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With the ultimate goal of improving patient care and public health through evidence-based information the drug discovery and development value chain involve a step-by-step approach beginning with drug discovery, preclinical research followed by clinical development stages and commercialization/market authorization.
Clinical research is a crucial aspect of drug development value chain that focuses on systematically evaluating the effectiveness, safety, and benefits of medications, medical devices, diagnostic products, and treatment regimens intended for human use.
What began with the Covid-19 pandemic, continues the same pace with constantly surging R&D pipelines surpassing 22,000 molecules as of January 2024, with over 8000 molecules in clinical development phase alone, as per Pharma Intelligence Annual R&D Review, 2024. Moreover, the industry dynamics has been witnessing a huge shift with much of the clinical research being conducted in emerging economies and third-world countries, such as India, Indonesia, China, Latin America, the Middle East, and South Africa. For example, within Asia Pacific, of the total R&D pipeline, China constituted over 6000 drugs whilst India stood at 600+ drugs in the pipeline. Furthermore, small to mid-segment companies continue to contribute the highest to the R&D pipeline, standing at about 17-18% of the total pipeline. This trend is likely to continue with small-to-medium-segment and emerging biopharma participants introducing novel therapies across various indications, primarily oncology, infectious diseases, and neurology as well as rare diseases.
Owing to the ever-increasing pipelines and a constant surge in small to mid-segment companies’ contribution to innovation, there is also a greater need for clinical research services, through outsourcing. Overall, clinical research entails different types of studies such as observational, interventional and epidemiological amongst others. The interventional trials further include phase 1 to 4 of clinical trials involving 1000’s of patients, as the phases progress.
Outsourcing - the way forward for clinical research
Alongside the growing innovation, pharma sponsors are keen on cutting down the cost of drug development especially clinical trials, which constitute the most share of the total clinical research costs. Right from site selection to trial design, to patient recruitment, a full proof trial design determines the potential success or failure of the drug under development. Also, post-trial activities including pharmacovigilance, health economics outcomes research, data management and many other areas, which also account to a significant share of the drug development costs. In this regard, there is a growing interest in outsourcing the clinical development activities to CROs as well as Contract Development and Manufacturing Organizations (CDMOs), which can not only improve the time to market, but also allow significant cost savings.
Emerging business models
Besides clinical trial services, pharma sponsors are looking to outsource more early-stage drug discovery and preclinical services to CROs. Small- to mid-segment and emerging biopharma mainly look at outsourcing early-stage drug development activities because they lack the capabilities. Drug discovery CROs are increasingly building their expertise with specialized lab capabilities supporting services such as analytical testing, increasing competition in the segmented CRO market. The interdependence between CROs and CDMOs concerning the services they offer is growing, with sponsors looking for one-stop solutions for drug development, leading to the emergence of CDMOs.
The global CRO market is expected to witness a 10.5% CAGR between 2023 to 2028, as per Frost & Sullivan estimates. Companies such as Syneos Health, Labcorp (Fortrea), Tigermed, Wuxi Apptec, Avance Clinical and many others are some of the leading CROs across the CRO industry providing end to end trial support. Whilst North America dominates the market landscape with over 45% of the market share, Asia Pacific is emerging as the fastest growing market with over 16% growth in the next 3 to 5 years. Within APAC, China, South Korea, Australia and Japan are amongst the leading markets owing to the presence of leading players such as Wuxi Apptec, Avance Clinical, CMIC and many more. However, India is considered as a growing opportunity with the rise of several niche CROs especially supporting early-stage drug discovery and preclinical activities. According to F&S estimates, the India’s clinical CRO market is expected to show over 14% of CAGR in the next 5 years, while the non-clinical segment will also showcase 10% growth. Players such as Syngene International, Aragen, Veeda Clinical, SIRO Clinpharm, Aurigene Discovery services and many more are at the forefront of the India CRO landscape.
Also, post the onset of the pandemic in 2020, there was a sudden increase in the adoption of remote clinical trials. Despite a comparatively lower adoption rate of about 6 to 8%, an accelerated reliance on adaptive trial designs, especially through decentralized modalities is driven by the focus on reducing burden of site investigators, clinical research associates, and patients to participate in trials. To ensure this, most sponsors and CROs have been adopting digital tools to support trial operations, including telemedicine, remote source data verification, and sensor/mobile technology-enabled direct data-capture solutions. Regulatory agencies around the world are coming up with initiatives and guidelines for large-scale adoption of DCT modalities, alongside existing alliances, such as Decentralized Trials & Research Alliance, that work toward increasing DCT awareness, propelling remote trial uptake. Many pure play DCT vendors including Science37, Medable, THREAD have been working alongside CROs to support remote patient recruitment, participation and management using their DCT platforms.
How is technology supporting clinical development?
With developing sound trial designs and identifying the right patient cohorts being crucial for drug success, there is a large-scale implementation of digital technologies in the form of Software as a Service Solutions (SaaS), Real World Data (RWD), cloud computing and other cloud infrastructure, Artificial Intelligence and Machine Learning amongst other technologies. Companies such as Phesi, ConcertAI, AWS, Oncoshot respectively and many more established and emerging players have developed unique in-house models and platforms that rely on large Language Models in identifying the patient groups for recruitment as well as supporting the right trial design with predictive analytics solutions.
On the other hand, other technology vendors such as eClinical solutions vendors further expand the remote trial participation options for patients, with the help of mobile devices such as smartphone, wearables, tablets and many more. Companies such as Oracle, Veeva Systems, Advarra, ArisGlobal, Castor and many more have developed cutting edge, electronic data capture, eCOA, ePRO , and other eclinical platforms that allow for better trial participation as well as adherence. Across India also, players such as Clinion, Consilx and many more have been developing unique AI enabled eclinical platforms supporting pharma companies in the region, there by establishing a strong positioning in the local markets, on par with the industry leaders.
What is making the clinical research services landscape thrive?
Across the global outsourcing industry, there is a rapid uptake of technology in the form of AI/ML, eClinical solution and many other digital health technologies which are playing a vital role in improving clinical development outcomes. As the industry sees a growing number of clinical trials, RWD and real-world evidence (RWE) are capturing attention to ensure high data quality and accuracy. RWD usage in early drug development phases helps plan investment in a drug's development as it progresses in trials.
AI-enabled tech vendors support CROs and pharma companies in shortening drug development timelines and enabling cost efficiency by building innovative computational platforms. Moreover, with patient centricity being the central goal, companies are looking to allow greater diversity in trial patients, thus supporting remote/virtual trial models. Pharma companies are adopting integrated platforms that offer a unified trial workflow view to improve clinical trial efficiencies.
To align their services with the growing pipeline volumes, CROs are developing specialized capabilities across niche services, such as analytical testing, biometrics, next generation sequencing and traditional nonclinical and clinical development, with the help of external partnerships, in-house expansions or mergers and acquisitions. Several mid- and large-segment players are constantly looking to acquire newer capabilities in early- to late-stage lab testing, geographic span, and therapeutic expertise, resulting in a large number of mergers and acquisitions (M&As).
For example, in October 2023, Veristat, a full service CRO acquired Instat Clinical Research, a biometric CRO strengthening the former’s capabilities in global data management, biostatistics, and statistical programming teams, leveraging Instat’s staff in the United States and India. These activities allow companies to not only expand their service portfolio but also expand across geographies and tapping newer markets. Also, increased focus on next-generation therapies, such as CGTs and rare diseases, is evident, with players such as the Emmes Group and Ergomed acquiring Orphan Reach and MedSource, respectively. A similar trend is observed across the India CRO market as well with several recent M&As. For instance, Veeda Clinical acquired a European CRO, HEADS, strengthening its capabilities in oncology clinical trials across Europe, APAC and the USA.
Moving forward, this trend is expected to continue owing to a large scale shift towards a CRDMO model, as pharma sponsors, especially the small to mid-segment players look at partnering with more and more integrated service providers.
Outlook
The clinical research landscape is rapidly evolving with the evolving R&D pipelines of over 22,000 molecules and the significant contributions from small to mid-segment companies (catering to 18% of the R&D pipelines) and emerging economies. Outsourcing clinical development activities to CROs and CDMOs has become essential for achieving cost efficiency and faster time to market. Moreover, the integration of digital technologies, decentralized trial designs, and technologies in the form of SaaS models and AI is transforming clinical operations, enhancing patient participation, and improving data accuracy.
India is positioning itself as a go to market for clinical research services, highlighted by its robust patient diversity, expert talent pool and a constantly improving infrastructure. As the industry continues to innovate, these trends will shape the future of clinical research, fostering therapeutic breakthroughs and advancing global healthcare. The focus on patient-centric approaches and the strategic expansion of capabilities will ensure a robust and dynamic clinical research services landscape.
(Author is senior industry analyst, Healthcare and Life Sciences, Frost & Sullivan)
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