Gene Therapies: Overcoming the Biggest Hurdles in Manufacturing

merck gene therapy wordpress cover

By 2024, the gene therapy market is expected to reach an estimated worth of $13B (€11.6B). With several therapies approved and hundreds of clinical trials underway, the sector is booming. However, its sudden and fast growth and the complexity of the therapy itself have resulted in a number of hurdles that need to be overcome.

Especially during manufacturing, researchers face challenges at different stages, including process development, safety testing, vector characterization, and when it comes to regulatory guidelines. One of the key issues is the highly compressed timeline researchers have to work with. Instead of the average eight to ten years that it takes to develop a drug, gene therapies are usually developed within three to five years.

Another challenge resulting from the rapid growth of the sector is the increasing demand for plasmids. As the key building blocks for the development of viral vectors, plasmids are needed for gene therapy development. Currently, the industry is struggling to meet the demand for plasmids, forcing companies to think outside the box. This bottleneck has resulted in the development of nonviral vector solutions, which we will see more of in the future.

But compressed timelines and viral vector bottlenecks are not the whole story. This infographic discusses the challenges at various stages of gene therapy manufacturing; what you can do to ace the manufacturing process; and what we can expect in the future.

You can download a free version of the infographic here!

Gene therapies

gene therapies, gene therapy manufacturing

gene therapy, gene therapies, manufacturing, gene therapy challenges

We developed this infographic in collaboration with Merck. With decades of experience, Merck has already developed three gene therapy products through to commercialization; tested over 10,000 cell and gene therapy samples in one year; and has over 500 batches of different viruses to ensure a smooth manufacturing process.

Visit Merck at and learn how to tackle the challenges in gene therapy manufacturing!

Author: Larissa Warneck, Science Journalist at

Design: Elena Resko

Explore other topics: Gene therapyMerck

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