Cold Chain Logistics Market for Healthcare: Focus on Cell Therapies, Vaccines, and Human Organs, 2018-2030

NEW YORK, Dec. 27, 2018 /PRNewswire/ -- INTRODUCTION
The origins of the cold chain for transportation of temperature sensitive products can be traced back to 1797, when British fishermen first used natural ice to preserve their fish stock. , Presently, a wide variety of pharmaceutical products, such as biologics, vaccines, human organs for transplantation and certain conventional pharmacological interventions as well, are temperature sensitive and require freezing / cryogenic holding temperatures for transport. In fact, over 95% of all approved biologics and 90% of all vaccines are cold chain dependent. Other healthcare products which are required to be shipped / stored under specific temperature conditions include aerosols, blood plasma samples, certain types of diagnostics kits, fertility samples, and laboratory specimens. For some products, even the slightest variations in temperature / storage conditions can adversely alter their integrity and / or viability.

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Over the years, the growing demand for such products has necessitated the need for well-defined infrastructure and protocols to support cold chain dependent logistics operations. Further, stakeholders in this segment of the industry have designed and established a variety of innovative solutions to serve the evolving demands of the healthcare sector. Moreover, connected cold chain solutions have been observed to offer a variety of advantages over conventional methodologies, such as automation of most of the steps and elimination of human handling errors that are associated with human intervention.

In addition, the industry has witnessed several facility / capability expansions and acquisitions owing to an increasing demand for cold chain logistics services, which is indicative of the growing interest of stakeholders in this particular type of supply chain. Given the recent technical breakthroughs and advances, and the steadily rising demand for biopharmaceuticals, the reliance on cold chain is expected to increase substantially, causing logistics service providers to contemplate, devise and implement flexible business strategies and operational models to cope up with the future needs.

SCOPE OF THE REPORT
The 'Cold Chain Logistics Market for Healthcare: Focus on Cell Therapies, Vaccines, and Human Organs, 2018-2030' report features an extensive study of the current landscape and future outlook of the growing cold chain logistics services market. The study features an in-depth analysis, highlighting the capabilities of the various service providers engaged in this domain.

Amongst other elements, the report features:
• An analysis comparing the logistical complexities associated with cell therapies, vaccines and human organs, based on several parameters, such as holding temperatures, delivery time restrictions, handling / transportation requirements, and storage related needs.
• A detailed assessment of the overall market landscape, featuring a comprehensive list of over 80 players that offer cold chain logistics services for cell therapies, vaccines and human organs, and detailed analyses based on a number of parameters, such as the location of headquarters, size of employee base, 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.
• An insightful 2X2 representation of the results of a competitiveness analysis of various logistics service providers (segregated into three peer groups based on their employee count (small-sized (1-200 employees), mid-sized (>201-1,000 employees) and large (>1,000 employees)), highlighting capable players in this domain, 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.
• Elaborate profiles of leading cold chain logistics service providers (shortlisted on the basis of the company competitiveness analysis), featuring an overview of the company, its financial information (if available), funding information (if available), information on cold chain logistics service(s) / product(s), recent partnerships, and a comprehensive future outlook.
• An analysis of the partnerships that have been established in the recent past, covering service alliances, logistics service agreements, merger / acquisitions, equipment development / manufacturing agreements, R&D agreements, and joint ventures.
• A detailed discussion on the various regulatory guidelines that have been laid down by major regulatory bodies (such as European Medicines Agency (EMA), United States Food and Drug Administration (USFDA), Health Canada (HC), International Air Transport Association (IATA), International Council for Harmonisation (ICH), International Safe Transit Association (ISTA), Parenteral Drug Association (PDA), United States Pharmacopeia (USP), and World Health Organization (WHO)), specific to cold chain management. In addition, it features an insightful analysis, comparing regulatory authorities based on the guidelines issued by them for different stages of the cold chain.
• A case study on the cold chain management strategies used for over 190 drugs (both biologics and small molecules) that were approved in the last five years, highlighting year-wise trend of cold chain adoption. In addition, it analyzes the cold chain temperature requirements of these drugs, based on several parameters, including type of molecule(s), dosage form and route of administration.
• A detailed estimation of the likely demand for logistics services for [A] cell therapies (including stem cell therapies, T-cell therapies, dendritic cell therapies, natural killer cell therapies and tumor therapies), considering the contributions of clinical and commercial stage products over the period 2018-2030; [B] vaccines (including over 15 types of mandatory and optional vaccines), considering the contributions of both clinical and commercially available products for both infants and adults, over the period 2018-2030; and [C] human organs (including heart, intestine, kidney, liver, lung, and pancreas) for transplants, over the period 2018-2030.
• A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industry's evolution, under a comprehensive SWOT framework. It also includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall cold chain logistics market.
• A discussion on the upcoming tools / technologies (such as integration of automation and robotics, cloud computing, blockchain technology, artificial intelligence and other such advanced technical solutions) in the field of cold chain logistics and their likely impact on the future evolution of this market.
One of the key objectives of the report was to estimate the existing market size and potential growth opportunities for cold chain logistics over the coming decade. Based on several parameters, we have provided an informed estimate of the likely evolution of this market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the future opportunity based on [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). In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry's evolution.

The opinions and insights presented in this study were also influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
• 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)
• Shehdeh Abusnineh (Supply Chain Manager, Tabuk Pharmaceuticals).

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
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.

EXAMPLE HIGHLIGHTS
1. Over 85 players are currently offering cold chain logistics services for cell therapies, vaccines and human organs across a wide range of recommended holding temperatures; of these, majority of the companies offer services to transport products at ambient and refrigerated temperatures (70+ each), followed by players that offer services at frozen (60+) and cryogenic temperatures (30+). Examples of players engaged in this domain include (in alphabetical order, no selection criteria) Air Liquide Company, American Airlines Cargo, Cryoport, DHL Express, PAREXEL, and United Parcel Service.
2. The market is characterized by the presence of several established as well as emerging players. Of the total, 43% are large companies (more than 1,000 employees), 16% are mid-sized companies (201-1,000 employees), while 41% are small-sized players (less than 200 employees). Examples of some of the established players (with more than 25 years of experience in the industry) include (in alphabetical order, no selection criteria) Bollore Logistics, Cardinal Health, DHL International, FedEx Express, GAC, Kuehne and Nagel International, Yusen Logistics, and Zuellig Pharma. On the other hand, some of the players that have recently entered this domain include (in alphabetical order, no selection criteria) Accelogix, Arcticold Logistics, Biotech & Pharma Logistics, Camio Logistics Solutions and Cold Box Express.
3. Over 40% of all drugs (small molecules and biologics) that have been approved so far in 2018 are cold chain dependent, having different holding temperature requirements for transportation. Particularly, within biologics, all the approved monoclonal antibodies and cell therapies are cold chain dependent. Examples of recently approved biologics that are cold chain dependent include LUXTURNA®, KYMRIAH® and YESCARTA®.
4. Specifically, for cell therapies, the current global commercial demand for cold chain logistics services is primarily driven by autologous therapies, which account for 83% of the currently approved cell therapies. However, in future (by 2030), as more of such therapy products are approved, the demand for cold chain logistics services is likely to increase significantly. In terms of clinical scale requirements, the demand for cell therapies is driven by over 1,000 active clinical trials, with 1,19,000+ enrolled patients, focused on evaluating different types of cell therapies in multiple centers / hospitals / institutions across the globe.
5. For vaccines, the current clinical demand is based on the requirement of these products in close to 1,300 trials that have been registered (ongoing / planned) across different geographies. Based on the number of trials, North America (~750 trials) has emerged as a major research / innovation hub in this domain; it is also worth highlighting that about 74% of the total number of patients enrolled in the aforementioned trials have been recruited in centers in Asia-Pacific and rest of the world.
6. Specifically, for human organs, around 140,000 organ transplants take place annually across the globe. Presently, kidneys are the most common type of human organ being transplanted (65%), followed by liver (23%). However, lung transplants are likely to witness the maximum CAGR (~ 7%) between 2018 and 2030.
7. A growing number of partnerships have been forged between logistics service providers and developer companies and / or other logistics service providers during the period 2014-H1 2018. It is worth mentioning that most of these partnerships were service alliances (36%). logistics service agreements (27%) are the next most popular partnerships, through which developer companies have recruited the services of logistics services providers. This is followed by mergers / acquisitions accounting for 24% of the total number of deals. Prominent logistics service providers that have entered into multiple partnerships in the given time period, include (in alphabetical order) Cryoport, Brooks Life Sciences, CSafe Global, TrakCel and Tower Cold Chain Solutions.
8. Amidst increasing competition in this domain, logistics service providers are actively investigating and adopting several innovative tools / techniques in order to expedite the controlled delivery of temperature sensitive products and improve the overall productivity. Examples of such tools / technologies (in no specific order) include automation and robotics, augmented reality, cloud computing, blockchain technology, artificial intelligence and other such advanced technical solutions. Examples of companies that are presently offering such tools / techniques include (in alphabetical order, no selection criteria) CargoSense, DeltaTrak, Dynamox, Entera Solutions, NexG, OpenPort, SwanLeap, TAG Sensors, and ZilionSouce Technologies.
9. The market for cold chain logistics is expected to grow at an annualized rate of nearly 5.9% between 2018 and 2030. While logistics services for cell therapies are expected to capture the majority share in the market, the vaccines segment is anticipated to witness a relatively faster growth rate. In terms of products, those that are required to be stored / transported at cryogenic and frozen temperatures are estimated to capture a significant proportion of the current market.
10. North America (primarily the US) and Europe currently hold the larger share (over 80%) in the overall cold chain logistics market. This is followed by Asia-Pacific and the rest of the world, which currently capture around 20% of the overall market share. We are led to believe that this trend is not likely to change significantly in the foreseen future.

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