Clinical trial supply market forecasts, developments and technology trends

Written by Priyanka Bhindel, Healthcare Market Research Team Leader, Markets & Markets

The pharmaceutical and biotechnology industry has witnessed rapid growth in recent years, with significant investments in research and development to develop new drugs and biologicals to treat various diseases. This has led to an increase in the number of registered clinical trials in recent years (up to more than 744,000 globally). The progress of new medicines depends on the successes of clinical trials, and effective supply chain management is one of the key variables that influence clinical trial outcomes. Recent advances in technology, rising costs, high trial failure rates, and the emergence of patient-centered trials have had a significant impact on the clinical trial supplies market.

According to our published market research, the clinical trial supplies market for services required during the phase I to phase IV clinical trial process for drug or medical device development is estimated at $3.9 billion in 2023 and is expected to reach $6.3 billion by 2028 with a growth rate CAGR of 9.9% during the forecast period (2023-2028). This growth is mainly due to factors such as increasing R&D investments by biopharmaceutical companies, increasing number of clinical trials, increasing decentralization of clinical trials, rising prevalence of orphan and rare diseases, and increasing outsourcing activities in emerging Asian economies.

We’ll take a look at some of the developments and forecasted trends for the clinical trials supply chain in this article.

Technological advancements to drive market growth for logistics and distribution services

The clinical trial supplies market is categorized into services; manufacturing; Packaging, labeling, and blinding; Comparison sources; logistics and distribution services; Storage and retention. And other services. Logistics and distribution are an integral part of the clinical trial supplies market. Factors such as increasing complexity, evolving treatment protocols, technological advancements, and data security challenges are playing a pivotal role in driving the growth of logistics and distribution services in the clinical trial supplies market.

Technology has significantly helped streamline the clinical trial supply chain by contributing to increased efficiency, accuracy and reliability in the handling, transportation and distribution of clinical trial materials. The key aspects of technological advancement and its impact on logistics and distribution services in the Clinical Trials Supplies market are as follows:

• Blockchain technology Ensures a secure, transparent and tamper-proof record of transactions within the clinical trials supply chain. This enhances data integrity, reduces the risk of errors, and enhances trust among stakeholders.
• IoT devices and IoT sensors Ensure continuous monitoring of temperature, humidity and other environmental conditions during transportation and storage. This is critical to maintaining the integrity of temperature-sensitive clinical trial supplies, such as biological materials.
• Data analytics and predictive modeling Historical data can be analyzed to forecast demand, improve inventory levels, and enhance distribution planning. This leads to more informed decision making and efficient supply chain operations.
• aArtificial Intelligence (AI) and Machine Learning (ML) Algorithms can be used to optimize logistics routes, predict potential delays, and improve overall supply chain efficiency. Specifically, AI-powered logistics optimization improves efficiency, reduces transportation costs, and contributes to just-in-time deliveries.

Collectively, these technological advances contribute to a more efficient, transparent and secure clinical trial supply chain. It enables logistics and distribution to meet the stringent requirements of the pharmaceutical and clinical research industries, ensuring safe and timely delivery of clinical trial supplies.

Small molecule dynamics for clinical trial supplies

The clinical trial supplies market is broadly segmented into biologics, small molecule drugs, and medical devices. The small molecule clinical trial supplies market is driven by the continuous development of conventional drugs and medicines. Thus, as precision medicine, advanced drug delivery systems, orphan drug development, digitalization, and regulatory flexibility continue to shape the industry, stakeholders can anticipate a future in which small molecule medicines play a pivotal role in driving innovation, improving patient outcomes, and addressing unmet medical needs. Furthermore, the low cost, ease of use, and advances in drug delivery technologies for small molecule drugs have led pharmaceutical companies to focus on their production, which in turn has led to the outsourcing of various activities, including clinical trial supplies. For example, in November 2023, Pfizer entered into a licensing agreement with Serina Therapeutics for its small molecule drug delivery technology. Under the agreement, Pfizer will have access to Serina’s POZ platform, which includes liposomal nanoparticle delivery systems for RNA-based therapeutics. Under the terms of the deal, Pfizer will non-exclusively license the drug delivery technology for Serina’s POZ platform.

Clinical trial supplies by therapeutic area

The clinical trial supplies market is expected to continue to grow in the coming years, driven by growing demand for new and innovative treatments. The clinical trial supplies market is segmented into oncology, infectious diseases, neuroscience, metabolic disorders, immunology, cardiology, genetic and rare diseases, and other therapeutic areas (respiratory disorders, skin disorders, ENT, kidney diseases). The areas of oncology, cardiology, and infectious diseases are expected to see the greatest growth. Oncology is the largest therapeutic area in the clinical trial supplies market, due to the high prevalence of cancer, the increasing focus on targeted therapies and immunotherapy, and the complex clinical trial designs required for these therapies. Moreover, factors such as development of specialized therapies, alternative regulatory pathways, demand for patient-centric and personalized approaches, biomarker-driven trials, and collaborative efforts by key industry players are likely to provide a boost in the oncology segment. Together, these factors shape the supply landscape for the oncology sector, reflecting the urgency and complexity of cancer research and treatment development.

For example, in September 2023, OncoNano Medicine, Inc. announced Announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination phase with ONM-501, a dual-activated STING (interferon gene agonist). In patients with advanced solid tumors and lymphomas, the first-in-human ONM-501 trial (NCT06022029) is a multicenter, phase 1a/b dose-escalation and dose-expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo. The clinical trial is sponsored by OncoNano, while cemiplimab will be provided by Regeneron. Strategic alliances between pharmaceutical companies, CROs, and logistics providers play a critical role in optimizing the clinical trial supply chain. This is likely to have a positive impact on market growth.

Players involved in clinical trial supplies

The prominent players in the clinical trial supplies market include: Thermo Fisher Scientific (US), Catalent (US), Eurofins Scientific (France), Piramal Pharma Solutions (India), PRA Health Sciences (US), Marken (a subsidiary of UPS) (United States). ), Parexel International Corporation (US), Biocair (UK), Almac Group (UK), Sharp Services LLC (US), PCI Pharma Services (US), Lonza Group (Switzerland), and others. Players offer end-to-end services, decentralized services with a larger and more flexible geographical reach, and just-in-time manufacturing, packaging and labeling services. These companies have adopted strategies such as collaborations, partnerships, acquisitions, service launches and geographic expansions to expand their global presence. Some of the strategic initiatives over the past few years in the clinical trial supplies market include:

• In September 2022, Parexel, a CRO, opened a new warehouse for clinical trial supplies and logistics in Suzhou, China. The new warehouse provides local and international biopharmaceutical customers with timely access to supplies and medicines for clinical trial sites and patients to accelerate clinical trials in the region.
• In March 2021, PCI Pharma Services expanded its Berlin facility to enhance its cold chain storage and distribution capabilities.
• In September 2020, PCI Pharma Services launched PCI Bridge, a platform that enables customers to track their clinical and commercial supply chain to make effective decisions.
• In July 2020, Catalent acquired Teva-Takeda Pharmaceuticals’ packaging facility to provide flexible clinical supply solutions to pharmaceutical and biotechnology companies globally.
• In January 2020, Catalent launched FlexDirect, a new direct-to-patient service for clinical trials. This service aims to send clinical supplies directly to patients’ homes to reduce/eliminate the need for in-person clinical field visits.

Strong focus on service launches, partnerships and geographical expansion by market players is contributing to their growth and is likely to have a positive impact on the market growth in the coming years.

Conclusion

As the healthcare and pharmaceutical industries continue to evolve, demand for effective and reliable clinical trial supplies remains strong. Technological advances such as blockchain technology, IoT devices, IoT sensors, data analytics, predictive modeling, artificial intelligence and machine learning are contributing to more efficient, transparent and secure logistics and distribution services in the clinical trials supply chain. These emerging technology trends will further revolutionize the development and management of clinical trial supplies, making the process more efficient, cost-effective and data-driven. Furthermore, the rising prevalence of cancer, increasing focus on targeted therapies and immunotherapy, simplified regulatory pathways, patient-centered and personalized approaches, cost considerations, and biomarker-driven trials collectively shape the clinical trial supply landscape for the oncology sector. The clinical trial supplies market is fragmented, with a large number of players competing for market shares. Most companies in the market focus on organic and inorganic growth strategies, such as service launches, expansions, acquisitions, partnerships, agreements and collaborations, to increase their service offerings, meet unmet customer needs, increase their profitability, and expand their business. Presence in the global market.

About the author:

Priyanka Bhindel has over eight years of experience in healthcare market research and consulting in the pharmaceutical, biotechnology and medical device sectors. Gained knowledge and experience in market assessment, market sizing and forecasting, end user perception analysis, opportunity analysis, competitive intelligence studies, and worked on growth correlations across bioprocessing technologies, cell culture technologies, contract research and manufacturing.