Biotech has become one of the most important innovation drivers in the clinical development industry. In 2025 alone, these companies originated over 60% of new drugs and drove more than two-thirds of global clinical trial activity. The data is clear: biotech now accounts for most new drug originations and a significant share of development activity worldwide. For sponsors, growth is happening in a far more demanding operating environment than even a few years ago.

The conversation has shifted to success, no longer being defined by strong science alone. Even as funding levels have stabilized, expectations have increased. There is greater scrutiny on how programs are designed, how efficiently they progress and how clearly they demonstrate value.

Biotech companies are operating under real pressure. Capital is tighter. Regulatory pathways are more complex. Competition in key therapeutic areas continues to intensify. Sponsors are being asked to demonstrate differentiation earlier, generate stronger evidence and move faster while operating with leaner teams.

That is forcing a fundamental rethink of how clinical development programs are designed and delivered.

Flexibility is not optional

One of the biggest shifts in our industry is the move toward more flexible, adaptive development models. Traditional trial designs with fixed protocols and limited ability to adjust are increasingly difficult to sustain, particularly as studies become more complex and resource-intensive.

Sponsors are leaning into adaptive study designs, expanding decentralized and hybrid approaches to improve patient access and accelerate enrollment and being more deliberate about where and how trials are run. Taking this approach to clinical research helps to balance speed, cost and data quality across geographies.

This is not about innovation for its own sake. It is about making smarter decisions upfront and reducing avoidable inefficiencies later. When programs are designed with flexibility in mind, sponsors are better positioned to respond, whether that’s recruitment delays, evolving endpoints or shifting regulatory expectations. In today’s environment, that adaptability can protect both timelines and capital.

“In today’s development environment, flexibility is not nice-to-have, it is what helps sponsors protect timelines, preserve capital and respond with confidence.“

Getting smarter earlier in development

Another meaningful change is how sponsors approach evidence generation.

Historically, real-world evidence and commercialization planning came later in the lifecycle. That is no longer the case. Leading biotech companies are integrating these elements much earlier, recognizing the need to provide clear evidence of real-world impact and not just clinical efficacy.

This early investment pays off. It can reduce protocol amendments, support more patient-centric trial designs and make it easier to demonstrate value. It also creates a stronger connection between development and market access strategy, something that is becoming essential.

In a market where access decisions are more complex, that alignment is critical to long-term success.

A practical approach to AI

There is significant interest in how AI can support clinical development, and rightly so. It has clear potential across trial design, patient identification, enrollment planning and forecasting. Not every organization has the infrastructure to support large-scale transformation (and that’s okay), it’s important for sponsors to focus on the practical application.

“The most effective approach is targeted: applying AI where it can reduce timelines, improve decision-making or control costs. Used this way, it becomes an enabler of better execution and not a distraction.“

Rethinking the path to value

Beyond development, we are also seeing a shift in how emerging biopharma companies position themselves for growth. While funding levels have remained relatively stable, access to capital is more selective and more competitive.

Companies are moving beyond a single-asset mindset and thinking more intentionally about platform value and how their science and capabilities can support multiple programs over time. This reflects evolving investor expectations, with greater emphasis on differentiation, scalability and sustainable value creation.

At the same time, commercialization expectations are rising. Payers and providers want clearer evidence of real-world impact, and biotech companies are being challenged to articulate a more complete value story earlier in the process.

The sponsors who succeed are the ones who plan early by engaging stakeholders, building the right evidence and aligning development decisions with long-term market access.

What it takes to succeed now

The margin for error has narrowed. Biopharma is leading the industry forward, and the scale of that impact continues to grow. But the environment demands greater discipline across every stage of development. Sponsors need to think globally from the start, design trials that can adapt, invest in evidence early and be intentional in how they apply new technologies.

Just as importantly, they need the right partners and organizations that bring not only executional expertise, but also the ability to anticipate challenges and guide strategy.

“The opportunity ahead is significant. But realizing it requires more than innovation. It requires clarity, flexibility and a relentless focus on execution.“

Read more of our thoughts in the Insight Brief The Evolving Landscape of Emerging Biopharma: Modern Trends and Flexible Trial Designs.

Learn how IQVIA Biotech can support your clinical development journey from strategy through execution.