Navigating 2025: Three Key Trends Shaping the Future of Pharma

The pharmaceutical industry went through major changes in 2024, and there’s no sign of things slowing down in 2025. With innovation speeding up and patient needs constantly evolving, the industry faces the challenge of staying competitive and managing regulatory hurdles — all while finding ways to improve R&D and move diversity initiatives forward.

Here are three key trends that pharma leaders and clinical operations teams should monitor this year, along with a checklist of strategic priorities to stay ahead.

Trend #1: Embracing diversity from the start

Trial diversity isn’t yet mandatory in some regions, but it is moving away from a “check the box” compliance exercise to a core part of the trial design process from the very beginning. 

In 2023, over 50% of participants in FDA-approved trials were white, a significant improvement from 74% in 2020 and 84% in 2014 (2024 data not yet available). While this data shows that diversity in late-stage clinical trials is improving, there’s still considerable room for growth in pre-clinical and Phase 1 trials.

The U.K’s draft Inclusion and Diversity Plan guides the way for inclusive trial designs beginning in early phases, advocating for a nuanced approach beyond traditional metrics like race and ethnicity. Researchers are now considering data on ethnic subgroups, transient populations, neurodiversity, sexual orientation, gender identity, and other underrepresented groups to design trials that reflect real-world populations.

This progressive approach will influence global standards, with the U.S. and other countries following suit; perhaps we’ll see this reflected in the FDA’s finalized diversity plan requirements expected in June.

For pharmaceutical leaders, prioritizing diverse clinical trials from the start means investing in equity-focused initiatives that enhance trial outcomes and build patient trust. Technology plays a key role here, with AI and machine learning helping to analyze social determinants of health (SDoH) and other granular diversity data to identify the right participants, sites, and principal investigators (PIs). These tools also help ensure diversity metrics are met, speeding up the FDA submission process and enabling therapies to reach the market faster.

2025 priorities:

• Equip teams with tools needed to develop diversity action plans ahead of FDA deadline
• Expand data collection to include underrepresented groups (ethnic subgroups, LGBTQIA+, people with disabilities)
• Identify diverse research sites and PIs
• Adopt patient-centric approaches, such as flexible scheduling and telehealth consultations, to remove participation barriers
• Leverage tools like AI and mobile apps to decentralize trials and improve recruitment

Trend #2: Leveraging AI to speed up rare disease diagnosis & treatment

Historically, the fight against rare diseases has been hindered by diagnostic delays, limited access to data, and limited treatment options. But AI is changing that.

With increasing FDA support for its use in medicine, AI is uncovering previously undetected disease patterns, enabling faster and more accurate diagnoses by linking symptoms and medical histories across fragmented datasets. This significantly reduces diagnostic timelines — currently averaging over five years, with many diagnoses taking over a decade.

A prime example of AI’s impact comes from Mayo Clinic researchers, who utilized the RENEW system to diagnose two brothers with an ultra-rare genetic disorder after nearly 12 years of undiagnosed symptoms. By reanalyzing their genetic data alongside newly discovered disease variants, RENEW identified a match to a genetic mutation in less than a minute, providing a diagnosis that had previously eluded traditional methods. This tool has helped over 20 patients with rare conditions receive definitive diagnoses.

For pharmaceutical leaders, integrating AI solutions that align with regulatory frameworks is key to accelerating breakthroughs in rare disease treatment. Beyond diagnosis, AI helps personalize treatment strategies to improve outcomes. And, in rare disease clinical trials, AI overcomes the challenges posed by limited patient populations by identifying potential participants and optimizing trial designs. 

2025 priorities:

• Invest in AI-powered diagnostic platforms to improve rare disease detection and management
• Collaborate with AI developers to create tailored applications for specific rare diseases
• Use AI to analyze disparate data sets to uncover new disease patterns and improve treatments

Trend #3: Prioritizing culturally compassionate care

Understanding and addressing the cultural, social, and individual factors that shape patient experiences is critical to building trust, improving trial participation, and ensuring effective treatments across diverse populations.

To make this happen, organizations can work with community leaders, build inclusive teams, and actively engage underrepresented patient groups. These efforts help integrate culturally sensitive practices into every aspect of the clinical trial process.

Pharmaceutical leaders should reevaluate data collection, recruitment strategies, operations, and trial processes through an inclusive lens. For example, gathering data from underserved populations, like transient communities or individuals with neurodiverse conditions, can offer insights that help improve clinical trial success.

2025 priorities:

• Reframe “DEI” as an inclusive priority throughout the clinical process (the PhRMA Equity Initiative is a good resource)
• Collaborate with diverse sites, PIs, and local healthcare providers (HCPs) to gather varied perspectives
• Collect data from underserved populations to improve trial designs
• Partner with community organizations and HCPs in underserved areas to build trust
• Develop targeted outreach programs to engage diverse communities and strengthen trust in clinical research

AI + diversity = progress

The road ahead requires bold, thoughtful strategies — but the reward is a healthier, more inclusive future for all. By embracing innovation and inclusion, pharmaceutical leaders can pave the way for meaningful change and tackle long-standing inequities to improve patient outcomes.

Photo: metamorworks, Getty Images

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.