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Bio/Pharma R&D Statistical Sourcebook 2008/2009
Cambridge Healthtech Institute, June 2008
Section 1: R&D Spending
Pharmaceuticals
Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2012P (EvaluatePharma)
Global R&D Spending by World’s Top 400 Pharma and Biotech Companies 2002-2012 (EvaluatePharma)
R&D Spending by Research-Based Pharmaceutical Companies, 1980-2007
R&D Investments by Research-Based Pharmaceutical Companies, 1975-2007
Industry-wide and Government R&D Spending, 1980-2007
Biopharmaceutical Industry Investment in Research and Development, 1980-2007
Biopharmaceutical R&D Expenditure and NIH Budget: 1995-2007
Booz Allen Hamilton Study on R&D Spending
Analysis of Top 20 Companies by 2007 Pharma R&D Spend (EvaluatePharma)
Top 20 Companies by Pharma R&D Spend in 2007 (EvaluatePharma)
Top 20 Companies by Pharma R&D Spend as f Pharmaceutical Revenues (EvaluatePharma)
Top 20: Average R&D Spend per Late-Stage Project (EvaluatePharma)
Total PhRMA R&D as a Percent of Sales, 1985-2007
Domestic U S R&D and R&D Abroad, 1985-2007
Domestic U S Sales and Sales Abroad, 1985-2007
Growth in Domestic U S R&D and R&D Abroad, 1970-2007
R&D Spending at Top 50 Pharmaceutical Companies in 2007
Productivity as Measured by R&D Spending per NME Approval “Deeply Flawed”
Various Measures of New Drug/Biologic R&D Productivity
Industry R&D Spending per NDA Submission in the U S , 1993-2007
Industry R&D Spending per NDA Approval in U S, 1996-2007
Industry R&D Spending per NME Submission to FDA, 1995-2007
Industry R&D Spending per NME Approved in the U S , 1995-2007
Global R&D Spending per Global New Active Substance (NAS) Launch, 1995-2007
Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2008 Analysis
Breakdown of World Pharma Market—2007 Sales
Pharmaceutical R&D Expenditure Annual Growth Rate, US vs Europe, 1993-2007
Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2007
Opening and Closing of Research Sites in Europe, US, and Asia, 2001-2006
Number of Compounds in Development by Country/Region: U S , Europe, Japan, and Rest of World
U S , European, Canadian, Japanese and Australian Biotech: Global Activity Measures, 2007
An Analysis of Pharma and Biotech Industry R&D Spending Growth Through 2008
Pharma R&D Spending, 2003-2008: Trailing 12-Month R&D Spending by Top Pharma and Biotech Companies
Pharma M&A Activity in 2007
R&D Spending by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2006
Domestic U S Scientific, Professional, and Technical R&D Personnel by R&D Function, Ethical Pharmaceuticals, 2006
Domestic R&D by Function, Ethical Pharmaceuticals, PhRMA Member Companies, 2006
Domestic R&D and R&D Abroad for Human-Use and Veterinary-Use Pharmaceuticals, PhRMA Member Companies, 2006
Domestic R&D by Origin of Product (Licensed-in vs Self-originated), PhRMA Member Companies, 2006
Phase 4 Postmarketing Research to Top $12 Billion in 2007—Cutting Edge
U S Government (NIH) Funding for Medical/Clinical Research, 1995-2008
NIH Appropriations, 1995-2009P
NIH Clinical Research and Clinical Trials Spending, 2003-2009P
Estimates of Funding for Selected Diseases, Conditions, and Research Areas, 2004-2008E
Growth in Domestic U S Sales and Sales Abroad, Ethical Pharmaceuticals, 1970-2007
Sales by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2006
A New Look at the Global Pharmaceutical Market: North America Sets Pace in 2007 Pharma Sales
Global Pharma Sales, 1999-2007
Global Pharmaceutical Sales in 2007 by Region
Leading Therapy Classes in 2007 Global Pharma Sales
Global Pharma Sales in 2007—Leading Products
Pharma Market Growth in Five Key Regions, 2008
Contribution to Drug Market by Age of Drug
Percentage Contribution to the Overall Market by Age of Drug, 2001-2011E
Top 20 Companies by Worldwide Prescription Drugs Sales in 2006/2007 (EvaluatePharma)
An Analysis of Worldwide Prescription and OTC Sales by Technology (2002-2012): Biotech vs Conventional Technology (EvaluatePharma)
Worldwide Prescription & OTC Sales by Technology, 2002-2012 (EvaluatePharma)
Top 100 Drug Sales by Technology, 2007-2012 (EvaluatePharma)
Two in Ten New Drugs Recoup Costs—New Study (EvaluatePharma)
An Analysis of the Sales Potential of New Drugs Approved in 2006 and 2007 (EvaluatePharma)
FDA Approval Count vs 5th Year after Launch US Product Sales (EvaluatePharma)
Top 10 New Molecular Entities in 2007: Ranked on US Consensus Sales in 2012 (EvaluatePharma)
Top 10 New Molecular Entities in 2006: Ranked on US Consensus Sales in 2011 (EvaluatePharma)
Few Drug Launches Vastly Successful—IMS Health
Biologic Drugs/Vaccine Sales to 2011E
The Future Pharma R&D Model: The New PharmaCo Threat
An Analysis of the U S Pharma Market: U S Prescription Drug Sales in 2007
Annual Growth Rate of U S Prescription Pharmaceutical Market, 1994-2012P
Top 10 Therapeutic Classes by U S Prescription Sales, 2007
Top 10 U S Prescription Products by Sales, 2007
Top 10 Pharma Companies by U S Prescription Sales, 2007
Your Own Lab—Oh, and a Home Mortgage
Want To Help Reduce Healthcare Costs? Then Smoke and Overeat!
Pharma Behind Networking and Mining/Oil Production Among Most Profitable U S Industries
Global and US Sales Growth of Branded Drugs by Therapeutic Category, 2004-2011E
Global Drug Sales and Growth Forecasts in Major Therapeutic Areas: 2004-2011E
US Sales and Growth Forecasts—Major Therapeutic Areas, 2004-2011E
Therapeutic Categories: Drug Sales as a Percentage of Worldwide Market, 2007 vs 2012P
Pharma Companies: Drug Sales as Percentage of Worldwide Market, 2007 vs 2012P
The Future of Pharma: Adjusting the Pharma R&D Model
An Opportunity Map for Pharma R&D
Large Rx Players Competing for the Same Real Estate
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, 2000-2013E
Pharma Sales in 2007E at Risk of Generic Competition in 2008-2012E as a Percentage of Pharma Sales at 13 Large Pharma Companies 30
Biomarker Market to $12 8bn by 2012
U S Generic Drug Market Outlook to 2012
2007 U S Sales of Drugs Losing Patent Protection, 2008-2012
Percent Sales Vulnerable to Patent Expirations Through 2012: Selected Leading Companies
Prescription Drugs Represent 10% of Health Care Dollar Spent—CMS Analysis
U S Disease Foundation Investment in Biopharma R&D Rises
New Global Pharma Outsourcing Market Model to 2011
CRO Market Opportunity, 2006E-2011E
CRO Market Opportunity by Stage
The Goldman Sachs Global R&D Outsourcing Model
A May 2008 Update to the Goldman Sachs Global R&D Outsourcing Model
EDC Spending to Top $500 Million in 2009—Health Industry Insights
The CRO Contribution to Drug Development: A 2005 Assessment
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)
Sources of Clinical Trial Funding, 2001-2007P
Breakdown of Government vs Industry-Sponsored Clinical Trials
Biopharmaceuticals
Top 100 Biotech Companies by 2007 R&D Spending
R&D Spending at Selected Leading Biotechnology Companies, 2007A-2012E
Biotech Industry Benchmarks from E&Y
Biotech R&D Spending to 2009E
Annual Biotechnology R&D Spending, 2004-2009E
Biologics and Biotech R&D: An Analysis of PhRMA Member Companies, 2006
Biologics and Biotechnology R&D, PhRMA Member Companies, 2006
mAb Sales Growth to Dwarf Small Molecules
Financial Markets Continue to Fuel Biotech’s R&D Efforts
Total Equity Raised by Biotech, 1995-2007
Does Biotech Have the Pharma Flu?
An Analysis of Global Biologics/Biotech Market: Worldwide Sales for Top Products and Top Product Classes in 2007
Top-Selling Categories of Biologic Products, 2007
Growth Rates of Top-Selling Classes of Biological Products, 2007
Top 20 Selling Biologic Products Worldwide, 2007
Section 2: Products in Development
Pharmaceuticals
Worldwide Drugs in the Pipeline by Therapeutic Category as of January 2008 (IMS Health)
Top 50 Drug Companies by Number of Drug Products in Development as of January 2008 (IMS Health)
Top 50 Drug Companies by Number of Drug Products in Development as of March 2008 (Pharmaprojects)
A Snapshot of the Pharma R&D Pipeline, Number of Projects by Development Phase, 1998-2008
Worldwide Active R&D Projects in Development by Stage, 1998-2008
The R&D Pipeline, 1998-2008
An Analysis of the Drug and Biotech Pipeline by Development Phase, Technology, Therapeutic Category, and Strategy (EvaluatePharma)
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)
Pipeline Expansion Accelerates
Drugs in Active Development, 1995-2008
Drug Development by World Status, 1995-2008
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
Wall Street No Longer Impressed by Pipeline
Top 20 Most Valuable R&D Projects (Ranked by Net Present Value)
Biotechs Responsible for 65% of Recent FDA New Drug Approvals—New Study
Valuing Company R&D Pipelines based on NPV Analysis: Top R&D Spenders
Valuing the R&D Pipeline based on NPV Analysis
Measures of Pharma Industry’s New Drug Output: NME/NAS Submissions to FDA and EMEA, 1995-2007
Annual Number of Marketing Applications for New Molecular Entities/New Active Substances Filed With the FDA and EMEA, 1995-2007
Active Clinical Drug Development Programs Worldwide by Phase, April 2008
Number of Active Clinical Development Programs, 2008
Total Average Number of Active Programs by Year, March 2002-April 2008
Comparison of Annual Growth Rate—2006 vs 2007 vs 2008
An Analysis of New US Clinical Trial Starts for Drugs as Measured by Commercial IND Submissions to FDA, 2007
New US Clinical Trial Starts for Drugs and Biologics/Biotechs, 1998-2007
Breakdown of CDER Divisional Workload by INDs Received in 2007
Segmentation of US Clinical Trial Starts for Drugs by Therapeutic Category, 2006 and 2007
Global New Active Substance Product Launches, 2007
An Analysis of U S -based Clinical Trial Activity for Drugs as Measured by Active INDs at Year-End 2007
Breakdown of CDER Drug Divisions’ IND Review Workload (Active as of Year-End 2007)
Segmentation of US Clinical Trials for Drugs by Therapeutic Category, 2007
Top Therapeutic Categories by Number of Projects in Development as of March 2008 (Pharmaprojects)
Number of Drugs in Preclinical Testing, 1995-2008 (Pharmaprojects)
Top Therapeutic Drug Categories Worldwide by Number of Projects in Development as of January 2008
Drug R&D Projects: Top Ten Areas of Research, 2007
The Late-Stage Pipeline: A 2008 Assessment
New Molecular Entities in Development at Major Pharmaceutical Organizations, 2004 vs 2006 vs 2007
U S Clinical Development Pipeline by Phase, 1997-2007
Did the Molecular Bulge Begin Shifting in Late 2007?
New Compounds in Various Stages of Development, Indexed, 1995-2007
New Compounds in Pharmaceutical Development, January 2005-October 2007
Proportion of Top Pharma and Biotech Company Pipelines In-Licensed: A 2008 Assessment
Leading Pharma Companies by Pipeline Size: Percent of Pipelines In-Licensed
Selected Leading Biotech Companies by Pipeline Size: Percent of Pipelines In-Licensed
Number of Companies in Pharma R&D on Rise, 1997-2007
The R&D Pipeline for Antibody-Derived Therapies, 2006-2012
The Future Pharma R&D Model: The NewPharmaCo Threat
The Pipeline and the New Realities of Drug Development
Pharma/Biotech Dealmaking: A 2008 Analysis
Increasing Cost of In-Licensing
Up-Front Payments Stable in Relative Terms, 2003-2007
Deals by Therapy Area, 2007
Early-Stage Discovery Deals by Therapy Area, 2007
Deals Signed by Stage of Development, 2007
Dealmaking Trends: Can Prices Continue to Grow?
Stingy Public Markets, 2005-2007
Average Acquisition Values are Rising, 2000-2007
Acquisitions of Recently Public Companies: Valuable… but Rare
Buying Discovery, 2000-2007
Phase II Deal Numbers and Values Increase
Up-Fronts for Phase III/NDA-Stage Compounds Grow Slightly in 2007
Pharma and Biotech Company Pipelines: An Assessment of “Replacement Power,” 2007
Large Pharma Replacement Power: 13 Major Companies
Large Biotech Replacement Power: 7 Major Companies
An Assessment of Pharma Industry Pipelines: Anticipated Launches to 2011e
Industry Summary: Launches, Peak Sales, and NPV by Year
Launch Expectations Over Time: Comparison of Lehman’s 2004-2007 Estimates
Number of Drugs by Phase of Development, 2002-2007
Breakdown of R&D Portfolio by Size
New Cancer Therapeutics and Vaccines Entering Clinical Study, 1993-2006
Composition of New Cancer Therapeutics, 1990 and 2006
Number of Annual New Drug Launches Projected for 62 Selected Companies in Lehman Universe, 2001-2011e
The Pharmaceutical Pipeline: A December 2007 Analysis
Compounded Growth by Stage of Development, 1999-2007
Compounded Growth by Therapeutic Category: May 1995-November 2007
Preclinical Compounds in Development, May 1998-November 2007
Phase 1 Compounds in Development, May 1998-November 2007
Phase 2/3 Compounds in Development, May 1998-November 2007
Phase 3b/4 Compounds in Development, May 1998-November 2007
An Assessment of Oncology Market and Pipeline
Novartis Looks to Build on New Growth Cycle in Pharmaceuticals in 2008
Novartis vs Leading Pharmas, Number of 2007 Drug Approvals and Success Rates, 2000-2007
The Novartis Clinical Pipeline
Novartis Clinical Pipeline by Phase and Therapeutic Area, September 2007
The DELPHI Model
Tufts CSDD Study on the Value of Follow-on Drugs and Indications
Roche Moves Ahead to Further Expand Innovation Capacity and Personalized Medicine Focus
The Roche R&D Model: Previous vs New Model
The Roche Pipeline, 2007 vs 2006
Roche’s Clinical Development Pipeline by Therapeutic Area, February 2008
More than 2,700 Drugs in US Clinical Development
Finding Biomarkers as Difficult as Finding New Drugs—Roche’s Humer
Merck Updates Its “Plan to Win” and New Operating Model
Merck R&D Pipeline, 2002 vs 2006 vs 2008
Key Clinical Study Cycle Time Intervals: Merck vs Peers
FDA Clears First Molecular Test to Profile Genetic Activity
Genetic Tests Could Accompany One in Five R&D Drugs Within Next Decade—Medco
AstraZeneca Reports Progress on Strategy to Strengthen its R&D Pipeline
AstraZeneca Candidates Entering Development, 2002-2007
AstraZeneca First-time-in Man Projects, 2002-2007
The AstraZeneca Pipeline, 2004-2007
AstraZeneca Delivers Early Portfolio Faster, 2006-2010 Target
AstraZeneca’s New Productivity Targets for MedImmune
Pfizer Acclerates and Refocuses Its Pipeline
The Pfizer R&D Pipeline
Pfizer Projections on Rebuilding the Phase 3 Portfolio
Pfizer’s Biotherapeutics R&D Pipeline, 2008
Phase 2 and 3 Success Rates: Pfizer vs Industry
Pfizer’s Phase 3 Success Rates, 2005-2007
Clinical Study Timelines: Pfizer, Industry-wide Medians, Best-in-Class Performance
Lilly Unveils Transformation Plan to Focus on Personalized Medicine
Prasugrel: Tailoring by Patient Characteristics
Lilly: From FIPCO to FIPNET
Lilly’s New Drug Launch Goals, 2008-2014
Lilly NMEs in Clinical Development, 2000-2011
Lilly’s Clinical Portfolio, Year-end 2007
GSK Highlights R&D Pipeline and CEDDs Model, Looks to Biopharm and Asia
GSK vs 11 Other Leading Pharmas, Mid- to Late-Stage Pipeline
The GSK Clinical Pipeline
GSK Tops Lehman Brothers Pharma Replacement Power Rankings
Bristol-Myers Squibb: Evolving to the “Next Generation BioPharma Model”
BMS Disease Areas and Unmet Medical Need
US NME Approvals by Review Status: BMS vs Leading Companies
BMS vs Industry Trends: Pharma R&D Spend and NME Approvals
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 Clinical Development for Cancer by Development Status and Indication, 2008
Analysis of Drugs in Development for Neurological Disorders by Development Status and Indication, 2008
Analysis of Drugs in Development to Treat Rare Illnesses, 2007
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, 2007
Analysis of Drugs in U S Clinical Development for Diseases of Aging, 2005
Analysis of Drugs in U S Development for AIDS and AIDS-Related Illnesses, 2007
Analysis of Drugs in U S Clinical Development to Treat Pediatric Illnesses, 2007
Analysis of Drugs in U S Clinical Development for Women by Development Status and Indication, 2007
Analysis of Drugs and Vaccines in U S Clinical Development for Infectious Diseases, 2007
Embryonic Stem Cells to Enter Clinical Trials in 2008?
Leading Pharmaceutical Company R&D Profiles
GlaxoSmithKline
Pfizer
Schering-Plough
Biogen Idec
Astellas
Bristol-Myers Squibb
Roche
Johnson & Johnson
Merck
Abbott
AstraZeneca
Bayer Schering Pharma
Eli Lilly
Amgen
Wyeth
Novartis
Sanofi-Aventis
Development Pipelines of Selected Leading Drug Companies: Number of Products by Stage of Development, March 2008
Large and Small/Mid-Tier Pharmas Relying on Each Other for Growth
Origin of New US Drug Approvals, 2000-2006
New Drug Clinical Trial Starts Surge at Top 10 Companies in 2003-2005 Period
AIDS Vaccine R&D Setback
FDA Reviewers Being Pressured into Approval Indecision—Vasella and Hassan
International Patenting of Pharmaceuticals and Biotechnology, 2004-2006: Top Innovators
Ranking of Top 30 Pharma/Biotech Patentees, 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
Biopharmaceuticals
Number of Biotechnology R&D Projects by Therapeutic Area, 2007
Biotech Company Development Pipelines: Number of Development Projects by Phase of Development, March 2008
Biotech Filling Pharma’s Pipeline Gaps, But With Blockbusters?
An Assessment of the Biotech Pipeline
Cumulative Number of Biotech Products Approved by FDA, 1993-2007
Biotechnology Pipeline: Number of Products in Clinical Trials and Late-Stage Trials
Biological Drugs: A Study of Additional Indications Approved Postlaunch in the US
Genetics, Genomics, Proteomics, and Now Epigenetics
Vaccines Entering Clinical Development Rise Only Modestly in 1990-2005
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
Development Project Pipelines for 19 Selected Leading Biotech Companies by Therapeutic Categories, March 2008
Section 3: Drug Development Costs/Complexity, Development Time, and Success Rates
Costs/Complexity
Recent Estimates of the Cost of Developing New Drugs, 2008
Measures of Clinical Trial Costs and Complexity, 2005-2007 (TTC)
Mean Cost per Patient in Clinical Trials, 2005-2007
Clinical Trial Complexity by Trial Phase, 2005-2007
Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2005-2007
Clinical Study Complexity by Therapeutic Area, Phase I-IV, 2005-2007
Measures of Clinical Trial Costs, 2005-2007 (TTC)
Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, 2005-2007
Index of Mean Cost per Patient in Clinical Trials by Country/Region
Index of Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2005-2007, Phase I-IV
Mean Site Fees per Clinical Study by Phase, 2005-2007
Index of Mean Cost per Patient by Oncology Disease Group, 2005-2007
Indices of US Clinical Trial Costs per Patient, 2005-2007 (TTC)
Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, US, 2005-2007
Index of Mean Phase I Cost per Patient in Clinical Trials by Therapeutic Area, US, 2005-2007
Index of Mean Phase II Cost per Patient in Clinical Trials by Therapeutic Area, US, 2005-2007
Index of Mean Phase III Cost per Patient in Clinical Trials by Therapeutic Area, US, 2005-2007
Index of Mean Phase IV Cost per Patient in Clinical Trials by Therapeutic Area, US, 2005-2007
Measures of Clinical Study Complexity, 2005-2007 (TTC)
Index of Clinical Study Complexity by Trial Phase, Worldwide, 2005-2007
Index of Clinical Study Complexity, US vs Western Europe, Phase I-IV, 2005-2007
Index of Clinical Study Complexity by Year, Phase I-IV, Worldwide, 2005-2007
Index of Clinical Study Complexity by Therapeutic Area, Phase I-IV, Worldwide, 2005-2007
Mean Number of Unique Procedures per Patient by Phase, 2005-2007
Biomedical Research and Development Price Index, 1980-2013
Selected Health Care Inflation Data, 1998-2007
New Drug Development Spending and Costs: A 2008 Analysis
R&D Expenses Regressions
R&D Expenses by Therapy Area for All Phases
Avandia, Vytorin, and Surrogate Endpoints
An Analysis of Site Performance within a Clinical Study and its Effect on Cost
Sample Hypercholesterolemia Study
Average Across Multiple Sites (enrollments/referrals)
Average Across Multiple Sites (cost)
Lilly Moves Relationships with Successful Sites to the Next Level
The Effects of Growing Clinical Trial Protocol Complexity: A 2008 Analysis
Change in Procedures per Protocol, 1995-2005
Change in Protocol Eligibility Criteria, 1999-02 vs 2003-06
Investigative Site Work Burden per Protocol, 1999-2005
Protocol Design Impact on Study Conduct Cycle Times
Protocol Design Impact on Patient Recruitment and Retention Rates, 1999-02 vs 2003-06
Percent Change in Grant Dollars per Protocol Procedure, 1999-2005
Study-Related Burdens vs Compensation for Clinical Trial Sites, 2000-2005
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
US Clinical Site Profitability: A 2007 Assessment
Average Site Expenditures, 2004 vs 2007
EDC Adoption in Clinical Trials: A 2008 Analysis
The FDA Amendments Act of 2007: An Analysis of Possible Effects on Phase 4 Clinical Trials and the CRO Market Opportunity
Lehman Analysis of Drug Approval and Post-marketing Commitment Trends, 1990-2006
Increase in PMCs Driven by More Conditional Approvals, 1997-2006
Lehman Analysis of Post-marketing Commitment Protocols, 2004-2007
Segmentation of US Clinical Trials by Therapeutic Area (TTC)
Industry Postmarketing Study Commitments: A 2007 Study
New Molecular Entity and Biologics Approvals with Commitments to Conduct Postmarketing Studies
Completion Times of Delayed Postmarketing Studies
Comparative Times to Complete Clinical vs Nonclinical Postmarketing Studies
Comparative Cost to Complete Clinical vs Nonclinical Postmarketing Studies
Where Today’s Clinical Trials Are Being Conducted: A Study of New FDA-Regulated Studies in 2007
Number of Investigators Signing 1572s Annually for FDA-Regulated Clinical Trials, 1995-2007
Number of Investigators Signing 1572s in Selected Countries: Year-over-Year Percentage Increase/Decrease
Number of Investigators Completing 1572s to Participate in FDA-Regulated Clinical Studies by Country in 2007
Location of FDA International (ex-US) Clinical Investigator Inspections, 2007
Active Clinical Trials by Phase and Country/Region: A 2008 Analysis
Clinical Studies Openly Recruiting by Phase and Region
Number of Clinical Trials Initiated Annually for U S Submissions: FDA Estimates
Analysis of Paying Clinical Study Subjects
Average Payment to Research Subjects by Phase
Clinical Trials Move Abroad: Chasing Patients
Global Patient Recruitment (Patients Enrolled per Site): Five Regions Compared
Geographic Locale of Active Clinical Investigators, 1997-2007E
The Globalization of Clinical Trials: Number of Recruiting Studies by Country
Recruiting Clinical Studies by Region: Percent of Recruiting Studies
Clinical Studies by Country: Number of Recruiting Studies, 2007
Speed of Patient Recuitment: A Ten-Country Comparison
Clinical Trial Cost-Competitiveness: India, China, and Africa vs US/Europe
Patient Recruitment Metrics at Pfizer
Demographics of Clinical Trial Populations: A Look at NIH Trials, 2007
Aggregate Enrollment Data for All Extramural and Intramural Research Protocols in FY2006 by Race and Gender
Aggregate Enrollment Numbers for All Extramural and Intramural Research Protocols Reported in FY2006, by Ethnicity
Emerging Clinical Trial Enrollment Benchmarks: Trial Size Statistics for New Drugs Approved in 2007
Key Clinical Trial Enrollment Statistics for NMEs Approved in 2000-2007
Clinical Trial Enrollments for Selected NMEs Approved in 2007
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
A 2007 Assessment of the Clinical Trial Experience: Volunteer Experiences, Study Enrollment, Consent Form Comprehension, and Study Dropout Rates
Would You Participate in a Clinical Trial Again?
Type of Support Received by Study Volunteers, 2006 vs 2007
How Did you First Contact the Study Center?
Who Reviewed the Informed Consent Form With You?
Emerging Markets Not a Solution to Rising R&D Costs—Vasella
US Clinical Trial Sites Rate Sponsors: A 2007 Assessment
Highest Frequency as a Top 3 Rated Sponsor Across 29 Relationship Attributes
General Project Management Attributes
Quality of the Study Initiation Process
Quality of Ongoing Study Support
Quality of the Grant Payment Process
The Case for New Drugs and Better Predictive Biomarkers
A 2007 Assessment of the Site Management Organization Space
Number of SMOs Worldwide
Assessing the Cost to Develop a New Biotech Product
Pre-Approval Cash Outlays and Time Costs per Approved New Biopharmaceutical
Pre-Approval Cash Outlays per Approved New Molecule
Pre-Approval Capitalized Cost per Approved New Molecule: Biotech vs Pharma
Capitalized Preclinical and Clinical Period Costs per Investigational Biopharmaceutical Compound
Medical Imaging Emerges in Clinical Trials: A 2007 Assessment
Size of the Medical Imaging Market, 2004-2009
The Medical Imaging Market: Analysis of Various Techniques, 2005-2009P
Estimating the Cost of New Drug Development: Is It Really $802 Million
Average Out-of-Pocket Clinical Costs for Investigational Compound
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
Achieving High Performance in Pharmaceuticals: Reversing the R&D Productivity Decline
R&D Productivity Challenge: Spend vs Value (Sales)
Pharmaceutica R&D Expenditure, Average R&D Expenditure per NAS and Average ROI
per NAS—Indexed four 7 year periods 1988-2000
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
Finding Biomarkers as Difficult as Finding New Drugs—Roche’s Humer
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
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
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
Clinical Research Offshoring: A Country Attractiveness Index for Clinical 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 Country Attractiveness Index
Overall Patient Availability Score by Country
Overall Indexed Clinical Trial Costs
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
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
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
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
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
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
Development Time
Analysis of U S New Drug Development Process by Average Time to Complete Each Phase of Product Development, 2008
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
Development Phase Lengths for Selected Therapeutic Categories
Development Phase Lengths and Attrition Rates for Selected Therapeutic Categories
The FDA’s Fast Track Program: Effect on Review Time and Approval Success
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
Biopharmaceutical Development Times: A 2007 Analysis
Mean Biopharmaceutical Development Times: Clinical Phase, Approval Phase, and Total Phase Lengths, 1982-2006
Top Factors Causing Clinical Study Delays: A 2007 Survey
Top Factors Delaying Study Progress
The FDA on Study Initiation 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
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 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
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
Mean Total Development Times for Drugs and Biological Products Approved in the United States, 1994-2004
The FDA’s Fast Track Program: Its Utilization and Impact on Drug Development Times: An April 2006 Update
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
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
Success Rates
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
The Pipeline and the New Realities of Drug Development
Development Attrition Rates for Selected Therapeutic Categories
Development Attrition Rates for Selected Therapeutic Categories
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
Almost Nothing Getting Through FDA Now—Wyeths’s Ruffolo
Smaller Companies and Biotechs More Reluctant to Discontinue R&D Projects—Pazdur
FDA Approvals and Phase III Failures: Pharma vs Biotech
Attrition Rates in Drug Development Phases
An Analysis of Late-Stage Success Rates: Biotech Products versus Pharmaceuticals
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
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
FDA Reviewers Being Pressured into Approval Indecision—Vasella and Hassan
Emerging FDA Approval Standard Creating Monopolies—Wyeth’s Essner
New Drug Success Rates at Top 10 Pharma Companies: A 2006 Study
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
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
Drews on Pharma Industry Productivity and Strategic Trends in the Drug Industry
Section 4: Regulatory/FDA Statistics
INDs
Number of IND Submissions, 1982-2007
Breakdown of Drug Divisions’ Active IND Review Workload as of Year-End 2007
Number of Active INDs at the Close of the Calendar Year, 1983-2007
Breakdown of CDER Divisions’ Workload by INDs Received in 2007
CDER Holds on Commercial IND Submissions, 1990-2006
Clinical Holds on Commercial IND Submissions by Division, 2006
NDAs
Number of NDAs Pending at the Close of the Calendar Year, 1983-2007
Breakdown of Drug Divisions’ Pending NDA Review Workload, Year-End 2007
Breakdown of Drug Divisions’ Workload by NDAs Received in Fiscal Year 2007
Breakdown of Divisions’ Workload by Pending NDA Supplements, Year-End 2007
CDER Refusal-to-File (RTF) Actions by Year, 1994-2007
Key Drug Submission and Approval Statistics, 1993-2007
Number of NME Approvals and Approval Times, 1984-2007
NME Review Time Ranges, 1995-2007
Priority/Standard NME Review Gap, 1995-2007 (in months)
Median Approval Times for All NMEs by Calendar Year, 1986-2007
Average NME Review Times in Months by CDER Division, 2005, 2006, and 2007
Average NME Review Times in Months by CDER Division, 1993-2004
Number of NDAs and NMEs Approved by Year, 1983-2007
NMEs Approved Based on Therapeutic Potential, 1985-2007
Percent of All Approved NDAs Receiving Priority Review Status, 1994-2007
CDER’s Priority NME Approvals by Class of Drug, 1994-2007
CDER-Wide First Action Performance for FY05, FY06, and FY07 User Fee Cohorts of NDAs, Resubmissions, Effectiveness Supplements, and Manufacturing Supplements
A 2008 Analysis of CDER First-Cycle Review Outcome Trends for NDAs, FY1996-FY2007
Percent of Original NDAs Approved in First Review Cycle by Submission Cohort, FY1996-FY2007
Percent of Standard/Priority Original NDAs Approved in First Review Cycle by Submission Cohort, FY1997-FY2007
Percent of Original NDAs Receiving Approvable, Not Approvable, and Withdrawal Actions, FY1997 to FY2007
An Analysis of Review Cycles to Approval for New Drugs
Summary Cycle to Approval Statistics for 2005-, 2006- and 2007-Approved NMEs
Distribution of Review Cycles to Approval, 2007, 2006, and 2005
Benchmarking the Review Cycles for NMEs Approved in 2007
Average Cycle Times for Approved NMEs, 2005, 2006, and 2007
Mean Review Cycle Times for Approved Priority/Standard NDAs in the FY2000-FY2006 Submission Cohorts
FDA: Refusing Few NDAs, but Delaying More Clinical Trials
FDA “Barely Hanging On”—Hutt
A Closer Look at the FDA’s 50 Fastest Drug Approvals, 1963-2007
Median Approval Times for Priority and Standard NDAs, 1993-2006
Median Approval Times for Priority and Standard NMEs, 1993-2006
Guardrails, Not Speedbumps, for FDA Drug Approval Process—FDA’s Von Eschenbach
A Comparison of FDA vs EMEA Drug Approval Times, 2000-2005
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
“Risk Averse” FDA? A Look at What’s Being Approved
U S New Drug Approvals of 2007: NDA Review Times by Drug
U S New Drug Approvals of 2006: NDA Review Times by Drug
U S New Drug Approvals of 2005: NDA Review Times by Drug
U S New Drug Approvals of 2004: NDA Review Times by Drug
U S New Drug Approvals of 2003: NDA Review Times by Drug
U S New Drug Approvals of 2002: NDA Review Times by Drug
U S New Drug Approvals of 2001: NDA Review Times by Drug
U S New Drug Approvals of 2000: NDA Review Times by Drug
U S New Drug Approvals of 1999: NDA Review Times by Drug
U S New Drug Approvals of 1998: NDA Review Times by Drug
U S New Drug Approvals of 1997: NDA Review Time for Each Drug
U S New Drug Approvals of 1996: NDA Review Time for Each Drug
U S New Drug Approvals of 1995: NDA Review Time for Each Drug
U S New Drug Approvals of 1994: NDA Review Time for Each Drug
U S New Drug Approvals of 1993: NDA Review Time for Each Drug
U S New Drug Approvals of 1990, 1991, and 1992: NDA Review Times for Each Drug
New Analysis on Factors Associated with First-Cycle Approvals
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, 2008
Industry’s Fast Track Designation Requests to CDER, FY1999-FY2007
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 2007
Percent of NMEs Approved with Postmarketing Commitments, 2001-2007
New Postapproval Requirements Less Harmful to Pharma R&D Than New Preapproval Burdens—Analysis
Safety-Based Drug Marketing Withdrawals in the United States, 1980-2008
CDER Safety-Based Drug Withdrawals: Pre-PDUFA vs PDUFA Era, 1971-2007
Drugs Cleared New User-Fee Review Deadlines More Likely to Present Safety Issues?
Molecular “Nose” to Sniff Out Drug Safety Issues Earlier?
Faster FDA Drug Approval Times and Drug Withdrawals: A 2005 Analysis
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 2007
Orphan Drug Designation and Approval Statistics, 1990-2007
Prevalence of Orphan Drugs in CDER’s NME Approvals, 2001-2007
Is FDA Failing to Use Advisory Committees?
NDAs Approved Under CDER’s Accelerated Approval Program, 1992-September 2007
Biologics
Summary of CBER Actions in 2007
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
Summary of CBER Actions in 2000
Key CBER Review Statistics for 2000
CBER’s New Biological Product Approvals for 2000
Orphan Drugs
Orphan Drug Designation and Approval Statistics, 1990-2007
Cumulative Growth of Orphan Drugs, 1984-2007
Orphan Drug Approval Times vs Approval Times of Other Drugs, 1993-2007
Orphan Drug and Biologic Approvals, 1993-2007
Orphan Drug and Biologic Approvals in 1990, 1991, and 1992
Over-the-Counter Drugs
Rate of Rx-to-OTC Switches per Year, 1951-2007
Generic Drugs
Generic Drug Approval Times: Median Time to Approval 1993 to 2007
Pending ANDAs Continue to Surge at FDA, 2000-2007
Mean and Median ANDA/AADA Review Times, 1995-2007
Annual ANDA and AADA Submission and Approval Statistics, 1995-2007
CDER Clinical Site Inspection Results, FY1997-FY2007
CDER Clinical Investigator Inspections, FY92-FY2007
CDER Inspections of Foreign Clinical Investigators, FY91-FY2007
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, 1980-2007
Pharmaceutical R&D Spending Within EFPIA Countries, 1990-2006
Mean EMEA Review Time for Human Drugs Submitted Under the EC’s Centralized Procedure, 2007
Mean EMEA Processing Time for Human Medicinal Products, 1997-2007
Mean Processing Times for Key Stages of Centralized Process, 1996-2007
Cancer, Anti-Infective, and Neurology Drugs Dominate New Centralized Submissions to EMEA in 2007
Marketing Authorization Applications Rise to Record Levels at the EMEA
Marketing Authorization Applications Undergoing Initial Evaluation, 2000-2007
CPMP Initial Evaluation Opinions and Sponsor Withdrawals for New Medicines, 2000-2007
An Analysis of the Mutual Recognition Procedure, 2007
UK R&D and Clinical Trials to Plummet After Drug Pricing Scheme Scapped
Comparison of FDA vs EMEA Drug Approval Times, 2000-2005
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
United Kingdom
Pharmaceutical Industry R&D Investment in the UK, 1989-2006
The MHRA’s Clinical Trials Work (by CTX submissions), 2006/2007
MHRA’s New Active Substances Assessed and Mean Assessment Times, 1993-2007
Japan
Pharmaceutical R&D Expenditures in Japan, 1985-2006 (in bill Yen)
Annual Number of New Chemical Entities Approved in Japan, 1983-2007
Number of INDs for Investigational New Drugs Submitted in Japan, 1990-2006
Success Rates of New Drug Development in Japan, 2002-2006
R&D Expenditures of 20 Leading Japanese Pharmaceutical Manufacturers, 2003-2006
Number of Prescription Drug Manufacture and Import Approvals Granted in Japan, 1985-2006
Median NDA Approval Trends in Japan by Year of Submission, 1996-2005
Number of Drugs in Development in Japan by Pipeline Stage and Disease/Therapeutic Category, 2008
Addressing Japan’s “Drug Lag”
Germany
Pharmaceutical R&D Expenditures by German Drug Industry, 1999-2006
Number of New Chemical Entities Approved in Germany, 1988-2006
Canada
Canadian Drugs Directorate New Active Substance (NAS) Approval Times, 1993-2007
R&D Spending by Canadian Drug (Rx&D Member) Companies, 1984-2006
New Drug Submission (NDS) Approval Times in Canada, 1997-2007
Latin America
Global Clinical Trials: A Focus on Latin America
Number of Clinical Trials Conducted in Various Countries/Regions
Clinical Studies in Latin America, by Country, Year-end 2007
New Latin America Clinical Trials Posted on ClinicalTrials gov by Country, 1999-2007
Regulatory Timelines Associated with Clinical Trials in Latin America, 13 Countries
Will Pharma Stop Drug Launches in the UK?
Orphan Drugs Get Closer Look
Global
Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2008 Analysis
Breakdown of World Pharma Market—2007 Sales
Pharmaceutical R&D Expenditure Annual Growth Rate, US vs Europe, 1993-2007
Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2007
Opening and Closing of Research Sites in Europe, US, and Asia, 2001-2006
Number of Compounds in Development by Country/Region: US, Europe, Japan, and ROW
U S , European, Canadian, Japanese and Australian Biotech: Global Activity Measures, 2007
Clinical Research Market in Central and Eastern Europe: A 2007 Assessment
Comparative Global Clinical Trial Growth in Emerging Markets, 2002-2006
Active Phase II-IV Sites in Eastern Europe/Russia
Russia’s Clincial Trials Market Heats Up
Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2012P
Global R&D Spending by World’s Top 400 Pharma & Biotech Companies, 2002-2012
Trends in Worldwide R&D Expenditure, 1993-2008P
Global New Active Substance Product Launches, 2007
Russia’s Clinical Trials Market: A 2007 Assessment
Clinical Trials Approved in Russia
Russian Patients Enrolled in Global Clinical Trials
Originating Country of Global Clinical Trials in Russia
Active Phase II-IV Sites in Eastern Europe/Russia
India’s Clinical Research Market: A 2006 Assessment
India’s Participation in Global Trials Grows: Number of Indian Clinical Investigators for U S INDs, 2001-2005
Number of Indian Investigators Participating in Global Trials, by City, 2002-2005
U S NIH Grants to Indian Investigative Sites, 2000-2005
India to Need 50,000 Clinical Trial Pros by 2010?
Unprecedented Chinese Government Investment to Boost Innovative Drug Development
China’s R&D Goal: $10B by 2010
China as a Site for Clinical Trials: A 2005 Assessment
China’s Participation in Global Clinical Trials Grows, 2001-2004
Clinical Trial Approvals in China, 2001-2003
Annual Number of Clinical Trials in Hong Kong, 1999-2004
Western Drugs Hard Sell in China?
Singapore as Hub for Clinical Trials in Asia
Clinical Trial Certificates Issued in Singapore, 1998-2004
Singapore Clinical Trials by Therapeutic Area, 2003-2004
Clinical Trials: Does East Cost Least?
Comparison of Phase II-III Costs per Patient as a Percentage of UK Costs Between 1995 and 2002
Changes in Phase II-III Costs per Patient in Three Eastern European Countries as a Percentage of UK Costs
Estimated Clinical Trial Applications Submitted per Year in Various European Countries
Clinical Trials in Spain, 1994-2000
Regulatory Approval Times, 1998-2004: US, Japan, and EU
Also available
Bio/Pharma R&D Statistical Sourcebook 2009/2010
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