The Path Forward for Biotech Startups in Europe

May 28, 2025 by May Harkin

Reducing risk and accelerating success

The European biotech market is changing form, with advanced therapies gaining increased traction. Post-2015, 51% of all new European biotech organizations have been focused on cell and gene therapies, immunotherapies and antibodies.

These markedly innovative therapeutics often have complex journeys to market. While large, more established organizations may have the capacity to navigate challenges like new regulatory requirements, or outsourcing complexities, a growing generation of new biotech start-ups can face significant hurdles to commercialization. These concerns were a recurring topic recently at the Advanced Therapies Congress in London, along with how to approach them as an emerging biotech business.

Navigating European regulatory environments
While the European Medicines Agency (EMA) oversees much of the regulatory process, ensuring compliance with EU standards is only part of the process; individual countries across Europe have their own regulatory frameworks and processes to adhere to.

Meanwhile, global institutions like the International Conference on Harmonization for Pharmaceuticals for Human Use (ICH) produce global recommendations that provide the basis for unified drug development standards, including for Good Clinical Practice (GCP).

In January 2025, the ICH E6(R3) guideline launched, providing a unified standard for GCP in clinical trials to align practices with modern scientific and technological advancements. These guidelines aim to offer a more flexible, risk proportionate, and transparent process for advanced therapies, with enhanced clinical trial registration and result reporting frameworks. For small biotech organizations aiming towards, or perhaps at clinical trial stages, adapting standard operating procedures (SOPs) quickly to secure GCP alignment will be pivotal to avoiding costly delays and setbacks.

Outsourcing challenges: Time, expertise, cost, and risk
For emerging biotech companies, outsourcing can offer a valuable method of returning time back to science, supporting faster development, and ultimately, a more cost-effective route to clinic, making the right partner, business critical.

An informed due diligence process should be established and followed to ensure that any outsourced partners not only have the right capacity, but the capability to deliver. This means understanding whether they have the right performance levels, expertise, and alignment with regulatory requirements; both for your research today, and for your future commercialized products.

Once an organization has established its intellectual property, a 20-year exclusivity window for commercialization begins. Any delays in getting your product to market cuts your projected revenue. For startups, this challenge is often heightened due to limited resources to accelerate timelines, or scale production. Leveraging the right expertise to streamline and scale in a way that avoids time-consuming regulatory or protocol issues can be pivotal to preserving timelines without compromising product quality.

Establishing a risk-proportionate approach to operations can be a fine balance for smaller biotech organizations, where resources are often limited. Working with experts to support complex stages of development can alleviate pressure without compromising on pace, or heightening risks.

The takeaway
While the European biotech market is fast evolving, it presents a host of opportunities to strengthen and advance research and improve patient access to advanced therapies. Navigating this exciting, and sometimes challenging landscape as a smaller biotech company can be daunting without the right operational expertise or regulatory experience.

At Aldevron, we are proud to support researchers from day one, through to cGMP with our tailored cell and gene therapy manufacturing solutions. From regulatory guidance, through to technical expertise, high-quality products, and reliable service, our flexible manufacturing solutions offer a complete template for success.

Learn how Aldevron supports clients at each manufacturing stage

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