoing Initial Evaluation, 2000-2006
- CPMP Initial Evaluation Opinions and Sponsor Withdrawals for New Medicines, 2000-2006
- An Analysis of the Mutual Recognition Procedure, 2006
- Ireland Urgently Needs New Health Research Strategy to Recruit Clinical Trials
- Comparison of FDA vs. EMEA Drug Approval Times, 2000-2005
- Mean Approval Times for New Substances Approved by EMEA and FDA, 2000-2005
- Time from Approval in First Market to Approval in Second Market
- EU vs. US Approval Time for Orphan Products
- EMEA Regulator
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| Scope |
Comprehensive Overview |
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| Level |
General Industry Strategies |
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| Data |
Detailed Market Forecasts |
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