The global cell and gene therapy market size is calculated at USD 21.28 billion in 2024 and is expected to be achieved around USD 117.46 billion by 2034, registering a double digit CAGR of 18.6% between 2024 and 2034. The North America cell and gene therapy market size was valued at USD 9 billion in 2023.

Ottawa, Aug. 28, 2024 (GLOBE NEWSWIRE) -- The cell and gene therapy market size is predicted to increase from USD 18.12 billion in 2023 to approximately USD 117.46 billion by 2034. The market is expected to expand at a solid CAGR of 18.6% from 2024 to 2034, According to Precedence Research. The cell and gene therapy market is driven by the increasing prevalence of chronic diseases and mental disorders.

Cell and Gene Therapy Market Overview

The cell and gene therapy market refers to a sector within the biopharmaceutical industry that focuses on developing, producing, and commercializing treatments for the cure or treatment of diseases by manipulating genetic material or living cells. Cell and gene therapy are overlapping areas of biological study and treatment that treat, prevent, or cure diseases. Both therapies help to abolish the primary causes of hereditary and acquired disorders.

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Cell therapy involves replacing or modifying specific cells in a body. In contrast, gene therapy involves introducing genes into a cell, inactivating a gene, or replacing a gene with a functional copy inside the cell, either in vivo or ex vivo. Some drugs act as both cell and gene therapies, as their mechanisms of action involve modifying genes in specific cell types and their subsequent delivery into the body.

• Oncology and rare diseases remain at the top of gene therapy development
  
  

Cell and Gene Therapy Market Key Highlights:

• North America dominated the cell and gene therapy market with the largest market share 49.70% in 2023.
• By therapy, the cell therapy segment contributed more than 86.19% of the market share in 2023.
• By therapeutic, the infectious disease segment accounted for the largest market share of 28.73% in 2023.
• By delivery method, the in vivo segment generated more than 79.19% of the market share in 2023.
• By end-users, the cancer care centers segment has captured the biggest market share of 40.20% in 2023.
  

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Cell and Gene Therapy Market Revenue (USD Million), By Therapy Type, 2020-2023

By Therapy Type	2020	2021	2022	2023
Cell Therapy	7,039.46	11,509.23	13,396.01	15,621.48
Gene Therapy	1,005.64	1,710.27	2,067.97	2,502.14

Cell and Gene Therapy Market Revenue (USD Million), By Delivery Method, 2020-2023 

By Delivery Method	2020	2021	2022	2023
In Vivo	6,333.10	10,427.20	12,221.99	14,352.68
Ex Vivo	1,712.00	2,792.30	3,241.99	3,770.93

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Cell and Gene Therapy Market Analysis by Geography

The U.S. cell and gene therapy market size reached USD 8.48 billion in 2023 and is expected to lead around USD 55.47 billion by 2034, growing at a CAGR of 18.7% from 2024 to 2034.

North America dominated the cell and gene therapy market in 2023 owing to continued research in gene therapy. However, various ethical and safety protocols limit the market expansion. The increasing need for quality healthcare for cancers and genetic diseases and the rising development of improved therapy and diagnostic techniques boost the market.

• For instance, in January 2024, the U.S. FDA announced the launch of its pilot program called Collaboration on Gene Therapies Global Pilot (CoGenT Global). Under the program, the Center for Oncology Excellence is collaborating with the World Health Organization and the International Council for Harmonisation through Project Orbis to discuss the potential for concurrent and collaborative review of gene therapy applications.
  
• In April 2024, the FDA approved Pfizer’s first gene therapy for the rare genetic bleeding disorder. The agency cleared the drug, to be sold under the brand name Hemgenix, for the treatment of adults with moderate to severe hemophilia B who require factor IX replacement therapy, as indicated. A Pfizer spokesperson confirmed to CNBC that eligible patients will be able to get the treatment this quarter by prescription. It comes with a whopping price tag of US$ 3.5 million before insurance and other rebates.

Cell and Gene Therapy Market Coverage

Report Attribute	Key Statistics
Market Size in 2024	USD 21.28 Billion
Market Size by 2034	USD 117.46 Billion
Growth Rate from 2024 to 2034	CAGR of 18.6%
Quantitative Units	Revenue/Size in USD Million/Billion and CAGR from 2024 to 2034
Largest Market	North America
Base Year	2023
Forecast Year	2024 to 2034
Segments Covered	Therapy Type, Therapeutic Class, End User, Delivery Method, Region
By Therapy Type	Cell Therapy and Gene Therapy
By Therapeutic Class	Cardiovascular Disease, Cancer, Genetic Disorder, Rare Diseases, Oncology Hematology, Ophthalmology, Infectious Disease, Neurological Disorders and Others
By Delivery Method	In Vivo and Ex Vivo
By End-Users	Hospitals, Cancer Care Centers and Others
Regions Covered	Asia Pacific, North America, Europe, Latin America, Middle East and Africa
Countries Covered	U.S., Canada, UK, Germany, France, Italy, Spain, Norway, Sweden, Denmark, Japan, China, India, Australia, South Korea, Thailand, Brazil, Mexico, Argentina, South Africa, Saudi Arabia, UAE, Kuwait

Cell and Gene Therapy Market Segmental Analysis

Analysis by Therapy

The cell therapy segment dominated the cell and gene therapy market in 2023. Cell therapy involves transplanting human cells to replace damaged tissue or repair tissues. With the advancement in technology, several types of cells can be used for several diseases and conditions.

Hematopoietic stem cells (HSCs) are used to treat blood cancers and hematologic conditions. Other potential applications are being researched for cancer, autoimmune, urinary problems, infectious diseases, repairing joint damage, repairing spinal cord damage, improving the immune system, and neurologic disorders.

Analysis by Therapeutic

The infectious disease segment dominated the market in 2023. Since the emergence of contagious agents such as HIV, various pharmaceutical compounds have been studied for treatment. However, these therapies have yet to be promising in curing SARS-CoV-2-associated lung injury.

Stem cell treatment, a new method with immunomodulatory effects on covering cells and inducing antioxidants, is being researched to restore damaged lungs and resolve the inflammatory response. Stem cells, which have CD marks and diminish the proinflammatory cytokines, can increase rapidly and are considered a well-recognized solution for cellular treatments.

Analysis by Delivery Mode

The in vivo therapy segment is anticipated to grow significantly during the projected period.

In vivo gene therapy involves coating a normal F8 gene through a viral vector and administering it into the body via intravenous infusion. This technique targets inside organs; no cells are removed from the body, so it is relatively easier. However, the genetic material should be delivered exactly at the injury site, which may trigger an immunological response if not properly done.

Cell and Gene Therapy Market Dynamics

Driver:

Rising prevalence of chronic diseases

The cell and gene therapy market is growing rapidly due to the growing prevalence of chronic disorders. Cancer is the leading cause of death in the U.S. and across the globe. The cost of cancer treatment in the U.S. was more than US$ 180 billion in 2015 and is estimated to reach US$ 246 billion by 2030.

Lung cancer is the leading cause of cancer death worldwide, followed by colorectal cancer. The cancer incidence rate is expected to rise by more than 40% by 2040, with the global cost of cancer likely to exceed US$ 25 trillion between the years 2020 and 2050.

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Aging people

The world's population is on the rise, and by 2030, one in every six people will be in their sixties or older. This aging trend, otherwise called the process of population aging, initially started in countries with a high-income economy but is very fast spilling over into countries with low- and middle-income earnings.

By 2050, these countries will have two-thirds of the world’s over-60 population. Aging is defined as the accumulation of molecular and cellular damage over time, which leads to the loss of physical and mental functionality, vulnerability to various pathologies, and, eventually, death. Ageing also lead to death.

Restraint: Targeting correct cell for therapy

Gene therapy cures some diseases by inserting one normal gene into the correct cells in the tissue. However, inserting that gene into the wrong cells will bring about inefficiency and yield severe health disorders. This mistargeting allows the therapeutic gene to enter the patient’s germline and could possibly be transmitted from the patient to his children.

Browse More Insights of Cell and Gene Therapy Market:

• Clinical Trials Market: The global clinical trials market size was valued at USD 57.37 billion in 2023 and is predicted to hit USD 90.59 bn by 2033 with a registered CAGR of 4.67% during the forecast period 2024 to 2033.
  
• Plasmid DNA Manufacturing Market: The global plasmid DNA manufacturing market size was valued at USD 1.8 billion in 2023 and is anticipated to reach around USD 10.22 billion by 2033, growing at a CAGR of 18.73% from 2024 to 2033.
  
• Viral Vectors & Plasmid DNA Manufacturing Market: The global viral vectors & plasmid DNA manufacturing market size calculated at USD 6.26 billion in 2024 and is projected to grow around USD 23.7 billion by 2033, growing at a CAGR of 15.94% from 2024 to 2033.
  
• Stem Cell Therapy Market: The global stem cell therapy market size was USD 14.15 billion in 2023, accounted for USD 16.02 billion in 2024, and is expected to reach around USD 48.89 billion by 2033, expanding at a CAGR of 13.2% from 2024 to 2033.
  
• CAR T-Cell Therapy Market: The global CAR T-cell therapy market size was accounted at USD 8.44 billion in 2023 and it is expected to hit around USD 107.92 billion by 2033 with a noteworthy CAGR of 30% from 2024 to 2033.
  
• Automated And Closed Cell Therapy Market: The global automated and closed cell therapy market size accounted for USD 1.23 billion in 2023 and is projected to hit around USD 9.66 billion by 2033, poised to grow at a CAGR of 22.9% from 2024 to 2033. 
  
• Cancer Gene Therapy Market: The global cancer gene therapy market size was estimated at USD 2.85 billion in 2023 and is projected to hit around USD 17.49 billion by 2033, poised to grow at a CAGR of 19.8% from 2024 to 2033.
  
• Clinical Trial Management System Market: The global clinical trial management system market size was estimated at USD 1.6 billion in 2022 and it is expected to reach around USD 5.22 billion by 2032, poised to grow at a CAGR of 12.6% from 2023 to 2032.

Opportunity: Evolving novel technologies

Advanced solutions are being developed to support the GMP manufacturing step of cell therapy, increasing speed and cost-effectiveness and opening the opportunity for cell and gene therapy market growth. These methods are also used to create novel cell therapy products for common ailments such as cancer and immune deficiency disorders.

These technologies can also work in areas where handling highly concentrated and complex recombinant biologic formulations poses challenges, including controlled release and injectability. New technology solutions are being created to better adoptive cell therapies such as CAR-T, TCR, and TIL by bringing down their prices, resolving rejection issues, guiding the CAR to act at a specific region, and generating new strategies for immunotherapies.

Cell and Gene Therapy Market Key Companies

• Alnylam Pharmaceuticals Inc.
• Novartis AG
• Dendreon Pharmaceuticals LLC.
• Amgen Inc.
• Helixmith Co. Ltd.
• JCR Pharmaceuticals Co. Ltd.
• Biogen Inc.
• Pfizer Inc.
• CORESTEM Inc.
• Kolon TissueGene Inc.
  

Recent Developments

• In August 2024, MIP Discovery rebranded to Tozaro and is taking technological innovation in cell and gene therapy bioprocessing to the forefront. Through computational chemistry, smart polymer technology empowers customers to transcend the realm of biological reagents toward new solutions in viral vector purification and analytical tools.
  
• In May 2024, Cellular Origins and CGT Catapult collaborated to demonstrate end-to-end automation of cell and gene therapy manufacturing, allowing scalable, cost-efficient, and efficacious production at commercial scale.
  
• In April 2024, Smt. Droupadi Murmu, the President of India, launched India's Indigenously Developed anti-cancer CAR-T cell therapy at the Indian Institute of Technology, Bombay.
  
• In December 2023, the FDA approved two gene therapies for sickle cell disease, including the first that utilizes a new gene-editing technology known as CRISPR: Lyfgenia from Bluebird Bio and Casgevy from Vertex Pharmaceuticals together with CRISPR Therapeutics for patients aged 12 and above.

Segments Covered in the Report

By Therapy Type

• Cell Therapy
  • Stem Cells
  • T Cells
  • Dendritic Cells
  • NK Cells
  • Tumor Cells
• Gene Therapy
  

By Therapeutic class

• Cardiovascular Disease
• Cancer
• Genetic Disorder
• Rare Diseases
• Oncology
• Hematology
• Ophthalmology
• Infectious Disease
• Neurological Disorders
  

By Delivery Method

• In Vivo
• Ex vivo
  

By End-Users

• Hospitals
• Cancer Care Centers
• Wound Care Centers
• Others

By Region

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait
    

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