The contract research organization (CRO) sector experiences continuous growth and transformation. This is influenced by several crucial factors such as increases in research funding, more government backing for research and development (R&D), a growing global patient population, the increasing burden of chronic diseases worldwide and easing of the pandemic restrictions, thus resulting in more demand for approved medicines and treatments.

COVID-19 caused major disruptions in the CRO market and R&D activities when it first emerged. Strict lockdowns, social distancing and self-isolation meant patients were unable to get to clinical sites. This resulted in a lot of trials being cancelled or placed on hold, especially for non-urgent treatments which harmed the market back in 2020.

Some CROs benefited from this and grow while others struggled if they had a pipeline of work that wasn’t related to urgent treatments or covid trials, however, 2021 and 2022 saw significant growth as social restrictions and attitudes towards the pandemic continue to ease. This has resulted in studies for non-urgent treatment starting again but also new consistent demand as covid trials continue. This growth is expected to continue into 2023 and beyond.

In 2022 it was estimated that the current CRO market size is at $56.7 billion.¹ The North American market makes up $24.4 billion of that and is predicted to see increased growth.

Recent research indicates² that by 2028, the global CRO market is projected to surpass $65.5 billion. This translates to a compound annual growth rate (CAGR) of roughly 6.4% from 2022 to 2028 due to the outsourcing of clinical trials trend consistently growing as the CRO market meets the demand for support drug developers require.

We’ve broken down some key areas of current trends in the CRO market.

Therapeutic areas

There are several therapeutic areas in clinical development that are seeing an increase in demand and CROs with a strong expertise and experience in these specific therapy areas are benefiting.

Oncology
Oncology trials have increased in demand due to the increased prevalence of cancer which has required sponsors to develop different therapies and medical devices for improved management of cancer. Therefore, we can expect to see the oncology segment grow beyond its current $30.85 billion revenue in 2022. With new regulatory guidance emerging and different alternatives from the standard maximum tolerated dosing in proving a treatment’s efficacy and toxicity, there are excellent opportunities for biostatistics CROs to carve a niche as sponsors will require specialist CROs who understand complex trial types and designs.

Rare diseases
With an estimated 300 million people worldwide affected by rare diseases, the demand for treatments is growing. The global rare disease treatment market was valued at $195 billion in 2020³ which has resulted in a rising demand for CROs to support sponsors of clinical trials. There are several reasons for this trend including regulatory incentives, advancements in genomics, precision medicines, patient advocacy groups, and the increased emergence of biotech, particularly in the U.S. market. Many CROs are expanding their capabilities and expertise in conducting rare disease trials to meet this demand.

Infectious disease
The infectious disease treatment market was valued at $72.5 billion In 2021 and is predicted to grow to $106.4 billion by 2026, at a CAGR of 8.2%.⁴ The biggest driver for this growth in demand is the vaccines or treatments for SARS-CoV2 virus. As well as COVID trials there has been an increase in occurrences of infectious diseases and a rise in the number of hospitalizations are the major factors driving the growth of this market.

Technology

The use of digital technologies helped overcome the challenges set out by the pandemic and has created new trends in the way CROs and pharma/biotech conduct clinical trial analysis.

Digital data-capturing technology is causing a significant shift and the market has truly moved away from traditional paper-based record-keeping methods. Technology advancements are allowing for more patient-centric approaches to the conduct of a study as CROs and sponsors use these data capturing technologies to collect data away from clinical sites. As the industry shifts in this direction, it is important for CROs and sponsors to have a good understanding of virtual/decentralized/hybrid trial approaches and also a good understanding of real-world data.

Virtual, decentralized, and hybrid trials
Decentralized clinical trials are an entirely different approach with a transformational philosophy. As the COVID-19 pandemic took hold in 2020, CROs reported that sites were becoming inaccessible or non-functional due to travel limitations for both patients and monitors and because of the decrease in available health workers in the hospitals to support research. As discussed, many trials were put on hold and planned trials postponed due to the crisis, the response from the industry was to pivot to virtual trial models or hybrid models to start or continue the research. The industry was already exploring how virtual models could improve patient participation and their experience during trials, the pandemic however accelerated this change.

The concept of decentralized trials is to remove the burden on patients and the costs of traditional methods for sponsors. With a main objective to make clinical trial participation as easy as possible so patients can continue with their day-to-day lives with minimal disruption. Technologies would have to be incorporated into the trial design and protocol to allow for a decentralized or virtual approach and the use of new technologies which we later review enables this approach to a clinical trial because it allows sponsors to interact with trial patients directly in the comfort of their homes and at their convenience.

eCOA / ePRO / wearables
More and more CROs are using eCOA systems to increase clinical data collection off-site and improve data quality. By using smartphones, tablets, or wearables that patients are either provided or use on their own on a “bring your own device” trial, the patient avoids the burden of having to visit sites. These devices are used to capture patient-reported outcomes (PRO) in a more efficient manner. Collecting data in real-time can potentially improve the quality of the data as it can be more accurate.

CROs are getting more and more experienced in the use of these technologies and the data handling, processing, and validation of data. Issues can arise such as patient compliance to record the data off-site and CROs should be able to work with their sponsors to overcome challenges and provide their sponsors with confidence in their ability to manage and design trials using eCOA approaches.

Real world evidence

There has been an increase in demand for sponsors to require real-world data (RWD) to aid in providing investigational drug analysis. This has been driven by several factors such as the technology advances to capture these data types, the growth in the rare disease market as conducting a trial with few patients across the globe is potentially logistically impossible to get these patients to the site, and how certain treatments required rapid analysis and patients were already in a real-world setting like the covid outbreak. Some sponsors are interested in this data type because they gain an understanding of how their investigational treatments will react in a real-world setting where patients may be taking other medicines and not in such a controlled randomized trial setting. Therefore, using data from real-world settings can be seen as just as effective as site data.

CROs will need to be well-rehearsed in how to handle RWD, analyze this data type and design RWE trials. There are many sources of RWD such as longitudinal databases, medical records, and data from other new device sources.

Niche CROs

There continues to be merger and acquisition behavior in the CRO market as larger CROs acquire smaller niche providers. In 2017 only 7 CROs made up 52% of the global market share, therefore the number of niche providers making up the remaining 48% is vast.⁵ In February 2021, ICON acquired PRA and in December 2021 Thermo Fisher, a software supplier, acquired the CRO PPD.⁶  As the larger CROs scale up, it puts pressure on smaller CROs to niche down as the market becomes more stratified. These smaller CROs are finding a competitive edge by carving out a niche focus as it can offer a competitive advantage. Once they are well-rehearsed in a certain field and hold expertise in an area, they can increase their sales in this niche area to grow their market share and avoid competing directly with large market players. These smaller niche CROs typically focus on a few therapeutic areas, development stages or reduced service portfolios.

With the use of virtual trials, new emerging technologies, and real-world evidence there is an increase in demand for biometric data CROs. Their skill sets are especially of value as they solely focus on trial data and can specialize in these activities without the distraction of clinical monitoring or patient requirement initiatives.

Clinical data management teams need to now handle multiple sources of data and increase the volume of data. Having a CDM team that is proficient in the understanding of eCOA, ePRO and understands the requirements and challenges of a virtual trial has increased in importance. CROs that are experts in biostatistics and understand more complex study designs because of these emerging technologies are growing in more complex treatments are also benefiting. We are seeing trends where biotech companies are preferring to outsource unique tasks or service areas to a specialized smaller CRO as their smaller product portfolios are more precious to them whereas larger pharmaceutical companies with large product portfolios have their risks spread across multiple products. However, larger pharmaceutical companies are still forming strategic partners with niche CROs under functional service provision models as they realize the value of the niche CRO’s expertise. 

References
1.  https://www.gminsights.com/industry-analysis/contract-research-organization-cro-market
2.  https://www.fnfresearch.com/contract-research-organization-cro-market
3.  https://www.gminsights.com/industry-analysis/rare-disease-treatment-market
4.  https://www.pharmiweb.com/press-release/2022-09-16/infectious-disease-treatment-market-forecast-business-growth-and-development-factors-by-2031-cag
5.  https://lumosresearch.files.wordpress.com/2018/07/cro-market-report-vf.pdf
6.  https://www.appliedclinicaltrialsonline.com/view/cro-update-where-are-contract-research-organizations-headed

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As head of clinical data management (CDM), Claude works closely with Quanticate’s executive leadership team, focusing on the delivery of high-quality data to customers and developing CDM service offerings to meet future requirements.