Five Predictions for the Biopharma and Biotech Industries in 2024
Experts share insights and trends to watch in 2024 from our recent R&D trends survey.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024.
This year, the U.S. Food and Drug Administration (FDA) has approved 47 new molecular entities for therapeutic use, already exceeding last year’s progress, which yielded 37 novel drug approvals. These advancements speak to a renewed momentum as the industry recovers from recent years’ challenges associated with the COVID-19 pandemic.
To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments. From the survey results, our experts identified major trends for the coming year in patient recruitment, patient diversity, use of AI, big data and analytics and outsourcing.
Overall, new technological approaches applied in these settings show remarkable potential to make trials more robust, promote more reliable data acquisition and keep trials on-time and on-budget.
Five Predictions for the Drug Development Industry in 2024
1. To overcome challenges with patient recruitment, trials will continue to become more accessible and efficient.
Patient recruitment has become particularly challenging in recent years, as the COVID-19 pandemic limited safe and accessible trial participation, and a crowded clinical trial landscape created competition for participants. In our survey, 55% of respondents said patient recruitment was a top challenge facing their organization.
One essential tactic for improving patient recruitment is to draw patients from new locations, not just ones to which drug developers have repeatedly returned. Furthermore, sponsors must bolster patient retention by reducing the burden of participation, and simplifying site visits and the way data are tracked.
The increased use of decentralized and hybrid trial designs has been a prominent player among clinical research trends for several years, particularly as the pandemic forced developers to accommodate safe and accessible trial participation. Decentralized and hybrid trial designs have rapidly transformed from a growing trend into an expectation. One-third of our survey respondents said that more than half of their trials currently incorporate decentralized elements. Nearly half of the group predicted that 90% of their trials will include decentralized elements by 2025.
Making better use of artificial intelligence (AI) and big data and analytics will be a vital part of supporting more accessible and efficient trials. As decentralized elements and in-depth data analytics become a more crucial part of trial operations, necessary technology for powerful data processing and management will come to fruition to support them. Sponsors that use advanced tools will reduce patient and caregiver burden, maximize the therapeutic and functional experience and improve the likelihood of hitting study milestones (like last patient in), on-time and more reliably. Partnership with contract research organizations (CROs) can help sponsors access a deeper wealth of resources, infrastructure and expertise to implement these technologies, driving innovation and trial excellence.
Novel technologies can also improve the patient experience to advance recruitment and retention. Our survey found that two of the most leveraged strategies for removing barriers to patient participation were remote monitoring and patient-centric platforms/apps, reported by 44% and 41% of sponsors, respectively. Sponsors that adopt innovative approaches to reaching qualified patients where they are make trial participation convenient and stand to better overcome long-standing hurdles to patient recruitment and retention.
2. Companies that adopt more inclusive and effective methods to improve participant diversity will accelerate regulatory acceptance.
Currently, the U.S. is the only country that sets regulatory expectations around patient diversity in Phase III trials, with additional regulatory bodies expected to follow suit in 2024. Shifting the emphasis on patient diversity from a stated priority to concrete action will be an impactful change echoing far beyond meeting regulatory mandates. This fundamental step will create more efficacious therapies by developing and researching their effects in a more inclusive population.
That said, our survey finds that large companies and those located in Asia are more likely to say that their ability to achieve patient diversity targets has worsened. In the coming year, these sponsors will have to explore new and innovative tactics to reach a broader global patient population. Nonetheless, there is a continued level of mistrust among some patient populations about participating in a clinical trial. CROs and sponsors that commit to listening and collaborating with the populations they aim to reach will likely have the most success. Partnerships with patient advocacy groups and community leaders, with whom many CROs have deep and established relationships, give patients a voice in their trials and can help sponsors build and maintain these vital connections.
Another way to help improve trial diversity is for sponsors to partner with CROs that have diversity-focused tools, such as dashboards that identify where diverse patient populations with given indications are concentrated. CROs can also offer ethnic bridging solutions to unlock data from specific populations in the U.S. or globally. In addition to meeting local regulatory expectations and accelerating regulatory acceptance worldwide, efforts that enhance patient diversity and representation in clinical trials will help drug developers create better therapies for all.
3. Stakeholders across the drug development sphere will unlock the transformative potential of AI.
In our survey, artificial intelligence (AI) ranked second among the top trends driving the transformation of clinical trials, but participants fully acknowledged they are not yet implementing AI to its fullest potential. Adopting AI is a monumental change in workflow, but it has vast potential to help sponsors get the data they need while keeping studies on time. The advantage of using AI is that rather than estimating, predictive modeling can be used to provide clarity on study timelines and identify potential roadblocks, risks and opportunities.
At first, AI will most heavily support patient recruitment and site identification, as it can be used to see potential outcomes of using particular sites and countries to ensure sponsors choose the best sites for enrollment outcomes. Additionally, sponsors will start using AI-based tools to build better protocols that reliably reach trial endpoints, while maximizing resource efficiency and patient centricity. As more developers use AI to shape their trials, it will fortify their ability to strategize and plan.
Another top challenge cited in the survey was sponsors’ need to maximize asset value and return on investment, with roughly one-third of respondents naming this among their top five challenges. This challenge was particularly of concern among small/mid-sized companies and those headquartered in Asia. Sponsors that partner with a CRO with established AI predictive modeling capabilities will gain an advantage in defining previously unknown costs that will give their investors and board members greater confidence in their investment.
The more AI is used in the coming years, the greater the need for people with the mindset and expertise necessary to implement it. As awareness, trust and familiarity with these tools grow, sponsors will increasingly build AI into clinical trials. This shift will yield more personalized medicine, automated and more accurate data analysis, more efficient study timelines and reduced costs.
4. The power of real-world evidence and big data analytics will make a wider impact in every stage of research.
According to our survey, 39% of respondents say using big data, including real-world data (RWD) and real-world evidence (RWE) to complement clinical trials, is among the top five trends of 2023. While 44% of respondents report pursuing RWD/RWE as a top strategy in their trials, drug developers are still just scratching the surface when it comes to using them.
Due to its applications for improving trial design, operations and efficiency, we predict that developers will continue exploring data applications in the years to come. For example, analyzing big data instead of running early clinical trials can help reduce site and patient burden. Doing so augments classic clinical trials and gets answers faster and at a lower cost.
Researchers can leverage big data analytic approaches to help predict how a compound will interact with the population, which can then be followed by less invasive clinical trials to validate clinical benefits. Furthermore, using big data can facilitate trials that are highly challenging to recruit for, and especially for major indications like cardiovascular and metabolic diseases (including obesity and Type 2 diabetes).
Companies that leverage innovative RWD approaches will be at the cutting edge. Sponsors should partner with a CRO with access to large swaths of data and the means to analyze it effectively. Only then can they overlay AI and machine learning with real-world data to develop the right questions that make their science more targeted. With the ability to analyze those data comes the potential for identifying more beneficial compounds to analyze, trials that reach their endpoints faster and development projects that go through the regulatory process and gain approval more quickly. These companies will accelerate their development pipelines and will be best positioned for success in 2024 and beyond.
5. Outsourcing models will drive clinical trial innovation.
Outsourcing continues to become more popular as the complexity of some aspects of clinical trials increases. Nearly three quarters (74%) of our survey respondents said they were extremely or very likely to outsource patient recruitment in the next two years, and 72% said they were extremely or very likely to outsource clinical lab and diagnostics testing. As this rate of reliance on outsourcing becomes a reality in 2024, it will further accelerate the clinical trial process closer to what it was prior to the challenges of recent years.
Vendor relationships and vendor performance will be increasingly critical to clinical trial performance. Still, in 2024, vendors will have to become more agile, switching between functional service partnerships (FSPs), full-service outsourcing (FSO) or hybrid models as needed to unlock value and maximize R&D dollars. FSP outsourcing has grown in importance, with 41% of respondents reporting increased use of FSP solutions, compared to only 27% increasing use of FSO. However, FSO remains the most used and preferred approach, except among sponsors based in Asia.
When sponsors and vendors work in harmony, vendors can offer solutions that complement a sponsor’s strengths to improve protocol development and trial execution. For example, companies may hesitate to be early adopters of new technology, no matter how promising it seems. However, CROs implement a test-and-learn approach on behalf of sponsors, coming to the table with new practices that have proven beneficial — in effect, lowering the risk for sponsors to implement innovative trial designs. Expansion of outsourcing partnerships will thus be critical in driving progress in many of the trends we’ve described thus far.
Biotech and Biopharma in the Year Ahead
Our survey demonstrates that new technology and approaches to trial design and an increasing focus on patient diversity and centricity are fueling changes in the biotech and biopharma industries that will continue to make drug development more inclusive, efficient and accurately designed. By making better use of time and resources and adopting more strategic, powerful data collection and management, we can promote greater certainty and success in clinical research.
As sponsors adapt to the changing landscape, vendors offer partnership and facilitate adoption of best practices. Sponsors will benefit from selecting a partner like Thermo Fisher Scientific’s PPD clinical research business, which can cater to the needs of any client, large or small, and is ready to jump at opportunities and navigate challenges to keep development progress moving forward on schedule. We empower sponsors by providing access to diverse populations, promoting technological innovation in clinical development and co-creating partnership models optimized for success.
Together, we will leverage these trends to accelerate your drug development initiatives into the new year and beyond.