As we look ahead to 2025, there’s no doubt that we’re at a transformative moment in the life sciences industry. The pace of change is accelerating, driven by groundbreaking advancements in technology, shifts in investment strategies, and a rapidly evolving regulatory landscape. At Kivo, we’re closely monitoring these dynamics, and we’d like to share some thoughts on how we see the market shaping the future of R&D operations — and how we’re committed to helping our customers and partners navigate these shifts.
Without further ado, here are the five top trends we're seeing in drug development for 2025:
1) AI-Fueled Drug Discovery
One of the most exciting developments is the role that artificial intelligence is playing in drug discovery. From optimizing drug candidates to identifying biomarkers, AI is helping to dramatically shorten the timeline from preclinical research to clinical trials. While this innovation is a game-changer for speeding up the discovery process, it also brings a new set of challenges — especially in regulatory affairs.
The number of clinical trials has risen steadily over the past decade (see figure 1, source: clinicaltrials.gov).
With the rise of AI-driven discovery, this growth rate is going to accelerate - fast. Over $60B has already been invested in AI drug discovery. As early-stage candidates grow, so too will clinical trial applications. Some estimates expect a 10x increase in the number of active trials over the next few years.
Number of AI-discovered molecules in Clinical Trials:
As the volume of trials rises, regulatory teams will need to keep pace, not only with the quantity of submissions but also with the complexity of the data being generated. This rapid growth demands the flexibility and agility that modern regulatory operations can provide, with the right tools.
2) Accelerating VC / Funding Timelines
At the same time, the venture capital environment is evolving. After a brief hiatus following the interest rate hikes in 2021, investment is on the rise again — especially in high-growth sectors of life sciences. However, this resurgence comes with its own set of expectations: VC backers are increasingly focused on quicker exits and business success.
This drive for speed is particularly evident in the regulatory space. With growing pressure from investors to accelerate product development and market entry, regulatory teams are facing higher expectations for faster submissions, approvals, and ultimately, quicker commercialization. This faster pace presents an opportunity for regulatory professionals to streamline their processes, reduce bottlenecks, and leverage new technologies to stay ahead of the curve.
3) Increased Decentralization & Outsourcing
Another major shift we’re seeing is the growing decentralization of regulatory operations. More and more, we’re witnessing small, agile teams work alongside a network of expert partners to navigate complex submission processes. This shift is being fueled by both the need for speed and the desire to scale with limited resources.
For small and emerging biotech companies, this means partnering with external resources like CROs, medical writers, and publishing experts. The challenge lies in managing these relationships effectively and ensuring seamless communication across teams that are often distributed globally. The rise of cloud-based tools, document management systems, and collaborative project management platforms is helping to address these challenges by providing transparency and visibility into the entire submission lifecycle.
At Kivo, we’ve designed our solutions to empower teams — no matter their size — to work efficiently with their partners while maintaining full control over the submission process. We’re seeing more and more customers rely on Kivo to bring together their internal teams and external partners, streamline workflows, and track progress in real-time. The goal is to ensure that every submission is managed as a project with clear milestones, dependencies, and accountability, which ultimately results in timely, high-quality submissions to regulatory agencies.
4) Asset-Centric Business Models
In addition to the market dynamics we've discussed, there's an evolving trend in the life sciences industry toward asset-centric business models. Nimble pharma companies are prioritizing the creation of a strong pipeline of drug candidates rather than focusing on building a full-fledged, vertically integrated organization to bring a single drug to market. This shift is largely driven by the growing preference for strategic partnerships, acquisitions, and divestitures.
Rather than investing in lengthy and capital-intensive commercialization efforts, these companies are building portfolios of promising assets with the intent to sell or partner them out. They may focus on drug discovery, preclinical development, and early-phase clinical trials, with the ultimate goal of attracting larger pharma companies or investors who are better equipped to handle commercialization. This model offers significant advantages, including reduced risk, quicker exits, and more efficient capital allocation.
For regulatory teams, this asset-centric model introduces unique challenges. The need for regulatory readiness and compliance across multiple programs, often with varying stages of development and regulatory requirements, demands greater flexibility, transparency, and coordination. Small teams must be able to scale rapidly, track multiple projects, and ensure that their regulatory strategy aligns with both development timelines and strategic business objectives.
At Kivo, we see this model as a natural evolution in the industry and work closely with our customers to ensure that our platform is optimized for managing multiple regulatory submissions, tracking diverse pipelines, and adapting to shifting business priorities. Whether you are building your own pipeline of assets or collaborating with external partners, Kivo helps you maintain regulatory visibility and control throughout the lifecycle of each asset.
5) Uncertainty in the Political Landscape
As we approach 2025, there is also the uncertainty of the political landscape to consider. Regulatory frameworks in life sciences can be subject to significant changes depending on the shifting priorities of government agencies, legislative bodies, and global regulators. While it’s impossible to predict every change, there’s a growing sense that drug development and regulatory policy could face increased scrutiny or even reform depending on the outcome of elections and evolving political agendas.
This potential for regulatory upheaval means that teams must remain agile and prepared for potential shifts in regulatory requirements, timelines, and approval processes. Companies will need to stay ahead of any changes and be ready to adapt quickly to new regulatory realities. The regulatory environment in 2025 and beyond will likely require even more proactive engagement with regulatory bodies, more robust compliance systems, and a heightened awareness of geopolitical influences.
At Kivo, we are closely monitoring the global regulatory landscape and will ensure that our platform reflects and supports any changes in regulations or compliance requirements. Our team is committed to helping you stay compliant and agile, no matter what shifts may arise.
