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Allogeneic Cell Therapy Market: Industry...

Allogeneic Cell Therapy Market

Allogeneic Cell Therapy Market: Industry Trends and Global Forecasts, until 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 dimension is estimated to develop from USD 0.54 billion in 2023 to USD 2.7 billion by 2035, representing a CAGR of 14.5% during the forecast interval 2023-2035.

Allogeneic cell therapies confer with off-the-shelf therapies that are isolated from donor tissues (resembling cord blood and bone marrow), https://autismtreatmentcare.com/ processed ex vivo within the labs after which administered into patients / cryopreserved in a cell bank. Since these therapies are manufactured upfront, they're readily available and eradicate the need for individualized manufacturing for every affected person. Owing to their varied benefits, reminiscent of improved and constant product quality (resulting from rigorous high quality control measures taken throughout processing), lowered value (due to centralized manufacturing course of) and flexibility in approaching the same donor or choosing a unique donor (in case the affected person requires one other course of the therapy), allogeneic cell therapies have gained vital traction within the healthcare business. Further, recent advancements in gene modifying technologies, comparable to CRISPR/Cas9, have opened up new potentialities for allogeneic cell therapies by enabling precise genetic modifications in the donor cells in order to boost their therapeutic properties and reduce the danger of immune rejection.

Over the previous few years, a lot of allogeneic cell therapies targeting a myriad of disorders, together with hematological malignancies (reminiscent of multiple myeloma, leukemia), put up-transplant lymphoproliferative disorders (PTLD), neurological disorders, musculoskeletal disorders and autoimmune / inflammatory disorders, have acquired approval from varied regulatory authorities, globally. In December 2022, the European Commission accepted the first allogeneic T-cell therapy, specifically Ebvallo, (developed by Atara Biotherapeutics) for the treatment of Epstein-Barr virus optimistic put up-transplant lymphoproliferative disease. As well as, the FDA accredited an allogenic mesenchymal stem cell therapy, Osteocel® Plus (developed by NuVasive), for the therapy of degenerative disc illness. Driven by the continuous efforts of each business and non-business gamers, rising prevalence of chronic diseases and non-malignant disorders, and challenges related to production of autologous cell therapies, the worldwide allogeneic cell therapies market is prone to witness substantial market development in the course of 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 extensive study of the current market landscape, market dimension and future opportunities for the allogenic cell therapy developers, throughout the given forecast interval. Further, the report highlights the efforts of a number of stakeholders engaged in this rapidly emerging phase of the pharmaceutical business. Key takeaways of the allogeneic therapy market report are briefly discussed beneath.

Allogeneic Cell Therapy vs Autologous Cell Therapy

Allogeneic cell therapy and autologous cell therapy are two distinct approaches in regenerative medicine market. In autologous cell therapy, the cells are derived from the affected person's own physique, processed ex-vivo and reintroduced into the same affected person; this personalized strategy ensures compatibility and minimizes the risk of immune rejection. However, these therapies require an extended manufacturing time, as every affected person's cells should be individually processed. Then again, allogeneic cell therapy includes using cells from a wholesome donor; these collected donor cells could be given on to a genetically comparable affected person or added to a cell bank. Allogeneic cell therapy has varied advantages, together with speedy accessibility, scalability and price-effectiveness, however, it may involve the risk 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 developing allogeneic cell therapies, for a wide range of indications. It is value highlighting that over 470 allogenic cell therapies are at the moment being evaluated in several preclinical / clinical stages, both as monotherapies or in combination with other medicine. In April 2023, Gamida Cell obtained 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 rising 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 interval.

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

Over time, corporations concerned in the event of allogeneic cell therapies have made important 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 disease, 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 totally different geographical regions to judge numerous allogenic cell therapies. Of these trials, majority (~180) have been registered in North America and most number of patients (9,300) have been noticed to be enrolled in clinical trials carried out in North America, accounting for about 55% of the general enrollment. It's worth mentioning that Fundamenta Therapeutics is conducting the utmost number of trials on this trade for various kinds of cancers, comparable 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 positive results within the Phase I clinical trials.

A number of allogeneic cell therapies are likely to enter clinical trials in 2024, with the drug developers receiving FDA clearance. In February 2024, FDA granted clearance to the IND utility for ACE2016, an allogeneic γδ2 T-cell therapy for the remedy of patients with solid tumors that categorical epidermal progress factor receptor (EGFR). In April 2024, Tr1X acquired 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-industry gamers for the development of allogeneic cell therapies. It's value highlighting that, since 2019, over 90 strategic partnerships have been established within the allogeneic cell therapy market. Majority of such deals are centered on analysis and growth, product / know-how licensing, and growth and commercialization of allogenic cell therapies. In March 2023, Tessa Therapeutics entered right into a analysis and development settlement with US National Cancer Institute for Tessa’s allogeneic CD30.Car-modified Epstein-Barr virus-particular T-cell therapy, TT11X, helpful 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 know-how (miCAR™) in order to advance multiplex gene silencing instrument (useful in the event of modern allogeneic Car T cell therapy).

In March 2024, Allogene Therapeutics and Arbor Biotechnologies, entered right into a strategic partnership agreement so as to make use of Arbor’s proprietary CRISPR gene-enhancing know-how in Allogene’s next era AlloCAR T platform for the treatment of autoimmune disease (Aid).

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

The growing curiosity in allogeneic cell therapy market will be validated by the truth that up to now four years, near USD 8.Eight billion has been invested by several buyers primarily based across the globe, in companies engaged in the event of allogeneic cell therapies. It is value noting that, majority of the funds have been raised by venture rounds. In terms of the funding quantity raised, Legend Biotech raised the maximum funding amount (USD 487.3 million) through preliminary public offering. In December 2022, Gamida Cell announced the closing of a convertible time period loan of USD 25 million with Highbridge Capital Management; the funding is deliberate for use 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 0.54 Million in 2023. Driven by the increasing need for novel allogenic cell therapies, together with rising growth pipeline and encouraging clinical trial outcomes, the allogenic cell therapies market is anticipated to grow at a CAGR of 14% during the forecast period. Specifically, by way 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 carry the largest Allogeneic Cell Therapy Market Share

Majority of the companies growing allogeneic cell therapies are headquartered in North America, followed by companies primarily based in Asia Pacific. Consequently, more than 60% of the worldwide market of allogeneic cell therapies is anticipated to be captured by players based mostly in North America, in 2035. The factors liable for the expansion of the allogeneic cell therapy market in North America include the rising incidence of acute in addition to chronic disorders, growing FDA approvals for novel allogenic cell therapies and growing adoption of progressive therapies in the developed countries. In addition, the US government has been actively concerned 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 key allogeneic cell therapy companies (based on number of merchandise below improvement; the whole checklist of players is obtainable in the total report) embody 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 contains an simply searchable excel database of all of the allogeneic therapy companies (builders) worldwide.

Recent Developments in Allogeneic Cell Therapy Market

Several latest developments have taken place in the sphere of allogenic cell therapy. We have now outlined a few of these latest initiatives beneath. These developments, even in the event that they befell submit the release of our market report, substantiate the general market traits which were outlined in our analysis.

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

Scope of the Allogeneic Cell Therapy Market Report

The market report presents an in-depth analysis of the varied firms / organizations that are engaged in the allogeneic cell therapy market, across totally different segments, as defined within the under table:

Base Year

2023

Forecast Period

2023 - 2035

Market Size 2023

$0.Fifty four 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 analysis, highlighting the capabilities of various stakeholders on this market, throughout completely different geographies. Amongst other components, the market report includes:

An govt summary of the insights captured throughout our analysis. It affords a excessive-level view on the current state of allogeneic cell therapy market and its likely evolution within the mid-long run.A common overview of allogeneic cell therapy, together with information on their manufacturing course of, key advantages, challenges and latest developments inside this market.An in depth evaluation of the general panorama of allogeneic cell therapies, primarily based on several relevant parameters, similar to yr of establishment, company measurement (in terms of worker rely), location of headquarters, part of growth (preclinical, clinical and marketed), route of administration (intravenous, intraarticular, topical, intramuscular, intrathecal, subretinal, intracoronary, inhalational and others), kind of cell therapy (stem cell therapies, T-cell therapies, NK cell therapies, dendritic cell therapies and others), supply of cell (peripheral blood, umbilical cord, bone marrow and placenta), dosing frequency (single dose and multiple dose), sort of therapy (monotherapies and combination therapies), target affected person phase (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 most cancers and gastric most cancers), and therapeutic area (oncological disorders, neurological disorders, musculoskeletal disorders, infectious diseases, autoimmune / inflammatory disorders, submit-transplant infections, cardiovascular disorders, respiratory disorders, cerebrovascular disorders, ophthalmic disorders, dermatological disorders, genetic disorders, kidney disorders, liver disorders, metabolic disorders and others).An in depth evaluation of the partnerships established between stakeholders engaged in this business, since 2019, protecting research and improvement agreements, product / expertise licensing agreements, product development and commercialization agreements, manufacturing / provide agreements, product development agreements, clinical trial agreements, mergers, acquisitions, product commercialization agreements and different relevant agreements.An evaluation of the funding and investments which have been made into corporations creating allogeneic cell therapies, which embody enterprise capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing. It contains an in depth evaluation of the funding situations which have taken place during the period 2019 to 2023, highlighting the growing interest of enterprise capital (VC) group and different strategic traders in this market.An evaluation of accomplished and ongoing clinical trials associated to allogeneic cell therapies, based on a number of related parameters, equivalent to trial registration 12 months, trial status, trial part, examine design, sort of sponsor, geography, and most lively trade and non-trade players (in terms of variety of trials).An insightful analysis, highlighting the important thing opinion leaders (KOLs) investigating clinical trials related to allogeneic cell therapies, based on a number of relevant parameters, reminiscent of kind of KOL, qualification, sort of group, affiliated organization, geographical location of KOLs and target illness indication. As well as, the chapter highlights probably the most distinguished KOLs, based mostly on our proprietary and third-celebration scoring criteria.

Considered one of the key goals of this market report was to estimate the current market measurement, alternative and the longer term development potential of the allogeneic cell therapies market, over the forecast interval. We have offered informed estimates on the possible evolution of the marketplace for the forecast period, 2023-2035. Our 12 months-sensible projections of the current and future alternative have additional been segmented primarily based on relevant parameters, reminiscent of type of cell therapy (virus-specific T-cell, stem cell and regulatory T-cell), supply 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 space (oncological disorders, neurological disorders, musculoskeletal disorders, autoimmune / inflammatory disorders, put up-transplant infections), and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). With a view to account for future uncertainties associated with some of the important thing parameters and so as to add robustness to our mannequin, we've offered three market forecast scenarios, namely conservative, base, and optimistic situations, representing totally different tracks of the industry’s evolution.

The opinions and insights presented in the report had been influenced by discussions held with senior stakeholders within the trade. The report options detailed transcripts of interviews held with some of the important thing business stakeholders.

All precise figures have been sourced and analyzed from publicly available data forums and main analysis discussions. Financial figures talked about on this report are in USD, unless otherwise specified.