Growth in the clinical research organization (CRO) industry can be attributed to the increasing number of drugs being developed, new therapeutic modalities, focus on personalized medicine, and emerging biopharma companies. As pharma and biopharma companies increasingly turn to outsourcing R&D, demand for CRO services is forecast to increase with growing pressure to lower costs and enhance productivity. Also, data-driven technology advancements, such as data mining, artificial intelligence, and digital health, are contributing to market growth. This report provides insights from top CROs on outsourcing trends, areas of investment, current industry challenges, and technology trends.

The Global Clinical Trials Market size was estimated at $29.7 billion in 2020, $32.3 billion in 2021, and is projected to grow at a CAGR of 8.96% to reach $49.7 billion by 2026,¹ according to the report by ResearchAndMarkets, “Clinical Trials Market Research Report by Design, by Phase, by Indication, by Region – Global Forecast to 2026 – Cumulative Impact of COVID-19.” 

Meanwhile, the Global Contract Research Outsourcing Market, which is inclusive of clinical, discovery, preclinical, and lab services, is expected to reach $67.1 billion by 2026,2 according to a report by Global Industry Analysts titled “Contract Research Outsourcing – Global Market Trajectory & Analytics.”

In this report, the U.S. market is estimated at $20.1 billion in 2022 and currently accounts for a 40% share in the global market, while China is forecast to reach $3.8 billion by 2026. Growth in North America is due to presence of well-established CROs and high investments in R&D of novel drugs and therapies, as well as the advanced infrastructure for clinical research and government incentive programs in the U.S. and Canada. Other noteworthy geographic markets of Japan and Canada, are each forecast to grow at 6.1% and 6.2% respectively over the analysis period.²

Key among the reasons for this is growth is the increasing number of drugs being developed, which has almost doubled over the past 10 years, from approximately 750 in 2007 to 1,500 in 2018,² according to the Global Industry Analysts report. Additionally, more than 1,600 gene therapies are currently in clinical trials,³ and the FDA has to date received more than 900 applications to initiate gene-based treatments.⁴ The agency expects that by 2025 it will issue upwards of 200 investigational new drug (IND) applications for advanced therapies per year, with approval of up to 20 such treatments.

Acquisition Strategies, Geography Expansion and R&D Capabilities

Market growth in the CRO segment is evidenced by recent M&A activity. In July 2021, ICON completed its acquisition of PRA Health Sciences in transaction valued at approximately $12 billion. The consolidation creates a healthcare intelligence and clinical CRO with a combined focus on applying transformational technology and innovation to execute clinical trials, offering capabilities and services through a combination of mobile and connected health platforms, a global site network, home health services and wearables, to deliver differentiated decentralized and hybrid trial services.

Also, in November 2021, Parexel, a global CRO, completed its acquisition by EQT Private Equity and Goldman Sachs Asset Management for $8.5 billion. The merger aims to fuel growth and business expansion. Most recently, in December 2021, Thermo Fisher Scientific completed its acquisition of PPD, a global provider of clinical research services, for $17.4 billion. With the addition of PPD, Thermo Fisher will offer services across the clinical development spectrum, from discovery, to assessing safety, efficacy, and health care outcomes, to managing clinical trial logistics, to the development and manufacturing of the drug product.

To further leverage the myriad of data resulting from trials, Syneos Health recently acquired RxDataScience, a healthcare-focused data analytics, data management and artificial intelligence (AI) company, adding technology-enabled, insights-powered services with the aim of accelerating performance across the product lifecycle. Maria Fotiu, Executive Vice President, Clinical Development, Sites and Patients, Syneos Health, said, “Syneos Health continues to evaluate opportunities that compete in higher growth segments of the market and look for complementary acquisitions that boost our capabilities and bring additional technology-enabled services to our Dynamic Assembly network, an open ecosystem of best-of-breed data and technology solutions that includes in-house capabilities and curated vendor relationships designed to strategically address the nuances of unique customer engagements.”

Fotiu noted recent acquisitions in the areas of remote patient engagement and data science with StudyKIK and RxDataScience, as well as partnerships with Science 37, Medable and Aetion to complement its Dynamic Assembly network, and decentralized clinical trial and Real World Evidence (RWE) capabilities.

For IQVIA, a global provider of advanced analytics, technology solutions, and clinical research services, the company continues to focus on making strategic investments in innovation. According to Wendy Stewart, President of Clinical Operations at IQVIA, this includes widening lab services and capabilities in bioanalytical, vaccine, biomarkers and genomics data strategies, expanding reach across various regions. “From opening a custom designed multi-lab space in the U.S. to lab expansions in Scotland to strategic acquisitions of expert partner companies, it is important for IQVIA to support sponsors looking to fast track the drug development process,” she said. “We enable this across varying therapeutic areas, better addressing complex biomarker testing with agile strategies through intelligent connections of solutions.”

With respect to areas CROs are investing in, according to Maria Fotiu at Syneos Health, much of the recent activity has been surrounding Decentralized Clinical Trials (DCT) capabilities for more streamlined engagement with patients, sites, healthcare professionals and sponsor needs. “This strategy was vital during the early days of the COVID-19 pandemic,” said Fotiu. “Many people benefited with a virtual/hybrid clinical model, so now CROs recognize they need to identify approaches that are more straightforward. Additional investment has been made in RWE strategies to support growing requirement for post-marketing studies and garnering RWE to support value-based claims from ongoing clinical studies.”

DCT capabilities, services and solutions are a key area of investment. According to Stewart at IQVIA, the integration of innovative DCT technologies into trials has proven to help engage patients while also increasing trial efficiency and reducing timelines in some cases. “But, it is as important to underpin the technology with the appropriate service and expertise, including clinical operations, therapeutics, technology and more,” she said. “The human factor is critical to optimizing DCT solutions.”

To further efficiencies and help sponsors accelerate drug development, CROs like IQVIA are also focusing on how to strategically leverage real-world data and advanced machine learning (ML) applications to better guide sponsors with decision making throughout the trial lifecycle, from planning to completion. According to Stewart, “These tools can help with important and specific trial decisions and activities, including forecasting enrollment rates per site and automating country and site-specific feasibility analytics, to help sponsors better understand what may be needed for the overall trial design and execution strategy.”

These tools and insights are particularly valuable for virtual and emerging biopharma companies (EBPs). “For EBPs with a single or a few key assets, data-driven decision making can help guide program and overarching business goals during their ‘make it or break it’ time,” said Stewart. “As EBPs are responsible for a record 65 percent of the molecules in the R&D pipeline,⁵ up from less than 50 percent in 2016, it is vital for CROs to help address their needs, given intense market competition. At IQVIA, we leverage a comprehensive suite of solutions—Asset Maximizer—to help EBPs and other sponsors ensure trial design endpoints demonstrate asset value to all key stakeholders at launch and throughout the product lifecycle, helping to get their therapy to patients faster.”

Areas of Uptick in Outsourcing

Sponsors increasingly seek outsourcing partners in the areas of therapeutic expertise, technology support, data management strategies, and scalable functional services to address drug development needs. Syneos Health’s Fotiu said, “We’re seeing strong growth across both the top pharma and smaller segment of the marketplace. With a boon of funding in the last couple years, the emerging biopharma segment outsources the majority of their work. Funding has largely covered key areas of rare disease, cell and gene therapy, oncology and selected CNS indications and we’re seeing an uptick in outsourcing from these areas. From a functional standpoint, safety work in a post-marketing world, specifically technology to support this discipline given the ongoing pandemic, increased number of patients with chronic conditions and an increase of medications available for patients.”

Stewart at IQVIA affirms, “As scientific innovation is a strong influence in how clinical trials are designed and executed—from planning, protocol design, site operations, technology integration and more—sponsors are turning to CROs and other service providers who have depth in experience and specialized skill sets to successfully work in these capacities.” According to a report Global Trends in R&D 2022, by IQVIA Institute for Human Data Science, recent analysis showed more than 40 percent of the pipeline in targeted therapies is for rare cancers,⁵ where next-generation biotherapeutics, including cell and gene therapies (CAGTs), are being deployed.

“CROs with deep scientific expertise combined with experience in adaptive and novel trial designs, AI/ML technologies, integration of biomarker strategies and lab capabilities can support management of complex trials with efficiency and increased predictability and speed in a competitive market, while keeping patient needs in mind,” said Stewart. “Also, as much of the innovations in CAGT stem from emerging biopharma and biotech companies, experienced CROs are offering these companies with make-or-break assets consultative guidance through the program to ensure trial efficiency and reduce costs and for therapeutic and clinical trial expertise to help meet their development objectives.”

Additionally, as trials become more complex and technology advances, data management strategies have evolved to offer a multitude of benefits, from driving decisions to helping reduce risks associated with trials. Stewart said, “With massive amounts of data collected and analyzed from increasing integration of connected devices in clinical trials and other forms of data capture, sponsors also need expertise and services to bring together disparate data in a meaningful way for deeper insights that guide their trials. Use of AI and advanced and predictive analytics can help predict and even prevent trial risks and provide decision intelligence in real-time.”

Finally, flexible Functional Service Provider (FSP) models, historically the backbone of the outsourcing industry, offer sponsors what’s needed, when it’s needed, filling in gaps along the drug development continuum. “To ensure the appropriate experts and capabilities are involved to meet trial objectives, sponsors are increasingly leveraging flexible service models, where they can receive the right mix of functional expertise, resource management and tech-enabled solutions for their needs. Scalable FSPs allow sponsors to maintain better control of resourcing and managing the changing demands as a program or portfolio progresses through its lifecycle,” Stewart concluded.

Regulatory Frameworks for Clinical Trials Today

In addition to flexibility for the conduct of clinical trials amid the pandemic, regulatory authorities have demonstrated the ability to adapt, streamline and collaborate in order to oversee and approve vaccines. Some of these adaptations, such as DCTs and greater use of RWE, may be here to stay.

Ilse-Maria Nolan, Ph.D., Senior Director, Regulatory Affairs, PPD Clinical Research Services, Thermo Fisher Scientific, said, “Regulatory frameworks are evolving to meet changing needs, increasing the importance of regulatory intelligence screening to inform business decisions. In response to the COVID-19 pandemic, regulatory authorities (RAs) worldwide established flexibilities to ensure trial participant continuity, while accelerating development of COVID-19 vaccines and treatments. Some RAs have established precedents that may lead to permanent change. We already see increasing flexibilities for DCTs.”

The pandemic also brought an additional focus on advanced therapies requiring sophisticated preclinical and clinical development, according to Nolan, and recent advanced therapy-specific legislation and guidance will support such development. “A major recent change in the EU is the long-anticipated application of the EU Clinical Trials Regulation 536/2014 on January 31, 2022 that will simplify and harmonize procedures for the authorization, assessment and supervision of trials over a three-year transition period. The clinical research industry needs to collaborate proactively with the RAs to ensure alignment regarding the use of novel DCT strategies that enable us to move forward with innovation and adoption at the incredible pace that was seen during the pandemic. Now that we have seen what can be done, we must ensure that progress continues,” said Nolan.

Additionally, there is a continuation and maturity of data and technology driven by increased Regulatory Agency acceptance of RWE use, according to Fotiu at Syneos Health. “As we move from innovation to common application and adoption, we are seeing the compliance structure behind the innovation infusing into SOPs, which over time will blur the lines between traditional clinical trials and low/non-interventional studies. Adaptive organizations will absorb these natural changes and reduce barriers for execution. Much of this is market dependent and regulatory policies are still being established,” said Fotiu.

With increased adoption of DCT and hybrid clinical trial designs during the pandemic, Stewart at IQVIA added, “We are seeing further shifts in regulatory guidance to maintain safety and data quality levels of on-site trials. Sponsors looking to integrate DCT elements need to have a deep understanding of Good Clinical Practice (GCP) and the European Union’s General Data Protection Regulation (GDPR) as they consider what personal data study teams collect, how those data are processed and what records must be maintained to be compliant with regulations.”

Finally, as drug development increasingly involves remote monitoring and new digital patient practices, such as those used in DCTs, Stewart noted it’s critical for sponsors to work with a CRO partner who understands the intricacies of data privacy and compliance that can help develop a comprehensive data collection and management strategy that adheres to all necessary regulations. 


References

1. https://www.prnewswire.com/news-releases/global-clinical-trials-market-research-report-to-2026—featuring-accell-clinical-research-clinipace-and-icon-plc-among-others-301517673.html
2. https://www.prnewswire.com/news-releases/global-contract-research-outsourcing-market-to-reach-67-1-billion-by-2026–301506515.html
3. https://www.biospace.com/article/global-cell-therapy-market-clinical-trials-development-patent-insight-2028-/#:~:text=Insight%20On%20More%20than%201600%20Cell%20Therapies%20in%20Clinical%20Trials
4. https://www.thegenehome.com/gene-therapy-process/examples?gclid=CjwKCAjwrqqSBhBbEiwAlQeqGnQcPXqXTCAFh7HDxQwJWvKT2G5cOMsvqXWSc82v1vvMp4el6QVWFxoCI34QAvD_BwE
5. https://www.iqvia.com/insights/the-iqvia-institute/reports/global-trends-in-r-and-d-2022