According to Vision Research Reports, the Cell And Gene Therapy Clinical Trials market size is expected to hit around US$ 48.4 billion by 2030 and is anticipated to grow at a CAGR of 24.3% during forecast period 2021 to 2030.
According to Vision Research Reports, the Cell And Gene Therapy Clinical Trials market size is expected to hit around US$ 48.4 billion by 2030 and is anticipated to grow at a CAGR of 24.3% during forecast period 2021 to 2030.
Growth Factors
Increasing funding, investments in research and development, and successful product launches are boosting the market growth.
Cell and gene therapies (CGTs) signify the next great movement of therapeutic innovation and have resulted in the development of promising therapies around the world. Although a few of the early therapies have got marketing approval in the U.S., there are numerous promising therapies in development across the world.
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The market of cell and gene therapy has witnessed significant growth over the past few years with pharma firms partnering to create effective and accessible therapies for patients. In addition, by the end of 2019, there were more than 1,000 cell and gene therapy clinical trials in the process including 452 gene-modified and cell-based immune-oncology, 352 gene therapies, 216 cell therapies, and 46 tissue engineering.
Besides, investment is rolling into companies of various types, ranging from startups to major acquisitions by significant biopharmaceutical companies. In 2019, 19 deals of M&A worth over USD 156 billion were completed.
Scope of the Report
| Report Coverage | Details |
| Market Size in 2021 | USD 48.4 Billion |
| Revenue Forecast by 2030 | USD 10.2 Billion |
| Largest Market | North America |
| Fastest Growing Region | Asia Pacific |
| Base Year | 2021 |
| Forecast Data | 2022 to 2030 |
Phase Insights
Phase II led the market and accounted for more than 50.0% in 2020. The phase I segment followed the phase II segment in terms of revenue in 2020. This is mainly attributed to the fact that a large number of new entrants are working in the market.
By representing that modified genes introduced within the targeted cells are stable, early phase clinical trials are demonstrating proof‐of‐concept for gene therapy, even in situations when they failed to attain a therapeutic benefit. This comprises early CGT trials of products targeting hemophilia A & B, X‐linked adrenoleukodystrophy, primary immunodeficiency disorders, and other rare diseases. Many of these are exhibiting clinical benefits and are on an expedited path to approval.
Though the vast majority of cell and gene therapy clinical trials are in phase I and II, the proportion of trials now in the late phase including phase III and phase IV has been growing. As of February 2020, cell and gene therapy products account for approximately 12% of the pharmaceutical industry’s clinical pipeline.
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Indication Insights
The oncology segment dominated the market with a share of 47.0% in 2020 and is anticipated to maintain its lead over the forecast period. As per the estimates, out of all the total number of CGT clinical trials, the oncology segment alone consists of 600 ongoing trials. The investment in oncology highlights the importance of developing innovative and faster ways to deliver CGT clinical trials and address the challenges of scaling to commercialization.
Besides, the development of CAR-T cell therapies, such as Kymriah and Yescarta, and their success in fighting hematological malignancies have paved the way for an increase in the investment in the CGTs in oncology. Both the biotech and pharmaceutical companies are investing globally in this approach to treat various types of cancer.
Regional Insights
North America accounted for the largest share of 48.3% in 2020 and is expected to maintain its lead over the forecast period. This is attributed to a favorable regulatory environment, especially in the U.S. The U.S. FDA has established a collaborative regulatory procedure for CGTs with early and steady engagement with the sponsor, along with special regulatory designations useful for many CGTs. Besides, the regulatory approval process in the U.S. is evolving and becoming favorable for vendors for developing cell and gene therapy products. The U.S. FDA is designating the orphan drug status, breakthrough designation, accelerated approvals, and RMAT designations for CGTs to expedite the approval process.
Asia Pacific is anticipated to expand at the fastest CAGR of 23.1% during the forecast period. A rising number of biotechnology firms in the Asia Pacific region are specializing in regenerative treatments. The market growth is boosted by the approval of the first genetic therapy agent by the U.S. FDA in 2017. Moreover, with the constant growth of medical tourism centers like Thailand, Singapore, and India, the region is projected to maintain its place as the epicenter of cell research and therapy.
Key Players
- IQVIA
- ICON Plc
- Covance
- Charles River Laboratory
- PAREXEL International Corporation
Market Segmentation
- Phase Outlook
- Phase I
- Phase II
- Phase III
- Phase IV
- Indication Outlook
- Oncology
- Cardiology
- CNS
- Musculoskeletal
- Infectious diseases
- Dermatology
- Endocrine, metabolic, genetic
- Immunology & inflammation
- Ophthalmology
- Hematology
- Gastroenterology
- Others
- Regional Outlook
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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