Four years ago, the FDA made the landmark prediction that it would be approving anywhere from 10 to 20 new cell and gene therapy products annually by 2025. Today, it’s a good time to pause and reflect on the state of the industry. Are we actually on track to reach that goal in just two years? Where are we seeing the most traction? What challenges remain? And from a workforce standpoint, what constraints potentially stand in the way of bringing that bold prediction to life? 

Here’s a quick rundown of everything you need to know. 

the industry is growing… 

There’s a lot of excitement around cell and gene therapy — the former involves the transfer of cells with relevant functions into a patient; the latter, the transfer of genetic material and subsequent uptake of the gene into the appropriate cells of the body — and it’s easy to see why. Consider the following: 

  • There are over 2,000 clinical trials for cell and gene therapies underway at the moment, and as many as 13 new cell or gene therapies could be approved in the U.S., Europe or both by the end of 2023. 
  • Those are remarkable numbers in light of the fact that the field remains, in many respects, in its infancy — the first therapy of this kind wasn’t approved by the FDA until 2017. 

All told, the market, valued at $18.61 billion last year, is expected to hit $93.78 billion by the end of the decade. And with such a healthy R&D pipeline, any number of blockbuster products as well as niche (or “orphan”) products will likely be launched in the next few years. 

So all signs indicate that the cell and gene therapy space is poised for takeoff — but as we’ll also see, that could also be the recipe for capacity crunch, especially for organizations looking to grow. 

… but capacity challenges remain 

From the outset, it’s worth pointing out that staffing shortages are a ubiquitous, perennial challenge for biopharma companies in general. This isn’t unique to the cell and gene therapy workforce per se. 

Talent scarcity was the most-often-cited pain point in Randstad Sourceright’s 2022 Talent Trends survey of C-suite and human capital leaders in the life sciences and pharma sector, for instance, a majority of whom (55%) also indicated that they would be hiring extensively this year in order to ensure their businesses can grow. 

For roles in cell and gene therapy talent, where niche expertise is required, the problem is still more pronounced. Indeed, among the many conclusions of a recent report from the U.S. GAO and Alliance for Regenerative Medicine was that the lack of trained workers is holding back R&D development efforts for companies across the board. In a similar vein, a survey found that “hiring… staff with cell/gene therapy R&D expertise” was a significant pain point for nearly a third of industry respondents. 

The underlying causes? They seem to be two-fold: 

  • Many of these roles come with extensive educational requirements, often including graduate-level work, immediately disqualifying a large chunk of the workforce. 
  • Meanwhile, there are relatively few two-year biotechnology degree or certificate programs equipped to train candidates for lower-level, research-oriented roles — and when companies opt to hire overqualified candidates for these positions, the practice often leads to churn.  

Finally, and further compounding the hiring challenge, there’s the fact that no nationally recognized or standardized education curriculum currently exists for the field. And yet, as cell and gene therapy techniques become increasingly prevalent as well as increasingly scalable, it stands to reason that most of the challenges touched on so far are only going to increase in turn. 

key takeaways and solutions for companies 

From a high level, three focus areas stand out for the life sciences field at large going forward. Prioritizing these areas should help organizations eventually overcome the critical shortage of qualified talent in the cell and gene therapy space. Namely: 

  • increasing the number of educational institutions that offer training programs, and working to standardize a curriculum for cell and gene therapy talent — of course, this will require partnership 
  • launching new initiatives to reskill or reskill existing workforces
  • doubling down on training and retention programs internally

Unfortunately, none of these things are going to solve the problem overnight — and in the case of the first one, in particular, it would likely be many years before organizations start seeing value. In that context, tapping into a strategic partner like Randstad may be the most viable path forward. We have a large database of STEM professionals, together with flexible staffing solutions, that can deliver immediate ROI for your business today. Get in touch with us to find out how.