Key Trends Drug Developers Need to Know to Succeed

We surveyed 150 drug developers around the globe to assess drug development trends and opportunities. Here’s what we found.

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape.

In response, the PPD™ clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. These annual results provide valuable insights into the state of drug development, highlighting shifts in industry practices and illuminating emergent areas of focus.

The report reveals critical insights into the challenges drug developers face, including rising costs and complex protocols, while also pinpointing opportunities for growth. As the industry grapples with these dynamics, these findings offer a benchmark for assessing progress and adapting strategies.

Key insights drug developers need to know to succeed

1. Drug development

• The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment. This is reinforced by challenges reported in the enrollment of hard-to-find populations and complex regulatory requirements.
• Large biopharma organizations face hurdles in patient centricity, greater use of real-world data (RWD)/real-world evidence (RWE) and patient diversity. Small/mid-size biopharma organizations are experiencing challenges in their approaches to investment and funding, vendor rationalization and greater use of RWD/RWE.
• Innovative trial design, artificial intelligence (AI), personalized/precision medicine and maximizing asset value are seen as opportunity areas across the board, regardless of company size.

2. Patient recruitment

• The ability to increase diverse patient enrollment has improved, primarily among large sponsors, with 42% seeing improvement compared to 29% in 2023.
• Respondents’ primary goals surrounding patient-focused strategies are to remove barriers to patient participation and increase overall enrollment.
• Top strategies include establishing or improving relationships with patient advocacy groups, using more sites for each clinical study and conducting research in more countries.
• Remote monitoring/telehealth visits have also declined substantially as the pandemic recedes, creating opportunities improve in-person patient experiences.

3. Decentralized trials

• The prevalence of decentralized clinical trials (DCTs) continues to grow with 36% of trials currently using DCT elements, furthering their status as an expectation in every successful drug developer’s toolkit for use in appropriate trials.
• Growth of DCTs is expected to continue, and in two years, respondents expect over 90% of their trials to be using decentralized elements, similar to 2023 estimates.
• As DCTs become standard across toolkits, there is greater opportunity to implement decentralized approaches when needed. Small/mid-size participants in particular indicate greater use of DCTs, expecting higher use by 2026.

4. Outsourcing

• One in three participants (35%) say they have increased functional service provider (FSP) outsourcing versus just 29% who have upped their use of full-service outsourcing (FSO).
• Respondents also said that FSO still makes up more than a third (34%) of clinical work that is currently outsourced, with FSP and hybrid models each comprising around the same (35%), with the remainder (13%) going to insourcing or temporary staffing.
• Patient recruitment and clinical laboratory and diagnostic services are the top drug development activities likely to be outsourced, similar to previous reports.
• FSP outsourcing is growing faster than full-service outsourcing, across both large and small/mid-size biopharma segments. Over 15% in each segment are decreasing their use of FSO.

Overcoming bottlenecks in drug development: The cost of complexity

Drug developers are acutely aware of the escalating costs associated with clinical trials, a challenge that has become a significant bottleneck in the development process. The rising expense is driven by several factors, including increasingly complex protocol designs, difficulties with patient recruitment and the extended trial timelines. These internal issues are compounded by external pressures like inflation, the development of innovative therapies that require complex protocols and the need to comply with shifting regulatory requirements.

Patient recruitment also continues to be a major hurdle, with ongoing difficulties in identifying suitable participants and managing competition from other trials or sites. This issue is particularly pronounced for rare diseases and trials requiring diverse patient populations. While nearly half of large companies express optimism about their recruitment capabilities, only 30% of small and mid-sized sponsors share this positive outlook, highlighting the need for improved recruitment strategies and resources. This uncertainty reflects the broader struggle to achieve both a qualified and diverse patient set, a task that remains a critical concern in the industry.

Trial complexity is also on the rise. Key factors contributing to this trend include the enrollment of hard-to-find patient populations and compliance with complex regulatory requirements. Furthermore, the development of innovative therapies often necessitates intricate protocols, adding layers of complexity to trial management. Addressing these challenges requires innovative solutions and a strategic approach to streamline trial processes and enhance overall efficiency.

A diverse view of the most impactful drug development trends emerges

There is no single consensus on the most impactful trends in drug development, but several key themes have emerged. Innovative trial design, especially favored by small and mid-sized organizations, is leading the charge alongside personalized medicine and the growing influence of AI. These trends are reshaping how trials are conducted and tailored to individual needs. Digitalization also stands out as a crucial trend for small biopharma companies that are focusing on maximizing asset value and exploring new funding avenues to stay competitive in a rapidly changing landscape.

On the other hand, large sponsors place significant emphasis on leveraging RWD and RWE to enhance their trials and drive patient centricity. This focus reflects a broader shift towards incorporating more comprehensive and patient-focused data to improve outcomes and efficiencies in drug development. Both sets of trends highlight the adoption of diverse strategies to address the challenges and opportunities in the current drug development environment.

2024 trends with momentum

Personalized/precision medicine: Tailoring treatments to individual genetic profiles and specific patient characteristics is becoming increasingly important. This approach is reshaping clinical trials and therapeutic development, offering more targeted and effective solutions.

Leveraging new technologies: The adoption of innovative technologies, including digital platforms and advanced analytics, is transforming drug development. Small and mid-sized organizations are particularly focused on digitalization to maximize asset value and uncover new funding opportunities.

Increasing focus on patient diversity: There is a growing emphasis on including diverse patient populations in clinical trials, especially among small and mid-sized sponsors. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinical research.

AI: Large sponsors are increasingly integrating AI into their strategies. AI is being used to analyze complex data sets, optimize trial designs and enhance patient recruitment efforts, reflecting a shift toward data-driven decision-making in drug development.

The path to sustained success in drug development requires responsiveness to industry shifts and trends

As the drug development landscape continues to grow in complexity, forward-thinking and staying agile is essential for overcoming obstacles and capitalizing on new opportunities, ensuring sustained success.

To effectively navigate these changes, drug developers must strategically respond to evolving challenges by embracing cutting-edge technologies and innovative approaches.