PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010

Published by: Barnett Educational Services

Published: Jun. 1, 2009 - 319 Pages

Table of Contents

Section 1: R&D Spending

Pharmaceuticals

Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2014P (EvaluatePharma)…

Global R&D Spending by World’s Top 500 Pharma and Biotech Companies 2002-2014P (EvaluatePharma).

R&D Spending by Research-Based Pharmaceutical Companies, 1980-2008

R&D Investments by Research-Based Pharmaceutical Companies, 1975-2008

Industry-wide and Government R&D Spending, 1980-2008

Biopharmaceutical Industry Investment in Research and Development, 1980-2008

Biopharmaceutical R&D Expenditure and NIH Budget: 1995-2008

Will Late-Stage Pipelines Outstrip R&D Budgets—Even at Pfizer?

Analysis of Top 20 Companies by 2008 Pharma R&D Spend (EvaluatePharma)

Top 20 Companies by Pharma R&D Spend in 2008 (EvaluatePharma)

Top 20 Companies by Pharma R&D Spend as a % of Pharmaceutical Revenues 2007 vs. 2008 (EvaluatePharma)

Top 20: Average R&D Spend per Late-Stage Project in 2008 (EvaluatePharma)

Total PhRMA R&D as a Percent of Sales, 1985-2008

Domestic U.S. R&D and R&D Abroad, 1985-2008

Domestic U.S. Sales and Sales Abroad, 1985-2008

Growth in Domestic U.S. R&D and R&D Abroad, 1970-2008

R&D Spending at Top 20 Pharmaceutical Companies in 2008

With Biotech Buzz, Don’t Forget Small Molecules and Chemistry—Lonza

Drug Investors Lose Patience

Various Measures of New Drug/Biologic R&D Productivity, 1993-2008

Industry R&D Spending per NDA Submission in the U.S., 1993-2008

Industry R&D Spending per NDA Approval in U.S, 1996-2008

Industry R&D Spending per NME Submission to FDA, 1995-2008

Industry R&D Spending per NME Approved in the U.S., 1995-2008

Global R&D Spending per Global New Active Substance (NAS) Launch, 1995-2008

Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2009 Analysis

Breakdown of World Pharma Market—2008 Sales

Markets of First Launch for 32 NASs Introduced in 2008

Pharmaceutical R&D Expenditure Annual Growth Rate, US vs. Europe, 1993-2008

Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2008

U.S., European, Canadian, and Asian/Pacific Biotech: Global Activity Measures, 2008

Clinical Development Budgets Expected to Grow Further, Shift From Preclinical to Clinical

An Analysis of Pharma and Biotech Industry R&D Spending Growth Through 2009

Pharma R&D Spending, 2003-2009E: Trailing 12-Month R&D Spending by Top Pharma and Biotech Companies

Major US Pharmaceutical Revenue and R&D Growth, 1991-2013E

Industry Shift Toward Specialty Drugs Continues: An Analysis to 2012

Sales Mix Within Pharma Shifting to Specialty Care, 1992-2012e

Significant R&D Investment Outside Home Market Associated with Growth: Annual Booz & Company Study

R&D Spending by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2007

Domestic U.S. Scientific, Professional, and Technical R&D Personnel by R&D Function,

Ethical Pharmaceuticals, 2007

Domestic R&D by Function, Ethical Pharmaceuticals, PhRMA Member Companies, 2007

Domestic R&D and R&D Abroad for Human-Use and Veterinary-Use Pharmaceuticals,

PhRMA Member Companies, 2007

Domestic R&D by Origin of Product (Licensed-in vs. Self-originated), PhRMA Member Companies, 2007

Two in Ten New Drugs Recoup Costs—New Study

U.S. Government (NIH) Funding for Medical/Clinical Research, 1995-2009

NIH Appropriations, 1995-2009P

NIH Clinical Research and Clinical Trials Spending, 2003-2008

Estimates of Funding for Selected Diseases, Conditions, and Research Areas, 2005-2008

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

The Innovation Curve: Generics

CBO Estimates on the Follow-on Biologic Effect

Cancer Treatments, Patients, and Third-Party Payers

How Virtual R&D Advances Will Reshape the Current R&D Model by 2020

The Current Research Process

What the research process might look like when virtual man exists

What the research process might look like in 2020

The Current Development Process

Model Trial

What the development process might look like in 2020

What the regulatory process might look like in 2020

How the R&D cost/revenue curve might look by 2020

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

An Analysis of Worldwide Prescription and OTC Sales by Technology (2002-2014):

Biotech vs. Conventional Technology (EvaluatePharma)

Worldwide Prescription & OTC Sales by Technology, 2002-2014 (EvaluatePharma)

Top 100 Drug Sales by Technology, 2007-2014 (EvaluatePharma)

An Analysis of the Sales Potential of New Drugs Approved in 2007 and 2008 (EvaluatePharma)

FDA Approval Count vs. 5th Year after Launch US Product Sales (EvaluatePharma)

Top 10 New Molecular Entities in 2008: Ranked on US Consensus Sales in 2013 (EvaluatePharma)

Top 10 New Molecular Entities in 2007: Ranked on US Consensus Sales in 2012 (EvaluatePharma)

Growth in Domestic U.S. Sales and Sales Abroad, Ethical Pharmaceuticals, 1970-2008

Sales by Geographic Area, Ethical Pharmaceuticals, PhRMA Member Companies, 2007

An Analysis of the U.S. Pharma Market: U.S. Prescription Drug Sales in 2008

Annual Growth Rate of U.S. Prescription Pharmaceutical Market, 1994-2009P

Top 15 Therapeutic Classes by U.S. Prescription Sales, 2008

Top 15 U.S. Prescription Products by Sales, 2008

Top 15 Pharma Companies by U.S. Prescription Sales, 2008

Estimated $16B in Branded Sales at Risk in 2009—Cowen and Company

Putting Your Genes on Backwards

Pharma Behind Networking Equipment and Internet Services Among Most Profitable U.S. Industries

A New Look at the Global Pharmaceutical Market: North America Sets Pace in 2008 Pharma Sales

Global Pharma Sales, 1999-2008

Global Pharmaceutical Sales in 2008 by Region

Leading Therapy Classes in 2008 Global Pharma Sales

Global Pharma Sales in 2008—Leading Products

Pharma Market Growth in Five Key Regions, CAGR 2009-2013

Top 20 Companies by Worldwide Prescription Drug Sales in 2006/2007 (EvaluatePharma)

Contribution to Drug Market by Age of Drug

Percentage Contribution to the Overall Market by Age of Drug, 2002-2012E

Trends in US Product Lifecycle Length: Drugs vs. Biologics

Average US Lifecycles for 900 Products in Lehman Universe

Suddenly, Some Looking to Exit Pharma

P&G Cites Lower Returns

Solvay as Well

Global Biologic Drug/Vaccine Sales to 2012E

The Future Pharma R&D Model: The New PharmaCo Threat

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, 2008 vs. 2013P

Pharma Companies: Drug Sales as Percentage of Worldwide Market, 2008 vs. 2013P

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, 2008-2014E

Percentage of Global Sales at Risk of Loss Over Time Through Patent Expiries, 2001-2014E

Pharma Sales at Risk of Generic Competition in 2009-2013E as a

Percentage of 2008 Group Economic Sales

Biomarker Market to $12.8bn by 2012

U.S. Generic Drug Market Outlook to 2015

2008 U.S. Sales of Drugs Losing Patent Protection, 2008-2015

Percent Sales Vulnerable to Patent Expirations Through 2013: Selected Leading Companies

Estimates of Generic Erosion at the Top 10 Pharmas, 2008 vs. 2015

Number of Patented Drugs Declines in 2008

A Contract Research Organization Industry Size Model to 2015e

A Conceptual Framework of Outsourced Industry Growth

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

An Analysis of the CRO Market to 2011

U.S. Biotech Funding, 1999-2008

Outsourced Drug Development Method, 2005-2011E

Revenue at Several Leading CROs by Segment

An Assessment of the CRO Market to 2012

UBS CRO Market Projections, 2004-2012E

Percentage of R&D Outsourced, 2003-2013

How Much Do You Expect Your Outsourcing Spending to Grow Next Year?

Pharma and Biotech R&D Market Share 2003-2013: Biotech Spending is

Capturing a Greater Share of R&D Spend

CRO Market—Revenue Growth by Phase, 2003-2013

A 2008 Analysis of Outcourcing Metrics

Percentage of Staffing Outsourced by Phase: CRAs/Monitors

Percentage of In-House and Outsourced Staff by Phase

Analysis of Project Elements for Outsourced Clinical Studies

Project Elements for Outsourced Clinical Studies

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 2008 Update to the Goldman Sachs Global R&D Outsourcing Model

Biopharmaceuticals

Top 100 Biotech Companies by 2008 R&D Spending

R&D Spending at Selected Leading Biotechnology Companies, 2008A-2013E

A Third of Biotechs to Disappear in 2009?

Biotech R&D Spending to 2009E

Annual Biotechnology R&D Spending, 2004-2009E

Biologics and Biotech R&D: An Analysis of PhRMA Member Companies, 2007

Biologics and Biotechnology R&D, PhRMA Member Companies, 2007

mAb Sales Growth to Dwarf Small Molecules

Biotech and the Short Runway

The State of Biotech: Key Industry Metrics from BIO, March 2009

Survival of the Fittest: The Financial Markets and Biotech

Total Equity Raised by Biotech, 1995-2008

viii

An Analysis of Global Biologics/Biotech Market: Worldwide Sales for Top Products and Top Product Classes in 2008

Top-Selling Categories of Biologic Products, 2008

Growth Rates of Top-Selling Classes of Biological Products, 2008

Top 20 Selling Biologic Products Worldwide, 2008

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 February 2009 (IMS Health)

Top 50 Drug Companies by Number of Drug Products in Development as of February 2009 (IMS Health)

Top 50 Drug Companies by Number of Drug Products in Development as of March 2009 (Pharmaprojects)

A Snapshot of the Pharma R&D Pipeline, Number of Projects by Development Phase, 1998-2009

Worldwide Active R&D Projects in Development by Stage, 1998-2009

The R&D Pipeline, 1998-2009

An Analysis of the Drug and Biotech Pipeline by Development Phase, Technology, Therapeutic Category,

and Strategy (EvaluatePharma), April 2009

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, 2008

New FDA-Regulated Clinical Trial Starts for Drugs and Biologics/Biotechs, 1998-2008

Breakdown of CDER Divisional Workload by INDs Received in 2008

Segmentation of US Clinical Trial Starts for Drugs by Therapeutic Category, 2006, 2007, and 2008

Global New Active Substance Product Launches, 2008

An Analysis of FDA-Regulated Clinical Trial Activity for Drugs as Measured by

Active INDs at Year-End 2008

Breakdown of CDER Drug Divisions’ IND Review Workload (Active as of Year-End 2008)

Segmentation of FDA-Regulated Clinical Trials for Drugs by Therapeutic Category, 2008

R&D Pipeline Expansion: A 2009 Assessment

Drugs in Active Development, 1995-2009

Drug Development by World Status, 1995-2009

Measures of Pharma Industry’s New Drug Output: NME/NAS Submissions to FDA and EMEA, 1995-2008

Annual Number of Marketing Applications for New Molecular Entities/New Active Substances

Filed With the FDA and EMEA, 1995-2008

Top 20 Most Valuable R&D Projects (Ranked by Net Present Value)

Drug Approvals Unlikely to Rise for A While—EMEA’s Lonngren

Valuing Company R&D Pipelines based on NPV Analysis: Top 20 R&D Spenders

Valuing the R&D Pipeline based on NPV Analysis

Measures of Diversity and Novelty of Drug Targets in Active R&D Projects

Target Diversity: Number of Protein Targets Under Study in R&D Projects, 1995-2009

Percentage of Products Involving “Unproven” Targets, by Phase

The Innovativeness of the 2008 NME Approvals

Still Waiting for the Rebound: ICTs vs. “Other” Drugs Approved, 1996-2008

Active Clinical Drug Development Programs Worldwide by Phase, April 2009

Number of Active Clinical Development Programs, 2009

Total Average Number of Active Programs by Year, March 2002-April 2009

Comparison of Annual Growth Rate—2006 vs. 2007 vs. 2008 vs. 2009

Top Therapeutic Categories by Number of Projects in Development as of March 2009 (Pharmaprojects)

Number of Drugs in Preclinical Testing, 1995-2009

Top Therapeutic Drug Categories Worldwide by Number of Projects in Development as of February 2009

Drug R&D Projects: Top Ten Areas of Research, 2008

Growth in the Number of Compounds in Development: A 2009 Assessment

New Compounds in Various Stages of Development, Indexed, 1995-2008

Absolute Number of New Compounds in Pharmaceutical Development: January 2007-March 2009

Pharma/Biotech Pipelines and Unmet Medical Need: A 2008 Analysis

Unmet Medical Need by Therapeutic Category

Various Major Pharmas: Focus on Unmet Medical Need by Percentage of Pipeline Projects

Various Biotechs: Focus on Unmet Medical Need by Percentage of Pipeline Projects

No R&D “Productivity Hits” in Pfizer/Wyeth Combination—Kindler and Mackay

Proportion of Top Pharma and Biotech Company Pipelines In-Licensed: A 2009 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, 1998-2009

Where Clinical Research is Heading: Trial Starts Signal Industry’s Direction in Six Key Therapeutic Areas, 2007-2008

Late-Stage Oncology Trials Initiated, 2007-2008 by Disease and Company

Late-Stage Oncology Trials Initiated, September 2007-September 2008 by Disease

Late-Stage Oncology Trials Initiated, September 2007-September 2008 by Company (Top 20)

Late-Stage Metabolic/Endocrinology Trials Initiated, 2007-2008 by Disease and Company

Late-Stage Metabolic/Endocrinology Trials Initiated, September 2007-September 2008 by Disease

Late-Stage Metabolic/Endocrinology Trials Initiated, September 2007-September 2008 by Company (Top 20)

Late-Stage CNS Trials Initiated, 2007-2008 by Disease and Company

Late-Stage CNS Trials Initiated, September 2007-September 2008 by Disease

Late-Stage CNS Trials Initiated, September 2007-September 2008 by Company (Top 20)

Late-Stage Cardiovascular Trials Initiated, 2007-2008 by Disease and Company

Late-Stage Cardiovascular Trials Initiated, September 2007-September 2008 by Disease

Late-Stage Cardiovascular Trials Initiated, September 2007-September 2008 by Company (Top 20)

Late-Stage Infectious Disease Trials Initiated, 2007-2008 by Disease and Company

Late-Stage Infectious Disease Trials Initiated, September 2007-September 2008 by Disease

Late-Stage Infectious Disease Trials Initiated, September 2007-September 2008 by Company (Top 20)

Late-Stage Autoimmune/Inflammation Trials Initiated, 2007-2008 by Disease and Company

Late-Stage Autoimmune/Inflammation Trials Initiated, September 2007-September 2008 by Disease

Late-Stage Autoimmune/Inflammation Trials Initiated, September 2007-September 2008 by Company (Top 20)

Waiter, There’s a Medicine in My Salad

An Analysis of 2008 New Drug Approvals by Company Size

91 NDAs Awaiting FDA Approval—Cowen and Company

International Patenting of Pharmaceuticals and Biotechnology: A 2009 Assessment of Top Innovators

Ranking of Top 20 Pharma/Biotech Patentees, May 2009

Therapeutic Focus in 2007 Patenting

High Throughput Screening Looks Ahead

Comparative Effectiveness Studies, Now de Regueur?

The Emergence and Future of Companion Diagnostics: A 2009 Assessment

Three Examples of Approved Drugs with Companion Diagostics

Companion Diagnostic Segments

Theranostic Drugs and Diagnostics: Currently Marketed Theranostic Drugs by

ATC Code and Diagnostics Utilized for Theranostic Drugs

Oncology Theranostic Landscape, 2007

Pharma and Diagnostic Development Timeline

New Generation of Personalized Medicine Diagnostics Command Value-Based Pricing

Pharma and Biotech Company Pipelines: An Assessment of “Replacement Power,” 2008

Large Pharma Replacement Power: 13 Major Companies

Large Biotech Replacement Power: 7 Major Companies

Numbers of mAbs Entering Clinicals Nearly Triple in Last Decade

Nanomaterials Move to Clinical Trials

Pipeline Rationalization: A 2009 Analysis

Announced Pipeline Project Cancellations for Pfizer and Merck, 2007-2008

A Call for an “Open Innovation” Model

Pharma/Biotech In-Licensing Trends, 2005-2008

Major Pharmaceutical and Biotech In-licensing Activity, 2005-2008

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 Leverages Molecular Pathways and Biologics to Improve Drug Discovery/Development Productivity

Novartis Pathways Research: Increasing Numbers of Drug Targets, 2004-2010P

The DELPhI Model

Percent of Successfully Transitioned PoC Candidates at Novartis, 2003-05 vs. 2006-07

What Makes the Novartis Approach Different?

NMEs Poised to Enter Clinical Trials at Novartis

Steady Growth of Biologic NMEs, 2004 vs. 2008

Roche Acquires Genentech and Marches to Further Expand “Innovation Power” and Personalized Medicine Focus

The Combined Roche and Genentch: The Numbers

Driving R&D Costs: NMEs in Phase 3 to Double, Key Diagnostics Launches Rising

The Roche R&D Pipeline, 2006-2008*

Roche’s Clinical Development Pipeline by Therapeutic Area, February 2009

Large Pharmas Team Up to Fund Early-Stage Technologies and Platforms

Building a “New Merck”: The Schering-Plough Merger and Science-based Diversification

The Combined Merck and Schering-Plough: The Numbers

Merck/Schering-Plough Mid- and Late-Stage Clinical Pipeline

Merck’s Cancer Pipeline: Clinical Proof of Concept Targets, 2008-2010

Merck BioVentures: Aggressive Targets

AstraZeneca Updates Progress on Strategy to Strengthen its R&D Pipeline

AstraZeneca’s 2010 Targets for R&D

The AstraZeneca Pipeline, 2004-2008

AZ Discovery Productivity, 2002-2008

AstraZeneca’s NME Clinical Pipeline by Therapeutic Area, January 2009

AstraZeneca’s Portfolio: Biologic vs. Small Molecules, 2005 vs. 2009

AstraZeneca’s In-house vs. In-licensed Pipeline, 2005 vs. 2009

AstraZeneca’s Completed Phase 1 Cycle Times and Volumes

Pfizer Further Refocuses Pipeline, Prepares for Wyeth Merger

The Pfizer/Wyeth Merger: By the Numbers

The Pfizer R&D Pipeline

The Pfizer Clinical Pipeline: Pre-Merger

Pfizer Projections on Rebuilding the Phase 3 Portfolio

The Wyeth Pipeline: Pre-Merger

Lilly Updates Transformation Effort, Highlights Aggressive Moves to FIPNet and Biotech

Lilly’s New Drug Launch Goals

The Lilly R&D Portfolio: Oncology and Non-Oncology Pipeline

Lilly’s NMEs in Clinical Development, 2000-2011

GSK Implements New Vision for R&D, Evolves CEDDs Model

Signs of GSK R&D Productivity

GSK Therapeutic Area Focus

Re-personalization of Drug Discovery: GSK’s DPUs

Bristol-Myers Squibb: Moving the “Next Generation BioPharma Model” Beyond ImClone

BMS Disease Areas and Unmet Medical Needs

US NME Approvals by Review Status: BMS vs. Leading Companies, January 2004-October 2008

String of Pearls: Priority Levels in Key Disease Areas

String of Pearls: Multiple Integration Approaches

Total New Drug Approvals Decline, But US Preferred Market for First Launch

Number of Priority, Standard, and All NCEs Approved, 1984-2007

Share of NCE Approvals by Location of Original Marketing, 1987-2007

Taking Out Options: Companies Hedging Their Bets in Some Deals

The Drug Pipeline and Attrition: A 2009 Assessment

Why Investigational Candidates Are Dropped, 2000-2008

Top 10 Most Popular Targets in Drug Development

Novel Drugs by Phase of Development

Dearth of New Drugs an Industry Issue, Not an FDA Issue—Lilly’s Paul

PhRMA’s Medicines in Clinical Development Series

Analysis of Drugs in Clinical Development for Cancer by Development Status and Indication, 2009

Analysis of Drugs in Development for Neurological Disorders by Development Status and Indication, 2008

Analysis of Drugs in Development to Treat Rare Illnesses, 2007

xi

Analysis of Drugs in U.S. Clinical Development to Treat Mental Illnesses, 2008

Analysis of Drugs in U.S. Development for Heart Disease and Stroke, 2009

Analysis of Drugs in U.S. Clinical Development for Diseases of Aging, 2008

Analysis of Drugs in U.S. Development for AIDS and AIDS-Related Illnesses, 2008

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

One Analyst on Big Pharma’s Biotech Aspirations

Leading Pharmaceutical Company R&D Profiles

GlaxoSmithKline

Pfizer

Bristol-Myers Squibb

Merck

Astellas

Roche

Biogen Idec

Eli Lilly

Johnson & Johnson

AstraZeneca

Bayer Schering Pharma

Amgen

Novartis

Sanofi-aventis

Abbott

Development Pipelines of Selected Leading Drug Companies: Number of Products by Stage of Development, March 2009

Large and Small/Mid-Tier Pharmas Relying on Each Other for Growth

Origin of New US Drug Approvals, 2000-2006

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

Biopharmaceuticals

Analysis of Biotechnology Medicines and Vaccines in US Clinical Development by

Development Status and Therapeutic Category, 2008

A 2008 Assessment of Gene Therapy trials

Gene Therapy Trials by Phase, 2008

Top Medical Conditions Targeted by Gene Therapy Trials

Biotech Products Facing FDA Action in 2009

Potential Biotechnology Approvals in 2009

Biotech Company Development Pipelines: Number of Development Projects by Phase of Development, March 2009

The Pipeline for Monoclonal Antibodies: A 2009 Assessment

Therapeutic mAbs in Development by Phase, 1995-2009

The Number of Monoclonal Antibody Therapies in Development by Subtype, 1995-2009

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

M&As Surge in 2008

Development Project Pipelines for 27 Selected Leading Biotech Companies by

Therapeutic Categories and Phases, March 2009

Section 3: Drug Development Costs/Complexity, Development Time, and Success Rates

Costs/Complexity

Measures of Clinical Trial Costs, 2006-2008 (TTC)

Mean Cost per Patient in Clinical Trials by Clinical Phase, Worldwide, 2006-2008

Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2006-2008

Mean Patient Reimbursement Per Visit in Clinical Trials, 2006-2008 Mean Patient Reimbursement Per Visit in Clinical Trials by Phase, Worldwide, 2006-2008

Mean Patient Reimbursement Per Visit in Clinical Trials by Therapeutic Area, Worldwide, 2006-2008

Indexed Measures of Clinical Trial Costs, 2006-2008 (TTC)

Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, 2006-2008

Index of Mean Cost per Patient in Clinical Trials by Country/Region

Index of Mean Cost per Patient in Clinical Trials by Therapeutic Area, 2006-2008, Phase I-IV

Mean Site Fees per Clinical Study by Phase, 2006-2008

Measures of Clinical Trial Costs per Patient, 2006-2008 (TTC)

Index of Mean Cost per Patient in Clinical Trials by Clinical Phase, US, 2006-2008

Index of Mean Phase I Cost per Patient in Clinical Trials by Therapeutic Area, US, 2006-2008

Index of Mean Phase II Cost per Patient in Clinical Trials by Therapeutic Area, US, 2006-2008

Index of Mean Phase III Cost per Patient in Clinical Trials by Therapeutic Area, US, 2006-2008

Index of Mean Phase IV Cost per Patient in Clinical Trials by Therapeutic Area, US, 2006-2008

Measures of Clinical Study Complexity, 2006-2008 (TTC)

Index of Clinical Study Complexity by Trial Phase, Worldwide, 2006-2008

Index of Clinical Study Complexity by Country/Region, Phase I-IV, 2006-2008

Index of Clinical Study Complexity by Year, Phase I-IV, Worldwide, 2006-2008

Index of Clinical Study Complexity by Therapeutic Area, Phase I-IV, Worldwide, 2006-2008

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

India Clinical Trials Costs One-Tenth of US Costs?

Analysis of Overhead Costs for U.S.-based Insititutions Conducting Clinical Trials

Recent Estimates of the Cost of Developing New Drugs, 2009

Biomedical Research and Development Price Index, 1980-2013

Selected Health Care Inflation Data, 1998-2008

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

Are Biomarkers Overrated Today? Advocates Counter that Biomarkers Lead to More Effective Early Clinical Trials

Genes and Disease: The Weakest Link?

Where Today’s Clinical Trials Are Being Conducted: A Study of New FDA-Regulated Studies in 2008

Number of Investigators Signing 1572s Annually for FDA-Regulated Clinical Trials, 1995-2008

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 2008

Clinical Trials by Region and Phase, 2005-2008 (PAREXEL Consulting)

Worldwide Clinical Trials, as first entered into ClinicalTrials.gov, in 2008

Worldwide Clinical Trials First Entered in Each Calendar Year, 2005-2008

Phase IV Clinical Trials, as first entered into ClincialTrials.gov, in 2008

Phase III Clinical Trials, as first entered into ClincialTrials.gov, in 2008

Phase II Clinical Trials, as first entered into ClincialTrials.gov, in 2008

Phase I Clinical Trials, as first entered into ClincialTrials.gov, in 2008

Where Are Clinical Trials Being Conducted? Follow the Inspections

CDER-DSI International Clinical Investigator BIMO Inspections, FY2008

EMEA GCP Inspections Related to the Centralised Procedure: Total GCP Inspections per Country, 1997-2008

Site Activation as the Driver to Patient Enrollment: A 2008 Assessment

Demographics of Clinical Trial Populations: A Look at NIH Trials, 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

Average Number of Patients per Trial Site, by Phase and Therapeutic Area: A 2008 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

Gene-Guided Dosing Not Cost Effective—Study

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

Health Spending to Consume 17.6% of U.S. Economy in 2009—CMS

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

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

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

European Clinical Trial Sites Rate Pharma Sponsors

Top Rated Sponsors in Europe

Average 2008 Rating for the Typical Sponsor in Europe

Factors That Could Best Prevent Future Delays

General Project Management Attributes

Quality of Staff Professionalism

Quality of the Grant Payment Process

New Drug Development Spending and Costs: A 2008 Analysis

R&D Expenses Regressions

R&D Expenses by Therapy Area for All Phases

Patient Recruitment Metrics at Pfizer

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)

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

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)

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 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

Achieving High Performance in Pharmaceuticals: Reversing the R&D Productivity Decline

R&D Productivity Challenge: Spend vs. Value (Sales)

Pharmaceutical R&D Expenditure, Average R&D Expenditure per NAS and Average ROI

per NAS—Indexed four 7 year periods 1988-2000

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

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 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, 2009

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 NCE 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

The FDA on Study Initiation Delays

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

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

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

Analysis of Reported Reasons for Drug Discontinuations, 2000-2008

Reported reasons for drug discontinuations, 2000-2008

The Drug Pipeline and Attrition: A 2009 Assessment

Why Investigational Candidates are Dropped, 2000-2008

Why Lehman Sees Phase 3 Success Rates Falling

Probabilities of Success for Phase 3 Drugs—2005 vs. 2008

Is Phase 2 “Choking” Drug Development?

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

Understanding Human Disease the Key in Attrition Rate

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

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

A Jump in Cancer R&D Success Rates?

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

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 Approval Standards Uncertain—Hassan

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

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

Section 4: Regulatory/FDA Statistics

INDs

Number of IND Submissions, 1982-2008

Breakdown of Drug Divisions’ Active IND Review Workload as of Year-End 2008

Concerns Over Heart Risks Biggest Recent Shift in Drug Reviews—Jenkins

Breakdown of CDER Divisions’ Workload by INDs Received in 2008

CDER Holds on Commercial IND Submissions, 1990-2008

Clinical Holds on Commercial IND Submissions by Division, 2008

NDAs

Number of NDAs Pending at the Close of the Calendar Year, 1983-2008

Breakdown of Drug Divisions’ Pending NDA Review Workload, Year-End 2008

Breakdown of Drug Divisions’ Workload by NDAs Received in Fiscal Year 2008

Breakdown of Divisions’ Workload by Pending NDA Supplements, Year-End 2008

CDER Refusal-to-File (RTF) Actions by Year, 1994-2008

Key Drug Submission and Approval Statistics, 1993-2008

Number of NME Approvals and Approval Times, 1984-2008

NME Review Time Ranges, 1995-2008

Priority/Standard NME Review Gap, 1995-2008 (in months)

Median Approval Times for All NMEs by Calendar Year, 1986-2008

Average NME Review Times in Months by CDER Division, 2005-2008

Average NME Review Times in Months by CDER Division, 1993-2004

How Are FDA’s Missed PDUFA Goals Affecting Drug Review Outcomes?

Missed CDER Review Goals and Ultimate Review Outcomes for NDA/BLAs and Efficacy Supplements

Mean and Median Total Time to Approval and FDA Review Time for NDAs and NMEs by

Priority/Standard Classification for Calendar Year 2008

A 2009 Analysis of CDER First-Cycle Approval Rates for NDAs, FY2006-FY2008

And Now Someone Who Thinks the FDA Overstaffed

Number of NDAs and NMEs Approved by Year, 1983-2008

NMEs Approved Based on Therapeutic Potential, 1985-2008

Percent of All Approved NDAs Receiving Priority Review Status, 1994-2008

CDER’s Priority NME Approvals by Class of Drug, 1994-2008

An Analysis of Review Cycles to Approval for New Drugs

Summary Cycle to Approval Statistics for 2005-, 2006-, 2007-, and 2008-Approved NMEs

Distribution of Review Cycles to Approval, 2008, 2007, 2006, and 2005

Benchmarking the Review Cycles for NMEs Approved in 2008

Average Cycle Times for Approved NMEs, 2005, 2006, 2007, and 2008

Mean Review Cycle Times for Approved Priority/Standard NDAs in the FY2000-FY2006 Submission Cohorts

A Closer Look at the FDA’s 50 Fastest Drug Approvals, 1963-2008

A Comparison of FDA vs. EMEA Drug Approval Times, 2000-2005

Mean Approval Times for New Substances Approved by EMEA and FDA, 2000-2005

Time from Approval in First Market to Approval in Second Market

EU vs. US Approval Time for Orphan Drugs

U.S. New Drug Approvals of 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

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

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 2008

Percent of NMEs Approved with Postmarketing Commitments, 2001-2008

New Postapproval Requirements Less Harmful to Pharma R&D Than New Preapproval Burdens—Analysis

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

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 Under New User-Fee Review Deadlines More Likely to Present Safety Issues?

Orphan Drug Activity Continues to Hover Near Record Levels

Orphan Drug Designation and Approval Statistics, 1990-2008

Prevalence of Orphan Drugs in CDER’s NME Approvals, 2001-2008

NDAs Approved Under CDER’s Accelerated Approval Program, 1992-December 2008 Biologics

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

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, 1990-2008

Cumulative Growth of Orphan Drugs, 1984-2008

Orphan Drug Approval Times vs. Approval Times of Other Drugs, 1993-2008

Orphan Drug and Biologic Approvals, 1993-2008

Orphan Drug and Biologic Approvals in 1990, 1991, and 1992

Over-the-Counter Drugs

Rate of Rx-to-OTC Switches per Year, 1951-2008

Generic Drugs

Generic Drug Approval Times: Median Time to Approval 1993 to 2008

Pending ANDAs Continue to Surge at FDA, 2000-2008

Mean and Median ANDA/AADA Review Times, 1995-2008

Annual ANDA and AADA Submission and Approval Statistics, 1995-2008

CDER Clinical Site Inspection Results, FY1997-FY2008

CDER Clinical Investigator Inspections, FY92-FY2008

Clinical Investigator Deficiency Categories, FY2008

Clinical Investigator Inspections Final Classification, FY2008

Clinical Investigator Deficiencies-CDER, FY2008 Final Classification of OAI

Section 5: International Statistics

European Union

R&D Spending in Europe’s Pharmaceutical Industry, 1980-2008

Pharmaceutical R&D Spending Within EFPIA Countries, 1990-2007

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

NICE’s Value Assessments to Be Studied

The Current State of Pharmaceutical Innovation in Europe: A 2008 Assessment

Percentage of Products in Development Considered to Have a Novel Mode of Action, 2001 vs. 2006

Proportion of Total Global R&D by Therapeutic Area, 2004 vs. 2006

New Drug Reviews at the FDA and EMEA: A 2008 FDA Analysis

Divergent Review Outcomes in EU and USA, 1995-2007

Comparison of New Molecular Entity Outcomes for FDA and EMEA

New Molecular Entities Having Outcomes in Both FDA and EMEA

The Challenges Faced by the Pharma Industry in the EU

United Kingdom

The MHRA’s Clinical Trials Work (by CTA submissions), 2004-2008

MHRA’s New Active Substances Assessed and Mean Assessment Times, 1993-2008

Japan

Pharmaceutical R&D Expenditures in Japan, 1985-2007 (in bill. Yen)

Annual Number of New Chemical Entities Approved in Japan, 1983-2007

Number of INDs for Investigational New Drugs Submitted in Japan, 1990-2007

Success Rates of New Drug Development in Japan, 2002-2007

R&D Expenditures of 20 Leading Japanese Pharmaceutical Manufacturers, 2004-2007

Number of Prescription Drug Manufacture and Import Approvals Granted in Japan, 1985-2007

Median NDA Approval Times in Japan by Year of Submission, 1996-2006

Median Development Times for NMEs in Japan, 2000-2007

Number of Drugs in Development in Japan by Pipeline Stage and Disease/Therapeutic Category, 2009

Drug Lag Stubborn in Japan

Canada

Canadian Drugs Directorate New Active Substance (NAS) Approval Times, 1995-2008

R&D Spending by Canadian Drug (Rx&D Member) Companies, 1984-2007

New Drug Submission (NDS) Approval Times in Canada, 1997-2008

Germany

Pharmaceutical R&D Expenditures by German Drug Industry, 1999-2007

Number of New Chemical Entities Approved in Germany, 1988-2007

The VFA Assesses the German Pharmaceutical Environment

Global

Comparative R&D Spending, Sales, and Product Launch Trends Worldwide: A 2009 Analysis

Breakdown of World Pharma Market—2008 Sales

Markets of First Launch for 32 New Active Substances Introduced in 2008

Pharmaceutical R&D Expenditure Annual Growth Rate, US vs. Europe, 1993-2008

Pharmaceutical R&D Expenditure in Europe, the United States, and Japan, 1990-2008

U.S., European, Asian Pacific, and Canadian Biotech: Global Activity Measures, 2008

The High Cost of Price Controls

Trends in Worldwide Pharma and Biotech R&D Expenditures, 2002-2014P

Global R&D Spending by World’s Top 500 Pharma & Biotech Companies, 2002-2014

Trends in Worldwide R&D Expenditure, 1993-2008P

Global New Active Substance Product Launches, 2008

Latin America

Global Clinical Trials: A Focus on Latin America

Number of Clinical Studies in Latin American Countries and Selected Other Emerging Countries

Growth in Clinical Trials for Selected Major and Emerging Countries and Regions, 2005 to 2008

Selected Countries Participating in Phase II Clinical Trials, 1999-2008

Selected Countries Participating in Phase III Clinical Trials, 1999-2008

Central and Eastern Europe

Central and Eastern Europe’s Participation in Global Clinical Trials: A 2008 Assessment

Growth in Emerging Markets, 2002-2007

CEE Investigators Increase Participation in Global Studies, 2003-2007

Proportion of Trials in Various CEE Countries, 2002-2007

Russia Sets Sights on Russian Drug Market

Clinical Trial Starts Rebound in Russia

Asia

India’s Proportion of Clinical Trials to Double, 2007-2012—RNCOS

Pharma Outsourcing in Asia: A 2008 Assessment of Key Dimensions in Various Countries

Framework for evaluating outsourcing destinations

Outsourcing Index—ranking of Asian territories across all factors

India’s Clinical Trial Market to Comprise 15% of Global Share by 2010—KPMG

Abstract

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 is the leading resource for statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analysis, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development - from product discovery, to R&D performance and productivity, to time-to-market trends.

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New proprietary analysis on US clinical trial starts, segmented by therapeutic category, as well as overall active clinical trials Emerging data on worldwide and company-specific R&D pipelines and product launch trends An all-new and comprehensive analysis of clinical research off-shoring revealing which pharma companies are now locating their new clinical trials overseas New analysis on emerging trends in pharma and biotech licensing deals and other partnerships critical to industry's efforts Drug approval statistics compiled from FDA, EMEA, and other regulatory agencies New global R&D spending trends and other international R&D data from key markets International statistics on drug development output and much more!

PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010 is a must-have resource for the drug development industry. It is an invaluable resource for executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.

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