What Can We Expect From The Immunotherapy Market In 2016?
By Trisha Gladd, Editor, Life Science Connect
Traditionally, the biopharma industry has been focused on recombinant protein therapeutics made from living cells. However, as we approach 2016, the realm of biopharma is expanding to also include cellular immunotherapy products. Promising clinical trial results of CAR T-cell therapies have sparked some noteworthy partnerships over the last year, including Celgene’s $1 billion investment in Juno Therapeutics and Kite Pharma’s strategic collaborations with Amgen. Most recently, CAR T-cell therapy (in this case, allogenic) made headlines when it was reported that a baby suffering from “incurable” leukemia is now cancer free after receiving the treatment. Other forms of immunotherapy treatments, such as immune checkpoint inhibitors, have also made their way into the spotlight.
In a recent report, it was projected that the value of the immunotherapy market is expected to rise from today’s worth of $41 billion in 2015 to $80 billion by 2020. Today’s key trends in the industry will be instrumental in shaping this space and forging a path toward lower costs and increased innovation. “New technology areas that have been influential over the past few years – such as the introduction of disposable technology and the reduction in dependence on large, complex biopharmaceutical manufacturing plants with fixed infrastructure – are likely to continue to evolve in order to keep costs as low as possible,” says Marc Better, vice president of product sciences at Kite Pharma. “Suppliers of components for biopharmaceutical manufacturing continue to introduce new products that align well with current trends, such as plant flexibility and cost containment.”
New Possibilities In An Automated World
Specifically, one area in the cell therapy field that Better says he’s excited about are new technologies for process automation. “Processes that have historically been highly dependent on complex, manual operations in clean rooms can be subject to human error, which, in some cases, could mean the difference between generating a therapeutic product for a patient in need or not,” he explains. “In the cell therapy space, we do continue to see new products being developed that are dependent on complex unit operations, often where technical solutions for separation technology or liquid handling are not yet easily managed.” Suppliers are introducing equipment to help meet these challenges, such as the Xuri system for cell culture expansion (GE Healthcare), and the Sepax (BioSafe) and Lovo (Fresenius Kabi) for cell separation, washing, and concentration. He adds that automated solutions offering real-time tracking would allow for error-proofing, specifically where technology such as bar coding or radio frequency identification (RFID), is used to prevent errors during manufacturing. “Using automated systems, it should become easier to implement robust processes for cell therapy manufacturing and reduce both the time and cost of cell therapy product manufacturing,” he explains. “I believe in a future where we can safely deliver cell therapy products, if approved, to an increasing number of patients with life-threatening diseases.”
While cell therapy and regenerative medicine products are clearly gaining traction as viable, specific modalities to treat a variety of diseases, it remains challenging to develop highly-specific, well-targeted products. Better says new solutions that could increase efficiency and accuracy in this space could have an impact on cell therapy effectiveness as well as the ability to overcome inhibitory signals, making the environment in the body less appealing to the tumor.
Planning Capacity For A Growing Market
As has been observed in the biopharmaceutical industry over the past 20 years, available contract manufacturing capacity can go through cycles of insufficient and excess capacity that dramatically influences the progress of an entire industry. While the value of the cell therapy market is expected to double by 2020, experts anticipate the biologics market will also see considerable growth by that same year, with the percentage of biopharmaceuticals in the pharma market rising from 20 percent to 50 percent. In an article on BioPharma Reporter, HighTech analyst William Downey says the needs of big biopharma will push outsourcing levels from 16 percent to 24 percent in the next five years. Only time will tell if this will be enough.
Kite has already begun to address its potential needs for capacity, even before the FDA approves its treatment for its most advanced product candidate, KTE-C19, an autologous, anti-CD19 CAR T-cell product for lymphoma and leukemia. At a site in El Segundo, CA, construction has begun on what will be a 44,000 square-foot facility intended to become the company’s central hub for development and manufacturing of KTE-C19. The building’s location near the Los Angeles International Airport will facilitate the shipment of T-cell specimens to and from the facility.
According to Better, the tremendous promise of these therapies to improve the lives of patients brings new hope not just to the US but to patients around the world. “In the US, the public markets have been tremendously supportive for these exciting new therapies, which has helped US companies invest in this space,” he notes. “That said, both European and Asian countries are increasingly supportive of cell therapy approaches, and I expect more products will be evaluated in these jurisdictions over the coming years.”