Sourcebook Table of Contents

 

2018 Biopharma Cold Chain Sourcebook

Table of Contents 

1     Executive Summary 9

2018 cold-chain logistics forecast (Chapter 3)      11

2018 clinical trials logistics forecast (Chapter 8) 14

Cold chain regulation (Chapters 4-5)    15

Logistics service providers and carriers (Chapter 6)     15

Packaging, instrumentation, specialized markets (Chapter 7)    16

2     Historical Background – Origins of Cold Chain 17

3     Cold Chain Logistics Forecast to 2022   21

3.1 Drivers of Growth in Temperature-Sensitive Drugs, Biologics and Cellular Therapeutics     21

Global pharma industry growth trend     23

New drugs   27

US trend    28

Biotech drugs    33

Biosimilars 35

Blood and plasma products    36

3.2   Cellular Therapies     37

Commercialization of cellular therapies 38

CAR-T and gene therapies     38

Stem cells  41

Stem cell therapies    41

Stem cell logistics    43

3.3   Overall Cold-Chain Biopharma Sales Forecast   43

Future direction 45

3.4   Distribution Dynamics  46

Regulatory background  47

Distribution channels  49

Modes of transport     51

Europe      53

World trade trends     56

US trade trends  59

Logistics business trends    61

3.5   Cold-Chain Logistics Market Sizing and Forecast     63

Risks and opportunities      66

4     Regulatory Environment 67

4.1   Global Regulations and Guidelines 69

4.2   European Union   71

European GDP Guidelines      71

Quality assurance in European Union good manufacturing practice      72

A perspective on enforcement from the UK      73

4.3   United States    74

US enforcement   75

USP <1079> “Good Storage and Shipping Practices” and quality management    76

Other US laws and regulations      78

4.4   Canada, Ireland, Australia   78

Canada      78

Ireland     79

Australia   80

4.5   China and Other Developing Markets 80

China’s revised GSP    81

Brazil’s regulations for biologics 83

Mexico’s import controls     83

Argentina’s cold-chain temperature indicator law    84

Singapore’s GDP guidance     85

United Arab Emirates’ instructions 85

Israel      85

Saudi Arabia     86

India, and other markets     87

4.6   Product Integrity 88

‘Falsified’ medicines and supply chain traceability 88

EU Falsified Medicines Directive  89

5     Guidance for Cold-Chain Handling  91

5.1   Parenteral Drug Association (PDA) 92

PDA Technical Report 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User 93

Other PDA Guidances    96

5.2   World Health Organization (WHO)    96

WHO “model guidance” for the cold chain 97

WHO vaccine guidelines 97

5.3   International Air Transport Association (IATA)      100

IATA Standard Acceptance Checklist 100

CEIV Pharma 101

5.4   Other Guidances  104

US Centers for Disease Control and Prevention (CDC) 104

Healthcare Distribution Alliance (formerly Healthcare Distribution Management Assn.) (HDA) 104

International Safe Transit Association  105

6  Third-Party Logistics Providers, and Carriers     107

6.1   3PL Market Trend and Top Companies 111

6.2   Global View of Economic Recovery and logistics      113

6.3   Top 3PLs    114

UPS   114

Deutsche Post-DHL 115

FedEx 116

Kuehne + Nagel   117

Other top 3PLs   117

Specialized suppliers  117

6.4   Passenger + Cargo Air Carriers     118

United      118

Lufthansa   118

Delta Air Lines  119

American Airlines 119

IAG Cargo   119

Cathay Pacific   120

6.5   Ocean and Truck Transport    120

“Qualified” road transport   122

7     Specialized Packaging and Instrumentation     123

7.1   Carton Delivery  125

Pallet packaging 127

Active containers 129

Container variations   131

Thermal blanketing     132

7.2   Stability Testing; Stability Budget     134

7.3   Monitoring Instruments and Systems 135

Sensitech   139

Elpro-Buchs AG   139

TempTime    140

OnAsset     140

7.4   Controlled Room Temperature  141

7.5   Special Safety and Security Issues 142

8     Clinical Trials Logistics Forecast to 2022    143

8.1 Market Drivers     143

R&D trends  144

Clinical trials trend  145

Regional trend   146

8.2 Clinical-Trials Logistics Forecast to 2022      149

9     Active Pharmaceutical Ingredients (APIs)      153

9.1   API Products and Manufacturers     153

Ranbaxy, APIs and generic Lipitor 154

Atorvastatin calcium   154

9.2   API Regulations and Guidances      156

WHO “Good trade and distribution practices for pharmaceutical starting materials”      156

European Commission draft GDP for APIs  156

European Union directive on falsified medicines as it affects APIs   157

9.3   Global Trade and Transport of APIs 159

9.4   Specialized Packaging for APIs     161

Vendor and Service Provider Directory   163

Vendors and Service Providers      163

Vendors and Service Providers by Product & Service Category    179

3PL Logistics Providers      179

Air Carriers     180

Clinical Trial Logistics     180

Instrumentation  181

Tertiary Packaging and Containers 181

Trucking Companies     183

Figures     184

Tables      187

References  190

 

The Biopharma Cold Chain Sourcebook 2018 is available for purchase at US$1695.
Order now and save: after July 30, the price goes to $2,195! It can be delivered as hardcopy or a PDF. Call us at (718) 282-6112, or e-mail nbasta@PharmaceuticalCommerce.com for more details.