Studie - Biomanufacturing Strategies: Market drivers, build-vs-buy decisions and opportunities in contract relationship management

Business Insights
182 Seiten

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The contract biomanufacturing market achieved a value of $2.5bn in 2006, with growth expected to continue at an annual rate of 0- 5% until at least 20. The proportion of biologics in new drug approvals has risen by over 30% during the last decade, and with the current pipeline containing more than 500 protein and 50 peptide developmental drugs, this trend is set to continue. The commercial success of over 350 approved biologics has prompted the biotechnology industry to accelerate discoveries in further protein-based therapeutics, placing greater emphasis upon the importance of biomanufacturing. Many biotechnology companies are faced with limited resources, and as large-scale manufacturing continues to intensify, deciding whether it should be internalised or outsourced to partners or CMO’s is increasingly crucial in the development of a biotech firm. Biomanufacturing Strategies is a new report published by Business Insights that examines the future direction of biomanufacturing through a detailed analysis of market drivers, restraints and trends. The production strategies and capacities of leading biopharma companies are assessed, and growth forecasts for microbial fermentations and mammalian cell culture are provided. This report will also detail the tactical balance required between a firm’s potential manufacturing capability and overall corporate strategy, in addition to profiling other key factors that bear crucial importance to the ‘build vs buy’ decision. Use this report to identify the key criteria involved in CMO selection, compare the expansion strategies and capacity shares of leading players and analyse the growth drivers shaping the future of biomanufacturing.
Table of Contents

Biomanufacturing Strategies

Executive Summary 10

Introduction 10

Manufacturing of biologics 11

The contract biomanufacturing market 12

Outsourcing biomanufacturing 13

Contract Manufacturing Organizations 14

Trends in biomanufacturing 15

Chapter 1 Introduction 18

Summary 18

Introduction 19

The state of the biomanufacturing industry 20

Biotech drugs as blockbusters 21

The contract biomanufacturing sector 22

Overview of the biomanufacturing process 23

Microbial Fermentation 24

Mammalian cell culture 24

Transgenics/plant systems 24

Conclusions and key findings 25

Chapter 2 Manufacturing of biologics 28

Summary 28

Introduction 29

The biopharmaceutical process 30

The Upstream Process 32

Cell banking and seed culture 32

Production 32

Harvest and concentration 37

The Downstream process 37

Purification of biopharmaceuticals 38

Formulation 41

The importance of process integration 42

Expression systems for therapeutic protein production 43

Therapeutic protein production in microbes 44

Mammalian cell culture 46

Emerging production systems 48

Pichia and filamentous fungi 48

Transgenic protein production systems 49

Transgenic animals 53

Chapter 3 The contract biomanufacturing

market 56

Summary 56

Introduction 57

Overview of the global contract biomanufacturing market 58

The contract biomanufacturing market as part of the global pharmaceutical

market 58

Total market size forecasts 59

Global biomanufacturing capacity forecasts 63

Current market drivers 67

Expansion of the market for biopharmaceutical products 67

Facility cost 70

Manufacturing expertise and innovation 72

Risk reduction and time to market 73

Growing regulatory burden and shortage of personnel 75

The emergence of biosimilars 78

Current market restraints 79

In-house production and overcapacity 79

Loss of manufacturing control 81

Technology transfer and intellectual property (IP) concerns 82

Increased competition among CMOs 83

Longer clinical and approval times for biopharmaceuticals 84

Chapter 4 Outsourcing biomanufacturing 88

Summary 88

Introduction 89

The build vs. buy decision 90

What is the strategy for the future of the biotech company? 90

The outsourcing option and availability of external manufacturing capacity 92

Capital requirements and operating cost structure 96

Risk management 99

Managing contract biomanufacturing 101

Key selection criteria 101

The CMO Selection Process 105

The sponsor — CMO relationship 108

Starting the relationship 108

Technology transfer 109

Weekly and daily interaction 112

The reality of costs 114

When things go wrong 114

Conclusions 117

Chapter 5 Contract Manufacturing

Organizations 120

Summary 120

Introduction 121

Major players 122

Lonza Group 122

Mammalian cell culture 122

Microbial fermentation 123

Biopharma services 124

Boehringer Ingelheim 125

Boehringer Ingelheim’s expansion strategy 125

Boehringer Ingelheim’s contract services and proprietary technology

platforms 126

DSM Pharmaceutical Products 128

DSM Pharmaceuticals’ contract services 129

Celltrion 130

Bioreactor facilities 130

Celltrion expansion 131

Diosynth 133

Diosynth’s contract manufacturing deals 135

Medium-sized and small players 136

Baxter BioPharma Solutions 136

Baxter’s contract services 137

Cobra Biomanufacturing plc 138

Cobra’s contract services and proprietary technology platforms 140

Xcellerex 141

PDMaxTM Process Development Platform 141

FlexFactoryTM Manufacturing 142

XDRTM — Xcellerex Disposable Reactor 142

Xcellerex’s funding and manufacturing deals 142

Avecia 143

The pAVEwayTM production platform 144

Avecia’s manufacturing deals 144

Chapter 6 Trends in Biomanufacturing 148

Summary 148

Introduction 149

Bioprocess development strategies 149

Production line selection and engineering 151

Cell culture media 153

Disposable technology 154

Drivers for disposable technologies 155

Single use and disposable bioreactor systems 156

Disposable systems in downstream processes 159

Improving productivity in downstream processing 159

Harmonizing upstream and downstream capacities 160

Transgenic production systems 161

Cost considerations 161

The perception of transgenics 163

Process analytical technology (PAT) 165

Regulation shifts from product to process 165

Defining PAT and its meaning to a biomanufacturing company 165

PAT in biomanufacturing 166

Process control tools used for PAT 167

Globalization / Offshoring to Asia 169

Shared capacity — the future of biomanufacturing? 172

Conclusions — The future of contract biomanufacturing 174

Chapter 7 Appendix 178

Bibliography 178

Index 181

List of Figures

Figure 2.1: Schematic flow diagram of a typical biopharmaceutical process 31

Figure 2.2: Expression system decision framework 44

Figure 3.3: CMO market growth as part of the global pharmaceutical market, 2001 and 2007 59

Figure 3.4: Size of the contract biomanufacturing market, 2000-2008e 60

Figure 3.5: Ratio of biopharma companies producing 100% in-house (mammalian cell culture), 2003-2011e 61

Figure 3.6: Biopharma companies planning to outsource at least part of their production, 2006 and 2011e 62

Figure 3.7: Mammalian Cell Culture Bioreactor Capacity, 2003 -2009e 64

Figure 3.8: Microbial Fermenter Volume Capacity, 2003 -2009e 65

Figure 3.9: Number of biotech drugs and global biotech industry revenues, 1990-2005 68

Figure 3.10: Antibody-derived therapies in biotechnology pipeline, 2007 69

Figure 3.11: Cash reserves of biotech companies, 2005 71

Figure 3.12: Sensitivity of fermentation volume required depending on yield and market demand74

Figure 3.13: Factors creating capacity constraints by 2008 77

Figure 3.14: CMO Mammalian Cell Culture Production Capacity Increase 2003 -2006 80

Figure 3.15: Mean clinical and approval time-frames for biopharmaceuticals approved, 1996-2000 vs. 2001-2005 85

Figure 4.16: Framework for the build vs. buy decision 92

Figure 4.17: Mammalian Cell Culture Capacity Distribution for CMOs, 2004 and 2008(estimate) 93

Figure 4.18: Distribution of biomanufacturing capacity 94

Figure 4.19: Proposed timeline for commercial contract biomanufacturing 95

Figure 4.20: Financial ‘Build or Buy’ decision tree 98

Figure 4.21: Transition (success) probabilities for biopharmaceuticals in different clinical phases, 2007 99

Figure 4.22: Key criteria for selecting a CMO, 2006 102

Figure 4.23: Critical issues when selecting a CMO, BioPlan Associates Survey, 2006 105

Figure 5.24: Celltrion’s bioreactor capacity in Incheon, South Korea, 2007 131

Figure 5.25: Revenue by lines of business in 2006 and 2007 139

Figure 5.26: Revenue by geographical origin in 2006 and 2007 140

Figure 6.27: Timelines for constructing and selecting high quality clonal cells 152

Figure 6.28: Different types of culture media 154

Figure 6.29: A 20L Wave bioreactor (Wave Biotech) 157

List of Tables

Table 1.1: Top 10 biotech drugs by US sales ($bn), 2005 and 2006 21

Table 2.2: Examples of production methods for recombinant therapeutic products 35

Table 2.3: Marketed biopharmaceuticals and their expression platforms 47

Table 2.4: Plant-based transgenic companies and their pipeline of recombinant proteins 52

Table 2.5: Therapeutic proteins produced in transgenic animals 53

Table 3.6: Number of operating facilities per segment 2004 and 2008(estimated) 63

Table 3.7: New Technology — Modified Production Plant: Kogenate Bayer/FS® 82

Table 4.8: Capital investment costs for antibody facilities using mammalian cell culture, 2000-2009e 97

Table 4.9: Cost of inaccurate capacity planning 100

Table 4.10: Example of a request for proposal (RFP) content 107

Table 4.11: Typical areas of responsibility as reported by sponsors 115

Table 5.12: Capacity expansions in mammalian cell culture fermentation 123

Table 5.13: Capacity expansions in microbial fermentation 124

Table 5.14: Diosynth Biotechnology, US facilities, Research Triangle Park, NC 134

Table 5.15: Diosynth Biotechnologies, microbial fermentation and mammalian cell culture volumes, 2007 135

Table 5.16: Process development and cGMP manufacturing at Avecia, 2007 144

Table 6.17: Capital investment estimates for antibody production for two different expression technologies 162

Table 6.18: Comparison of cost per gram estimates at specified production rate 163

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