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

Bioassay – A Prerequisite for the Cell and Gene Therapy Development

Over the past few years, investigational new drug (IND) filings for cell and gene therapy product 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 cell and gene therapy domain has led to the rise in demand of bioassay services for cell and gene therapy.

Bioassays 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 Services 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%).

Growing Network of Bioanalytical Facilities for Cell and Gene Therapy

Presently, more than 55 facilities are providing bioanalytical 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.

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.

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.

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 market evolution.

For further information on this domain, check out the report –

Cell and Gene Therapy Bioassay Services Market 

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