Sourcebook Table of Contents

 

2019 Biopharma Cold Chain Sourcebook

Table of Contents 

 

1        Executive Summary. 9

2019 cold-chain logistics forecast (Chapter 3). 11

2019 clinical trials logistics forecast (Chapter 8). 15

Cold chain regulation (Chapters 4-5). 16

Logistics service providers and carriers (Chapter 6). 16

Packaging, instrumentation, specialized markets (Chapter 7). 16

2       Historical Background – Origins of Cold Chain. 19

3       Cold Chain Logistics Forecast to 2023. 23

3.1 Drivers of Growth in Temperature-Sensitive Drugs, Biologics and Cellular Therapeutics. 23

Global pharma industry growth trend. 25

New drugs. 30

US trend. 35

Biotech drugs. 36

Biosimilars. 38

Blood and plasma products. 39

3.2         Cellular Therapies. 40

Commercialization of cellular therapies. 41

CAR-T and gene therapies. 42

Stem cells. 44

Stem cell therapies. 44

Stem cell logistics. 46

3.3         Overall Cold-Chain Biopharma Sales Forecast 46

Future direction. 48

3.4        Distribution Dynamics. 49

Regulatory background. 50

Distribution channels. 52

Modes of transport 54

Europe. 56

World trade trends. 59

US trade trends. 63

Logistics business trends. 66

3.5         Cold-Chain Logistics Market Sizing and Forecast 67

Risks and opportunities. 70

4       Regulatory Environment 71

4.1         Global Regulations and Guidelines 73

4.2        European Union. 75

European GDP Guidelines. 75

Quality assurance in European Union good manufacturing practice. 76

A perspective on enforcement from the UK.. 77

4.3        United States. 78

US enforcement 78

USP <1079> “Good Storage and Shipping Practices” and quality management 80

Other US laws and regulations. 81

4.4        Canada, Ireland, Australia. 83

Canada. 83

Ireland. 83

Australia. 84

4.5        China and Other Developing Markets. 85

China’s revised GSP. 85

Brazil’s regulations for biologics. 87

Mexico’s import controls. 89

Argentina’s cold-chain temperature indicator law.. 89

Singapore’s GDP guidance. 89

United Arab Emirates’ instructions. 89

Israel 90

Saudi Arabia. 90

India, and other markets. 91

4.6        Product Integrity. 92

‘Falsified’ medicines and supply chain traceability. 93

EU Falsified Medicines Directive. 94

5       Guidance for Cold-Chain Handling. 95

5.1         Parenteral Drug Association (PDA). 96

PDA Technical Report 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User. 97

Other PDA Guidances. 100

5.2         World Health Organization (WHO). 100

WHO “model guidance” for the cold chain. 101

WHO vaccine guidelines. 101

5.3         International Air Transport Association (IATA). 104

IATA Standard Acceptance Checklist 104

CEIV Pharma. 105

5.4        Other Guidances. 108

US Centers for Disease Control and Prevention (CDC) 108

Healthcare Distribution Alliance (formerly Healthcare Distribution Management Assn.) (HDA) 108

International Safe Transit Association. 109

6 Third-Party Logistics Providers, and Carriers. 111

6.1         3PL Trend and Top Companies. 111

6.2        Top 3PLs. 115

UPS. 115

Deutsche Post-DHL. 117

FedEx. 117

Kuehne + Nagel 118

Other top 3PLs. 118

Specialized suppliers. 118

6.3        Passenger + Cargo Air Carriers. 119

United. 119

Lufthansa. 119

Delta Air Lines. 120

American Airlines. 120

Southwest Air. 120

IAG Cargo. 120

Cathay Pacific. 121

6.4        Drug Delivery by Drone. 121

6.5        Ocean and Truck Transport 123

“Qualified” road transport 126

7       Specialized Packaging and Instrumentation. 127

7.1         Carton Delivery. 129

Pallet packaging. 131

Active containers. 133

Container variations. 135

Thermal blanketing. 136

7.2         Stability Testing; Stability Budget 138

7.3         Monitoring Instruments and Systems. 139

Sensitech. 143

Elpro-Buchs AG.. 143

TempTime. 144

OnAsset 144

7.4        Controlled Room Temperature. 145

7.5         Special Safety and Security Issues. 146

8       Clinical Trials Logistics Forecast to 2023. 147

8.1         Market Drivers. 147

R&D trends. 148

Clinical trials trend. 150

Regional trend. 150

8.2        Clinical-Trials Logistics Forecast to 2023. 156

9       Active Pharmaceutical Ingredients (APIs) 159

9.1         API Products and Manufacturers. 159

Ranbaxy, APIs and generic Lipitor. 160

Atorvastatin calcium.. 160

9.2        API Regulations and Guidances. 162

WHO “Good trade and distribution practices for pharmaceutical starting materials” 162

European Commission draft GDP for APIs. 162

European Union directive on falsified medicines as it affects APIs. 163

9.3        Global Trade and Transport of APIs. 165

9.4        Specialized Packaging for APIs. 167

Vendor and Service Provider Directory. 169

Vendors and Service Providers. 169

Vendors and Service Providers by Product & Service Category. 186

3PL Logistics Providers. 186

Air Carriers. 187

Clinical Trial Logistics. 187

Instrumentation. 187

Ocean Carriers and Containers. 188

Tertiary Packaging and Containers. 188

Trucking Companies. 190

Consulting. 190

Figures. 191

Tables. 194

References. 197

 

 

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