Cell and Gene Therapy Market Size to Reach USD 97.33 Bn by 2033

According to the latest research by nova one advisor, the global cell and gene therapy market size was valued at USD 18.13 billion in 2023 and is anticipated to reach around USD 97.33 billion by 2033, growing at a CAGR of 18.3% from 2024 to 2033.

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The cell and gene therapy market provides therapeutic solutions related to genes and cells. The market deals with research & development, testing, production, and distribution of products and treatment procedures related to genes and cells. Hospitals, research laboratories, pharmaceutical companies, pharmacies, research institutions, and universities are involved in delivering the applications associated with gene and cell therapies. Gene and cell therapies are developed to prevent, treat, or potentially cure numerous diseases. The potential of these therapies to cure, treat, or prevent diseases that are life-threatening increases the demand and boosts the growth of the market. Gene and cell therapies are used in blood stem cell transplantation, gene editing, engineering of the immune system, tissue regeneration, in-vivo gene transfer, cancer treatment, and treatment of different disorders. These therapies can provide better results and enhance quality of life.

North America dominated the cell and gene therapy market in 2023. North America is a developed region that has developed healthcare and research infrastructure, better facilities, and government support that boosts the growth of the market. Governments in the North American region have a huge national budget for healthcare and research. Countries like the U.S. and Canada contribute to the growth of the market in the North American region. As of now, the FDA has approved 37 products for gene and cell therapy. The U.S. has the American Society of Gene & Cell Therapy (ASGCT) for professionals, scientists, physicians, and patient advocates that help advance knowledge, education, and awareness for discovering and developing clinical applications of gene and cell therapy.

• For instance, the U.S. has decided to launch the Cell and Gene Therapy (CGT) Access Model. The enrollment for which will start in January 2025. The main goals of the model are to increase access for people, improve healthcare outcomes, and reduce healthcare expenditure. The major focus will be on sickle cell anemia, which impacts 100,00 people in the U.S.

The Canadian government is also focusing on improving health with the help of genes and therapies and is launching various programs to help with this. The government launched Disruptive Technology Solutions, which will help tackle the challenges associated with gene and cell therapies. The treatment procedures will be done to cure rare genetic disorders and chronic diseases.

Key Takeaways:

• The North America region accounted for more than 50.85% of revenue share in 2023.
• By therapy type, the gene therapy segment held a revenue share of 14.37% in 2023.
• The cell therapy segment accounted revenue share of 87.13% in 2023.
• The oncological disorder segment held a revenue share of 13.53% in 2023

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The cell and gene therapy market is exploding globally

Ground-breaking developments in next-generation cell and gene therapies (CGTs) offer curative value for patients with few to no other therapeutic interventions for either maintenance or cure within specific disease areas, many of which include rare and ultra-rare diseases. The largest therapeutic area is cancer, followed by musculoskeletal diseases and eye diseases. Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. In Europe, these therapies are classified under Advanced Therapeutic Medicinal Products (ATMPs) and are driven by a diverse set of scientific advancements including CAR-T, TCR-T, stem cells, siRNA, oligonucleotides, gene editing (CRISPR, Zinc Fingers, TALENs) and viral transfection.

The global CGT market is projected to grow at a compound annual growth rate of over 36 percent from 2019-2025, to ~ €10 billion. With more than 900 companies globally focusing on CGTS and over 1,000 clinical trials being conducted, the industry could see numerous approvals—as many as 10 to 20 new advanced therapies per year starting in 2025. Moreover, 33% of these clinical trials is being conducted in Europe.1

Global biopharma companies as well as smaller, venture backed-up start-ups are rapidly investing in this complex space. In 2018, about $13 billion has been invested globally in advanced therapies such as cell, gene and gene modifying therapies. In 2019, 19 CGT-related M&A deals worth over $156 billion were completed.

As with any innovative and disruptive technology, CGT developers face challenges along several key stages of the product life cycle. Compared to chemical-based pharmaceuticals, key success factors such as enabling patient access, managing supply chain and manufacturing operations, evidencing compliance with increasingly complex regulatory requirements and alternate business models impose a greater burden.

Segments Insights:

By Therapy Insights

The market for cell and gene treatments consists of companies (organizations, sole proprietors, and partnerships) that sell the therapies they have developed. Cell therapy is the transfer of whole, living cells derived from allogeneic or autologous sources, while gene therapy is the introduction, deletion, or alteration of the genome to treat disease. The market is made up of the money that businesses creating goods for cell and gene therapy make from the sales of those items.

Cell treatment and gene therapy are the two primary product categories in this field. Gene therapy is a field of medicine that focuses on altering cells’ genetic make-up to treat disease or reverse it by repairing or replacing genetic material that has been damaged. Oncology, dermatological, musculoskeletal, and other applications are among the many that are used in hospitals, ambulatory surgery centers, cancer treatment facilities, wound care facilities, and other industries.

Cell & Gene Therapy Market Revenue, By Therapy Type, 2022-2032 (USD Million)

By Therapeutic class

Based on application, the market is divided into cardiovascular disease, cancer, genetic disorder, rare diseases, oncology, hematology, ophthalmology, infectious disease, neurological disorders. Among these, the infectious disease segment dominates the market in 2023. The oncological disorder segment held a revenue share of 13.53% in 2023. Research and treatment in the biomedical domains of cell therapy and gene therapy. Both treatments have the ability to lessen the underlying cause of hereditary disorders and acquired diseases. Both therapies aim to treat, prevent, or perhaps cure diseases. By repairing or changing specific cell types, or by employing cells to transport a medication across the body, cell therapy tries to treat diseases. Cell therapy involves growing or modifying cells outside of the body before injecting them into the patient. The cells may come from a donor (allogeneic cells) or the patient (autologous cells)6. By replacing, deactivating, or introducing genes into cells, either inside the body (in vivo) or outside the body, gene therapy seeks to treat disorders (ex vivo).

The market for genetic disorders is expanding as a result of factors like the high prevalence of genetic and chronic disease cases and the growing government initiatives to raise public knowledge of genetic testing and diagnosis. Researchers are developing novel techniques for screening, diagnosing, and treating patients for a variety of cardiac diseases as they investigate the genetic roots of heart and vascular illness. Some researchers are looking for new ways to nine patients who are at risk for sudden cardiac death. Others are examining how medicines that could postpone or obviate the need for cardiac surgery could benefit patients with uncommon illnesses.

The intricacy of mitochondrial genetics and the diverse clinical and biochemical symptoms of primary mitochondrial disorders (PMDs) have shown to be a significant obstacle to the development of effective disease-modifying medications. A successful clinical transition of genetic medicines for PMDs is possible, according to encouraging evidence from gene therapy trials in patients with Leber hereditary optic neuropathy and improvements in DNA editing tools.

Cell & Gene Therapy Market Revenue, By Therapeutic Class, 2022-2032 (USD Million)

By Delivery Method

The market is split into In Vivo therapy and Ex Vivo therapy according to the type of therapy. In vivo therapy market is anticipated to grow exponentially throughout the projected period. When it comes to gene therapy, there are two different methods: ex vivo and in vivo, setting aside cell therapies. The altered human gene must first enter the diseased person’s cells for gene therapy to take effect. There are two methods for doing this; Genetic material is supplied in vivo to afflicted cells (cancer cells or other cells) that are still present within an individual’s body. After cells are collected and exposed to the genome in Ex vivo, altered genes are transferred to a person’s body.

Cell & Gene Therapy Market Revenue, By Delivery Method, 2022-2032 (USD Million)

Regional Insights

A significant number of ongoing clinical trials and a rise in corporate involvement in gene and cell therapy R&D are the primary drivers of regional market expansion. The North America region accounted for more than 50.85% of revenue share in 2023.

North America scored first for having the greatest number of gene therapy clinical trials, with more than 400 enterprises in the region actively engaged in the development of cell and gene therapy products for a variety of disorders.

Numerous brand-new collaborative research and innovation initiatives have been launched across Europe under the Horizon 2021 initiative. One of these endeavors is testing gene therapy utilizing viral vectors. This is expected to accelerate the growth of cell and gene therapy manufacturing services across Europe. The rise of the market is anticipated to be aided by the developed infrastructure and skilled labor force in European countries.

• North America cell and gene therapy market was valued at USD 8.67 billion in 2023 and it is expanding around USD 45.24 billion by 2033.
• Europe cell and gene therapy market size was reached at USD 6.24 billion in 2023 and it is poised to hit around USD 30.04 billion by 2033.
• Asia Pacific cell and gene therapy market size was accounted for USD 2.44 billion in 2023 and it is expected to surpass around USD 15.12 billion by 2033.
• LAMEA cell and gene therapy market size was estimated at USD 619.22 million in 2023 and it is projected to rake around USD 4.82 billion by 2033.

Recent Developments

• McKinsey will launch a new Digital Capability Center to quicken the development of cell and gene therapies (CGT). The Digital Capability Center will focus on accelerating operational excellence and digital transformations in biopharmaceutical manufacturing. The Digital Capability Center will join McKinsey’s rapidly growing global network of Digital Capability Centers, immersive learning environments that inspire and prepare organizations to deliver sustainable performance improvement from operational-excellence and tech-enabled transformations.
• on october 3, 2022, Alexion’s genomic medicines annuoced the acquisition of LogicBio’s technology, by this acquiestuion they are looking to incorpate knowledgeable team for preclinical development, and team for research and development on rare diseases. LogicBio has developed a number of technical systems for the delivery and insertion of genes to address genetic disorders. Additionally, they will built a platform to improve the creation of viral vectors.
• On October 12, 2022, Moderna disclosed that Merck(MSD) has decided to exercise its $250 million option to co-develop and commercialize PCV mRNA-4157/V940. The vaccine is now being tested in a phase II clinical trial as adjuvant therapy for patients with high-risk melanoma in combination with pembrolizumab, Merck’s programmed cell death protein 1 (PD-1) antibody.
• On October 3, 2022, Pfizer announced that they have successfully purchased Biohaven Pharmaceuticals which is a migraine drug manufacturing company. They recently manufactured NURTEC ODT (rimegepant) which is approved for both acute therapy and episodic migraine prevention in adults. With Pfizer’s global reach and this acquisition, they will be able to provide migraine patients with more treatment alternatives.

Browse More Insights:

• Cell And Gene Therapy CDMO Market : The global Cell And Gene Therapy CDMO market size was estimated at USD 5.90 billion in 2023 and is projected to hit around USD 69.11 billion by 2033, growing at a CAGR of 27.9% during the forecast period from 2024 to 2033.
• Cell And Gene Therapy Manufacturing Market: The global cell and gene therapy manufacturing market size was estimated at USD 9.95 billion in 2023 and is projected to hit around USD 106.03 billion by 2033, growing at a CAGR of 26.7% during the forecast period from 2024 to 2033.
• Next Generation Sequencing Market: The global next generation sequencing market size was estimated at USD 9.19 billion in 2023 and is projected to hit around USD 66.04 billion by 2033, growing at a CAGR of 21.8% during the forecast period from 2024 to 2033.

• Oncology Clinical Trials Market : The global oncology clinical trials market size reached USD 13.19 billion in 2023 and is projected to hit around USD 22.11 billion by 2033, expanding at a CAGR of 5.3% during the forecast period from 2024 to 2033.

Key Companies & Market Share Insights

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

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cell and Gene Therapy market.

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
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)

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