CRO Industry Trends for 2025 

Navigating the complexity of today’s drug development landscape grows more challenging every day with emerging and advanced biopharmaceuticals, vast amounts of data, new technologies, and evolving regulatory requirements. Pharma and biopharma companies increasingly engage CROs to help expedite development leveraging clinical trial management, data, therapeutic, and regulatory expertise.

Gary Ellsworth, Head of North America Alliance Management, IQVIA shares insight on key trends driving outsourcing in today’s market.

Contract Pharma: What are the key trends driving outsourcing in today’s market? 

Gary Ellsworth: Clinical trial sponsors are experiencing increasing pressure to accelerate clinical research and development while navigating multiple broader factors, including regulatory changes, policy shifts, investment challenges, adoption of artificial intelligence and other advanced technologies, geopolitical conflicts, etc. 

Despite the highly dynamic environment, R&D funding reached a 10-year high in 2024 at $102 billion, substantially increasing from $71 billion in 2023, and driving innovative science to ensure novel therapeutic modalities receive regulatory approval and reach patients. Though clinical trial starts have returned to pre-pandemic levels, there have been notable shifts in clinical research priorities. 

Support needs of EBPs and mid-sized pharmaceuticals 

For one, emerging biopharma companies, mostly pre-commercial, are responsible for 63% of trial starts, up from 56% in 2019. Given the growing investments in the sector and the related growing market competition, it can be a make-or-break time for EBPs heavily focused on one or two key assets. As such, they may rely on continual guidance from experienced clinical research organization service partners to effectively move from clinical trial design and execution to commercialization.

Meanwhile, mid-sized pharmaceutical companies contributed less to overall clinical trial starts compared to large pharmaceuticals and EBPs across all development stages and most therapeutic areas in 2024. Mid-size pharmaceuticals may experience change during pipeline expansion and company growth. They typically need a CRO service partner that knows where their resource gaps are and how to prioritize where they most need support based on extensive experience working in similar capacities for other drug developers of similar size, focus and situation.

Growth of China-based R&D/reprioritizing country use  

While U.S.-based companies continued to account for most trial starts in 2024, there has been a noteworthy increase in trials from China-headquartered companies, predominantly EBPs, with 30% share of starts in 2023 and 2024 and 80% of these trials only involving sites in China. 

As China inches closer to Europe and the U.K. in terms of novel active substance treatment launches, it will be critical for global trial sponsors and those interested in single-country trials in China to partner with CROs and other vendors with experience in the region, including regulatory experience. For example, as China’s Center for Drug Evaluation aims to implement International Council for Harmonisation guidelines to align with other countries’ regulators, sponsors may rely on experienced CRO service partners for ongoing monitoring and guidance on strategy adjustments.

With China shifting focus to homegrown innovation in R&D, life sciences companies based in the U.S. and elsewhere may also be interested in buying or licensing pharmaceutical assets developed domestically. One key example is how U.S.-based Kailera Therapeutics secured a licensing deal for an investigational anti-obesity treatment from China-based Jiangsu Hengrui Pharmaceuticals, which has secured noteworthy findings from Phase II trials in China to compete alongside Ozempic® (semaglutide) and Zepbound® (tirzepatide) along with three other weight-management treatments from the Chinese company. Kailera Therapeutics can now move forward with Phase III trials in the U.S. faster due to the previous research conducted in China. It will be helpful for companies acquiring treatments via these licensing deals to rely on a CRO service partner that houses the clinical, operational and regulatory experience in both regions to anticipate what is needed to effectively accelerate programs. 

Steadfast focus on increasing efficiencies 

In 2024, there was a continued decrease in the number of countries per trial, particularly in Phase II and Phase III trials. This was due to disease prevalence variations across countries, evolving regulatory requirements, lack of in-house capabilities and relationships with trial sites and other factors. Additionally, while trial eligibility criteria and the number of primary and secondary endpoints are increasing to better establish earlier signs of treatment efficacy, they are significant contributors to trial complexity. As such, the need to create more efficiencies within R&D efforts remains an important objective for all trial sponsors. 

Working with expert CRO service partners that can provide varying clinical productivity enablers at scale from the organizational level through the clinical program and trial levels will be essential. From artificial intelligence/machine learning to real-world evidence, protocol simplification, novel trial design, decentralized solutions, community engagement, etc., drug developers have significant opportunities to streamline efficiencies from end-to-end and increase probabilities of success without compromising quality outcomes. 

From our experience, sponsors are recognizing the value in measuring the “white space” between development phases, especially as on average, new drugs spend 45% of their development time in this period. For trials completed in the past five years, white space has increased by 14 months due to varying complexities. Regarding time-to-market, sponsors are not concerned on exactly where they save time and cost during the full development cycle as long as there is improvement. This makes it essential to have a strong strategic sponsor/CRO partnership to quickly engage, align and make decisions to transition to the next development phase. For example, neurology studies typically have 2-3 years of white space between Phase II and III studies. Focusing on collaborative start-up acceleration activities with an EBP sponsor, we recently reduced 1-2 years of this white space, including eliminating a year of program development time and related costs by 40%.  

Contract Pharma: What are the key therapeutic areas driving CRO growth, and how are CROs adapting to these trends?

Gary Ellsworth: Key therapeutic focuses are oncology, immunology, neurology and cardiovascular, which represent 71% of the 5,318 clinical trials started in 2024. 

• Oncology continues to be the most prominent therapeutic area for research and development efforts globally. Novel modalities, including antibody-drug conjugates, cell and gene therapies, multi-specific antibodies, etc., account for 35% of oncology trial starts in 2024.
  • Three neurological conditions — Alzheimer’s disease, depression and Parkinson’s disease — each saw more than 200 new trial starts in the last five years. 2024 saw increased early-stage activity in the additional areas of amyotrophic lateral sclerosis, multiple sclerosis and muscular dystrophy. Last year, the U.S. Food and Drug Administration also approved the first new mechanism of action in more than 30 years for treating schizophrenia. 

EBPs, primarily pre-commercial organizations, account for most trial starts (63% in 2024) across all therapeutic areas. Unlike large, established pharmaceutical companies, these trial sponsors may lack the in-house resources and/or clinical expertise to develop an asset through commercialization, especially at the critical stage of scaling up from a smaller Phase II study to a much larger Phase III study. 

Experienced CRO service partners can help EBPs to reduce oversight responsibilities and effectively navigate the nuances and challenges of expanding into multiple regions and countries, including tailored protocol development, varying regulatory considerations, patient and site support needs, decreasing vendor management needs by sourcing multiple services from a single provider, etc. Consultative and guided engagement with a CRO service partner that has applicable experience and capabilities across a broad range of R&D needs allows for holistic, streamlined support throughout the development process, which EBPs may need more than ever. 

Additionally, the 101 obesity trials in 2024 represent more than a nine-fold increase in the last 10 years and a 77% increase in trial starts compared to 2023. We can anticipate more growth in this highly dynamic market because the obesity pipeline — from Phase I to post-approval — now includes 173 drugs. 

Now that the anti-obesity treatment market has taken shape, it is important for CROs to continuously monitor where obesity R&D is heading and what patient subpopulations need if they are to make a positive impact on this global health epidemic. 

For one, CROs can help ensure patient sensitivities and experiences are considered earlier in obesity trial design to strengthen recruitment and engagement. Targeted patients may consider trial participation yet another potential failure in their weight management journeys, especially if they have concerns about anti-obesity medication side effects, impact on daily life and ongoing social stigmas around their condition. As such, tailored trial design that includes supplemental support, such as weekly counseling and access to a dietician, may keep patients engaged. 

CROs and trial sponsors are also focused on further evaluating obesity as a complex, heterogeneous, chronic multi-disease and its related impact on cardiovascular health, diabetes, kidney disease, osteoarthritis, sleep apnea and liver disease. When exploring the potential for indication expansions, real-world evidence is helping to secure insights into the implications of obesity treatments while also accounting for nuanced variables in patient populations (e.g., multiple comorbidities) and degrees of adherence and behaviors around treatment switching. As the breadth of data insights expands, anti-obesity drug developers will be well-positioned to better examine what their assets’ key market differentiators may be for the long-term. 

Contract Pharma: How are CROs adapting to the rise of decentralized clinical trials, and what are the key challenges and opportunities?

Gary Ellsworth: Five years post-pandemic, life science companies continue to recognize benefits of decentralized trials to effectively recruit, engage and retain patients while addressing their needs. Gauging where DCT components are most valuable, if appropriate at all, has been top of mind. In early trial design stages, advanced design analytics applications and patient market research are helping to provide key insights to where it may be possible or necessary to integrate DCTs to increase patient engagement and reduce their burdens while adequately supporting sites and expanding the trial’s geographic reach. 

DCTs can embrace a broad range of advanced solutions that have been found to enhance patient and site experiences, including DCT platforms, eCOA, eConsent, telehealth, connected devices and tools for self-collection of blood samples. However, it is also important to consider the human touch in DCTs and design trials with empathy. A noteworthy way to strengthen a patient’s experience and expand trial access to individuals in remote or rural areas is to establish mobile research teams. These highly skilled healthcare professionals can engage patients where they live to collect data and specimens and deliver and/or administer the investigational treatment. 

Because trial sponsors’ in-house DCT capabilities vary, CRO service partners will need to offer flexibility in DCT strategies spanning support needed by small EBPs and mid-size and large, global pharmaceuticals. Additionally, it will be key for CROs to offer ongoing training and support for the design and use of DCT components for sponsors, site teams and/or patients. 

Contract Pharma: What are the key challenges CROs face in data management and regulatory compliance, and how do CROs address them?

Gary Ellsworth: Trial sponsors’ ability to successfully navigate regulatory submissions has improved in recent years. Sponsors received fewer FDA Complete Response Letters in 2024 than in 2023, and clinical reasons were cited in fewer cases.  

Because today’s clinical trials collect approximately three times as much data as they did 10 years ago and it comes from a growing number of sources, it is no longer feasible to manually collect, monitor, clean and analyze what are now millions of data points from one individual trial. Sponsors are recognizing the value of developing comprehensive and connected data management strategies, from data collection to endpoint analysis, during protocol design, not after protocol is finalized, as traditionally done. 

CRO service partners can recommend the optimal data collection, vendor selection and end-to-end standardization needed for a comprehensive data management strategy that meets regulatory requirements. This includes continuous but streamlined end-to-end data flow enabling automated data review for all relevant stakeholders and associated data insights throughout the study life cycle. To increase data quality and not add burden to patients and sites, sponsors are engaging the necessary experts during trial design planning, including data strategists, digital health solutions specialists, data standards engineers, therapeutic specialists, biostatisticians, etc.

Specifically, as Clinical Data Interchange Standards Consortium standards and regulatory guidance are routinely updated, data standards engineers can keep up with documentation requirements as well as the intent behind the guidance. In many cases, data standards engineers are part of CDISC committees that lead industrywide discussions and can provide trial sponsors with guidance on how to quickly adapt to regulatory changes and different collection methods. This role will be especially critical as regulators facilitate improvements in international harmonization of standards, which sponsors will need to consider.

*All figures and statistics are sourced from the IQVIA Institute 2025 Global Trends in R&D Report

**Resources for this section are from IQVIA proprietary data.

Gary supports the facilitation of cross-functional collaboration among various business lines and functions, ensuring effective communication and delivery for EBP and midsize partnership customers. Prior to his role leading Alliance Management, Gary held various roles in strategy and operations at IQVIA.