Cell and Gene Therapy Supply Chain Software Market: Industry Trends and Global Forecasts, Till 2035: Distribution by Process Component, Type of Software, Mode of Deployment, Scale of Operation, Type of End-user and Key Geographical Regions

Featuring Profiles of Azenta Life Sciences, NMDP BioTherapies, Biocair, BioLife Solutions, CareDx, Cryoport, Lonza, TraceLink, TrakCel, and Veeva Systems

The global cell and gene therapy (CGT) supply chain software market is projected to grow from $274 million in 2024 to $1,329 million by 2035, representing a CAGR of 15.2%, during the forecast period 2024-2035. This research study consists of industry trends, detailed cell and gene therapy supply chain software market analysis, funding and investment trends, partnerships and collaborations analysis, platform utilization trends, stakeholder needs analysis and market impact analysis. The report includes cell and gene therapy supply chain software market forecast and opportunity analysis.

Advanced therapies, including cell and gene therapy products, have revolutionized healthcare practices. The introduction of such therapeutic options has led to a paradigm shift in the development, production, and consumption of modern medicine. Moreover, such therapies have enabled healthcare providers to treat several rare clinical conditions. In the last few decades, more than 30 such therapeutic modalities have been approved; recent approvals include ELEVIDYS® (2023), Adstiladrin® (2022), Breyanzi® (2022), CARVYKTI® (2022), Abecma® (2021), Allocord™ (2019), LUXTURNA™ (2017) and Yescarta® (2017).

Further, according to a report published by Novotech, it was anticipated that more than 12 novel cell and gene therapies would be approved by the end of 2023, highlighting lucrative opportunities for stakeholders in this market. Moreover, post-2018, over 40% of the clinical trials registered for the treatment of rare diseases involved the evaluation of novel cell and gene therapy products. It is worth highlighting that, based on an assessment of the current pipeline of cell and gene therapy and the historical clinical success of such products, it is assumed that around 10-20 advanced therapies would get approved by the United States Food and Drug Administration, each year, till 2025. Owing to the increase in the number of approved therapies, the demand for novel software solutions to manage the supply chain is also expected to rise, providing subsequent growth opportunities for cell and gene therapy software providers.

It is important to note that the commercial success of cell and gene therapy products depends not only on their ability to provide the desired therapeutic benefits but also on developers' capacity to efficiently meet all supply chain needs. The cell and gene therapy supply chain is relatively more complex compared to the conventional pharmaceutical supply chain owing to the temperature sensitivity and uniqueness of such products. As a result, there are a number of risks in terms of process inconsistency, including possible operational inefficiencies, capacity scheduling concerns, process delays leading to capital loss, and delivery / tracking-related issues, which needs to be taken care by therapy developers.

This has generated a need for bespoke software solutions, which can be integrated into existing processes and enable the drug developers to oversee and manage the various aspects of the cell and gene therapy supply chain at each step. Over the years, several innovative software solutions, offering supply chain orchestration and needle-to-needle traceability, have been developed. The market has also witnessed an increase in the number of partnerships inked for the advancement of such software solutions. Further, given the growing demand for cost-effective personalized medicinal products, and the cost saving potential of implementing such software solutions, the cell and gene therapy supply chain software market is poised to grow significantly in the foreseen future.

Cell and Gene Therapy Supply Chain Software Market Share Insights

The cell and gene therapy supply chain software market research report presents an in-depth analysis of various software solutions that are involved in managing cell and gene therapies supply chain, across different segments, as defined below:

• Historical Trend: 2018-2023
• Base Year: 2023
• Forecast Period    2024-2035
• Market Size 2024: $274 Million
• Market Size 2035: $1,329 Million
• Growth Rate: CAGR of 15% from 2024 to 2035
• PowerPoint Presentation (Complimentary)
• Customization scope: 15% Free Customization
• Process Component
  • Sample Collection and Processing Component
  • Manufacturing Component
  • Logistics Component
  • Patient Identification and Treatment Follow-up Component
• Type of Software
  • Enterprise Manufacturing System (EMS)
  • Laboratory Information Management System (LIMS)
  • Inventory Management System (IMS)
  • Cell Orchestration Platform (COP)
  • Quality Management System (QMS)
  • Logistics Management System (LMS)
  • Patient Management System (PMS)
• Mode of Deployment
  • On-premises Deployment
  • Cloud-based Deployment
• Type of End-user
  • Pharmaceutical Companies
  • Cell Therapy Labs
  • Hospitals / Medical Centers
  • Research Institutes / Biobanks
• Scale of Operation
  • Clinical Scale
  • Commercial Scale
• Geography
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Key Companies Profiled
  • Azenta Life Sciences
  • Biocair
  • BioLife Solutions
  • CareDx
  • Cryoport
  • Lonza
  • NMDP BioTherapies
  • TraceLink
  • TrakCel
  • Veeva Systems
  • Emerson
  • LabVantage Solutions
  • Marken
  • MasterControl
  • QuickSTAT
  • Siemens
  • Stafa Cellular Therapy
  • Steiner
  • STEMSOFT Software
  • TECHNIDATA
  • Thermo Fisher Scientific
• Excel Data Packs (Complimentary):
  • Market Landscape Analysis
  • Company Competitiveness Analysis
  • Funding and Investment Analysis
  • Partnership and Collaborations Analysis
  • Platform Utilization Cases Analysis
  • Market Size an Opportunity Analysis

Cell and Gene Therapy Supply Chain Software Market Key Segments

Market Share by Process Component

The global cell and gene therapy supply chain software market is segmented into different process components, such as sample collection and processing component, manufacturing component, logistics component, and patient identification and treatment follow-up component. The manufacturing component occupies the highest share in 2024 and is expected to remain dominant during the forecast period. This can be attributed to the high adoption of supply chain software solutions in manufacturing processes to streamline the overall therapy development and deliver quality products.

Market Share by Type of Software

This segment highlights the distribution of the cell and gene therapy supply chain software market across different types of software solutions, such as EMS, LIMS, IMS, COP, QMS, LMS and PMS. Owing to the fact that there is a high demand for supply chain management solutions to meet production and quality requirements, the enterprise manufacturing system (EMS) market holds the largest market share in 2024. However, cell orchestration platforms (COP) are easier to deploy and have witnessed an increased adoption among pre-clinical drug developers, following which, these novel software platforms are expected to grow at a relatively higher rate.

Market Share by Mode of Deployment

The global cell and gene therapy supply chain management software industry highlights the distribution of software solutions based on mode of deployment, such as on-premises deployment and cloud-based deployment. It is worth highlighting that the market share for cloud-based software is likely to grow at a higher CAGR in the coming years as compared to the software solutions which are deployed on-premises.

Market Share by Scale of Operation

The global cell and gene therapy supply chain software market features different software solutions which can be used to manage operations at clinical and commercial scales. It is worth highlighting that software solutions employed for managing clinical operations are likely to grow at a higher CAGR in the coming years as compared to the software solutions which are used to manage commercial scale supply chain.

Market Share by Type of End-User

The global cell and gene therapy supply chain software market caters to a variety of end-users, including pharmaceutical companies, cell therapy labs, hospitals / medical centres and research institutes / biobanks. Pharmaceutical companies capture the highest share in 2024 and are expected to dominate the market during the forecast period. This can be attributed to the high adoption of supply chain software solutions by pharmaceutical companies to orchestrate different processes of therapy development, including sample collection, processing and shipment.

Market Share by Geography

This segment highlights the distribution of the cell and gene therapy supply chain software market across various geographies, such as North America, Europe, and Asia-Pacific and rest of the world. According to the projections, North America captures the majority share (54%) of the market opportunity, and this trend is unlikely to change during the forecast period. It is worth highlighting that the CGT supply chain software market in Asia-Pacific is expected to grow at a relatively higher CAGR (20%), during the forecast period, 2024-2035.

Cell and Gene Therapy Supply Chain Software Market Key Insights

The report features an extensive study of the current market landscape, market size and future opportunities associated with software providers within the cell and gene therapy supply chain software industry, during the given forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the software providers industry. Key takeaways of the peptide synthesis market report are briefly discussed below.

Advantages of Using Supply Chain Software for Cell and Gene Therapies

The software providers engaged in the cell and gene therapy supply chain software market have a well-established product portfolio and skilled professionals having technical expertise related to different software platforms. The software solutions provided by these companies follow stringent regulatory guidelines in order to ensure the data integrity and confidentiality of the samples used for cell and gene therapy development. Additionally, the supply chain software solutions assist in providing regulatory compliance for various processes, such as sample collection, sample processing and shipment activities.

Further, one of the primary benefits of using CGT supply chain software is its cost-saving potential. Companies integrating these software solutions can curb the costs associated with improper manual data handling at different stages of the supply chain. Moreover, companies engaged in the cell and gene therapy supply chain software market have specialized teams to provide services to multiple consumers; additionally, these software solutions assist in cold chain logistics management of raw materials procured by the end-user from the donor itself.

Competitive Landscape of Software Solutions in the Cell and Gene Therapy Supply Chain Software Market

The current market landscape features the presence of close to 175 supply chain software solutions, to manage a variety of steps in the cell and gene therapy development; these software solutions include EMS, LIMS, IMS, COP, QMS, LMS and PMS. Further, these software solutions offer a variety of applications, including regulatory compliance, sample inventory management, workflow management, ordering and scheduling, logistics management, manufacturing management, and patient engagement. Moreover, CGT supply chain software solutions can also be used to maintain the chain of identity and custody throughout the cell therapy cycle in order to provide an end-to-end traceability of the samples.

It is interesting to highlight that close to 100 companies are engaged in providing such software solutions. In order to meet the increasing demand for CGT supply chain software, these companies have undertaken several initiatives, such as entering into strategic collaborations, and expanding their existing capabilities / product portfolios.

Cell and Gene Therapy Supply Chain Software Market Trends: Increasing Partnerships and Collaborations Amongst the Software Providers to Foster Progress and Innovation

Software providers in the cell and gene therapy supply chain software market have forged several partnerships with other companies in order to enhance their product portfolios. It is worth highlighting that a significant increase in partnership activity has been witnessed in 2023. This can be attributed to the incessant efforts of software providers to further advance the development of their software solutions for cell and gene therapy supply chain. Notably, the majority of the deals were focused on acquiring other companies engaged in the CGT supply chain software market, followed by platform utilization agreements and service alliances.

In December 2023, LabWare entered into a platform integration agreement with Körber to integrate the former company’s LIMS platform with Körber’s proprietary manufacturing execution system. Such partnerships are expected to drive growth of the cell and gene therapy supply chain software market during the forecast period.

Key Drivers of the Cell and Gene Therapy Supply Chain Software Market

Cell and Gene Therapy Supply Chain Software Market Size: Cell Orchestration Platforms to Drive Market Growth

The global market opportunity for cell and gene therapy supply chain software providers is estimated to be USD 243 million in 2024, driven by the rapidly increasing demand for personalized medicine. In terms of type of software, the market for cell orchestration platforms (COP) in the cell and gene therapy supply chain software market is anticipated to grow at relatively higher CAGR of 18.1%, during the forecast period, 2024-2035. The market growth is primarily fueled by increasing popularity of COPs, owing to their proven ease of deployment and capability to provide needle-to-needle traceability withing the cell and gene therapy supply chain.

North America Holds the Largest Share of the Cell and Gene Therapy Supply Chain Software Market

Presently, close to 55% of the cell and gene therapy supply chain software market opportunity is created by the demand for personalized medicines in North America. This can be attributed to the increasing R&D investments, partnership activity and funding received by various therapy developers for the development of novel cell and gene therapies. Further, the market for these software solutions in Asia-Pacific is expected to grow at a relatively higher CAGR of 20.2%, during the forecast period.

Leading Software Providers in the Cell and Gene Therapy Supply Chain Software Market

Examples of key software providers involved in the cell and gene therapy supply chain software industry (which have also been captured in this market report, arranged in alphabetical order) include Azenta Life Sciences, NMDP BioTherapies, Biocair, BioLife Solutions, CareDx, Cryoport, Lonza, TraceLink, TrakCel, Veeva Systems. This market report includes an easily searchable excel database .for all the companies offering software solutions for cell and gene therapy along with information on their proprietary software solutions offered to orchestrate the overall processes.

Recent Developments in the Cell and Gene Therapy Supply Chain Software Market

Several recent developments have taken place in the market, some of which have been outlined below. These developments even though they took place post the release of the cell and gene therapy supply chain software market report, substantiate the overall market trends that the analyst has outlined in the analyses.

• In January 2024, Veeva Systems entered into a partnership with SK Biopharmaceuticals to utilize the former company’s proprietary quality management system and reduce potential risks associated with quality compliance of regenerative medicine.
• In December 2023, Hypertrust entered into a joint venture with Tamer Health to build a robust infrastructure for the advancement of personalized therapies, primarily focusing on cell and gene therapies.
• In November 2023, BioLife Solutions raised USD 10.4 million through a private placement, which the company plans to utilize for advancing its supply chain offerings for cell and gene therapies.

Cell and Gene Therapy Supply Chain Software Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various software providers in this market, across different segments. Amongst other elements, the market report includes:

• A preface providing an introduction to the full report, Cell and Gene Therapy Supply Chain Software Market (2nd edition), 2018-2023 (Historical Trends) and 2024-2035 (Forecasted Estimates).
• An outline of the systematic research methodology adopted to conduct the study on cell and gene therapy supply chain software industry, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of the findings.
• An overview of economic factors that impact the overall cell and gene therapy supply chain software market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the insights captured during the research. It offers a high-level view on the current state of software solutions for cell and gene therapy supply chain and its likely evolution in the mid-long term.
• A general overview of cell and gene therapy supply chain, highlighting details on different types of software solutions with their key features and applications. It also features various advantages of supply chain software in the cell and gene therapy industry. Further, it provides information on the different challenges related to conventional supply chain, along with the opportunities and future perspectives associated with supply chain management software.
• A detailed overview of the current market landscape of software solutions in the cell and gene therapy supply chain software market, along with information on several relevant parameters, such as type of software (cell orchestration platform (COP), enterprise manufacturing system (EMS), inventory management system (IMS), laboratory information management system (LIMS), logistics management system (LMS), patient management system (PMS), quality management system (QMS) and tracking and tracing system (TTS)), key features (compatibility and integration, traceability, data analytics and visualization, scalability, user-friendliness and chain of identity and custody), application area (regulatory compliance, sample inventory management, workflow management, ordering and scheduling, logistics management, manufacturing management and patient engagement), mode of deployment (on-premise / web-based, cloud or both), scale of operation (pre-clinical, clinical and commercial), regulatory guidelines followed (Code of Federal Regulations (21 CFR Part 11), Good Manufacturing Practices (GMP), International Organization for Standardization (ISO), Health Insurance Portability and Accountability Act (HIPAA), European Directives (EU Directives), General Data Protection Regulation (GDPR), The Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee - ISCT and EBMT (FACT-JACIE), Clinical Laboratory Improvement Amendments (CLIA) and Good Automated Manufacturing Practice (GAMP5)) and type of end-user (pharmaceutical companies, cell therapy labs, hospitals / medical centers, research institutes and biobanks). In addition, this section provides a detailed list of developers providing cell and gene therapy supply chain software solutions, along with analysis based on various parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters (North America, Europe, Asia-Pacific, and rest of the world). Further, this section also presents most active players based on the number of software solutions offered.
• An insightful competitiveness analysis of companies offering software solutions in the cell and gene therapy supply chain software industry, based on several relevant parameters, such as developer strength (in terms of number of years of experience of a company in this domain and company size) and product portfolio strength (in terms of number of partnership deals inked, number of application areas, number of key features offered, number of end-users, mode of deployment, scale of operation and number of regulatory guidelines followed).
• Elaborate profiles of key software providers (shortlisted on the basis of the number of partnership deals inked by a company and the number of software solutions offered) engaged in the cell and gene therapy supply chain software market. Each profile features a brief overview of the cell and gene therapy supply chain software companies, along with information on location of headquarters, year of establishment, number of employees, leadership team, software solutions portfolio, financial information, recent developments, and an informed future outlook.
• An in-depth analysis of funding and investments in this domain, since 2014, including seed funding, venture capital, debt financing, grants / awards, capital raised from IPOs and subsequent offerings received by companies that are engaged in cell and gene therapy supply chain software market.
• A detailed analysis of the partnerships inked between various cell and gene therapy supply chain software companies in this market, since 2019, including acquisitions, platform utilization agreements, service alliances, platform integration agreements, product development agreements, service agreements and other agreements.
• An in-depth analysis of the platform utilization agreements inked in this domain since 2019, providing information on the different types of software utilized by end-users in the cell and gene therapy supply chain.
• 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 gene therapy supply chain, featuring a summary of the diverse needs of the stakeholders. This section also highlights the opinion (based on past and prevalent trends) on the impact of these needs on the supply chain and how the industry is preparing to cater to these needs.
• An in-depth analysis of the factors that can impact the growth of the cell and gene therapy supply chain software market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
• A detailed estimate of the current market size and the future growth potential of the cell and gene therapy supply chain software market over the next decade. Based on multiple parameters, such as likely adoption trends and through reliable secondary and primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the cell and gene therapy supply chain software industry. Further, in order to account for future uncertainties and to add robustness to the model, the analyst has provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the cell and gene therapy supply chain software market growth.
• Detailed projections of the current and future opportunity for software providers in the cell and gene therapy supply chain software market across various process components, such as sample collection and processing component, manufacturing component, logistics component, and patient identification and treatment follow-up component.
• Detailed projections of the current and future opportunity for software providers in the cell and gene therapy supply chain software market across various type of software, such as EMS, LIMS, IMS, COP, QMS, LMS and PMS.
• Detailed projections of the current and future opportunity for software providers in the cell and gene therapy supply chain software market across various modes of deployment, such as on-premise deployment and cloud-based deployment.
• Detailed projections of the current and future opportunity for software providers in the cell and gene therapy supply chain software market across different scales of operations, such as clinical scale and commercial scale.
• Detailed projections of the current and future opportunity for software providers in the cell and gene therapy supply chain software market across various type of end-users, such as pharmaceutical companies, cell therapy labs, hospitals / medical centers and research institutes / biobanks.
• Detailed projections of the current and future opportunity for software providers in the cell and gene therapy supply chain software market across key geographical regions, such as North America, Europe, Asia-Pacific and rest of the world.

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of the software developers in the cell and gene therapy supply chain software market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035.

The market report also features the likely distribution of the current and forecasted opportunity for software developers in the market across various segments, such as process component (sample collection and processing component, manufacturing component, logistics component, and patient identification and treatment follow-up component), type of software (EMS, LIMS, IMS, COP, QMS, LMS and PMS), mode of deployment (on-premise deployment and cloud-based deployment), scale of operation (clinical scale and commercial scale), type of end-user (pharmaceutical companies, cell therapy labs, hospitals / medical centers and research institutes / biobanks) and key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for future uncertainties associated with some of the key parameters and to add robustness to the model, the analyst has provided three cell and gene therapy supply chain software market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

• Former Chief Business Officer, Mid-sized Company, UK
• Chief Clinical Officer, Mid-sized Company, UK
• Former Senior Director, Corporate Strategy and Business Development, Very Large Company, US
• International Sales and Transfusion Manager, Small Company, France
• Former General Manager, Cell Therapy, Very Large Company, US

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

Key Benefits of Buying this Report

• The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with a pulse on the cell and gene therapy supply chain software market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.