Allogeneic Cell Therapy Market

Allogeneic Cell Therapy Market: Industry...

Allogeneic Cell Therapy Market

Allogeneic Cell Therapy Market: Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Cell Therapy, Source of Cell, Target Indication, Therapeutic Area and Key Geographical Regions

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Allogeneic Cell Therapy Market Overview

The global allogeneic cell therapy market size is estimated to grow from USD 0.54 billion in 2023 to USD 2.7 billion by 2035, representing a CAGR of 14.5% during the forecast period 2023-2035.

Allogeneic cell therapies discuss with off-the-shelf therapies which are remoted from donor tissues (corresponding to cord blood and bone marrow), https://autismtreatmentcare.com/ processed ex vivo within the labs and then administered into patients / cryopreserved in a cell bank. Since these therapies are manufactured upfront, they are readily obtainable and eliminate the need for individualized production for each patient. Owing to their numerous benefits, akin to improved and consistent product quality (attributable to rigorous quality control measures taken throughout processing), lowered value (as a result of centralized manufacturing course of) and suppleness in approaching the same donor or selecting a special donor (in case the affected person requires one other course of the therapy), allogeneic cell therapies have gained vital traction in the healthcare trade. Further, latest advancements in gene modifying technologies, comparable to CRISPR/Cas9, have opened up new prospects for allogeneic cell therapies by enabling precise genetic modifications in the donor cells in order to enhance their therapeutic properties and cut back the danger of immune rejection.

Over the previous few years, quite a lot of allogeneic cell therapies focusing on a myriad of disorders, including hematological malignancies (comparable to a number of myeloma, leukemia), put up-transplant lymphoproliferative disorders (PTLD), neurological disorders, musculoskeletal disorders and autoimmune / inflammatory disorders, have acquired approval from various regulatory authorities, globally. In December 2022, the European Commission permitted the primary allogeneic T-cell therapy, namely Ebvallo, (developed by Atara Biotherapeutics) for the remedy of Epstein-Barr virus constructive put up-transplant lymphoproliferative illness. In addition, the FDA accepted an allogenic mesenchymal stem cell therapy, Osteocel® Plus (developed by NuVasive), for the therapy of degenerative disc disease. Driven by the continuous efforts of both industry and non-business players, rising prevalence of chronic diseases and non-malignant disorders, and challenges associated with manufacturing of autologous cell therapies, the worldwide allogeneic cell therapies market is prone to witness substantial market progress during the forecast period.

Allogeneic Cell Therapy Market 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 in depth examine of the current market panorama, market size and future opportunities for the allogenic cell therapy builders, in the course of the given forecast period. Further, the report highlights the efforts of a number of stakeholders engaged in this quickly rising phase of the pharmaceutical industry. Key takeaways of the allogeneic therapy market report are briefly mentioned under.

Allogeneic Cell Therapy vs Autologous Cell Therapy

Allogeneic cell therapy and autologous cell therapy are two distinct approaches in regenerative drugs market. In autologous cell therapy, the cells are derived from the patient's personal body, processed ex-vivo and reintroduced into the same affected person; this customized approach ensures compatibility and minimizes the risk of immune rejection. However, these therapies require an extended production time, as every affected person's cells have to be individually processed. Alternatively, allogeneic cell therapy entails the use of cells from a healthy donor; these collected donor cells could be given on to a genetically similar affected person or added to a cell financial institution. Allogeneic cell therapy has varied advantages, including fast accessibility, scalability and value-effectiveness, however, it might contain the danger of immune rejection.

Pipeline Analysis: Competitive Landscape of Allogeneic Cell Therapy

Allogeneic cell therapy market landscape features the presence of near 195 large, mid-sized and small corporations creating allogeneic cell therapies, for a variety of indications. It is price highlighting that over 470 allogenic cell therapies are at the moment being evaluated in numerous preclinical / clinical levels, either as monotherapies or in combination with other medication. 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 deal with patients with hematologic malignancies. The growing demand for novel allogeneic cell therapies, approvals from varied regulatory bodies and continuous advancements in cell therapy manufacturing course of, are expected to drive the allogeneic cell therapies market development during the forecast interval.

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

Through the years, companies involved in the event of allogeneic cell therapies have made vital efforts to conduct clinical trials for evaluating the efficacy of allogeneic cell therapies, for the treatment of assorted disorders, together with infectious diseases (adenovirus infection, coronavirus infection and cytomegalovirus infection), neurological disorders (autism, bipolar depression, Parkinson’s illness, stroke) and oncological disorders (acute myeloid leukemia, biliary tract most cancers, breast most cancers and a number of myeloma). Over 365 clinical trials have been registered across different geographical regions to evaluate numerous allogenic cell therapies. Of those trials, majority (~180) had been registered in North America and most number of patients (9,300) have been noticed to be enrolled in clinical trials conducted in North America, accounting for about 55% of the overall enrollment. It's value mentioning that Fundamenta Therapeutics is conducting the utmost number of trials on this trade for various kinds of cancers, similar to 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 remedy of relapsed / refractory a number of myeloma has demonstrated constructive outcomes in the Phase I clinical trials.

Quite a few allogeneic cell therapies are more likely to enter clinical trials in 2024, with the drug builders receiving FDA clearance. In February 2024, FDA granted clearance to the IND software for ACE2016, an allogeneic γδ2 T-cell therapy for the treatment of patients with solid tumors that express epidermal development factor receptor (EGFR). In April 2024, Tr1X received the FDA clearance of first investigational new drug utility for TRX103, an allogeneic regulatory T-Cell therapy for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT).

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

Several stakeholders have been forging alliances with other business / non-business players for the event of allogeneic cell therapies. It's worth highlighting that, since 2019, over 90 strategic partnerships have been established in the allogeneic cell therapy market. Majority of such offers are centered on research and development, product / expertise licensing, and development and commercialization of allogenic cell therapies. In March 2023, Tessa Therapeutics entered right into a research and growth settlement with US National Cancer Institute for Tessa’s allogeneic CD30.Car-modified Epstein-Barr virus-specific T-cell therapy, TT11X, helpful within the remedy of non-Hodgkin’s lymphoma. In January 2022, Allogene Therapeutics signed a licensing agreement with Antion Biosciences for the latter company’s miRNA know-how (miCAR™) as a way to advance multiplex gene silencing tool (useful in the development of innovative allogeneic Car T cell therapy).

In March 2024, Allogene Therapeutics and Arbor Biotechnologies, entered into a strategic partnership settlement so as to use Arbor’s proprietary CRISPR gene-editing technology in Allogene’s subsequent generation AlloCAR T platform for the therapy of autoimmune disease (Aid).

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

The rising curiosity in allogeneic cell therapy market will be validated by the fact that up to now four years, close to USD 8.Eight billion has been invested by several investors primarily based across the globe, in companies engaged in the event of allogeneic cell therapies. It's price noting that, majority of the funds have been raised by way of venture rounds. When it comes to the funding amount raised, Legend Biotech raised the utmost funding amount (USD 487.3 million) by means of preliminary public offering. In December 2022, Gamida Cell introduced the closing of a convertible term mortgage of USD 25 million with Highbridge Capital Management; the funding is planned for use to advance the company’s allogeneic NK cell therapy pipeline.

Market Analysis: Global Allogeneic Cell Therapies Market Size

The worldwide allogeneic cell therapy market is estimated to be value USD 0.54 Million in 2023. Driven by the rising need for novel allogenic cell therapies, along with rising improvement pipeline and encouraging clinical trial outcomes, the allogenic cell therapies market is anticipated to develop at a CAGR of 14% through 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 therapy of lymphoma and leukemia.

Regional Analysis: North America to carry the largest Allogeneic Cell Therapy Market Share

Majority of the businesses creating allogeneic cell therapies are headquartered in North America, followed by corporations based mostly in Asia Pacific. Consequently, greater than 60% of the worldwide market of allogeneic cell therapies is anticipated to be captured by gamers primarily based in North America, in 2035. The factors chargeable for the expansion 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 rising adoption of modern therapies within the developed nations. As well as, the US authorities has been actively involved in offering reimbursement for costly allogeneic cell therapies, recognizing their potential to revolutionize healthcare and improve affected person outcomes.

Leading Allogeneic Cell Therapy Companies

Examples of the important thing allogeneic cell therapy companies (based mostly on number of products under growth; the complete checklist of players is offered in the total 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 additionally consists of an simply searchable excel database of all of the allogeneic therapy firms (developers) worldwide.

Recent Developments in Allogeneic Cell Therapy Market

Several latest developments have taken place in the field of allogenic cell therapy. We now have outlined some of these latest initiatives beneath. These developments, even in the event that they happened post the release of our market report, substantiate the general market developments which were outlined in our evaluation.

In August 2023, Artiva Biotherapeutics introduced the FDA clearance of investigational new drug application for AlloNK® cell therapy candidate in combination with Rituximab in Lupus Nephritis.In July 2023, Poseida Therapeutics announced the FDA clearance of investigational new drug utility for P-CD19CD20-ALLO1, an allogeneic twin Car-T cell therapy, being evaluated for the therapy of B-cell malignancies.In July 2023, Immunity Bio announced the discovering of part 1 study demonstrating that allogeneic cytokine-induced memory-like pure killer cells plus N-803, ImmunityBio’s IL-15 superagonist, might induce tumor regression in superior head-and-neck cancer patients.In March 2023, Catamaran Bio and OmniaBioTo entered into a strategic partnership settlement develop and manufacture Catamaran Bio’s allogeneic chimeric antigen receptor (Car)-NK cell therapies for the remedy of solid tumors.

Scope of the Allogeneic Cell Therapy Market Report

The market report presents an in-depth analysis of the varied corporations / organizations that are engaged in the allogeneic cell therapy market, throughout different segments, as outlined within the below desk:

Base Year

2023

Forecast Period

2023 - 2035

Market Size 2023

$0.54 billion

CAGR

14.5%

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

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

An government summary of the insights captured throughout our research. It presents a high-degree view on the present state of allogeneic cell therapy market and its probably evolution in the mid-long run.A normal overview of allogeneic cell therapy, along with information on their manufacturing course of, key benefits, challenges and current developments inside this market.A detailed evaluation of the general landscape of allogeneic cell therapies, based mostly on several relevant parameters, corresponding to 12 months of establishment, firm size (when it comes to employee rely), location of headquarters, phase of development (preclinical, clinical and marketed), route of administration (intravenous, intraarticular, topical, intramuscular, intrathecal, subretinal, intracoronary, inhalational and others), sort 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), sort of therapy (monotherapies and combination therapies), goal affected person phase (youngsters, adults and elderly patients), goal indication (acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, a number of myeloma, B-cell lymphoma, COVID-19, osteoarthritis, acute respiratory distress syndrome, myelodysplastic syndrome, colorectal most cancers and gastric cancer), and therapeutic space (oncological disorders, neurological disorders, musculoskeletal disorders, infectious diseases, autoimmune / inflammatory disorders, publish-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 on this trade, since 2019, overlaying research and improvement agreements, product / expertise licensing agreements, product growth and commercialization agreements, manufacturing / provide agreements, product improvement agreements, clinical trial agreements, mergers, acquisitions, product commercialization agreements and different relevant agreements.An evaluation of the funding and investments that have been made into corporations growing allogeneic cell therapies, which include venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing. It consists of a detailed analysis of the funding situations which have taken place during the interval 2019 to 2023, highlighting the growing curiosity of venture capital (VC) group and different strategic investors in this market.An analysis of completed and ongoing clinical trials associated to allogeneic cell therapies, based on a number of relevant parameters, akin to trial registration 12 months, trial status, trial phase, study design, type of sponsor, geography, and most energetic industry and non-business gamers (in terms of variety of trials).An insightful evaluation, highlighting the important thing opinion leaders (KOLs) investigating clinical trials associated to allogeneic cell therapies, based mostly on several related parameters, comparable to kind of KOL, qualification, sort of organization, affiliated group, geographical location of KOLs and target disease indication. As well as, the chapter highlights probably the most distinguished KOLs, based mostly on our proprietary and third-get together scoring criteria.

One among the important thing goals of this market report was to estimate the present market dimension, alternative and the future progress potential of the allogeneic cell therapies market, over the forecast period. Now we have supplied informed estimates on the seemingly evolution of the market for the forecast period, 2023-2035. Our year-smart projections of the current and future opportunity have further been segmented based mostly on relevant parameters, equivalent to sort of cell therapy (virus-particular T-cell, stem cell and regulatory T-cell), source of cell (peripheral blood, bone marrow, umbilical cord blood, adipose tissue and placenta), goal 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 an effort to account for future uncertainties related to some of the important thing parameters and so as to add robustness to our model, we have provided three market forecast eventualities, namely conservative, base, and optimistic eventualities, representing totally different tracks of the industry’s evolution.

The opinions and insights presented within the report were influenced by discussions held with senior stakeholders within the industry. The report features detailed transcripts of interviews held with a few of the important thing trade stakeholders.

All precise figures have been sourced and analyzed from publicly out there data forums and major research discussions. Financial figures mentioned on this report are in USD, except otherwise specified.