TABLE OF CONTENTS. 1.2 Market Overview Introduction Industry Drivers Market Size 1-5

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1 TABLE OF CONTENTS Chapter 1: EXECUTIVE SUMMARY 1.1 Introduction Market Overview Introduction Industry Drivers Market Size Summary of Customer Needs Products Outsourcing Strategies Outsourcing Budgets Summary of Fill-and-Finish Contractors Capabilities Dosage Forms Capacity Increases Industry and Company Growth Rates Contracting Business by Product Type Industry Trends and Observations 1-15 Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS 2.1 Research Objectives Research Methodology Definition of Parenteral Fill-and-Finish Manufacturing Box-and-Whiskers Plot Definition Acronyms 2-5 Chapter 3: FILL-AND-FINISH CONTRACT MANUFACTURING: MARKET OVERVIEW 3.1 Introduction Suppliers: The Fill-and-Finish Contract Manufacturers Types of Fill-and-Finish Contract Companies Fill-and-Finish Contract Manufacturing Companies Dosage Forms and Services Fill-and-Finish Contract Manufacturing Organizations 3-7 Capacities

2 TABLE OF CONTENTS (continued) Chapter 3: 3.3 The Customers: Pharmaceutical and Biotechnology 3-9 Companies Customers Products Outsourced Fill-and-Finish by Dosage Form Customers Future Outsourcing Expectations Outsourcing Needs Market Capacity Market Size Estimates of Market Size Based on Customer Spending Estimates of Market Size Based on Contractor Revenues Market Size by Dosage Form and Service Categories Market Growth Forecasts Trends in the Fill-and-Finish Contract Manufacturing 3-20 Market Industry Opportunities and Challenges Overall Industry Trends 3-21 Chapter 4: PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES: CLIENT ANALYSIS 4.1 Introduction Respondent Titles and Location In-House Manufacturing Sites Recombinant Large-Molecule Drug Products on Market Manufacturing Demand Manufacturing Needs Dosage Forms Clinical and Commercial Products Manufacturing Technologies Planned Format for Drug Launch New Delivery Technologies Special Handling Requirements Yield Loss 4-27

3 TABLE OF CONTENTS (continued) Chapter 4: 4.4 Outsourcing Strategies Current In-House Filling Capacity and Outsourcing 4-32 Strategy Changes to In-House Filling Capacity Impact of Core/Non-Core Technology Impact of Standard/Non-Standard Technology Focus of Filling Outsourcing over Next 5 Years Outsourcing Needs Outsourced Services Areas Underserved by Fill-and-Finish CMOs Key Challenges a Fill-and-Finish CMO Can Help 4-60 Alleviate 4.6 Contractor Selection Essential Characteristics Sought in a F&F Contractor Key Components for Successful Collaboration with a 4-72 Fill-and-Finish CMO Regional Outsourcing Preference Opinion of Emerging Market CMOs Contractor Pricing Price Models Used Fee Structure: Technology Transfer Fee Structure: Reservation Fee Structure: Cancelation Outsourced Spending Prices Paid to Fill-and-Finish CMOs Outsourcing Budgets Outsourcing Budgets by Service Category Contractor Relationships Identifying Contract Partners Preferred Contractors Top Concerns of Contractors Meeting Expectations Warranties, Guarantees and Indemnifications Ideal Production Network or Alliance Structure Future Trends and Expectations Regulatory Requirement Challenges Future F&F Manufacturing Challenges and Bottlenecks Future Technology and Operational Trends Future Trends in Biopharmaceutical Fill-and-Finish Contract Manufacturing

4 TABLE OF CONTENTS (continued) Chapter 5: FILL-AND-FINISH CONTRACT MANUFACTURERS 5.1 Introduction Respondents Titles and Experience Company Locations Regulatory Approval Status One-Stop-Shop CMO Model Capacity Dosage Forms Current Capacity for Fill-and-Finish Current Capacity for Lyophilization Capacity Expansions Manufacturing Practices Contracting Business by Product Type Current and Future Capacity Utilization Average Batch Size and Batches per Fill Line Number of Employees by Function Cost Reduction Plans Manufacturing Technologies Technology Impacts on Operations Average Yield Loss Focus of Capabilities in Next 5 Years Pricing Price Structures for Fill-and-Finish Batch Pricing Contractors Technology Transfer Fees Contractors Reservation Fees Contractors Cancellation Fees Gross Profit Margin Customer Relationships Strengths and Weaknesses of Contract Manufacturers Competitive Attributes Warranties, Guarantees and Indemnifications Production Networks or Alliances Trade Shows 5-59

5 TABLE OF CONTENTS (continued) Chapter 5: 5.7 Fill-and-Finish Industry Revenues and Growth Opportunities for Growth in the Fill-and-Finish Industry Industry and Company Growth Rates Current and Expected Revenue Categories Revenues from Industry Segments Revenues from World Regions Challenges and Future Trends for F&F Manufacturing Most Significant Challenges/Threats Regulatory Requirement Challenges Potential Growth Areas Trends for the Future of F&F Contract Manufacturing 5-78 Appendix A: Write-Ups of Interviews with 26 Pharmaceutical and Biotechnology Company BioManufacturing Directors Worldwide, Unnamed and Edited for Confidentiality Appendix B: Directory of Biopharmaceutical Fill-and-Finish Contract Manufacturers Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents Appendix D: Interview Guide for Biopharmaceutical Fill-and-Finish Contract Manufacturers

6 LIST OF TABLES Chapter Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry 1-4 Capacity Estimate in Units Respondents Capacity by Segment Outsource Decision Criterion Fill Line Expansion Plans Industry Trends and Challenges 1-16 Chapter Market Research Steps Acronyms 2-5 Chapter Rating of Respondents Fill-and-Finish Contract Manufacturers CMO Revenue Mix by Service Category: Biopharmaceutical F&F Contract Manufacturing Industry Capacity 3-8 Estimates in Units Estimates of Needs for Outsourced Volumes for the Respondent Group Biopharmaceutical F&F Outsourced Manufacturing Capacity Utilization Worldwide 2015 Market Size for Biopharmaceutical Fill-and-Finish 3-16 Contract Manufacturing: Estimates Based on Customer Spending: US$ Worldwide 2015 Market Size for Biopharmaceutical Fill-and-Finish 3-17 Contract Manufacturing: Estimates Based on Contractors Revenues: US$ Market Size by Dosage Forms: US$ Market Size by Service Category: US$ Observations on Biopharmaceutical Fill-and-Finish Contract Manufacturing 3-21 Industry Trends: Manufacturing Trends Chapter Titles of Pharmaceutical and Biotechnology Company Respondents Location of In-House Fill-and-Finish Manufacturing Sites Number of Recombinant Large-Molecule Drug Products on Market 4-4

7 LIST OF TABLES (continued) Chapter Respondents Current and Expected Capacity Needs for Outsourced 4-6 Product Vials (Lyophilized) Respondents Current and Expected Capacity Needs for Outsourced 4-7 Product Vials (Not Lyophilized) Respondents Current and Expected Capacity Needs for Outsourced 4-8 Products Syringes (Lyophilized) Respondents Current and Expected Capacity Needs for Outsourced 4-9 Products Syringes (Not Lyophilized) Respondents Current and Expected Capacity Needs for Outsourced 4-9 Products Cartridge (Not Lyophilized) Number of Outsourced Products by Phase by Year Average Outsourcing Percentage by Dosage Form Number of Biopharmaceutical Products Filled by Dosage Form Types of Respondents Biopharmaceutical Products by Dosage Form Delivery Technologies Under Investigation Cause for Fill-and-Finish Yield Losses Respondent Capacity by Segment Outsource Decision Criterion Respondents with In-House Capacity Outsource Decision Criterion Respondents with No In-House Capacity Impact of Core Technology on Outsourcing Decision Focus of Fill-and-Finish Outsourcing Efforts in Next 5 Years Outsourcing of Fill-and-Finish Related Services Number of Products Currently and Planned to Outsource by Service Areas Underserved by Fill-and-Finish CMOs Challenges Fill-and-Finish CMOs can Help Alleviate Ranked Characteristics of a Good Service Level at F&F Contractor Rationale for Number 1 Ranked Good Service Characteristic Key Component for Successful Collaboration Regional Outsourcing Preferences Observations and Influences on Opinion about Emerging-Market CMOs Price Model Used for Fill-and-Finish Services by Respondent Type Average Technology Transfer Fees Paid by Dosage Form Price Per-Batch by Dosage Form by Product Phase Examples of Other Services and Material Charges Fill-and-Finish Outsourcing Budgets by Respondent Type: 2015, 2017, Simple Average: Percentage of F&F Outsourcing Budget by Service Weighted Average: Percentage of F&F Outsourcing Budget by Service 4-111

8 LIST OF TABLES (continued) Chapter Search Modes for Fill-and-Finish Contractors Rating of Respondents Fill-and-Finish Contract Manufacturers Top Concerns of Fill-and-Finish Contractors Meeting Expectations Warranties, Guarantees and Indemnifications Negotiated by Respondents Proposed Models and Arrangements with a CMO Regulatory Requirements That Present the Greatest Challenges Challenges and Bottlenecks Facing Fill-and-Finish Manufacturing Technology Trends in Drug Presentations Technology Trends at CMOs Operational and Business Trends in Fill-and-Finish Contract Manufacturing Future Trends in Biopharmaceutical Fill-and-Finish Contract Manufacturing Chapter Titles of Fill-and-Finish Contractor Respondents Fill-and-Finish Contractors: Headquarter Locations Regulatory Agency Approvals Relevance of Being a One-Stop-Shop Average Batch Size per Fill Line and Contractor Fill Capacity by Batch Size at Respondents Facilities in Lyophilizer Capacity by Shelf Space at Respondents Facilities in Lyophilizer Capacity by Batch Size at Respondents Facilities in Fill Line Expansion Plans Lyophilizer Expansion Plans Percent of Contracting Business by Product Type: 2015 and Capacity Utilization Rate: Fill Line Capacity Utilization Rate: Lyophilization Number of Batches Ran per Fill Line Batch Size Ran by Fill Line Number of Employees by Function Plans to Reduce Fill-and-Finish Manufacturing Costs Technology Impacts on Fill-and-Finish Operations Sources of Product Yield Loss Focus of Manufacturing Capabilities Pricing Methods for Clinical and Commercial Phase Calculation Methods of Technology Transfer Fees Contractors Cancellation Fees: Average Percentage of Total Project Fee Gross Profit Margin 5-46

9 LIST OF TABLES (continued) Chapter Contract Manufacturers Strengths and Weaknesses Contractor Competitive Advantage Warranties, Guarantees and Indemnifications Accepted by F&F CMOs Desired Arrangements with Clients Trade Shows Named by Fill-and-Finish Contractors Trade Shows for Best Quality Leads Trade Shows for Best Technical Information Opportunities for Growth in the Fill-and-Finish Industry Annual Growth Rates: Industry Estimate versus Company Forecast Revenue by Service Category: Revenue Change Expected by Service Category: 2015 to Customer Mix Geographic Mix Future Challenges to Business Operations Current Regulatory Challenges Potential Fill-and-Finish Manufacturing Growth Areas Future Technology Trends Future Business Trends 5-79

10 LIST OF FIGURES Chapter A Size of Worldwide Biopharmaceutical Fill-and-Finish Contract 1-6 Manufacturing Industry in US$B 1.3-A Respondents 82 Biopharmaceutical Products by Phase B Number of Products Outsourced by Dosage Form: C Simple Average Percentages of Expected Overall Outsourced Budget A Dosage Forms Produced by Number of Contractor Respondents B Percent of Fill Lines Available among Contractor Respondents for Various 1-12 Dosage Forms 1.4-C Annual Growth Rates: Industry Estimate versus Company Forecast D Percent of Contracting Business by Product Type: 2015 and Chapter A Explanation of Box-and-Whiskers Plot 2-5 Chapter A Dosage Forms Produced by Number of Contractor Respondents B Percent of Fill Lines Available among Contractor Respondents for Various 3-6 Dosage Forms 3.3-A Respondents 82 Biopharmaceutical Products by Phase B Percent of Products Outsourced: C Simple Average Percentages of Expected Overall Outsourcing Budget D Number of Products Outsourced by Dosage Form: E Estimates of Needs for Outsourced Batches for the Worldwide Industry A Size of the Worldwide Biopharmaceutical Fill-and-Finish Contract 3-19 Manufacturing Market in US$B Chapter A In-House Fill-and-Finish Manufacturing Capability A Summation of Outsourced Units Required Vials B Summation of Outsourced Units Required Syringes C Percentage of Products Outsourced D Number of Respondents Products Produced by Dosage Form E Respondents 82 Biopharmaceutical Products by Phase F Respondents 82 Biopharmaceutical Products by Company Type A Format Used for Drug Product Launch B Investigation of New Delivery Technologies C Needle-Based versus Needle-Free Delivery Technologies Under 4-21 Investigation

11 LIST OF FIGURES (continued) Chapter D Respondents Special Handling Requirements E Distribution of Percent of Products with Special Handling Needs F Special Handling Needs Required G Handling Needs for Typical Biologics H Distribution of Average Fill-and-Finish Yield Losses A Distribution of Respondents with In-House Capacity B Changes to In-House Filling Capacity C Core Technology s Impact on Outsourcing Decisions D Standard Technology s Impact on Outsourcing Decisions A Number 1 Ranked Good Service Characteristics B Most Important Good Service Characteristics by Weighted Ranking C Changing Opinion about Emerging-Market CMOs A Different Price Model Used for Commercial Products B Average Technology Transfer Fees Paid by Respondent Type C Payment of Reservation Fee D When Cancellation Charges are First Expected to be Incurred E Cancellation Fees: Average Percentages of the Total Contract Fee A Average Per-Batch Price by Clinical Phase B Unit Price versus Batch Size: Non-Lyophilization C Unit Price versus Batch Size: Lyophilization D Price per Batch by SafeBridge Level: Vials E Price per Batch by SafeBridge Level: Prefilled Syringes F Average Fill-and-Finish Outsourcing Budgets by Respondent Type G Simple Average: Percentage of F&F Outsourcing Budget by Service: H Weighted Average: Percentage of F&F Outsourcing Budget by Service A Search Modes for Fill-and-Finish CMOs B Warranties, Guarantees and Indemnifications C Negotiation of Contractor s Final Product Quality and Consequential Damages 4.9-D Preference for Production Networks or Alliances E Preferred Characteristics of Production Networks or Alliances Chapter A Number of Years Fill-and-Finish Services Offered B One-Stop-Shop CMO Model A Dosage Forms Produced by Percent of Contractors Respondents B Percent of Fill Lines Available among Contractor Respondents for Various 5-9 Dosage Forms 5.2-C Comparison of Percent of Dosage Forms Produced by Contractor Type D Capacity Expansion Plans E Dosage Forms Being Added 5-16

12 LIST OF FIGURES (continued) Chapter A Percent of Contracting Business by Product Type: 2015 and B Fill Line Capacity Utilization Rate C Lyophilization Capacity Utilization Rates D Average Number of Employees by Function E Plans to Reduce Fill-and-Finish Manufacturing Costs A Average Yield Loss A Pricing Methods B Use of Different Pricing Methods Based on Product Phase C Dosage Form D Batch Size E Batch Pricing F Technology Transfer Fee Charged G Reservation Fee Charged H When Cancellation Fees Are First Charged I Average Targeted and Achieved Gross Profit Margins A Warranties, Guarantees and Indemnifications Accepted by F&F CMOs B Comparison of CMO and Pharma Respondents Always Negotiation Term C Plans for Production Network or Alliances with Clients A Average Annual Growth Rates: Industry Estimate versus Company Forecast B Service Revenue by Contractor Type: C Revenue Contribution from Customer Groups by Contractor Type D Percentage of Business from the World Regions by Contractor Type 5-71