In 2021, the cell and gene therapy market size was estimated to be worth USD 5.34 billion. The market is expected to rise at a CAGR of 19.02% in the forecast period of 2023-2031 and by 2030, the market value is anticipated to be worth USD 21.5 billion.
In July 2022, the National Institute for Innovation in Manufacturing Biopharmaceuticals and the Alliance for Regenerative Medicine released the standard practices and methodologies for cell and gene therapy field assistance. This will also help the scientists to overcome the manufacturing challenges.
In July 2022, a company called Discovery Life Sciences announced its acquisition of AllCells to create a combined business, “AllCells, a Discovery Life Sciences Company”.
The cell and gene therapy market is a comparatively new integration of technology and genomics, that has been enthralled by substantial new developments in the healthcare industry. Cell and gene therapy are the two conjoining therapies incorporated as a single therapy for efficient and effective treatment. The emerging new cell and gene therapies are sure to burgeon the biotechnological and biopharmaceutical industry in the coming years.
Cell therapy works on the principle of alteration, implantation, or restoration of cells or by extrapolating cells to carry the treatment through the body. In cell therapy, cells are modified outside the body, that is, in ex vivo conditions and then injected into the patient.
On the other hand, gene therapy works by incorporating, deactivating, or displacing the genes into cells which can occur both inside (in vivo) and outside (ex vivo) of the body.
In the healthcare sector, some of the major treatments and curative remedies are developed using cell and gene modifications. Cell and gene therapy works by modifying the genes in particular cells and injecting them into the body. The essential resemblance between cell and gene therapy is the ability to mitigate the underlying cause of genetic disorders. There are enormous cell and gene therapies based on the origin or destination as per the treatment requirements.
Based on the genetic manipulation and source, cell and gene therapies are classified into two categories- ex vivo and in vivo. The ex vivo ones are further categorised into allogenic and autologous.
Autologous therapies require raw materials to be referenced and returned to the same subject. At the same time, allogeneic therapies deliver it through material from any optimum donor. Cell therapies utilise genetically modified (for example CAR-T therapy) and non-genetically modified cells (Beta cells T1D) as medicines. In contrast, gene therapies use viral (lipid/polymer based) and non-viral (mRNA) vectors as medicines.
Researchers are working on several new cell and gene therapies in the new disease sectors, which will help in improving the overall market outlook.
According to the cell and gene therapy market research report, the market can be categorised into the following segments:
Market Breakup by Therapeutic Class
Market Breakup by Therapy Type
Market Breakup by Product Type
Market Breakup by Route of End User
Market Breakup by Region
The emerging cell and gene therapies seem promising in commercial aspects. Key market leaders will be the gene therapy companies that will provide fast and effective treatment for debilitating diseases.
Gene therapies developed by small, medium, and big biotech and pharmaceutical companies also tend to attract the attention of investors. According to Food and Drug Administration’s anticipation, by 2025, 10 to 20 new cell and gene therapies can be approved.
According to the research surveys, publicly traded cell and gene therapies also witnessed a 70% increase in stocks compared to the previous year. This demonstrates the substantial growth of the cell and gene therapy market in the upcoming years.
The increase in the prevalence of chronic disorders, like cancer, is responsible for driving the growth of this market. The increased expenditure in the R&D sector and enhanced government support are also expected to boost the cell and gene therapy market development during the forecast period.
Advanced technologies and better healthcare infrastructure facilities are the additional factors helping in the development of this market.
North America accounts for a significant share of the global market due to the growth of the market in the United States. The United States of America has witnessed a substantial increase in biopharmaceutical companies performing clinical trials in cell and gene therapy. Thus, the United States hold a significant share in the global cell and gene therapy market.
The growth of the market in the United States can be attributed to the higher presence of the key players in the region. It was found that more than 1000 companies worldwide are working on cell and gene therapy, out of which more than 500 companies are based in the United States.
Across the globe, around 250 are from Europe, about 150 are in the Asian region and the rest are found in other regions like Oceania, New Zealand, Australia, and Africa.
Over the last decade, cell and gene therapy have accelerated and resulted in multiple effective treatments for various indications. These novel therapies and strategies have grabbed the attention of the entire biotech and pharma industry and are visible as future hallmarks of the global cell and gene therapy market. The field of cell and gene therapy is still young compared to other modalities.
A collaborative industry effort has focused on applying chimeric anti-receptor T-cells for oncology indications. The incorporation of cell and gene therapy in hematopoietic stem cells has paved the pathway for new therapeutic strategies, including haematological, neurological, and ocular symptoms.
CRISPR-Cas-9 gene editing works on the principle of cell and gene editing, which is brought into the market to treat several genetic forms of vision loss that conventional therapies cannot treat.
Xenotransplantation, an organ transplantation technique based on cell and gene editing application, makes it possible to do the needful organ transplant in the best way possible with comparable ease and precision. In this technique, animal organs are harvested and placed into human patients. This will help the patients to get rid of the prolonged waiting time and thus decreasing the risks of mortalities.
The eye has been the leading centre for emerging cell and gene therapies. Incorporating stem cells from the retina can give rise to photoreceptors (light-sensitive cells) required for vision. Researchers are also developing cell and gene editing methodologies to help treat incurable eye disorders.
There is another novel therapy available in the market, which uses stem cells from one’s healthy eye to rectify or treat the other eye’s affected cornea, thus helping in vision rectification.
Treatment of glioblastoma can be done by incorporating microRNAs in emerging technology. Apart from this, microRNAs have also been beneficial through miR-10b blocking activity, leading to the death of tumour cells. These novel treatment strategies will help in the substantial growth of the cell and gene therapy market in the forecast period.
Several viral vectors have also proved functional in treating neurogenerative disorders. For example, a frequently used vehicle for cell and gene therapy, AAV viral vector, has been modified to enter the blood-brain barrier and treat the needful.
Scientists have also discovered an innovative cell replacement technique for treating gastrointestinal diseases. In this technique, the donor cells can be extracted from the patient’s gut or subcutaneous fat and then cultivated ex vivo to form the progenitors, giving rise to enteric neurons. These neurons pave the treatment pathway for the heart, brain, and spinal cord.
Novel regenerative approaches that work on the cell and gene editing principle have also been discovered. This technique helps restore the hair cells that are either damaged or lost, which aids in hearing. This is done by stimulating the ear’s existing cells to convert and birth to novel hair cells.
Cell and gene therapies are not only used for diagnostic or treatment purposes but also as effective modes of drug delivery systems. For example, microneedles which can easily access the legion of immune cells, are the critical targets of vaccination.
These therapies reawaken the inactive X-chromosome, which could help in the devastating, rare neurodevelopmental disorders, especially in females.
Tremendous efforts of scientists, researchers and healthcare professionals will lead to innovative cell and gene therapies, that will lay the foundation for next-generation technologies.
Henceforth, all these novel treatments will help in the improvement of healthcare and the global economy. These new treatment strategies will majorly drive the growth of the global cell and gene therapy market.
According to Alliance for regenerative medicine data, thousands of clinical trials are in progress by diverse healthcare organisations and pharma companies. Despite the numerous constraints and hindrances, some cell and gene therapies aim to provide effective treatment. Thus, to get a safer and more efficient treatment, researchers are modifying and reformulating the conventional therapies with the incorporation of cell and gene editing leading to the development of new targeted therapies.
More than 50% of cell and gene therapy trials are from oncology, followed by cardiovascular and musculoskeletal disorders.
Novartis Pharmaceuticals were doing clinical trials to monitor the long-term safety of CAR-T patients. The purpose of this trial was to monitor all patients who were incorporated with CAR-T therapies for fifteen years following their last CAR-T infusion.
Researchers did clinical trials for the first FDA-approved in vivo therapy to treat retinal dystrophies caused by the modified RPE65 gene. This therapy is incorporated with the help of the adeno-associated vector, which will target the retinal cells and insert the healthy genes into the patient’s eye.
Cell and gene therapy for Haemophilia is also entering the last stage of the clinical trials. There are already ten ongoing trials for Haemophilia A and six for Haemophilia B. In this therapy, a single injection of adeno-associated virus (AAV) is engineered in the liver to produce the essential clotting factor for the rest of the patient’s life.
Another set of clinical trials utilising cell and gene alteration is under process in the USA to treat degenerative retinal diseases. In this therapy, an intraocular injection pass on the genes encoding for MCO protein into the retinal cells. These trials are also in the phase II stage.
Implementing cell and gene technology in healthcare has already provided enormous benefits to human health. Researchers’ tremendous efforts have anticipated a rapid increase in the approvals for cell and gene therapies. A rapid rise in authorisations for gene therapies is also expected. Careful planning and research are done to overcome all the hurdles and hindrances and for the vast development.
Several ongoing clinical trials are emerging as a driving factor for cell and gene therapy market growth and development.
The report gives an in-depth analysis of the key players involved in the cell and gene therapy market, sponsors manufacturing the therapies, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Therapeutic Class||
|Breakup by Type||
|Breakup by Product Type||
|Breakup by End User||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.1.1 Research Objectives
1.1.2 Key Findings of the Report
1.2 Limitations of the Study and Scope for Future Research
2 Research Methodology
3 Executive Summary
4 Global Cell and Gene Therapy Overview
4.1 Guidelines and Stages
4.3 Screening and Diagnosis
4.4 Treatment Pathway
5 Patient Profile
5.1 Patient Profile Model
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Global Cell and Gene Therapy Market
6.1 Market Overview
6.2 Global Cell and Gene Therapy Market Analysis
6.2.1 Market Overview
220.127.116.11 Global Historical Cell and Gene therapy Market Value (2016-2022)
18.104.22.168 Global Forecast Cell and Gene therapy Market Value (2023-2031)
6.2.2 Global Cell and Gene Therapy Market by Therapeutic Class
22.214.171.124 Market Overview
126.96.36.199.1 Rare Diseases
6.2.3 Global Cell and Gene Therapy Market by Type
188.8.131.52 Cell Therapy Types
184.108.40.206.1 Autologous Cell Therapy
220.127.116.11.2 Autogenic Cell Therapy
18.104.22.168.3 Ex-vivo Cell Therapy
22.214.171.124.4 In-vivo Cell Therapy
126.96.36.199 Gene Therapy Types
188.8.131.52.1 Somatic Cell Gene Therapy
184.108.40.206.2 Germline Gene Therapy
220.127.116.11.3 Ex-vivo Gene Therapy
18.104.22.168.4 In-vivo Gene Therapy
6.2.4 Global Cell and Gene Therapy Market by Product Type
22.214.171.124 Market Overview
6.2.5 Global Cell and Gene Therapy Market by End User
126.96.36.199 Market Overview
188.8.131.52.2 Ambulatory Surgical Centres
184.108.40.206.3 Wound Care Centres
220.127.116.11.4 Cancer Care Centres
6.2.6 Global Cell and Gene Therapy Market by Region
18.104.22.168 Market Overview
22.214.171.124.1 North America
126.96.36.199.3 Asia Pacific
188.8.131.52.4 Middle East & Africa
184.108.40.206.5 Latin America
6.2.7 North America
220.127.116.11 Historical Trend (2016-2022)
18.104.22.168 Forecast Trend (2023-2031)
22.214.171.124 Break Up by Country
126.96.36.199.1 United States of America
188.8.131.52 Historical Trend (2016-2022)
184.108.40.206 Forecast Trend (2023-2031)
220.127.116.11 Break Up by Country
18.104.22.168.1 United Kingdom
6.2.9 Asia Pacific
22.214.171.124 Historical Trend (2016-2022)
126.96.36.199 Forecast Trend (2023-2031)
188.8.131.52 Break Up by Country
6.2.10 Latin America
184.108.40.206 Historical Trend (2016-2022)
220.127.116.11 Forecast Trend (2023-2031)
18.104.22.168 Break Up by Country
6.2.11 Middle East and Africa
22.214.171.124 Historical Trend (2016-2022)
126.96.36.199 Forecast Trend (2023-2031)
188.8.131.52 Break Up by Country
184.108.40.206.1 Saudi Arabia
220.127.116.11.2 United Arab Emirates
18.104.22.168.4 South Africa
7 Current Scenario Evaluation
7.1 Emerging Therapies & Clinical trials Synopsis
7.2 Patent Landscape and Impact
7.3 Cost of Treatment
8 Challenges & Unmet Needs
8.1 Treatment Pathway Challenges
8.2 Compliance and Drop- out Analysis
8.3 Awareness and Prevention Gaps
9 Global Cell and Gene Therapy Industry Dynamics
9.1 Industry Drivers and Constraints
9.2 SWOT Analysis
9.3 Porter’s Five Forces
9.4 Key Demand Indicators
9.5 Key Price Indicators
9.6 Industry Events, Initiatives & Trends
9.7 Value Chain
10 Supplier Landscape
10.1 Amgen, Inc.
10.1.1 Company Overview
10.1.2 Product Portfolio
10.1.3 Demographic Reach and Achievements
10.1.4 Mergers and Acquisitions
10.2 Bluebird Bio, Inc.
10.2.1 Company Overview
10.2.2 Product Portfolio
10.2.3 Demographic Reach and Achievements
10.2.4 Mergers and Acquisitions
10.3 Castle Creek Pharmaceutical Holdings
10.3.1 Company Overview
10.3.2 Product Portfolio
10.3.3 Demographic Reach and Achievements
10.3.4 Mergers and Acquisitions
10.4 Kite Pharma, Inc.
10.4.1 Company Overview
10.4.2 Product Portfolio
10.4.3 Demographic Reach and Achievements
10.4.4 Mergers and Acquisitions
10.5 Novartis AG
10.5.1 Company Overview
10.5.2 Product Portfolio
10.5.3 Demographic Reach and Achievements
10.5.4 Mergers and Acquisitions
10.6 Orchard Therapeutics plc.
10.6.1 Company Overview
10.6.2 Product Portfolio
10.6.3 Demographic Reach and Achievements
10.6.4 Mergers and Acquisitions
10.7 Pfizer, Inc.
10.7.1 Company Overview
10.7.2 Product Portfolio
10.7.3 Demographic Reach and Achievements
10.7.4 Mergers and Acquisitions
10.8 Spark Therapeutics, Inc.
10.8.1 Company Overview
10.8.2 Product Portfolio
10.8.3 Demographic Reach and Achievements
10.8.4 Mergers and Acquisitions
10.9 Vericel Corporation
10.9.1 Company Overview
10.9.2 Product Portfolio
10.9.3 Demographic Reach and Achievements
10.9.4 Mergers and Acquisitions
10.10 Dendreon Pharmaceuticals LLC.
10.10.1 Company Overview
10.10.2 Product Portfolio
10.10.3 Demographic Reach and Achievements
10.10.4 Mergers and Acquisitions
10.11 Human Stem Cells Institute
10.11.1 Company Overview
10.11.2 Product Portfolio
10.11.3 Demographic Reach and Achievements
10.11.4 Mergers and Acquisitions
10.11.5 C ertifications
10.12 Kolon Tissuegene Inc.
10.12.1 Company Overview
10.12.2 Product Portfolio
10.12.3 Demographic Reach and Achievements
10.12.4 Mergers and Acquisitions
10.13 Organogenesis Holdings Inc.
10.13.1 Company Overview
10.13.2 Product Portfolio
10.13.3 Demographic Reach and Achievements
10.13.4 Mergers and Acquisitions
10.14 Renova Therapeutics
10.14.1 Company Overview
10.14.2 Product Portfolio
10.14.3 Demographic Reach and Achievements
10.14.4 Mergers and Acquisitions
11 Recommendations and Discussion
12 Global Cell and Gene Therapy Market Distribution Model (Additional Insight)
12.2 Potential Distributors
12.3 Key Parameters for Distribution Partner Assessment
13 Payment Methods (Additional Insight)
13.1 Government Funded
13.2 Private Insurance
The market is rising at a CAGR of 19.02% during 2023-2031.
The different types of cell therapy are Tumour-Infiltrating Lymphocyte therapy, Engineered T Cell Receptor therapy, Chimeric Antigen Receptor T cell therapy, and Natural Killer cell therapy.
The regions involved in the market are North America, Middle East and Africa, Latin America, Asia Pacific, and Europe.
The key companies involved in this market are Amgen Inc., Bluebird Bio, Inc., Castle Creek Pharmaceutical Holdings, Kite Pharma, Inc., Novartis AG, Orchard Therapeutics plc., Pfizer, Inc., Spark Therapeutics, Inc., Vericel Corporation, Dendreon Pharmaceuticals LLC., Human Stem Cells Institute, Kolon Tissuegene Inc., Organogenesis Holdings Inc., and Renova Therapeutics.
Cell and gene therapies involve the extraction of protein, genetic material, cells or genes from a patient, altering them as per the therapy, and then reinjecting them back into the patient.
Cell therapy works on the principle of alteration, implantation, or restoration of cells or by extrapolating cells to carry the treatment through the body. In contrast, gene therapy works by incorporating, deactivating, or displacing the genes into cells which can occur both inside (in vivo) and outside (ex vivo) of the body.
The three types of gene therapy are: in vivo, ex vivo, and in situ.
Cell and gene therapy treats a wide range of diseases. It is also used as a drug delivery system.
The risks associated with cell and gene therapy include inflammation and toxicity.
The cell and gene therapy incorporate cell and gene alteration; thus, these mutations can be a risk for future generations.
Genes are present within the cells, whereas cells are the basic building blocks of all living matter.
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