Cell Therapy Manufacturing Market by Type of Cell Therapy (T Cell Therapies, NK Cell Therapies, Dendritic Cell Therapies, and Stem Cell Therapies), Source of Cells (Autologous, Allogeneic and Unspecified), Scale of Operation (Clinical and Commercial), Typ

Cell Therapy Manufacturing Market by Type of Cell Therapy (T Cell Therapies, NK Cell Therapies, Dendritic Cell Therapies, and Stem Cell Therapies), Source of Cells (Autologous, Allogeneic and Unspecified), Scale of Operation (Clinical and Commercial), Type of Manufacturer (In-house Manufacturers and Contract Manufacturing Organizations) and Geography (North America, Europe, Asia Pacific, and Rest of the World): Industry Trends and Global Forecasts, Till 2035

CELL THERAPY MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, 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.

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: 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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

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.

Example Players in the Cell Therapy Manufacturing Market

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

Primary Research Overview

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

Marketing Manager, Cell Therapy, Invetech

Director, Imperial College London

Marketing Director, Cellistic

Chief Commercial Officer and Executive Vice-President, FamiCord

Senior Director of Sales Advanced Therapies, GenCure

Business Administration Department Manager, Japan Tissue Engineering

Chief Business Officer, Medace

Director of Finance and Facility Operations, Laboratory for Cell and Gene Medicine, University of Stanford

Senior Director, Sumitomo Pharma

Chief Executive Officer, RoslinCT

Chief Technical Officer, Cell and Gene Therapy, Discovery Life Sciences

Chief Executive Officer, Glycostem Therapeutics

General Manager, Bio Elpida

Chief Executive Officer, Gracell Biotechnologies

Executive VP Research and Development, Kadimastem

Ex-Business Development Manager, Roslin CT

Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota

Ex- Co-Founder and Chief Executive Officer, Lion TCR

Ex-Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy

Manager of Business Development, Waisman Biomanufacturing

Ex-Department Leader, Cell Therapy Innovation and Development, Yposkesi

Ex-Chief Executive Officer, Cell Therapies

Chief Executive Officer, CiMaas

CELL THERAPY MANUFACTURING MARKET: RESEARCH COVERAGE

The report features an in-depth analysis of the cell therapy manufacturing market, focusing on key market segments, including type of cell therapy, source of cells, scale of operation, type of manufacturer and key geographical regions.

The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.

A comprehensive evaluation of companies involved in cell therapy manufacturing, considering various parameters, such as company size, year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer (in-house manufacturers and contract manufacturing organizations), type of cell manufactured (immune cells, stem cells and others), source of cells (autologous and allogeneic), scale of operation (preclinical, clinical and commercial) and additional services offered (research and development, cell culture development, cell banking, documentation, testing, packaging, supply chain management and regulatory support).

Thorough analysis of non-industry players involved in cell therapy manufacturing, detailing information on their year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer (in-house manufacturers and contract manufacturing organizations), type of cell manufactured (immune cells, stem cells and others), source of cells (autologous and allogeneic), scale of operation (preclinical, clinical and commercial) and additional services offered (research and development, cell culture development, cell banking, documentation, testing, packaging, supply chain management and regulatory support).

A comprehensive discussion on regulations governing cell therapy manufacturing across different regions, specifically North America (with an emphasis on the US), Europe, and Asia (highlighting Japan and China). This analysis includes a review of the various certifications and accreditations granted to manufacturing facilities by key regulatory authorities worldwide.

An overview of the diverse roadmaps released by various global agencies in order to advance the cell therapy manufacturing process.

An in-depth analysis of the impact of technological automation on cell therapy manufacturing aims to enhance existing production methods by utilizing closed and single-use systems. The discussion includes a strategic roadmap outlining the necessary steps for developing automation devices, bolstered by two illustrative case studies. Additionally, it offers a qualitative assessment of the costs associated with manufacturing cell-based therapies through manual versus automated processes. Furthermore, it lists organizations that provide automated technologies for manufacturing operations or assist therapy developers in automating their cell therapy production processes.

In-depth profiles of key industry players in cell therapy manufacturing market, focusing on company overviews, service portfolio, manufacturing capabilities and facilities, recent developments, and an informed future outlook.

In-depth profiles of key non-industry players in cell therapy manufacturing market, focusing on organization overviews, service portfolio and manufacturing facilities.

A comprehensive overview of non-profit organizations engaged in the manufacturing of cell therapies, including a list of organizations actively involved in the development and production of cell-based therapies across various regions. This discussion will also highlight different international and national societies dedicated to disseminating knowledge about advancements in these therapies to the broader community.

Examination of completed, ongoing, and planned clinical studies based on parameters like trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, study design, most active players (in terms of number of clinical trial conducted) and geographical distribution of trials.

An analysis of partnerships established in this sector, since 2016, based on several relevant parameters, such as the year of partnership, type of partnership, type of cells manufactured, scale of operation, most active players (in terms of number of partnerships) and geographical distribution.

An examination of the different expansion efforts made by service providers in this field to enhance their cell therapy manufacturing capabilities, since 2017. This analysis considers various factors, including the year of expansion, type of expansion, type of cells produced, scale of operations, location of the expanded manufacturing facilities and the most active companies based on the number of expansion initiatives undertaken.

Assessment of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.

Estimation of global cell-based therapies manufacturing capacity, derived from data provided by various industry and non-industry sources in the public domain. This analysis emphasizes the distribution of the available capacity (in terms of cleanroom area and number of cleanrooms) on the basis of scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific and Rest of the World).

Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of patients), based on type of cell therapy and key geographical regions.

An in-depth examination of the various factors that may impact the pricing of cell-based therapies, highlights the different models and strategies used by manufacturers to establish the prices of their proprietary products.

A qualitative analysis that highlights the various factors that need to be taken into consideration by cell therapy developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

A comprehensive total cost of ownership analysis for cell therapy manufacturing organizations, categorized by company size, spanning 20 years.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading CDMOs / CMOs in this market?

What kind of partnership models are commonly adopted by industry stakeholders?

What kinds of expansion initiatives have been undertaken by industry stakeholders?

What are the factors that are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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