Cell and gene therapies are transforming today’s healthcare landscape and the biopharma industry supply chain must be prepared to face, and embrace, the unique challenges associated with this developing class of drugs.

According to BIS Research, the global cell and gene therapy industry was valued at $1.07 billion in 2018 and is projected to grow over $8.95 billion by 2025 at a compound annual growth rate (CAGR) of 36.52% to nearly $12 billion.

While the market is young, it is growing fast—supported and driven by the underlying cell and gene therapy service market. One company growing fast within the space is supply chain expert Cryoport.

“We’re supporting 465 clinical trials in the regenerative medicine market around the world, plus three products on the market being delivered to patients right now,” said Mark Sawicki, chief commercial officer, Cryoport. “Cryoport has supported the development of these therapies from Phase I to distribution to patients in need.”

Revenues in its biopharma business shot up by 33% in the first quarter of 2020, driven largely by commercial tie-ups supporting Gilead’s Yescarta® and Novartis’ Kymriah®. In April, Gilead’s subsidiary Kite Pharma renewed its agreement with Cryoport, which covers its entire portfolio of therapies in development and any new commercial launches.

In another deal, Cryoport is supporting bluebird bio’s commercial launch of Zynteglo®, which is expected to rollout in the second half of this year.

“In the cell and gene industry, the therapies are, on an individual shipment basis, quite expensive, so there’s a huge risk to the client,” said Phil Wilson, senior vice president, global operations and supply chain, Cryoport. “Our goal throughout our processes, not only from a technology standpoint, but from a logistics standpoint, is to minimize the amount of risk to our clients.”

These days, the industry’s reliance on Cryoport’s support is especially critical as the world faces the COVID-19 pandemic and industry works to ensure patients have access to life-saving therapies.

“On the clinical side, there have been some companies we work with that have announced temporary holds on dosing patients in the cell and gene space, but I would say the vast majority of our clients are still continuing to dose patients,” said Sawicki. “They’re still trying to drive their clinical portfolios. On the commercial side, we’ve experienced minimal disruption resulting from the COVID-19 pandemic.”

The company has actually reported a bit of an uptick in support for some of its clients who are actively trying to find a treatment therapy for COVID-19—it reports providing logistics support for six COVID-19 treatments and vaccines in clinical development.

“One strange side effect that we’ve seen around COVID-19 is that companies are actually accelerating a lot of the long-term planning aspects of their programs,” said Wilson. “If anything, when we come out of this, we may even see more aggressive behavior from the cell and gene space.”
 

Ahead of the curve

Moving forward the cell and gene therapy market is poised for explosive growth as biopharma firms continue to research and develop critical life-saving medicines. For service providers like Cryoport, the only way to truly stay ahead of the curve, and the competition, is through new technology innovation. 

On the new product front, Cryoport has recently added Veri-Clean™ to its portfolio.   

“It’s a proprietary cleaning process, which no other life science logistics provider offers,” said Sawicki. “It’s actually the life science logistics industry’s first and only validated cleaning and disinfection process.”

According to the company, Veri-Clean™ virtually eliminates the risk of cross-contamination by decontaminating all Cryoport Express cryo-shippers and stainless steel accessories. The cleaning methodology utilizes a multi-purpose reagent effective against bacteria, fungi, and viruses, including the Human Coronavirus.

With support from a third-party accredited laboratory, Cryoport says Veri-Clean™ cleaning and disinfection procedures: reduces external contaminants by nearly 100%; results in a 6-log drop of tested biological indicators; reliably verifies no environmental flora—including bacteria, fungi and viruses—are present; and manually confirms the shipper is free from protein and hemoglobin.

“This process comes as close to sterilization as you can for a transportation related product,” said Sawicki. “We think it’s going to be a significant game changer.”

It’s technology innovations like Veri-Clean™ that have propelled Cryoport to its position as a life sciences industry leader in temperature-controlled logistics and biostorage.  

As today’s biopharma companies continue to advance cell and gene therapies and vaccines through the various stages of development through to commercial launch, they will continue to rely on the essential and highly specialized solutions service providers like Cryoport offer. 

Simply put, without them, new cell and gene therapies can’t be developed or, more importantly, delivered to the patients who need them most.

Learn more about Cryoport at www.cryoport.com