Market Trends of Global Contract Research Organization Industry
The Phase II Clinical Research Services Segment is Poised to Witness Significant Growth During the Forecast Period
CROs are pivotal in navigating the logistical complexities of multinational trials. Phase II clinical research serves as a crucial checkpoint, assessing the safety and efficacy of investigational candidates before advancing to larger-scale trials. These trials often demand specialized expertise in specific therapeutic domains. To ensure effective trial conduct, sponsors frequently enlist CROs with established expertise in these areas. Furthermore, pharmaceutical companies are increasingly conducting trials across various regions and countries, aiming to engage with a broader spectrum of patient populations.
Given the robust pipeline of investigational candidates, the demand for CRO services is poised to surge, driving segment growth. For instance, as of March 2024, ClinicalTrials.gov reported approximately 77,918 Phase II studies spanning 223 countries. This underscores the anticipated contribution of Phase II clinical trials to segment growth in the coming years.
Market players are actively engaging in strategic activities, such as collaborations, agreements, and product launches, which are anticipated to bolster segment growth. These players are deeply involved in strategic dialogues with pharmaceutical companies, facilitating various research outsourcing endeavors. For instance, in November 2023, TC BioPharm (Holdings) PLC appointed Fortrea (FTRE) as its CRO for global trials, encompassing the ACHIEVE and ACHIEVE2 studies. Similarly, in July 2023 Molecule SA, a biotech company, signed an agreement with France's Orion Sante Sarl (CRO) to oversee a comprehensive Phase II clinical trial for OATD-01, a candidate under investigation for its potential in treating pulmonary fibrosis.
Moreover, in May 2023, Lipigon Pharmaceuticals AB collaborated with LINK Medical, a Nordic CRO, to meticulously plan and design their Phase II study. This study aims to evaluate the safety and treatment effects of Lipisense in patients with significantly elevated triglyceride levels in their blood. Such strategic moves by industry players, aimed at expediting the development of Phase II candidates, are set to amplify segment growth over the forecast period.
In conclusion, with a robust pipeline in Phase II development and a surge in collaborations among key players, the segment is poised for significant growth opportunities.
North America is Expected to Hold Significant Market Share During the Forecast Period
Major pharmaceutical companies are increasingly outsourcing R&D and clinical trials, driven by shifts in reimbursement policies and rising competition from generic drugs. This trend is bolstering the growth of the CRO market in North America. Furthermore, escalating in-house drug development costs, the growing complexity of clinical trials, and a surge in investigational candidates in the development pipeline are all set to further fuel this regional market expansion.
The high in-house drug discovery and development expenses, pharmaceutical firms are turning to contract research organizations (CROs) for clinical trials. This shift not only alleviates their financial burden but also addresses the heightened complexities of these trials, given that CROs possess the necessary infrastructure and expertise.
For instance, a 2022 study by the World Health Organization (WHO) highlighted that developing a new drug can cost between USD 43.4 million and USD 4.2 billion. Such staggering costs underscore the growing reliance on CROs by pharmaceutical companies, as these organizations bring superior experience and infrastructure for conducting research services. Consequently, this heightened demand for CROs is anticipated to bolster the country's market growth in the coming years.
Moreover, supportive government legislation aimed at promoting clinical trials in the region further underpins this market growth. For instance, in January 2023, the Canadian Institutes of Health Research made significant investments to bolster the country's clinical trials and research projects. Such governmental backing is poised to invigorate clinical trials in the country, thereby propelling market growth.
Additionally, strategic moves by market players are set to further energize regional market growth. For instance, in November 2023, Fortrea, a prominent CRO, teamed up with Medidata to harness AI-driven intelligent trials, aiming to broaden patient diversity in Fortrea's clinical studies. This partnership ensures a smoother integration of varied populations into the trial framework. Similarly, in November 2023, CEBIS International broadened its preclinical and clinical trial services in North America, signaling its commitment to enhancing drug development and trial efficiency.
Thus, factors such as rising drug development costs and proactive industry strategies are poised to drive regional market growth over the forecast period.
