Number of pages: 100 | Report Format: PDF | Published date: July 05, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023 to 2031
According to the deep-dive market assessment study by Growth Plus Reports, the global cell & gene therapy clinical trials market was valued at US$ 9.59 billion in 2022 and is expected to register a revenue CAGR of 13.5% to reach US$ 29.69 billion by 2031.
Cell & Gene Therapy Clinical Market Fundamentals
Cell and gene therapy clinical trials refer to research studies conducted to evaluate the safety, efficacy, and potential applications of cell and gene therapies in human patients. These trials aim to assess the therapeutic benefits and risks associated with these innovative treatment approaches. Clinical trials for cell and gene therapies are typically conducted in multiple phases. In early-phase trials (Phase I and Phase II), the primary focus is on evaluating the safety and tolerability of the therapy, determining the optimal dosage and administration route, and gathering preliminary efficacy data. These trials often involve a small number of participants and closely monitor their responses.
Cell & Gene Therapy Clinical Market Dynamics
The rising incidence of genetic disorders, chronic diseases such as cancer and cardiovascular diseases, and other conditions with limited treatment options have created a strong demand for innovative therapies like cell & gene therapy. Clinical trials in this field aim to develop effective treatments for these diseases, driving cell & gene therapy clinical trials market growth. According to the WHO, cardiovascular diseases are the main cause of mortality worldwide, accounting for an estimated 17.9 million lives per year, or 32% of all fatalities worldwide. More than 75% of deaths occur in low and middle-income nations. Rapid advancements in biotechnology, gene editing technologies (such as CRISPR-Cas9), and our understanding of genetics have significantly contributed to developing cell and gene therapies. These advancements have enabled scientists to identify target genes and develop precise therapies, leading to increased clinical trials. Several landmark clinical trials have demonstrated the safety and efficacy of cell and gene therapies in treating various diseases. Positive outcomes in trials for diseases like leukemia, lymphoma, and inherited retinal disorders have generated enthusiasm among researchers, clinicians, and patients, leading to increased participation in clinical trials and further driving the cell & gene therapy clinical trials market demand. The field of cell & gene therapy has attracted significant investments and funding from both public and private sources. Pharmaceutical companies, venture capitalists, and government organizations recognize the potential of these therapies and are investing in research and development, infrastructure, and clinical trials, which are also expected to boost the growth of the cell & gene therapy clinical trials market.
However, developing and conducting cell & gene therapy clinical trials can be extremely expensive due to the complexity of these therapies. Costs are associated with research and development, manufacturing, regulatory compliance, and clinical trial operations. These high costs pose a challenge for small biotech companies and academic institutions with limited resources, restricting the growth of gene therapy clinical trials. While regulatory agencies have made efforts to facilitate the development and approval of cell and gene therapies, navigating the regulatory landscape can still be challenging. Meeting regulatory requirements for safety, efficacy, and quality is essential but can involve complex processes and lengthy approval timelines, which is also hindering the growth of the gene therapy clinical trials market.
Cell & Gene Therapy Clinical Market Ecosystem
The global cell & gene therapy clinical trials market is analyzed from three perspectives: phase, indication, and region.
Cell & Gene Therapy Clinical Market by Phase
Based on the phases, the global cell & gene therapy clinical trials market is segmented into phase I, phase II, phase III, and phase IV.
The phase II segment accounted for the largest revenue share, with a 51% cell & gene therapy clinical trials market share. Phase II trials aim to assess the efficacy of the therapy in a larger patient population. They provide more extensive data on the therapeutic benefits and effectiveness of the treatment. This phase often involves comparing the therapy to existing standard treatments or placebos, allowing for a more comprehensive evaluation of its efficacy. Phase II trials help refine the dosage and administration protocols of the therapy. The initial Phase I trials provide some insight into dosage levels, but Phase II allows for a more systematic exploration of different doses and administration schedules to identify the optimal therapeutic regimen. Phase II trials often involve a larger number of patients, allowing for better selection and inclusion of a diverse patient population. This enables researchers to assess the therapy's efficacy in different subgroups and evaluate its potential benefits across a broader range of patients. Regulatory agencies typically require data from well-designed Phase II trials to support the advancement of therapies to Phase III and subsequent stages. The data collected from Phase II trials are crucial for demonstrating the therapy's efficacy and safety profile, supporting regulatory submissions, and obtaining further approvals for larger-scale trials. Positive results from Phase II trials often generate significant interest from investors, as they indicate the therapy's potential for success. Promising efficacy and safety data from Phase II trials can attract funding and partnerships for further development and commercialization of the therapy, driving market dominance in this phase.
Cell & Gene Therapy Clinical Market by Indication
Based on the indications, the global cell & gene therapy clinical trials market is segmented into oncology, cardiology, CNS, musculoskeletal, infectious diseases, immunology & inflammation, ophthalmology, dermatology, endocrine, metabolic, genetic, hematology, gastroenterology, and others.
The oncology segment accounted for the prominent cell & gene therapy clinical trials market share in 2022, with a 45% market share. Oncology represents a significant unmet medical need, with a wide range of cancers having limited treatment options. According to GLOBOCAN 2020 report, approximately 10 million deaths were cases by cancer in 2020. Cell and gene therapies offer potential breakthroughs in cancer treatment by targeting specific genetic alterations or enhancing the immune system's ability to recognize and eliminate cancer cells. The urgent need for effective cancer treatments drives the focus on oncology in clinical trials. Oncology has been a well-established area of research and development for many years. This has led to a deeper understanding of cancer biology, genetic alterations, and immune responses in the context of cancer. The infrastructure and expertise required for conducting clinical trials in oncology are well-established. Oncology research centers, academic institutions, and specialized hospitals often have the necessary infrastructure, multidisciplinary teams, and patient populations available to conduct cell & gene therapy clinical trials. The market potential for oncology treatments is significant, given the high prevalence of cancer and the increasing demand for more effective therapies. Successful cell and gene therapies in oncology have the potential for commercial success, attracting investments from both pharmaceutical companies and venture capitalists. This market potential further drives the growth of the oncology segment in the cell & gene therapy clinical trials market.
Cell & Gene Therapy Clinical Market by Region
Geographically, the global cell & gene therapy clinical trials market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The North America region has the largest cell & gene therapy clinical trials market size in terms of revenue generation accounting for around 46.2% share of the market. North America boasts a strong biotechnology and pharmaceutical industry, with numerous research institutions, academic centers, and biotech companies at the forefront of cell & gene therapy development. These entities contribute to the discovery, development, and commercialization of innovative therapies, driving the growth of clinical trials in the region. North America has a well-established, advanced healthcare infrastructure, including specialized treatment centers, research institutions, and clinical trial networks. This infrastructure supports the conduct of clinical trials by providing access to patient populations, expert clinicians, and specialized facilities required to deliver cell and gene therapies. North America is a hub for biotech and venture capital investments, attracting significant funding for cell & gene therapy research and development. Academic institutions, government agencies, and private investors provide financial support to advance clinical trials in the region. North America fosters a collaborative environment, with academic institutions, biotech companies, and research organizations working together on cell & gene therapy projects. Collaborations between academia and industry and partnerships between different stakeholders facilitate knowledge sharing, access to resources, and the progression of clinical trials.
Cell & Gene Therapy Clinical Market Competitive Landscape
The prominent players operating in the global cell & gene therapy clinical trials market are:
Cell & Gene Therapy Clinical Market Strategic Developments
Cell and gene therapy clinical trials refer to research studies conducted to evaluate the safety, efficacy, and potential applications of cell and gene therapies in human patients. These trials aim to assess the therapeutic benefits and risks associated with these innovative treatment approaches.
Asia Pacific is the key growth region due to the surge in cell & gene therapy clinical trials industry trends in China, Japan, and the Indian subcontinent.
The prominent players operating in the global cell & gene therapy clinical trials market are ICON Plc, IQVIA, Charles River Laboratories International, Inc., Laboratory Corporation of America Holdings, and Syneos Health.
The global cell & gene therapy clinical trials market growth is estimated to grow at a revenue CAGR of 13.5% during the forecast period from 2023 to 2031.
The estimated size of the global cell & gene therapy clinical trials market in 2031 is US$ 29.69 billion.
*Insights on financial performance are subject to the availability of information in the public domain