Cell And Gene Therapy Clinical Trials Market: Oncology Indication Segment Accounted For The Largest Share
Cell And Gene Therapy Clinical Trials Industry Overview
The global cell and gene therapy clinical trials market size was valued at USD 8222.4 million in 2022 and is anticipated to exhibit a compound annual growth rate (CAGR) of 14.80% from 2023 to 2030. The market is majorly driven by an increase in R&D funding, rising patient demand for innovative therapies, growing interest in cell and gene therapies for cancer treatment, and a favorable regulatory environment. Cell and gene therapy (CGT) represents a new frontier in the fight against many deadly diseases, including rare genetic disorders and cancers. It represents the new wave of innovation in the life sciences industry. The COVID-19 pandemic reduced the number of gene therapy clinical trials in the early 2020s as the majority of studies were focused on treating and diagnosing COVID-19.
In 2021, global data stated that the percentage of gene therapy clinical studies increased significantly as compared to previous years, as many researchers are now shifting their focus to gene therapy due to its potential in treating cancer and other rare diseases. This shift is expected to boost the market growth in the coming years. Patients can look forward to the next generation of cell & gene treatments as an alternate therapy choice or tailored medication. In addition, when compared to small-molecule drugs, these medications have a higher success rate. This is because CGT focuses on specific disease causes rather than broad targets like small-molecule treatment.
Gather more insights about the market drivers, restrains and growth of the Global Cell And Gene Therapy Clinical Trials market
Between 2008 and 2018, CGT drugs had an R&D success rate of 11% from Phase I to launch, compared to 8.2% for small-molecule compounds. Substantial growth is happening in the size and sophistication of the companies entering the market. Many of the early movers in this market were small biotech startups. A significant interest was seen in the major biopharma firms. The majority of the large-sized pharmaceutical companies are now investing in CGT. For instance, Novartis, in December 2021, stated that it has signed an acquisition agreement with an ocular gene therapy company, Gyroscope Therapeutics.
This acquisition will strengthen Novartis’s position in ophthalmology gene therapy. Other noteworthy acquisitions include those of Kite Pharma by Gilead; Spark Therapeutics by Roche; and Celgene by Bristol-Myers Squibb. Interest in the CGT field has grown gradually since technological advancements in 2000. There were only about 20 FDA-approved Biologics License Applications (BLAs) for cell-based therapeutics in the 20 years, between 1997 and 2017. The FDA, in 2019, stated that it projects to approve 10 to 20 new BLAs for cell therapy products each year in the U.S. alone by 2025. The U.S. FDA has also improved the approval of CGT in recent years.
For instance, in May 2022, the FDA gave the third approval for CAR T Cell Therapy, developed by Penn Medicine for the treatment of relapsed or Refractory Follicular Lymphoma (FL) in adults. Such approvals are expected to increase the demand for research in CGT, thereby boosting the market growth. CGT is not only used in treating cancer but also has gained importance in treating COVID-19. The FDA approved BioCardia’s Investigational New Drug (IND) application in April 2022, allowing the company to initiate Phase I/II clinical trial of BCDA-04 in adults recovering from COVID-19-linked Acute Respiratory Distress Syndrome (ARDS). Such approvals are likely to support market growth.
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Cell And Gene Therapy Clinical Trials Market Segmentation
Grand View Research has segmented the global cell and gene therapy clinical trials market into phase, indication, and region:
Cell And Gene Therapy Clinical Trials Phase Outlook (Revenue, USD Million, 2018 - 2030)
- Phase I
- Phase II
- Phase III
- Phase IV
Cell And Gene Therapy Clinical Trials Indication Outlook (Revenue, USD Million, 2018 - 2030)
- Oncology
- Cardiology
- CNS
- Musculoskeletal
- Infectious Diseases
- Dermatology
- Endocrine, Metabolic, Genetic
- Immunology & Inflammation
- Ophthalmology
- Hematology
- Gastroenterology
- Others
Cell And Gene Therapy Clinical Trials Regional Outlook (Revenue, USD Million, 2018 - 2030)
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
Market Share Insights:
- April 2022: Labcorp, collaborated with, Xcell Biosciences, to support the company in developing CGTs for treating cancer, Parkinson’s, and other rare diseases.
Key Companies profiled:
Some prominent players in the global cell and gene therapy clinical trials market include:
- IQVIA
- ICON Plc
- Laboratory Corporation of America Holdings
- Charles River Laboratories International, Inc.
- PAREXEL International Corp.
- Syneos Health
- Medpace Holdings, Inc.
- PPD Inc.
- Novotech
- Veristat, LLC
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