The Year Ahead: Six Predictions for the Biopharma and Biotech Industries in 2023
Our recent R&D trends survey foreshadows the trends shaping the field in 2023.
As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023.
The U.S. Food and Drug Administration (FDA) has granted 26 novel drug approvals to date in 2022, moving at a remarkably slower pace than 2020 and 2021, which yielded 53 and 50 approvals, respectively. In the third year of the COVID-19 pandemic, we also see the virus’s lingering effect on industry operations.
The PPD™ clinical research business of Thermo Fisher Scientific surveyed more than 150 biotech and biopharma leaders this year to assess trends in the drug development industry, yielding data we’ll cite throughout this blog. Nine in 10 respondents reported that the pandemic altered their drug development strategy, with new priorities and collaborative approaches shaping how organizations proceed today.
As biopharma and biotech companies adapt to these lasting effects and adopt new advancements in drug development processes, 2023 will be a season of growth and change for the field.
Six predictions for the drug development industry in 2023
1. Decentralized clinical trials continue to take shape.
Decentralized clinical trials (DCT) became a critical strategy as the pandemic took hold. As the world returns to a “new normal,” sponsors still see alternative trial designs as an opportunity to collect data more widely and efficiently.
Over half (55%) of respondents in our survey cited “challenges with patient recruitment in clinical trials” as a top pain point facing their organization. DCTs are a potential balm for the issue, offering a means to recruit and engage a wider patient base outside the limits of a centralized site.
Survey respondents not yet using DCT strategies estimated that a quarter (27%) of their trials would be decentralized by 2024. Organizations currently using DCTs expect another 24% of their trials to become decentralized by 2024, as well.
As companies continue to offer new tools and infrastructure to support DCT operations, it’s clear that this format will become increasingly robust. Biopharma and biotech organizations should seek a DCT partner whose digital-based trial strategy — embedded in speed, deep regulatory expertise and a technology-agnostic approach — is built around improving patient experience, engagement and retention.
2. Novel therapeutic platforms will drive developments in priority therapeutic areas.
The approval of mRNA-based COVID-19 vaccines was a key step in reifying a mainstream future for novel therapeutic platforms, including other nucleic acid therapeutics and cell and gene therapies. While these technologies aren’t new, advances in development and production are bringing them closer to their full potential.
As such, the rise of these platforms has had a heavy hand in shaping organizations’ priorities. Drug developers report that leveraging new technologies (including mRNA and drug discovery platforms) is one of the greatest opportunity areas in clinical trials.
Our survey revealed that hematology/oncology is the leading therapeutic area for 59% of respondents’ development pipelines, followed by rare diseases (39%) and immunology/rheumatology (38%).
These areas are already dominant in cell, gene and nucleic acid therapeutic development; for example, rare disease indications dominate the list of approved RNA therapeutics, while over half of approved cell and gene therapies target cancers. Additionally, surges of research funding from programs like the Biden administration’s Cancer Moonshot Initiative will fuel continued development of advanced therapies into 2023 and beyond.
As developers become more familiar with the complexities of these clinical trials and associated regulatory hurdles, novel therapeutics will dominate the development pipeline. Look for a dedicated clinical research organization (CRO) partner with a track record of success in new therapeutic platforms. For example, we began working with mRNA vaccines years before the pandemic, and in 2022, Thermo Fisher Scientific announced a long-term strategic collaboration with Moderna to continue expanding manufacturing capacity and applications of mRNA technology.
3. Increasing digitalization will open new doors in clinical trials.
Processes throughout the medical field are becoming increasingly digitalized, and the clinical trial space is no exception. Organizations are readily adopting new technologies to overcome challenges in recruitment and trial efficiency.
Of those surveyed, 62% of biopharma and biotech leaders reported using digital tools such as cloud computing, APIs and digital platforms in their trial operations. As DCTs and hybrid trials become a larger component of the clinical trial sphere, new digital tools will emerge to facilitate necessary process changes and ensure compliance with regulatory guidelines.
Digitalization is also a promising avenue for overcoming challenges in patient recruitment and retention, helping organizations reach previously untapped patient populations and improve patient experiences. The rising popularity of electronic clinical outcome assessment (eCOA) tools spurred by COVID-19 has persisted, with many trials now taking a “BYOD” (bring your own device) approach rather than providing study-issued tablets or other devices for data collection.
By allowing participants to use their own devices, trial sponsors have the benefit of lowered costs and accelerated startup times. Participants, in turn, are more likely to be compliant with study protocols that involve reminders and data collection through a familiar device already woven into their daily lives. As this becomes a larger component of more trials, innovation in apps and wearable devices will increase to harmonize with these practices.
4. New trial design methods and data insights will transform study outputs.
Trends in data collection and innovative trial designs will also influence the industry in 2023. The uplift in utilization of data related to direct and target monitoring as well as the site/trial risk profile will positively shape monitoring models, so that studies can quickly adjust to new risks and critical findings. In conjunction, better and more enhanced use of artificial intelligence and machine learning to analyze this data will enable companies to make informed decisions on site identification, study progression, trending and risk management.
Real-world data (RWD) and real-world evidence (RWE) collection are becoming increasingly relied upon in trial design, and advances in data science are enabling developers to use RWD/RWE to their full potential.
Among those surveyed, 45% of biopharma and biotech leaders see the use of RWD/RWE to complement clinical trial data as a top opportunity area in the trial space. The number of Phase IV clinical trials leveraging RWD in 2022 more than doubled in comparison to 2020 — a figure that will increase into 2023 as experience collecting and analyzing RWD grows. In addition, adaptive trial designs will contribute to innovations in clinical research insights. Adaptive clinical trial designs introduce new flexibility into study processes by planning for specified, data-driven changes at interim points throughout the course of the trial. This enables trials to be more efficient, cost-effective and informative, which could remedy mounting concerns over the financial and logistical demands of clinical trials.
Sixty-four percent of respondents to our survey reported using adaptive trial designs in their organization already. As more complex and specific clinical trials are underway, increased reliance on adaptive trial designs will foster efficiency.
5. Vendors will rise to meet the demand for outsourcing.
One of the most notable findings from our industry survey was the reported increase in outsourcing of clinical trial activities. As developers experience the struggles of slowed drug development timelines, increasing trial complexity, and challenges in recruitment and retention of staff and patients, many are increasing collaboration with other entities — in fact, four out of 10 respondents to our survey report greater collaboration across entities since COVID-19. Over the past two years, surveyed leaders reported being more likely to outsource some (47%) or all (35%) of a clinical trial’s activities to a CRO.
Outsourcing models aren’t one-size-fits-all, as each drug developer varies in needs, experience, priorities and capabilities. Our respondents most often leveraged a full-service, trial-by-trial approach (32%), followed by a hybrid functional service provider (FSP) relationship (16%). Clinical laboratory diagnostic services were most likely to be outsourced (80%), with data management, clinical trial management and biostatistical analyses (74%, 63% and 58%, respectively) close behind.
As data science and digitalization become increasingly prevalent in clinical development and cell and gene therapy trials dominate the landscape, organizations will benefit from partnerships with CROs that have specialized expertise in these areas.
6. Drug developers that succeed at creating real-world diversity will be better positioned to serve patients and achieve regulatory compliance.
A patient population that imitates the real world is central to the testing and creation of safe and effective drugs.
The FDA’s recent mandate calls for a “Race & Ethnicity Diversity Plan” for every study. It requires sponsors, CROs, patient organizations and site communities to adapt the way they collectively approach trial feasibility, design and execution, now and in the future.
Our survey found that patient recruitment, including patient retention and patient diversity, is the biggest pain point for biotech and biopharma companies, with 55% citing it as a top challenge faced by their organization. As more targeted therapies are developed, increasing complexity of clinical trials (51%) and regulatory hurdles (46%) also emerged as common barriers.
Drug developers’ ability to remove barriers to participation and provide training and support to sites and patients will be key to recruiting and retaining diverse populations. Sponsors should consider tapping community organizations and advocacy groups to advance their studies alongside a CRO that expertly navigates the changing landscape and understands the importance of inclusive trial design.
The insights and expertise that biotech and biopharma companies need to tackle the year ahead
Our survey of biopharma and biotech leaders offered some enlightening insights into trends shaping the drug development landscape. While we don’t have a crystal ball, the PPD clinical research business of Thermo Fisher Scientific aims to empower drug developers by embracing innovation, leveraging expertise and access to diverse patient populations, and delivering success as a true partner, not just a vendor of CRO services.
Together, we can capitalize on these opportunities to expertly advance your therapies into the new year.