2025 is nearly here—and it’s positioned to be a defining year for the life sciences industry.

As we move to the middle of the decade, the rate of rapid transformation continues to accelerate. This year ahead is anticipated to show great advancements across the life sciences, driven by advancements in technology, regulation, and collaboration. With the integration of artificial intelligence (AI) in therapeutic methods and diagnostic solutions, the evolution of technological delivery, and breakthroughs in both traditional and emerging therapeutic areas, the industry is redefining how we develop and deliver care to patients worldwide.

At Bracken, our consultants are at the forefront of these shifts, bringing deep expertise in scientific, regulatory, analytical, medical, and operational domains to deliver informed insights into what’s next. Drawing on these perspectives, we’ve outlined our predictions for 2025—highlighting key trends that will shape the industry’s trajectory, including evolving regulatory pathways, significant administrative changes, and accelerated progress in clinical trials and beyond.

The Path Ahead: Regulatory Affairs, Drug Development, & AI

It’s no surprise that the regulatory landscape in 2025 is predicted to have continuous, widespread evolution. This is in tandem with and alongside the swift development of artificial intelligence and big data. As 2024 demonstrated, AI has become increasingly critical to drug development, offering powerful tools for data analysis, trial optimization, and predictive modeling. In 2025, finding a balance between the innovation and regulation of artificial intelligence will remain a priority.

• AI Integration and Refinement: Continued advancements in AI tools will build and define more refined, efficient drug development processes. The industry's focus on better data analysis will improve outcomes, reduce costs, and streamline development timelines.
• Real-World Evidence (RWE): The role of RWE in regulatory decision-making will gain further momentum. In complementing traditional clinical trials, RWE will enable regulators to make more informed decisions, particularly for therapies or treatments aimed at serving underserved patient populations.
• Regulatory Dynamics: The FDA is expected to continue issuing guidance on emerging technologies, drugs, and therapies, but official regulatory resources may tighten. With the possibility of deregulation under a new administration, we could see faster pathways for drug and device approvals, including greater emphasis on initiatives like Right to Try and emergency use authorizations (EUAs).
• Global Standards & Stability: Global regulatory standards may face an increase in fragmentation as countries focus on domestic priorities, reducing the consistency and harmony of cross-border processes and related communications.

Radiopharmaceuticals: On the Rise, Again

In 2024, radiopharmaceuticals rose through the ranks as one of life science’s hottest topics. The radiopharmaceutical field continued to demonstrate significant progress across development, production, and market adoption. We predict that this momentum will only accelerate in 2025—as theranostics, emerging isotopes, and AI-powered tools continue to redefine possibilities in precision nuclear medicine.

Key Predictions for Radiopharmaceuticals:

• Theranostics: a Hot Topic: Theranostic approaches—combining diagnostics and therapeutics—will gain additional traction, providing patients access to previously unavailable treatment options, particularly for cancers resistant to traditional therapies.
• Emerging Isotopes: Beyond Lu-177 and Ac-225, new isotopes with improved half-lives, imaging clarity, and therapeutic indices will enter development, enhancing both safety and efficacy.
• Next-Generation Production Platforms: Compact cyclotrons and generator-based systems will shorten supply chains, making radiopharmaceuticals more accessible globally—dependent, of course, on the aforementioned security of regulatory pathways and international relations.
• Combination Therapies: Investigations into pairing radiopharmaceuticals with non-radiopharmaceutical drugs will expand, offering additional, synergistic benefits for patients.

Risks to Address:

• Workforce Shortages: Radiochemists, nuclear medicine physicians, and other specialists remain in limited supply. However, investments in this higher education and training—often spearheaded by industry and professional societies—will help bridge the gap.
• Clinical Trial Capacity: The limited number of specialized centers capable of running radiopharmaceutical trials could constrain progress. Increasing infrastructure and equipping community centers will be key to overcoming this challenge.
• Supply Chain Vulnerability: Geopolitical tensions and disruptions remain a continuing, ever-present risk for radiopharmaceutical production, where delays can ripple across multiple geographies. This is predicted to increase with a new administration and subsequent rollout—or rollback—of regulatory and public health guidance and laws.
• Cost and Reimbursement Pressures: Payers may push back against high therapy costs, requiring health economic research to articulate radiopharmaceutical value propositions effectively.

CNS & Neurology: Digital Technologies Take Center Stage

Central nervous system (CNS) research and neurology will remain a focal point of clinical development in 2025. Driven by the acceptance of digital endpoints and a growing appetite for new therapies and treatments, this space will see significant transformation in 2025 and beyond.

• Digital Health Evolution: The approval and adoption of digital technology endpoints in 2024 set the stage for broader use in 2025. Due to this advantageous, wide-scale change, non-centralized trials will become more common, leveraging wearables and remote monitoring devices for greater accessibility and efficiency.
• Neurodegeneration Advances: Treatments targeting neurodegenerative diseases will be at the forefront of development, reflecting the continued desire and urgent need for solutions across Alzheimer’s, Parkinson’s, and related conditions.
• AI in Radiology: Artificial intelligence will enhance existing and up-and-coming radiology workflows, offering better image analysis and diagnostics while reducing turnaround times.
• Psychiatry Innovations: Psychiatry will experience a renaissance, with biotech driving the development of novel new chemical entities (NCEs). After years of stagnation, this trend is likely to continue—and progress—in 2025.

Life Science Marketing: On the Up & Up

Life science marketing is data-driven—that's how the best results are tailored, produced, and delivered. Based on the trendline of the past year, technological advancements, shifting audience preferences, and increasing online and in-person visibility are priorities for the year ahead. As organizations look to differentiate and connect meaningfully with their audiences, several key trends stand out for 2025:

• Prominence of In-Person Events: Following virtual fatigue and sustained resurgence of in-person events during 2024, conferences and events will continue to be a vital component of marketing strategy. Companies should prioritize attending or sponsoring events that align with their strategic goals to maximize networking, visibility, and impact.
• Content Marketing & Thought Leadership: High-quality content remains vital for demonstrating expertise and building trust. Promoting thought leadership through articles, panels, and speaking engagements will continue to position companies as authoritative sources and industry frontrunners.
• Generative AI in Content Creation: Tools like ChatGPT are transforming content workflows by generating ideas and drafts, streamlining the creation process at the beginning so human resources can be saved for quality checks and thorough reviews for accuracy, tone, and clarity. Marketing automation powered by AI will also become an established industry tool, assisting with deeper audience segmentation, precise targeting, and streamlined operations, allowing teams to focus on strategy.
• Data Elevating SEO: SEO was an industry buzzword throughout 2024—this will continue in 2025. Leveraging intentional, personalized data analytics to continuously improve SEO, organic and paid search, increase click-through rates, convert users to leads, and reinforce authority will continue to be a crucial growth strategy.
• Social Media Humanizing Brands: Storytelling and employee-generated content foster engagement and showcase the real people driving innovation, creating stronger connections with audiences. In our digital world, and with the increase of AI tools, prioritizing this face-forward, authentic approach will see positive results. 

Innovation in Motion

Across the life sciences, broader themes like technological innovation, policy shifts, and market dynamics will shape the entire industry in 2025:

• AI: Still Everywhere: From drug discovery to clinical practice, AI will continue to become increasingly ubiquitous industry-wide, streamlining tasks in established practices and uncovering new therapeutic opportunities.
• Gene Therapy and Vaccines: Advances in delivery technologies for gene therapies and mRNA vaccines will expand their reach and potential in treating both rare and widespread diseases.
• Wearables and At-Home Diagnostics: Health monitoring devices and at-home treatment solutions will continue to grow, driven by patient demand for convenience and accessibility.

Policy & Administration Changes

A shift in the United States’ political administration is likely to bring notable impacts to the life sciences industry. Deregulation, reshoring initiatives, and public-private partnerships may provide growth opportunities, but significant challenges remain:

• FDA Deregulation: Policies promoting faster drug and device approvals could benefit innovation but raise concerns about long-term safety and efficacy.
• Domestic Manufacturing: Incentives for reshoring production will encourage U.S.-based manufacturing, though companies may face higher costs tied to labor and infrastructure.
• Talent Shortages: Stricter immigration policies could hinder access to international talent, pushing companies to invest in domestic STEM education and training.
• Vaccine Challenges: Vaccine hesitancy will continue to grow, leading to increased vulnerability to preventable diseases like measles, particularly in underserved regions.

Mergers & Acquisitions: Momentum Rebuilding?

Despite a challenging 2024, signs point to a resurgence in M&A in 2025. Big Pharma is actively pursuing assets, and investors remain optimistic—particularly in attractive, growing areas like CNS.

• Geopolitical Risks: While funding remains available for companies with strong value propositions and well-crafted strategic business plans as of late 2024, geopolitical uncertainty is expected to add complexity to global M&A activities in 2025.
• Investor Priorities: Investors are increasingly focused on efficiency, favoring lean operations with well-defined strategies and expert teams. Companies that demonstrate a commitment to utilizing their expertise and experience alongside a strong business plan will be well-positioned to secure funding.
  
  

Looking Ahead—What’s Next?

2025 is certainly on target to be full of transformations, development, and change—we’re starting to see it as 2024 wraps. The year ahead promises shake-ups and new opportunities alike. From AI-powered drug development to radiopharmaceutical breakthroughs and CNS innovation, the opportunities for the year ahead are both widespread and immense.

As we enter the new year, anticipating its challenges, uncertainties, and exciting opportunities, we at Bracken remain deeply committed to advancing work that will define the future of healthcare for generations to come—and equipping our clients with the expertise, strategy, and insights they need to thrive in 2025 and beyond.