Personalized Cell Therapy Market (By Technique: Platelet Transfusions, Bone Marrow Transplantation, Packed Red Cell Transfusions, Organ Transplantation; By Therapeutic Area: Cardiovascular Diseases, Neurological Disorders, Inflammatory Diseases, Diabetes, Cancer) -- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2034

Personalized Cell Therapy Market Size and Growth

The personalized cell therapy market size was exhibited at USD 30.38 billion in 2024 and is projected to hit around USD 251.37 billion by 2034, growing at a CAGR of 23.53% during the forecast period 2024 to 2034. The growth of the personalized cell therapy market can be linked to ongoing advancements in cell therapy research and rising incidences of chronic disorders. Adoption of advanced healthcare systems across the globe is creating the demand for personalized medicine.

Personalized Cell Therapy Market Key Takeaways

• The North America personalized cell therapy market size reached USD 11.98 billion in 2024 and is expected to attain around USD 100.02 billion by 2033, poised to grow at a CAGR of 23.64% between 2024 and 2034.
• North America dominated the personalized cell therapy market in 2024.
• Asia Pacific is expected to host the fastest-growing market during the projected period.
• By technique, the platelet transfusions segment dominated the market in 2024.
• By technique, the bone marrow transplantation segment is expected to grow at the highest CAGR in the market during the forecast period.
• By therapeutic area, the cardiovascular diseases segment led the market in 2024.
• By therapeutic area, the neurological disorders segment is expected to grow at a significant rate during the forecast period.

U.S. Personalized Cell Therapy Market Size and Growth 2024 to 2034

The U.S. personalized cell therapy market size is evaluated at USD 10.45 billion in 2024 and is projected to be worth around USD 87.95 billion by 2034, growing at a CAGR of 23.74% from 2024 to 2034.

North America dominated the personalized cell therapy market in 2024. The United States, in particular, has a highly developed healthcare system that is supported by a vast infrastructure that enables state-of-the-art treatment practices and medical research. Both the public and commercial sectors contribute a considerable amount to research and development. The creation of novel treatments, such as customized cell therapies, is encouraged by this financing.

North America is home to several of the top pharmaceutical and biotechnology corporations in the world. These businesses possess the means and know-how to create and market cutting-edge cell treatments. There are regulatory structures in place in North America, including the Food and Drug Administration (FDA) of the United States, that make it easier to approve and market individualized cell treatments. Strong regulatory procedures guarantee the security and effectiveness of novel therapies.

Asia Pacific is expected to host the fastest-growing personalized cell therapy market during the projected period. The region's nations are investing much more in medical research and infrastructure for healthcare. Funding for the creation and marketing of cutting-edge treatments, such as customized cell therapies, is included.

Asia Pacific's biotechnology and pharmaceutical sectors are growing quickly. The expansion of these industries is being aided by public and private funding, which has enhanced the capacity for creating and producing customized cell treatments. In Asia Pacific, the prevalence of chronic illnesses, including cancer, diabetes, and cardiovascular disease, is rising. This increases the need for novel and potent therapeutics, such as customized cell therapies that provide specialized methods of treating certain illnesses.

South Korea’s Personalized Cell Therapy Prowess

South Korea is emerging as a major player in the personalized cell therapy market in Asia Pacific. Government’s active support for promoting the biopharmaceutical and biotechnology sectors as well as strategies like “Bioeconomy 2030” are driving the market growth. Fast track approvals for cell and gene therapies from the Ministry of Food and Drug Safety (MFDS) are attracting investments from local and international companies. Increased emphasis on scaling up manufacturing capabilities like the establishment of the Korean Cell Therapy Manufacturing Innovation Center is supporting the commercial manufacturing of advanced therapies like CAR-T for local companies. 

Moreover, South Korea’s focus on developing a well-established regulatory framework for advanced regenerative medicine and biopharmaceuticals such as the “Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products” (ARMAB) is facilitating the development of safe and effective therapies for patients, further bolstering the market growth. 

Evolution of the Regulatory Landscape in Personalized Cell Therapy Market

Continuous advancements and developments in the personalized cell therapy market are creating the need for effective and harmonized regulatory frameworks across the globe. Regulatory agencies are focused on addressing gaps like complexities in manufacturing, assessing potency and characterization, comparability and safety concerns such as off-target effects and immunogenicity of cell therapies. Development of expedited review pathways such as the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and the EMA’s PRIME scheme, increased focus on rare diseases through regulatory incentives like Orphan Drug designations, addressing issues related with scalability and cost, ongoing efforts for international collaboration and harmonization of regulatory standards as well as integration of advanced analytical tools and technologies is encouraging the development of a tailored, risk-based approach for evaluating these therapies in regulatory evaluation process. 

Market Overview

The personalized cell therapy market refers to a medical approach that customizes treatment to each patient’s unique characteristics, especially at the cellular level. This is the process of treating or curing diseases with the help of the patient’s own modified or cultured cells. Personalized cell therapy uses both autologous and allogeneic cells. Since autologous cells reduce the chance of immune rejection, they are favored.

The T-cells, dendrite cells, and stem cells are frequently utilized cell types. The T-cells are an essential part of the immune response, whereas stem cells have the ability to differentiate into different types of cells to improve their therapeutic qualities. The T-cells, for instance, can be modified to express CAR-T or chimeric antigen receptors.

The personalized cell therapy market is fragmented with multiple small-scale and large-scale players, such as AbbVie Inc., Bausch Health Companies Inc., Teva Pharmaceutical Industries Ltd., Cipla Inc., Lupin, Sun Pharmaceuticals Industries Ltd., Hikma Pharmaceuticals PLC, AstraZeneca, GSK Plc., Pfizer Inc., Amneal Pharmaceuticals LLC., Alvogen, F. Hoffmann-La Roche Ltd, Amgen Inc., Jazz Pharmaceuticals, Inc., Amicus Therapeutics, Inc, MeiraGTx Limited, Rocket Pharmaceuticals, Inc., Gilead Sciences, Inc.

Major Trends in the Market

• Combination therapies: Researchers are focused on enhancing therapeutic outcomes by combining cell therapies with gene therapies or other treatment approaches. 
• Expanding applications: Besides the success of CAR-T cell therapy for haematological cancers, widening applications of personalized cell therapies such as for solid tumors, autoimmune diseases like lupus and multiple sclerosis, cardiovascular diseases, and neurological disorders like Alzheimer’s and spinal cord injuries are being explored. 
• Enhancements in gene editing technologies: Advancements in CRISPR-Cas9 and other gene editing technologies are enabling precise modification of patient’s cell, further improving their therapeutic potential or ability for correcting disease-causing mutations.
• Emergence of autologous and allogenic therapies: These potential therapies are enabling their development of more personalized and effective treatments. 
• Innovative delivery systems: Development of safe and effective delivery techniques for gene therapies which includes non-viral vectors like lipid nanoparticles and electroporation offering high payload capacity and lower immunogenicity. 
• Integration of artificial intelligence (AI) and real-world data: Use of AI algorithms for predicting patient response to therapies and identification of ideal candidates for clinical trials as well as analysis of real-world data from electronic health records (EHRs) for optimizing treatment protocols and advancing cell and gene therapy research. 
• Scalable manufacturing processes: Manufacturers are adopting standardized and scalable manufacturing processes for enabling access of personalized cell therapies to a bigger patient pool.
• Synergizing biomaterials and tissue engineering: Creation of sophisticated and functional tissues for transplantation and regenerative purposes is gaining traction with the combination of cell therapies with advanced biomaterials and tissue engineering approaches.

Report Scope of Personalized Cell Therapy Market

Personalized Cell Therapy Market Dynamics

Driver

Rising cases of chronic disease

The rising cases of chronic disease can boost the personalized cell therapy market. Chronic diseases like cancer, diabetes, and heart problems frequently call for efficient long-term care solutions. The demand in this market is being driven by the customized approach that personalized cell therapy offers, which may yield longer-lasting and more effective results than traditional treatments.

Restraint

High cost of personalized cell therapy

The high cost of personalized cell therapy may slow down the personalized cell therapy market. The healthcare systems and providers may have to bear a heavy financial burden due to the high costs of customized cell therapies. Because of this, medical facilities may be hesitant to use these treatments extensively.

Opportunity

Rising clinical trials

The rising clinical trials may be the opportunity to boost the personalized cell therapy market. Personalized cell therapies are validated more when there are more clinical trials. Effective trials show efficacy and safety, which can bolster patient, regulatory, and healthcare provider confidence. Obtaining regulatory approvals for clinical trials is crucial. The likelihood that more individualized cell therapies will be approved by regulatory agencies such as the FDA or EMA rises as they demonstrate their value in clinical trials. This opens the door for the commercialization of these treatments.

The clinical trial outcomes that show promise can lead to increased funding from the public and private sectors. Promising businesses and research projects are more likely to receive funding from investors, which will hasten the creation and application of customized cell treatments. New techniques and technologies are frequently developed as a result of clinical trials.

Personalized Cell Therapy Market By Technique Insights

The platelet transfusions segment dominated the personalized cell therapy market in 2024. When treating a number of ailments, such as cancer, trauma, and surgery, as well as individuals with thrombocytopenia (low platelet count), platelet transfusions are essential. The healthcare industry will always need platelet transfusions due to their extensive use. Platelet transfusions are often necessary for many cancer patients, particularly those receiving chemotherapy, in order to control the negative effects of the medication. The great demand that cancer patients have is a major factor in the platelet's supremacy.

The bone marrow transplantation segment is expected to grow at the highest CAGR in the personalized cell therapy market during the forecast period. The increase in hematologic illnesses, including multiple myeloma, lymphoma, and leukemia, is driving up the need for bone marrow transplants. For these kinds of problems, these transplants are frequently the best course of action. The technological developments in bone marrow transplantation are increasing the treatment's application and success rates. These developments include reductions in transplant-related problems and enhancements in matching donor and recipient compatibility.

A growing number of people are undergoing bone marrow transplantation due to its improved patient outcomes and success rates. The improvements in post-transplant care, graft manipulation, and conditioning regimens all lead to higher survival rates and fewer problems. One major factor is the increasing utilization of stem cells, particularly hematopoietic stem cells from bone marrow, peripheral blood, and umbilical cord blood.

Personalized Cell Therapy Market By Therapeutic Area Insights

The cardiovascular diseases segment led the personalized cell therapy market in 2024. In the world, cardiovascular diseases (CVDs) are among the main causes of morbidity and death. Personalized cell therapy is one of the novel medicines that are in great demand due to the increased frequency of cardiovascular diseases (CVDs). The development of cell treatments intended primarily to treat cardiovascular disorders has advanced significantly. The aforementioned treatments, which have demonstrated potential in restoring damaged cardiac tissue and enhancing cardiac function, encompass stem cell therapies and regenerative medicine techniques.

The research on the effectiveness of customized cell treatments for cardiovascular disorders is centered on a significant number of clinical trials and studies. The novel treatments are brought to market through innovation fueled by this research effort. The chronic nature of cardiovascular disorders means that they frequently require long-term care since they develop over time.

The neurological disorders segment is expected to grow at a significant rate in the personalized cell therapy market during the forecast period. Neurological conditions such as multiple sclerosis, stroke, Parkinson's disease, and Alzheimer's disease are becoming more common. The need for novel, efficient therapies is being driven by this rising incidence. Many neurological illnesses have poor effectiveness and serious negative effects associated with traditional treatment approaches.

Potential novel strategies that might lead to more focused and efficient treatment alternatives are presented by personalized cell treatments. The novel cell-based therapeutics have been made possible by substantial advances in neuroscience and our knowledge of neurological illnesses. The particularly exciting areas of research include regenerative medicine and neural stem cells.

Some of the prominent players in the personalized cell therapy market include:

• AbbVie Inc.
• Bausch Health Companies Inc.
• Teva Pharmaceutical Industries Ltd.
• Cipla Inc.
• Lupin
• Sun Pharmaceuticals Industries Ltd.
• Hikma Pharmaceuticals PLC
• AstraZeneca
• GSK Plc.
• Pfizer Inc.
• Amneal Pharmaceuticals LLC.
• Alvogen
• F. Hoffmann-La Roche Ltd
• Amgen Inc.
• Jazz Pharmaceuticals, Inc.
• Amicus Therapeutics, Inc
• MeiraGTx Limited
• Rocket Pharmaceuticals, Inc.
• Gilead Sciences, Inc.

Personalized Cell Therapy Market Recent Developments

• In May 2025, BioIVT, a globally well-known research partner and biospecimen solutions provider company for drug and diagnostic development, launched the VivoSTART Cryopreserved GMP Leukopaks which is flexible, high-quality and regulatory-compliant cellular starting material facilitating improved cell therapy development in preclinical and clinical settings.
• In April 2025, CellFE, a leading non-viral gene editing technology company entered into a strategic alliance with the Harbottle Lab at German Cancer Research Center (DKFZ) and its offshoot company, TcellTech. By merging TcellTech's innovative nanoSMAR gene expression DNA vector platform with CellFE's Ryva Mechanoporation System, the partnership aims at advancing development of personalized cell therapy.
• In February 2025, Cellino in partnership with Mass General Brigham’s Gene and Cell Therapy Institute (GCTI) introduced the world’s first-of-a-kind hospital-based based autologous induced pluripotent stem cell (iPSC) Foundry which is powered Cellino’s AI-based Nebula technology. The hospital-based foundry launch is paving the way for a countrywide network of decentralized biomanufacturing hubs created for delivering point-of-care personalized cell and tissue therapies.
• In January 2025, Mytos, a leading innovator in automated cell manufacturing, established a manufacturing partnership with Aspen Neuroscience, Inc. The collaboration aims at automating the manufacturing of autologous dopaminergic neuronal precursor cells (DANPCs) for ANPD001 for Aspen’s investigational cell therapy program developed for Parkinsons’s disease (PD).

Segment Covered in the Report

By Technique

• Platelet Transfusions
• Bone Marrow Transplantation
• Packed Red Cell Transfusions
• Organ Transplantation

By Therapeutic Area

• Cardiovascular Diseases
• Neurological Disorders
• Inflammatory Diseases
• Diabetes
• Cancer

By Geography

North America

Asia Pacific

Europe

Latin America

Middle East & Africa