Cell Therapy Media, Kits, Reagents and Surfaces Market (2nd Edition), 2023-2035

Cell Therapy Media, Kits, Reagents and Surfaces Market (2nd Edition), 2023-2035

1.1. INTRODUCTION

The therapeutic approach involving the injection of healthy cells in the human body to replace the diseased / non-functioning cells, in order to regulate certain functions, is referred to as cell therapy. In the past few years, this therapeutic approach has emerged as one of the key areas of interest in the healthcare sector, given its ability to treat diseases which were previously considered untreatable. Consequently, driven by the benefits offered by cellular therapies and recent approvals granted by regulatory authorities, the demand for cellular therapies has increased considerably; this has led to a rise in the requirement of cell therapy raw materials. Specifically, cell therapy consumables refer to materials that are used in the manufacturing of cell therapies. It is worth mentioning that the selection of cell therapy consumables, specifically the cell culture media and supplements, is a crucial step in cell therapy manufacturing as they directly impact the potency and safety of the final product. In this report, we have considered the four predominant types of consumables applicable to cell therapy, namely cell culture media, media kits providing culture media along with the necessary media supplements, reagents and extracellular matrices.

1.2. KEY MARKET INSIGHTS

The Cell Therapy Media, Kits, Reagents and Surfaces Market (2nd Edition): Distribution by Type of Product (Culture Media, Kits, Reagents and Extracellular Matrices), Type of Cell Therapy (T-Cell Therapy, Stem Cell Therapy, Dendritic Cell Therapy and NK Cell Therapy), Scale of Operation (Clinical and Commercial), Type of End-User (Industry and Non-Industry) and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa (MENA) and Latin America): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape and the likely future potential of the cell culture media (supplied alone or in kits as a combination with cell growth supplements), cell culture reagents and ECM market, over the next 12 years. It highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key inclusions of the report are briefly discussed below.

Growing Demand for Cell Therapies

Since the development of the first cell therapy, this therapeutic segment has garnered significant attention from researchers and medical practitioners. This can be attributed to the fact that cell therapies have been demonstrated to possess a vast potential in the treatment of rare disorders, which were previously considered incurable. The popularity of this therapeutic class of products can also be validated from the fact that, since 2019, more than 1,000 clinical trials focused on cell therapies have been initiated. It is also worth mentioning that over 35 cell and gene therapies have already been commercialized, across various geographical locations, till date. Notable examples of recently approved cell therapies include (in reverse chronological order) Breyanzi® (June 2022), Carvykti™ (February 2022) and Abecma® (March 2021).

Need for High-Quality Cell Therapy Consumables

Driven by the rise in popularity of cell therapies, there is a growth in demand for cell culture media, reagents and surfaces. It is worth mentioning that, amidst the increasing demand for such products, there is a rise in stringency from regulatory authorities to ensure that the quality of raw materials is good. Therefore, to meet the industry needs, cell therapy manufacturers are actively adopting serum free and xeno free products, which are known to reduce the risk of batch-to-batch variability.

Role of Consumables in Commercialization of Cell Therapies

Currently, the marketed cell-based therapies are exorbitantly priced. Even though, with the introduction of automation technologies in cell therapy bioprocessing, the cost and time required for development of such products has reduced significantly, there is still a considerable scope of improvement to make these therapies affordable.

In this context, it is worth mentioning that consumables, including media, reagents and matrices, currently constitute nearly 25% of the overall cost of cell therapy manufacturing. Optimization of raw materials, by streamlining the production processes, can help mitigate wastage and further reduce the manufacturing cost. Moreover, for commercial applications, it is crucial to obtain consistent outcomes during the manufacturing process. Cell culture media, with chemically defined formulation, provides enhanced consistency for production purposes.

Current Market Landscape of Cell Therapy Media, Kits, Reagents and Surfaces

The cell therapy consumable providers market landscape features more than 80 companies, which claim to possess the necessary expertise for manufacturing of over 450 research and / or therapeutic grade raw materials. Some of these players also claim to have developed GMP certified facilities for the production of consumables, which are intended to be used for a range of human cells, including T-cells, stem cells, dendritic cells and NK cells. Subsequently, cell therapy media market represents majority share (57%) of consumables offered, followed by the share captured by media and supplement kits (26%), extracellular matrices (14%) and cell culture reagents (3%). The ancillary materials offered by these companies are available in various volumes and can be utilized for numerous functions, such as cell proliferation, cell differentiation and cell isolation. Recent developments in this domain indicate that cell therapy consumable providers are actively expanding their capacity and product portfolio in order to accommodate the current and anticipated demand for cell therapies.

Recent Trends Related to Cell Culture Media

In recent years, there has been a considerable rise in regulatory stringency as well as awareness related to disadvantages of using animal-based medica formulations, in the cell therapy domain. Specifically, animal-based media pose an undesirable risk of transfecting infectious agents. This has resulted in a shift towards the higher adoption of chemically defined, animal-component free (serum-free and xeno-free) media, in the cell culture media market. It is worth mentioning that, currently, majority of the cell culture media are being used for the development of stem cell therapies, followed by those intended for T-cell therapies.

Key Drivers in the Cell Therapy Consumables Market

One of the key drivers of the investments in this market is the success of previously commercialized cell therapies. More than USD 35 billion has already invested in cell therapy domain by private investors. In the last few years, cell therapies have offered a relatively more reliable approach for the treatment of rare diseases. According to a study published in 2019, the prevalence rate of rare diseases is about 263 to 446 million individuals, at any point of time. This necessitates the need for more such life-saving therapies. It is worth highlighting that, by 2030, close to 60 cell and gene therapies are anticipated to receive regulatory approval, further expanding the opportunities associated within the market. These factors will, in turn, lead to a surge in the requirement for cell therapy consumables products, driving significant growth of the domain.

Market Size of the Cell Therapy Consumables Market

Driven by the indubitably rising need for cell therapies, the market for cell therapy media and other consumables is anticipated to grow at a CAGR of 12%, during the period 2023-2035. Specifically, in terms of scale of operation, the demand for consumable products for commercial operations are expected to expand rapidly with the anticipated approval of numerous cell therapies. Additionally, it is worth highlighting that more than 80% of the current market share is captured by players based in North America and Asia-Pacific.

Example Players in the Cell Therapy Consumables Market

Examples of players engaged in this domain (which have also been captured in this report) include BD Biosciences, Bio-Techne, CellGenix, Corning, Irvine Scientific (Acquired by FUJIFILM), Lonza, Miltenyi Biotech, Sartorius, STEMCELL Technologies and Thermo Fisher Scientific.

1.3. SCOPE OF THE REPORT

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments as defined in the below table:

Cell Therapy Consumables Market: Report Attribute / Market Segmentations

Key Report Attributes Details

Forecast Period 2023 – 2035

Type of Product Extracellular Matrices

Kits

Media

Reagents

Type of Cell Therapy Dendritic cell therapy

NK cell therapy

Stem cell therapy

T-Cell therapy

Scale of Operation Clinical

Commercial

Type of End-User Industry

Non-Industry

Key Geographical Regions North America

Europe

Asia-Pacific

Middle East and North Africa

Latin America

Key Companies Profiled BD Biosciences

Bio-Techne

CellGenix

Corning

Irvine Scientific (Acquired by FUJIFILM)

Lonza

Miltenyi Biotech

Sartorius

STEMCELL Technologies

Thermo Fisher Scientific.

Customization Scope 15% Free Customization Option (equivalent to 5 analyst working days)

PowerPoint Presentation (Complimentary) Available

Excel Data Packs (Complimentary) Market Landscape Analysis

Company Competitiveness Analysis

Brand Positioning Analysis

Recent Developments and Initiatives

Likely Partners Analysis

Roots Analysis Competitive Pricing Framework

Demand Analysis

Market Forecast and Opportunity Analysis

Source: Roots Analysis

The report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different regions. Amongst other elements, the report includes:

An executive summary of the insights captured during our research, offering a high-level view on the current state of the cell therapy consumables market and its likely evolution in the mid-long term.

A general introduction to cell therapies, including details related to the development and manufacturing of such therapeutics products, with addition focus on role of raw materials in cell therapy production. It further provides a brief overview of the different types of cell therapy consumables and key challenges associated with their development.

A detailed assessment of the overall market landscape of companies offering cell therapy consumables, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of product (kits, media, reagents and extracellular matrices), number and location of consumable facilities, accreditations received, type of end-user (industry and non-industry), media compatibility (serum free , xeno free and both), type of cell therapy (T-cell therapies, stem cell therapies, NK cell therapies, dendritic cell therapies and others), type of function (cell proliferation, cell expansion, cell differentiation, cell activation, cell isolation, cell attachment), kit components (supplements / reagents, growth / induction medium, expansion medium, differentiation medium and others), type of ECM coating (laminin, fibronectin, vitronectin, basement membrane extract and others), type of formulation (powder, liquid, pre-coated cultureware), shelf life (6-12 months, 13-18 months, 19-24 months and 25-36 months), scale of operation (discovery, preclinical, clinical and commercial), application area (research use and therapeutic use), storage temperature (refrigerated, frozen, ultra-low and room temperature), as well as volume of media, reagents and extracellular matrices.

A detailed competitiveness analysis of cell therapy consumable providers (kits, media, reagents and extracellular matrices) based on supplier strength (in terms of years of experience and company size), portfolio strength (considering media compatibility, number of unique type of cell therapy, application area, product manufacturing practices and number of consumable facilities) and number of products offered.

A detailed brand positioning analysis of prominent industry players (shortlisted on the basis of strength of service portfolio), highlighting the current perceptions regarding their proprietary brands across different consumable classes.

Elaborate profiles of key players offering cell therapy consumables (shortlisted on the basis of portfolio strength and number of products offered); each profile includes a brief overview of the company, along with information on its cell therapy consumables focused product portfolio, consumable facilities, recent developments and an informed future outlook.

An analysis of recent developments within the cell therapy consumable industry, highlighting information on several partnerships and collaborations, mergers and acquisitions, and expansion initiatives that have taken place within this domain, during the period 2016-2022.

A list of over 250 cell therapy developers that are anticipated to partner with cell therapy consumable providers; these players have been shortlisted based on several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development), and availability of other cell therapy capabilities.

A proprietary Roots Analysis competitive pricing framework, which analyzes the competitive position of various companies engaged in this domain, by taking into consideration the prices and features of their consumable offerings (such as media and extracellular matrices). In addition, it presents an equation devised to calculate the likely price of cell therapy consumables based upon their characteristics.

An informed estimate of the annual demand for cell therapy consumables (in terms of volume of media required for total number of cells), based on scale of operation and key geographical regions.

An in-depth discussion on the upcoming trends and future growth opportunities within the cell therapy consumables market, featuring details related to the significance of automation in cell therapy manufacturing processes and benefits of single use technologies for production of cell therapies.

One of the key objectives of the report was to estimate the current opportunity and the future growth potential of the cell therapy consumables market over the coming years. We have provided an informed estimate on the likely evolution of the market for the period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as type of product (kits, media, reagents and extracellular matrices), type of cell therapy (t-cell therapies, stem cell therapies, dendritic cell therapies and NK cell therapies), scale of operation (clinical and commercial), type of end-user (industry and non-industry) and key geographical regions (North America, Europe, Asia-Pacific, MENA and Latin America). In order to account for future 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 scenarios of the industry’s evolution.

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

Anant Kamath (Chief Operating Officer, Cellular Engineering Technologies)

Vishal G. Warke (Director, R&D, Cell Culture and Immunology, HiMedia Laboratories) and Gauri W. Page (Assistant R&D Manager, Animal Cell Culture, HiMedia Laboratories)

Michael Maloney (Vice President, Business Development, Cell Culture, Akadeum Life Sciences)

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.

1.4. RESEARCH METHODOLOGY

The data presented in this report was gathered via primary and secondary research. For all our projects, we conduct interviews / surveys with reputed domain experts (academia, industry, medical practice 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. Wherever 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’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and 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.

1.5. FREQUENTLY ASKED QUESTIONS

Question 1: What are the factors driving the cell therapy consumables market?

Answer: The growing demand for cell therapies, as a result of the increasing number of commercialized cell therapies and the rise in cell therapy focused clinical trials, is one of the key factors driving the growth of the cell therapy consumables market.

Question 2: How many players are engaged in offering cell culture media for manufacturing of cell therapies?

Answer: Currently, more than 65 companies claim to offer different types of cell culture media for the growth, proliferation, expansion and differentiation of numerous types of cell therapies.

Question 3: How many players are engaged in offering kits for manufacturing cell therapies?

Answer: At present, nearly 40 players claim to offer several types of kits required to manufacture cell therapies. These kits comprise of various key components, including supplements / reagents for isolation, activation and differentiation of cells, growth media, differentiation media and expansion media.

Question 4: How many media products are available in the market for culturing cell therapies?

Answer: The current market features the presence of nearly 260 media products, which can be used for the manufacturing of cell therapies intended for culturing of human cells.

Question 5: What are the partnership and collaboration trends in the cell therapy consumables domain?

Answer: At present, distribution agreements, mergers and acquisitions, and product commercialization agreements are the most common types of partnerships inked by stakeholders engaged in the cell therapy consumables domain.

Question 6: Which geographical segment has the largest market share in the current cell therapy consumables market?

Answer: North America captures the largest share in the current cell therapy consumables market, followed by Asia-Pacific. It is worth mentioning that, within Asia-Pacific, majority of the market share is contributed by China.

Question 7: Which type of product contributes to the largest share of the cell therapy consumables market?

Answer: In 2023, the cell therapy consumables market is expected to be dominated by media. This trend can be attributed to the large quantity of media required for manufacturing of cell therapies.

1.6. CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, Cell Therapy Consumables Market (2nd Edition), 2023-2035.

Chapter 2 is an executive summary of the insights captured during our research, offering a high-level view on the current state of the cell therapy consumables market and its likely evolution in the mid-long term.

Chapter 3 provides a general introduction to cell therapies, including details related to the development and manufacturing of such therapeutics products, with addition focus on role of raw materials in cell therapy production. It further provides a brief overview of the different types of cell therapy consumables and key challenges associated with their development.

Chapter 4 includes a detailed assessment of the overall market landscape of companies offering cell therapy consumables, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of product (kits, media, reagents and extracellular matrices), number and location of consumable facilities, accreditations received, type of end-user (industry and non-industry), media compatibility (serum free , xeno free and both), type of cell therapy (T-cell therapies, stem cell therapies, NK cell therapies, dendritic cell therapies and others), type of function (cell proliferation, cell expansion, cell differentiation, cell activation, cell isolation, cell attachment), kit components (supplements / reagents, growth / induction medium, expansion medium, differentiation medium and others), type of ECM coating (laminin, fibronectin, vitronectin, basement membrane extract and others), type of formulation (powder, liquid, pre-coated cultureware), shelf life (6-12 months, 13-18 months, 19-24 months and 25-36 months), scale of operation (discovery, preclinical, clinical and commercial), application area (research use and therapeutic use), storage temperature (refrigerated, frozen, ultra-low and room temperature), as well as volume of media, reagents and extracellular matrices.

Chapter 5 presents a detailed competitiveness analysis of cell therapy consumable providers (kits, media, reagents and extracellular matrices) based on supplier strength (in terms of years of experience and company size), portfolio strength (considering media compatibility, number of unique types of cell therapies, application area, product manufacturing practices and number of consumable facilities) and number of products offered.

Chapter 6 includes a detailed brand positioning analysis of prominent industry players (shortlisted on the basis of service portfolio strength), highlighting the current perceptions regarding their proprietary brands across different consumable classes.

Chapter 7 features elaborate profiles of key players offering cell therapy consumables (shortlisted on the basis of portfolio strength and number of products offered); each profile includes a brief overview of the company, along with information on its cell therapy consumables focused product portfolio, consumable facilities, recent developments and an informed future outlook.

Chapter 8 provides an analysis of recent developments within the cell therapy consumables domain, highlighting information on recent partnerships, collaborations, mergers, acquisitions and expansion initiatives that have taken place within this domain, during the period 2016-2022.

Chapter 9 presents list of over 250 cell therapy developers that are anticipated to partner with cell therapy consumable providers; these players have been shortlisted based on several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development), and availability of other cell therapy capabilities.

Chapter 10 features a proprietary Roots Analysis competitive pricing framework, which analyzes the relative position of various companies engaged in this domain, by taking into consideration the prices and features of their consumable offerings (such as media and extracellular matrices). In addition, it presents an equation devised to calculate the likely price of cell therapy consumables based upon their characteristics.

Chapter 11 includes an informed estimate of the annual demand for cell therapy consumables (in terms of volume of media required for total number of cells), based on scale of operation and key geographical regions.

Chapter 12 presents a comprehensive market forecast analysis, highlighting the future potential of the market till 2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as type of product (kits, media, reagents and extracellular matrices), type of cell therapy (t-cell therapies, stem cell therapies, dendritic cell therapies and NK cell therapies), scale of operation (clinical and commercial), type of end-user (industry and non-industry) and key geographical regions (North America, Europe, Asia-Pacific, MENA and Latin America).

Chapter 13 features an in-depth discussion on the upcoming trends and future growth opportunities within the cell therapy consumables market. It presents information on the evolving trends related to cell culture media. Further highlighting the importance of automation in cell therapy manufacturing and the benefits of single use technologies in the production pipelines for cell therapies.

Chapter 14 is a summary the overall report. The chapter provides the key takeaways from the report, and presents facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the cell therapy consumables market.

Chapter 15 is a collection of transcripts of interviews conducted with various stakeholders in the industry. We have presented details of interviews held with Anant Kamath (Chief Operating Officer, Cellular Engineering Technologies), Vishal G. Warke (Director, R&D, Cell Culture and Immunology, HiMedia Laboratories) and Gauri W. Page (Assistant R&D Manager, Animal Cell Culture, HiMedia Laboratories) and Michael Maloney (Vice President, Business Development, Cell Culture, Akadeum Life Sciences).

Chapter 16 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

Chapter 17 is an appendix, which contains a list of companies and organizations mentioned in this report.