The global cell and gene therapy market size attained a value of USD 17.4 billion in 2022. The market is expected to rise at a CAGR of 23.17% during the forecast period of 2023-2031 to attain a value of USD 113.64 billion by 2031, driven by the rising prevalence of chronic diseases.
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The global 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:
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Market Breakup by Type
Market Breakup by Indications
Market Breakup by Product Type
Cell and Gene Therapy Market Breakup by End User
Market Breakup by Region
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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.
Based on regions, 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.
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 United States 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 therapy and 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 Type||
|Breakup by Indications||
|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
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Cell and Gene Therapy Market Overview
3.1 Global Cell and Gene Therapy Market Historical Value (2016-2022)
3.2 Global Cell and Gene Therapy Market Forecast Value (2023-2031)
4 Global Cell and Gene Therapy Market Landscape
4.1 Global Cell and Gene Therapy Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Cell and Gene Therapy Product Landscape
4.2.1 Analysis by Type
4.2.2 Analysis by Indications
4.2.3 Analysis by End Users
5 Global Cell and Gene Therapy Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Cell and Gene Therapy Market Segmentation
6.1 Global Cell and Gene Therapy Market by Type
6.1.1 Market Overview
6.1.2 Cell Therapy Types
220.127.116.11 Autologous Cell Therapy
18.104.22.168 Autogenic Cell Therapy
22.214.171.124 Ex-vivo Cell Therapy
126.96.36.199 In-vivo Cell Therapy
6.1.3 Gene Therapy Types
188.8.131.52 Somatic Cell Gene Therapy
184.108.40.206 Germline Gene Therapy
220.127.116.11 Ex-vivo Gene Therapy
18.104.22.168 In-vivo Gene Therapy
6.2 Global Cell and Gene Therapy Market by Indications
6.2.1 Market Overview
6.2.6 Infectious Diseases
6.2.8 Endocrine, Metabolic, Genetic
6.2.9 Immunology and Inflammation
6.3 Global Cell and Gene Therapy Market by Product Type
6.3.1 Market Overview
6.4 Global Cell and Gene Therapy Market by End User
6.4.1 Market Overview
6.4.3 Ambulatory Surgical Centres
6.4.4 Wound Care Centres
6.4.5 Cancer Care Centres
6.5 Global Cell and Gene Therapy Market by Region
6.5.1 Market Overview
6.5.2 North America
6.5.4 Asia Pacific
6.5.5 Latin America
6.5.6 Middle East and Africa
7 North America Cell and Gene Therapy Market
7.1 Market Share by Country
7.2 United States of America
8 Europe Cell and Gene Therapy Market
8.1 Market Share by Country
8.2 United Kingdom
9 Asia Pacific Cell and Gene Therapy Market
9.1 Market Share by Country
10 Latin America Cell and Gene Therapy Market
10.1 Market Share by Country
11 Middle East and Africa Cell and Gene Therapy Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.5 South Africa
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
17 Supplier Landscape
17.1 Amgen, Inc.
17.1.1 Financial Analysis
17.1.2 Financial Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisitions
17.2 Bluebird Bio, Inc.
17.2.1 Financial Analysis
17.2.2 Financial Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisitions
17.3 Castle Creek Pharmaceutical Holdings
17.3.1 Financial Analysis
17.3.2 Financial Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisitions
17.4 Kite Pharma, Inc.
17.4.1 Financial Analysis
17.4.2 Financial Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisitions
17.5 Novartis AG
17.5.1 Financial Analysis
17.5.2 Financial Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisitions
17.6 Orchard Therapeutics plc.
17.6.1 Financial Analysis
17.6.2 Financial Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisitions
17.7 Pfizer, Inc.
17.7.1 Financial Analysis
17.7.2 Financial Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisitions
17.8 Spark Therapeutics, Inc.
17.8.1 Financial Analysis
17.8.2 Financial Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisitions
17.9 Vericel Corporation
17.9.1 Financial Analysis
17.9.2 Financial Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisitions
17.10 Human Stem Cells Institute
17.10.1 Financial Analysis
17.10.2 Financial Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisitions
17.11 Kolon Tissuegene Inc.
17.11.1 Financial Analysis
17.11.2 Financial Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisitions
17.12 Organogenesis Holdings Inc.
17.12.1 Financial Analysis
17.12.2 Financial Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisitions
18 Global Cell and Gene Therapy Market - Distribution Model (Additional Insight)
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
*Additional insights provided are customisable as per client requirements.
The market attained a value of USD 17.4 billion in 2022, driven by the rising technological advancements.
The market is expected to rise at a CAGR of 23.17% during the forecast period of 2023-2031 to attain a value of USD 113.64 billion by 2031, driven by the rising prevalence of chronic diseases.
The types of cell therapy include autologous cell therapy, autogenic cell therapy, ex-vivo cell therapy, and in-vivo cell therapy. gene therapy can be divided into somatic cell gene therapy, germline gene therapy, ex-vivo gene therapy, and in-vivo gene therapy.
The segmentations based on indication include oncology, cardiology, CNS, musculoskeletal, infectious diseases, dermatology, endocrine, metabolic, genetic, immunology and inflammation, ophthalmology, haematology, and gastroenterology, among others.
The product types in the market include Yescarta, Provenge, Luxtura, Kymriah, Imlygic, Gintuit, MACI, Laviv, Gendicine, Oncorine, Neovasculgen, Strimvelis, Invossa, Zolgenesma, Tecartus, Lisocel, and Zyntelego, among Others.
The end-users in the market include hospitals, ambulatory surgical centres, wound care centres, and cancer care centres, among others.
The regions involved in the market are North America, Middle East and Africa, Latin America, Asia Pacific, and Europe.
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 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, Vericel Corporation, Human Stem Cells Institute, Kolon Tissuegene Inc., and Organogenesis Holdings Inc., among others.
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