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Cell Therapy Manufacturing Market by Type of Cell Therapy, Source of Cells, Scale of Operation, Type of Manufacturer and Geography : Industry Trends and Global Forecasts, Till 2035
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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

Source of Cells

Scale of Operation

Type of Manufacturer

Key Geographical Regions

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(R) 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

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:

CELL THERAPY MANUFACTURING MARKET: RESEARCH COVERAGE

KEY QUESTIONS ANSWERED IN THIS REPORT

REASONS TO BUY THIS REPORT

ADDITIONAL BENEFITS

TABLE OF CONTENTS

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

4. EXECUTIVE SUMMARY

5. INTRODUCTION

6. CELL THERAPY MANUFACTURERS (INDUSTRY PLAYERS): MARKET LANDSCAPE

7. CELL THERAPY MANUFACTURERS (NON-INDUSTRY PLAYERS): MARKET LANDSCAPE

8. REGULATORY LANDSCAPE

9. ROADMAPS FOR OVERCOMING CHALLENGES

10. AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING

11. COMPANY PROFILES: INDUSTRY PLAYERS

12. COMPANY PROFILES: NON-INDUSTRY PLAYERS

13. NON-PROFIT ORGANIZATIONS IN CELL THERAPY MANUFACTURING

14. CLINICAL TRIAL ANALYSIS

15. PARTNERSHIPS AND COLLABORATIONS

16. RECENT EXPANSIONS

17. BIG PHARMA INITIATIVES

18. CAPACITY ANALYSIS

19. DEMAND ANALYSIS

20. COST PRICE ANALYSIS

21. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

22. TOTAL COST OF OWNERSHIP FOR CELL THERAPY MANUFACTURING ORGANIZATIONS

23. GLOBAL CELL THERAPY MANUFACTURING MARKET

24. CELL THERAPY MANUFACTURING MARKET, BY TYPE OF CELL THERAPY

25. CELL THERAPY MANUFACTURING MARKET, BY SOURCE OF CELLS

26. CELL THERAPY MANUFACTURING MARKET, BY SCALE OF OPERATION

27. CELL THERAPY MANUFACTURING MARKET, BY TYPE OF MANUFACTURER

28. CELL THERAPY MANUFACTURING MARKET, BY GEOGRAPHY

29. SWOT ANALYSIS

30. SURVEY ANALYSIS

31. CONCLUDING REMARKS

32. EXECUTIVE INSIGHTS

33. APPENDIX 1: TABULATED DATA

34. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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