The global cell and gene therapy market size was estimated to be worth USD 19,978 million in 2022, and it is expected to reach USD 133,619 million by 2031, expanding at a CAGR of 22.7% from 2023 to 2031.
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.
|Market Size||USD 133,619 million by 2031|
|Fastest Growing Market||Europe|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
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.
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.
The global market for cell and gene therapy market is segmented into the following categories: type, indication, application, end-user 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.
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.