Table of Contents. Presented by

Improving Markets, Services, and Technologies Table of Contents Presented by HighTech Business Decisions 3150 Almaden Expressway, Suite 222, San Jose, CA 95118 Tel: (408) 978-1035 Fax: (408) 978-8925 www.hightechdecisions.com October 2014

TABLE OF CONTENTS Chapter 1: EXECUTIVE SUMMARY 1.1 Introduction 1-1 1.2 Market Overview 1-2 1.2.1 Introduction 1-2 1.2.2 Industry Drivers 1-3 1.2.3 Market Size 1-4 1.3 Summary of Customer Needs 1-6 1.3.1 Products 1-6 1.3.2 Outsourcing Strategies 1-8 1.3.3 Outsourcing Budgets 1-10 1.3.4 Change in CMO Pricing 1-11 1.3.5 Industry Trends and Observations 1-12 1.4 Summary of Contractors Capabilities 1-13 1.4.1 Annual Revenue Ranges 1-13 1.4.2 Technology Capabilities 1-14 1.4.3 Capacity 1-15 1.4.4 Expectations for the Future of the Industry 1-17 Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS 2.1 Research Objectives 2-1 2.2 Research Methodology 2-2 2.3 Definition of Biopharmaceutical Manufacturing 2-3 2.4 Box-and-Whiskers Plot Definition 2-4 2.5 Acronyms 2-4 Chapter 3: BIOPHARMACEUTICAL CONTRACT MANUFACTURING: MARKET OVERVIEW 3.1 Introduction 3-1 3.2 Suppliers: The Contract Biomanufacturers 3-3 3.2.1 Types of Contract Biomanufacturing Companies 3-3 3.2.2 Major Players: Contract Biomanufacturing Companies 3-4 3.2.3 Organizational Changes in the Industry 3-6 3.2.4 Technologies and Services 3-8 3.2.5 Contract Biomanufacturers Capacities 3-9 3.2.6 Contractor Revenues 3-13

TABLE OF CONTENTS (continued) Chapter 3: 3.3 The Customers: Pharmaceutical and Biotechnology Companies 3-13 3.3.1 Outsourced Biomanufacturing 3-14 3.3.2 Outsourcing Biomanufacturing by Production Technology 3-15 3.3.3 Examples of Contractors Used by Client Companies 3-18 3.3.4 Customers Future Outsourcing Expectations 3-19 3.3.5 In-House Capacity 3-20 3.3.6 Outsource Requirements 3-22 3.4 Industry Drivers 3-26 3.4.1 Supply and Demand 3-26 3.5 Market Size 3-31 3.5.1 Estimates of Market Size Based on Contractor Revenue 3-31 3.5.2 Market Size by Technology and Service Categories 3-31 3.6 Market Growth Forecasts 3-33 3.7 Trends in the Biopharmaceutical Contract Mfg. Market 3-36 3.7.1 Industry Opportunities and Challenges 3-36 3.7.2 Overall Industry Trends 3-37 Chapter 4: PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES: CLIENT ANALYSIS 4.1 Introduction 4-1 4.2 Respondent Company Backgrounds 4-3 4.2.1 Respondents Titles and Experience 4-3 4.2.2 Locations and Sites 4-4 4.2.2 Respondents Biopharmaceutical Products on Market 4-7 4.2.3 Respondents Preclinical Products 4-8 4.2.4 Respondents Clinical and Commercial Products 4-10 4.2.5 Respondents Outsourced Products 4-13 4.3 Biomanufacturing Needs 4-19 4.3.1 Current and Forecast Tank Size Requirements 4-20 4.3.2 Number of Outsourced Batches 4-23 4.3.3 Current and Forecast Outsourced Demand 4-26 4.3.4 Future Production Technology Requirements 4-27 4.4 Biomanufacturing Strategies 4-30 4.4.1 Outsource versus In-House Decision 4-30 4.4.2 Early Clinical-Stage Programs 4-38 4.4.3 Change in Project Scope to Separate Contracts 4-41

TABLE OF CONTENTS (continued) Chapter 4: 4.5 Outsourcing Biomanufacturing 4-50 4.5.1 Percentage Outsourced and Expected to Be Outsourced 4-50 4.5.2 Current and Anticipated Needs for Outsourced Services 4-54 4.5.3 Change in CMO Pricing 4-57 4.5.4 Budgetary Considerations for Engineering Runs 4-62 4.5.5 New Services Sought in a Contractor 4-69 4.6 Biomanufacturing Technologies 4-74 4.6.1 Current Expression Levels 4-74 4.6.2 Commercially Available Proprietary Expression System 4-77 4.6.3 Ideal Bioreactor Size 4-89 4.6.4 Use of Chemically-Defined Media 4-91 4.7 Contractor Selection 4-94 4.7.1 Primary Screening Criteria 4-94 4.7.2 Number of CMOs Contacted 4-101 4.7.3 CMO Repeat Business 4-103 4.7.4 Essential Characteristics Sought in a Contractor 4-107 4.7.5 Suggestions for New CMO 4-111 4.7.6 Importance for Services to be at Same Location 4-118 4.7.7 Fill-and-Finish Capability at Site 4-126 4.7.8 Production at Location Product Marketed 4-131 4.7.9 Clinical-Phase CMO Differentiation 4-136 4.7.10 CMO Customer-Facing Organization Skills 4-144 4.8 Contractor Relationships 4-155 4.8.1 Favorite Contractors 4-155 4.8.2 Describing Flexibility and Ease of Use with a Contractor 4-163 4.8.3 Client Expectation Regarding Failed Batch Runs 4-172 4.8.4 Expectation of Initial Payment to Secure Slot 4-181 4.9 Outsource Spending 4-186 4.9.1 Outsourcing Budgets 4-186 4.9.2 Outsourcing Budgets by Technology 4-188 4.9.3 Outsourcing Budgets by Service 4-192 4.10 Future Trends and Expectations 4-196 4.10.1 Opinion on Strategic Partnerships 4-196 4.10.2 Interest in Strategic Development/Manufacturing 4-204 Partnership 4.10.3 Long-Term Industry and Market Trends 4-211

TABLE OF CONTENTS (continued) Chapter 5: BIOPHARMACEUTICAL CONTRACT MANUFACTURERS 5.1 Introduction 5-1 5.1.1 Study Participants 5-1 5.1.2 Types of Suppliers 5-2 5.1.3 Locations 5-6 5.1.4 Regulatory Inspections and Status 5-8 5.1.5 Acquisitions and Organizational Changes 5-9 5.1.6 Revenues 5-11 5.2 Company Organization 5-12 5.2.1 Ratio of Business Development to Program Management 5-12 5.2.2 Ratio of Quality to Manufacturing 5-14 5.2.3 GMP Manufacturing Staff Activities 5-15 5.2.4 Education Level of GMP Manufacturing Operators 5-18 5.2.5 Technical Staff Turnover Rate 5-20 5.3 Technologies and Capacities Offered 5-24 5.3.1 Number of cgmp Phase III and Commercial Products 5-24 5.3.2 Technologies Offered 5-25 5.3.3 Percentage of Business by Service Category 5-29 5.3.4 Contract Manufacturers Current Capacities 5-34 5.3.5 Contract Manufacturers Expansion Plans 5-39 5.4 Manufacturing Technologies 5-43 5.4.1 Expression Yields and Batch Success Rates 5-43 5.4.2 Number of Batches Run per Tank 5-44 5.4.3 Investment in New Technologies 5-46 5.4.4 Effect of Disruptive Technologies on Manufacturing 5-49 5.4.5 Single-Use Capability 5-53 5.4.6 Full Lot Release Testing Capability 5-60 5.4.7 Analytical, Bioassay, Formulation, Stability Capabilities 5-61 5.4.8 Quality by Design 5-66 5.4.9 Advantage of Drug Substance and Drug Product 5-69 Capability 5.4.10 Use of Platform Technologies 5-73 5.4.11 Electronic Access to Data 5-78

TABLE OF CONTENTS (continued) Chapter 5: 5.5 Marketing and Customer Relationships 5-80 5.5.1 Request for Proposals 5-80 5.5.2 Clients Served 5-83 5.5.3 Number of Phase II/III and Commercial Contracts 5-84 5.5.4 Revenue Spent on Business Development and Proposals 5-86 5.5.5 Portion of Fully Integrated Projects 5-87 5.5.6 Typical Contract Guarantees 5-88 5.5.7 Number of MBR Reviews Done by Clients 5-90 5.5.8 Characteristics of the Customer Base 5-91 5.5.9 Proportion of Business by World Regions 5-95 5.5.10 Reasons for Winning Business 5-97 5.5.11 Metrics Used to Benchmark Business Performance 5-100 5.6 Industry and Future Trends 5-102 5.6.1 Contractor Change in Demand for Outsource Services 5-102 5.6.2 Expectation of Industry Growth 5-106 5.6.3 Price Changes for Biopharmaceutical Production 5-110 5.6.4 Regulatory Challenges 5-114 5.6.5 Expectations for the Biopharmaceutical Contract 5-118 Manufacturing Industry Appendix A: Write-Ups of Interviews with 50 Pharmaceutical and Biotechnology Company BioManufacturing Directors Worldwide, Unnamed and Edited for Confidentiality Appendix B: Directory of Biopharmaceutical Contract Manufacturers Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents Appendix D: Interview Guide for Biopharmaceutical Contract Manufacturers

LIST OF TABLES Chapter 1 1.3-2 Users Opinions on Future of the Industry 1-12 1.4-1 Future Trends Noted by CMO Respondents 1-17 Chapter 2 2.2-1 Market Research Steps 2-2 2.5-1 List of Acronyms 2-4 Chapter 3 3.2-1 Contractors Manufacturers Preferred by Respondents 3-5 3.2-2 Examples of Changes or Events in the CMO Industry: Past Two Years 3-7 3.2-3 Major Contract Biomanufacturing Technology Categories 3-8 3.2-4 Biopharmaceutical Contract Manufacturing Industry Capacity Estimates 3-10 3.2-5 Examples of New Capacity for Biopharmaceutical Contract Manufacturing 3-11 3.3-1 Examples of Contract Biomanufacturers and their Client Companies 3-18 3.3-2 Examples of Pharmaceutical/Biotechnology Companies Building Capacity 3-21 3.3-3 Estimates of Totaled Needs for Outsourced Volumes by Respondents 3-24 3.3-4 Estimates of Needs for Outsourced Volumes for the Worldwide Industry 3-25 3.4-1 Outsourced Manufacturing Capacity vs Needs: Mammalian Cell Culture 3-27 3.4-2 Outsourced Manufacturing Capacity vs Needs: Microbial Fermentation 3-29 3.5-1 Worldwide 2013 Market Size for Contract Biomanufacturing: Revenues 3-31 3.5-2 Market Size by Technology Category: US$ 3-32 3.5-3 Market Size by Service Category: US$ 3-33 3.6-1 Worldwide 2014 Market Size for Contract Biomanufacturing 3-34 3.7-1 Major Biopharmaceutical Contract Manufacturing Industry Trends 3-37 Chapter 4 4.1-1 Respondent Pharmaceutical and Biotechnology Companies 4-2 4.2-1 Respondents Titles by Segment 4-3 4.2-2 Respondent Locations 4-5 4.2-3 Respondents Bulk Biopharmaceutical Manufacturing Sites 4-6 4.2-4 Respondents Fill-and-Finish Biopharmaceutical Manufacturing Sites 4-6 4.2-5 Respondents Preclinical Products 4-9 4.2-6 Number of Products Produced Using Mammalian Technologies 4-10 4.2-7 Number of Products Produced Using Microbial Technologies 4-10 4.2-8 Types of Respondents Products by Production Technology 4-13 4.2-9 Outsourced Products by Phase by Year 4-15 4.2-10 Number of Products Outsourced by Tank Size Needs in 2014: 4-17 Mammalian Cell Culture 4.2-11 Number of Products Outsourced by Tank Size Needs in 2014: 4-17 Microbial Fermentation

LIST OF TABLES (continued) Chapter 4 4.3-1 Tank Size Distribution for Outsourced Products: Mammalian Cell Culture 4-20 4.3-2 Tank Size Distribution for Outsourced Products: Microbial Fermentation 4-22 4.3-3 Outsource Batches per Project: Mammalian Cell Culture 4-23 4.3-4 Outsource Batches per Project: Microbial Fermentation 4-25 4.3-5 Outsource Demand by Phase 4-26 4.3-6 Expected Changes in Technologies Used 4-29 4.4-1 Drivers for Companies Who Outsource 100% GMP Manufacturing 4-31 4.4-2 Drivers for Companies Who Outsource Some GMP Manufacturing 4-32 4.4-3 Respondents Outsourcing of Clinical-Stage Programs 4-39 4.4-4 Separate Outsourced Services 4-43 4.5-1 Outsource Budget Allocated by Production Technology 4-52 4.5-2 Services Currently Outsourced 4-55 4.5-3 Services Planned Outsourced 4-55 4.5-4 No Plans to Outsource Services 4-56 4.5-5 Summary of Service Categories Based on Number of Products 4-57 4.5-6 Reasons for Pricing Change for CMO Biopharmaceutical Services 4-58 4.5-7 Budget Considerations by Respondent Segment 4-63 4.5-8 New CMO Services Sought 4-70 4.6-1 Expression Levels Reported by Respondents in Grams per Liter 4-75 4.6-2 Expression Levels Reported for Mammalian mab Products 4-76 4.6-3 Proprietary Expression System Used 4-78 4.6-4 Reason for Choosing Proprietary Expression System 4-79 4.6-5 Ideal Bioreactor Size (L) 4-90 4.7-1 Criteria for Initial Selection of CMO 4-95 4.7-2 Number of CMOs by Selection Step 4-102 4.7-3 Essential Characteristics for Choosing a CMO 4-108 4.7-4 Weighted Characteristics Distributed By Respondent Segment 4-110 4.7-5 Criteria for Using a New CMO without Manufacturing History 4-112 4.7-6 Reasons Regarding CMOs Having All Services in One Location 4-121 4.7-7 Reasons for Selection of Bulk Production CMO without F&F Capability 4-127 4.7-8 Production Location at Sites Where Product Marketed 4-132 4.7-9 Factors that Differentiate Clinical-Phase CMOs 4-137 4.7-10 Skills Needed by CMOs Customer-Facing Organization 4-145 4.8-1 Contract Manufacturers Preferred by Respondents 4-155 4.8-2 Examples of CMO Flexibility and Ease of Use 4-164 4.8-3 Initial Payment to Secure Manufacturing Slot 4-181 4.9-1 Expenditures on Outsourcing of Biopharmaceutical Production: 2014 4-187 4.9-2 Expenditures on Outsourcing of Biopharmaceutical Production: 2016 4-187 4.9-3 Average Percentage of Budgets Spent on Each Technology: 2014 and 2016 4-189 4.9-4 Weighted Average Percentage of Budgets Spent on Each Technology 4-191 4.9-5 Simple Average: Percentages of Budgets by Service Expected in 2014 4-192 4.9-6 Simple Average: Percentages of Budgets by Service Expected in 2016 4-193 4.9-7 Weighted Average: Percentages of Budgets by Service Expected in 2014 4-194 4.9-8 Weighted Average: Percentages of Budgets by Service Expected in 2016 4-195

LIST OF TABLES (continued) Chapter 4 4.10-1 Benefits and Challenges of Production Networks or Alliances 4-198 4.10-2 Consideration for Co-Investing in a CMO 4-205 4.10-3 Long-Term Industry Trends 4-212 Chapter 5 5.1-1 Respondents from Companies Offering Contract Biomanufacturing Services 5-2 5.1-2 Types of Biopharmaceutical Contract Manufacturers 5-4 5.1-3 Contract Biomanufacturers: Headquarter Locations 5-7 5.1-4 Examples of Company Changes in Contract Biomanufacturing 5-9 5.1-5 Organization Changes Over Last Two Years 5-10 5.1-6 2013 Revenues for Contract Biomanufacturers in US$M 5-11 5.2-1 Technical Staff Turnover Rate 5-21 5.2-2 Incentive Programs Provided to Retain GMP Manufacturing Staff 5-22 5.3-1 Phase III and Commercial cgmp Products Manufactured 5-24 5.3-2 Business Mix by Production Technology and Year 5-26 5.3-3 Business Mix in 2014 by Production Technology and Contractor Segment 5-27 5.3-4 Averaged Percentages of Business from Biopharmaceutical Services 5-30 5.3-5 2014 Averaged Percentages of Business from Biopharmaceutical Services 5-31 By Company Type 5.3-6 Mammalian Cell Culture Capacity at 19 Respondents Facilities in 2014 5-35 5.3-7 Microbial Fermentation Capacity at 13 Respondents Facilities in 2014 5-38 5.3-8 New Capacity Expected: 2015 to 2019 5-41 5.4-1 Contractor Yields and Success Rates 5-43 5.4-2 Number of Batches Run per Tank 5-45 5.4-3 New Technology Investments 5-46 5.4-4 Disruptive Technologies in Biopharmaceutical Manufacturing 5-50 5.4-5 Percentage of Single-Use at Respondent Sites 5-53 5.4-6 Advantages and Disadvantages of Single-Use Bioreactors 5-55 5.4-7 Analytic Testing Capability 5-63 5.4-8 Analytic Technology Capability 5-64 5.4-9 Bioassay Capability 5-65 5.4-10 Formulation Capability 5-65 5.4-11 Stability Capability 5-66 5.4-12 Advantage of Drug Substance and Drug Product Capability 5-70 5.4-13 Time and Cost Savings Through Use of Platform Technology 5-75 5.5-1 Number of Request for Proposals Received per Month 5-80 5.5-2 RFP Proposal Success Rate 5-81 5.5-3 Number of Clients in 2013 5-83 5.5-4 Number of Phase II/III and Commercial Contracts 5-85 5.5-5 Percent of Revenue Spent on Business Development and Proposals 5-86

LIST OF TABLES (continued) Chapter 5 5.5-6 Percent of Fully Integrated Projects Awarded 5-87 5.5-7 Typical Contract Guarantees 5-88 5.5-8 Number of MBR Reviews Done by Clients 5-90 5.5-9 Simple Average Percent of Business by Segment: Customer Base 5-92 5.5-10 Simple and Weighted Average Percent of Business: Customer Base 5-93 5.5-11 Types of Customers Served and Number of Products 5-94 5.5-12 Average Percentage of International Clients 5-94 5.5-13 Simple Average Percent of Business by Segment: World Regions 5-95 5.5-14 Simple and Weighted Average Percent of Business: World Regions 5-96 5.5-15 Reasons Why Chosen by Client 5-98 5.5-16 Top Benchmarking Metrics 5-101 5.6-1 Reasons for Demand Increase Over Last 12 Months 5-103 5.6-2 Average Expectations of Growth: Next Twelve Months 5-107 5.6-3 Average Expectations of Growth: Next Three Years 5-107 5.6-4 Reasons for Price Changes Observed by Contractors 5-111 5.6-5 Regulatory Challenges 5-114 5.6-6 Industry Prospects and Trends Noted by Contractor Respondents 5-119

LIST OF FIGURES Chapter 1 1.2-A Outsourcing Demand vs Contract Biomanufacturers Capacity: Mammalian 1-3 1.2-B Outsourcing Demand vs Contract Biomanufacturers Capacity: Microbial 1-4 1.2-C Size of Worldwide Biopharmaceutical Contract Manufacturing Market 1-6 1.3-A Number of Respondents Biopharmaceutical Products by Phase 1-7 1.3-B Respondents Preclinical Products by Company Type 1-8 1.3-C Respondents Outsourcing Strategies 1-9 1.3-D Respondents Expected Change in Biopharmaceutical Outsourcing Budgets 1-10 1.3-E Price Change for CMO Biopharmaceutical Services 1-11 1.4-A Contract Biomanufacturers Annual Revenue Ranges in 2013 1-14 1.4-B Technology Comparisons: Average Weighted Percentage of Business 2014 1-15 1.4-C Worldwide Biopharmaceutical Contract Manufacturing Capacity 1-16 Chapter 2 2.4-A Explanation of Box-and-Whiskers Plot 2-4 Chapter 3 3.2-A Worldwide Biopharmaceutical Contract Manufacturing Capacity 3-11 3.3-A Number of Products Outsourced versus Produced In-House 3-14 3.3-B Outsourced Products by Development Stage in 2014 3-15 3.3-C Percentage of Respondents Portfolio Outsourced by Production Technology 3-16 3.3-D Tank Sizes Required for Outsourced Mammalian Cell Culture Products 3-17 3.3-E Tank Sizes Required for Outsourced Microbial Fermentation Products 3-17 3.3-F Simple Averaged Expected Percentages of Overall Outsourced Production 3-20 3.3-G Trends by Number of Products Outsourced by Phase 3-23 3.3-H Trends by Number of Products Outsourced by Technology 3-24 3.4-A Outsourcing Demand versus Contract Capacity: 2014 to 2019: Mammalian 3-27 3.4-B Outsourcing Demand versus Contract Capacity: 2014 to 2019: Microbial 3-30 3.6-A Size of the Worldwide Biopharmaceutical Contract Manufacturing in US$B 3-35 Chapter 4 4.2-A Percentage of Respondents by Number of Biomanufacturing Sites 4-5 4.2-B Number of Bulk and Fill-and-Finish Biopharmaceutical Manufacturing Sites 4-7 4.2-C Number of Biopharmaceutical Products on Market 4-8 4.2-D Respondents Preclinical Products 4-9 4.2-E Respondents Biopharmaceutical Products by Technology and Phase 4-11 4.2-F Respondents 155 Biopharmaceutical Products by Phase 4-12 4.2-G Respondents 155 Biopharmaceutical Products by Company Type 4-12 4.2-H Number of Products Outsourced versus Produced In-House 4-14 4.2-I Outsourced Products by Phase in 2014 4-14 4.2-J Outsourced Products by Phase by Year 4-16

LIST OF FIGURES (continued) Chapter 4 4.2-K Tanks Sizes Required for Outsourced Microbial Fermentation Products 4-18 4.2-L Tanks Sizes Required for Outsourced Mammalian Cell Culture Products 4-19 4.3-A Percent of Tanks Size for Outsourced Products: Mammalian Cell Culture 4-21 4.3-B Percent of Tanks Size for Outsourced Products: Microbial Fermentation 4-22 4.3-C Outsource Batches per Project: Mammalian Cell Culture 4-24 4.3-D Outsource Batches per Project: Microbial Fermentation 4-25 4.3-E Summation of Outsourced Volumes Required by Respondents 4-27 4.3-F Technology Usage Patterns Top 6 Mentions 4-28 4.4-A Respondents Outsourcing Strategies 4-30 4.4-B Respondents Outsourcing of Clinical-Stage Programs 4-38 4.4-C Number of Outsourced Clinical-Phase Programs 4-39 4.4-D Project Scope Changes 4-42 4.5-A Average Percentages of Outsourced Production 4-51 4.5-B Average Percentages of Outsourced Budget: 2014 4-53 4.5-C Numbers of Respondents Increasing, Decreasing, or Keeping the Same 4-54 Outsourcing Percentage 4.5-D Price Change for CMO Biopharmaceutical Services 4-58 4.5-E Budget Considerations for Engineering Runs 4-62 4.6-A Expression Levels by Phase and Technology 4-75 4.6-B Use of Proprietary Expression Systems 4-77 4.6-C Pricing Agreements for Proprietary Expression Systems 4-84 4.6-D Fees Paid for Proprietary Expression Systems 4-84 4.6-E Preferred Pricing Agreement for Proprietary Expression Systems 4-85 4.6-F Average Ideal Bioreactor Size by Respondent Segment 4-90 4.6-G Average Ideal Bioreactor Size Distribution 4-91 4.6-H Average Use of Chemically-Defined Media 4-92 4.6-I Distribution of Use of Chemically-Defined Media 4-92 4.7-A Top 5 Criteria for Initial Selection of CMO 4-96 4.7-B Average Number of CMOs by Selection Step 4-102 4.7-C Average Percentage of CMO Repeat Awards 4-103 4.7-D Distribution of Percentage of CMO Repeat Awards 4-104 4.7-E Top Criteria for Selecting a CMO 4-109 4.7-F Top 5 Weighted Characteristics by Respondent Segment 4-111 4.7-G Importance for CMO to Have All Services at Same Location 4-119 4.7-H Importance for CMO to Have All Services at Same Location: Segment 4-120 4.7-I Selection of Bulk Production CMO without Fill-and-Finish Capability 4-127 4.7-J Importance of Having Production Location at Sites Product Marketed 4-132 4.8-A Top Attributes of Flexible CMOs 4-164 4.8-B Financial Responsibility for Non-Negligent Batch Failures 4-173 4.8-C Distribution of Initial Payment to Secure Manufacturing Slot 4-182 4.9-A Respondents Expected Change in Outsourcing Budgets: 2014 to 2016 4-188 4.9-B Simple Average Percentage of Budgets Spent on Each Technology 4-190 4.9-C Weighted Average Percentage of Budgets Spent on Each Technology 4-191 4.9-C Simple Averages: Percentages of Budgets by Service: 2014 and 2016 4-193 4.9-D Weighted Averages: Percentages of Budgets by Service: 2014 and 2016 4-195

LIST OF FIGURES (continued) Chapter 4 4.10-A Interest in Production Networks or Alliances 4-197 4.10-B Interest in Production Networks or Alliances by Respondent Segment 4-198 4.10-C Interest in Co-Investment in a CMO 4-204 4.10-D Interest in Co-Investment in a CMO by Respondent Segment 4-205 Chapter 5 5.1-A Year Respondent Company Entered into CMO Business 5-5 5.1-B Number of CMO Respondent Sites 5-6 5.1-C Number of FDA or EMA Inspections 5-8 5.1-D Contract Biomanufacturers Annual Revenue Ranges in US$ in 2013 5-12 5.2-A Ratio of Business Development to Project Management Employees 5-13 5.2-B Ratio of Quality to Manufacturing Employees 5-14 5.2-C GMP Manufacturing Staff Performing GMP Support Activities 5-15 5.2-D GMP Manufacturing Staff Performing GMP Support Activities by Segment 5-16 5.2-E Education Level of GMP Manufacturing Operators 5-18 5.2-F Percentage of GMP Manufacturing Operators Education Level 5-19 5.2-G Distribution of Technical Staff Turnover Rate 5-21 5.3-A Average Number of Phase III and Commercial Products 5-25 5.3-B Technology Comparisons: Average Percentage of Business: 2014 5-28 5.3-C Technology Comparisons: Average Weighted Percentage of Business: 2014 5-29 5.3-D Service Category Comparisons: Average Percentage of Business: 2014 5-32 5.3-E Production Category Comparisons: Average Percentage of Business: 2014 5-32 5.3-F Average Percentage of Revenue from Each Service Category: Weighted 5-33 5.3-G Individual Mammalian Cell Culture Capacity Utilization Rates: 2014/2016 5-36 5.3-H Individual Microbial Fermentation Capacity Utilization Rates: 2014/2016 5-39 5.3-I Additional Mammalian Cell Culture Capacity by Year 5-40 5.3-J Additional Microbial Fermentation Capacity by Year 5-40 5.2-K Summary of Current and Future Capacity at Surveyed Contractor Facilities 5-42 5.4-A Expression Yields by Technology and Contractor Size 5-44 5.4-B Average Number of Batches Run per Tank 5-45 5.4-C Distribution of Single-Use Percentages at Respondent Sites 5-54 5.4-D Full Lot Release Testing Capability 5-60 5.4-E Analytical, Bioassay, Formulation and Stability Capabilities 5-62 5.4-F Analytic Capability 5-63 5.4-G QbD Principles Applied to Development 5-67 5.4-H Advantage of Drug Substance and Drug Product Capability 5-70 5.4-I Platform Technology Usage by CMOs 5-74 5.4-J Electronic Data Access and Raw Data Access 5-78 5.5-A Average Number of RFPs Received Each Month 5-81 5.5-B Average Percentage of RFP Proposal Success Rates 5-82 5.5-C Distribution of Clients Served in 2013 5-84

LIST OF FIGURES (continued) Chapter 5 5.5-D Distribution of Phase II/III and Commercial Contracts 5-85 5.5-E Distribution of Revenue Spent on Business Development and Proposals 5-86 5.5-F Distribution of Fully Integrated Projects Awarded 5-87 5.5-G Distribution of MBR Reviews Done by Clients 5-91 5.5-H Simple Average Percent of Business by Segment: Customer Base 5-92 5.5-I Simple and Weighted Average Percent of Business: Customer Base 5-93 5.5-J Simple Average Percent of Business by Segment: World Regions 5-96 5.5-K Simple and Weighted Average Percent of Business: World Regions 5-97 5.6-A Change in Demand for Outsourced Services Over Last 12 Months 5-103 5.6-B Expectations of Industry Growth: Twelve Months and Three Years 5-108 5.6-C Price Changes Observed by Contractors 5-110 5.6-D Price Changes Observed by Contractor Segment 5-111