Allogeneic Cell Therapy Market,2023-2035

Allogeneic Cell Therapy Market,2023-2035

1.1. ALLOGENEIC CELL THERAPY MARKET OVERVIEW

The global allogeneic cell therapy market is estimated to be worth USD 0.9 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of 14% during the forecast period 2023-2035.

Allogeneic cell therapies refer to off-the-shelf therapies that are isolated from donor tissues (such as cord blood and bone marrow), processed ex vivo in the labs and then administered into patients / cryopreserved in a cell bank. Since these therapies are manufactured in advance, they are readily available and eliminate the need for individualized production for every patient. Owing to their various benefits, such as improved and consistent product quality (due to rigorous quality control measures taken during processing), reduced cost (due to centralized manufacturing process) and flexibility in approaching the same donor or choosing a different donor (in case the patient requires another course of the treatment), allogeneic cell therapies have gained significant traction in the healthcare industry. Further, recent advancements in gene editing technologies, such as CRISPR/Cas9, have opened up new possibilities for allogeneic cell therapies by enabling precise genetic modifications in the donor cells in order to enhance their therapeutic properties and reduce the risk of immune rejection.

Over the past few years, a number of allogeneic cell therapies targeting a myriad of disorders, including hematological malignancies (such as multiple myeloma, leukemia), post-transplant lymphoproliferative disorders (PTLD), neurological disorders, musculoskeletal disorders and autoimmune / inflammatory disorders, have received approval from various regulatory authorities, globally. In December 2022, the European Commission approved the first allogeneic T-cell therapy, namely Ebvallo, (developed by Atara Biotherapeutics) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. In addition, the FDA approved an allogenic mesenchymal stem cell therapy, Osteocel® Plus (developed by NuVasive), for the treatment of degenerative disc disease. Driven by the continuous efforts of both industry and non-industry players, rising prevalence of chronic diseases and non-malignant disorders, and challenges associated with production of autologous cell therapies, the global allogeneic cell therapies market is likely to witness substantial market growth during the forecast period. ,

1.2. KEY MARKET INSIGHTS

The Allogeneic Cell Therapy Market, 2023-2035 - Distribution by Type of Cell Therapy (Virus-Specific T-Cell, Stem Cell and Regulatory T-Cell), Source of Cell (Peripheral Blood, Bone Marrow, Umbilical Cord Blood, Adipose Tissue and Placenta), Target Indication (Bone Disorder, Critical Limb Ischemia, Crohn’s Disease, Diabetic Foot Ulcer, Graft versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndrome, Cytomegalovirus Infection, Others), Therapeutic Area (Oncological Disorders, Neurological Disorders, Musculoskeletal Disorders, Autoimmune / Inflammatory Disorders and Post-Transplant Infections), and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts market report features an extensive study of the current market landscape, market size and future opportunities for the allogenic cell therapy developers, during the given forecast period. Further, the report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the allogeneic therapy market report are briefly discussed below.

Allogeneic Cell Therapy vs Autologous Cell Therapy

Allogeneic cell therapy and autologous cell therapy are two distinct approaches in the field of regenerative medicine. In autologous cell therapy, the cells are derived from the patient's own body, processed ex-vivo and reintroduced into the same patient; this personalized approach ensures compatibility and minimizes the risk of immune rejection. However, these therapies require a longer production time, as each patient's cells need to be individually processed. On the other hand, allogeneic cell therapy involves the use of cells from a healthy donor; these collected donor cells might be given directly to a genetically similar patient or added to a cell bank. Allogeneic cell therapy has various advantages, including immediate accessibility, scalability and cost-effectiveness, however, it may involve the risk of immune rejection.

Pipeline Analysis: Competitive Landscape of Allogeneic Cell Therapy

Allogenic cell therapy market landscape features the presence of close to 195 large, mid-sized and small companies developing allogeneic cell therapies, for a wide range of indications. It is worth highlighting that over 470 allogenic cell therapies are currently being evaluated in different preclinical / clinical stages, either as monotherapies or in combination with other drugs. In April 2023, Gamida Cell received approval from the FDA for its umbilical cord blood-derived, allogeneic stem cell therapy, Omisirge® (omidubicel-onlv); the therapy is used to treat patients with hematologic malignancies. The growing demand for novel allogeneic cell therapies, approvals from various regulatory bodies and continuous advancements in cell therapy manufacturing process, are expected to drive the allogeneic cell therapies market growth during the forecast period.

Clinical Trials Analysis: More than 365 Trials are Evaluating Allogeneic Cell Therapies to Treat Various Hematologic Malignancies and Solid Tumors

Over the years, companies involved in the development of allogeneic cell therapies have made significant efforts to conduct clinical trials for evaluating the efficacy of allogeneic cell therapies, for the treatment of various disorders, including infectious diseases (adenovirus infection, coronavirus infection and cytomegalovirus infection), neurological disorders (autism, bipolar depression, Parkinson’s disease, stroke) and oncological disorders (acute myeloid leukemia, biliary tract cancer, breast cancer and multiple myeloma). Over 365 clinical trials have been registered across different geographical regions to evaluate various allogenic cell therapies. Of these trials, majority (~180) were registered in North America and maximum number of patients (9,300) were observed to be enrolled in clinical trials conducted in North America, accounting for about 55% of the overall enrollment. It is worth mentioning that Fundamenta Therapeutics is conducting the maximum number of trials in this industry for different types of cancers, such as acute lymphoblastic leukemia, acute lymphoblastic lymphoma and non-Hodgkin’s lymphoma. In addition, an allogeneic CAR T cell therapy, ALLO-715 (developed by Allogene) for the treatment of relapsed / refractory multiple myeloma has demonstrated positive results in the Phase I clinical trials. ,

Market Trends Analysis: Partnerships and Collaborations have Fueled Allogenic Cell Therapy Market Growth

Several stakeholders have been forging alliances with other industry / non-industry players for the development of allogeneic cell therapies. It is worth highlighting that, since 2019, over 90 strategic partnerships have been established in the allogeneic cell therapy market. Majority of such deals are focused on research and development, product / technology licensing, and development and commercialization of allogenic cell therapies. In March 2023, Tessa Therapeutics entered into a research and development agreement with US National Cancer Institute for Tessa’s allogeneic CD30.CAR-modified Epstein-Barr virus-specific T-cell therapy, TT11X, useful in the treatment of non-Hodgkin’s lymphoma. In January 2022, Allogene Therapeutics signed a licensing agreement with Antion Biosciences for the latter company’s miRNA technology (miCAR™) in order to advance multiplex gene silencing tool (useful in the development of innovative allogeneic CAR T cell therapy).

Market Trends Analysis: Increase in Funding Reflect the Rising Interest in Allogenic Cell Therapy Market

The growing interest in allogeneic cell therapy market can be validated by the fact that in the past four years, close to USD 8.8 billion has been invested by several investors based across the globe, in companies engaged in the development of allogeneic cell therapies. It is worth noting that, majority of the funds have been raised through venture rounds. In terms of the funding amount raised, Legend Biotech raised the maximum funding amount (USD 487.3 million) through initial public offering. In December 2022, Gamida Cell announced the closing of a convertible term loan of USD 25 million with Highbridge Capital Management; the funding is planned to be used to advance the company’s allogeneic NK cell therapy pipeline.

Market Analysis: Global Allogeneic Cell Therapies Market Size

The global allogeneic cell therapy market is estimated to be worth USD 900 million in 2023. Driven by the increasing need for novel allogenic cell therapies, along with growing development pipeline and encouraging clinical trial results, the allogenic cell therapies market is anticipated to grow at a CAGR of 14% during the forecast period. Specifically, in terms of target disease indication, the market is anticipated to be driven by allogeneic cell therapies being developed for the treatment of lymphoma and leukemia.

Regional Analysis: North America to Hold the Largest Allogeneic Cell Therapy Market Share

Majority of the companies developing allogeneic cell therapies are headquartered in North America, followed by companies based in Asia Pacific. Consequently, more than 60% of the global market of allogeneic cell therapies is anticipated to be captured by players based in North America, in 2035. The factors responsible for the growth of the allogeneic cell therapy market in North America include the rising incidence of acute as well as chronic disorders, increasing FDA approvals for novel allogenic cell therapies and growing adoption of innovative therapies in the developed countries. In addition, the US government has been actively involved in providing reimbursement for expensive allogeneic cell therapies, recognizing their potential to revolutionize healthcare and improve patient outcomes.

Leading Allogeneic Cell Therapy Companies

Examples of the key allogeneic cell therapy companies (based on number of products under development; the complete list of players is available in the full report) include Artiva Biotherapeutics, Allogene Therapeutics, Atara Biotherapeutics, Cellenkos, Cell2Cure, Celularity, Cellular Biomedicine Group, CHABiotech, CRISPR Therapeutics, Fate Therapeutics, Fundamenta Therapeutics, GC Cell, Hope Biosciences, Immunity Bio, Mesoblast, Nanjing Bioheng Biotech, Orca Bio, Pluristem Therapeutics, Poseida Therapeutics and Stemedica Cell Technologies. This market report also includes an easily searchable excel database of all the allogeneic therapy companies (developers) worldwide.

1.3. SCOPE OF THE REPORT

The market report presents an in-depth analysis of the various firms / organizations that are engaged in the allogenic cell therapy market, across different segments, as defined in the below table:

Allogeneic Cell Therapy Market: Report Attribute / Market Segmentations

Report Attributes Details

Base Year 2023

Forecast Period 2023 – 2035

Market Size 2023 $ 4 million

CAGR 14%

Type of Cell Therapy Virus-Specific T-Cell

Stem Cell

Regulatory T-Cell

Source of Cell Peripheral Blood

Bone Marrow

Umbilical Cord Blood

Adipose Tissue

Placenta

Target Indication Bone Disorder

Critical Limb Ischemia

Crohn’s Disease

Diabetic Foot Ulcer

Graft versus Host Disease

Leukemia

Lymphoma

Myelodysplastic Syndrome

Cytomegalovirus Infection

Others

Therapeutic Area Oncological Disorders

Neurological Disorders

Musculoskeletal Disorder

Autoimmune / Inflammatory Disorders

Post-Transplant Infections

Key Geographical Regions North America

Europe

Asia-Pacific

Rest of the World

Customization Scope 15% Free Customization Option

Excel Data Packs (Complimentary) Market Landscape

Partnerships and Collaborations

Funding and Investment Analysis

Clinical Trial Analysis

Key Opinion Leader Analysis

Market Forecast and Opportunity Analysis

Source: Roots Analysis

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

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

A general overview of allogeneic cell therapy, along with information on their manufacturing process, key advantages, challenges and recent developments within this market.

A detailed assessment of the overall landscape of allogeneic cell therapies, based on several relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters, phase of development (preclinical, clinical and marketed), route of administration (intravenous, intraarticular, topical, intramuscular, intrathecal, subretinal, intracoronary, inhalational and others), type of cell therapy (stem cell therapies, T-cell therapies, NK cell therapies, dendritic cell therapies and others), source of cell (peripheral blood, umbilical cord, bone marrow and placenta), dosing frequency (single dose and multiple dose), type of therapy (monotherapies and combination therapies), target patient segment (children, adults and elderly patients), target indication (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma, B-cell lymphoma, COVID-19, osteoarthritis, acute respiratory distress syndrome, myelodysplastic syndrome, colorectal cancer and gastric cancer), and therapeutic area (oncological disorders, neurological disorders, musculoskeletal disorders, infectious diseases, autoimmune / inflammatory disorders, post-transplant infections, cardiovascular disorders, respiratory disorders, cerebrovascular disorders, ophthalmic disorders, dermatological disorders, genetic disorders, kidney disorders, liver disorders, metabolic disorders and others).

A detailed analysis of the partnerships established between stakeholders engaged in this industry, since 2019, covering research and development agreements, product / technology licensing agreements, product development and commercialization agreements, manufacturing / supply agreements, product development agreements, clinical trial agreements, mergers, acquisitions, product commercialization agreements and other relevant agreements.

An analysis of the funding and investments that have been made into companies developing allogeneic cell therapies, which include venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing. It includes a detailed analysis of the funding instances that have taken place during the period 2019 to 2023, highlighting the growing interest of venture capital (VC) community and other strategic investors in this market.

An analysis of completed and ongoing clinical trials related to allogeneic cell therapies, based on several relevant parameters, such as trial registration year, trial status, trial phase, study design, type of sponsor, geography, and most active industry and non-industry players (in terms of number of trials).

An insightful analysis, highlighting the key opinion leaders (KOLs) investigating clinical trials related to allogeneic cell therapies, based on several relevant parameters, such as type of KOL, qualification, type of organization, affiliated organization, geographical location of KOLs and target disease indication. In addition, the chapter highlights the most prominent KOLs, based on our proprietary and third-party scoring criteria.

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of the allogeneic cell therapies market, over the forecast period. We have provided informed estimates on the likely evolution of the market for the forecast period, 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of cell therapy (virus-specific T-cell, stem cell and regulatory T-cell), source of cell (peripheral blood, bone marrow, umbilical cord blood, adipose tissue and placenta), target indication (Bone Disorder, Critical Limb Ischemia, Crohn’s Disease, Diabetic Foot Ulcer, Graft versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndrome, Cytomegalovirus Infection, Others), therapeutic area (oncological disorders, neurological disorders, musculoskeletal disorders, autoimmune / inflammatory disorders, post-transplant infections), 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 our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with some of the key industry stakeholders.

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 has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice, and other associations) to solicit their opinions on emerging trends in the market. This information 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:

Allogeneic Cell Therapies Market: Example List of Secondary Sources

Category of Source Examples

Annual Reports / Investor Presentations Industry Databases Government Policy Documents and Regulatory Guidelines

Journals News / Press Releases Source: Roots Analysis

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 is allogeneic cell therapy?

Answer: Allogeneic cell therapy involves the isolation of cells from a donor, followed by ex vivo manipulation and subsequent administration into the patients.

Question 2: What is allogenic vs autologous cell therapy?

Answer: Allogenic cell therapy refers to a cellular therapy in which the cells from a healthy donor are used to treat a patient while autologous cell therapy refers to a cellular therapy in which the cells are used from the patient’s peripheral blood.

Question 3: What are the advantages of allogeneic cell therapy?

Answer: Allogeneic cell therapy has various advantages, including availability as a scalable off-the-shelf product, diversity of cells or tissues, higher quality product, cost effectiveness and easy automation.

Question 4: What is an example of autologous cell therapy?

Answer: An example of autologous cell therapy is Epicel (developed by Genzyme Biosurgery) for the treatment of deep dermal or full thickness burns. ,

Question 5: Which are the most common sources from which allogeneic cells can be derived?

Answer: Allogeneic cell therapies can be derived through different sources, such as adipose tissue, amniotic sac, bone marrow, cord blood, peripheral blood and placenta.

Question 6: How many companies are developing allogeneic cell therapies?

Answer: At present, close to 195 companies claim to develop allogeneic cell therapies for different therapeutic areas. The majority of allogeneic cell therapies are stem cell therapies, followed by T-cell therapies (including CAR T cell, gamma delta T cell, virus-specific T cell, regulatory T cell, TCR and TIL).

Question 7: What are the partnership trends in the allogeneic cell therapies domain?

Answer: Research and development, product / technology licensing agreements, product development agreements, are the most common types of partnerships inked by stakeholders in this industry.

Question 8: How big is the global allogeneic cell therapies market?

Answer: The global market for allogeneic cell therapies is anticipated to be worth USD 0.9 billion in 2023.

Question 9: What is the likely growth rate (CAGR) of allogeneic cell therapy market?

Answer: The global allogeneic cell therapy market is expected to grow at a CAGR of 14% during the forecast period 2023 to 2035.

Question 10: Which region captures the largest market share of the allogeneic cell therapy market?

Answer: At present, the allogeneic cell therapies market is dominated by North America, capturing more than 60% of the overall market size.

Question 11: Which segment is likely to have the largest market share in the allogeneic cell therapy market?

Answer: Currently, the oncological disorders segment dominates the allogeneic cell therapy market.

1.6. CHAPTER OUTLINES

Chapter 1 is a preface providing an overview to the full report, Allogeneic Cell Therapy Market, 2023-2035.

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

Chapter 3 provides a brief overview of allogeneic cell therapy, along with information on their manufacturing process, advantages, challenges and recent developments in this market.

Chapter 4 includes a detailed assessment of the overall landscape of allogeneic cell therapies, based on several relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters, phase of development (preclinical, clinical and marketed), route of administration (intravenous, intraarticular, topical, intramuscular, intrathecal, subretinal, intracoronary, inhalational and others), type of cell therapy (stem cell therapies, T-cell therapies, NK cell therapies, dendritic cell therapies and others), source of cell (peripheral blood, umbilical cord, bone marrow, placenta), dosing frequency (single dose and multiple dose), type of therapy (monotherapies and combination therapies), target patient segment (children, adults and elderly patients), target indication (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma, B-cell lymphoma, COVID-19, osteoarthritis, acute respiratory distress syndrome, myelodysplastic syndrome, colorectal cancer and gastric cancer), and therapeutic area (oncological disorders, neurological disorders, musculoskeletal disorders, infectious diseases, autoimmune / inflammatory disorders, post-transplant infections, cardiovascular disorders, respiratory disorders, cerebrovascular disorders, ophthalmic disorders, dermatological disorders, genetic disorders, kidney disorders, liver disorders, metabolic disorders and others).

Chapter 5 includes detailed analysis of the partnerships established between stakeholders in this industry, since 2019, covering research and development agreements, product / technology licensing agreements, product development and commercialization agreements, manufacturing / supply agreements, product development agreements, clinical trial agreements, mergers, acquisitions, product commercialization agreements and other relevant agreements.

Chapter 6 provides details on the various funding and investments that have been made into companies developing allogeneic cell therapies, which include venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing. It includes a detailed analysis of the funding instances that have taken place during the period between 2019 to 2023, highlighting the growing interest of venture capital (VC) community and other strategic investors in this market.

Chapter 7 provides an overview of completed and ongoing clinical trials related to allogeneic cell therapies, based on several relevant parameters, such as trial registration year, trial status, trial phase, type of sponsor, geography, and most active industry and non-industry players (in terms of number of trials).

Chapter 8 highlights the key opinion leaders (KOLs) investigating clinical trials related to allogeneic cell therapies, based on several relevant parameters, such as type of KOL, qualification, type of organization, affiliated organization, geographical location of KOLs and target disease indication. In addition, the chapter highlights the most prominent KOLs, based on our proprietary and third-party scoring criteria.

Chapter 9 presents a comprehensive market forecast and opportunity analysis, highlighting the future potential of the allogeneic cell therapy market, till 2035. We have segregated the current and upcoming opportunity based on relevant parameters, such as type of cell therapy (virus-specific T-cell, stem cell and regulatory T-cell), source of cell (peripheral blood, bone marrow, umbilical cord blood, adipose tissue and placenta), target indication (Bone Disorder, Critical Limb Ischemia, Crohn’s Disease, Diabetic Foot Ulcer, Graft versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndrome, Cytomegalovirus Infection, Others), therapeutic area (oncological disorders, neurological disorders, musculoskeletal disorders, autoimmune / inflammatory disorders, post-transplant infections), and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

Chapter 10 provides the transcripts of interviews conducted with key stakeholders in this industry.

Chapter 11 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

Chapter 12 is an appendix, which contains a list of companies and organizations mentioned in this report.