Cold Chain Logistics

Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the state of the healthcare cold chain logistics market in the short to mid-term and long term.

Chapter 3 is an introductory chapter that provides a detailed comparison of the traditional supply chain and cold chain, along with information on the various processes and procedures associated with cold chain logistics, including a discussion on its historical evolution. It also elaborates on the key steps involved in cold chain logistics operations of temperature-sensitive healthcare products, including cold chain storage, packaging, transportation and monitoring. Further, the chapter provides a brief overview of different kinds of healthcare products, which require cold chain operations, along with the preferred storage / transportation temperature ranges for each product. It also features a comprehensive discussion on the various modes of transportation used for such shipments. Further, the chapter features a discussion on the various advantages and limitations associated with the cold chain logistics and management industry.

Chapter 4 features a detailed discussion on various complexities associated with the cold chain logistics operations for cell therapies, vaccines and human organs. It also highlights the criticality of cold chain logistics during product manufacturing, storage, packaging and transportation. Furthermore, it provides information on recommended cold chain temperature profiles and best practices for shipping and storage of the aforementioned product types. The chapter also elaborates on the various challenges related to cold chain logistics operations and their solutions. It includes two case studies of recent advancements, namely cell orchestration platforms for management of cell therapy logistics and innovative beating heart-in-a-box technology for efficient human organ logistics. It also includes an informative multi-valent analysis to compare the logistical complexities related to cell therapies, vaccines and human organs based on several parameters, such as temperature conditions, delivery time restrictions, handling / transportation requirements, and storage related needs.

Chapter 5 includes a comprehensive market landscape analysis of companies that offer cold chain logistics services, particularly for the shipping of cell therapies, vaccines and human organs. The chapter presents detailed analyses on the basis of the location of their headquarters, employee count, type of products (cell therapies, vaccines, human organs, pharmaceutical products, and others), type of services offered (storage, packaging, and transportation), mode of transportation (ground, air, and ocean), holding temperature range (ambient, refrigerated, frozen, and deep frozen / cryogenic), type of packaging methods (dry ice, liquid nitrogen, and gel packs), type of container (active and passive containers), type of end-users (industry players and non-industry players), geographical activity and location of cold chain facilities. The chapter also provides a list of cold chain equipment / technologies and monitoring systems, along with their developers. Further, it includes an indicative list of players offering cold chain logistics for other pharmaceutical products,and a list of companies that are acting as air ambulances for the transportation of human organs.

Chapter 6 features a comprehensive 2X2 analysis offering a comparative summary of all the cold chain logistics service providers that we came across during our research. The analysis compares the aforementioned companies within three peer-groups, established based on size of employee base (small-sized (1-200 employees), mid-sized (>201-1,000 employees) and large (>1,000 employees)). The companies were compared based on their cold chain logistics capabilities, such as type(s) of container, type(s) of service(s) offered, holding temperature range, modes of transportation employed, geographical activity and type(s) of cold chain product(s) and supplier power.

Chapter 7 provides detailed profiles of some of the important cold chain logistics providers (shortlisted on the basis of the company competitiveness analysis), based in different geographies. Each company profile includes a brief overview of the company, financial information (if available), funding information (if available), details on its cold chain logistics service(s) / product(s) capabilities, recent partnerships, and a comprehensive future outlook.

Chapter 8 features an elaborate discussion and analysis of the various partnerships / collaborations that have been inked amongst players in this market. It includes a brief description on the various types of partnership models (such as service alliances, logistics service agreements, merger / acquisitions, equipment development / manufacturing agreements, R&D agreements, and joint ventures) that have been employed by stakeholders in this domain, and analysis on the trend of partnerships inked since 2014. It also consists of a schematic representation showcasing the service providers that have established the maximum number of alliances. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents. In addition, it includes an analysis of the mergers and acquisitions that have taken place in the last five years. The chapter also highlights the recent facility expansions undertaken by cold chain logistics providers in the given time period.

Chapter 9 provides information on the regulatory guidelines that have been laid down by key regulatory bodies / organizations, specific to cold chain management in the healthcare industry. These include EMA, USFDA, HC, IATA, ICH, ISTA, PDA, USP, and WHO. In addition, it features an insightful analysis, comparing different regulatory authorities, based on the guidelines issued by them for different stages of the cold chain.

Chapter 10 presents a case study on the cold chain management strategies for over 190 drugs (both biologics and small molecules) approved by the USFDA from 2014 to 2018 (till July), highlighting year-wise trend of cold chain adoption. The chapter comprises of in-depth analyses, highlighting the cold chain temperature requirements of these drugs, based on several parameters, including type of molecule(s), dosage form and route of administration. Furthermore, we have also highlighted the leading players in this domain, based on the number of cold chain drug approvals received in the given time period.

Chapter 11 features a holistic view on the demand for cell therapy products (both clinical and commercial stage) in the market, allowing us to present an informed opinion on the required scale of supply (in terms of cold chain logistics support). For the purpose of estimating the current clinical demand, we looked at the active clinical studies that have been registered in the last five years for different types of cell therapy product candidates, including stem cell therapies, T-cell therapies, dendritic cell therapies, natural killer cell therapies and tumor therapies. Further, the data was analyzed on the basis of various parameters, such as number of trials, type of cell therapies, regional distribution, leading industry and non-industry players, key indications, and enrolled patient population across different geographies. In order to estimate the commercial demand, we looked at the currently available and late-stage cell therapies across the aforementioned classes, which are expected to receive approval in the coming decade.

Chapter 12 features a holistic view on the demand for vaccines (both clinical and commercially available) in the market, allowing us to present an informed opinion on the required scale of supply (in terms of cold chain logistics support). For the purpose of estimating the current clinical demand, we looked at the active clinical studies that have been registered in the last five years for different types of vaccines. Further, the data was analyzed on the basis of various parameters, such as number of trials, recommended holding temperature, regional distribution, leading industry and non-industry players, and enrolled patient population across different geographies. In order to estimate the commercial demand, we looked at the commercially available vaccines (both mandatory and optional) that are shipped in different countries across the globe, to be administered to the patients (both infants and adults), over the period 2018-2030.

Chapter 13 features a detailed analysis of the current demand for cold chain logistics for human organs, wherein we considered the actual transplants, patients on the waiting list and available donors for vital human organs (including heart, kidney, liver, lung, and intestine / pancreas), across different geographies.

Chapter 14 features a comprehensive market forecast, highlighting the future potential of cold chain logistics market till 2030. We have segmented the market on the basis of [A] regional evolution of the market covering key geographies, such as North America (the US, Canada and Mexico), Europe (the UK, Germany, France, Germany, Spain and Italy), Asia-Pacific and Rest of the World (Australia, China, India, and Japan), [B] type of products (cell therapies, vaccines, and human organs), [C] holding temperature ranges (refrigerated, frozen, and cryogenic), [D] type of containers (active and passive containers), and [E] type of end-users (industry players and non-industry players).

Chapter 15 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of cold chain management in the healthcare industry, under a comprehensive SWOT framework.

Chapter 16 provides a discussion on the upcoming tools / technologies, which are being developed / adopted by the cold chain logistics service providers, that are likely to have a notable influence on the industry’s evolution over the coming decade. These include (but not limited to) integration of automation and robotics, augmented reality, cloud computing, internet of things (IoT), radio frequency identification (RFID), blockchain technology, artificial intelligence and big data analytics. In addition,the chapter presents an exemplary list of players that are offering the aforementioned technologies for cold chain logistics to the healthcare and pharmaceutical industry. It also features a qualitative Harvey ball analysis to project their adoption in cold chain industry in the short and long term.

Chapter 17 is a collection of executive insights of the discussions that were held with key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Elena Boykova (Marketing Communications Manager, AirBridgeCargo Airlines), Jacqueline Barry (Chief Clinical Officer, Catapult Cell and Gene Therapy), Michelle Arnot-Kruger (Health Specialist, Cold Chain Logistics, UNICEF), and Shehdeh Abusnineh (Supply Chain Manager, Tabuk Pharmaceuticals).

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix, which contains the list of companies and organizations mentioned in the report.

Table of Contents

1 PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2 EXECUTIVE SUMMARY