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U.S. Cell and Gene Therapy Bioanalytical Testing Services Market Key Takeaways:
• The bioavailability & bioequivalence studies dominated the market with a share of 33.4% in 2024. The segment is also expected to witness the fastest CAGR during the forecast period.
• The pharmacokinetic segment is expected to grow at a CAGR of 7.6% over the forecast period.
• The non-clinical segment dominated the market with a market share of 62.2% in 2024 and is also expected to witness the fastest growth at a CAGR of 7.6% during the forecast period.
• The clinical segment is expected to grow with a CAGR of 7.1% CAGR during the forecast period.
• The cell therapy segment dominated the product segment market with a market share of 39.1% in 2023.
• The gene-modified cell therapy segment is expected is expected to register the fastest CAGR of 7.8% during the forecast period.
• The oncology segment dominated the market and accounted for the largest revenue share of 49.0% in 2024.
• The rare diseases segment is expected to register the fastest CAGR during the forecast period.
Breakthroughs In Gene Editing Technologies Propels Market Expansion
Bioanalytical testing services play a vital role in the production of cell and gene therapies (CGT) by facilitating the manipulation of cells throughout the manufacturing process. These services are essential for stimulating various cellular functions, such as proliferation, differentiation, and survival—each of which is crucial for developing effective therapies. The presence and activity of growth factors are central to the success of these therapies; therefore, rigorous analysis of their concentration, biological activity, and potency is imperative. To ensure consistency and minimize potential unwanted or off-target effects during manufacturing, these bioanalytical testing services must accurately quantify growth factor levels. The rapid expansion of the CGT industry acts as a significant driver for these testing services, especially as regulatory bodies increase their scrutiny. This has led to a demand for thorough characterization of CGT products, particularly through growth factor analysis.
Given the inherent complexity of CGT, there is a pressing need for specialized bioanalytical expertise. Providers of bioanalytical testing services must offer a diverse array of techniques to measure growth factor levels and their activity effectively. These methods include enzyme-linked immunosorbent assays (ELISA), flow cytometry, quantitative polymerase chain reaction (qPCR), and mass spectrometry, among others. As the number of CGT clinical trials and commercial products surges, the demand for sophisticated bioanalytical testing services is also increasing. This demand translates into significant market growth for companies specializing in these services. Furthermore, rising research and development investments from pharmaceutical and biopharmaceutical companies are expected to bolster expansion in the U.S. cell and gene therapy bioanalytical testing services market throughout the forecast period. The increasing prevalence of life-threatening and rare diseases will likely further support the growth of bioanalytical testing services within the cell and gene therapy sector.
Moreover, the impact of artificial intelligence (AI) on cell and gene therapy is poised to be transformative for the bioanalytical testing services market.
U.S. Cell & Gene Therapy Bioanalytical Testing Services Market Trends
• Growth of the Cell and Gene Therapy (CGT) Sector - The expansion of the CGT sector is significantly influenced by the rising number of clinical trials and commercial product approvals. This surge in surgical interventions not only showcases the potential of CGTs but also necessitates extensive bioanalytical testing to ensure product safety and efficacy. The integration of bioanalytical processes at the onset of CGT activities is pivotal, facilitating
• Emphasis on Personalized Medicine- A notable trend within CGTs is the customization of therapies to meet the unique genetic and physiological needs of individual patients. These tailored treatments demand highly specific and sensitive bioanalytical assays, which are crucial for monitoring therapeutic effectiveness and potential adverse effects. This shift towards personalized medicine is propelling the development of advanced testing methodologies
• Technological Advancements- The field is witnessing remarkable progress due to cutting-edge technologies such as next-generation sequencing, mass spectrometry, flow cytometry, and artificial intelligence (AI) coupled with machine learning techniques. These technologies enhance the accuracy, efficiency, and throughput of bioanalytical testing
• Regulatory Scrutiny- With the increased adoption of CGTs comes heightened regulatory scrutiny from governing bodies that are mandating more thorough characterization of CGT products. Regulatory agencies are insisting on rigorous testing protocols that evaluate the safety, efficacy, and consistency of these innovative therapies. This stricter framework is propelling the demand for specialized bioanalytical services
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U.S. Cell & Gene Therapy Bioanalytical Testing Services Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 181.73 million |
|
Revenue Forecast in 2034 |
USD 349.29 million |
|
Growth rate |
CAGR of 7.3% from 2024 to 2034 |
|
Actual estimates/Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million and CAGR from 2024 to 2034 |
|
Report Coverage |
Revenue forecast, company share, competitive landscape, growth factors and trends |
|
Segments Covered |
Test type, product type, stage of development, indication, region |
|
Key companies profiled |
BioAgilytix Labs; KCAS Bioanalytical Services; IQVIA, Inc.; Laboratory Corporation of America Holdings; Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.); Prolytix; Pharmaron; Charles River Laboratories; Syneos Health; SGS SA; Intertek Group Plc |
Market Concentration & Characteristics
The market is characterized by moderate-to-high level degree of innovation, including the rapid advancements in cell and gene therapy technologies like development of biosimilars, combination products, and other innovative medicines. Industry participants are investing in innovative techniques and technologies to meet the global demand of the market.
The market is also characterized by the leading players with moderate levels of merger and acquisition (M&A) activity and product launches. Market players such as Syneos Health, Thermos Fischer Scientific Inc., Bayer and others are involved in R&D investments, new product launches and merger and acquisition activities. For instance, in October 2023 , Bayer invested in a new USD 250 million cell therapy manufacturing facility in Berkeley, California. This marks a significant commitment to in-house production of complex medicines, including bemdaneprocel for Parkinson's disease. By developing capabilities for cell therapy manufacturing, Bayer planned to accelerate the production of transformative treatments and enhance its global supply chain. Such strategic activities as M&A, expansions, partnership, and collaboration, help increase companies’ competitiveness and expand their geographic reach to enter new territories.
Regulatory control and increasing awareness regarding bioanalytical testing of cell & gene therapy (CGT) are paramount in ensuring the safety, efficacy, and quality of these advanced treatments. Regulatory agencies such as the FDA and EMA have established stringent guidelines to govern the development and approval of cell and gene therapies, mandating thorough bioanalytical testing throughout the product lifecycle. This heightened regulatory scrutiny underscores the critical importance of comprehensive testing to mitigate risks and ensure patient safety. Global regulatory policies are being standardized to accelerate the approval process for cell and gene therapy bioanalytical testing services.
The market is characterized by a moderate level of service expansion with the help of specialized expertise and advanced equipment used for accurate testing. The expansion of bioanalytical testing facilities for CGT reflects a growing recognition of the importance of rigorous testing in ensuring the safety and efficacy of these advanced therapies. Introduction of novel methods might act as key factor for expansion. However, widespread adoption of these technologies would depend on regulatory approval and acceptance by industry.
Regional expansion is crucial for any manufacturer in the market space. Bioanalytical testing facilities are expanding to accommodate this demand, equipped with state-of-the-art technology and expertise to characterize these complex therapies accurately. For instance, a January 2023 report from the American Society of Gene and Cell Therapy highlighted a significant expansion in the gene, cell, and RNA therapy pipeline, including various therapeutic interventions in different developmental stages.
U.S. Cell & Gene Therapy Bioanalytical Testing Services Market Segment Insights
Test Type Insight
Within the U.S. cell and gene therapy bioanalytical testing services market, the segment dedicated to bioavailability and bioequivalence studies has emerged as a dominant force. These studies, essential in drug development, assess how effectively a therapeutic agent is absorbed and how it compares to other formulations. The market segment is expected to maintain its leading position over the forecast period, driven by the necessity for thorough evaluation of new therapies.
On the other hand, the pharmacokinetics segment, which examines the absorption, distribution, metabolism, and excretion (ADME) of drugs within the body, is anticipated to experience substantial growth in the American market. This study provides insights into how long a drug remains active in the system, which is essential for optimizing dosing regimens and ensuring therapeutic efficacy, making it a critical focus in the bioanalytical landscape for CGTs.
Product Type Insights
In the U.S. cell and gene therapy bioanalytical testing services market, the cell therapy segment stands out as the leading category. Cell therapy entails the transplantation of living cells to repair, replace, or regenerate damaged tissues or organs for therapeutic outcomes. The types of cells used for transplantation are tailored to individual patient needs and specific medical conditions, encompassing both autologous cells (derived from the patient's own body) and allogeneic cells (sourced from another individual). This innovative treatment approach has proven highly effective in managing a broad range of diseases, including various types of cancers, autoimmune conditions, neurological disorders, and urinary tract issues. Notably, cell therapy also plays a crucial role in orthopedic medicine, aiding in the reconstruction of damaged cartilage and providing support for spinal cord injuries, as well as addressing certain infectious diseases.
The gene-modified cell therapy segment is emerging as the fastest-growing area within this market. This category includes advanced therapies such as CAR-NK (Natural Killer) cell therapy, CAR T-cell therapies, and TCR-T (T Cell Receptor T) therapies, among others. In recent years, CAR T-cell therapies have surged in popularity due to their remarkable success rates against various malignancies, showcasing the potential of genetic engineering to revolutionize cancer treatment. Continuous advancements in genetic modification techniques are driving significant innovations in this field, suggesting robust growth for gene-modified cell therapy in the near.
Stage of Development by Product Type Insights
The non-clinical segment is currently the dominant force within the U.S. cell and gene therapy bioanalytical testing services market. Pharmaceutical companies place a premium on ensuring safety, quality, and efficacy during drug development phases. Furthermore, the increasing demand from researchers eager to transition new therapies into clinical testing is further accelerating the need for comprehensive non-clinical bioanalytical testing services.
Conversely, the clinical segment is recognized as the fastest-growing area within this landscape. Clinical trials are essential for assessing new drugs' safety profiles, therapeutic effectiveness, and optimal dosing regimens, providing critical data required for regulatory approval before therapies can be made available to patients.
Indication Insights
Within the realm of indications, the oncology segment is the most significant player in the U.S. cell and gene therapy bioanalytical testing services market. This segment's rapid expansion is primarily attributed to the increasing cancer burden in America, which intensifies the demand for effective cancer therapies. Cell and gene therapies represent a groundbreaking approach to oncology, offering promising treatment strategies that target malignancies at their core.
Additionally, the rare diseases segment is emerging as the fastest-growing area within this market. Cell and gene therapies have demonstrated remarkable effectiveness in treating rare diseases, often considered challenging due to their unique underlying genetic causes. These innovative therapies have produced encouraging outcomes for patients grappling with life-threatening conditions as they address the root causes of their disorders, paving the way for more personalized and effective treatment options.
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U.S. Cell and Gene Therapy Bioanalytical Testing Services Market Top Key Companies:
• BioAgilytix Labs
• KCAS Bioanalytical Services
• IQVIA, Inc.
• Laboratory Corporation of America Holdings
• Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
• Prolytix
• Pharmaron
• Charles River Laboratories
• Syneos Health
• SGS SA
• Intertek Group Plc
Recent Developments
• In February 2025, Miltenyi Biotec, a global leader in cell and gene therapy (CGT) solutions, launched the Cell & Gene Therapy Center of Excellence (CoE) in Hyderabad, India, and the company sets a goal to support research and development in advanced biotechnology.
• In May 2024, KCAS Bio announced a partnership with Australia-based Crux Biolabs to provide harmonized spectral flow cytometry across Europe, the United States and Australia. The alliance enables KCAS Bio and Crux Biolabs to support the global needs of clinical research by offering advanced spectral flow cytometry using the Cytek Aurora platform. Crux Biolabs is expected to be the first CRO in Australia to offer spectral flow cytometry accredited for clinical research. Together, the partnership is focused on being the global provider of choice for outsourced flow cytometry clinical research.
U.S. Cell and Gene Therapy Bioanalytical Testing Services Market Report Segmentation
By Test Type
• Bioavailability & Bioequivalence Studies
• Pharmacokinetics
• Pharmacodynamics
• Other Test Type
By Product Type
• Gene Therapy
o Ex-vivo
o In-vivo
• Gene-Modified Cell Therapy
o CAR T-cell therapies
o CAR-NK cell therapy
o TCR-T cell therapy
o Other
• Cell Therapy
By Stage of Development by Product Type
• Non-Clinical
o Gene Therapy
o Gene-Modified Cell Therapy
o Cell Therapy
• Clinical
o Gene Therapy
o Gene-Modified Cell Therapy
o Cell Therapy
By Indication
• Oncology
• Infectious Diseases
• Neurological disorders
• Rare Diseases
• Others
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