Bioassay Services – A Prerequisite for the ATMPs Development

Bioassay Services – A Prerequisite for the Cell and Gene Therapy Development

Over the past few years, investigational new drug (IND) filings by cell and gene therapy companies have significantly increased. In fact, from year 2016 to 2020 more than 300 IND filing for cell and gene therapy product have been recorded, indicating that several developers and innovators are more attracted towards the cell and gene therapies. Therefore, increase in development of novel cell and gene therapies has led to the rise in demand of bioassay services for cell and gene therapy CRO market.

Bioassay services are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance. In fact, to obtain the regulatory approval for the biological products, such bioanalytical evaluations are must. Further, various researchers have demonstrated that the cell and gene therapies show different mechanism of actions; majority of the times these actions are unpredictable. As a result, different evaluation approaches are to be applied on the different therapies, due to which the evaluation of the aforementioned therapies becomes a challenging task for the innovators. Therefore, to overcome these issues, several contract service providers have emerged in this domain to develop bioassays.

Companies Offering Bioassay for Cell and Gene Therapies

More than 40 companies are currently available that offers bioassay services for cell and gene therapies, across the globe. Majority of these companies are established in North America (61%), followed by Europe (36%).

Companies Offering Bioassay Services for Cell and Gene Therapies

Growing Network of Bioanalytical Facilities for Cell and Gene Therapy

Presently, more than 55 facilities are providing bioassay services for cell and gene therapies. Majority (~55%) of these facilities are based in US, followed by UK (~10%) and Belgium (~10%). Most of the facilities are providing in vitro bioassay services for cell and gene therapies.

Growing Network of Bioanalytical Facilities for Cell and Gene Therapy

How Players are Complying with Developing Market?

To capture better position in market, stakeholders in this domain are actively expanding their existing capabilities to enhance their respective offerings and comply to the evolving industry benchmarks.

How Players are Complying with Developing Market?

Increasing Number of Events and Initiative Related to Bioassay Services

Increase in participation of stakeholders in global events and strategic initiative related bioassay services reflects the increasing interest of players in this domain. In fact, close to 45% stakeholders have reported initiatives related to gene therapies; of these, ~30% claim to have taken initiatives related to immunogenicity assay and assay development.

Increasing Number of Events and Initiative Related to Bioassay Services

To get detailed information on the key players, strategic initiatives in this domain, likely partners for cell and gene therapy service providers, and the likely evolution of the bioassay services market, you can also download the SAMPLE REPORT on bio-assay services by Roots Analysis.

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