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PAREXEL Biopharmaceutical Statistical Sourcebook 2011/2012Barnett Educational ServicesJuly 1, 2011 387 Pages - SKU: BNT6490027 |
With key analysis and contributions from leading consultancies and experts, the Sourcebook provides real-world data and analysis, including:
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- Section 1: R&D Spending
- Pharmaceuticals
- Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2016P (EvaluatePharma)
- Global R&D Spending by World’s Top 500 Pharma and Biotech Companies 2002-2016P (EvaluatePharma)
- R&D Spending by Research-Based Pharmaceutical Companies (PhRMA), 1980-2010
- R&D Investments by Research-Based Pharmaceutical Companies (PhRMA), 1975-2010
- Industry-wide and Government R&D Spending, 1980-2010
- Biopharmaceutical Industry Investment in Research and Development, 1980-2010
- Biopharmaceutical R&D Expenditure and NIH Budget: 1995-2010
- Innovation Not in Line with R&D Spending—EMA’s Lonngren
- Analysis of Top 20 Companies by 2010 Pharma R&D Spend (EvaluatePharma)
- Top 20 Companies by Pharma R&D Spend in 2010 (EvaluatePharma)
- Top 20 Companies by Pharma R&D Spend as a % of Pharmaceutical Revenues 2009 vs. 2010 (EvaluatePharma)
- Top 20 Companies by Count of Late-Stage Projects (Phase II to Filed) and PDUFA Dates
- Top 20: Average R&D Spend per Late-Stage Project in 2010 (EvaluatePharma)
- GSK’s Redfern: Pharma R&D Running Out of Time?
- Total PhRMA R&D as a Percent of Sales, 1995-2010
- Domestic U.S. R&D and R&D Abroad, 1996-2010
- Domestic U.S. Sales and Sales Abroad, 1996-2010
- Growth in Domestic U.S. R&D and R&D Abroad, 1970-2010
- Various Measures of New Drug/Biologic R&D Productivity, 1995-2010
- Industry R&D Spending per NDA Submission in the U.S., 1994-2010
- Industry R&D Spending per NDA Approval in U.S, 1997-2010
- Industry R&D Spending per NME Submission to FDA, 1996-2010
- Industry R&D Spending per NME Approved in the U.S., 1996-2010
- Global R&D Spending per Global New Active Substance (NAS) Launch, 2002-2010
- Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2011 Analysis
- Breakdown of World Pharma Market—2010 Sales
- Markets of First Launch for 25 NASs Introduced in 2010
- Pharmaceutical R&D Expenditure Annual Growth Rate, US vs. Europe, 1994-2010
- Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2010
- U.S., European, Canadian, and Asia/Pacific Biotech: Global Activity Measures, 2010
- Top 20 Pharmaceutical Companies by 2010 R&D Spending
- An Analysis of Global R&D Spending on Clinical Trials, by Phase and by Region, 2002-2016P
- The Global Clinical Trials Market: Global R&D Spending on Phase 1-3 Clinical Trials, 2002-2016P
- Global R&D Spending by Clinical Trial Phase, 2002-2016P
- Share of Biopharmaceutical Industry Clinical Trial R&D Spending (Percentage) by Region, 2008 vs. 2009
- Estimate of Global Pharmaceutical Clinical Trial Spending (Phases 1-3) by Region, 2010
- So You Think Pharma Has Challenges?
- Projected R&D Spending Trends in 2011
- 2011 R&D Spending Forecasts for Selected Leading Pharma and Biotech Companies
- Global Drug Development Spending: A 2011 Forecast
- Global Recession Takes Toll on Industry R&D Spending—Annual Booz Study
- Annual R&D Spending Versus New Drug Approvals, 1992-2010
- R&D Spending by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2009
- Domestic U.S. Scientific, Professional, and Technical R&D Personnel by R&D Function,
- Ethical Pharmaceuticals, 2009
- Domestic R&D by Function, Ethical Pharmaceuticals, PhRMA Member Companies, 2009
- Domestic R&D and R&D Abroad for Human-Use and Veterinary-Use Pharmaceuticals, PhRMA Member Companies, 2009
- Domestic R&D by Origin of Product (Licensed-in vs. Self-originated), PhRMA Member Companies, 2009
- U.S. Government (NIH) Funding for Medical/Clinical Research, 1995-2011P
- NIH Appropriations, 1995-2012P
- NIH Clinical Research and Clinical Trials Spending, 2003-2011P
- Estimates of Funding for Selected Diseases, Conditions, and Research Areas, 2007-2011P
- The “Net Innovation Trend” and What It Means for Big Pharmas, Biotechs, and Generics
- Large Cap Pharma Accounted for Two-Thirds of Healthcare Value in 2000
- Biotech and Med Tech Gained at Expense of Pharma in 2008
- The Innovation Curve: Major Pharmaceuticals
- The Innovation Curve: Biotechnology
- An Analysis of Worldwide Prescription and OTC Drug Sales by Therapy Area, 2008-2016P
- WW Rx and OTC Sales by EvaluatePharma Therapy Area: Top 16 Categories and Total Market, 2009-2016P
- Global Clinical Trial Spending by Region
- Share of Biopharmaceutical Industry Clinical Trial R&D Spending by Region, 2009 vs. 2008
- Global Pharma Market to Grow 5-7% in 2011—IMS Health
- Specialty Drugs Capture Larger Portion of Drug Spending
- An Analysis of Worldwide Prescription Drug Sales, 2009-2016P
- Worldwide Total Prescription Drug Sales, 2002-2016P
- Worldwide Sales at Risk from Patent Expiration, 2002-2016P
- WW Prescription Drug Sales (2009/16): Top 20 Companies and Total Market
- An Analysis of Worldwide Prescription and OTC Sales by Technology (2002-2016):
- Biotech vs. Conventional Technology (EvaluatePharma)…
- Worldwide Prescription & OTC Sales by Technology, 2002-2016 (EvaluatePharma)
- Top 100 Drug Sales by Technology, 2010 vs. 2016P (EvaluatePharma)
- An Analysis of the Sales Potential of New Drugs Approved in 2010 and 2009 (EvaluatePharma)
- Number of New Drugs Approved, 1997-2010
- FDA Approval Count vs. 5th Year after Launch US Product Sales, 1997-2010 (EvaluatePharma)
- Top 10 New Molecular Entities in 2010: Ranked on US Consensus Sales in 2015 (EvaluatePharma)
- Top 10 New Molecular Entities in 2009: Ranked on US Consensus Sales in 2014 (EvaluatePharma)
- Trends in Global Spending on Medicines: A 2011 Analysis
- Spending by Geography, 2005 vs. 2010 vs. 2015P
- Spending by Segment: Brand, Generic, Other, 2005 vs. 2010 vs. 2015
- PhRMA’s Castellani: Reimbursement Will Drive Industry’s Ability to Innovate
- Growth in Domestic U.S. Sales and Sales Abroad, Ethical Pharmaceuticals, 1970-2010
- Sales by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2009
- An Analysis of the U.S. Pharma Market: U.S. Prescription Drug Sales in 2010
- Annual Growth Rate of U.S. Prescription Pharmaceutical Market, 1994-2010P
- Top 20 Therapeutic Classes by U.S. Prescription Sales, 2010
- Top 25 U.S. Prescription Products by Sales, 2010
- CRO Market Penetration to Approach 70% by 2016?
- Top 20 Companies by Worldwide Prescription Drug Sales in 2009 and 2010
- Top 20 Companies by Worldwide Prescription Drug Sales in 2009 and 2010
- A New Look at the Global Pharmaceutical Market: North America Sets Pace in 2010 Pharma Sales
- Global Pharma Sales, 2003-2010
- Global Pharmaceutical Sales in 2010 by Region
- Leading Therapy Classes in 2010 Global Pharma Sales
- Global Pharma Sales in 2010—Leading Products
- Top 20 Global Drug Companies by Sales, 2010
- GAO: Brand Drug Prices Rising Faster Than Other Medical Goods/Services
- Re-Characterizing the Pharmerging Markets: The 17 Pharmergings to Overturn Current Pharma World Order
- Redefining Pharmerging Markets
- The Pharmerging Markets Will Be the Biggest Contributor to Global Growth from 2009-2013
- Old Order Gives Way to a New World Ranking of Pharmaceutical Markets: Top 20 Projected Markets by 2013
- Contribution to Drug Market by Age of Drug
- Percentage Contribution to the Overall Market by Age of Drug, 2002-2012E
- Which Therapeutic Categories Are Growing the Fastest?: Global and US Sales Growth of
- Branded Drugs by Therapeutic Category, 2005-2012E
- Global Drug Sales and Growth Forecasts in Major Therapeutic Areas: 2005-2012E
- US Sales and Growth Forecasts—Major Therapeutic Areas, 2005-2012E
- Therapeutic Categories: Drug Sales as a Percentage of Worldwide Market, 2010 vs. 2015P
- Pharma Companies: Drug Sales as Percentage of Worldwide Market, 2010 vs. 2015P
- The Truth About Drug Innovation: Thirty-Five Summary Case Histories on Private Sector
- Contributions to Pharmaceutical Science
- Central Private-Sector Scientific Contributions to Thirty-five Drugs/Classes
- U.S. Generic Drug Market Outlook to 2015
- 2010 U.S. Sales of Drugs Losing Patent Protection, 2011-2015P
- Percent Sales Vulnerable to Patent Expirations Through 2013 and 2015: Selected Leading Companies
- Estimates of Generic Erosion at the Top 10 Pharmas, 2008 vs. 2015
- Assessing Patent Risk: Industry and Company-specific Exposure to Generics, 2008-2015E
- U.S. Major Pharma: Percent of 2010 Global Sales at Risk of Patent Expiration through 2015
- European Major Pharma: Percent of 2010 Global Sales at Risk of Patent Expiration through 2015
- Japanese Pharma: Percent of 2010 Global Sales at Risk of Patent Expiration through 2015
- Biotech: Percent of 2010 Global Sales at Risk of Patent Expiration through 2015
- Specialty Pharma: Percent of 2010 Global Sales at Risk of Patent Expiration through 2015
- Generic Market Share in the United States, 2006-2010
- Generic Market Share in the United States, 2006-2010
- Generic Makers More Aggressively Attacking Brand Drug Patents
- A CRO Industry Size Model to 2015E
- BioPharmaceutical Industry Revenue and Year-over-Year Growth, 2003-2015E
- BioPharmaceutical Industry R&D Spending and Year-over-Year Growth, 2003-2015E
- CRO Addressable Market by Phase, 2003-2015E
- Outsourcing Penetration Assumptions by Phase, 2003-2015E
- CRO Market Size by Phase and YOY Growth, 2003-2015E
- Estimates of Global Demand for Clinical Services Outsourcing, 2001-2009P
- Trends Driving the Clinical Outsourcing Industry: A 2011 Assessment
- Total R&D Growth Expectations, 2010-2013
- Total R&D Growth Expectations by Size
- Total R&D Growth Expectations by Phase of Development
- Expected Changes in Pipeline over the Next Two to Three Years
- Expected Changes in Pipeline for Large Pharma Over the Next Two to Three Years
- Expected Changes in Pipeline for Midsize Pharma Over the Next Two to Three Years
- Expected Changes in Pipeline for Small Pharma Over the Next Two to Three Years
- Changes in R&D Budget Outsourced in Past Two Years—Large Pharma
- Changes in R&D Budget Outsourced in Past Two Years—Midsize Pharma
- Changes in R&D Budget Outsourced in Past Two Years—Small Pharma
- Percentage of Total Annual Budget Outsourced by Phase
- Percentage of Total Annual Budget Outsourced by Phase—Large Pharma
- Percentage of Total Annual Budget Outsourced by Phase—Midsize Pharma
- Percentage of Total Annual Budget Outsourced by Phase—Small Pharma
- Impact of Strategic Partnerships to CROs
- Impact of Strategic Partnerships on Outsourcing to CROs by Size
- Impact of Strategic Partnerships on Rate of Outsourcing to CROs
- A CRO Outsourcing Model to 2011
- Clinical Trial Enrollment Trends, 2004-2009
- Patients in Starting and Completing Phase II-III Trials, 2006-2009
- Patients in Starting and Completing Phase II-IV Trials, 2006-2009
- The Barclays Capital Outsourcing Model, 2005-2011
- A Global CRO Market Model: A December 2009 Assessment
- Estimated CRO Addressable Market, 2003-1013E
- CRO Market Penetration Estimates, 2003-2013E
- CRO Industry Growth to 2013
- CRO Market Overview, 2003-2013
- Biopharmaceuticals
- Top 100 Biotech Companies by 2010 R&D Spending
- R&D Spending at Selected Leading Biotechnology Companies, 2010A-2015E
- Biologics Spending Growth Outdoes Small Molecules—IMS
- Biologics and Biotech R&D: An Analysis of PhRMA Member Companies, 2009
- Biologics and Biotechnology R&D, PhRMA Member Companies, 2009
- An Analysis of the Public Biotechs: Products and Profits
- Top 10 Biotech Companies by 2010 R&D Spending
- Biotech Sector Breaks Its Own Record in 2010: Financing Activity in Biotech Sector
- Total Equity Raised by Biotech, 1995-2010
- Equity Investments in Biotechnology, 2010 vs. 2009
- Biotech Industry Grows Again in 2010, but Faces R&D Challenges—Ernst & Young
- An Analysis of Global Biologics/Biotech Market: Worldwide Sales for Top Products and Top Product Classes in 2010
- Top-Selling Categories of Biologic Products, 2010
- Growth Rates of Top-Selling Classes of Biological Products, 2010
- Top 20 Selling Biologic Products Worldwide, 2010
- Follow-on Biologics: Assessments of Impact and Appropriate Exclusivity Period
- Estimates of/Support for Appropriate Data/Market Exclusivity for Biological Products
- Total World Biogenerics Market Potential
- Section 2: Products in Development
- Pharmaceuticals
- Worldwide Drugs in the Pipeline by Therapeutic Category as of January 2011 (IMS Health)
- Top 50 Drug Companies by Number of Drug Products in Development as of January 2011 (IMS Health)
- Top 50 Drug Companies by Number of Drug Products in Development as of March 2011 (Pharmaprojects/Pipeline)
- A Snapshot of the Pharma R&D Pipeline, Number of Projects by Development Phase, 1998-2011
- Worldwide Active R&D Projects in Development by Stage, 1998-2011
- The R&D Pipeline, 1998-2011
- An Analysis of the Drug and Biotech Pipeline by Development Phase, Technology, Therapeutic Category,and Strategy (EvaluatePharma), May 2011
- R&D Project Count by Current Phase (EvaluatePharma)
- R&D Project Count by Technology (EvaluatePharma)
- R&D Project Count by Therapy Area (EvaluatePharma)
- R&D Project Count by Strategy, Organic, Licensed (EvaluatePharma)
- An Analysis of New Clinical Trial Starts for Drugs as Measured by Commercial IND Submissions to FDA, 2010
- New FDA-Regulated Clinical Trial Starts for Drugs and Biologics/Biotechs, 1998-2010
- Breakdown of CDER Divisional Workload by INDs Received in 2010
- Segmentation of US Clinical Trial Starts for Drugs by Therapeutic Category, 2008, 2009, and 2010
- Global New Active Substance Product Launches, 2010
- An Analysis of FDA-Regulated Clinical Trial Activity for Drugs as Measured by Active INDs at Year-End 2010
- Breakdown of CDER Drug Divisions’ IND Review Workload (Active as of Year-End 2010)
- Segmentation of FDA-Regulated Clinical Trials for Drugs by Therapeutic Category, 2010
- The R&D Pipeline: A 2011 Assessment
- Drugs in Active Development, 1995-2011
- Drug Development by World Status, 1995-2011
- Top 20 Most Valuable R&D Projects, May 2011 (Ranked by Net Present Value)
- Measures of Pharma Industry’s New Drug Output: NME/NAS Submissions to FDA and EMA, 1995-2010
- Annual Number of Marketing Applications for New Molecular Entities/New Active Substances
- Filed With the FDA and EMA, 1995-2010
- R&D Productivity by Company: A 2011 Assessment
- U.S. Major Pharma: R&D Productivity by Company
- European Pharma: R&D Productivity by Company
- Japanese Pharma: R&D Productivity by Company
- Biotech: R&D Productivity by Company
- A Call for Pharmas to Exit Internal Research and Externalize Research
- Attrition Rate for Drug Development Is Front-end Loaded
- A Two-Year Reduction in Development Increases a Drug’s ROIC by c.34%
- Risk-Adjusted Invested Capital is Driven by Attrition Risk and Development Time
- Cumulative risk-adjusted Economic Value Added of an In-licensed Phase IIb Drug
- Is significantly Higher than Cumulative Risk-Adjusted Economic Value Added of Internally Developed Drug
- Late-stage In-licensing Approximate Returns Characteristics of a Risk Reversal Option
- Trade Capping Upside and Downside Risk
- As Demonstrated by the Difference in the Cumulative Risk-Adjusted Economic Value Added
- TC-5214 Risk Adjusted EVA from Late-Stage In-licensing is >3 Times EVA from Internal Research
- Weak Economic Arguments for Continuing Research in GI, CNS, Cardiovascular or
- Respiratory—Clinical Approval Success Rates by Therapeutic Class
- Success Rates for In-licensed Drugs Exceed Those of Internally Discovered Drugs
- Probability of Success in Each of the Clinical Phases and at Submission
- High Unkowns, Low Success Rates in Neuroscience R&D Makes It a Target
- Valuing Company R&D Pipelines based on NPV Analysis: Top 20 R&D Spenders
- Valuing the R&D Pipeline: Pipeline NPV Minus Pharma R&D in 2009
- Measures of Diversity and Novelty of Drug Targets in Active R&D Projects, 1995-2011
- Target Diversity: Number of Protein Targets Under Study in R&D Projects, 1995-2011
- Percentage of Products Involving “Unproven” Targets, by Phase
- Lilly Chief on the Future of Pharma Innovators
- The Innovativeness of the 2010 NME Approvals
- The Approval Rebound Begins: ICTs vs. “Other” Drugs Approved, 1996-2010
- Industry Follow Through on Discoveries Frustrating—NIH’s Collins
- Active Clinical Drug Development Programs Worldwide by Phase, April 2011
- Number of Active Clinical Development Programs, 2011
- Total Average Number of Active Programs by Year, March 2001-April 2011
- Comparison of Annual Growth Rate—2006 vs. 2007 vs. 2008 vs. 2009 vs. 2010
- Top Therapeutic Categories by Number of Projects in Development as of March 2011 (Pharmaprojects)
- Number of Drugs in Preclinical Testing, 1995-2011
- Top Therapeutic Drug Categories Worldwide by Number of Projects in Development as of January 2011
- Drug R&D Projects: Top Ten Areas of Research, 2010
- Growth in the Number of Compounds in Development: A 2011 Assessment
- New Compounds in Each Stage of Development, 2008-2011
- Proportion of Top Pharma and Biotech Company Pipelines In-Licensed: A 2011 Assessment
- Leading Pharma Companies by Pipeline Size: Percent of Pipelines In-Licensed, 2009-2011
- Selected Leading Biotech Companies by Pipeline Size: Percent of Pipelines In-Licensed, 2009-2011
- Number of Companies in Pharma R&D on Rise, 1998-2011
- Dealmaking Trends: Accessing Innovation, Jettisoning Risk
- In 2010, Private Acquisitions Still Dominated by CVRs
- The Rise of Option-Based Licensing, 2007-2010
- Accessing Academic Innovation
- Average Deal Upfronts Are Falling
- Alliance Volume by Therapeutic Category
- What’s Pharma Buying? Total Acquisition Spend by Development Phase (2007-2010)
- Pharma Flight from Traditional R&D Focus Areas
- Pharma/Biotech Dealmaking: An Analysis of Activity in 2010
- Top 10 Dealmakers in 2010
- Dealmaking Trends 2006-2010: Biologics vs. Small Molecules
- Pharma/Biotech Product and Technology Deal Metrics by Therapeutic Area, 2010
- Biosimilars: A Look at the Metrics
- The Direction of Clinical Research: Trial Starts Signal Industry’s Direction in Six Key Therapeutic Areas, 2000-2010
- Top 10 Companies by Number of Trials: Novel vs. Approved Therapies
- Late-Stage Oncology Trials Initiated, October 2009-September 2010 by Disease
- Late-Stage Oncology Trials Initiated, October 2009-September 2010 by Company (Top 20)
- Late-Stage Metabolic/Endocrinology Trials Initiated, October 2009-September 2010 by Disease
- Late-Stage Metabolic/Endocrinology Trials Initiated, October 2009-September 2010 by Company (Top 20)
- Late-Stage CNS Trials Initiated, October 2009-September 2010 by Disease
- Late-Stage CNS Trials Initiated, October 2009-September 2010 by Company (Top 20)
- Late-Stage Cardiovascular Trials Initiated, October 2009-September 2010 by Disease
- Late-Stage Cardiovascular Trials Initiated, October 2009-September 2010 by Company (Top 20)
- Late-Stage Infectious Disease Trials Initiated, October 2009-September 2010 by Disease
- Late-Stage Infectious Disease Trials Initiated, October 2000-September 2010 by Company (Top 20)
- Late-Stage Autoimmune/Inflammation Trials Initiated, October 2010-September 2010 by Disease
- Late-Stage Autoimmune/Inflammation Trials Initiated, October 2010-September 2010 by Company (Top 20)
- The Emergence and Future of Companion Diagnostics: A 2010 Assessment
- Definition of Theranostics
- Number of Theranostic Drugs by ATC Code
- Sales of Theranostic Drugs by ATC Code (2008)
- Total Sales of Theranostic Drugs Totalled over USD $9.4 Billion
- Theranostic Growth, 2008-2014
- Rank of Theranostic Drugs in 2014
- Leading Theranostic Drugs in Develoopment
- Growing Role of Personalized Medicine in the Drug Pipeline: A 2010 Assessment
- Expected Increase in Company Investment for Personalized Medicine, 2006-2015
- Share of Companies Pursuing Various Strategies to Advance the Science of Personalized Medicine
- Share of Companies Using Personalized Medicine Practices in Discovery and Development
- Average Share of Company Pipeline Relying on Biomarker Data
- State of Personalized Medicine: Percent of Companies Investing in Personalized Medicine and
- Percent of Late-Stage Pipeline That Includes Companion Diagnostics
- The Availability of Comparative Effectiveness Information at Approval
- An Assessment of the Personalized Medicine Market Size, 2009-2015
- Industry Seeking New/Modified Indications in Greater Numbers in US: A 2011 Analysis
- Trends in the Number of U.S. New Indication Approvals
- New Indication Approvals by Therapeutic Class and Period of New Indication Approval
- Number of New Indications per Drug for Drugs with New Indications Approved 1998-2009
- Average Time from Original Regulatory Approval to New Indication Approval (years)
- Average Regulatory Approval Times for New Indications (Months)
- Theranostics and Already Approved Drugs: What You Don’t Know Can Hurt You
- Clinical Trials Utilizing CYP2C19 to Segment Clopidogrel Patients Before FDA Action in June 2009
- Impact of FDA Labeling on Revenue Growth
- Pharma and Biotech Company Pipelines: An Assessment of “Replacement Power,” 2011
- U.S. Pharma: NPV of New Launches and Pipeline Products as Proportion of Marketed Products
- U.S. Pharma: Peak Sales of New Launches and Pipeline Candidates as Proportions of 2010e Sales
- European Pharmas: NPV of New Launches and Pipeline Products as Proportion of Marketed Products
- European Pharmas: Peak Sales of New Launches and Pipeline Candidates as Proportions of 2010e Sales
- Japanese Pharma: NPV of New Launches and Pipeline Products as Proportion of Marketed Products
- Japanese Pharma: Peak Sales of New Launches and Pipeline Candidates as Proportions of 2010e Sales
- Biotech: NPV of New Launches and Pipeline Products as Proportion of Marketed Products
- Biotech: Peak Sales of New Launches and Pipeline Candidates as Proportions of 2010e Sales
- An Assessment of Pharma Industry Pipelines: The Number and Value of Anticipated Launches to 2012e
- Industry Summary: Launches, Peak Sales, and NPV by Year of First Launch, 2002-2012E
- Launch Expectations Over Time: Comparison of Lehman’s 2004-2008 Estimates
- Number of Drugs by Phase of Development, 2002-2008
- Breakdown of R&D Portfolio by Development Stage and Potential Peak Sales, 2006-2008
- Probabilities of Success for Phase 3 Drugs—2005 vs. 2008
- Number of Annual New Drug Launches Projected for 58 Selected Companies in Lehman Universe, 2002-2012e
- Novartis Looks to “Focused Diversification” Approach and to Leverage “Innovation Premium” to Drive Growth
- Novartis vs. Selected Leading Companies by Number of Approved NMEs, 2007-2010
- Novartis Success Rates vs. Industry
- Size of Early Clinical Portfolio: Novartis vs. Nine Peers
- The Evolution of the Novartis Clinical Pipeline, 2008-2010
- Novartis Vaccines Pipeline vs. Key Industry Peers
- Pfizer Slashes and Reorganizes R&D as Post-Lipitor Era Approaches
- The Current Pfizer R&D Operating Model
- The Pfizer R&D Pipeline, 2011
- The Pfizer Clinical Pipeline, 2011
- Roche Continues with Pure Pharma Innovation Approach
- Roche’s Five-Year Pipeline Ambitions
- Select Roche/Genentech Pipeline Metrics: One Year On
- Roche’s Phase 3 Pipeline of NMEs, 2007-2011E
- Roche’s Clinical Development Pipeline Projects by Therapeutic Area, April 2011
- The Post-Merger Merck Focuses R&D Pipeline and Investments
- Merck Funds Outcomes Studies: A Look at Merck Cardiovascular Candidates
- The New Merck’s Integrated Pipeline
- Merck BioVentures: Aggressive Targets
- AstraZeneca Enters 2011 with Newly Streamlined R&D Program and Portfolio
- AstraZeneca’s iMeds
- AstraZeneca’s R&D Operating Model
- Criteria Used for AZ’s Portfolio Review/Attrition Analysis
- AstraZeneca Pipeline by Clinical Phase, 2005-2010
- AstraZeneca’s Pipeline Prioritization Criteria
- AstraZeneca’s NME Clinical Pipeline by Therapeutic Area, January 2011
- Lilly Steadfast in Pipeline-as-Lifeline Strategy
- Lilly’s R&D Productivity Goals
- Lilly NMEs in Clinical Development, 2001-2011
- The Lilly Clinical Pipeline by Indication, 2011
- From FIPCO to FIPNET Transition
- Bristol-Myers Squibb Looks to Build Momentum as “Focused,
- Differentiated BioPharma Company”
- Next Generation BioPharma
- Evidence of BMS’ R&D Productivity: Selected Metrics
- BMS String of Pearls
- BMS Disease Areas and Unmet Medical Need
- BMS Goals in Key Disease Areas
- The BMS Pipeline by Development Phase and Disease, 2011
- GlaxoSmithKline Seeks ROI from R&D
- GSK: Growing a Diversified Global Business
- GSK: Shifting R&D Spend from Early to Late-Phase Research
- Driving Efficiencies at GSK—Selected Metrics
- GSK’s Discover Performance Units
- GSK’s R&D Organization
- Selected Metrics on GSK’s Late-Stage Pipeline
- GSK Grows the Biopharm Pipeline, 2002-2010
- PhRMA’s Medicines in Clinical Development Series
- Analysis of Drugs in Clinical Development for Alzheimer’s Disease and Other Dementias, 2010
- Analysis of Drugs in U.S. Development for Heart Disease and Stroke, 2011
- Analysis of Drugs in Development to Treat Rare Illnesses, 2011
- Analysis of Drugs in U.S. Clinical Development to Treat Mental Illnesses, 2010
- Analysis of Drugs in U.S. Clinical Development to Treat Pediatric Illnesses, 2010
- Analysis of Drugs in U.S. Development for AIDS and AIDS-Related Illnesses, 2010
- Analysis of Drugs in U.S. Clinical Development for Diabetes and Related Conditions, 2010
- Analysis of Drugs and Vaccines in U.S. Clinical Development for Infectious Diseases, 2010
- Analysis of Drugs in Clinical Development for Cancer by Development Status and Indication, 2009
- Analysis of Drugs in U.S. Clinical Development for Women by Development Status and Indication, 2009
- Analysis of Drugs in U.S. Clinical Development for Diseases of Aging, 2008
- Analysis of Drugs in Development for Neurological Disorders by Development Status and Indication, 2008
- Is R&D Productivity Really “Dead”?
- Leading Pharmaceutical Company R&D Profiles
- GlaxoSmithKline
- Merck
- Sanofi-aventis
- Pfizer
- Eli Lilly and Company
- Bayer Healthcare Pharmaceuticals
- Abbott
- Johnson & Johnson
- Astellas
- Amgen
- Roche
- AstraZeneca
- Bristol-Myers Squibb
- Novartis
- Development Pipelines of Selected Leading Drug Companies: Number of Products by Stage of Development, March 2011
- HIV Drug Development Slows as Past Successes Create Hurdles
- Biopharmaceuticals
- Biotech Company Development Pipelines: Number of Development Projects by Phase of Development, March 2011
- Biotechnology Products as a Percentage of Total R&D Pipeline (EvaluatePharma®)
- R&D Project Count by Technology
- Bain on Why Biotech Projects Can’t Fill Big Pharma’s Revenue Gap
- The Pipeline for Monoclonal Antibodies: A 2011 Assessment
- Therapeutic mAbs in Development by Phase, 1995-2011
- The Number of Monoclonal Antibody Therapies in Development by Subtype, 1995-2011
- Development Project Pipelines for Selected Leading Biotech Companies by
- Therapeutic Categories and Phases, March 2010
- Fewer Biotech M&A Deals in 2010, but Value Rises
- Antibiotics and the “10 by 20” Campaign
- Big Biotech: Innovation is the Only Fix
- Innovation Takes Time: Biotechs need to restructure now for future growth
- Long Gaps Between Product Launches Are Common: Six Leading Biotechs, 1985-2010
- Vaccine Development Growth: A 2010 Assessment
- Primarily Phase I and II Growth in the Vaccines Development Pipeline, 2001-2009
- Analysis of Biotechnology Medicines and Vaccines in U.S. Clinical Development by Development Status and Therapeutic Category, 2008
- A 2008 Analysis of the Mid- and Late-Stage R&D Pipeline: Size, Developer Type, Indications, and Success Rates
- Number of Drugs in Phase 2-Pre-Registration by Developer Type
- Number of Indications per Drug in Phase 2-Pre-Registration by Developer Type for Select Years
- Likelihood of Approval by Phase for Large Company Products
- Likelihood of Approval by Phase for Small Company/Institution Products
- Trends in the Clinical Development and Approval of Peptides: A 2009 Assessment
- Average annual number of peptide therapeutics entering study during seven time periods
- Therapeutic categories for peptide candidates entering study in three time periods
- Mean clinical and US approval phases for peptide new chemical entities approved after 1992
- RNAi Activity Declines as Scientific Realities Set In
- Multi-Drug Approaches to Cancer Set to Transform Cancer Treatment—Bloomberg BusinessWeek
- Section 3: Drug Development Costs/Complexity, Development Time, and Success Rates Costs/Complexity
- Measures of Clinical Trial Costs, 2008-2010 (TTC)
- Mean Cost per Patient in Clinical Trials by Clinical Phase, Worldwide, 2008-2010
- Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2008-2010
- Mean Patient Reimbursement Per Visit in Clinical Trials, 2008-2010
- Mean Patient Reimbursement Per Visit in Clinical Trials by Phase, Worldwide, 2008-2010
- Mean Patient Reimbursement Per Visit in Clinical Trials by Therapeutic Area, Worldwide, 2008-2010
- Indexed Measures of Clinical Trial Costs, 2008-2010 (TTC)
- Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, 2008-2010
- Index of Mean Cost per Patient in Clinical Trials by Country/Region
- Index of Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2008-2010, Phases I-IV
- Mean Site Fees per Clinical Study by Phase, 2008-2010
- Measures of Clinical Trial Costs per Patient, 2008-2010 (TTC)
- Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, US, 2008-2010
- Index of Mean Phase I Cost per Patient in Clinical Trials by Therapeutic Area, US, 2008-2010
- Index of Mean Phase II Cost per Patient in Clinical Trials by Therapeutic Area, US, 2008-2010
- Index of Mean Phase III Cost per Patient in Clinical Trials by Therapeutic Area, US, 2008-2010
- Index of Mean Phase IV Cost per Patient in Clinical Trials by Therapeutic Area, US, 2008-2010
- Measures of Clinical Study Complexity, 2008-2010 (TTC)
- Index of Clinical Study Complexity by Trial Phase, Worldwide, 2008-2010
- Index of Clinical Study Complexity by Country/Region, Phase I-IV, 2008-2010
- Index of Clinical Study Complexity by Year, Phase I-IV, Worldwide, 2008-2010
- Index of Clinical Study Complexity by Therapeutic Area, Phase I-IV, Worldwide, 2008-2010
- Recent Estimates of the Cost of Developing New Drugs, 2011
- R&D Costs by Phase: Recent Leading Estimates
- Light and Warburton Attempt “A More Realistic” Estimate of Drug Development Costs
- Trends in Patient Access to Investigational Drugs: A 2010 Assessment
- Number of Expanded-Access Requests to the FDA, 2008-2010
- Biomedical Research and Development Price Index, 1980-2016P
- Selected Health Care Inflation Data, 2000-2010
- Relative Clinical Study Costs: U.S., Western Europe, Eastern Europe, and Asia
- Relative per Visit Grant Costs in Selected Western European Countries
- Relative per Visit Grant Costs in Selected Eastern European Countries
- Relative per Visit Grant Costs in Various Asian Countries
- Indian vs. U.S. Procedure and Professional Fees
- Well Over 20,000 Clinical Trials Ongoing—Citeline
- Analysis of Overhead Costs for U.S.-based Institutions Conducting Clinical Trials
- The Global Clinical Trial Site Landscape: A 2010 Assessment
- Global Distribution of Trials
- Types of Investigative Sites
- Investigative Site Staffing by Region
- Experience Conducting Clinical Research by Region
- Clinical Trial Activity by Region
- Annual Investigative Site Activity
- Ability to Operate Profitably
- An Analysis of Clinical Trial Protocol Complexity and Execution Burden by Phase and Therapeutic Area
- Protocol Complexity and Burden Across All Therapeutic Areas and Phases
- Highest Growth Areas in Complexity and Execution Burden by Clinical Trial Phase, 2002-2007
- Therapeutic Areas with the Highest Number of Phase I Procedures, 2002-2007
- Therapeutic Areas with the Greatest Complexity and Work Burden for Phase II Protocols, 2002-2007
- Therapeutic Areas with the Highest Average Work Burden per Phase III Protocol, 2002-2007
- Top Therapeutic Areas with the Greatest Complexity and Work Burden for Phase IV Protocols, 2002-2007
- Activating Investigative Sites in a Staggered Process: Challenges and Solutions
- A Typical Site Activation Curve by Using Staggered Site Activation
- First Quartile of Country Activation Cycle Times
- Altered Site Activation Curve by Activating All the Sites Spontaneously
- Study Start Up Resource Curve in a Staggered Site Activation
- Study Start Up Resource Curve in an “All Out” Site Activation
- Why Conduct Clinical Trials Overseas? Because U.S. Has Only 4.5% of the World’s Population
- The Predictive Value of an EMR-Enabled Approach to Enrollment Validation and Protocol Optimization: A 2011 Analysis
- Executability Scorecard
- Recruitment Funnel
- Comparative Assessment 1: Pre-Screening % Loss
- Comparative Assessment 2: Predictive Value of Centerphase Estimates for Top 3 Pre-Screen Failure Reasons
- Recruitment Funnel Analysis
- A 2009 Assessment of U.S. Clinical Research
- Ongoing U.S. Clinical Trials: By Interventions Being Tested
- Clinical Trials Breakdown by Phase and Enrolled Subjects
- Ongoing U.S. Clinical Trials: Number of Trials and Subjects Across Four Therapeutic Indications
- Phase II-IV Trials and Subjects by Phase and Indication for Eight Therapeutic Areas
- Summary of Key Findings
- Early-Phase Trials and Facilities: A 2010 Assessment
- Market Share in 2009 of Global Phase I Facilities
- Global Phase I Facility Locations
- Valuing Medicines: How the UK’s NICE Measures the Effectiveness and Cost Effectiveness of New Treatments
- How a QALY is Calculated
- In the U.S., Cost Threshold Much Lower
- Comparative Effectiveness and Access to Cancer Drugs: A 2010 Assessment
- FDA- and TGA-Approved Oncology NMEs and Biologics, 2000-2009
- Coverage of Cancer Drugs in U.S. and Australia
- Differences in Reimbursement Practices in Australia, the UK, and Canada
- Trial Sponsors Focus on Northeast Asia and Eastern Europe—Clinical Trial Magnifier
- Clinical Trial Patient Numbers Drop in “Traditional Geographies”—TTC
- How Scientific Advances and New Drug Approvals Raise the Bar for New Clinical
- Trials and Approvals: An Oncology Case Study
- New Drugs Developed with Standard Regimen: Regulatory and Clinical Hurdles are Raised with Each New Approved Regimen
- The Statistical Dilemma
- The Limited Utility of Biomarkers: A 2008 Assessment of Biomarkers in Early Cancer Drug Development
- Biomarkers and Surrogate Endpoints are Often Confused
- Biomarkers Have Much Appeal in Expediting Cancer Drug Development
- However, Biomarkers Don’t Offer an Easy Solution
- European Clinical Trial Sites Rate Pharma Sponsors
- Top Rated Sponsors in Europe
- Highest Frequency as Top 3 Rated Sponsor Across 29 Relationship Attributes
- Most Important Sponsor Attributes
- General Project Management Evaluated
- Quality of Staff Professionalism
- U.S. Clinical Study Sites Rate Clinical Trial Sponsors: A 2009 Assessment
- Highest Frequency as Top 3 Rated Sponsor Across 29 Relationship Attributes
- Quality of General Project Management
- Quality of Staff Professionalism
- Quality of Workstyle
- Quality of the Study Initiation Process
- Quality of Ongoing Study Support
- Sanofi Chief Focuses on External R&D
- Where Today’s Clinical Trials Are Being Conducted: A Study of New FDA-Regulated Studies in 2010
- Percentage of Clinical Investigators Signing 1572s to Participate in New FDA-Regulated
- Research in 2009 and 2010, by Country
- Industry-Sponsored Clinical Trials by Region and Phase, 2006-2010 (PAREXEL Consulting)
- Worldwide Clinical Trials First Entered in Each Calendar Year, by Country/Region, 2006-2010
- Phase IV Clinical Trials, as first entered into ClinicalTrials.gov, by Country/Region, 2006-2010
- Phase III Clinical Trials, as first entered into ClinicalTrials.gov, by Country/Region, 2006-2010
- Phase II Clinical Trials, as first entered into ClinicalTrials.gov, by Country/Region, 2006-2010
- Phase I Clinical Trials, as first entered into ClinicalTrials.gov, by Country/Region, 2006-2010
- Clinical Trial Enrollment Across Key Countries/Regions
- Estimates on Patient Recruitment Services
- Where Are Clinical Trials Being Conducted? Follow the Inspections
- CDER-DSI International Clinical Investigator BIMO Inspections, FY2010
- EMA GCP Inspections Related to the Centralized Procedure: Total GCP Inspections per Country, 1997-2010
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2010
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 2003-2010
- Clinical Trial Enrollments for Selected NMEs Approved in 2010
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2009
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 2003-2009
- Clinical Trial Enrollments for Selected NMEs Approved in 2009
- Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2008
- Key Clinical Trial Enrollment Statistics for NMEs Approved in 2000-2008
- Clinical Trial Enrollments for Selected NMEs Approved in 2008
- Site Activation as the Driver to Patient Enrollment: A 2008 Assessment
- Demographics of Clinical Trial Populations: A Look at NIH Trials, 2010
- Benchmarking the Regulatory Affairs Function
- Annual Company Activity, 2008
- Median Major Project Volume per Company in 2008
- Regulatory Affairs Function Structure, 2008
- The Changing Clinical Investigator Landscape: A 2009 Assessment
- Number of Individual Principal Investigators, US-based and Non-US-based
- Global Distribution of Total FDA-Regulated Principal Investigators, 1997-2008
- Snapshot of the FDA-Regulated PI Landscape
- Number of Principal Investigators per Active IND, 1997-2007
- Mean Numbers of Patients per NDA, 1997-2007
- The Case for New Drugs and Better Predictive Biomarkers
- Average Per-Patient Clinical Trial Costs: A 2008 Assessment
- Average Per-Patient Clinical Trial Costs by Phase
- 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
- A Market Model for EDC in Clinical Trials
- Percentage of Trials Using EDC, Today vs. in Three Years
- Electronic Data Capture (EDC) Market Model, 2006E-2012E
- Estimates on U.S. Electronic Data Capture Adoption
- U.S. Electronic Data Capture Adoption, 2003-2012
- Optimizing and Supporting Remote Data Capture
- Competing for Clinical Investigators: Numbers of Trials vs. Investigators, 2000-2009
- Laptop Provisioning Rates by Clinical Trial Region
- Selected Metrics on Clinical Trial Spending and Comparative Trial Costs
- Global Clinical Grant Spending by Phase, 2008 and 2010
- Global Clinical Grant Spending by Therapeutic Area and Phase
- Index of Cost per Visit in Clinical Trials by Country, 2008-2010
- Cost per Patient Increases in Phase 2 and Phase 3 Clinical Trials, 2008-2009
- US Institutional Overhead: Actual versus Officially Reported Overhead
- UK Institutional Overhead: Actual versus Officially Reported Overhead
- Procedure and Professional Fees: US vs. China
- Average Cost in Phase 3 Studies (Cost per Patient): India vs. US
- Procedure and Professional Fees: US vs. Russia
- Number of Countries and Corresponding Study Completion Times
- Clinical Site Overhead Rates Surge in China and India, 2008-2010, TTC
- New Drug Development Spending and Costs: A 2008 Analysis
- R&D Expenses Regressions
- R&D Expenses by Therapy Area for All Phases
- An Analysis of Ways to Reduce Central Recruitment Costs
- Probability of Randomizing Relative Average
- Price Per Randomized for an Average Study by Recruitment Timeline
- Price per Randomized for an Average Study by FOV Rate
- 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
- 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
- Estimates of Nonclinical Study Costs and Durations
- The Phase I Clinical Study Market: A 2007 Assessment
- Phase I Still Stands Out: Projected Spending by Phase (U.S. $ in billions)
- The Phase IIIb/IV Market: A 2006 Assessment
- 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
- Development Time
- Analysis of U.S. New Drug Development Process by Average Time to Complete Each Phase of Product Development, 2010
- Biotech Development Time and Approval Success Rates in Cancer: A 2010 Study
- Attrition Rates for 164 RBI Oncology Compounds That Have Reached a Definitive Clinical Outcome
- Utilization of FDA Mechanisms for FDA-Approved Compounds: Oncology vs. All Others
- Impact of FDA Mechanisms on Mean Development Times for 27 Oncology Compounds
- Mean Clinical Phase and FDA Review Times for RBI Oncology Drugs
- The Problem with Accelerated Approval: FDA Oncologists Make Case
- Drug Approvals Show Signs of Rebound in Early 2011—CDER’s Woodcock
- FDA Review Times for Drugs and Biologics: A 2009 Comparison
- Average Approval Times for New Biotech Therapies, 1996-2009
- Average Approval Times for Biotech Drugs and Biologics, 1996-2009
- Median Approval Times for Biotech Drugs and Biologics, 1996-2009
- Development Times for Biotech Products Lengthen: A 2010 Analysis
- Phase Lengths for FDA-Approved Novel Recombinant Proteins and mAb Therapeutics, 1982-2009
- Reasons and Possible Solutions for Clinical Study Delays: A 2009 Assessment of Site Perceptions
- Factor Most Often Causing Study Delays
- Factors That Could Best Prevent Future Delays
- Enrollment Delays: U.S., Europe, Canada, Asia-Pacific, and Latin America
- Marketing Exclusivity Periods for First-in-Class Drugs: A 2009 Assessment
- Period of Marketing Exclusivity for First Entrants to a Therapeutic Class
- Average Time in Years to Market Entry for Second and Third Follow-on Drugs
- FDA Ratings of Therapeutic Significance for Follow-on Drugs Approved in the U.S., 1960-2007
- Share of Therapeutic Classes with at Least One Follow-on Drug with Development
- Phase Initiated Prior to First-in-Class Approval
- Share of Follow-on Drugs with Development Phase Initiated Prior to First-in-Class Approval
- Share of Follow-on Drugs Approved in the U.S., 1970-2007
- Your Severance: Here, Take These Drug Patents
- New Drug Clinical and Approval Times: A 2008 Assessment
- Clinical and Approval Times, 1984-2007
- Clinical Phases for Priority and Standard NCEs Approved 1984-2007
- Clinical Phases for NCEs Approved 1999-2007 by Therapeutic Area
- Clinical and Approval Times by Therapeutic Class, 2005-2007
- The FDA’s Fast Track Program: A 2008 Assessment
- Clinical and Approval Phases for Fast Track New Chemical and Biological Entities, Fast Track vs. All Drugs
- Therapeutic Categories of Drugs Obtaining Fast Track Designations, 1998-2007
- Reasons for Terminating Fast Track Candidates, 1998-2002 vs. 2003-2007
- Phase Transition Probabilities for Fast Track Candidates, 1998-02 and 2003-07
- Clinical Trial Cycle Times: Planned Timelines vs. Actuals
- Percentages of Planned Timelines That Trials Exceeded by Phase
- IRBs Take Almost 50 Days to Approve Research Protocols—AAHRPP
- The Factors Associated with Multiple FDA Review Cycles and Approval Phase Times: A 2009 Study
- Mean US Approval Phase Times by Number of Review Cycles for NDA/BLAs Submitted FY1996-2006
- Total Approval Phase for Drugs with NDAs or BLAs Submitted FY1996-FY2006
- Number of FDA Review Cycles for Approved Drugs by Therapeutic Class
- Distribution of FDA Review Cycles for Approved Drugs by Priority Rating for NDA/BLAs Submitted FY1996-FY2006
- Percent of Single-Cycle Approvals for Products by Regulatory Characteristic and FDA-Sponsor Interaction for NDA/BLAs Submitted FY1996-FY2006
- Mean Total FDA Review and Sponsor Response Times and Shares for NDAs and BLAs Submitted FY1996-FY2006
- New Drug Development Times: A 2007 Analysis
- Mean Clinical and Approval Times: 1994-2006
- Mean Clinical and Approval Phase Lengths by Therapeutic Class, 2002-2006
- Cancer Therapy Development Times vs. Other Drugs: A 2007 Study
- Clinical and FDA Approval Phases for New Cancer Therapeutics
- The FDA’s Fast Track Program: Effect on Review Time and Approval Success
- Number and Total Approval Time (in months) of Approved NDAs and BLAs, by Fiscal Year of Submission, and by Review Procedure
- Delays in Study Enrollment Timelines: A 2007 Assessment
- Distribution of Delays in US Site Enrollment Timelines
- Distribution of Delays in Site Enrollment Globally: US, Europe, Latin America, and Asia Pacific
- Factor Most Often Causing Study Delays
- 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
- xvii
- 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
- Biopharmaceutical Development Times: A 2007 Analysis
- Mean Biopharmaceutical Development Times: Clinical Phase, Approval Phase,
- and Total Phase Lengths, 1982-2006
- 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’ Perceptions 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
- 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
- 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
- Success Rates
- R&D Attrition Rates: Commonly Cited and Emerging Benchmarks
- Are New Drug Success Rates Really Dropping?: A 2011 Analysis
- Summary of Phase 3, Adcom, and FDA Outcomes, 2005-2010
- FDA Approval Rates, 2005-2010
- Favorable Adcomms, 2005-2010
- Favorable Phase 3 Trials
- FDA Approval Rates, Severe Diseases
- Favorable Adcomms, Severe Diseases
- Favorable Phase 3, Severe Diseases
- Difference in FDA Approval Rates Between Severe Diseases and All Diseases
- Difference in Favorable Adcomms Between Severe Diseases and All Diseases
- Difference in Phase 3 Success Rates Between Severe Diseases and All Diseases
- Overall Rate of FDA Approvals in Oncology
- Overall Rate of Phase 3 Outcomes in Oncology
- FDA NDA Outcomes by Disease Category
- Adcomm Outcomes by Disease Category
- Phase 3 Outcomes by Disease Category
- Outcomes Following a Complete Response Letter for the FDA
- New Drug and Biologic R&D Success Rates, 2003-2010
- Overall Success Rates: Results from Leading Studies
- Success Rates by Phase
- Phase Success Rates for Lead and Secondary Indications
- Overall Success Rates by Molecule Type
- Overall Success Rates by Therapeutic Area
- Overall Success Rates at Phase 2 and Phase 3 by Therapeutic Area
- Overall Success Rates by Oncology Indication
- If at First You Don’t Succeed
- Lechleiter: “Same Old Rituals” in R&D Will Not Work
- Innovation Needed, But Are Investors Becoming More Risk Averse?
- Clinical Approval Success Rate Trends Among Top 50 Pharma and Biopharma Companies
- Share of Compounds Entering Clinical Testing by Source and Molecule Type
- Share of All Compounds Entering Clinical Testing by Therapeutic Class
- Share of Self-Originated Small Molecules Entering Clinical Testing by Therapeutic Class
- Distribution of Failures by Phase for Self-Originated Compounds by Firm Size
- Clinical Approval Success Rates for Self-Originated Compounds by Firm Size
- Phase Transition Probabilities for Self-Originated Compounds
- Knowles: Good Enough Just Not Good Enough Any Longer
- Analysis of Reported Reasons for Drug Discontinuations, 2002-2010
- Reported reasons for drug discontinuations, 2002-2010
- The Drug Pipeline and Attrition: A 2009 Assessment
- Why Investigational Candidates are Dropped, 2000-2008
- Comparative Success Rates for Self-Originated/Licensed-in and Small/Large Molecule Drugs: A 2010 Analysis
- Phase Transition Probabilities and Clinical Approval Success Probabilities by Compound Source (Compounds First Tested in Humans from 1993-2004)
- Phase Transition Probabilities and Clinical Approval Success Probabilities by Type of Compound, for Self-Originated Compounds First Tested in Humans from 1993 to 2004
- New Drug Success Rates for Top 50 Pharma Companies: A 2009 Study
- Share of Compounds Entering Clinical Testing, 2003-2007
- Share of Compounds Entering Clinical Testing by Therapeutic Area
- Phase Transition Probabilities for Self-Originated Drugs of Leading Firms
- Phase Transition Probabilities for Relatively High Success Rate Classes, 1993-2004
- Phase Transition Probabilities for Relatively Low Success Rate Classes, 1993-2004
- Clinical Approval Success Rates by Therapeutic Class, 1993-2004
- Viebacher: R&D Portfolios Should be Put Through Ringer
- Are Fewer NMEs Gaining FDA Approval?
- Approval Rate Trends for Priority NMEs by PDUFA Submission Cohort
- Approval Rate Trends for Standard NMEs by PDUFA Submission Cohort
- The Higher Bar for R&D Drugs Today
- An Analysis of Phase III and Submission Failures, 2007-2010
- Phase III and Submission Failures, 2007-2010: The 83 Failures by Therapeutic Area
- Phase III and Submission Failures, 2007-2010: The 83 Failures by Reason for Failure
- Attrition Rates and Transition Probabilities for Fast Track Drugs: A 2008 Assessment
- Reasons for Terminating Fast Track Candidates, 1998-2002 vs. 2003-2007
- Phase Transition Probabilities for Fast Track Candidates, 1998-02 and 2003-07
- Attrition Rates in Drug Development Phases
- A 2008 Analysis of Approval Success Rates by Product Type and Novelty
- NME Success Rates by Compound Type, 1997-2007
- NME Success Rates by Target Type, 1997-2007
- Product Type and Target Novelty, 1997-2008
- NME Success Rates by Compound Type, 2002-2007
- NME Success Rates by Target Type, 2002-2007
- Product Type and Target Novelty, 2002-2007
- A 2008 Analysis of the Mid- and Late-Stage R&D Pipeline: Size, Developer Type, Indications, and Success Rates
- Number of Drugs in Phase 2-Pre-Registration by Developer Type, 1997-2007
- Number of Indications per Drug in Phase 2-Pre-Registration by Developer Type for Select Years, 1997-2007
- Likelihood of Approval by Phase for Large Company Products, 2000-2007
- Likelihood of Approval by Phase for Small Company/Institution Products
- Emerging Success Rates for New Cancer Therapies, 1990-2006
- New Cancer Therapeutics and Vaccines Entering Clinical Study, 1993-2006
- Clinical Phase Transition Probabilities for Cancer Therapeutic Candidates
- Kola on Emerging Attrition Rate Trends, 2007
- Estimates of Drug Success Rates: Unprecedented vs. Precedented Molecules
- Drug Success Rates: Unprecedented vs. Precedented Molecules
- 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
- An Analysis of Late-Stage Success Rates: Biotech Products versus Pharmaceuticals
- Section 4: Regulatory/FDA Statistics
- INDs
- Number of IND Submissions, 1982-2010
- Breakdown of Drug Divisions’ Active IND Review Workload as of Year-End 2010
- Drug Regulators and Drug Payers to Interact More Closely—EMA’s Lonngren
- Breakdown of CDER Divisions’ Workload by INDs Received in 2010
- CDER Holds on Commercial IND Submissions, 1990-2010
- Clinical Holds on Commercial IND Submissions by Division, 2009
- NDAs
- Number of NDAs Pending at the Close of the Calendar Year, 1983-2010
- Breakdown of Drug Divisions’ Pending NDA Review Workload, Year-End 2010
- Breakdown of Drug Divisions’ Workload by NDAs Received in Fiscal Year 2010
- Breakdown of Divisions’ Workload by Pending NDA Supplements, Year-End 2010
- CDER Refusal-to-File (RTF) Actions by Year, 1994-2010
- Key Drug Submission and Approval Statistics, 1993-2010
- Number of NME Approvals and Approval Times, 1984-2010
- NME Review Time Ranges, 1995-2010
- Priority/Standard NME Review Gap, 1995-2010 (in months)
- Median Approval Times for All NMEs by Calendar Year, 1986-2010
- Average NME Review Times in Months by CDER Division, 2005-2010
- Average NME Review Times in Months by CDER Division, 1993-2004
- A 2010 Analysis of CDER First-Cycle Approval Rates for NDAs, FY1996-FY2009
- First-Cycle Review Outcomes for NMEs, FY2000-FY2010 Submission Cohorts
- Number of NDAs and NMEs Approved by Year, 1984-2010
- NMEs Approved Based on Therapeutic Potential, 1985-2010
- Percent of All Approved NDAs and NMEs Receiving Priority Review Status, 1996-2010
- CDER’s Priority NME Approvals by Class of Drug, 1997-2010
- An Analysis of Review Cycles to Approval for New Drugs
- Summary Cycle to Approval Statistics for 2005-2010-Approved NMEs
- Distribution of Review Cycles to Approval, 2005-2010
- FDA Review Times for Drugs and Biologics: A 2009 Comparison
- Average Approval Times for New Biotech Therapies, 1996-2009
- Average Approval Times for Biotech Drugs and Biologics, 1996-2009
- Median Approval Times for Biotech Drugs and Biologics, 1996-2009
- Is Drug Pricing a “Psychological Factor” in FDA Reviews?
- “Hidden Agenda” Against High-Priced Drugs?
- A Closer Look at the FDA’s 50 Fastest Drug Approvals, 1963-2010
- A Comparison of FDA vs. EMA Drug Approval Times, 2000-2005
- Mean Approval Times for New Substances Approved by EMA 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 2010: NDA Review Times by Drug
- The Problem with Accelerated Approval: FDA Oncologists Make Case
- U.S. New Drug Approvals of 2009: NDA Review Times by Drug
- U.S. New Drug Approvals of 2008: NDA Review Times by Drug
- 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
- Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved in 2010
- Percent of NMEs Approved with Postmarketing Commitments, 2001-2010
- Drug Approvals Show Signs of Rebound in Early 2011—CDER’s Woodcock
- When Approving a Drug is Necessary to Determine If It’s Safe
- Is There a “New” Drug Lag? A 2011 Assessment of FDA and EMA Review Times
- Mean US New Drug Approval Delay
- Risky Research Needs Appropriately Aligned Rewards—Study Authors
- An Analysis of the Factors Associated with First-Cycle Approvals: A 2008 Update
- Approval Rate vs. Novelty and Indication
- First-Cycle Approval Rate by Application Type
- Effect of Pre-NDA/BLA Meetings and Timing on Approval Rate for FY2005-FY2007 Cohort
- Major Deficiencies Cited in First Action Letter of Multi-Cycle Applications by Category for FY2002-FY2007 Cohort
- Single-Cycle Approval Rates by Sponsor Experience
- Approval Rate vs. Sponsor Type and Origin
- Safety-Based Drug Marketing Withdrawals in the United States, 1980-2010
- CDER Safety-Based Drug Withdrawals: Pre-PDUFA vs. PDUFA Era
- Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved in 2009
- Percent of NMEs Approved with Postmarketing Commitments, 2001-2009
- Postmarketing Study Requirement Trends in the U.S., Europe, and Japan: A 2008 Assessment
- Average Number of PMCs per Approval by Region
- Types of Postmarketing Studies Requested
- Timing of Agreement between Sponsor and Regulatory Agency on Nature and Design of Studies
- Orphan Drug Activity Continues to Hover Near Record Levels
- Orphan Drug Designation and Approval Statistics, 1991-2010
- Prevalence of Orphan Drugs in CDER’s NME Approvals, 2001-2010
- NDAs Approved Under CDER’s Accelerated Approval Program, 1992-December 2010
- Biologics
- Summary of CBER Actions in 2010
- Key CBER Review Statistics for 2010
- CBER’s New Biological Product Approvals for 2010
- Summary of CBER Actions in 2009
- Key CBER Review Statistics for 2009
- CBER’s New Biological Product Approvals for 2009
- Summary of CBER Actions in 2008
- Key CBER Review Statistics for 2008
- CBER’s New Biological Product Approvals for 2008
- Summary of CBER Actions in 2007
- Key CBER Review Statistics for 2007
- CBER’s New Biological Product Approvals for 2007
- 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
- Orphan Drugs
- Orphan Drug Designation and Approval Statistics, 1991-2010
- Cumulative Growth of Orphan Drugs, 1984-2010
- Orphan Drug Approval Times vs. Approval Times of Other Drugs, 1993-2010
- Orphan Drug and Biologic Approvals, 1993-2010
- Orphan Drug and Biologic Approvals in 1990, 1991, and 1992
- Over-the-Counter Drugs
- Rate of Rx-to-OTC Switches per Year, 1951-2010
- Generic Drugs
- Pending ANDAs Continue to Surge at FDA, 2000-2010
- Generic Drug Approval Times: Median Time to Approval 1993 to 2010
- Annual ANDA and AADA Submission and Approval Statistics, 1995-2010
- Mean and Median ANDA/AADA Review Times, 1995-2010
- Compliance
- CDER Clinical Site Inspection Results, FY1998-FY2010
- CDER Clinical Investigator Inspections, FY1992-FY2010
- Clinical Investigator Deficiency Categories, FY2010
- Clinical Investigator Inspections Final Classification, FY2010
- Clinical Investigator Deficiencies-CDER, FY2010 Final Classification of OAI
- Section 5: International Statistics
- European Union
- R&D Spending in Europe’s Pharmaceutical Industry, 1980-2010
- Pharmaceutical R&D Spending Within EFPIA Countries, 1990-2009
- Mean EMA Review Time for Human Drugs Submitted Under the EC’s Centralized Procedure, 2009
- Mean EMA Processing Time for Human Medicinal Products, 1997-2009
- Mean Processing Times for Key Stages of Centralized Process, 1996-2009
- Cancer, Anti-Infective, Blood, and Cardiovascular Drugs Dominate New Centralized Submissions to EMA in 2009
- New Drug Reviews at the FDA and EMA: A 2009 FDA Analysis
- Comparison of New Molecular Entity Outcomes for FDA and EMA
- Review Outcomes for New Molecular Entities Having Similar Submission Timing at Both FDA and EMA
- Review Outcomes for New Molecular Entities Having Similar Submission Timing at Both FDA and EMA:
- Priority and Standard Applications
- United Kingdom
- The MHRA’s Clinical Trials Work, 2009/2010
- MHRA’s New Active Substances Assessed and Mean Assessment Times, 1993-2009
- Companies Transitioning Products More Quickly to Pharmerging Markets—IMS Health
- Japan
- Japan’s PMDA Claims Performance Gains on Drug Reviews
- Pharmaceutical R&D Expenditures in Japan, 1985-2009 (in bill. Yen)
- Annual Number of New Chemical Entities Approved in Japan, 1983-2009
- Number of INDs for Investigational New Drugs Submitted in Japan, FY2002-2009
- Success Rates of New Drug Development in Japan, 2004-2009
- R&D Expenditures of 20 Leading Japanese Pharmaceutical Manufacturers, 2005-2009
- Number of Prescription Drug Manufacture and Import Approvals Granted in Japan, 1985-2009
- Median NDA Approval Times in Japan by Year of Submission, 1996-2008
- Median Development Times for NMEs in Japan, 2000-2009
- Number of Drugs in Development in Japan by Pipeline Stage and Disease/Therapeutic Category, 2011
- Canada
- Canadian Drugs Directorate New Active Substance (NAS) Approval Times, 1997-2010
- New Drug Submission (NDS) Approval Times in Canada, 1999-2010
- Germany
- Pharmaceutical R&D Expenditures by German Drug Industry, 2001-2009
- Number of New Chemical Entities Approved in Germany, 1990-2009
- The VFA Assesses the German Pharmaceutical Environment
- Global
- Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2011 Analysis
- Breakdown of World Pharma Market—2010 Sales
- Markets of First Launch for 35 New Active Substances Introduced in 2010
- Pharmaceutical R&D Expenditure Annual Growth Rate, US vs. Europe, 1994-2010
- Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2010
- U.S., European, Canadian and Asia/Pacific Biotech: Global Activity Measures, 2010
- CRO Industry in Asia Pac Expands Rapidly—Frost & Sullivan
- Global Clinical Trials: A Focus on Latin America
- Number of Clinical Studies Conducted in Key Emerging Market Countries
- Growth in Clinical Trials for Selected Major and Emerging Countries and Regions, 1999 to 2009
- Country Participation in Clinical Trials Evolution During the Last Three Years
- Selected Countries/Regions Participating in Phase III Clinical Trials, 2008 vs. 2009
- Growth in Clinical Trials in Selected Latin American Countries, 2005-2008 vs. 2009
- Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2016P
- Global R&D Spending by World’s Top 500 Pharma & Biotech Companies, 2002-2016
- Global New Active Substance Product Launches, 2010
- Has India Hit a Speed Bump in Clinical Trials?
Related Markets
- Pharmaceuticals
- Manufacturing, Packaging & Detailing
- Research & Development
- Drug Discovery
- Biopharmaceuticals
Biopharmaceuticals Reports
- Research Report on Chinese Bio-pharmaceutical Industry, 2012
- Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes
- Biologics Market in Brazil
- Global Biosimilars Market Forecast to 2015
- Biosimilars: Current Situation & Future Prospects, Worldwide