As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re tracking—drawn from what we’re seeing in the market and what analysts and leaders across the life sciences ecosystem are anticipating.
1. AI Is Moving from Experiment to Infrastructure
Artificial intelligence has long held promise in biotech—but in 2025, it’s becoming foundational. We’re seeing AI and machine learning used to accelerate early-stage drug discovery, optimize clinical trial design, identify new therapeutic targets, and simulate outcomes with a speed and precision that would have been impossible just a few years ago. Platforms like Insilico and AlphaFold are already demonstrating what AI-first biotech looks like in practice. As the technology matures, companies that integrate AI early into their R&D and regulatory workflows may be better positioned to compete.
2. RNA Therapeutics Are Rapidly Expanding
The success of mRNA vaccines broadened the horizon—but RNA-based therapies are now being explored far beyond infectious disease. In conjunction with the development of delivery technologies, antisense oligonucleotides, siRNAs, and mRNAs are being investigated for rare diseases, cancer, and autoimmune disorders, offering therapeutic possibilities for targets that traditional small molecules can’t reach.
We're watching how regulatory agencies and IP landscapes evolve to support this new modality.
3. Intellectual Property Disputes Intensify
The biotech sector is seeing more IP disputes where biotech companies litigate against other innovators—particularly for foundational technologies like CRISPR and mRNA. At the same time, high-volume patent monetization entities, which have long targeted the information technology and software sectors, are increasingly turning their focus to biotech.
Companies should refresh their enforcement and defense playbooks and review their IP agreements to be prepared for this evolving litigation landscape.
4. Clinical Trials Are Becoming Smarter and More Patient-Centric
AI and advanced analytics are transforming how clinical trials are run, from protocol design to patient recruitment and real-time monitoring. Sponsors are increasingly using decentralized models and wearable tech to reduce trial burden, improve data quality, and detect safety signals earlier.
This shift isn’t just technological. It’s also cultural, requiring companies to rethink trial logistics, ethics, and infrastructure.
5. Cell and Gene Therapies Are Entering a New Phase of Scalability
Once viewed as moonshot treatments, cell and gene therapies are gaining traction with more streamlined manufacturing processes, clearer regulatory pathways, and broader clinical applications. Still, questions around cost, access, and reimbursement remain.
We’re tracking how industry players are addressing scalability—scientifically, operationally, and commercially.
6. Data Is the New Competitive Edge
Across the industry, companies are turning to integrated data platforms to inform decisions across R&D, commercial, and clinical operations. Whether it’s real-world evidence, biomarker insights, or patient population analytics, access to meaningful, well-structured data is becoming as valuable as IP.
For legal teams, this raises important considerations around data ownership, privacy, and compliance across jurisdictions.
7. Sustainability Is Now a Strategic Priority
Biotech’s role in addressing environmental challenges is expanding—through greener manufacturing, biologically derived materials, and sustainable agriculture. Increasingly, investors and strategic partners are asking about ESG metrics alongside clinical milestones.
We anticipate that sustainability may soon become a due diligence priority, not just a PR message.
8. Synthetic Biology Is Powering the Next Generation of Therapeutics and Materials
Synthetic biology continues to push the boundaries of what’s possible—not only in drug development but also in agriculture, biomaterials, and sustainable manufacturing. Companies are engineering living systems to produce novel compounds, enhance vaccine delivery, and create sustainable alternatives to petrochemical products.
This field is evolving rapidly, and regulatory frameworks will need to keep pace with innovation.
Looking Ahead
Whether you're an early-stage company preparing for your first Investigational New Drug application or a public biotech planning your next strategic partnership, these shifts will impact how you operate, grow, and compete.
As BIO 2025 convenes global leaders in Boston, Fenwick’s life sciences and technology teams are watching these developments closely—and helping companies navigate them every day. We look forward to the conversations to come.