Sourcebook Table of Contents

 

2016 Biopharma Cold Chain Sourcebook
Table of Contents 
Acknowledgements 2
Purpose and Scope of the 2016 Sourcebook 3
Some boundaries and definitions 3
About Pharmaceutical Commerce magazine 6
Table of Contents 7
1. Executive Summary 11
1.1 Driving forces for cold-chain spending growth 12
1.1 Forecast 2011-2017 15
1.2 Clinical trials logistics 18
1.3 Risks and opportunities to these forecasts 18
1.4 The rest of this Sourcebook 19
2. A Brief Historical Introduction 21
2.1 Origins of the cold chain: vaccine, insulin and blood 21
2.2 Fast Forward to Today 24
3. Products Requiring Cold-Chain Handling 27
3.1 Drug stability and storage requirements 28
3.2 Requirements for biologics 28
3.3 Cold-chain drugs and biologics 28
3.4 Introduction of new cold-chain drugs 37
3.5 Background tables for US drugs and biologics approvals 38
4. The Expanding Market for Temperature-Sensitive Drugs and Biologics 43
4.1 The global pharmaceutical economy 44
4.2 US specialty “trend” 45
4.3 Biotechnology products 46
4.4 Vaccines 49
4.5 Blood and plasma products 52
4.6 Cold-chain biopharma products in the global supply chain 54
4.7 Generics 55
4.8 Insulin products 57
4.9 Biosimilars 60
5. Regulatory Environment 67
5.1 Global regulations and guidelines 68
5.1 European Union 70
5.2 A perspective on enforcement from the UK 73
5.3 United States 74
5.4 Canada 78
5.5 Ireland 80
5.6 Developing markets 81
5.7 Product integrity 88
6. Guidance for Cold-Chain Handling 91
6.1 Parenteral Drug Association (PDA) 92
6.2 World Health Organization (WHO) 96
6.3 International Air Transport Association (IATA) 99
6.4 Healthcare Distribution Management Association (HDMA) 102
6.5 International Safe Transit Association 104
7. The Global Supply Chain and Modes of Transport 105
7.1 Manufacturer to distributor to pharmacy, then to clinic or patient 105
7.2 Import and export trade 110
7.3 Modes of transport 115
7.4 Europe 116
7.5 Mail-order markets 118
7.5 Background tables for pharmaceutical trade information 120
8. Third-Party Logistics Providers, and Carriers 123
8.1 3PL market trend and top companies 123
8.2 Global view of economic recovery and logistics 126
8.3 Top 3PLs 128
8.4 Passenger + cargo air carriers 132
8.5 Ocean options 134
9. Specialized Packaging and Instrumentation 137
9.1 Packaging and pack-out 138
9.2 Active temperature control 140
9.3 Passive systems 143
9.4 Monitoring 146
9.5 Controlled room temperature 147
9.6 Special safety and security issues 148
10. Clinical Trials Logistics 151
10.1 Clinical trial market dynamics 152
10.2 3PLs and specialized logistics suppliers for clinical trials 156
10.3 Clinical trial research and supply specialists 160
10.4 Background tables for clinical trials 162
11. Cold-Chain BioPharma Logistics 2011-2017 Market Sizing and Forecast, and Clinical Trials Logistics Market Estimate 165
11.1 Cold-chain biopharma logistics market sizing and forecast 166
11.2 Market sizing and forecast for clinical-trials logistics 172
11.3 Connecting the cold chain with other supply-chain issues 175
11.4 Conclusion and future direction 175
Appendices 177
A. Vendor and Service Provider Directory 177
B. Government trade and transportation data 193
C. Selected text – related to temperature control and cold-chain logistics — of the revised EC “Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use” going into effect in July 2012 198
D. Health Canada’s newly implemented GUIDE-0069 204
Figures 211
Tables 214
References 218

The Biopharma Cold Chain Sourcebook 2016 is available for purchase at US$1495.
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