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Cell & Gene Therapy Bioanalytical Testing Services Market to Grow with a CAGR of 8.85% through 2030

Increasing investment in cell and gene therapy research and development and the rising prevalence of genetic and rare diseases are factors driving the global Cell & Gene Therapy Bioanalytical Testing Services market in the forecast period 2026-2030. 

 

According to TechSci Research report, “Cell & Gene Therapy Bioanalytical Testing Services Market – Global Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the Global Cell & Gene Therapy Bioanalytical Testing Services Market stood at USD 523.26 Million in 2024 and is anticipated to grow with a CAGR of 8.85% in the forecast period through 2030. The field of cell and gene therapy has witnessed unprecedented growth and innovation over the past decade. These cutting-edge therapies hold the promise of revolutionizing the treatment of various diseases by harnessing the power of genetics and cellular biology. As the cell and gene therapy industry continues to advance, the demand for robust bioanalytical testing services has surged.

One of the primary drivers of the Global Cell & Gene Therapy Bioanalytical Testing Services Market is the significant investment in research and development (R&D) within the cell and gene therapy sector. Both pharmaceutical companies and biotechnology firms are pouring substantial resources into developing innovative therapies to address previously untreatable diseases, such as genetic disorders and certain cancers. To ensure the safety, efficacy, and quality of these therapies, comprehensive bioanalytical testing services are essential. Consequently, this investment in R&D fuels the demand for specialized testing services.

The prevalence of genetic and rare diseases is on the rise globally. Patients suffering from these conditions often have limited treatment options, making cell and gene therapies a ray of hope. Bioanalytical testing is crucial in the development and manufacturing of these therapies, ensuring they meet regulatory standards and are safe for patient use. The growing need for specialized testing to support the development of therapies for these conditions is a significant market driver.

Regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have recognized the potential of cell and gene therapies and have established regulatory pathways for their approval. These agencies require rigorous testing and analysis to ensure the safety and efficacy of these therapies. As a result, companies engaged in cell and gene therapy development must collaborate with specialized bioanalytical testing service providers to meet these regulatory requirements, further propelling market growth.

Advancements in analytical technologies have enabled more precise and comprehensive bioanalytical testing. These technologies include next-generation sequencing (NGS), mass spectrometry, and flow cytometry, among others. These cutting-edge tools allow for the in-depth analysis of cellular and genetic components, providing valuable insights during the development and production of cell and gene therapies. The adoption of these advanced technologies has increased the demand for specialized testing services.

The cell and gene therapy industry has seen a surge in collaborations and partnerships between pharmaceutical companies, biotech firms, academic institutions, and research organizations. These collaborations often involve global players coming together to leverage their expertise and resources. Such collaborations require standardized and high-quality bioanalytical testing services to ensure consistency and reliability across different locations, thereby driving the demand for testing services on a global scale.

As more cell and gene therapies receive regulatory approval and reach the market, patient awareness is increasing. Patients and their healthcare providers are increasingly seeking these innovative therapies as treatment options. To gain market approval and patient trust, companies must invest in robust testing services to demonstrate the safety and efficacy of their therapies.


Browse over XX market data Figures spread through XX Pages and an in-depth TOC on "Global Cell& Gene Therapy Bioanalytical Testing Services Market.”


The Global Cell & Gene Therapy Bioanalytical Testing Services Market is segmented into Test Type, Product Type,  Stage of Development , Indication, Regional Distribution and Company.


Based on Indication, the Oncology segment stands out as the fastest-growing category within the Cell & Gene Therapy Bioanalytical Testing Services Market. This growth is primarily fueled by the escalating global incidence of cancer, which has intensified the demand for innovative and effective treatment modalities. Cell and gene therapies, particularly those involving gene-modified cells like CAR-T and CAR-NK therapies, have shown significant promise in targeting and eliminating cancer cells. These advanced therapies necessitate comprehensive bioanalytical testing to ensure their safety, efficacy, and regulatory compliance. As a result, there is an increasing reliance on specialized bioanalytical services to support the development and validation of these treatments. The complexity of oncology-related therapies, coupled with the need for precise and reliable testing methodologies, underscores the pivotal role of bioanalytical services in this domain. Consequently, the oncology indication is experiencing rapid growth, reflecting the broader trend towards personalized medicine and targeted cancer therapies.

Based on Region, ​the Asia Pacific region is experiencing the fastest growth in the Cell & Gene Therapy Bioanalytical Testing Services Market, driven by a combination of factors that enhance its appeal for research and development activities. Countries such as China, India, Japan, and South Korea are at the forefront, benefiting from substantial investments in healthcare infrastructure and a surge in clinical trials related to cell and gene therapies. The region's cost-effective outsourcing options and a large, diverse patient population make it an attractive destination for pharmaceutical and biotechnology companies seeking efficient and economical testing services. Moreover, supportive government policies and funding initiatives are fostering an environment conducive to advanced therapeutic research. The increasing prevalence of chronic diseases, including cancer and genetic disorders, further amplifies the demand for innovative treatments, thereby propelling the need for comprehensive bioanalytical testing services. As a result, the Asia Pacific region is not only accelerating in market growth but also establishing itself as a pivotal hub for the advancement of cell and gene therapy solutions

 

Major companies operating in Global Cell & Gene Therapy Bioanalytical Testing Services Market are:

  • BioAgilytix Labs Inc.
  • KCAS Bioanalytical & Biomarker Services
  • IQVIA, Inc.
  • Laboratory Corporation of America Holdings
  • Thermo Fisher Scientific Inc.
  • Prolytix pvt ltd
  • Pharmaron Biologics (UK) Ltd
  • Charles River Laboratories International, Inc.
  • Syneos Health Ltd
  • Intertek Group Plc

 

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“The Global Cell & Gene Therapy Bioanalytical Testing Services Market is poised for sustained growth due to several key market drivers. These include increasing investments in R&D, the rising prevalence of genetic and rare diseases, supportive regulatory frameworks, advancements in analytical technologies, global collaborations, and growing patient awareness and demand. As the cell and gene therapy field continues to evolve and expand, bioanalytical testing services will remain a critical component, ensuring the development and delivery of safe and effective therapies to patients in need.,” said Mr. Karan Chechi, Research Director of TechSci Research, a research-based management consulting firm.

Cell & Gene Therapy Bioanalytical Testing Services Market By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Other test Stage of Development), Product Type ( Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy), By Stage of Development (Non-Clinical, Clinical), By Indication ( Oncology, Infectious Diseases, Neurological disorders, Rare Diseases, Others), By Region and Competition, 2020-2030F”, has evaluated the future growth potential of Global Cell & Gene Therapy Bioanalytical Testing Services Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Cell & Gene Therapy Bioanalytical Testing Services Market.


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