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New Frontiers in cell and gene therapies: commercial, insurance and legal risks.

The article explores the complexities of cell and gene therapies, highlighting commercial, insurance, and legal risks, alongside the need for skilled professionals and innovative insurance models.

09/06/2025 · 6 minute read

The unique complex nature of cell and gene therapies (CGTs), the significant costs associated with their development and commercialisation, as well the long-term uncertainties present unique challenges for life sciences companies and insurers.

These revolutionary treatments also introduce a broad spectrum of legal risks, particularly in relation to regulatory compliance and liability. The complex regulatory landscape is set out in the second article in this series.

This article considers the challenges faced by life sciences companies in bringing these products to market, the potential legal risks and insurance considerations.

Commercial development

As CGTs involve risks beyond those associated with conventional treatments, it is necessary for life sciences companies to prepare to overcome several challenges: 

Clinical Trials: CGTs give rise to novel, additional risks that need to be considered compared to other types of therapies during the clinical trials process. For example, gene therapies might have direct effects on the recipient genome or toxic responses to the vector itself. Cell therapies are even more complex as a result of the nature of the product, and it may not be possible to completely predict the risks.

Furthermore, patient-related considerations present significant challenges during clinical trials, including those related to recruitment of limited patient populations in rare disease trials, retention of clinical trial participants throughout extended follow-up periods, and compliance with complex therapeutic administration procedures that may require specialised clinical trial facilities and personnel.

Manufacturing: The manufacture of CGTs, which involve live cells, is significantly different to the production of traditional pharmaceuticals. The manufacturing of living therapeutics can be extremely complex (for example, ensuring rigorous aseptic techniques and comprehensive contamination prevention protocols) and are subject to inflated cost, particularly to ensure consistency of product quality.

Live cells are often sensitive to the smallest changes in the manufacturing process, such as a change in temperature, which could, in turn, have an impact on the quality and toxicity of the final product. Significant manufacturing gaps, including in relation to infrastructure and knowledge, also have the potential to impact on product quality, safety, and efficacy.

Supply chains: The supply chains for CGTs are long and complex. It is common for cells to be collected from multiple sites, either directly from the patient or a donor, before delivery to the manufacturer, with the resulting therapy then returned to the patient. Finished therapies may require liquid nitrogen shipment or dewars at cryogenic temperatures. The ability of the packaging to hold its temperature variance within stated tolerances can be challenging, especially when opposing climatic regions may need to be considered in a single shipment, as well as any potential logistical delays. A break in the supply chain has potentially significant financial consequences.

Product safety:  CGTs’ product safety considerations extend throughout the entire product lifecycle, from development through pharmacovigilance. In particular, safety considerations for CGTs require careful attention due to their biological nature as they present unique safety challenges including potential unintended genetic modifications that could affect cellular function, unexpected immune system responses that may lead to rejection or inflammation, complications from how the therapy integrates with the patient’s existing condition, and long-term biological effects that may not be immediately apparent.

As a result, understanding and monitoring these safety aspects requires robust safety management systems that encompass pharmacovigilance procedures specific to CGTs with extended patient follow-up protocols.

Shortage of talent: There is a critical shortage of talent at all levels in the CGT arena; from technicians and development scientists, manufacturing, and analytics staff, to clinical expertise in the management of cell and gene patients. There is a growing need for more CGT-specific education programs as scientific and clinical development has outpaced the training of new professionals to meet the demand.

Intellectual property (IP): The significant cost and time involved to take CGTs to approval means that it is essential for companies to implement an effective IP strategy to maintain their market status. As CGTs are entirely different from a standard small molecule drug, they require a unique patenting strategy. To obtain effective IP protection, any IP strategy in this area needs to consider the differences in UK, EU, and US patent practice. Consideration must also be given to third party IP in this increasingly crowded field to avoid infringement of any third-party rights.

Insurance considerations

The rapid growth of the CGT market requires insurers to adapt traditional risk models. Life sciences companies developing and producing CGTs require specialist risk assessments and bespoke coverage solutions, including in relation to:

Product liability: the potential for CGTs to trigger adverse immune responses, unforeseen mutations and cancerous growths as well as long-lasting effects means that they carry greater liability risks as compared with traditional pharmaceuticals. Product liability cover will need to account for the possibility of late notifications, difficulty in establishing causation for adverse events and long-tail claims.

Clinical trial: clinical trial insurance of CGTs may require extensive coverage for immediate and long-term patient care unlike traditional pharmaceutical clinical trials. This includes comprehensive protection for patient injuries or adverse events that patients may experience during the clinical trial, whether they appear immediately or develop over time. Therefore, the insurance coverage may account for extensive follow-up monitoring costs, which span several years after the clinical trial. 

Cargo: insurance covering supply chains should account for temperature deviations, transit delays and product damage or loss due to handling errors. As a result, cargo insurance policies ought to provide for sufficient coverage limits given the significant value and sensitivity of materials being transported. Insurers may need to establish immediate notification and response protocols related to any potential cargo claims and also address cross-border transportation requirements.

Professional liability: Professional liability insurance is essential for protecting healthcare professionals, organisations and other key stakeholders involved in the development of CGTs. This coverage specifically addresses potential claims arising from healthcare professionals’ negligence during treatment delivery, which can be particularly complex given the sophisticated nature of CGTs. Additionally, this insurance may extend to corporate directors and officers, and other clinical research or consulting services involved in CGT development, implementation, and regulatory compliance.

Given the complex nature of CGTs and their potential long-term effects, innovative risk-sharing models may be required to allocate liability among various stakeholders. These models include collaborative insurance arrangements, where CGT manufacturers and healthcare providers enter into joint liability agreements during clinical development.

Additionally, performance-based coverage is another approach, where the policy is linked to the efficacy of CGTs. This model allows for pricing adjustments based on the performance of the therapy.

Looking ahead

The future of CGTs presents a unique intersection of legal, commercial and insurance considerations that will require continued evolution and adaptation. From a legal standpoint, regulatory frameworks in the UK, EU and US are becoming more sophisticated and stringent to address innovative therapies while maintaining patient safety and ethical standards.

Commercially, the industry is making efforts to develop sustainable pricing models and market access strategies that balance clinical development costs with national healthcare systems and reimbursement policies.

Lastly, insurers may wish to address the prominent level of risk associated with CGTs while exploring innovative insurance models such as risk-sharing and performance-based coverage pricing to foster innovation within the CGT sector.

This convergence of challenges and opportunities will demand unprecedented collaboration among all stakeholders to ensure the successful development and implementation of CGTs in the years ahead.  

Meet the authors

Jenny Yu

Marsh UK Industries - Chemicals & Life Sciences Industries Leader

  • United Kingdom

Emilie Civatte

Partner, Kennedys

  • United Kingdom

Barnaby Winckler

Partner, Kennedys

  • United Kingdom