Shifting Landscapes and Technologies: The State of Biotech (So Far) in 2025

Chancellor says he believes a disproportionate amount of attention has been focused on using AI to discover and tweak new molecules. “I think perhaps the biggest impact will be in the less sexy but more operational [aspects] — finding patients, designing a protocol, getting your clinical trials done more efficiently, higher success rates, lower costs. That’s going to have a dramatically bigger effect on moving new drugs through to patients than shaving a couple of months off your preclinical timelines to optimization.”

Competitive intelligence provides an edge

According to Riches, in the present pharma climate, “me-too” assets will not make it to market, and assets that are second or third to market in their therapeutic category will not do as well. “There’s a race to the market all the time,” she says.

Competitive intelligence is all about having that edge in the market, Riches says. “The great thing is we now have access to so much data, which really gives us much more visibility into that kind of competitive landscape.”

“It’s not a zero-sum game either,” Chancellor adds. “I think if each company is doing their landscape and their competitive intelligence correctly, then each company is creating a bigger pocket of space in which they can operate, in which they can differentiate from drugs that are on the market in terms of what’s coming through from the pipe. When done very well, when being cognizant of the competition, it allows the benefits of all stakeholders — the companies that are doing it, but certainly the patients if we bring more therapies through to market that are differentiated and have a meaningful impact.”

“The uniqueness that is required these days from new assets has never been greater,” Riches says. “And that’s great, because it really pushes the boundaries and advances medicine.”

The pressure on patient recruitment

Chancellor notes there are an estimated 24,000 drugs in active development globally, a nearly 150% increase since 2010. And close to 7,000 companies are involved in RNA development, a 250% jump.

“Much of this growth has actually come from outside the traditional hotspots,” he says. “China is now nearing us in terms of its ability to create new drugs at scale. Also in Asia, South Korea has overtaken the traditional world-leading long heritage of the UK and Switzerland. … All of this is creating a lot of competition for finding patients to enroll into clinical trials.”

Riches agrees that over the last 15 years patient recruitment has become even more challenging. “I think that, ultimately, the landscape is congested.”

Riches says she views the rise of players like China and South Korea as a good thing. “We’ve long known that countries like China have been early adopters of AI and use of data. So, we need to, as an industry, utilize what we have at our disposal to really make the landscape more favorable from a competitive intelligence perspective, but also to optimize things.”

Riches suggests some ways in which competitive intelligence like real-world data can be used is in making protocols more accessible for patients, “so patients, healthcare practitioners, and investigators aren’t so burdened when it comes to running trials.

“[Trials are] hard things to run. They’re complicated. So, utilizing methods of data collection like synthetic data, synthetic arms to remove placebo controls from trials, straight away, in a lot of trials, you’re reducing patient count by probably around 50% and maybe making it much more attractive for a patient to go on a trial, because they know they’re actually getting a drug, as opposed to … a placebo.”

Chancellor notes these changes are layered on existing dynamics that may not yet be fully digested by the market: European pharma reform, changes to Medicare Part D, and the negotiation of maximum fair drug prices in the US.

Riches did sound one note of caution. “If the FDA really does what it says it’s going to do and trim head count but become more efficient, then great. That is fantastic. But you’ve lost a lot of intelligence there, a lot of SMEs. And our industry is very SME-heavy, and it needs to be because we’re developing new medicines and putting them in patients, and we need to be 100% sure that that things will go well from a safety perspective.”

Riches says she believes factors such as tariffs will hit the large pharma side more than biotechs. “Not many biotechs take their drug to market themselves. [But] how that will bear out for large pharma in terms of what it costs them versus then what have they got to spend on things like M&A and partnerships with bringing new biotechs along that clinical development pathway, I think, is still to be seen.”

Riches notes that in the face of the US changes, a lot of countries are working to make themselves more attractive to companies looking to conduct clinical trials. “We’re seeing a lot of companies going into places like Australia, for example, to do their first-in-human trials … .”

Research and data are key

When it comes to prioritizing decision-making during these uncertain times, Riches advises biotechs to do their research. “Take your data, look at what it’s saying, find a thought partner who can help you with that competitive landscape, with what’s going on with various regulatory agencies.”

Since the FDA has expressed comfort with the use of real-world data and real-world evidence and synthetic arms, Riches says that’s an opportunity for biotechs to lean into those tools. “The opportunity is there, the framework is there, and it will save you time, it will save you money. And it will bring those assets either to market quicker or to the interest of large pharma, who are really scouring the landscape at the moment to restock their pipes with huge patent cliffs coming up.

“Anyone who's developing an innovative medicine in an innovative way is going to be a winner at the end of the day.”

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