Pharma stands at the threshold of 2025 with a blend of cautious optimism and strategic urgency. Scientific breakthroughs, regulatory shifts, and technological advancements continue to reshape the sector, forcing companies to adapt to new realities.
From cutting-edge drug delivery systems to AI-driven research models, the coming year will demand agility, innovation, and forward-thinking strategies. As geopolitical uncertainties and supply chain disruptions persist, companies are sharpening their focus on operational resilience, regulatory efficiency, and next-generation manufacturing solutions.
Emerging therapies such as antibody-drug conjugates, bispecific antibodies, and cell and gene therapies are pushing the boundaries of medicine, creating new challenges in development, scalability, and regulatory approval.
Meanwhile, advancements in 3D printing, modular manufacturing, and AI-driven pharmacovigilance signal a shift toward more efficient and precise drug production. The industry’s ability to integrate these innovations into existing workflows will determine how quickly groundbreaking treatments can reach patients.
Regulatory trends will also play a pivotal role in shaping 2025. Simultaneous global submissions, streamlined safety reporting, and evolving compliance frameworks will redefine how drugs move from discovery to market. Companies investing in digital transformation, automated quality assurance, and AI-assisted data processing will gain a competitive edge, reducing inefficiencies that have traditionally slowed regulatory approvals. At the same time, sustainability and ethical sourcing will remain top of mind as drugmakers navigate the intersection of innovation and responsibility.
To provide a comprehensive outlook on what’s ahead, we’ve gathered insights from leaders across the industry. Their predictions offer a glimpse into the trends, challenges, and opportunities that will shape biopharma in 2025. From manufacturing and supply chain strategies to scientific breakthroughs and regulatory evolution, these perspectives illustrate how companies are preparing for the next phase of pharmaceutical advancement.
Modular manufacturing for complex modalities
“The growing prominence of antibody-drug conjugates, bispecific antibodies, viral gene therapies, and other complex modalities in 2025 will amplify the need for innovation in development and manufacturing. By emphasizing product attributes rather than the process itself, modular manufacturing drives greater productivity, flexibility, and cost efficiency.
Modular units enable us to further optimize and adopt new technologies post-commercialization. As the adoption of modular manufacturing continues to expand, we are actively enabling this transformation, and we remain committed to innovative reagents and single-use technologies that will improve processes in the future.
Together, we can unlock the full potential of modular manufacturing for complex modalities to boost efficiency and improve product quality.”
— Benoit Gourdier, Executive Vice President, Bioscience Production, Avantor
The rise of cellulose-based capsules
“In 2025, advancements in manufacturing technology and polymer science are revolutionizing the capsule industry, driving the widespread adoption of cellulose-based capsules. These innovations address raw material concerns, enhance API release and stability, and offer formulators significant advantages.
As the limitations of gelatin become increasingly evident, scientists are leveraging modern technologies to optimize product development and adapt to shifting market demands. The adoption of cellulose capsules continues to grow significantly. While costs may pose challenges, the industry’s focus on rapid market entry and first-time-right development underscores the advantages of vegetarian alternatives, which provide superior properties and reliable performance.”
— Dr. Subhashis Chakraborty, General Manager, Head - Global Product Management, ACG Capsules, ACG
AI and the future of pharmacovigilance
“In 2025, pharmacovigilance will undergo a bold transformation as AI and machine learning move beyond buzzwords to become the backbone of proactive safety management, reshaping how the pharmaceutical industry engages with real-world data and patient outcomes.”
— Ana Pedro Jesuíno, Associate Director of Marketed Product Safety, IQVIA SRC team
Quality assurance and AI integration
“Although quality assurance (QA) and quality control (QC) business processes are connected, the legacy systems underpinning them are not. To address this challenge, leading companies are connecting QA, QC, and partners through a common technology. In 2025, this investment in digital quality will shorten testing time and accelerate time to market.
Quality organizations will unify their data and applications to significantly advance their reporting and analytics. This will deliver metrics to proactively manage risks and identify and address bottlenecks early. For example, having QA and QC data available at the batch decision point will result in faster batch release. Working from a single source of data will standardize collaboration with partners, eliminating manual work and the risk of data errors.”
— Ashley McMillan, Senior Director, Vault LIMS Strategy, Veeva
AI-driven drug discovery and the lab-in-a-loop model
“For AI to make a meaningful impact in life sciences, the drug discovery process must evolve into a Lab-in-a-Loop model. In this model, R&D and clinical data from various applications, databases, and lab equipment are ingested, centralized, and used to create predictive models for guiding the next set of experiments.
While traditional workflows are often viewed as linear, this approach requires flexibility to integrate new insights as they emerge from ongoing experiments.”
— Christian Olsen, Associate Vice President, Dotmatics
AI-powered drug discovery to improve clinical success
“In 2024, the biotech sector faced significant funding challenges, but VeriSIM Life has been at the forefront of demonstrating how a biology-first AI approach can derisk early-stage assets and increase the likelihood of clinical success.
Our platform’s ability to simulate complex biological systems and predict drug outcomes with high precision is not just an innovation—it’s a necessity for navigating the challenges of modern drug discovery. The next wave of biotech innovation will come from data-driven insights, and our hybrid AI approach is leading that charge.
As more pharma companies and investors look to data for making smarter, more predictive decisions, VeriSIM Life’s proprietary biological models and AI simulations will become indispensable tools for reducing development risk and unlocking new opportunities.”
— Dr. Jo Varshney, CEO and Founder, VeriSIM Life
3D printing’s role in drug delivery
“3D printing is poised to revolutionize oral solid drug delivery systems, bringing precision, personalization, and innovation to the forefront of pharmaceutical development. This technology meets the growing demand for customized therapies, enabling tailored doses, intricate geometries, and advanced drug-release profiles.
Notably, it facilitates the delivery of highly potent drugs, such as anti-cancer treatments, by balancing efficacy with minimized toxicity. By supporting controlled, delayed, and immediate drug-release mechanisms, this technology optimizes treatment regimens.
As regulatory bodies adapt to these advancements, 3D printing will reshape the future of oral solid delivery systems, offering more personalized, efficient, and patient-centric healthcare solutions.”
— Dr. Jnanadeva Bhat, Vice President, Head – Formulation R&D Pharma and Nutra, ACG
The future of cell therapies for solid tumors
“In 2024, we witnessed historic breakthroughs in cancer treatment with the FDA’s approval of the first cell therapies specifically for solid tumors. The approvals of Amtagvi for metastatic melanoma and Tecelra for metastatic synovial sarcoma mark a significant milestone in the development of personalized treatments for various types of solid tumors.
These advancements underscore the progress being made in cell therapies and highlight the urgent need for innovative strategies and strategic technology collaborations to tackle the complexities of targeting solid tumors.
Advanced licensing platforms and techniques are crucial to ensure robust production and scalability. The current funding landscape makes it unlikely that many cell therapy biotechs will have the capital to make investments on their own.
Leveraging manufacturing models that prioritize proximity to patients and incorporate advanced technologies is vital for the efficient development of cell therapies for solid tumors.”
— Jason Bock, Co-Founder and CEO, CTMC
Simultaneous submissions will speed approvals
“Once a practical reality, sequential submissions should now be seen as an outdated obstacle to getting medicines to patients faster. Regulatory veterans will remember the not-so-distant past when submissions were shipped to health authorities in trucks full of documents. Even with digitalization, the volume and complexity have persisted. Regulatory teams still take a largely sequential approach, seeking approval in core markets first and then moving to others over time. This process leaves patients in downstream markets — often smaller and underserved — waiting longer for new medicines.
New methods like active dossiers, which represent the outcomes of complex submission processes, will let teams use prior submissions faster and more easily. Submission processes that once took five years or more will take fewer as more companies and health authorities invest in closing the gap to simultaneous submissions.”
— Marc Gabriel, Vice President, Vault RIM
ADC manufacturing and supply chain challenges
“Antibody-drug conjugates (ADCs) will continue to be of great interest to biotech and pharmaceutical companies for targeted cancer therapies. However, the manufacturing processes for ADCs present several challenges. Since ADCs consist of an antibody, a cytotoxic payload, and a chemical linker, companies tend to rely on different vendors for each component, complicating the supply chain.
Biotech and pharmaceutical companies are overcoming these challenges by partnering with contract organizations that have specialized facilities for ADC manufacturing and the analytical capabilities necessary to support every stage of ADC development and manufacturing. These contract organizations also strive to be one-stop shops for ADCs, eliminating the need for collaboration among multiple vendors supplying each molecule component.”
— Songyoung Kim, Principal Scientist and Director of ADC Process Development, Samsung Biologics
Sustainability focus
“There are various ongoing trends in the pharma and CDMO sector that could be considered as ‘predictions for 2025,’ including obvious topics such as artificial intelligence and machine learning integration, advanced technologies, and further diversification of therapeutic modalities.
To add my personal perspective, I am expecting—and hoping—to see ‘sustainability’ become a major theme. Pharma companies must focus on reducing their environmental footprint, for example, completely decarbonizing their own operations as well as their full supply chain (scope 1 to 3). This will also be increasingly mandated by governments, consumers, and investors.
I believe that CDMOs will continue to play a vital role as (integrated) partners for pharma and biotechs, providing capacity and—at least as importantly—offering expert knowledge, flexibility, and speed to handle more diverse product requirements. This includes small batch sizes, quick scale-ups, fast turnaround times, and transfers, as well as the provision of specific solutions that might otherwise be unavailable or not delivered in the required timeframe.”
— Hanns-Christian Mahler, CEO, ten23 health
