Cell and Gene Therapy Market Size To Expand USD 93.78 Bn By 2030

The global cell and gene therapy market size was exhibited at USD 18.61 billion in 2022 and is expected to expand around USD 93.78 billion by 2030, poised to grow at a projected CAGR of 22.41% from 2022 to 2030.

The market for producing cell and gene therapies was dominated by the cell therapy manufacturing sector. The growth is attributed to a significant number of active clinical trials as well as an increase in the quantity of products hitting the market. More than 250 clinical studies focusing on CAR T cell therapies and other therapies have been done to better understand the potential of cell therapies for the treatment of various cancer indications. Additionally, biopharma firms are realizing that the market for allogeneic CAR T cell therapy is more lucrative than their present distribution and marketing strategies.

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Mesenchymal stem cells have low immunogenicity, tissue repair capacity, and immunosuppressive properties, making allogeneic MSC implantation, a promising strategy for the development of cell-based therapy. Another option for reducing the costs and time involved in producing cell therapies on a big scale is process automation. According to predictions, this technological development in therapy production will significantly benefit the growth of the market for the production of cell and gene therapies.

Following the first U.S. After the FDA approved gene therapy in 2017, the market is growing swiftly. Due to operational entities’ increased investments and the clinical success of these therapies, many gene therapy enterprises are focusing on the production and marketing of their products. In order to improve their position in the gene therapy manufacturing industry, the leading producers are taking part in a number of strategic initiatives.

Cell and Gene Therapy Market Report Scope

Report Highlights

By Vectors Insights

• The gene therapy market is divided into non-viral and viral vectors based on the type of vector used. Non-viral vector is expected to acquire the prominent share during the forecast period. The development of this market is being driven by elements like the lower immunogenicity of non-viral vectors compared to viral vectors and the simpler mass production of non-viral vectors.

By Delivery Insights

• The market is split into In Vivo Therapy and Ex Vivo Therapy according to the type of therapy. Vivo therapy is expected to grow throughout the projected period.

By Therapeutic Class Insights -

• 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 oncological disorder segment is expected to acquire the dominant position during the upcoming years.

Regional Snapshots

In 2021, North America is anticipated to account for the largest portion of worldwide revenue, and it is anticipated that it will continue to hold the lead during the forecast period. A favorable regulatory framework, particularly in the US, is a reason behind this. In addition to early and consistent involvement with the sponsor and unique regulatory designations helpful for many CGTs, the U.S. FDA has established a collaborative regulatory method for CGTs. Additionally, the U.S. regulatory approval procedure is expanding and becoming more advantageous for vendors creating CGT products. To speed up the approval procedure, the U.S. FDA has given CGTs the orphan drug category, breakthrough designation, accelerated approvals, and RMAT designations.

During the forecast period, Asia Pacific is anticipated to grow at the fastest CAGR. Regenerative medicine-focused biotechnology companies are becoming more prevalent in the Asia Pacific region. Furthermore, the area is expected to continue to hold its position as the hub of cell research and therapy thanks to the steady expansion of destinations for medical tourists including Thailand, Singapore, and India. Additionally, compared to North America and Europe, Asia is seeing a rise in the number of participants in CGT clinical studies. This benefits the Asia Pacific market because there is a vast patient pool and low trial cost.

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Market Dynamics for Hospital Information System Market:

Market Driver:

Overall, CGTs have caught the interest of the pharmaceutical industry because they offer a different way to treat diseases that are underserved by pharmacological and/or medical therapies, such as uncommon and orphan diseases. Private investors keep investing in this industry since a single shot has the potential to provide patients with long-lasting clinical advantages.

Additionally, regulators have endorsed a number of products and implemented a fast-track designation to hasten patient access to these vital medications. Additionally, in order to lower obstacles to accessing these expensive products, manufacturers and healthcare providers have negotiated value- and outcome-based contracts.

High-profile mergers and acquisitions, such as those involving bluebird bio/BioMarin, Celgene/Juno Therapeutics, Gilead Sciences/Kite, Novartis/AveXis and the CDMO CELLforCURE, Roche/Spark Therapeutics, and Smith & Nephew/Osiris Therapeutics, have been made recently as a result of the CGT market’s expansion.

The market for cell and gene therapies (CGT) has expanded as a result of consistent investment and consolidation. The market for commercial upstream manufacturing is being driven by supportive regulatory. Beginning in July 2020, the U.S. 18 cellular and gene therapy products have received FDA approval for use and commercial manufacture.

Beginning in 2020, the regulatory body anticipates receiving more than 200 INDs for gene and cell therapies, and starting in 2025, it plans to approve up to 20 items yearly. The commercial scale manufacturing segment is predicted to be driven by such advancements in the industry.

Market Restraint:

There are many difficulties in development, including safety and efficacy problems, drawn-out clinical study protocols, strict regulatory frameworks, and high prices of cell and gene therapy. Gene therapy carries some possible dangers. It’s difficult to implant a gene straight into your cells. Instead, it typically has to be sent through a carrier, also known as a vector.

As viruses can recognize specific cells and insert genetic information into the genes of those cells, they are the most popular gene therapy vectors. Researchers take the viruses’ original illness-causing genes out and swap them out for the genes required to end sickness.

To realize gene therapy’s full potential, that is, long-term therapeutic benefit or, ideally, cure, a thorough understanding of the barriers to therapeutic intervention and the development of techniques to overcome these barriers is required.

A significant obstacle to effective cancer gene therapy is achieving optimal transgene expression for silencing a cancer-related gene or delivering a cancer-therapeutic gene to diseased tissue at effective dosages. Success will also depend on finding the right therapeutic gene(s) that can stop the spread of the disease.

Market Opportunity:

Although many pharmaceutical companies have developed their own internal CGT good manufacturing practices (GMP) operation capabilities, others are seeking to decentralize manufacturing and improve distribution by relying on contracts with CDMOs and CMOs like CELL for CURE, CCRM, Cell Therapies Pty Ltd (CTPL).

Market Challenge:

The production of CGTs is labor-intensive and expensive, accounting for around 25% of operational costs. Additionally, there is still a large level of fluctuation in the amount of product produced. On the medical front, a lot of people could not be good candidates for CGTs or might not produce a long-lasting response because of inadequate gene expression, pre-exposure to the viral vector, or the development of immunogenicity because of pre-exposure to viral vectors. Patients who are eligible for these treatments may experience infusion site responses as well as rare adverse events like cytokine release syndrome and neurological issues, both of which can be fatal if untreated quickly.

The durability of responses needs to be improved, biomanufacturing efficiency and consistency needs to be increased, and a seamless supply chain needs to be implemented. Only then can individuals in need have access to these agents in a way that is affordable, sustainable, and efficient.

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Key Developments

• In March 2022, the National Heart Lung and Blood Institute granted USD 12 million to an Indiana University School of Medicine researcher. The grant is for exploring major themes in a gene therapy approach to safer and potentially curative treatments for hemophilia.
• Leading provider of RNA-targeting gene therapy Locana, Inc., got USD 55 million in Series A funding in May 2019 from ARCH Venture Partners, Temasek, and Lightstone Ventures (all existing investors). The company will use this money for its pipeline programmes for RNAtargeting gene therapy.
• The current SARS-CoV-2 outbreak is expected to boost market growth. in line with what the U.S. An FDA representative stated that the regulatory agency is receiving more applications to treat COVID-19 with cell therapies. For instance, Cartesian Therapeutics started enrolling patients in June 2021 for the clinical trial of Descartes-30, their RNA cell therapy for COVID-19 Related ARDS.
• Sarepta Therapeutics (US) and GenEdit (UK) established a partnership in February 2022 to develop gene-editing treatments to treat neuromuscular diseases using Sarepta’s gene-editing technology and GenEdit’s NanoGalaxy platform.
• Novartis AG (Switzerland) received FDA approval for KYMRIAH in May 2022 for adult patients with relapsed or refractory follicular lymphoma following two or more courses of systemic therapy.

Major Key Players

• 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.

Market Segmentation

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

Regional Segmentation

• North America (U.S., Canada, Mexico)
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Southeast Asia and Rest of APAC)
• Latin America (Brazil and Rest of Latin America)
• Middle East and Africa (GCC, North Africa, South Africa, Rest of MEA)

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