Cell Therapy Manufacturing Industry Forecast to 2035: High Demand for T-Cell Therapies to Generate 45% of Clinical Need by 2035 - ResearchAndMarkets.com

The "Cell Therapy Manufacturing Market Industry Trends and Global Forecasts to 2035, by Type of Cell Therapy, Source of Cells, Scale of Operation, Type of Manufacturer and Geography" report has been added to ResearchAndMarkets.com's offering.

The global cell therapy manufacturing market is estimated to grow from USD 4.90 billion in the current year to USD 13.83 billion by 2035, at a CAGR of 9.90% during the forecast period, till 2035.

Cell Therapy Manufacturing Market: Research Coverage

• Comprehensive analysis of key market segments: therapy type, cell source, operation scale, manufacturer type, and geography.
• Assessment of market drivers, restraints, opportunities, and challenges.
• Detailed evaluation of industry and non-industry players by size, location, operation scale, cell type, and additional services offered.
• Overview of regulations, certifications, and accreditations across North America, Europe, and Asia.
• Insights into global initiatives and roadmaps to advance cell therapy manufacturing.
• Impact of automation and closed systems on manufacturing efficiency, supported by case studies and cost comparisons.
• Profiles of key industry and non-industry players, including services, facilities, developments, and outlooks.
• Analysis of clinical studies by trial parameters, geography, and sponsor activity.
• Review of partnerships since 2016, categorized by type, cells manufactured, and geography.
• Examination of expansion efforts by service providers since 2017, focusing on scale, cell type, and location.
• Big pharma initiatives in cell therapy manufacturing by type, purpose, and scale.
• Global manufacturing capacity estimates by scale, cleanroom availability, and region.
• Demand projections for cell therapies by therapy type and geography.
• Pricing strategies and factors influencing cell-based therapy costs.
• Comparison of in-house manufacturing versus CMOs for therapy developers.
• Total cost of ownership analysis for manufacturing organizations over 20 years.

Cell Therapy Manufacturing Market: Growth and Trends

Recent advancements in cellular therapies, along with several FDA-approved cell therapies, highlight the potential of these innovative therapies for treating cancer, rare diseases, and chronic illnesses. As a result, the healthcare sector is increasingly prioritizing this promising therapeutic approach. It is worth noting that more than 1,930 clinical trials are currently underway to investigate cell therapies for the treatment of a wide range of diseases, across different geographies.

Moreover, several commercialized cell therapies have emerged as top selling drugs in the healthcare industry. For example, Gilead Sciences reported that Yescarta has achieved annual sales surpassing USD 1.5 billion. Given the substantial evidence supporting the clinical advantages and therapeutic potential of cellular therapies, the focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. At present, over 260 industry and non-industry players are engaged in the cell therapy manufacturing industry. Notably, over 50% of the organizations in the cell therapy manufacturing industry are based in the US.

Given the continuous efforts of various stakeholders to ease the manufacturing related complexities, and a heightened emphasis on the advancement of such therapies, we anticipate a healthy growth in the cell therapy manufacturing market in the foreseen future. Owing to the relatively high efficacy of cell therapies, there is an increased interest and involvement of the big pharma players in this market. This has played a crucial role in the increasing adoption of cell therapies.

Cell Therapy Manufacturing Market: Key Insights

The report delves into the current state of the cell therapy manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

• Presently, over 265 industry and non-industry stakeholders are engaged in cell therapy manufacturing; more than 70% of these are industry players, with the required capability to manufacture various types of cells.
• Immune cells and stem cells are the most prominent type of cells being manufactured by stakeholders in this industry; over 60% of the players operate at preclinical, clinical and commercial scales of operation.
• More than 70 automation technologies are currently available for the manufacturing of cell therapies to minimize manual interventions; this is likely to attract the interest of stakeholders in the cell therapy domain.
• In the past few years, the number of clinical studies has increased at an annualized rate of nearly 10% across the world; majority of the clinical studies are evaluating cell therapies in phase I studies.
• The rise in partnership activity in this domain highlights the growing interest of players in the cell therapy manufacturing market; majority of the deals have been inked for the clinical manufacturing of T cell therapies.
• To gain a competitive edge and establish themselves as one-stop shops, stakeholders are actively consolidating their capabilities related to cell therapy manufacturing through mergers and acquisitions.
• 80% of the industry players have expanded their existing capacities and capabilities through the establishment of new facilities; among these more than 40% of facilities are dedicated to the manufacturing of T cells.
• Nearly 50% of the big pharma initiatives have been undertaken for the purpose of expanding their portfolio and capabilities through partnerships and collaborations; among these, 70% initiatives were undertaken post-2019.
• More than 70% of the current installed cell therapy manufacturing capacity (in terms of number of cleanrooms) is presently available with industry players; maximum capacity is installed in facilities based in North America.
• In 2035, more than 45% of the clinical demand for cell therapies is likely to be generated by T cell therapies, including CAR-T, TCR and TIL therapies, for the treatment of patients suffering from various disorders.
• Owing to the increased disease burden and shift in patient preferences towards tailored cell therapies, the market is poised to witness substantial growth in the next decade.
• The cell therapy manufacturing domain is poised to grow at a CAGR of 10%; the opportunity is well distributed across different types of cell therapies, sources of cells, scale of operation, type of manufacturer and geography.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Cell Therapy

• T Cell Therapies
• NK Cell Therapies
• Dendritic Cell Therapies
• Stem Cell Therapies

Source of Cells

• Autologous
• Allogeneic
• Unspecified

Scale of Operation

• Clinical
• Commercial

Type of Manufacturer

• In-house Manufacturing
• Contract Manufacturing Organization

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

Cell Therapy Manufacturing Market: Key Segments

Currently, T Cell Therapy Holds Maximum Share of the Cell Therapy Manufacturing Market

Based on the type of cell therapy, the market is segmented into T cell therapies, NK cell therapies, dendritic cell therapies and stem cell therapies. It is worth highlighting that the market for dendritic cell therapies is likely to grow at a relatively faster pace (CAGR of 11.1%) in the next decade. This can be attributed to high effectiveness of dendritic cell therapies in treating oncological disorders.

At Present, Autologous Source of Cell Market Segment Captures the Largest Market Share of the Overall Cell Therapy Manufacturing Market

Based on the source of cell, the market is segmented into autologous, allogeneic, and unspecified sources. It is worth highlighting that autologous source of cell is likely to grow at an annualized rate of 9.8% in the next decade. This can be attributed to the fact that more than 90% of the FDA approved cell therapies are derived from the patients.

Cell Therapies Manufactured at Clinical Scale is Likely to Dominate the Cell Therapy Manufacturing Market During the Forecast Period

Based on scale of operation, the market is segmented into clinical and commercial. It is worth highlighting that the cell therapies manufactured at clinical scale capture the larger share of the market and is poised to capture 58% of the revenue share by 2035. This can be attributed to the increasing number of cell therapy pipeline candidates in clinical trial phases.

Contract Manufacturing is Likely to Dominate the Cell Therapy Manufacturing Market During the Forecast Period

Based on type of manufacturer, the market is segmented into contract manufacturing and in-house manufacturing. It is worth highlighting that, currently, contract manufacturing of cell therapies holds the larger share in the cell therapy manufacturing market. This trend is unlikely to change in the coming decade. This can be attributed to the fact that contract manufacturers offer scalability and flexibility, enabling them to quickly adapt to evolving manufacturing needs and accommodate increased production volumes. In addition, by outsourcing cell therapy manufacturing operations, the drug developers can prevent significant capital investments for the establishment of in-house manufacturing facilities

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Some Key Players in the Cell Therapy Manufacturing Market include:

• AGC Biologics
• BioNTech Innovative Manufacturing Services
• Cell and Gene Therapy Catapult
• Cell Therapies
• Center for Cell and Gene Therapy, Baylor College of Medicine
• Centre for Cell Manufacturing Ireland, National University of Ireland
• Charles River Laboratories
• Clinical Cell and Vaccine Production Facility, University of Pennsylvania
• FUJIFILM Cellular Dynamics
• Guy's and St. Thomas' GMP Facility, Guy's Hospital
• KBI Biopharma
• Laboratory for Cell and Gene Medicine, Stanford University
• Lonza
• MEDINET
• Minaris Regenerative Medicine
• Molecular and Cellular Therapeutics, University of Minnesota
• Newcastle Cellular Therapies Facility, Newcastle University
• Nikon CeLL Innovation
• Rayne Cell Therapy Suite, King's College London
• RoslinCT
• Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
• Sydney Cell and Gene Therapy
• Thermo Fisher Scientific
• WuXi AppTec

For more information about this report visit https://www.researchandmarkets.com/r/et4j05

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