CGT Diagnostic Testing Partners Require Pioneering Spirit in Rapidly Evolving Landscape

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With the rapid evolution of cell and gene therapies (CGTs), the CGT sector is witnessing the real-time pioneering of a bio/pharmaceutical industry that already has, and will continue to, change the landscape of modern medicine. As more of these therapies are set to come to market in 2025 and beyond, leaders across the CGT space are recognizing the value of developing and incorporating novel testing methods to minimize risk and maximize contributions to the delivery of faster and better patient outcomes.

The CGT sector itself is set to grow at an aggressive rate during the next decade. Predicting the future growth of any industry is more of an art form than a science, but one would be hard pressed to find any estimated compound annual growth rate (CAGR ) for the next 10 years below 20%. With various reports estimating a CAGR range of 20–24% CAGR, this rapid acceleration represents the industry as a whole growing from its current $20 billion valuation in 2024 to more than $180 billion by 2034. Most notably, the largest contributor to this anticipated CAGR and the estimated leader in growth is the United States. This should not be a surprise, as the US currently contributes roughly 50% of the segment’s revenue to the global CGT landscape. However, the future of CAGR is reliant on the continued growth of other global regions, specifically the Asia-Pacific area, which is set to catch-up quickly with increased CGT adoption (1–2).

To fully understand the growth opportunities of CGTs, it’s critical to understand the foundational treatment types driving this momentum. Cell and gene therapies encompass two primary approaches—autologous and allogeneic —each with distinct implications for manufacturing, logistics, and regulatory frameworks (3), as detailed below:

• Autologous refers to medicines where the patient serves as the donor for the cells or tissues needed to create the product. After the cells complete the scientific process to turn them into a lifesaving therapeutic, they go right back into that same patient. Autologous therapies make up most of the available offerings in the market today.
• Allogeneic refers to medicines derived from a single donor that are then given to many people. This scenario is more reminiscent of a classic bio-production manufacturing environment, and these medicines are currently in the earlier stages of development. As a result, allogeneic medicines make up the minority of current CGT offerings.

Personalized autologous cell therapies force rethinking of manufacturing and quality control at scale

The current emphasis on autologous therapies is due to its primary benefit—a highly reduced chance of the patient’s immune system rejecting the treatment since the treatment is using the patient’s own cells as the starting point.

However, from a production standpoint, autologous treatments have created one of the biggest manufacturing challenges the pharma industry has ever seen when it comes to rapidly scaling the therapies for mass market adoption. For most autologous therapies, one patient represents one lot of product, but, as the industry continues to embrace autologous cell therapies, bio/pharmaceutical companies have gone from producing 50–100 lots of product per year to producing 10x that amount at roughly more than 5000 lots per year.

Scaling manufacturing is a daunting task for CGT production facilities, notwithstanding the logistical issues of getting the product to and from the patient in need. To account for the growing adoption of CGTs, this paradigm shift in manufacturing has created the need for new quality control/diagnostic testing solutions. Creating and adopting these new solutions requires producers and diagnostic partners to take on a pioneering spirit to navigate this new age of medicine.

Navigating regulatory complexity and diagnostic innovation in a rapidly evolving CGT landscape

It is worth discussing the regulatory hurdles within the CGT arena. In bio/pharmaceutical production overall, regulatory hurdles can make traditional production difficult. The novel nature of CGTs makes meeting strict regulatory requirements even more challenging. With rapid growth of new therapies outpacing regulatory frameworks, regulatory agencies are working to adapt at the same rate; however, the lack of harmonization across global markets adds another layer of complexity. This lack of harmonization is especially taxing for companies aiming for international approvals to maximize therapy development that requires costly investment. In particular, the personalized nature of autologou therapies poses additional logistical and regulatory challenges, including patient-specific manufacturing and tracking requirements.

Being a pioneer in the GCT space means that one will likely use a methodology, product, or assay that an auditor has not seen before. In an effort to minimize these challenges, producers are aiming to design methods that can easily be understood and described to assist with approval. In turn, regulatory bodies are increasingly engaging with industry stakeholders to streamline pathways to approval. Such initiatives as FDA’s Regenerative Medicine Advanced Therapy Designation and the European Medicines Agency’s Priority Medicines scheme aim to expedite development and review processes of CGTs. Still, navigating the regulatory maze requires significant expertise, strategic planning, and early engagement with regulators. As the field matures, continued collaboration between industry, regulators, and policymakers will be essential to ensure that life-changing therapies reach patients without unnecessary delay.

The pillars of diagnostic value: rugged, usable, and understandable testing methods

As regulatory pathways evolve, the role of diagnostics becomes even more critical in requiring not just compliance, but practical, proven solutions that can meet the demands of modern CGT manufacturing.

This is more than just considering the specific tests and processes that work best for the facility and product. There’s inherent value in selecting a diagnostic partner that understands the nuance and experience required to support a pioneer company in an emerging field.

The right partner should be able to leverage this experience to deliver a testing solution that is rugged and robust, easy to use, simple to understand, and has a streamlined onboarding process. Important pillars that ultimately support the primary goal of a test method bringing value to an organization include:

• Rugged and robust: The method is fit for purpose and designed to withstand everyday life without having its integrity compromised. Test methods should be able to endure complex manufacturing facilities and frequent handling without risk of contamination. It should be able to withstand an employee having a bit of an “off” day with a pipettor or someone vortexing 30 seconds instead of 60 seconds because they had a bit too much coffee during their break.
• Easy to use: Methods that are easy to execute have many advantages; however, being “easy to use” is highly subjective. What is easy to one person might seem difficult to another. Typically, ease of use is associated with minimal steps needed to complete the process and straightforward processes during each step. Easy-to-use test methods allow for companies to cross-train multiple employees, lessening the impact of employee turnover in the lab. The more complex the method, the more one relies on a single expert. Another reason easy-to-use methods are preferred is employee morale. Complex methods can lead to burnout and high turnover in the lab.
• Simple to understand: Understanding how the method works is extremely important. Complete understanding of a method allows users to troubleshoot more effectively when things go wrong, significantly minimizing downtime.
• Seamless onboarding: Once a test method adequately addresses the criteria above, it’s equally important to weigh the onboarding process within the facility. With time playing a much more significant role in CGT development compared with traditional bio/pharmaceuticals, qualifying solutions must minimize the change management process by being designed for easy training and application that doesn’t require one single expert or specialist to run.

Each of these pillars contributes value to each organization’s overall diagnostic testing plan in critical ways.

The right partner matters as much as the right tool

When selecting a diagnostics partner to help bring CGT to market, there are additional aspects to focus on besides the solution itself. While standard partner questions for bio/pharmaceutical quality control partners remain applicable to the CGT space, there are a few additional characteristics to evaluate to ensure that the environment is ripe for collaboration and ultimate success:

• Financial health:This is first on the list as it is often the most unaccounted for criteria when selecting a partner. The time investment in developing a drug and getting it to the commercial stage is, on average, a decade or more. Even with the increased adoption of CGTs into the mainstream market, it’s imperative that a diagnostic partner has a cash runway that meets this need. A clear understanding of a potential partner’s minimizes implementation risk.
• Service network: A product is only as good as its service network. As new hardware and software enter the market for the first time to support these lifechanging therapies, it is necessary to understand how products can be serviced by the provider. Inquiring about the basics of a service network—How many engineers make up the network? Are they local to your manufacturing sites?—will give a more wholistic understanding of the risk of downtime when an instrument fails.
• R&D spend: A great solution is one that meets the need in the moment but can also be adapted for future development. A diagnostic partner must be positioned to evolve the development of a tool to meet future needs. The capability to keep pace often lies in the partner’s commitment to fund annual research and development within their own organization. This information is easy to obtain if the company is public, but more challenging if private. Companies investing 10%+ of their profits back into R&D is a promising sign that existing solutions are being improved, while new ones are simultaneously in development.

The best partners are true collaborators that are willing to offer not only a product or test, but also critical thinking skills as to the design of a comprehensive plan that has low barriers to adoption and is confidently based on a data-led approach that proves successful implementation outweighs risk.

While these criteria can seem like a tall task for diagnostic partners, new technology and scientific advancement in diagnostic tools have allowed a pathway for quality control programs to evolve to better meet the needs of the CGT field, which allows diagnostic partners to facilitate quicker, more efficient, and more thorough approaches to client timelines. Such a partnership can better navigate and pioneer the constantly evolving landscape of the CGT space.

References

1. Toward Healthcare. Cell and Gene Therapy Market Size, Trends, Challenges & Strategies. Market Research Report. August 2025. https://www.towardshealthcare.com/insights/cell-and-gene-therapy-market
2. Precedence Research. Cell and Gene Therapy Market Size, Share and Trends 2025 to 2034. Market Research Report. August 2025. https://www.precedenceresearch.com/cell-and-gene-therapy-market
3. Locatelli, F.; Cavazzana, M.; Frangoul, H.; et al. Autologous Gene Therapy for Hemoglobinopathies: From Bench to Patient's Bedside. Mol. Ther. 2024, 32 (5),1202–1218. DOI: 10.1016/j.ymthe.2024.03.005

About the author

Phil Robertson, Philip.Robertson@biomerieux.com, is associate director, Regional Sales, Pharma Quality Control, at bioMérieux.