The global cell and gene therapy market size was estimated to be worth USD 24.67 billion in 2023, and it is expected to reach USD 133.62 billion by 2032, expanding at a CAGR of 22.7% from 2024 to 2032.
Cell therapy refers to the process of administering live cells to patients with the purpose of treating various diseases. Both autologous and allogeneic cells, which can be produced from stem cells found in places like bone marrow, can serve as the source of the cell. The treatment of bone marrow transplant patients often involves stem cell therapy. In the context of medical practice, "gene therapy" refers to any procedure that modifies, deletes, or otherwise alters a patient's genetic code. In addition, it can change the way a person's genes are expressed or fix genes that aren't functioning properly. In this treatment, nucleic acid (DNA or RNA) is given to the patient together with carriers that are referred to as vectors.
The introduction of advanced therapeutics has played a significant part in the transformation of the treatment paradigm for a number of life-threatening and uncommon diseases, as well as in the restructuring of the biopharmaceutical sector as a whole. A primary element that is driving the expansion of the industry is the rapid development of new sophisticated therapies and associated infrastructure.
The majority of pharmaceutical companies continue to make significant investments in the development of new medications and equipment. The pharmaceutical business, in particular, is heavily invested in research and development. A study by EvaluatePharma estimates that global investments in pharmaceutical research and development would reach $ 186 billion by 2019 from an expected USD 136 billion in 2012. Due to COVID-19, the global pharmaceutical research and development growth rate decreased to 0.3 percent between 2019 and 2020. The analysis's findings indicate that, compared to the historical CAGR of 4.6 percent between 2012 and 2019, R&D investment would increase at a CAGR of 3.2 percent between 2019 and 2026, reaching $ 232.5 billion.
As a result of expanded pharmaceutical R&D, the number of cell and gene therapy candidates under development has rapidly increased. It has become crucial to outsource manufacturing services in order to create cell and gene therapies that are both affordable and effective.
Cell therapy targets different diseases at the cellular level, such as by restoring a certain cell population or by using cells as carriers of therapeutic carriers, whereas gene therapy aims to influence the course of various genetic and acquired disorders at the genetic level. Gene therapies also aim to treat inherited disorders as well as acquired ones. It is anticipated that the high incidence of cardiovascular illness would accelerate demand for cell and gene therapy, which will in turn fuel the growth of the market. As of May 2017, the World Health Organization (WHO) reported that cardiovascular disease was the cause of death for around 17.9 million persons throughout the world in 2016. This figure represents 31 percent of all deaths that occurred across the globe. According to the World Health Organization (WHO), in 2012, cancer was the second biggest cause of morbidity and mortality worldwide. In that same year, around 14 million new cases of cancer were diagnosed worldwide. In 2015, cancer was the cause of 8.8 million deaths throughout the globe. In addition, the WHO reported that they anticipate a rise in the number of new cases of around 70 percent by the year 2030.
There are around 1,200 cell and gene treatments being tested in clinical settings across the world. Only in the United States are there now more than 700 experimental cell and gene treatments being tested in human patients. However, the production facilities have not kept up with the demand. It is projected that hundreds of different types of facilities will be required in order to produce the medications that are now undergoing clinical testing. The capacity of the viruses is one of the areas that have to be improved upon. The vast majority of viral vectors are created by adherent manufacturing, which is a labor- and capital-intensive process. For example, the production of a vial containing 20 million cells can cost between 20,000 and 30,000 United States Dollars. The costs associated with manufacturing gene therapy can range anywhere from $500,000 to $1 million. This does not include the costs associated with research and development, the costs associated with running crucial clinical trials, or the costs associated with building the commercial infrastructure required to provide access to patients.
Clinical tests are an essential component of medical research, and they provide assistance to the pharmaceutical and biopharmaceutical industries in their efforts to develop and bring innovative cell and gene treatments to market. As a consequence of the increased need for innovative medications to satisfy unmet medical requirements, there has been a worldwide increase in the number of clinical trials that have been conducted during the past several years. In 2018, there were 289 cell and gene treatments that were in the clinical development stage at biopharmaceutical firms, as stated in a study that was published by PhRMA on the cell and gene therapy pipeline in 2020.
In the year 2020, there were 362 cell and gene treatments that were in the clinical development stage. This represented a 25 % increase from the previous year. In addition to this, according to data that was made public by CGT Catapult, there were 154 ATMP clinical studies happening in the UK in the year 2020. This number represents an increase of more than 20 percent when compared to the 127 trials that were recorded in 2019. It is anticipated that the considerable increase in the number of cell and gene therapy clinical trials would boost the need for manufacturing services, which will, in turn, promote expansion in the market for cell and gene therapy manufacturing services.
| Study Period | 2020-2032 | CAGR | 22.7% |
| Historical Period | 2020-2022 | Forecast Period | 2024-2032 |
| Base Year | 2023 | Base Year Market Size | USD 24.67 Billion |
| Forecast Year | 2032 | Forecast Year Market Size | USD 133.62 Billion |
| Largest Market | North America | Fastest Growing Market | Europe |
The cell and gene therapy market in North America is driven by the region's high economic position as well as the region's high spending on healthcare services. Sponsorship and financial support for cell and gene therapy products come mostly from national health institutions, companies, academic institutes, and hospitals respectively.
The steadily rising financing is the primary factor that is driving the expansion of the cell and gene therapy business in Europe. In Europe, it was stated that CGTs raised around 2.6 billion USD in funding in 2020, which is a 103 percent growth in comparison to prior years' totals. The funding accounted for in the cell treatment sector in 2020 was USD 1.8 billion, while the money accounted for in the gene therapy segment was USD 2.3 billion. These figures represent increases of 196 percent and 111 percent respectively.
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The global market for cell and gene therapy market is segmented into the following categories: therapy type, indication, application, end-user, delivery mode and region.
In this market in the year 2020, the most significant share was held by cell therapy. This is mostly attributable to reasons such as increased public awareness of cell treatment, increased financing for novel cell lines, an increase in the number of partnerships and acquisitions, and the development of improved genomics technologies for cell analysis.
Based on Indication the cell and gene therapy market is classified into Oncology Diseases, Cardiovascular Diseases, Orthopaedic Diseases, Ophthalmology Diseases, Central Nervous System Disorders, Infectious Diseases, and Other Indications.
Based on application the cell and gene therapy market is segmented into: Oncology, Dermatology, Musculoskeletal and others. The need for solutions including cell and gene therapy will be driven by factors such as the growing use of target gene treatments for dermatological conditions, the increasing demand for wound healing, and the treatment of burnt skin. According to the Alliance Regenerative Medicine Report from 2021, more and more pharmaceutical companies are becoming interested in using CGTs to treat dermatological conditions. According to the survey, there were around 27 novel products in the works to treat dermatological problems in 2021.
Based on end-user the cell and gene therapy market is divided into Pharmaceuticals and Biotechnologies companies, academic and research institutes and other end users. It is anticipated that the section representing pharmaceutical and biotechnology firms would record the greatest CAGR by the end of the projected period in the year 2020. The high growth rate in this sector can be attributed to a number of factors, including the rising expenditure on research and development by pharmaceutical and biotechnology companies, the growing number of cell and gene therapies in the research and development pipeline, and the rising number of collaborations between pharmaceutical and biotechnology companies.
Based on therapy type the cell and gene therapy market is segmented into cell therapy, and gene therapy.
The cell therapy segment holds a significant share in the cell and gene therapy market. This segment includes sub-segments such as CAR-T, CAR-NK, B-Cell, and others. CAR-T therapies are particularly prominent, especially for treating blood cancers like leukemia and lymphoma. These therapies work by modifying a patient's own T cells to target and eliminate cancer cells. The U.S. Food and Drug Administration (FDA) has approved several autologous CAR-T therapies, including Kymriah (Novartis) and Yescarta (Gilead), which have demonstrated high efficacy in clinical trials and real-world applications. These approvals and the resulting clinical success have significantly contributed to the dominance of the CAR-T sub-segment. According to the FDA, these therapies have provided substantial benefits, often achieving remission in patients with refractory or relapsed blood cancers, thereby underscoring their pivotal role in advancing cancer treatment and driving the growth of the cell therapy segment.
Based on delivery mode the cell and gene therapy market is segmented into in vivo, ex vivo.
Ex-Vivo is the dominant segment in the cell and gene therapy market. Ex vivo delivery methods involve modifying cells outside the body and then reintroducing them, which has proven highly effective, particularly for cell therapies like CAR-T. This approach allows for precise control over cell modification and expansion, ensuring higher efficacy and safety. According to the FDA, ex vivo gene therapy approaches are prevalent in approved treatments, with successful outcomes reported in multiple clinical trials. These therapies have demonstrated significant benefits, particularly in treating cancers and genetic disorders, by providing targeted and personalized treatments. The ability to manipulate cells in a controlled environment before administering them to patients has led to more reliable and consistent results, making ex vivo methods a cornerstone in the advancement of cell and gene therapies. This dominance is further supported by the numerous clinical successes and ongoing research in this field.
COVID-19 has positive and negative market consequences, as carbon emissions have decreased globally due to the lockout. COVID-19's reduction in emissions is a short-term benefit. Still, when industries and enterprises attempt to recoup some of their financial losses in the first quarter of the year, carbon emissions will rise dramatically. COVID-19 had a negative impact on global recycling efforts. Countries, notably the United States, have halted or decreased recycling programs to focus on collecting additional domestic waste or because services have been disrupted by the virus.
Also, with industries slowly returning to normalcy following the COVID-19 outbreak, this shift in workplace health and safety is expected to increase due to mandatory social distancing and continuous personal care through sanitization to eliminate even the tiniest possibility of COVID-19 spread. COVID-19 has impacted various companies' revenues, and if the lockdown is lifted, companies will turn their attention to operations to make up for their losses.
In 2021, Charles River Laboratories expanded its cell and gene therapy manufacturing capabilities by purchasing Cognate BioServices, a contract manufacturing organization (CMO) specializing in cell and gene therapy.
Thermo Fisher Scientific paid roughly USD 859.7 million to buy Henogen S.A. in 2021. Henogen S.A. was the viral vector production company that Novasep operated in Belgium. Through this purchase, it will be able to strengthen its position in the manufacturing therapeutic market for cell and gene therapies.
In 2019, Thermo Fisher Scientific spent $1.7 billion to purchase Brammer Bio, a firm whose primary business was the production of viral vectors for use in gene and cell treatments.
