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.     

According to Fortune Business Insights, the global contract research organization (CRO) services market size was valued at $79.5 billion in 2023 and is projected to grow from $86.3 billion in 2024 to $175.5 billion by 2032, at a CAGR of 9.3% during the forecast period.¹  

Continued growth in outsourcing can be attributed to increasing complexity and cost of drug development requiring specialized services and expertise, in addition to navigating regulatory compliance. Data analytics and AI are also playing an important role in clinical trial design, execution, and data management, leading to more efficient and effective trials.

Contract Pharma spoke with top CROs to discuss these and other trends, as well as new opportunities going forward. These include the rise of functional CRO services, which focus on specific areas of clinical trial management, guidance and expertise in emerging therapeutic areas, virtual and decentralized clinical trials, and data management and regulatory compliance.

Outsourcing in today’s market

Among the key trends driving outsourcing in today’s drug development landscape is trial complexity encompassing several areas that can range from, trial design, vast data, advanced technologies such as AI, to regulatory changes and geopolitical conflicts, as well as rising costs and the need to create efficiencies. “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.,” says Gary Ellsworth, Head of North America Alliance Management at IQVIA.

With respect to outsourcing, emerging biopharma companies (EBPs) and mid-sized pharma companies have specific needs. “EBPs, mostly pre-commercial, are responsible for 63% of trial starts, up from 56% in 2019,²” says Ellsworth. “It can be a make-or-break time for EBPs heavily focused on one or two key assets. As such, they may rely on guidance from CRO partners to effectively move from clinical trial design and execution to commercialization,” Ellsworth notes. 

Meanwhile mid-size pharmaceutical companies may experience change during pipeline expansion and company growth, according to Ellsworth. 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 experience working in similar capacities for other drug developers of similar size, focus and situation,” Ellsworth adds.

There is a focus on increasing R&D efficiencies for trial sponsors. Significant contributors to trial complexity are trial eligibility criteria and the number of primary and secondary endpoints are increasing to better establish earlier signs of treatment efficacy, Ellsworth notes.

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 is essential, says Ellsworth. Leveraging artificial intelligence/machine learning, real-world evidence, protocol simplification, novel trial design, decentralized solutions, and community engagement, for example, drug developers have significant opportunities to streamline efficiencies without compromising quality outcomes. 

“As the clinical trial landscape becomes increasingly complex, sponsors face heightened time and cost pressures as well as a rapidly growing amount of data. To navigate these challenges, it is more important than ever to seek opportunities through outsourcing partners that can enhance efficiency and agility,” says Deb Tatton, President, Global Clinical & Data Operations, Parexel. Key trends driving this shift include the use of AI, the globalization of trials, and the blending of FSP (Functional Service Provider) and FSO (Full Service Organization) models, according to Tatton. 

Specifically, blending FSP and FSO models is a critical component of the outsourcing toolbox in the current drug development landscape, Tatton points out. “These enable pharmaceutical companies to achieve the bespoke strategies that align with the diverse and distinct needs for each trial. Traditional “one-size-fits-all” approaches limit this agility,” says Tatton.

FSP models have evolved beyond traditional staff augmentation. For example, blended models can be performance-based, with CROs accountable for delivery within the defined scope. “This typically includes CRO responsibility for resource utilization, timelines and quality. In parallel, process innovation and continuous productivity enhancement responsibilities are shared,” adds Tatton. These models enable sponsors to maintain control and oversight over their trials, while leveraging their outsourcing partner’s operational expertise.

Les Enterline, Senior Vice President, Global Head of Functional Service Partnership Solutions, Clinical Research, Thermo Fisher Scientific, adds, “In response to various drug discovery challenges, including rising costs and increased complexity, we’re increasingly seeing biopharma companies leverage FSP partnerships to meet their timelines and ensure their projects stay on budget.” 

According to the latest FSP Trends Report by The PPD clinical research business of Thermo Fisher Scientific, 35 percent of sponsors say they’ve increased FSP outsourcing compared to 29 percent who’ve increased their use of FSO.³ The report also shows a growing preference for hybrid FSP/FSO partnerships, with 33 percent of sponsors preferring a mixed-model approach compared to 26 percent in 2023. According to the report, these trends are seen in both large and small/mid-size biopharma segments. 

Therapeutic areas driving CRO growth

Shaped by the demand for clinical trials in specific therapeutic areas, CROs recognize the need to adapt to R&D pipeline trends and hone resources and expertise accordingly. Key therapeutic focuses are oncology, immunology, neurology and cardiovascular, which represent 71% of the 5,318 clinical trials started in 2024,² according to IQVIA’s recent Global Trends in R&D 2025 report.

Oncology continues to be the most prominent therapeutic area for R&D globally, with novel modalities, including antibody-drug conjugates, cell and gene therapies, multi-specific antibodies, among others, accounting for 35% of oncology trial starts in 2024.² 

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 2023.² “We can anticipate more growth in this highly dynamic market because the obesity pipeline — from Phase I to post-approval — now includes 173 drugs, says IQVIA’s Gary Ellsworth. Now that the anti-obesity treatment market has taken shape, it’s important for CROs to monitor where obesity R&D is heading.

“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,” adds Ellsworth.

Clinical trials focused on treating endocrine cardiometabolic diseases, such as obesity and Type 2 Diabetes, are increasing at an exponential pace, agrees Deb Tatton, President, Global Clinical & Data Operations at Parexel. “Second generation GLP-1 clinical trials are at the forefront, with over 100 anti-obesity drug candidates currently in development, and CROs are crucial in navigating this competitive and evolving landscape,” says Tatton.

Additionally, rare disease and cell and gene therapies (CGTs) are also seeing significant growth. Innovative trial designs that address challenges posed by smaller patient populations and ethical concerns, and facilitating regulatory approval for rare disease assets, CROs are incorporating decentralized trial options to improve patient access and data collection, while leveraging real-world evidence and the patient perspective to refine trial designs and outcomes, notes Tatton.

Also, the surge in CGTs has prompted more pharma and biopharma companies to engage CROs to expedite development. Cell and gene research presents unique challenges for patients given the novelty of this field. “CROs must focus on improving the patient journey in these trials and provide adequate upfront education to ensure informed consent. CROs are essential in scaling up the development and delivery of these therapies to patients,” adds Tatton.

Virtual and decentralized trials 

CROs are adapting to the rise of virtual and decentralized clinical trials (DCTs) by advancing solutions and addressing certain challenges that arise. By leveraging advanced technologies, such as telemedicine, remote monitoring, electronic data capture and home healthcare, many CROs are also building flexible hybrid models combining traditional site visits with remote monitoring capabilities, according to Jenna McDonnell, Executive Director, Patient First Digital Solutions, Clinical Research, Thermo Fisher Scientific. 

Key challenges have included site adoption, managing the varied regulatory landscape, and the logistics of remote patient interactions, notes McDonnell. “These challenges can be addressed by CROs developing new competencies in these virtual and decentralized solutions while maintaining support for sites and patients.​​​​​​​​​​​​​​​​ However, significant opportunities still lie in the ability to reach more clinically relevant patient populations, increase retention, reduce trial costs, and accelerate timelines,” McDonnell says.

CROs have integrated technologies and other service elements to enable decentralized clinical trials, ultimately boosting trial efficiency and patient engagement, according to Deb Tatton at Parexel. “Innovation like remote monitoring and digital data collection tools offer enhanced flexibility, minimize logistical challenges, improve patient recruitment and retention, and near-real time data collection. However, as these decentralized approaches continue to advance, CROs must also address challenges related to adoption, data security and meeting regulatory standards across various sites and countries,” says Tatton.

Life science companies continue to recognize benefits of decentralized trials to effectively recruit, engage and retain patients while addressing their needs, according to IQVIA’s Gary Ellsworth. “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,” says Ellsworth.

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 pharmaceutical companies, Ellsworth notes. 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. 

Data management and regulatory compliance 

Data integrity and regulatory compliance are key elements of successful clinical trials and as such, CROs need robust systems and processes to tackle them. “Data overload, interoperability of various systems, as well as protecting the privacy and security of patient data, are among key challenges CROs face in today’s drug development landscape. To address this, CROs are investing in AI-driven platforms that can efficiently process and interpret large datasets, enabling swift decision-making and adherence to regulatory standards,” says Parexel’s Deb Tatton.

Additionally, as regulations change, CROs must stay updated to effectively safeguard sensitive patient information and ensure compliance, notes Tatton. Here, employing robust security systems and data governance practices help CROs stay up to date on Good Clinical Practices (GCPs).

Nancy Andrade, Director, PPD FSP Clinical Data Management solutions, Clinical Research, Thermo Fisher Scientific, and Myriam Antoun, Functional Lead, PPD FSP Regulatory Affairs solutions, Clinical Research, Thermo Fisher Scientific, agree, “As clinical trial complexity continues to increase, driven by continued growth in the number of procedures, endpoints, and data points collected, as well as increased use of real-world data, CROs face several key challenges in data management and regulatory compliance.” 

For data management, Andrade and Antoun note key challenges include ingesting data from many disparate sources, deploying novel technologies, such as AI/ML and data warehouses/workbenches, and upskilling staff as data review best practices and technologies evolve from data-point driven methods to more risk-based and exploratory approaches. This includes using data science strategies that combine typical centralized monitoring, data management, and biostatistics roles to generate deeper insights and critically assess data. 

Meanwhile, for regulatory compliance, key challenges include ensuring patient safety, effectively monitoring changing regulations across different regions, and managing complex documentation requirements. “To help mitigate these challenges, CROs increasingly provide sponsors with FSP teams that provide specialized clinical data management and regulatory affairs expertise, systems, and training – which helps sponsors enhance their existing capabilities and maintain adherence to regulatory standards,” says Andrade and Antoun. CROs continue to adapt to help address today’s drug development complexities. Here, CROs can recommend data collection options and standardization needed for comprehensive data management that meets regulatory requirements.

References

1. https://www.fortunebusinessinsights.com/industry-reports/contract-research-organization-cro-services-market-100864

2. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2025 

3. https://www.ppd.com/resource/2025-fsp-trends-report/