A time of flux: opportunities and challenges

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In this blog, Katherine Moynihan, VP of Business Development and Marketing at Genezen explores the trends that have shaped the biotech and pharma outsourcing space in 2021 and looks at the challenges and opportunities the sector will see in the coming years.

COVID-19’s impact on the market

Over the course of the pandemic, the biotech and pharma outsourcing industry has experienced significant change.

Despite the devastating impact of COVID-19 both socially and economically, and the pressure put on healthcare providers, it has also presented the CDMO industry with some significant opportunities to improve and grow.

Roughly half of the products developed for COVID-19 that received emergency use authorizations had an associated contract manufacturing agreement. That number rose to 100% for vaccines . The overall result was an unprecedented increase in new service agreements and as a result new pressure and demand these contract partners.

This surge in vaccine development also changed the top focus of contract manufacturing agreements in 2020 to infectious disease, knocking oncology from the top-spot where it has sat for decades . With a number of vaccines now being distributed globally, the focus is starting to shift back towards non-COVID products. The immuno-oncology market in particular is expected to continue its pre-pandemic growth, following its momentary decline in 2020 .

Given the complexity of these products and the prevalence of small biotechs involved in the market without the necessary infrastructure to scale and manufacture products, this reliance on CDMO partners will continue to be a key requirement for the foreseeable future.

Back to the Future

To pave the way to develop products, companies often seek to avoid time and capital expenditure for facility buildout and hiring for GMP manufacturing by partnering with specialist CDMOs and this trend continues to grow.

Many organizations had clinical trials delayed or postponed by the pandemic and they are now pushing to recommence those trials at the same time as products they had in their pre-clinical pipeline reach early phase trials.

Research and development (R&D) is a central pillar of the pharmaceutical and biotech industry. In 2001, there were just over a thousand companies with active R&D pipelines across pharma and biotech, in 2020, this figure reached almost 5,000.

Data from The American Society of Gene & Cell Therapy shows that, as of May 2021, there are over 3,000 cell, gene and RNA therapies in development (from preclinical through preregistration).
Numerous start-up companies have entered the market with a single lead product that they wanted to get into a clinical trial. Now those ‘first’ products are moving towards regulatory approval, and we are seeing a pipeline of other products moving into trials of their own. Add to this the continuing entry of new, often well-funded, start-up companies into the cell and gene therapy space and there are even more products vying for limited capacity in the CDMO industry.

As pharma and biotech companies focus development pipelines on more complex, personalized therapies with smaller-scale manufacturing requirements, the downstream impact will be a continued squeeze on niche manufacturing capacities that require specialist or small-scale equipment.

Addressing capacity needs

Recently, these strains on capacity were highlighted and compounded by the limited supply of raw materials and disposables as a result of the demand created by the production of COVID vaccines.

It is likely that manufacturing capacity will continue to be an issue for the biologics industry over the next 5-10 years and we will see continued physical and technological expansion as a result. Capacity will increase through investment in new facilities, as well as through the introduction of new technologies that increase throughput and yields on each production batch. These technologies will also lower the overheads and material costs for each batch, which will be essential to getting high-value biologics to market at costs that are acceptable to payers and insurers.

Genezen

With specific expertise and dedicated capabilities in lentivirus and retrovirus vector development, scale-up and manufacture, companies typically seek us out to capitalize on our flexibility and ability to develop processes in clinical stages that are robust enough to be scaled up for commercial production. Our focused expertise is also increasingly appealing for pharma companies as its de-risks development and scale-up.

Earlier this year (2021) we broke ground on a new multiphase master plan for a 75,000+ square foot cGMP-compliant state-of-the-art facility for the aseptic manufacture of lentivirus and retrovirus vectors. The facility will include multiple cGMP production suites including capabilities for host cell expansion, host cell banking, and viral vector production via transient transfection and producer cell lines.

The site will also deliver a full suite of complementary process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research grade and preclinical vector production, and analytical assay development and validation from the site. Analytical testing services, including Recombinant Competent Lentivirus (RCL) testing, vector stability testing, and safety and sterility testing, will also be available.

Want to learn more about how we could support your therapy? Get in touch today. 

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