
Five Key Trends Shaping Biopharma and Biotech in 2025
Experts share insights and trends to watch in 2025 from our recent R&D trends survey.

As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities.
However, amid this progress, the complexities of drug development have never been more apparent. In 2024, the U.S. Food and Drug Administration (FDA) approved 38 new molecular entities for therapeutic use, a decline from 47 in the previous year. This decrease brings into sharp focus the growing challenges facing the field: Clinical trials now demand greater complexity, as well as increased data and diversity requirements. And as a result, biopharma sponsors are facing extended timelines and increased costs. These pressures are prompting companies to reevaluate their portfolios, focusing on investments that promise the greatest impact.
To better understand current challenges and their impact, the PPD™ clinical research business of Thermo Fisher Scientific surveyed global drug developers on the current state of the industry. The data revealed five key trends poised to shape biopharma and biotech in 2025. By adapting your strategies to address these challenges and embracing the insights shared here, you can successfully navigate industry challenges and position your organization for long-term success.
Trend 1: Scenario modeling will allow companies to evaluate entire trial timelines, revealing potential bottlenecks that help them achieve optimal outcomes.
As clinical trials grow increasingly complex, predicting timelines, managing costs and ensuring success have become formidable challenges for biopharma companies. The introduction of new regulatory requirements, diversity mandates and intricate data demands have further intensified the need for optimized trial designs and execution strategies. In this environment, scenario modeling is emerging as a transformative solution, enabling companies to navigate these complexities with precision.
Scenario modeling leverages artificial intelligence (AI) and predictive analytics to simulate trial outcomes under various conditions, empowering drug developers to explore “what-if” scenarios and identify optimal strategies. According to our survey, 66% of large sponsors and 44% of small and mid-sized sponsors cite AI as the top technology they are pursuing, underscoring the growing adoption of this innovative approach. This shift is timely: nearly half (45%) of both large and small/mid-size sponsors report extended clinical development timelines, with delays ranging from one month to more than 24 months, making efficiency a critical focus for the industry.
Simulating trial timelines and resource allocation
Through scenario modeling, sponsors can test different trial approaches to find the best balance between timeline length, resource use and cost efficiency. For example, by predicting periods of high activity — such as peak data collection phases — teams can proactively adjust staffing, monitoring and support, ensuring resources are available precisely when needed. This optimization reduces waste and accelerates time-to-market, allowing savings to be reinvested into additional trials or extended studies.
This focus on efficiency is especially vital as trial costs continue to rise. In our latest industry survey, half (49%) of all drug developers identified rising costs as the top challenge in 2024. The second top challenge was patient recruitment, reported at 39%, making it overwhelmingly clear that the rising cost of clinical trials is the prominent challenge for sponsors.
Refining trial protocols for better outcomes
Scenario modeling also refines protocol design by simulating various structures, eligibility criteria and endpoints. Sponsors can predict how each protocol impacts trial duration, costs and patient compliance, enabling data-driven adjustments to maximize outcomes. These insights are fueling innovation: Over half of surveyed sponsors across all company sizes highlighted innovative trial designs as the top trend transforming the industry and the top innovative strategy they’re currently pursuing.
This predictive approach improves trial success rates while supporting patient-centric designs. By revealing how protocol requirements influence retention and engagement, teams can make informed decisions to reduce dropout rates and improve the overall participant experience. Additionally, scenario modeling helps sponsors meet regulatory standards with greater confidence, minimizing the need for costly resubmissions or supplementary studies.
As the next trend reveals, these advancements are also deeply connected to the rise of precision medicine, where AI-driven insights continue to play a pivotal role.
Trend 2: Precision medicine and personalized therapies will increasingly leverage AI to deliver highly individualized treatments, especially in complex diseases.
The rise of precision medicine marks a transformative shift in biopharma, enabling highly tailored treatments that consider each patient’s unique biology. Advances in genetic profiling, biomarker research and immunotherapy are fueling this revolution, with over half (51%) of industry respondents identifying personalized medicine as a top opportunity. This approach is particularly promising in areas like oncology, immunology and rare diseases, where traditional therapies often fall short due to the diversity of disease subtypes.
By integrating AI into precision medicine, sponsors are advancing their strategic focus on maximizing asset value. Both large and small/mid-sized organizations are prioritizing this innovative field to deliver treatments that are both highly effective and economically viable.
Expanded applications across complex diseases
Precision medicine is expanding its reach across complex therapeutic areas, delivering breakthroughs in conditions that have long challenged traditional approaches. In oncology, for example, AI enables treatments to be customized to the genetic profile of individual tumors, increasing success rates while minimizing side effects. Similarly, immunology and neurology are benefiting from molecular profiling techniques that tailor therapies to individual patient needs, addressing chronic, complex and treatment-resistant conditions with greater precision.
These advancements underscore the adaptability of personalized therapies to a wide range of diseases, offering solutions that are as unique as the patients themselves. This adaptability improves outcomes and reduces inefficiencies, making precision medicine a cornerstone of biopharma’s future strategy.
Reducing risk with AI-driven monitoring
The application of AI in precision medicine extends beyond treatment design to enhance clinical monitoring and patient safety. AI-driven tracking and monitoring ensures meticulous oversight throughout the therapeutic process, enabling immediate adjustments that maintain efficacy while minimizing risks. This is especially critical in managing complex therapies, where precision and safety are paramount.
Given the demanding nature of precision medicine monitoring, 63% of respondents anticipate outsourcing these activities. By leveraging AI and outsourcing partnerships, sponsors can focus on innovation while maintaining robust safety protocols.
Precision medicine, supported by AI, is poised to redefine treatment paradigms in biopharma, offering tailored solutions that align with the industry’s pursuit of maximizing impact and value. These advancements also lay the groundwork for future innovations, where technologies like scenario modeling and AI integration continue to shape a more patient-focused and efficient clinical trial experience.
Trend 3: Drug developers should prioritize long-term studies on precision treatments to ensure safety and efficacy for chronic conditions requiring lifelong management.
As biopharma companies push the boundaries of precision medicine, the focus is shifting to long-term studies that ensure the safety and efficacy of treatments for chronic conditions requiring lifelong management. The growing complexity of clinical trials — driven by the need to capture more data and insights — underscores this trend. In fact, 30% of sponsors cite data capture as a key factor increasing trial complexity, with many turning to real-world data (RWD) and real-world evidence (RWE) to complement clinical insights.
Sponsors are also leveraging data and technology for patient recruitment, with 45% of large sponsors and over a third of small/mid-size sponsors planning to use advanced tools to identify target populations. By integrating these strategies, biopharma companies are creating a foundation for robust, patient-centric trials that address the long-term needs of diverse populations.
Exploring long-term safety and efficacy studies
A prime example of this shift is the ongoing research into GLP-1 receptor agonists. Initially developed for Type 2 diabetes, the pipeline for GLP-1 drugs is expanding, with clinical trials exploring applications for cardiovascular disease, diabetic kidney disease (DKD), diabetic retinopathy, obesity and Type 1 diabetes. This growing market is projected to reach tens of billions of dollars by 2030, prompting sponsors to collaborate with experienced contract research organizations (CROs) to accelerate development. As their use expands, understanding their long-term effects on vital systems such as the liver, kidneys and cardiovascular health becomes essential.
To meet this need, 55% of large sponsors and 43% of small/mid-size sponsors are prioritizing investments in big data and analytical capabilities. These efforts aim to ensure that GLP-1 therapies and other long-term treatments remain safe and effective as they are prescribed to more diverse patient populations.
Driving market growth and personalized approaches
The ongoing expansion of GLP-1 applications highlights the industry’s commitment to personalized medicine. By tailoring these therapies to specific patient needs and addressing long-term safety, sponsors are setting the stage for market growth and innovation. As chronic conditions increasingly dominate health care priorities, these efforts will be instrumental in delivering effective, sustainable solutions.
The success of these long-term strategies will rely on collaboration, advanced analytics and a focus on patient accessibility — building a future where chronic conditions are managed with precision and confidence.
Trend 4: Sponsors are prioritizing high-ROI areas, with reprioritization of lower-impact fields to streamline resources and accelerate key developments.
Economic pressures and rising development costs are prompting drug developers to focus on therapeutic areas with the highest return on investment (ROI). Faced with increasing complexity and competition, many organizations are strategically streamlining resources to focus on high-impact fields. With 64% of respondents prioritizing oncology, 41% emphasizing immunology/rheumatology and 31% focusing on rare diseases, these areas are emerging as key drivers of innovation and investment.
For small and mid-size sponsors, limited funding compounds the challenge, with 35% citing financial constraints as a significant hurdle. Across the board, more than one-third of both large and small/mid-size sponsors highlight maximizing asset value as a critical challenge, underscoring the growing need for targeted strategies that ensure efficient resource allocation. By homing in on high-ROI areas and deprioritizing less impactful projects, companies are paving the way for faster, more cost-effective drug development.
Increased investment in high-demand therapeutic areas
To maximize impact, drug developers are channeling resources into therapeutic areas with substantial patient populations and chronic disease management needs. Oncology, cardiovascular diseases, immunology and metabolic disorders stand out due to their potential for targeted therapies and personalized medicine.
This focused approach aligns with clinical priorities and addresses the challenge of prolonged development timelines. By concentrating resources on fewer, high-impact projects, companies can streamline processes and timelines, reduce delays and deliver innovative treatments to patients more efficiently.
Deprioritizing less profitable or high-risk areas
In parallel, therapeutic areas with lower demand, limited market potential or elevated development risks are being deprioritized. For example, some companies are scaling back investments in smaller patient populations or crowded markets unless those projects align with their core strengths.
This recalibration supports the industry-wide emphasis on personalized medicine, with 51% of both large and small/mid-size sponsors viewing it as a top transformational trend. By focusing efforts on areas that align with long-term strategies and market opportunities, companies can reduce financial risk and redirect resources toward advancements with the greatest impact.
The reprioritization of resources is not just about improving financial outcomes — it’s also about addressing unmet patient needs more effectively. By investing in therapeutic areas with high patient demand and significant innovation potential, biopharma companies are accelerating the development of life-changing treatments. This targeted approach enhances efficiency, reduces time-to-market and ensures that critical therapies reach patients in need more quickly.
As the industry continues to adapt to economic challenges and evolving market dynamics, this focus on high-ROI areas will be instrumental in driving sustainable growth and innovation. By concentrating resources where they matter most, companies are setting the stage for a future of impactful, patient-centered drug development.
Trend 5: Biopharma is expanding trials to emerging markets and benefiting from greater compliance and streamlined approvals.
Biopharma companies are increasingly looking to emerging markets as key regions for clinical trials, driven by evolving regulatory standards and the promise of faster, more efficient trial processes. Countries like China have implemented significant reforms to simplify trial applications, accelerate approvals and encourage partnerships with international sponsors, making them highly attractive locations for global clinical research. This trend reflects a broader shift toward globalization in clinical trials, with companies aiming to address recruitment challenges, enhance compliance and extend access to life-saving therapies in underserved regions.
Survey data reinforces this direction, with over 90% of respondents anticipating the use of decentralized clinical trials (DCTs) within the next two years. Coupled with top strategies such as building relationships with patient advocacy groups and expanding research sites across more countries, this globalization effort is not only tackling logistical challenges but also creating a more inclusive clinical research environment.
Regulatory reforms drive global accessibility
Emerging regions are actively positioning themselves as attractive trial sites by updating their regulatory standards. China’s reforms have simplified the application process, allowing for quicker trial initiation and stronger partnerships with international sponsors. Likewise, African and Middle Eastern countries are incrementally introducing pathways to streamline approvals. These changes enable biopharma companies to navigate complex requirements more efficiently, accelerating access to diverse patient populations and addressing the regulatory hurdles that often delay trial progress.
Enhancing diversity in clinical research
Conducting trials in emerging markets allows sponsors to recruit patients from diverse genetic, environmental and lifestyle backgrounds, which enriches the data collected and ensures therapies are effective across varied populations. Regulatory bodies like the FDA and European Medicines Agency (EMA) are increasingly emphasizing the importance of this diversity, requiring companies to demonstrate efficacy and safety for broad demographic groups. By expanding trials globally, sponsors can meet these diversity guidelines while creating datasets that more accurately reflect real-world use, ultimately improving the validity and applicability of their findings.
Faster access to treatments for underserved regions
For patients in emerging markets, clinical trials often provide access to potentially life-saving therapies, particularly in regions where health care infrastructure is limited or certain diseases are more prevalent. Trials targeting infectious diseases or region-specific genetic conditions, for instance, can directly address the needs of these communities. At the same time, faster regulatory approvals in these markets enable companies to distribute treatments more rapidly on a global scale, aligning their commercial goals with patient care priorities. This is especially valuable as 45% of sponsors report that their clinical development timelines have grown longer compared to two years ago.
Embracing innovation and partnership in drug development
The biopharma and biotech markets are undergoing a transformative shift. Strategic investments in high-impact therapeutic areas, the integration of AI into clinical processes and the expansion of trials into emerging markets are reshaping drug development. These advancements are empowering sponsors to optimize their resources, overcome logistical and regulatory hurdles, and deliver innovative treatments more effectively to patients worldwide.
Global CROs are essential allies for sponsors aiming to navigate these trends. With their specialized expertise, access to diverse patient populations and ability to provide strategic insights, CROs streamline clinical research processes, mitigate risks and ensure greater predictability in outcomes. Importantly, the best CROs transcend the role of a traditional service provider; they become true partners — fully committed to their sponsor’s success, delivering quality-driven solutions that accelerate progress.
As the industry continues to evolve, sponsors must seize the opportunity to align with these trends. By forming strategic partnerships with CROs, they can navigate the growing intricacies of today’s drug development landscape and stay competitive, positioning themselves for success in 2025 and beyond.
Now is the time to embrace innovation and collaboration to drive impactful change in global health care.
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