Trends in Pharmaceuticals Research and Development
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Data report: The state of the drug development industry
Between COVID-19, a sizeable uptick in the number of therapies under development, and increasing trial complexity, the drug development industry is in a season of change. Patient centricity is in the spotlight, and an exciting slate of new technologies and data capabilities position innovators to lead the pack.
In 2022, the PPD™ clinical research business of Thermo Fisher Scientific surveyed more than 150 leaders at biotech and pharmaceutical organizations around the globe to assess trends in drug discovery and development. Respondents shared the therapeutic areas in their pipelines, barriers to bringing drugs to market, innovations in pursuit and lingering effects of COVID-19.
The results are illuminating. Two years after the pandemic arrived and “mRNA vaccines” joined the mainstream rhetoric, many in the industry are facing elongated development timelines, talent shortages and regulatory hurdles. Over the past two years, patient recruitment has become the biggest barrier to advancing therapies, closely followed by the increasing complexity of clinical trials.
The COVID-19 pandemic has also encouraged drug developers to work differently and more collectively. As a result, the majority are embracing new technologies like adaptive trial design and digitalization to hasten the speed to market, enable better access to data and improve scalability. Many have also moved to decentralize trials or work with partners that can do so, identified areas for process improvements and sought greater collaboration across other entities.
Note: for purposes of this report, terms such as “biopharma,” “pharmaceutical companies” and “large pharmaceutical organizations” refer to companies with an annual R&D spend above $1 billion, while terms such as “biotech” and “smaller drug developers” refer to companies with an annual R&D spend below $1 billion.
Read on to gauge the state of the industry and the outlook on pharmaceutical research and development.
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Patient recruitment emerges as top challenge
More than half of respondents said their companies face challenges with patient recruitment in clinical trials (55%), including patient retention and population diversity. As more targeted therapies are developed, increasing complexity of clinical trials (51%) and regulatory hurdles (46%) also emerged as common barriers.
Some interesting differences between company sizes also surfaced. Trial complexity and talent shortages are more frequently noted as a challenge among respondents at large pharmaceutical organizations, while small drug companies report more trouble with funding – 57% of biotech companies reported funding troubles, compared to 15% of pharmaceutical companies. Small drug developers were also twice as likely to note elongated study times as a challenge compared to their pharmaceutical counterparts.
A third of drug developers say that keeping up with technology and innovation, including hybrid and decentralized trials, is a challenge. At the same time, COVID-19 spurred 51% of respondents to decentralize trials or work with partners that can do so.
What are the biggest challenges your organization is currently facing?
Global pandemic puts pharmaceutical production and research timelines to the test
Nearly half of drug developers report that the average timeline to produce a drug – from first-in-human trials through market approvals – is longer now than it was two years ago (48%). Of those, the majority note that the timeline to get a new pharmaceutical product to market today takes 12 months or longer compared to pre-COVID-19.
Conversely, one-quarter of drug developers report a faster timeline to produce new drugs (24%), while one out of five drug developers say they have seen no change in development timelines.
An organization’s resources and scale influence the perception of pharmaceutical research and development timeframes: Respondents from biopharma organizations are more likely to view pharmaceutical timelines as moving more quickly today, while respondents from companies with an annual R&D spend below $1 billion are more likely to regard the drug production timeline as slower. This finding dovetails with respondents from biotech companies similarly reporting greater challenges related to funding and elongated study startup times.
Compared to two years ago, how has the average timeline to produce a drug (from first-in-human trials through market approval) changed at your organization?
Real-world data is the next frontier in clinical research
When asked what they consider to be the greatest opportunity areas in pharmaceutical research in clinical trials, the largest portion of respondents readily selected greater use of real-world data and evidence, closely followed by the leveraging of new technologies. More than one out of three respondents consider improved patient recruitment via digital and decentralized trials as an opportunity (39%), mimicking the reported challenges in patient recruitment. Drug developers based in Asia-Pacific (APAC) regions reported artificial intelligence and data collection through wearables as greater opportunities than their counterparts in the U.S./Canada, while developers based in Europe are more likely to embrace big data and analytics (data science) compared to those in APAC.
What did not emerge as opportunity areas? The influx of investment in the industry and renewed public interest in trials as a result of COVID-19.
What do you consider to be the greatest opportunity areas in drug development in clinical trials?
Use of new technology in drug discovery varies based on geography
Responses to the survey uncovered statistically significant, geography-based differences in the industry’s use of technologies and innovation.
- European drug developers are turning more readily to data science and analytics than their global counterparts. Nearly half of European respondents view data science as an industry opportunity, compared with about one in five respondents based in APAC. Today, two in three European respondents use data science in their trials, as compared with roughly two in five respondents in the U.S./Canada.
- APAC drug developers are more likely to embrace innovation, such as artificial intelligence and data collected from wearables, compared to their counterparts in U.S./Canada.
- APAC respondents are also engaging in decentralized, digital and remote trials nearly twice as often as respondents in North America – 68 percent compared to 36 percent of U.S./Canada respondents.
European and APAC drug developers are two- and three-times more optimistic, respectively, about artificial intelligence as an opportunity than their US/Canada counterparts.
Artificial intelligence as one of the greatest industry opportunities:
of APAC respondents
of European respondents
of US/Canada respondents
The hematology/oncology therapeutic area is dominating pharmaceutical research
Three out of five respondents reported that Hematology/Oncology is a therapeutic area leading their company’s drug development pipeline. Rare diseases, immunology and rheumatology, neuroscience and cardiology rounded out the top five therapeutic areas in drug discovery and development plans.
Respondents from biopharmaceutical organizations are more likely to focus therapeutic development in hematology/oncology, immunology and rheumatology, cardiovascular and vaccines. Though only a small proportion of respondents selected pediatrics or urology as leading therapeutic areas for their company, it’s worth noting that these rates were significantly higher among those from small organizations compared to their larger counterparts.
Which therapeutic areas/therapeutics are leading your organization’s drug development pipeline today? Respondents selected up to 5.
Keys to success include:
- Early engagement with participants and sites. Competition within specific research indications and geographic locations is intense, as groups vie to recruit from within a limited pool of candidates. Early engagement with participant populations and sites – and use of feasibility data, when accessible – is critical to simplifying and increasing efficiency in the trial ecosystem.
- Real-world diversity. A patient population that imitates the real world is central to the testing and creation of safe and effective drugs, and will only increase in regulatory significance. 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.
- Partnerships that strengthen pipelines and clinical development. Community organizations and advocacy groups can connect sponsors with new trial sites and facilitate more diverse participation to advance studies. In alignment with that strategy, drug developers that extend their contract research organization (CRO) relationship from vendor to partner will benefit from early engagement, shared governance, and a consistent and engaged team – enabling a stronger go-forward strategy.
- Ingenuity and adaptability. The ability to stay on the cutting edge – such as early involvement with mRNA vaccines and trial decentralization before the start of the pandemic – is a requirement in today’s pharmaceutical research landscape. To hone these capabilities, sponsors should demonstrate prowess with the latest technologies and strategies – or tap a partner that can – while practicing new ways of thinking so they’re primed for innovation.