Top 10 Leading Cell and Gene Therapy CRO Supporting Move of Drugs from Bench to Clinic

Published: March 2024


The growing demand for contract research services for cell and gene therapies has compelled the players engaged in this domain to expand their existing capabilities / capacities in order to accommodate the future needs of their clients. We analyzed more than 105 industry players that offer contract research services for cell and gene therapies. In this article, discover top 10 Cell and Gene Therapy CRO.


Cell and gene therapy candidates have demonstrated the potential to treat rare and complex diseases, including indications for which no effective treatment is currently available. In this context, it is important to mention that, in case of cell therapy, human cells are transplanted to repair or replace the damaged cells / tissues, thereby, enabling their treatment through alteration or restoration of certain sets of cells. The cells may originate from the patient (autologous cells) or a donor (allogeneic cells). On the other hand, gene therapy aims to correct the underlying genetic problem to ensure the treatment, as well as prevention of diseases, by replacing, inactivating or introducing genes into cells, either inside or outside of the body.

Over the past few years, a number of cell and gene therapies have received approval from various regulatory authorities, globally. In 2023, FDA approved two gene therapies, namely Elvediys, (developed by Sarepta Therapeutics) for the treatment of Duchenne Muscular Dystrophy and Vyjuvek (developed by Krystal Biotech) for the treatment of Dystrophic Epidermolysis Bullosa and two cell therapies, namely Omisirge (developed by Gamida Cell) for bone marrow transplant and stem cell transplant, and Lantidra (developed by CellTrans) for the treatment for Type 1 Diabetes Mellitus. Driven by the continuous efforts of CROs for the ongoing research and development efforts for cell and gene therapies (CGT) and other advanced therapy medicinal products, the cell and gene therapy market is anticipated to witness steady market growth during the forecast period.

Roots Analysis has conducted an exhaustive study on Cell and Gene Therapy CRO Market featuring the current market landscape of cell and gene therapy contract research organizations and future opportunity associated with the cell and gene therapy CRO domain, over the forecast period, till 2035. These cell and gene therapy CRO are a part of the larger biologics contract research organization market.

Table of Contents

Below, we have listed (in alphabetical order), the top 10 cell and gene therapy CRO:

Company    Year of Establishment                     Headquarters     Employee Count          
Aixial 2004 Aixial-headquarter 1,001-5,000
Altasciences 1992 Altasciences -Headquarter 1,001-5,000
CMIC 1985 CMIC - Headquarter 5,001-10,000
ICON 1990 ICON - Headquarter 10,000+
Labcorp 1996 Labcorp - Headquarter 10,000+
Linical Accelovance  2005 Linical Accelovance - Headquarter 501-1,000
Medpace 1992 Medpace - Headquarter 1,001-5,000
PPD 1985 PPD - Headquarter 10,001+
Precision for Medicine  2012 Precision for Medicine - Headquarter 1,001-5,000
QPS 1995 QPS - Headquarter 1,001-5,000


Interested in exploring all 105+ cell and gene therapy contract research organizations?

Discover Below the Details on 10 Cell and Gene Therapy CROs

Let us deep dive to understand the activity of the top cell and gene therapy CRO (shortlisted on the basis of their service portfolio / capabilities). It is essential to note that the selection of top players can differ substantially according to the defined criteria.

Aixial is a Mid-Sized, Global CRO Post the Complete Integration of Larix and Cmed Group

Aixial - Cell and Gene Therapy CRO Market

With an experience of 20 years, Aixial is a clinical research organization that collaborates with sponsors to develop oncology, cell & gene, and rare diseases therapies. In addition, the company provides solutions in order to overcome the challenges and complexities faced by biotech and pharma companies worldwide. Further, the company claims to have clinical development capabilities along with integrated consulting expertise in order to streamline development in a cost efficient way.

The following table presents the details on the contract research services offered by Aixial:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Toxicology Studies
  • PK / ADME Studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Trial Management / Clinical Project Management
  • Clinical Research Monitoring
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered The company offers following regulatory services:
  • Gap Analysis
General Support Services Offered The company offers following general support services:
  • Consulting
  • Biostatistics


Recent Capability / Capacity Expansion Initiatives Undertaken by Aixial:

  • In June 2021, the company acquired CMED, enabling it to extend its expertise and offerings and become a leading CRO with presence in the US and European market.

Further details on recent initiatives taken by Aixial as well as other cell and gene therapy CRO have been provided in detail in the report.

Altasciences, Expanding Capabilities in the Cell and Gene Therapy Market

Altasciences - Cell and Gene Therapy CRO Market

Altasciences is a privately held, US-based CRO / CDMO that claims to offer a wide range of services for the development and manufacturing of therapeutic product candidates. The firm is engaged in providing preclinical, clinical, bioanalysis and research support services. It is worth mentioning that the company holds an experience of 30 years in this domain and has partnered with various sponsors in order to accelerate their drug development processes.

The following table presents the details on the contract research services offered by Altasciences:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Bioanalytical Services
  • In-vivo Testing 
  • PK/ADME Studies
  • Safety Studies
  • Toxicology Studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered  The company offers following regulatory services:
  • Legal Representation
  • Gap Analysis
  • Technical Dossier Submission
  • IND Preparation
General Support Services Offered The company offers following general support services:
  • Consulting
  • Biostatistics
  • Post-Market Assessment
  • Re-Imbursement


Recent Capability / Capacity Expansion Initiatives Undertaken by Altasciences:

  • In October 2023, the company expanded its new state-of-the-art laboratory in Missouri, US to increase its bioanalytical capabilities.
  • In January 2022, the company acquired Sinclair Research, with an aim to offer preclinical services to its clients based in the US.

Further details on recent initiatives taken by Altasciences as well as other cell and gene therapy CRO have been provided in detail in the report.

CMIC, a Japan based CRO Offers Both Non-clinical as Well as Clinical Services to Support the Development of Cell-based Products, Gene Therapies and Regenerative Medicine

CMIC - Cell and Gene Therapy CRO Market

CMIC claims to be one of the first companies to provide CRO services in Japan. Operating on a unique business model, the company extends its services as a contract development and manufacturing organization (CDMO) and contract sales organization (CSO). In addition, it claims to offer manufacturing services and post marketing services for regenerative medicines. The company also provides regulatory consultancy through a specialized team of experienced consultants in this field. Further, the group aims to offer services that are likely to aid pharmaceutical companies to deliver safe and effective drugs to patients.

The following table presents the details on the contract research services offered by CMIC:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Bioanalytical Services
  • In-vivo Testing
  • Safety Studies
  • Toxicology Studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered The company offers following regulatory services:
  • Gap Analysis
  • Technical Dossier Submission
General Support Services Offered The company offers following general support services:
  • Consulting
  • Post-Market Assessment


Recent Capability / Capacity Expansion Initiatives Undertaken by CMIC:

  • In November 2020, the company launched a set of services using SUSMED’s trial management system covering subject registration, software assignment and distribution for digital therapeutics.

Further details on recent initiatives taken by CMIC as well as other cell and gene therapy CRO have been provided in detail in the report.

ICON Has Worked as a Trusted Partner with Several Cell and Gene Therapy Developers

ICON - Cell and Gene Therapy CRO Market

ICON is a clinical CRO firm, offering various services in the field of cell and gene therapy targeting a range of therapeutic areas. ICON claims to have conducted over 150 cell and gene therapy trials involving more than 7,000 patients in various stages.  In addition, the company claims to have developed tools to transform cell and gene therapy trial design and execution.

The following table presents the details on the contract research services offered by ICON:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Toxicology Studies
  • PK / ADME Studies
Types of Clinical Services Offered The company offers following clinical services:
  • Data Management
  • Safety and Pharmacovigilance
General Support Services Offered The company offers following general support services:
  • Consulting


Recent Capability / Capacity Expansion Initiatives Undertaken by ICON:

  • In September 2020, the company launched Accellacare, a global clinical research network focused on increasing patient recruitment with a patient centric approach.

Further details on recent initiatives taken by ICON as well as other cell and gene therapy CRO have been provided in detail in the report.

Labcorp is Collaborating to Expand its Cell and Gene Therapy Capabilities Beyond Clinical Development

Labcorp - Cell and Gene Therapy CRO Market

Labcorp is a US-based global life science company, which provides diagnostic testing, drug development and technology-enabled solutions through its Labcorp Diagnostics (Dx) and Labcorp Drug Development (DD) business segments. As per the firm’s website, it offers companion diagnostics services through its CRO business segment. It is worth highlighting that in February 2022, the company was named in FORTUNE magazine's annual list of the World’s Most Admired Companies for the fourth consecutive year.

The following table presents the details on the contract research services offered by Labcorp:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Bioanalytical Services
  • In-vivo Testing
  • PK/ADME Studies
  • Safety Studies
  • Toxicology Studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered The company offers following regulatory services:
  • Legal Representation
  • Gap Analysis
  • Technical Dossier Submission
  • IND Preparation
General Support Services Offered The company offers following general support services:
  • Consulting
  • Training
  • Biostatistics


Recent Capability / Capacity Expansion Initiatives Undertaken by Labcorp:

  • In July 2023, the company announced the opening of a new kit production facility and the expansion of its immunology and immunotoxicology lab in China in order to harness China’s drug development capabilities to advance a pipeline of innovative therapies.
  • In May 2023, the company entered into an agreement with Forge Biologics for the development and manufacturing of AAV gene therapies.5
  • In May 2023, Labcorp partnered with Resilience to provide its CGT clients with manufacturing process development, technology scale-up, technology transfer and GMP manufacturing capabilities.

Further details on recent initiatives taken by Labcorp as well as other cell and gene therapy CRO have been provided in detail in the report.

Linical and Accelovance Merged in 2018 to Form a Global CRO

Linical - Cell and Gene Therapy CRO Market

With an experience of more than 15 years, Linical Accelovance is a global contract research organization with a significant presence across all major markets, including North America, Europe, and Asia-Pacific.   The company claims to provide full-service drug development across all stages. In addition, the company has expertise across Phase I-IV studies in oncological, neurological, immunological, endocrinological and metabolic diseases. It is worth highlighting that the company has been honored as a ViE Award nominee for Best CRO by industry leaders for 11 consecutive years.

The following table presents the details on the contract research services offered by Linical Accelovance:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered  The company offers following regulatory services:
  • Legal Representation
General Support Services Offered The company offers following general support services:
  • Consulting
  • Training
  • Biostatistics
  • Post-Market Assessment


Recent Capability / Capacity Expansion Initiatives Undertaken by Linical Accelovance:

  • In October 2022, the company announced the establishment of its subsidiary in Italy with an aim to expand its business in Europe.

Further details on recent initiatives taken by Linical Accelovance as well as other cell and gene therapy CRO have been provided in detail in the report.

Medpace is Driven by a Full-service CRO Model that Coordinates and Integrates all Services for its Clientele

Medpace - Cell and Gene Therapy CRO Market

Medpace is a full-service CRO that offers clinical development services to medical devices and biopharmaceutical companies. The company aims to provide highest quality ethical standards and performance in their services. Further, it is actively engaged with various stakeholders, such as innovators, regulators, key opinion leaders and investigators to accelerate the development process of advanced therapies. The company provides clinical, operational and regulatory solutions for tissues, cell therapies and gene therapies to its clients. Medpace claims to comprise a team of specialized physicians having experience of more than 30 years in the clinical development of cell and gene therapies. In addition, the company has developed a customizable clinical trial management system, ClinTrak, for overall study management and better data integration of clinical studies.

The following table presents the details on the contract research services offered by Medpace:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Toxicology Studies 
  • In-vivo Testing
  • PK/ADME Studies
  • Safety Studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered The company offers following regulatory services:
  • Legal Representation
  • Gap Analysis
  • Technical Dossier Submission
General Support Services Offered The company offers following general support services:
  • Training
  • Biostatistics


Further details on recent initiatives taken by Medpace as well as other cell and gene therapy CRO have been provided in detail in the report.

PPD, Thermo Fisher’s Clinical Research Subsidiary, Offers a Broad Range of Clinical Development and Analytical Services

PPD - Cell and Gene Therapy CRO Market

PPD is a US-based CRO that offers development and lifecycle management services of therapy candidates. Through the use of novel technologies and its therapeutic expertise, the firm claims to be capable of accelerating the drug development process.  It is worth mentioning that the firm has facilities across 46 countries.  PPD’s client portfolio includes pharmaceutical, biotechnology and medical device industries, as well as government organizations. Further, it is important to highlight that the company has been acquired by Thermo Fisher Scientific in December 2021.

The following table presents the details on the contract research services offered by PPD:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Bioanalytical Studies
  • In-vivo Testing
  • PK/ADME Studies
  • Toxicology studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered  The company offers following regulatory services:
  • IND Preparation
General Support Services Offered The company offers following general support services:
  • Consulting
  • Training
  • Biostatistics
  • Post- Market Assessment
  • Re-Imbursement


Recent Capability / Capacity Expansion Initiatives Undertaken by PPD:

  • In September 2023, the company invested USD 59 million to expand its laboratory operations in Kentucky, US to deliver life-changing medicines to patients.

Further details on recent initiatives taken by PPD as well as other cell and gene therapy CRO have been provided in detail in the report.

Precision for Medicine, is Expanding its CGT Capabilities Through Acquisitions and Expansions

Precision for Medicine - Cell and Gene Therapy CRO Market

Precision for Medicine is a privately held, US-based CRO that claims to be engaged in offering services for clinical research, advanced data sciences and development of novel therapeutics. As per the firm’s website, it works on an integrated approach named, precision convergence, in order to deliver key insights related to patient biology, ranging from early development to approval.

The following table presents the details on the contract research services offered by Precision for Medicine:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Bioanalytical Studies
  • PK/ADME Studies
  • Safety Studies
  • Toxicology studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered The company offers following regulatory services:
  • IND Preparation
General Support Services Offered The company offers following general support services:
  • Consulting
  • Training
  • Biostatistics


Recent Capability / Capacity Expansion Initiatives Undertaken by Precision for Medicine:

  • In June 2023, the company acquired Baseline Controls with the aim to help its CGT clients with solutions to manufacturing challenges.
  • In April 2023, the company announced the expansion of its cell biology and genomics laboratory in Texas, US with an aim to increase company’s global biomarker capabilities and laboratory operations.

Further details on recent initiatives taken by Precision for Medicine as well as other cell and gene therapy CRO have been provided in detail in the report.

QPS Offers a Comprehensive Range of Clinical Research Services

QPS - Cell and Gene Therapy CRO Market

QPS is a US-based CRO that claims to offer drug discovery and development services to pharmaceutical and biotechnology companies. As per the firm’s website, it uses a flexible approach to ensure maximum client satisfaction by providing high quality services with the help of state-of-the art facilities and technical expertise.

The following table presents the details on the contract research services offered by QPS:

Parameter Description               
Scale of Operation Preclinical and Clinical
Types of Preclinical Services Offered The company offers following preclinical services:
  • Bioanalytical Studies
  • In vivo Testing
  • PK/ADME Studies
  • Safety Studies
  • Toxicology studies
Types of Clinical Services Offered The company offers following clinical services:
  • Clinical Research Monitoring
  • Clinical Trial Management/ Clinical Project Management
  • Data Management
  • Safety and Pharmacovigilance
Types of Regulartory Services Offered  The company offers following regulatory services:
  • Gap Analysis
  • Technical Dossier Submission
  • IND Preparation
General Support Services Offered The company offers following general support services:
  • Biostatistics


Recent Capability / Capacity Expansion Initiatives Undertaken by QPS:

  • In January 2024, the company announced the expansion of its mass spectrometry capacity, adding 13 LC-MS machines at its laboratories in Delaware, US and Groningen, Netherlands.

Further details on recent initiatives taken by QPS as well as other cell and gene therapy CRO have been provided in detail in the report.

What About the Other Cell and Gene Therapy CROs?

The above presentation features 10 cell and gene therapy CRO selected from a pool of over 105+ companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

About Author

Jasmeet Bhalla

With an experience of over 4 years with Roots Analysis, Jasmeet is adept at generating useful insights from unstructured / structured datasets. As a senior analyst at Roots Analysis, she has assisted several clients across multiple industry verticals within the healthcare industry. These verticals include contract services, devices / technologies, and drugs / disease indications. Since the findings of the research are aimed at supporting the clients to make thoughtful decisions for their business, she has hands-on experience on competitive landscape assessment, benchmarking, market sizing and forecasting, as well as several quantitative / qualitative / strategic frameworks.

Sources:

1. “Altasciences completes expansion of new state-of-the-art laboratory in Columbia, Missouri”
https://www.altasciences.com/press-release/altasciences-completes-expansion-new-state-art-laboratory-columbia-missouri

2. “Altasciences acquires Sinclair Research and continues to expand preclinical platform”
https://www.altasciences.com/press-release/altasciences-acquires-sinclair-research-and-continues-expand-preclinical-platform

3. “CMIC and SUSMED form a strategic partnership to provide one-stop contract services for the digital therapeutics application market”
https://en.cmicgroup.com/news-events/cmic-and-susmed-form-a-strategic-partnership-to-provide-one-stop-contract-services-for-the-digital-therapeutics-application-market/

4. “ICON launches Accellacare a global clinical research network focused on increasing patient recruitment with a patient centric approach”
https://www.iconplc.com/news-events/press-releases/icon-launches-accellacare-a-global-clinical-research-network/

5. “Forge Biologics and Labcorp announce strategic AAV gene therapy development and manufacturing collaboration”
https://www.labcorp.com/forge-biologics-and-labcorp-announce-strategic-aav-gene-therapy-development-and-manufacturing

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