Fairfield Market Research Cell & Gene Therapy Bioanalytical Testing Services Market 2030

Cell & Gene Therapy Bioanalytical Testing Services Market

Global Cell & Gene Therapy Bioanalytical Testing Services Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2030 - (By Test Type Coverage, By Therapy Type Coverage, By End User Coverage, By Indication Coverage, By Geographic Coverage and Leading Companies)

Published Date: Sep 2023 | Format: | No. of Pages: 310

Industry: Pharmaceuticals & Biotechnology


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Global Cell & Gene Therapy Bioanalytical Testing Services Market Forecast

  • Global market valuiation to rise high a CAGR of 8% during 2023 - 2030
  • Market size likely to reach approximately US$0.8 Bn by the end of 2030

Market Analysis in Brief

Cell and gene therapy bioanalytical testing services refer to specialised laboratory services that analyse cellular and genetic components of therapeutic products. Cell and gene therapies are innovative medical treatments that involve manipulating or modifying a patient's cells or genes to treat or prevent diseases. Bioanalytical testing services ensure these therapies' safety, efficacy, and quality by conducting various tests and analyses on the therapeutic products. Cell and gene therapies are experiencing rapid advancements, with innovative treatments being developed for various diseases, including genetic disorders, cancer, and autoimmune conditions.

Cell & Gene Therapy Bioanalytical Testing Services Market

As more therapies reach clinical trials and approval stages, the demand for comprehensive bioanalytical testing services increases. Regulatory agencies such as the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) impose stringent requirements on cell and gene therapies' quality, safety, and efficacy. Bioanalytical testing services are crucial for meeting these regulatory standards and obtaining necessary approvals. Cell and gene therapies involve manipulating a patient's cells or genetic material. Ensuring these therapies' safety is paramount; rigorous testing is required to identify potential risks and adverse effects.

Key Report Findings

  • The market for cell & gene therapy bioanalytical testing services will demonstrate massive expansion in revenue between 2023 and 2030.
  • Demand for bioavailability & bioequivalence studies remains higher in the cell & gene therapy bioanalytical testing services market.
  • Demand for non-clinical products remains higher in the cell & gene therapy bioanalytical testing services market.
  • Cell therapy held the highest market share in 2022.
  • North America will continue to lead, whereas the Asia Pacific market will experience the strongest growth till 2030.

Growth Drivers

Rapid Advancements in Cell & Gene Therapies

Rapid advancements in cell and gene therapies significantly fuel the growth of the cell & gene therapy bioanalytical testing services market. These advancements create a higher demand for rigorous and comprehensive testing to ensure these innovative therapies' safety, efficacy, and quality.

As cell and gene therapies become more sophisticated, involving intricate genetic modifications and cellular manipulations, the need for specialised testing services increases. Comprehensive bioanalytical testing is essential to assess complex interactions and outcomes of these therapies.

Advances in cell and gene therapies lead to the development of new treatment approaches for previously untreatable or poorly managed diseases. Before reaching patients, bioanalytical testing ensures these novel therapies meet the highest safety and efficacy standards. The rapid rate of cell and gene therapy research translates into more therapies entering clinical trials.

Bioanalytical testing services are crucial in monitoring these trials, assessing patient responses, and generating valuable data for regulatory submissions. Regulatory agencies are working to expedite the approval process for promising cell and gene therapies.

However, this acceleration requires thorough and reliable testing to demonstrate the therapies' safety and efficacy within shorter timeframes. Many cell and gene therapies are personalised and tailored to individual patients. Bioanalytical testing ensures accurate characterisation of patient-specific materials and validates the therapy's identity and quality.

The rapid progress in cell and gene therapies drives the demand for thorough bioanalytical testing services. These services are essential to support the development, regulatory approval, clinical trials, and post-market monitoring of these innovative therapies, ensuring they meet the highest safety and efficacy standards.

Regulatory Requirements

Regulatory requirements drive the cell & gene therapy bioanalytical testing services market. The stringent standards and guidelines set by regulatory agencies ensure cell and gene therapies' safety, efficacy, and quality before they are approved for clinical use. As a result, the demand for comprehensive and specialised bioanalytical testing services increases.

Regulatory agencies prioritise patient safety, such as the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). They require rigorous testing to identify potential risks, adverse effects, and toxicity associated with cell and gene therapies. Regulatory bodies demand data that demonstrate the efficacy of cell and gene therapies. Bioanalytical testing provides evidence of the therapy's intended effects and contributes to patient benefit-risk assessment.

Regulatory agencies mandate stringent quality control measures to ensure consistent and reliable therapeutic products. Bioanalytical testing services validate the therapies' quality, identity, and purity, meeting regulatory criteria. Any changes to the manufacturing process or therapy components require extensive testing to ensure the therapy's consistency and effectiveness.

Regulatory agencies mandate comparability studies, which drive the need for bioanalytical testing. Cell and gene therapies must undergo rigorous clinical trials to obtain regulatory approval. Bioanalytical testing generates critical data used to evaluate the safety and efficacy of these therapies during trials.

Regulatory agencies require comprehensive characterisation of cell and gene therapies, including the specific cell types, genetic modifications, and vector components. Bioanalytical testing verifies product identity and composition. Cell and gene therapies need to demonstrate stability over their intended shelf life. Regulatory agencies require data on the therapy's stability profile, obtained through thorough bioanalytical testing.

Growth Challenges

Lack of Standardisation in Testing Protocols

Like any other industry, the market of cell & gene therapy bioanalytical testing services faces various challenges and restraints that can impact its growth and development. Cell and gene therapies are often complex and involve intricate cellular and genetic modifications. This complexity poses challenges for developing accurate and standardised testing methodologies.

The lack of standardised testing protocols across several therapies and manufacturers can lead to consistency in testing results. Harmonising testing methods can be challenging due to the unique nature of each therapy. The specialised nature of bioanalytical testing for cell and gene therapies requires skilled professionals with expertise in diverse scientific fields. More qualified experts are needed to ensure the availability of testing services.

Regulatory agencies require rigorous testing to ensure cell and gene therapies' safety, efficacy, and quality. Meeting these regulatory standards can be time-consuming and resource-intensive for testing service providers.

Developing and conducting bioanalytical testing services can be costly due to the advanced equipment, skilled personnel, and specialised facilities required. Balancing competitive pricing while maintaining quality can be a challenge.

Overview of Key Segments

Bioavailability and Bioequivalence Studies Prominent

Bioavailability and bioequivalence studies play an important role in the cell & gene therapy bioanalytical testing services market by providing valuable insights into cell and gene therapies' pharmacokinetics, safety, and effectiveness. These studies offer several benefits contributing to these therapies' development, regulatory approval, and successful clinical implementation.

Bioavailability studies help determine how much of the administered therapy reaches the bloodstream and is available for the body. This information is crucial for understanding the therapy's pharmacokinetics, including absorption, distribution, metabolism, and excretion. Bioavailability studies provide data on the therapy's rate and extent of absorption. This information helps optimise dosing strategies, ensuring that the therapy reaches therapeutic levels in the body for the desired duration.

Bioequivalence studies compare the bioavailability of a generic or biosimilar therapy to the original reference therapy. These studies ensure that generic or biosimilar versions regarding safety and efficacy are equivalent. Regulatory agencies require bioavailability and bioequivalence data to demonstrate the safety and efficacy of therapies, especially for generic versions. These studies are essential for gaining regulatory approvals for commercialisation.

Bioavailability studies contribute to quality control by ensuring consistent delivery of the therapy. Variations in bioavailability can impact the therapy's performance and patient outcomes. Bioavailability and bioequivalence studies provide critical insights into how cell and gene therapies behave in the body, ensuring their safety, efficacy, and consistent performance. These studies are essential for regulatory compliance, treatment optimisation, and successful clinical implementation of cell and gene therapies.

Demand for Testing Services in Demand

Oncology-focused bioanalytical testing services offer several cancer treatment and research benefits in the Cell & Gene Therapy market. These services contribute to developing, evaluating, and optimising cell and gene therapies targeting various forms of cancer. Oncology-focused bioanalytical testing helps develop cell and gene therapies targeting cancer cells, minimising damage to healthy tissues and reducing side effects.

Bioanalytical testing allows for the customisation of therapies based on the patient's unique genetic and molecular profile, improving treatment efficacy and patient outcomes. These studies provide insights into how cancer patients absorb, distribute, metabolise, and excrete the therapy. This information helps optimise dosing regimens for maximum therapeutic benefit.

Bioanalytical testing allows for monitoring the concentration of the therapeutic agent in a patient's blood over time, ensuring that the therapy remains within the therapeutic range. In immunotherapies, bioanalytical testing helps assess the potential for immune responses to the therapy, which is crucial for treatment safety and efficacy. Bioanalytical testing helps measure treatment response by analysing biomarkers that indicate tumor progression or regression, guiding treatment adjustments.

In the field of oncology, where the need for effective and targeted therapies is critical, bioanalytical testing services play an instrumental role in advancing the development and optimisation of cell and gene therapies. These services enable researchers and clinicians to tailor treatments to individual patients, monitor responses, and refine therapeutic approaches for improved outcomes.

Growth Opportunities Across Regions

North America at the Forefront

North America is a leader in the cell & gene therapy bioanalytical testing services market. Several factors have contributed to North America's prominent position in this sector. North America, particularly the United States, has a well-established and vibrant biotechnology industry.

The region is home to many biotech companies actively involved in developing and commercialising cell and gene therapies. Leading research institutions, universities, and medical centers in North America have been at the forefront of cell and gene therapy research. This research excellence has driven the demand for bioanalytical testing services to support preclinical and clinical studies.

North America has been an early adopter of novel medical therapies, including cell and gene therapies. The region's regulatory agencies have been relatively receptive to these therapies, creating an environment conducive to their development and testing.

Many global clinical trials for cell and gene therapies are conducted in North America. This high level of clinical trial activity requires extensive bioanalytical testing to assess safety, efficacy, and regulatory compliance.

Regulatory agencies like the US Food and Drug Administration (FDA) have proactively created regulatory pathways for cell and gene therapies. Their guidance and expertise have facilitated the development and testing of these therapies. The success and innovation generated in North America's biotechnology sector have a global impact, influencing developments and collaborations in other regions.

Asia Pacific Represents a Highly Profitable Pocket

Due to several key factors, Asia Pacific has emerged as a growing and potentially lucrative market for cell & gene therapy bioanalytical testing services. Asia Pacific is experiencing significant economic growth, leading to increased investment in healthcare infrastructure, research, and development. This growth provides a fertile ground for developing and adopting innovative therapies like cell and gene therapies.

Many countries in the Asia Pacific have been investing in biotechnology research and development. The region has seen the emergence of biotech companies focused on developing and commercialising advanced therapies. The region has attracted substantial investment from local and global investors, fostering the growth of the cell and gene therapy sector. This funding supports research, clinical trials, and testing services.

Asia Pacific's diverse population and patient pool make it an attractive location for conducting clinical trials. As cell and gene therapies improve through clinical phases, the demand for comprehensive bioanalytical testing services increases. Some countries in the Asia Pacific have been working to establish clear regulatory frameworks for cell and gene therapies. Regulatory advancements create a more predictable environment for testing services and commercialisation.

Cell & Gene Therapy Bioanalytical Testing Services Market: Competitive Landscape

Some of the leading players at the forefront in the cell & gene therapy bioanalytical Testing Services market space include BioAgilytix Labs, KCAS Bioanalytical Services,  Laboratory Corporation of America Holdings, Pharmaceutical Product Development, Inc., Prolytix, Pharmaron, Charles River Laboratories, Syneos Health, SGS SA, and CD BioSciences.

Recent Notable Developments

In February 2023, KCAS Bioanalytical and Biomarker Services, a Vitruvian Partners portfolio Company, announced the acquisition of FlowMetric, LLC. The acquisition of FlowMetric LLC by KCAS empowers KCAS to address customer demands better and expedite its swift expansion, solidifying its position as the preferred clinical research organisation (CRO) for outsourced cell and gene therapy initiatives.

In March 2021, Charles River successfully finalised the acquisition of Cognate BioServices, a move to establish a top-tier scientific collaborator in cell and gene therapy advancement. Cognate BioServices is a leading contract development and manufacturing organisation (CDMO) specialising in cell and gene therapies. Their comprehensive manufacturing solutions encompass the production of cell therapies, plasmid DNA, and other critical components within the CDMO value chain.

Global Cell & Gene Therapy Bioanalytical Testing Services Market is Segmented as Below:

By Test Type

  • Bioavailability Bioavailability & Bioequivalence Studies
  • Pharmacokinetics
  • Pharmacodynamics
  • Non-clinical
  • Tissue Bioanalysis
  • Miscellaneous

By Therapy Type

  • Gene Therapy
  • Gene-Modified Cell Therapy
  • Cell Therapy

By End user

  • Non-Clinical Contract Manufacturing Organizations (CMO)
  • Pharma and Biopharma Companies
  • Contract Research Organizations (CRO)

By Indication

  • Oncology Cancer
  • Infectious Diseases
  • Neurological disorders
  • Cardiovascular Disorders
  • Gastrointestinal Diseases
  • Autoimmune Diseases
  • Others

By Geographic Coverage

  • North America 
    • The U.S.
    • Canada 
  • Europe 
    • Germany
    • The U.K.
    • France
    • Italy
    • Turkey
    • Russia
    • Rest of Europe 
  • Asia Pacific 
    • China
    • Japan
    • South Korea
    • India
    • Southeast Asia
    • Rest of Asia Pacific 
  • Latin America 
    • Brazil 
    • Mexico 
    • Argentina
    • Rest of Latin America 
  • Middle East & Africa  
    • GCC 
    • South Africa
    • Egypt
    • Nigeria
    • Rest of the Middle East & Africa

1. Executive Summary
    1.1. Global Remote Power Panel Market Snapshot
    1.2. Future Projections
    1.3. Key Market Trends
    1.4. Regional Snapshot, by Value, 2022
    1.5. Analyst Recommendations

 

2. Market Overview
    2.1. Market Definitions and Segmentations
    2.2. Market Dynamics
          2.2.1. Drivers
          2.2.2. Restraints
          2.2.3. Market Opportunities
    2.3. Value Chain Analysis
    2.4. Porter’s Five Forces Analysis
    2.5. Covid-19 Impact Analysis
          2.5.1. Supply
          2.5.2. Demand
    2.6. Impact of Ukraine-Russia Conflict
    2.7. Economic Overview
          2.7.1. World Economic Projections
    2.8. PESTLE Analysis

 

3. Global Remote Power Panel Market Outlook, 2018 - 2030
    3.1. Global Remote Power Panel Market Outlook, by Type, Value (US$ Mn), 2018 - 2030
          3.1.1. Key Highlights
                3.1.1.1. Wall Mounted
                3.1.1.2. Floor Standing
    3.2. Global Remote Power Panel Market Outlook, by Application, Value (US$ Mn), 2018 - 2030
          3.2.1. Key Highlights
                3.2.1.1. Network Cabinets
                3.2.1.2. Server Rooms
                3.2.1.3. Data centers
    3.3. Global Remote Power Panel Market Outlook, by Region, Value (US$ Mn), 2018 - 2030
          3.3.1. Key Highlights
                3.3.1.1. North America
                3.3.1.2. Europe
                3.3.1.3. Asia Pacific
                3.3.1.4. Latin America
                3.3.1.5. Middle East & Africa

 

4. North America Remote Power Panel Market Outlook, 2018 - 2030
    4.1. North America Remote Power Panel Market Outlook, by Type, Value (US$ Mn), 2018 - 2030
          4.1.1. Key Highlights
                4.1.1.1. Wall Mounted
                4.1.1.2. Floor Standing
    4.2. North America Remote Power Panel Market Outlook, by Application, Value (US$ Mn), 2018 - 2030
          4.2.1. Key Highlights
                4.2.1.1. Network Cabinets
                4.2.1.2. Server Rooms
                4.2.1.3. Data centers
4.2.2. Market Attractiveness Analysis
    4.3. North America Remote Power Panel Market Outlook, by Country, Value (US$ Mn), 2018 - 2030
          4.3.1. Key Highlights
                4.3.1.1. U.S. Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                4.3.1.2. U.S. Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                4.3.1.3. Canada Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                4.3.1.4. Canada Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
          4.3.2. BPS Analysis/Market Attractiveness Analysis

 

5. Europe Remote Power Panel Market Outlook, 2018 - 2030
    5.1. Europe Remote Power Panel Market Outlook, by Type, Value (US$ Mn), 2018 - 2030
          5.1.1. Key Highlights
                5.1.1.1. Wall Mounted
                5.1.1.2. Floor Standing
    5.2. Europe Remote Power Panel Market Outlook, by Application, Value (US$ Mn), 2018 - 2030
          5.2.1. Key Highlights
                5.2.1.1. Network Cabinets
                5.2.1.2. Server Rooms
                5.2.1.3. Data centers
                5.2.2. BPS Analysis/Market Attractiveness Analysis
    5.3. Europe Remote Power Panel Market Outlook, by Country, Value (US$ Mn), 2018 - 2030
          5.3.1. Key Highlights
                5.3.1.1. Germany Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                5.3.1.2. Germany Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                5.3.1.3. U.K. Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                5.3.1.4. U.K. Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                5.3.1.5. France Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                5.3.1.6. France Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                5.3.1.7. Italy Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                5.3.1.8. Italy Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                5.3.1.9. Russia Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                5.3.1.10. Russia Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                5.3.1.11. Rest of Europe Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                5.3.1.12. Rest of Europe Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
          5.3.2. BPS Analysis/Market Attractiveness Analysis

 

6. Asia Pacific Remote Power Panel Market Outlook, 2018 - 2030
    6.1. Asia Pacific Remote Power Panel Market Outlook, by Type, Value (US$ Mn), 2018 - 2030
          6.1.1. Key Highlights
                6.1.1.1. Wall Mounted
                6.1.1.2. Floor Standing
    6.2. Asia Pacific Remote Power Panel Market Outlook, by Application, Value (US$ Mn), 2018 - 2030
          6.2.1. Key Highlights
                6.2.1.1. Network Cabinets
                6.2.1.2. Server Rooms
                6.2.1.3. Data centers
6.2.2. BPS Analysis/Market Attractiveness Analysis
    6.3. Asia Pacific Remote Power Panel Market Outlook, by Country, Value (US$ Mn), 2018 - 2030
          6.3.1. Key Highlights
                6.3.1.1. China Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                6.3.1.2. China Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                6.3.1.3. Japan Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                6.3.1.4. Japan Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                6.3.1.5. South Korea Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                6.3.1.6. South Korea Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                6.3.1.7. India Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                6.3.1.8. India Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                6.3.1.9. Southeast Asia Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                6.3.1.10. Southeast Asia Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                6.3.1.11. Rest of Asia Pacific Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                6.3.1.12. Rest of Asia Pacific Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
          6.3.2. BPS Analysis/Market Attractiveness Analysis

 

7. Latin America Remote Power Panel Market Outlook, 2018 – 2030
    7.1. Latin America Remote Power Panel Market Outlook, by Type, Value (US$ Mn), 2018 - 2030
          7.1.1. Key Highlights
                7.1.1.1. Wall Mounted
                7.1.1.2. Floor Standing
    7.2. Latin America Remote Power Panel Market Outlook, by Application, Value (US$ Mn), 2018 - 2030
                7.2.1.1. Network Cabinets
                7.2.1.2. Server Rooms
                7.2.1.3. Data centers
                7.2.2. BPS Analysis/Market Attractiveness Analysis
    7.3. Latin America Remote Power Panel Market Outlook, by Country, Value (US$ Mn), 2018 - 2030
          7.3.1. Key Highlights
                7.3.1.1. Brazil Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                7.3.1.2. Brazil Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                7.3.1.3. Mexico Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                7.3.1.4. Mexico Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                7.3.1.5. Rest of Latin America Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                7.3.1.6. Rest of Latin America Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
          7.3.2. BPS Analysis/Market Attractiveness Analysis

 

8. Middle East & Africa Remote Power Panel Market Outlook, 2018 - 2030
    8.1. Middle East & Africa Remote Power Panel Market Outlook, by Type, Value (US$ Mn), 2018 - 2030
          8.1.1. Key Highlights
                8.1.1.1. Wall Mounted
                8.1.1.2. Floor Standing
    8.2. Middle East & Africa Remote Power Panel Market Outlook, by Application, Value (US$ Mn), 2018 - 2030
          8.2.1. Key Highlights
                8.2.1.1. Network Cabinets
                8.2.1.2. Server Rooms
                8.2.1.3. Data centers
          8.2.2. BPS Analysis/Market Attractiveness Analysis
    8.3. Middle East & Africa Remote Power Panel Market Outlook, by Country, Value (US$ Mn), 2018 - 2030
          8.3.1. Key Highlights
                8.3.1.1. GCC Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                8.3.1.2. GCC Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                8.3.1.3. South Africa Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                8.3.1.4. South Africa Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
                8.3.1.5. Rest of Middle East & Africa Remote Power Panel Market by Type, Value (US$ Mn), 2018 - 2030
                8.3.1.6. Rest of Middle East & Africa Remote Power Panel Market End-user, Value (US$ Mn), 2018 - 2030
          8.3.2. BPS Analysis/Market Attractiveness Analysis

 

9. Competitive Landscape
    9.1. Type vs Application Heatmap
    9.2. Manufacturer vs Application Heatmap
    9.3. Company Market Share Analysis, 2022
    9.4. Competitive Dashboard
    9.5. Company Profiles
          9.5.1. ABB Group
                9.5.1.1. Company Overview
                9.5.1.2. Type Portfolio
                9.5.1.3. Financial Overview
                9.5.1.4. Business Strategies and Development
          9.5.2. Eaton Corporation PLC
                9.5.2.1. Company Overview
                9.5.2.2. Type Portfolio
                9.5.2.3. Financial Overview
                9.5.2.4. Business Strategies and Development
          9.5.3. Toshiba Corporation
                9.5.3.1. Company Overview
                9.5.3.2. Type Portfolio
                9.5.3.3. Financial Overview
                9.5.3.4. Business Strategies and Development
          9.5.4. Lyntec
                9.5.4.1. Company Overview
                9.5.4.2. Type Portfolio
                9.5.4.3. Financial Overview
                9.5.4.4. Business Strategies and Development
          9.5.5. Vertiv Holdings Co
                9.5.5.1. Company Overview
                9.5.5.2. Type Portfolio
                9.5.5.3. Financial Overview
                9.5.5.4. Business Strategies and Development
          9.5.6. Schneider Electric SE
                9.5.6.1. Company Overview
                9.5.6.2. Type Portfolio
                9.5.6.3. Financial Overview
                9.5.6.4. Business Strategies and Development
          9.5.7. Delta Electronics, Inc.
                9.5.7.1. Company Overview
                9.5.7.2. Type Portfolio
                9.5.7.3. Financial Overview
                9.5.7.4. Business Strategies and Development
          9.5.8. Anord Mardix (Flex Ltd.)
                9.5.8.1. Company Overview
                9.5.8.2. Type Portfolio
                9.5.8.3. Business Strategies and Development
          9.5.9. Lutron Electronics Co., Inc.
                9.5.9.1. Company Overview
                9.5.9.2. Type Portfolio
                9.5.9.3. Financial Overview
                9.5.9.4. Business Strategies and Development
          9.5.10. Socomec
                9.5.10.1. Company Overview
                9.5.10.2. Type Portfolio
                9.5.10.3. Financial Overview
                9.5.10.4. Business Strategies and Development

 

10. Appendix
    10.1. Research Methodology
    10.2. Report Assumptions
    10.3. Acronyms and Abbreviations

BASE YEAR

HISTORICAL DATA

FORECAST PERIOD

UNITS

2022

 

2018 - 2022

2023 - 2030

Value: US$ Million

 

REPORT FEATURES

DETAILS

Test Type Coverage

  • Bioavailability Bioavailability & Bioequivalence Studies
  • Pharmacokinetics
  • Pharmacodynamics
  • Non-clinical
  • Tissue Bioanalysis
  • Miscellaneous 

Therapy Type Coverage

  • Gene Therapy
  • Gene-Modified Cell Therapy
  • Cell Therapy

End User Coverage

  • Non-Clinical Contract Manufacturing Organizations (CMO)
  • Pharma and Biopharma Companies
  • Contract Research Organizations (CRO)

Indication Coverage

  • Oncology Cancer
  • Infectious Diseases
  • Neurological disorders
  • Cardiovascular Disorders
  • Gastrointestinal Diseases
  • Autoimmune Diseases
  • Others 

Geographical Coverage

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of EU
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Rest of APAC
  • Latin America
    • Brazil 
    • Mexico 
    • Rest of Latin America 
  • Middles East & Africa
    • GCC Countries 
    • South Africa 
    • Rest of Middle East & Africa

Leading Companies

  • BioAgilytix Labs
  • KCAS Bioanalytical Services
  • CD BioSciences
  • Laboratory Corporation of America Holdings
  • Pharmaceutical Product Development, Inc.
  • Prolytix
  • Pharmaron
  • Charles River Laboratories
  • Syneos Health
  • SGS S.A.

Report Highlights

Key Market Indicators, Macro-micro economic impact analysis, Technological Roadmap, Key Trends, Driver, Restraints, and Future Opportunities & Revenue Pockets, Porter’s 5 Forces Analysis, Historical Trend (2019-2021), Market Estimates and Forecast, Market Dynamics, Industry Trends, Competition Landscape, Category, Region, Country-wise Trends & Analysis, COVID-19 Impact Analysis (Demand and Supply Chain)

FAQs : Cell & Gene Therapy Bioanalytical Testing Services Market

Cell and gene therapy bioanalytical testing services involve a range of laboratory services that are essential for the development, characterisation, and quality control of cell and gene therapy products. These services include analytical testing, safety assessment, potency determination, and characterisation to ensure the safety, efficacy, and compliance of these advanced therapies.

The global market valuation will rise high at a CAGR of 8% during 2023 – 2030, reaching the revenue of US$0.8 billion till the end of this decade. The demand for bioavailability & bioequivalence studies remains higher, whereas non-clinical products continue to be prominent throughout the period of forecast. By the type of therapy, cell therapy holds the largest share of the market value pie.

Cell and gene therapies are experiencing rapid advancements, with innovative treatments being developed for various diseases, including genetic disorders, cancer, and autoimmune conditions. The growth of this market is also driven by the increasing development and adoption of cell and gene therapies. The rising number of clinical trials, regulatory approvals, and the need for rigorous testing and quality assurance are the key contributing factors.

Challenges include the complexity of testing these novel therapies, the need for standardisation and harmonisation of testing methods, and navigating the evolving regulatory landscape. Additionally, as the field expands, there is a growing need for skilled professionals and advanced technologies to support comprehensive testing services.

KCAS Bioanalytical Services, Laboratory Corporation of America Holdings, Prolytix, Pharmaron, Syneos Health, and Charles River Laboratories are some of the kay industry players leading the cell & gene therapy bioanalytical testing services market.

Our Research Methodology

Considering the volatility of business today, traditional approaches to strategizing a game plan can be unfruitful if not detrimental. True ambiguity is no way to determine a forecast. A myriad of predetermined factors must be accounted for such as the degree of risk involved, the magnitude of circumstances, as well as conditions or consequences that are not known or unpredictable. To circumvent binary views that cast uncertainty, the application of market research intelligence to strategically posture, move, and enable actionable outcomes is necessary.

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