Innovation Accelerates into the Future

Train moving fast from 2023 to 2025 in tunnel | Image Credit: ©xy – stock.adobe.com

Taking stock of the past 12 months, it is fair to say the biopharma industry has witnessed some exciting trends, including significant therapeutic successes and interesting industry deals. However, there have also been challenges, such as supply constraints and, particularly for smaller companies, investment concerns, that will continue to play a role in the progression of the industry into 2025 and beyond.

“At a strategic product development level, the industry has shifted focus toward biologics,” notes Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. “At a practical and operational level, companies are revising and refining approaches to regulatory, cost containment, and supply chain demands and challenges.”

Therapeutic innovation

“If I reflect upon 2024, what really sticks out to me is the innovation, and I feel like we’re accelerating quite a bit in a number of areas,” remarks Michelle Bridenbaker, COO of Unbiased Science and vice-president of the Medical Information Leaders in Europe. “The first area that I really see as being very consequential has been the advances we’ve made in personalizing medicine. So, being able to say, ‘let’s take this tissue and decide what is the best therapeutic for a patient,’ and really thinking what is the best course of care and the safest as well.”

Preeya Beczek, director of Beczek Consulting, a specialist in regulatory affairs and compliance, agrees that personalized medicine is a trend that will continue from 2024 into 2025 and beyond. “If we think about personalized medicine, there’s a real focus on personalizing precision medicine, including cell and gene therapies, [at the moment], and there’s expected to be quite a major trend in this area to really focus on that personalized part,” she says.

“On the technology point of view and indication point of view, I think there’s a certain signal of maturity of the system, which is new indications that we’ve moved into. We saw great results and great excitement, for instance, in autoimmunity, with new approaches delivering significant value,” adds Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics. “Again, in those indications, [these approaches are] opening up a series of newer perspectives to patients and to the business in general.”

For Edwin Stone, CEO, Cellular Origins—a company focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies, there have been some big themes from 2024 that he anticipates will continue to impact the biopharma industry moving forward. Therapeutically-speaking, he highlights the glucagon-like peptide-1 (GLP-1) therapies, pointing out that, while not revolutionary, these drugs have dominated the attention of many companies and have impacted the supply chain as a result of their growth.

Additionally, there have been earlier line approvals, such as those for Bristol Myers Squibb’s (1) and Johnson & Johnson’s (2) chimeric antigen receptor T-cell (CAR-T) therapies, moving cell therapies on from being viewed as third and fourth-line treatments to second-line options, Stone specifies. “[These advances] really open up that question of, when do we start to see first line treatments? And of course, part of that comes down to not just the safety and efficacy profiles, but the cost of goods,” he says.

However, with these advancements, it will be important for industry to show that it has the capacity and capability to manufacture these innovative therapies so that they may reach the end user. “Manufacturing really matters. Our ability to get therapies to people really matters. And I think the scientific piece is great, but it’s only going to be successful if we can actually apply that in the real world,” confirms Stone.

The investment environment

“Investment is the oil that gets everything moving and enables us to do the process development, the work, and the product development in the end,” specifies Forte. The past year was tough in terms of investment with discussions proving to be slow-going, he notes; however, funding has eventually come through, which is indicating that companies are looking to different opportunities and finding different ways of funding to continue their activities.

“One thing that I would like to see being discussed in 2025 is the overall value proposition of these products to patients with a clear focus on manufacturing and optimization of technology to impact the cost of goods and the efficiency,” Forte adds. These are the sorts of topics that should be prioritized as they can improve therapeutic access for patients, he states.

“We’ve continued to see the impact of the COVID bubble, where you had substantial capital inflow, lots of companies launching many big, ambitious programs, and then reality set in,” remarks Erik Wiklund, CEO of Circio, a biotechnology company developing novel circular RNA vector platform. “I think now, we’re still in this sort of post COVID nuclear winter for small biotech where capital is very difficult to access. The consequence has been layoffs in a large proportion of companies, both in the [United States] and in Europe. I think this looks like it will continue for the foreseeable future. But maybe we’re starting to see signals of a change as we move into 2025 as interest rates drop and the capital markets start to open up again for smaller and earlier stage companies, as is starting to happen in other industries.”

There was a huge bubble of investment activity in and around COVID‑19 with private equity investors expecting to hold onto those businesses for four or five years, confirms Adam Sherlock, CEO at Qinecsa, an international pharmacovigilance technology and services solution provider. Now, those assets are set to come back to market, meaning there could be some investment momentum in 2025, he explains.

“There’s a huge amount of dry powder out there in terms of actual cash, not yet deployed and not yet put to work, building businesses, creating value, and enabling other deals,” Sherlock says.

Furthermore, governmental support and investment is key in helping the industry progress, comments Alexander Seyf, CEO, Autolomous, a company that uses smart technology to help advanced therapy medicinal product manufacturers. “Right now, I’ve seen a good trend in the US this year where they are beginning to realize that this is an industry to invest in,” he says. “In the [United Kingdom], we have seen Innovate UK making more funding available, and from the European Union perspective, we’ve seen a lot of activities to support the industry more than we did before.”

“We can expect to see increased R&D investments in Europe, too. Governments will incentivize R&D, particularly in green pharma manufacturing and advanced therapies,” concurs Bergsteiner.

Additionally, the geopolitical instability that has been experienced globally through various events, including COVID-19, the wars in Ukraine and Israel, and the political shifts happening across many countries, has demanded industry invest in the supply chain. “One of the real positives out of the period we’ve been through is it has led people to put a lot more thought, a lot more effort, and, frankly, a lot more capital behind their supply chains,” Stone states.

Supply chain considerations

“I think the driver of supply chain security, the real catalyst for what has become a big shift was, was COVID,” asserts Sherlock. “And I see that trend continuing.” Onshoring or near-shoring of manufacturing and supply chains is a priority for many in the industry at the moment, with investment happening along these lines to bring operations closer to a company’s headquarters versus in India or China, he adds.

“I think this really all started with ICH [International Council for Harmonisation] Q9, [which] spoke specifically about assessing the risks to the supply chain and to drug availability, essentially, and drug availability is the big thing we need to think about in terms of the geopolitical situations,” specifies Kate Coleman, vice president regulatory affairs, quality and compliance at Arriello, a life sciences consultancy. “Because even if we have countries that are under sanctions, at the end of the day, there are patients in those countries. And you do need people on the ground that are doing things like pharmacovigilance, and managing local regulatory requirements. So, it’s really a balancing act to make sure that we’re serving patients globally in all of these countries, but at the same time we’re respecting sanctions.”

According to Seyf, the biopharma industry is a nascent one where lots of innovation is forecasted to happen and so the geopolitical instability will spur on further innovation. “I believe we going to be more resilient towards [supply chain] disruptions, and we will equalize abnormalities in [the near future],” he asserts.

“Obviously, it’s been a challenging few years, but as we move into 2025, and beyond, hopefully we’re actually starting to see that while I think people will inevitably have to consider their supply chains differently to what they did, certainly in 2019, and before that, actually, what we’ve got is a more robust supply chain,” Stone concludes. “We had a long period of a very significant level of stability, and I think we’ve now recognized that as an exception rather than the norm.”

References

1. Bristol Myers Squibb. Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the US Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma. Press Release, May 15, 2024.
2. J&J. CARVYKTI is the First and Only BCMA-Targeted Treatment Approved by the US FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy. Press Release, April 6, 2024.

About the author

Felicity Thomas is associated editorial director of the PharmTech Group.

Article details

BioPharm International®
Vol. 38, No. 1
January/February 2025
Pages: 7–9

Citation

When referring to this article, please cite it as Thomas, F. Innovation Accelerates into the Future. BioPharm International 2025 38 (1).