Cell and Gene Therapy Market Size to Cross USD 117.46 Bn By 2034

Cell and Gene Therapy Market Analysis by Geography

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 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.

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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.

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.

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.