Biopharmaceuticals make up a significant portion of the pharmaceutical market, and as of 2024, the biopharma market size was estimated to be over US$400 billion with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. Even more substantial is the growth being observed in the biotechnology sector; in 2020, the market size for biotech was nearly US$500 billion and had an estimated CAGR of 9.4% between 2021 and 2027. These industries are developing rapidly largely due to advancements in technological capabilities, evolving regulatory frameworks, and a shift towards patient-centered care in clinical trials.

Although such fast-paced change undoubtedly comes with some challenges, the dynamic landscapes of the biopharma and biotech industries also present exciting opportunities for clinical trial sponsors, pharmaceutical firms, contract research organizations (CROs), and biotech startups. In this article, we will explore five key predictions for the biopharma and biotech sectors in 2025, examining how emerging trends and innovations are expected to shape the future of medicine. These predictions provide a glimpse into a future with healthcare that is increasingly personalized, efficient, and accessible for all.

Read on to discover our top five predictions for the 2025 biopharma and biotech industries!

 

1. Accelerated Clinical Trial Designs Reshape Drug Development

As our understanding of human diseases grows, clinical trials in therapeutic areas such as oncology, neuroscience, rare disease, and several others have become increasingly complex. To promote more efficient timelines and avoid exposing too many patients to ineffective therapies, we can expect to see traditional clinical trials shift toward more innovative study designs in 2025.

According to the United States (U.S.) Food and Drug Administration (FDA), adaptive clinical trials allow for planned modifications based on interim data analysis, enabling researchers to optimize study protocols in real-time. The adaptive design is increasingly being explored as a more efficient alternative to traditional trial models because they can reduce the time and cost associated with bringing new therapies to market, but also increase the likelihood of predicting the efficacy of an experimental drug early in the pipeline. For example, if at interim analysis the primary endpoint (e.g., overall survival) is lower than expected, the trial can be terminated early on. Conversely, if the data is more positive than expected, the sample size can be increased knowing patients are likely to benefit from the experimental drug.

We will likely also see a greater emphasis on using synthetic control arms (SCA), which are derived from historical real-world evidence (RWE) using advanced statistical methods. Implementing an SCA eliminates the need for enrolling placebo groups in certain clinical trials, which can improve retention rates because patients are guaranteed to receive the experimental therapy. With this approach, researchers can increase their trial’s generalizability with more diverse populations being represented in the data.

Further, more sponsors and CROs are embracing decentralized clinical trials, or trials with decentralized components, by leveraging advanced digital health technologies to enable remote patient monitoring and data collection processes. Benefits of DCTs include greater cost-effectiveness, improved trial accessibility to underserved populations, greater convenience for participants, and more efficient resource allocation.

 

2. Regulatory Landscape Evolves to Keep Pace with Innovation

With the expected shifts toward more innovative trial designs, rather than traditional study models, the regulatory landscape in the biopharma and biotech industries can be expected to undergo similar change in 2025. Agencies like the U.S. FDA and the European Medicines Agency (EMA) are striving to keep pace with rapid technological advances driving increasing complexity within clinical trials, as well as evolving healthcare needs worldwide. Most recently, in September 2024, the FDA released their final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested Parties” (CTDE guidance). This builds on prior drafts to highlight the agency’s continued support of well-designed DCTs, but also provides valuable insights into unique challenges they may present. Read more about the latest FDA guidance document on DCTs here.

Regulatory agencies are also changing to eliminate inefficiencies in the drug review process. Notably, January 31, 2025 marks the end of the three-year transition period granted to sponsors with ongoing clinical trials since the Clinical Trial Regulation (CTR) No 536/2014 became applicable in the European Union (EU) in January 2022. The purpose of passing the CTR was to enable better efficiency in the regulatory process for new trials because sponsors can apply for clinical trial authorization in up to 30 European countries with only a single application. As we quickly approach this deadline, sponsors and CROs operating in the EU will need to transition fully to the use of the Clinical Trials Information System (CTIS) regulatory platform. To learn more, visit our article on the Evolving Landscape of EU Clinical Trials Post-Regulation.

 

3. Precision Medicine Takes Center Stage in Medical Innovation

Precision medicine is already taking center stage in several therapeutic areas, particularly oncology and rare diseases, but we can expect it to grow further into a cornerstone of medicine in 2025. Also known as personalized medicine, this approach tailors disease prevention, diagnosis, and treatment strategies to individual patients based on their unique genetic, lifestyle, and environmental factors. As we approach the new year, we may see significant changes in the clinical applications of precision medicine in the biopharma and biotech industries. For example, as genetic testing becomes routine practice in healthcare, the genetic causes of common disorders can be identified, resulting in a surge of novel targeted therapies entering clinical trials.

Earlier this year in April, the National Human Genome Research Institute (NHGRI) convened to discuss strategies for large-scale utilization of genomic sequence data in delivery of genomic healthcare. As we enter 2025, electronic health records (EHR) will make strides in becoming genome-aware and make pharmacogenomics more accessible. We may also see such data be moved more easily between the EHR and other secure databases such as patient-facing health apps or clinical trial recruitment platforms. In fact, this 2024 published Nature article introduced an open-source Python framework using deep learning models for end-to-end analysis of EHR data.

Such database frameworks assisted by machine learning (ML) algorithms, sponsors, CROs, and investigators can perform end-to-end analysis of genomic data in EHRs to create well-defined patient subgroups in clinical trials. Precision medicine strategies can also match patients to effective therapies more accurately using genetic data.

 

4. Patient-Centric Approaches and Sustainability Drive Industry Transformation

We are already seeing a significant shift towards more patient-centric approaches and sustainable practices in clinical trials, but they will likely become more widespread in 2025. Sponsors and CROs will place an increasingly greater emphasis on patient perspectives and experiences throughout the drug development processes. We can expect to see more clinical trials adopting digital health technologies, such as wearables and mobile health (mHealth), to enable remote patient monitoring and continuous data collection. As these devices are widely implemented, study protocols can include fewer visits requiring patients to come on-site. Digital health technologies, especially when combined with DCTs, offer participants more convenient trial experiences, while expanding the study’s reach to geographically isolated patient populations.

Learn more about digitally-enabled, patient-centric clinical trial design in this publication here.

Interested in how patient-centric approaches can enhance pediatric rare disease studies? Watch our webinar here!

Sustainability will also become a greater focus for the biopharma and biotech industries, with more companies implementing eco-friendly principles in drug manufacturing, reducing waste, and minimizing their overall carbon footprint. Recently, TFS released an article discussing key strategies being adopted by CROs and sponsors to make clinical trials more sustainable. These approaches involved running more virtual or DCTs, streamlining data management with digital data capture over paper-based traditional methods, and reducing clinical trial waste by optimizing drug supply chain management and transportation of materials to clinical research sites.

Read the full article here.

Discover how TFS HealthScience CRO is making significant strides in environmental stewardship, social responsibility, and sustainable business practices in our 2023 Sustainability Report.

 

5. Artificial Intelligence Revolutionizes Drug Discovery and Development

Artificial intelligence (AI) and ML frameworks are already presenting novel opportunities for change in medicine and clinical research, and it will only continue to expand its impact on these fields in 2025. From optimizing drug screening methods to streamlining clinical trials, AI/ML technologies offer greater speed and accuracy in their ability to process and analyze large volumes of data. Based on the growing success of these algorithms in the biopharma and biotech industries, the market size of AI in healthcare is forecasted to skyrocket from a value of US$13.6 billion in 2022 to US$164.1 billion by 2029.

As described in this 2024 review, AI/ML models have shown promise across each stage of the drug development process. During preclinical drug screening and optimization, AI was used to analyze molecular images of the effects of drugs on a cell, using deep generative modeling to design virtual novel candidate molecules. In drug target discovery, ML algorithms mined existing genomic, chemical, and clinical databases to find previously unknown connections for novel molecular targeting. Finally, AI/ML was applied to conduct clinical outcome analysis using pattern-recognition approaches that identified correlations between immune responses and patient survival. Although the review found these applications were focused primarily on anticancer and neurological therapies, in 2025, we can expect to see more therapeutic areas benefit from AI/ML analytics.

Conclusion

In 2025, the biopharma and biotech industries will continue to undergo a significant shift defined by unprecedented scientific breakthroughs and exciting technological innovation. The five predictions outlined in this article, from evolving clinical trial designs and regulatory frameworks to a rise in precision medicine and AI/ML technologies have already begun to shape pharmaceutical research. As we begin to close out 2024, key stakeholders such as study sponsors, CROs, principal investigators, and patients can look forward to a greater focus on patient needs, ethical and sustainable practices, and improved efficiency in the clinical trials industry.

 

TFS CRO: Your Industry Partner in Data Management

At TFS HealthScience, we understand that strong data management is the foundation of a successful clinical trial. Our Data Management & Biostatistics team combine cutting-edge technology with seasoned expertise to deliver unparalleled accuracy and efficiency in clinical trials for clients worldwide. From study design to database lock, you can expect data integrity, compliance with regulatory standards, and seamless integration across all study phases. Our adaptive approach allows us to tailor our services to your unique needs, ensuring that your data not only meets but exceeds industry standards.

Ready to transform your clinical data management and biostatistics experience? Contact a TFS representative today or visit our website to learn what solutions we can offer for your next clinical trial!