By Priyanka Bhendale, team lead – Healthcare Market Research, Markets and Markets
The pharmaceutical and biotechnology industry has witnessed rapid growth in recent years, with significant investments in R&D to develop novel drugs and biologics to treat various diseases. This led to an increased number of registered clinical trials in recent years (up to more than 744,000 globally). The advancement of novel medicines depends on clinical trial successes, and effective supply chain management is one of the key variables that affect a clinical trial's outcome. Recent advancements in technology, rising costs, high rates of trial failures, and the rise of patient-centric trials have had a substantial impact on the clinical trial supplies market.
According to our published market research, the clinical trial supplies market for services required during the clinical trial process from Phase 1 to Phase 4 of drug or medical device development is estimated at $3.9 billion in 2023 and is projected to reach $6.3 billion by 2028 with a CAGR of 9.9% during the forecast period (2023-28). This growth is mainly driven by factors such as the increasing R&D investments by biopharma companies, the growing number of clinical trials, the growing decentralization of clinical trials, the rising prevalence of orphan and rare diseases, and the increasing outsourcing activities in emerging Asian economies.
We will look at some of the anticipated developments and trends for the clinical trial supply chain in this article.
Technology Advancements To Drive Market Growth For Logistics & Distribution Services
The clinical trial supplies market is categorized into services; manufacturing; packaging, labeling, and blinding; comparator sourcing; logistics and distribution; storage and retention; and other services. Logistics and distribution are integral components of the clinical trial supplies market. Factors such as increasing complexity, evolving treatment protocols, technological advancements, and data security challenges play a pivotal role in driving the growth of logistics and distribution services in the clinical trial supplies market.
Technology has significantly aided in streamlining the clinical trial supply chain by contributing to increased efficiency, accuracy, and reliability in the handling, transportation, and distribution of clinical trial materials. The following are key aspects of technology advances and their impact on logistics and distribution services in the clinical trial supplies market:
- Blockchain technology ensures a secure, transparent, and tamper-proof record of transactions within the clinical trial supply chain. This enhances data integrity, reduces the risk of errors, and fosters trust among stakeholders.
- IoT devices and IoT sensors ensure continuous monitoring of temperature, humidity, and other environmental conditions during transportation and storage. This is crucial for maintaining the integrity of temperature-sensitive clinical trial supplies, such as biologics.
- Data analytics and predictive modeling can analyze historical data to forecast demand, optimize inventory levels, and enhance distribution planning. This leads to more informed decision-making and efficient supply chain operations.
- Artificial intelligence (AI) and machine learning (ML) algorithms can be employed 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 timely deliveries.
These technological advancements collectively contribute to a more efficient, transparent, and secure clinical trial supply chain. They enable logistics and distribution services to meet the stringent requirements of the pharmaceutical and clinical research industries, ensuring the safe and timely delivery of clinical trial supplies.
Small Molecule Dynamics Of Clinical Trials Supplies
The clinical trial supplies market is broadly segmented into biologic drugs, small molecule drugs, and medical devices. The clinical trial supplies market for small molecules is driven by the consistent development of conventional pharmaceuticals and generics. And so, as precision medicine, advanced drug delivery systems, orphan drug development, digitalization, and regulatory flexibility continue to shape the industry, stakeholders can anticipate a future where small molecule drugs play a pivotal role in driving innovation, improving patient outcomes, and addressing unmet medical needs. Moreover, low cost, ease of use, and advancements in drug delivery technologies for small molecule drugs have driven pharmaceutical companies to focus on their production, which, in turn, has driven the outsourcing of various activities, including clinical trial supplies. For instance, in November 2023, Pfizer entered into a license agreement with Serina Therapeutics for its drug delivery technology for small molecules. Under the agreement, Pfizer will have access to Serina’s POZ platform, which includes lipid nanoparticle delivery systems for RNA-based therapeutics. Under the terms of the deal, Pfizer will license Serina’s POZ platform drug delivery technology non-exclusively.
Clinical Trial Supplies By Therapeutic Area
The clinical trial supplies market is expected to continue to grow in the coming years, driven by the increasing demand for new and innovative treatments. The clinical trial supplies market is segmented into oncology, infectious diseases, neurology, metabolic disorders, immunology, cardiology, genetic and rare diseases, and other therapeutic areas (respiratory disorders, dermatological disorders, ENT diseases, and nephrology). The areas of oncology, cardiology, and infectious diseases are expected to see the most significant 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. Furthermore, factors such as the 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 an uplift in the oncology segment. These factors collectively shape the supplies landscape for the oncology segment, reflecting the urgency and complexity of cancer research and treatment development.
For example, in September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist. In patients with advanced solid tumors and lymphomas, the ONM-501 first-in-human trial (NCT06022029) is a multicenter Phase 1a/b dosage escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo. The clinical trial is being sponsored by OncoNano, while Regeneron will provide cemiplimab. Strategic alliances between pharmaceutical companies, CROs, and logistics providers play a crucial role in optimizing the clinical trial supply chain. This is likely to have a positive impact on the growth of the market.
The Players Operating In Clinical Trial Supplies
Prominent players in the clinical trial supplies market include Thermo Fisher Scientific (U.S.), Catalent (U.S.), Eurofins Scientific (France), Piramal Pharma Solutions (India), PRA Health Sciences (U.S.), Marken (a subsidiary of UPS) (U.S.), Parexel International Corporation (U.S.), Biocair (U.K.), Almac Group (U.K.), Sharp Services LLC (U.S.), PCI Pharma Services (U.S.), and Lonza Group (Switzerland), among others. Players provide end-to-end services and decentralized services with greater and more flexible geographic reach, 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 strategic initiatives over the past few years in the clinical trial supplies market include:
- In September 2022, Parexel, a CRO, opened a new clinical trial supplies and logistics depot in Suzhou, China. The new depot offers local and international biopharmaceutical customers timely access to supplies and medications for clinical trial sites and patients to accelerate clinical trials in the region.
- In March 2021, PCI Pharma Services expanded its facility in Berlin to enhance its cold chain supply storage and distribution capabilities.
- In September 2020, PCI Pharma Services launched PCI Bridge, a platform that enables customers to follow their clinical and commercial supply chain for effective decision-making.
- 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 site visits.
Strong emphasis on service launches, partnerships, and geographic expansion by market players contributes to their growth and will likely have a positive impact on market growth in the coming years.
As the healthcare and pharmaceutical industries continue to evolve, the demand for efficient and reliable clinical trial supplies remains robust. Technological advancements such as blockchain technology, IoT devices and IoT sensors, data analytics and predictive modeling, and AI and ML contribute to more efficient, transparent, and secure logistics and distribution in the clinical trial 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 high prevalence of cancer and an increasing focus on targeted therapies and immunotherapy, streamlined regulatory pathways, patient-centric and personalized approaches, cost considerations, and biomarker-driven trials collectively shape the landscape of clinical trial supplies for the oncology segment. The clinical trial supplies market is fragmented, with a huge 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, cater to the unmet needs of customers, increase their profitability, and expand their presence in the global market.
About The Author:
Priyanka Bhendale has more than eight years’ experience in healthcare market research and consulting across the pharmaceutical, biotechnology, and medical device verticals. She acquired knowledge and expertise in market assessment, market sizing and forecasting, end user perception analysis, opportunity analysis, and competitive intelligence studies and has worked on the growth engagements across bioprocessing technologies, cell culture technologies, and contract research and manufacturing.