Cell And Gene Therapy Clinical Trials Market Size to Hit USD 47.40 Bn by 2033

The global cell and gene therapy clinical trials market size was exhibited at USD 11.62 billion in 2023 and is projected to hit around USD 47.40 billion by 2033, growing at a CAGR of 15.09% during the forecast period 2024 to 2033.

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The market is significantly fueled by a rising favorable regulatory environment, growing interest in cell and gene therapies for cancer treatment, increasing patient demand for innovative therapies, and increasing research and development funding are expected to enhance the growth of the cell and gene therapy clinical trials market during the forecast period.

As many researchers shifted focus to gene therapy for treating cancer and other care diseases, the percentage of gene therapy clinical studies increased significantly in the last few years. This preference is estimated to drive the market growth in the coming years. An increase in demand for novel therapies, an increasingly supportive regulatory climate, and an increasing prevalence of cardiovascular disease are the major factors driving the growth of the cell and gene therapy clinical trials market during the forecast period.

In addition, increasing commercialization of cell and gene treatments, increasing speedier product approvals, increasing research expenditure, increasing prevalence of uncommon chronic illnesses, rising greater emphasis on healthcare, and rising medical tourism are further expected to enhance the growth of the cell and gene therapy clinical trial market.

Key Takeaways:

  • North America accounted for the largest share of 49.76% of the global revenue in 2023 and is expected to maintain its lead during the forecast period.
  • Asia Pacific is anticipated to expand at the fastest CAGR 15.7% during the forecast period.
  • The phase II segment dominated the global market in 2023 and accounted for the largest share of more than 54.19% of the total revenue
  • Phase I segment is expected to register a significant share 15.8 in 2023.
  • The oncology segment dominated the global market with a revenue share of more than 49.1% in 2023 and is anticipated to grow at CAGR 15.1% over the forecast period.

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U.S. Cell and Gene Therapy Clinical Trials Market Size, Industry Report, 2033

The U.S. cell and gene therapy clinical trials market size was exhibited at USD 4.05 billion in 2023 and is projected to be worth around USD 16.71 billion by 2033, poised to grow at a CAGR of 15.23% from 2024 to 2033.

North America accounted for the largest share of 49.76% of the global revenue in 2023. and is expected to maintain its growth in the forecast period. The presence of a robust biopharmaceutical industry with various biotechnology and pharmaceutical companies significantly engaged in cell and gene therapy development and activities in the region combined with substantial investment in innovative therapies and technologies accelerates the demand for cell and gene therapy clinical trial services.

  • In addition, the increasing prevalence of genetic and chronic diseases tailored with the lack of available treatment modalities, underscores the demand for advanced therapies to meet unmet medical needs.
  • Cell and gene therapies provide new approaches for treating these diseases, accelerating the demand for clinical trials to enhance their efficacy and safety. The U.S. and Canada are the major countries in the region. Thus, these factors are expected to drive the growth of the cell and gene therapy clinical trials market in North America.

U.S. cell and gene therapy clinical trials market trends

In the U.S., gene and cell therapies have been gaining traction across the medical community. As research and development activities expand, demand for cell and gene therapy is estimated to grow. Various novel gene and cell therapies are being established for the type of ailments, aimed at cardiovascular diseases and cancer treatments. These medications are waiting for FDA approval and are in clinical development.

  • For instance, In March 2024, In the U.S., Seattle Children’s was set to launch its first chimeric antigen receptor (CAR T-Cell) clinical trial. The students have received FDA authorization to launch this clinical trial for children under 18 with the most common form of lupus.

Asia Pacific is expected to grow fastest during the forecast period.

The increasing number of biotechnology companies in the region, the constant growth of medical tourism centers in developing countries, the increasing geriatric population, and increasing cardiovascular diseases are expected to drive the growth of the cell and gene therapy clinical trials market in the region. Due to the low trial cost and large patient pool, the recruitment for CGT clinical trials is increasing in Asia Pacific. China, India, Japan, and South Korea are the major countries in the region.

China cell and gene therapy clinical trials market trends

China is the major and fastest-growing country in this market. There are more than 400 cell therapies in clinical trials in China. Due to the exponential growth in clinical research and development activity, China has emerged as one of the world’s largest pharmaceutical markets. CAR T cell therapy is the most popular immunotherapies in China. Around 20%-30% of clinical trials are being conducted for the treatment of various diseases globally.

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Cell and Gene Therapy Clinical Trials Market Segments.

By phase type,

On the basis of phases, the overall market has been further categorized into phase I, phase II, phase III, and phase IV. The phase II segment dominated the global market in 2023 and accounted for the largest share of more than 54.19% of the total revenue as the majority of cell and gene therapies are in this phase of the clinical trial. The segment is also estimated to grow with the fastest growing due to the complexities associated with phase ll clinical trials, a growing number of non-industries sponsored, and industry-sponsored clinical trials in phase ll, and increasing investments in research and development activities. In addition, the effective translation of medicines from non-clinical projects into First-in-Human clinical trials is the major reason for the phase ll segment growth.

By Indication Type,

On the basis of indications, the market is divided into oncology; cardiology; CNS; musculoskeletal; infectious diseases; dermatology; endocrine, metabolic, genetic; immunology & inflammation; ophthalmology; hematology; gastroenterology; and others. The oncology segment dominated the global market with a revenue share of more than 49.1% in 2023 and is anticipated to grow at CAGR 15.1% over the forecast period. The significant investment in oncology shows the importance of developing innovative, addressing the challenges of scaling to commercialization and faster ways to deliver CGT clinical trials. The oncology cell and gene therapy program helps expedite the development of transformative cancer therapies depending on advanced technologies with curative potential and focus on clinical developments. In addition, both pharmaceutical and biotechnology companies are investing in this approach to treat numerous types of cancer globally.

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Cell and gene therapy clinical trials company insights

Some of the major companies in the clinical trial management system market are Laboratory Corporation of America Holdings, ICON Plc, IQVIA, Syneos Health, Medpace Holdings, Inc., Veristat, LLC, Novotech, PPD Inc., and others. Leading to the competitive landscape of the market, the major companies have been adopting strategies such as effective distribution, portfolio expansions, new product launches, and innovation hacked by improved research and development.

  • IQVIA, Inc., is one of the major companies in cell and gene therapy clinical trials. They have innovative Perspective across the landscape of cell and gene therapy and working extensively with large pharma and biotech clients. Over 18,000 patients from 70 countries have participated in 210 cell and gene therapy clinical trials in this company. The 76 cell and gene therapies have been launched by IQVIA, as of the end of 2023.
  • ICON’s extensive experience with cell and gene therapies spans the globe. They have expertise and insights built from more than 20 gene therapy studies, and more than 170 studies in more than 45 countries such as Asia Pacific. ICON has deep therapeutic experience and expertise with indications in infectious diseases, oncology, pediatrics, central nervous system, women’s health, surgery, and others. 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

Cell and Gene Therapy Clinical Trials Market Recent Developments.

  • In April 2024, Smt Droupadi Murmu, the President of India launched India’s first home-grown gene therapy for cancer at IIT Bombay. The launch of India’s first gene therapy is a breakthrough in our battle against cancer, said the President.
  • In August 2024, a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, Precigen, Inc. Announced a strategic reprioritization of the Company’s streamlining of resources and clinical portfolio such as a reduction of over 20% of its workforce, to focus on potential commercialization of the PRGN-2012 AdenoVerse® gene therapy for the treatment of recurrent respiratory papillomatosis (RRP).
  • In May 2024, for treating multiple myeloma, a Gilead Company and Arcellx, Kite announced plans to commence a Phase III clinical trial of anitocabtagene autoleucel (anito-cel).

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cell And Gene Therapy Clinical Trials market.

By Phase

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Indication

  • Oncology
  • Cardiology
  • CNS
  • Musculoskeletal
  • Infectious Diseases
  • Dermatology
  • Endocrine, Metabolic, Genetic
  • Immunology & Inflammation
  • Ophthalmology
  • Hematology
  • Gastroenterology
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

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