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1 Improving Markets, Services, and Technologies Table of Contents Presented by HighTech Business Decisions 3150 Almaden Expressway, Suite 222, San Jose, CA Tel: (408) Fax: (408) October 2014

2 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 Change in CMO Pricing Industry Trends and Observations Summary of Contractors Capabilities Annual Revenue Ranges Technology Capabilities Capacity Expectations for the Future of the Industry 1-17 Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS 2.1 Research Objectives Research Methodology Definition of Biopharmaceutical Manufacturing Box-and-Whiskers Plot Definition Acronyms 2-4 Chapter 3: BIOPHARMACEUTICAL CONTRACT MANUFACTURING: MARKET OVERVIEW 3.1 Introduction Suppliers: The Contract Biomanufacturers Types of Contract Biomanufacturing Companies Major Players: Contract Biomanufacturing Companies Organizational Changes in the Industry Technologies and Services Contract Biomanufacturers Capacities Contractor Revenues 3-13

3 TABLE OF CONTENTS (continued) Chapter 3: 3.3 The Customers: Pharmaceutical and Biotechnology Companies Outsourced Biomanufacturing Outsourcing Biomanufacturing by Production Technology Examples of Contractors Used by Client Companies Customers Future Outsourcing Expectations In-House Capacity Outsource Requirements Industry Drivers Supply and Demand Market Size Estimates of Market Size Based on Contractor Revenue Market Size by Technology and Service Categories Market Growth Forecasts Trends in the Biopharmaceutical Contract Mfg. Market Industry Opportunities and Challenges Overall Industry Trends 3-37 Chapter 4: PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES: CLIENT ANALYSIS 4.1 Introduction Respondent Company Backgrounds Respondents Titles and Experience Locations and Sites Respondents Biopharmaceutical Products on Market Respondents Preclinical Products Respondents Clinical and Commercial Products Respondents Outsourced Products Biomanufacturing Needs Current and Forecast Tank Size Requirements Number of Outsourced Batches Current and Forecast Outsourced Demand Future Production Technology Requirements Biomanufacturing Strategies Outsource versus In-House Decision Early Clinical-Stage Programs Change in Project Scope to Separate Contracts 4-41

4 TABLE OF CONTENTS (continued) Chapter 4: 4.5 Outsourcing Biomanufacturing Percentage Outsourced and Expected to Be Outsourced Current and Anticipated Needs for Outsourced Services Change in CMO Pricing Budgetary Considerations for Engineering Runs New Services Sought in a Contractor Biomanufacturing Technologies Current Expression Levels Commercially Available Proprietary Expression System Ideal Bioreactor Size Use of Chemically-Defined Media Contractor Selection Primary Screening Criteria Number of CMOs Contacted CMO Repeat Business Essential Characteristics Sought in a Contractor Suggestions for New CMO Importance for Services to be at Same Location Fill-and-Finish Capability at Site Production at Location Product Marketed Clinical-Phase CMO Differentiation CMO Customer-Facing Organization Skills Contractor Relationships Favorite Contractors Describing Flexibility and Ease of Use with a Contractor Client Expectation Regarding Failed Batch Runs Expectation of Initial Payment to Secure Slot Outsource Spending Outsourcing Budgets Outsourcing Budgets by Technology Outsourcing Budgets by Service Future Trends and Expectations Opinion on Strategic Partnerships Interest in Strategic Development/Manufacturing Partnership Long-Term Industry and Market Trends 4-211

5 TABLE OF CONTENTS (continued) Chapter 5: BIOPHARMACEUTICAL CONTRACT MANUFACTURERS 5.1 Introduction Study Participants Types of Suppliers Locations Regulatory Inspections and Status Acquisitions and Organizational Changes Revenues Company Organization Ratio of Business Development to Program Management Ratio of Quality to Manufacturing GMP Manufacturing Staff Activities Education Level of GMP Manufacturing Operators Technical Staff Turnover Rate Technologies and Capacities Offered Number of cgmp Phase III and Commercial Products Technologies Offered Percentage of Business by Service Category Contract Manufacturers Current Capacities Contract Manufacturers Expansion Plans Manufacturing Technologies Expression Yields and Batch Success Rates Number of Batches Run per Tank Investment in New Technologies Effect of Disruptive Technologies on Manufacturing Single-Use Capability Full Lot Release Testing Capability Analytical, Bioassay, Formulation, Stability Capabilities Quality by Design Advantage of Drug Substance and Drug Product 5-69 Capability Use of Platform Technologies Electronic Access to Data 5-78

6 TABLE OF CONTENTS (continued) Chapter 5: 5.5 Marketing and Customer Relationships Request for Proposals Clients Served Number of Phase II/III and Commercial Contracts Revenue Spent on Business Development and Proposals Portion of Fully Integrated Projects Typical Contract Guarantees Number of MBR Reviews Done by Clients Characteristics of the Customer Base Proportion of Business by World Regions Reasons for Winning Business Metrics Used to Benchmark Business Performance Industry and Future Trends Contractor Change in Demand for Outsource Services Expectation of Industry Growth Price Changes for Biopharmaceutical Production Regulatory Challenges Expectations for the Biopharmaceutical Contract 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

7 LIST OF TABLES Chapter Users Opinions on Future of the Industry Future Trends Noted by CMO Respondents 1-17 Chapter Market Research Steps List of Acronyms 2-4 Chapter Contractors Manufacturers Preferred by Respondents Examples of Changes or Events in the CMO Industry: Past Two Years Major Contract Biomanufacturing Technology Categories Biopharmaceutical Contract Manufacturing Industry Capacity Estimates Examples of New Capacity for Biopharmaceutical Contract Manufacturing Examples of Contract Biomanufacturers and their Client Companies Examples of Pharmaceutical/Biotechnology Companies Building Capacity Estimates of Totaled Needs for Outsourced Volumes by Respondents Estimates of Needs for Outsourced Volumes for the Worldwide Industry Outsourced Manufacturing Capacity vs Needs: Mammalian Cell Culture Outsourced Manufacturing Capacity vs Needs: Microbial Fermentation Worldwide 2013 Market Size for Contract Biomanufacturing: Revenues Market Size by Technology Category: US$ Market Size by Service Category: US$ Worldwide 2014 Market Size for Contract Biomanufacturing Major Biopharmaceutical Contract Manufacturing Industry Trends 3-37 Chapter Respondent Pharmaceutical and Biotechnology Companies Respondents Titles by Segment Respondent Locations Respondents Bulk Biopharmaceutical Manufacturing Sites Respondents Fill-and-Finish Biopharmaceutical Manufacturing Sites Respondents Preclinical Products Number of Products Produced Using Mammalian Technologies Number of Products Produced Using Microbial Technologies Types of Respondents Products by Production Technology Outsourced Products by Phase by Year Number of Products Outsourced by Tank Size Needs in 2014: 4-17 Mammalian Cell Culture Number of Products Outsourced by Tank Size Needs in 2014: 4-17 Microbial Fermentation

8 LIST OF TABLES (continued) Chapter Tank Size Distribution for Outsourced Products: Mammalian Cell Culture Tank Size Distribution for Outsourced Products: Microbial Fermentation Outsource Batches per Project: Mammalian Cell Culture Outsource Batches per Project: Microbial Fermentation Outsource Demand by Phase Expected Changes in Technologies Used Drivers for Companies Who Outsource 100% GMP Manufacturing Drivers for Companies Who Outsource Some GMP Manufacturing Respondents Outsourcing of Clinical-Stage Programs Separate Outsourced Services Outsource Budget Allocated by Production Technology Services Currently Outsourced Services Planned Outsourced No Plans to Outsource Services Summary of Service Categories Based on Number of Products Reasons for Pricing Change for CMO Biopharmaceutical Services Budget Considerations by Respondent Segment New CMO Services Sought Expression Levels Reported by Respondents in Grams per Liter Expression Levels Reported for Mammalian mab Products Proprietary Expression System Used Reason for Choosing Proprietary Expression System Ideal Bioreactor Size (L) Criteria for Initial Selection of CMO Number of CMOs by Selection Step Essential Characteristics for Choosing a CMO Weighted Characteristics Distributed By Respondent Segment Criteria for Using a New CMO without Manufacturing History Reasons Regarding CMOs Having All Services in One Location Reasons for Selection of Bulk Production CMO without F&F Capability Production Location at Sites Where Product Marketed Factors that Differentiate Clinical-Phase CMOs Skills Needed by CMOs Customer-Facing Organization Contract Manufacturers Preferred by Respondents Examples of CMO Flexibility and Ease of Use Initial Payment to Secure Manufacturing Slot Expenditures on Outsourcing of Biopharmaceutical Production: Expenditures on Outsourcing of Biopharmaceutical Production: Average Percentage of Budgets Spent on Each Technology: 2014 and Weighted Average Percentage of Budgets Spent on Each Technology Simple Average: Percentages of Budgets by Service Expected in Simple Average: Percentages of Budgets by Service Expected in Weighted Average: Percentages of Budgets by Service Expected in Weighted Average: Percentages of Budgets by Service Expected in

9 LIST OF TABLES (continued) Chapter Benefits and Challenges of Production Networks or Alliances Consideration for Co-Investing in a CMO Long-Term Industry Trends Chapter Respondents from Companies Offering Contract Biomanufacturing Services Types of Biopharmaceutical Contract Manufacturers Contract Biomanufacturers: Headquarter Locations Examples of Company Changes in Contract Biomanufacturing Organization Changes Over Last Two Years Revenues for Contract Biomanufacturers in US$M Technical Staff Turnover Rate Incentive Programs Provided to Retain GMP Manufacturing Staff Phase III and Commercial cgmp Products Manufactured Business Mix by Production Technology and Year Business Mix in 2014 by Production Technology and Contractor Segment Averaged Percentages of Business from Biopharmaceutical Services Averaged Percentages of Business from Biopharmaceutical Services 5-31 By Company Type Mammalian Cell Culture Capacity at 19 Respondents Facilities in Microbial Fermentation Capacity at 13 Respondents Facilities in New Capacity Expected: 2015 to Contractor Yields and Success Rates Number of Batches Run per Tank New Technology Investments Disruptive Technologies in Biopharmaceutical Manufacturing Percentage of Single-Use at Respondent Sites Advantages and Disadvantages of Single-Use Bioreactors Analytic Testing Capability Analytic Technology Capability Bioassay Capability Formulation Capability Stability Capability Advantage of Drug Substance and Drug Product Capability Time and Cost Savings Through Use of Platform Technology Number of Request for Proposals Received per Month RFP Proposal Success Rate Number of Clients in Number of Phase II/III and Commercial Contracts Percent of Revenue Spent on Business Development and Proposals 5-86

10 LIST OF TABLES (continued) Chapter Percent of Fully Integrated Projects Awarded Typical Contract Guarantees Number of MBR Reviews Done by Clients Simple Average Percent of Business by Segment: Customer Base Simple and Weighted Average Percent of Business: Customer Base Types of Customers Served and Number of Products Average Percentage of International Clients Simple Average Percent of Business by Segment: World Regions Simple and Weighted Average Percent of Business: World Regions Reasons Why Chosen by Client Top Benchmarking Metrics Reasons for Demand Increase Over Last 12 Months Average Expectations of Growth: Next Twelve Months Average Expectations of Growth: Next Three Years Reasons for Price Changes Observed by Contractors Regulatory Challenges Industry Prospects and Trends Noted by Contractor Respondents 5-119

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

12 LIST OF FIGURES (continued) Chapter K Tanks Sizes Required for Outsourced Microbial Fermentation Products L Tanks Sizes Required for Outsourced Mammalian Cell Culture Products A Percent of Tanks Size for Outsourced Products: Mammalian Cell Culture B Percent of Tanks Size for Outsourced Products: Microbial Fermentation C Outsource Batches per Project: Mammalian Cell Culture D Outsource Batches per Project: Microbial Fermentation E Summation of Outsourced Volumes Required by Respondents F Technology Usage Patterns Top 6 Mentions A Respondents Outsourcing Strategies B Respondents Outsourcing of Clinical-Stage Programs C Number of Outsourced Clinical-Phase Programs D Project Scope Changes A Average Percentages of Outsourced Production B Average Percentages of Outsourced Budget: C Numbers of Respondents Increasing, Decreasing, or Keeping the Same 4-54 Outsourcing Percentage 4.5-D Price Change for CMO Biopharmaceutical Services E Budget Considerations for Engineering Runs A Expression Levels by Phase and Technology B Use of Proprietary Expression Systems C Pricing Agreements for Proprietary Expression Systems D Fees Paid for Proprietary Expression Systems E Preferred Pricing Agreement for Proprietary Expression Systems F Average Ideal Bioreactor Size by Respondent Segment G Average Ideal Bioreactor Size Distribution H Average Use of Chemically-Defined Media I Distribution of Use of Chemically-Defined Media A Top 5 Criteria for Initial Selection of CMO B Average Number of CMOs by Selection Step C Average Percentage of CMO Repeat Awards D Distribution of Percentage of CMO Repeat Awards E Top Criteria for Selecting a CMO F Top 5 Weighted Characteristics by Respondent Segment G Importance for CMO to Have All Services at Same Location H Importance for CMO to Have All Services at Same Location: Segment I Selection of Bulk Production CMO without Fill-and-Finish Capability J Importance of Having Production Location at Sites Product Marketed A Top Attributes of Flexible CMOs B Financial Responsibility for Non-Negligent Batch Failures C Distribution of Initial Payment to Secure Manufacturing Slot A Respondents Expected Change in Outsourcing Budgets: 2014 to B Simple Average Percentage of Budgets Spent on Each Technology C Weighted Average Percentage of Budgets Spent on Each Technology C Simple Averages: Percentages of Budgets by Service: 2014 and D Weighted Averages: Percentages of Budgets by Service: 2014 and

13 LIST OF FIGURES (continued) Chapter A Interest in Production Networks or Alliances B Interest in Production Networks or Alliances by Respondent Segment C Interest in Co-Investment in a CMO D Interest in Co-Investment in a CMO by Respondent Segment Chapter A Year Respondent Company Entered into CMO Business B Number of CMO Respondent Sites C Number of FDA or EMA Inspections D Contract Biomanufacturers Annual Revenue Ranges in US$ in A Ratio of Business Development to Project Management Employees B Ratio of Quality to Manufacturing Employees C GMP Manufacturing Staff Performing GMP Support Activities D GMP Manufacturing Staff Performing GMP Support Activities by Segment E Education Level of GMP Manufacturing Operators F Percentage of GMP Manufacturing Operators Education Level G Distribution of Technical Staff Turnover Rate A Average Number of Phase III and Commercial Products B Technology Comparisons: Average Percentage of Business: C Technology Comparisons: Average Weighted Percentage of Business: D Service Category Comparisons: Average Percentage of Business: E Production Category Comparisons: Average Percentage of Business: F Average Percentage of Revenue from Each Service Category: Weighted G Individual Mammalian Cell Culture Capacity Utilization Rates: 2014/ H Individual Microbial Fermentation Capacity Utilization Rates: 2014/ I Additional Mammalian Cell Culture Capacity by Year J Additional Microbial Fermentation Capacity by Year K Summary of Current and Future Capacity at Surveyed Contractor Facilities A Expression Yields by Technology and Contractor Size B Average Number of Batches Run per Tank C Distribution of Single-Use Percentages at Respondent Sites D Full Lot Release Testing Capability E Analytical, Bioassay, Formulation and Stability Capabilities F Analytic Capability G QbD Principles Applied to Development H Advantage of Drug Substance and Drug Product Capability I Platform Technology Usage by CMOs J Electronic Data Access and Raw Data Access A Average Number of RFPs Received Each Month B Average Percentage of RFP Proposal Success Rates C Distribution of Clients Served in

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

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