Cell & Gene Therapy Bioanalytical Testing Services Market to Grow with a CAGR of 8.18% through 2028
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 2024-2028.
According to TechSci Research report, “Cell &
Gene Therapy Bioanalytical Testing Services Market – Global Industry Size,
Share, Trends, Competition Forecast & Opportunities, 2028”, the
Global Cell & Gene Therapy Bioanalytical Testing Services Market stood at
USD 411.01 million in 2022 and is anticipated to grow with a CAGR of 8.18% in
the forecast period, 2024-2028. 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.
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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.
The Global Cell & Gene Therapy Bioanalytical
Testing Services Market is segmented into Test Type, Product Type, Stage of Development ,
indication and company.
Based on Product Type, the Cell Therapy segment has
emerged as the predominant market leader. Cell therapies involve the use of
living cells to treat various medical conditions, including cancer, autoimmune
diseases, and regenerative medicine. The demand for cell therapies has been
steadily increasing due to their potential to provide effective and
personalized treatments. This heightened demand drives the need for
bioanalytical testing services to ensure the safety, efficacy, and quality of
these therapies. The range of
cell therapies has been expanding beyond traditional applications. New cell
therapy approaches are being explored for conditions like neurodegenerative
diseases, cardiovascular disorders, and more. This expansion of the cell
therapy portfolio further drives the demand for bioanalytical testing services.
Based on region, North America segment is expected to
grow during the forecast period. Regions such as Boston, San Francisco, and San
Diego have become global biotech hubs, hosting numerous biopharmaceutical
companies, research institutions, and contract service providers. These hubs
foster collaboration and knowledge sharing within the industry, attracting
talent and investment. North America
boasts a skilled and diverse workforce in the field of biotechnology, including
scientists, researchers, clinicians, and regulatory experts. This talent pool
is essential for conducting clinical trials, developing bioanalytical testing
methods, and ensuring compliance with regulatory requirements.
The Asia Pacific market is experiencing rapid market
growth. The region has a significant market demand for cell and gene therapies
due to a large patient population and a healthcare system that often supports
innovative treatments. This creates a favorable environment for companies
offering bioanalytical testing services, as they play a crucial role in
ensuring the safety and efficacy of these therapies.
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
- Pharmaceutical Product Development, Inc.
(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 with 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, By Competition Forecast
& Opportunities, 2018-2028F”, 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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