NEW YORK, Jan. 6, 2020 /PRNewswire/ --

INTRODUCTIONAdvanced therapy medicinal products, such as cell and gene therapies, have revolutionized healthcare practices. The introduction of such treatment options has led to a paradigm shift in drug development, production and consumption. Moreover, such therapies have actually enabled healthcare providers to treat several difficult-to-treat clinical conditions. In the past two decades, more than 30 such therapy products have been approved; recent approvals include Zolgensma (2019), RECELL System (2018), AmnioFix (2018), EpiFix (2018), EpiBurn (2018), Alofisel (2018), LUXTURNA (2017), Yescarta (2017), and Kymriah (2017). Further, according to a report published by The Alliance for Regenerative Medicine in 2019, more than 1,000 clinical trials are being conducted across the globe by over 900 companies. In 2018, around USD 13 billion was invested in this domain, representing a 73% increase in capital investments in this domain, compared to the previous year. It is worth highlighting that, based on an assessment of the current pipeline of cell therapies and the historical clinical success of such products, it is likely that around 10-20 advanced therapies are approved by the US FDA each year, till 2025.

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The commercial success of cell and advanced therapies is not only tied to whether they are capable of offering the desired therapeutic benefits, but also on whether the developers are able to effectively address all supply chain requirements. The advanced therapy medicinal products supply chain is relatively more complex compared to the conventional pharmaceutical supply chain. As a result, there are a number of risks, such as possible operational inefficiencies, capacity scheduling concerns, process delays leading to capital losses, and deliverable tracking-related issues, which need to be taken into consideration by therapy developers. This has generated a need for bespoke technological solutions, which can be integrated into existing processes to enable the engaged stakeholders to oversee and manage the various aspects of the cell and advanced therapies supply chain, in compliance to global regulatory standards. Over the years, several innovative, software-enabled systems, offering supply chain orchestration and needle-to-needle traceability, have been developed. The market has also recently witnessed the establishment of numerous partnerships, most of which are agreements between therapy developers and software solutions providers. Further, given the growing demand for cost-effective personalized medicinal products, and a myriad of other benefits of implementing such software solutions, the niche market is poised to grow significantly in the foreseen future.

SCOPE OF THE REPORTThe 'Cell and Advanced Therapies Supply Chain Management Market: Focus on Technological Solutions, 2019-2030' report features an extensive study of the growing supply chain management software solutions market. The focus of this study is on software systems, including cell orchestration platforms (COP), enterprise manufacturing systems (EMS), inventory management systems (IMS), laboratory information management systems (LIMS), logistics management systems (LMS), patient management systems (PMS), quality management systems (QMS), tracking and tracing software (TTS), and other such platforms that are being used to improve / optimize various supply chain-related processes of cell and advanced therapies.

Amongst other elements, the report features: A detailed assessment of the current market landscape, featuring a comprehensive list of over 160 technological platforms that are being used to manage the cell and advanced therapies supply chain, along with information on the different types of software systems (COP, EMS, IMS, LIMS, LMS, PMS, QMS, TTS, and others), their key specifications and benefits (chain of identity and custody, compatibility and integration, data management and analytics, regulatory compliance, reliability and security, scalability, software-as-a-service, traceability, user-friendliness, workflow management, and others), affiliated modes of deployment (cloud and on-premises), scale of management (small enterprise, mid-size enterprise and large enterprise), end users (biobanks, cell therapy labs, hospitals, research institutes, commercial organizations, and others), applications (ordering and scheduling, sample collection, manufacturing, logistics, and patient verification and treatment follow-up), regulatory certifications / accreditations (21 CFR Part 11, CLIA, FACT-JACIE, GAMP 5, GDPR, HIPAA, and others), and key support services offered (customization, installation / implementation, maintenance, training / technical support, upgradation, validation and testing, and others). An insightful company competitiveness analysis, taking into consideration the supplier power (based on their employee base and years of experience in the industry) and portfolio-related parameters, such as number of software solutions offered, affiliated modes of deployment, scale of management, end users, applications, regulatory certifications / accreditations, support services offered, and key platform specifications and benefits. Comprehensive profiles of industry players that are currently offering software solutions for supply chain management, featuring an overview of the company, its financial information (if available), and a detailed description of its software system(s). Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future. A detailed review of the cell and advanced therapies supply chain, offering insights on the processes associated with various stages, such as donor eligibility assessment, sample collection, manufacturing, logistics, and patient verification and treatment follow-up, along with information on cost requirements and existing opportunities for improvement in the supply chain management practices. A qualitative assessment of the current and long-term needs of different stakeholders (patients, healthcare providers, collection centers, manufacturers, logistics service providers and regulators / payers) involved in the cell and advanced therapies supply chain, featuring a summary of the diverse needs and areas of concern, along with our opinion (based on past and prevalent trends) on how the industry is preparing to address such issues. An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are engaged in this field. An analysis of the partnerships that have been established in the domain, in the period between 2014 and Q3 2019, covering software licensing agreements, mergers and acquisitions, product development agreements, product integration agreements, distribution agreements, asset purchase agreements, and other relevant deals. A detailed analysis of the platform utilization use cases where aforementioned software systems were leveraged by various stakeholders in the domain, in the period between 2014 and Q3 2019, highlighting the ways in which companies have implemented such systems to improve / optimize various supply chain-related processes of cell and advanced therapies. An in-depth analysis of the cost saving potential across various processes of the cell and advanced therapies supply chain that can be brought about by the implementation of bespoke and integrated technological solutions / software systems. A case study on COPs, featuring insights on their key functions and implementation strategies, while also considering their strategic position and connectivity with other adjacent systems within the cell and advanced therapies supply chain. In addition, it provides a brief discussion on the growing popularity of COPs on the social media platform, Twitter.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the supply chain management software solutions market. Based on multiple parameters, such as number of cell and advanced therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different software systems, we have developed informed estimates of the evolution of the market, over the period 2019-2030. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] different software systems (COP, EMS, IMS, LIMS, LMS, PMS, QMS, and TTS), [B] applications (donor eligibility assessment, sample collection, manufacturing, logistics, and patient verification and treatment follow-up), [C] modes of deployment (cloud and on-premises), [D] end users (biobanks, cell therapy labs, hospitals, research institutes, and commercial organizations), and [E] key geographical regions (North America, Europe and Asia-Pacific). 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 influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: Bryan Poltilove (Vice President and General Manager, Thermo Fisher Scientific) Jacqueline Barry (Chief Clinical Officer, Cell and Gene Therapy Catapult) Jill Maddux (Director, Cell and Gene Therapy Product Strategy, McKesson) and Divya Iyer (Senior Director, Corporate Strategy and Business Development, McKesson) Martin Lamb (Chief Business Officer, TrakCel)

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 METHODOLOGYThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews 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 technology 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' viewsWhile 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 OUTLINESChapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the cell and advanced therapies supply chain solutions market in the mid to long term.

Chapter 3 is an introductory chapter that presents a general overview of the cell and advanced therapies domain, along with details on the various types of such products and the current therapy landscape. It features a detailed discussion on the cell and advanced therapies supply chain and key challenges related to different processes / stakeholders involved in this segment of the industry. The chapter also provides information on various software-enabled systems, highlighting their key advantages and associated challenges. Further, the chapter describes the key growth drivers and roadblocks related to the use of such solutions in the cell and advanced therapies supply chain, offering insights on the emergence of advanced, digital technologies in the domain, as well.

Chapter 4 includes information on more than 160 technological platforms that are currently being used for managing the critical intricacies within the cell and advanced therapies supply chain. It features detailed information on the different types of software systems (COP, EMS, IMS, LIMS, LMS, PMS, QMS, TTS, and others), their key specifications and benefits (chain of identity and custody, compatibility and integration, data management and analytics, regulatory compliance, reliability and security, scalability, software-as-a-service, traceability, user-friendliness, workflow management, and others), affiliated modes of deployment (cloud and on-premises), scale of management (small enterprise, mid-size enterprise and large enterprise), end users (biobanks, cell therapy labs, hospitals, research institutes, commercial organizations, and others), applications (ordering and scheduling, sample collection, manufacturing, logistics, and patient verification and treatment follow-up), regulatory certifications / accreditations (21 CFR Part 11, CLIA, FACT-JACIE, GAMP 5, GDPR, HIPAA, and others), and key support services offered (customization, installation / implementation, maintenance, training / technical support, upgradation, validation and testing, and others).

Chapter 5 features an insightful competitiveness analysis of the software solutions providers based on various parameters, such as number of software systems offered, affiliated modes of deployment, scale of management, end users, applications, regulatory certifications / accreditations, support services offered, and key platform specifications and benefits. In the chapter, stakeholder entities have been plotted on a 2X2 matrix, having a company's Supplier Power (based on its employee base and years of experience in the industry) and Company Competitiveness as the two axes.

Chapter 6 includes elaborate profiles of companies that are currently offering core supply chain management software systems, such as EMS, IMS, LIMS, LMS, PMS, QMS, and TTS (shortlisted on the basis of company competitiveness analysis scores); each profile features an overview of the company, its financial information (if available), and a detailed description of the platform(s). Each profile also includes a list of recent developments, highlighting key achievements, partnership activity and the likely strategies that may be adopted by these players to fuel growth in the foreseen future.

Chapter 7 presents a brief introduction to COPs, along with insights into their key functions and implementation strategies, while also considering their strategic position and connectivity with other adjacent systems within the entire cell and advanced therapies supply chain. Further, the chapter includes a brief discussion on the growing popularity of COP on the social media platform, Twitter, and presents a snapshot of how the public opinion about such technological solutions has evolved in the period 2014-2018. In addition, the chapter features detailed profiles of all the industry players that are currently offering COPs for supply chain management. For each of these companies, we have presented detailed profiles, featuring an overview of the company, its financial information (if available), and a detailed description of the platform(s). Each profile also includes a list of recent developments, highlighting key achievements, partnership activity and the likely strategies that may be adopted by these players to fuel growth in the foreseen future.

Chapter 8 provides information on funding instances and investments that have been made within the cell and advanced therapies supply chain management market. The chapter includes details on various types of investments (such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings) received by companies between 2014 and Q3 2019, highlighting the growing interest of the venture capital community and other strategic investors in this domain.

Chapter 9 features an elaborate discussion and analysis of partnerships / collaborations that have been established in the domain in the period between 2014 and Q3 2019. It includes a brief description of various types of partnership models (such as software licensing agreements, mergers and acquisitions, product development agreements, product integration agreements, distribution agreements, asset purchase agreements, and others) that have been employed by stakeholders within this domain. It also consists of a schematic representation showcasing the players that have established the maximum number of alliances in this industry. 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.

Chapter 10 presents a detailed analysis of platform utilization use cases where the aforementioned software systems were leveraged by various stakeholders in the domain, in the period between 2014 and Q3 2019. It includes a brief discussion on the ways in which companies have implemented such software solutions to improve / optimize various supply chain-related processes of cell and advanced therapies.

Chapter 11 provides a qualitative assessment of the current and long-term needs of different stakeholders (patients, healthcare providers, collection centers, manufacturers, logistics service providers and regulators / payers) involved in the cell and advanced therapies supply chain. It also presents a summary of the diverse needs and areas of concern, along with our opinion (based on past and prevalent trends) on how the industry is preparing to address the aforementioned issues.

Chapter 12 presents a detailed review of the cell and advanced therapies supply chain, offering insights on the processes associated with various stages, such as donor eligibility assessment, sample collection, manufacturing, logistics, and patient verification and treatment follow-up, along with information on cost requirements and existing opportunities for improvement in the supply chain management practices.

Chapter 13 features an insightful analysis, highlighting the cost saving potential across various processes of the cell and advanced therapies supply chain that can be brought about by the implementation of bespoke and integrated technological solutions / software systems.

Chapter 14 features a comprehensive market forecast, highlighting the future potential of the supply chain management software solutions market till 2030, based on multiple parameters, such as number of cell and advanced therapies in development, expected pricing, likely adoption rates, and cost saving opportunity from different software systems. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] different software systems (COP, EMS, IMS, LIMS, LMS, PMS, QMS, and TTS), [B] applications (donor eligibility assessment, sample collection, manufacturing, logistics, and patient verification and treatment follow-up), [C] modes of deployment (cloud and on-premises), [D] end users (biobanks, cell therapy labs, hospitals, research institutes, and commercial organizations), and [E] key geographical regions (North America, Europe and Asia-Pacific). 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.

Chapter 15 is a collection of executive insights of the discussions that were held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Bryan Poltilove (Vice President and General Manager, Thermo Fisher Scientific), Jacqueline Barry (Chief Clinical Officer, Cell and Gene Therapy Catapult), Jill Maddux (Director, Cell and Gene Therapy Product Strategy, McKesson) and Divya Iyer (Senior Director, Corporate Strategy and Business Development, McKesson), and Martin Lamb (Chief Business Officer, TrakCel).

Chapter 16 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 17 is an appendix, which provides a comprehensive list of technological solutions / software systems that are being used to effectively manage and streamline the supply chain processes of the overall healthcare industry.

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 provides the list of companies and organizations mentioned in the report.

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Cell and Advanced Therapies Supply Chain Management Market: Focus on Technological Solutions, 2019-2030 - PRNewswire

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