U.S. Clinical Trials Supply And Logistics Market Size, Share & Trends Analysis Report By Service, By Phase (Phase I, Phase II), By Therapeutic Area (Oncology, Cardiovascular), By End-user, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The U.S. clinical trials supply and logistics market size was estimated at USD 1.3 billion in 2023 and is estimated to grow at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2030. The market's growth is primarily driven by technological advancements in the supply chain, increased R&D investment by pharmaceutical and biopharmaceutical companies, and the expansion of clinical trial sites.

As businesses embrace new technologies, the need for software in inventory management, supply chain planning, and ancillary supply chain management is growing rapidly. The push for cost reduction in R&D also drives the adoption of supply chain management technologies like enterprise resource planning, advanced planning management systems, and Interactive Voice Response Systems (IVRS). These technologies help businesses improve operational efficiency, optimize costs, and make data-driven decisions throughout the supply chain process.

Government programs like Medicare significantly impact private spending on research and development. By subsidizing the purchase of prescription drugs, Medicare increases the demand for new drug development, which can boost R&D investments and increase the chances of successful drugs and medicines. This surge in demand further fuels market growth.

The outsourcing of clinical trials is rising due to the growing demand for efficient logistics and supply chain management, including temperature control and cold chain management. Global biopharmaceutical spending on cold chain logistics has seen a significant increase, and this trend is expected to continue, driving the clinical trial supply and logistics market.

Market Concentration & Characteristics

The U.S. clinical trials supply and logistics industry is highly fragmented due to the presence of many companies that hold industry shares operating in the industry. In the last few years, pharma companies have adopted several strategic initiatives to improve their efficiency through outsourcing. For instance, in November 2021, PCI Pharma Services announced the development of a new clinical hub in Massachusetts, which would offer clinical storage, packaging, and distribution to fulfill the needs of the expanding New England clinical supply logistics industry.

Industry players are implementing a range of strategic activities, such as new partnership agreements, and collaborations to strengthen their services. For instance, in September 2022, US-based Medidata announced a strategic partnership with InventisBio. This collaboration would result in efficient trial operation and more possibilities for decentralized clinical trials (DCTs).

Regulations and restrictions for clinical trials have evolved rapidly, and the pandemic accelerated the need for continual monitoring by regulatory professionals and clinical teams, to maintain study integrity.

Several key companies are focusing on regional expansion initiatives to expand their geographic exposure and fulfill the needs of consumers in that region. For instance, In February 2022, Catelent the company announced plans to build its Waigaoqiao Free Trade Zone (FTZ) facility in Shanghai, China to enhance capacity for the distribution and storage of clinical supplies under temperature control as well as add more packaging capabilities which are secondary.

End-user Insights

Based on the end-user, pharmaceuticals dominated the market with a share of about 45% in 2023, owing to many contract research organizations. The U.S. is the center for the operation of major players in the supply and logistics market, such as PAREXEL International Cooperation, Thermo Fisher Scientific, Inc., and Marken. Moreover, the availability of strong infrastructure, the necessary funds, and the ability to adapt to advanced technology fuel market growth.

The biological segment is expected to expand at the fastest CAGR of 7.7% from 2024 to 2030. This can be attributed to increasing demand for biological products, such as cell & gene therapies and vaccines, and increased product development investments. Biological companies are undertaking strategic agreements to improve distribution channels and customer reach, as well as to outsource clinical trial supplies and logistics to CROs to increase profit margins & expand their product portfolio in new markets.

Service Insights

Based on the services, logistics, and distribution held the largest market share of 25.3% in 2023 and is expected to grow at the fastest CAGR over the forecast period. This growth is driven by increasing biologics pipeline and growing usage of temperature-sensitive drugs. Logistics experts of various market companies handle the logistics and distribution of labeled or packaged clinical trial materials, comparator medicinal products, investigational medicinal products, etc. They are involved in geographical expansion to boost the growth of the market. For instance, in February 2024, FedEx, an International Shipping Company Headquarters in the U.S., launched the “FedEx Life Science Center” in India to build a strong clinical trial supply chain. This move would support the clinical trial storage and logistics requirements of healthcare customers within the Indian market and those shipping to India worldwide.  

The manufacturing segment is projected to grow at a significant CAGR of 7.6% from 2024 to 2030, owing to the high demand for material supplies, further increasing the demand for quality drugs. Complex molecules and high demand for biologics are expected to boost the manufacturing segment of the global clinical trial supplies market. Manufacturers of clinical trial materials and supplies are required to meet the supply needs of different phases of pharmaceutical clinical trials. They are also required to be fully GMP compliant. Many material supplies are outsourced, which drives the demand for efficient clinical trial supplies. Outsourcing in manufacturing can be attributed to introducing new technologies to manufacture complex molecules and increasing the demand for developing cost-efficient products.

Phase Insights

Based on the phase type, phase III dominated the market with a revenue share of 43.5 % in 2023. Phase III trial is an essential stage for vaccine approval. Despite no or lesser incidences of COVID-19, manufacturers are still focusing on the new generation vaccine-manufacturing practices to prevent serious consequences of the disease shortly. As per clinicaltrial.gov, around 550 novel vaccines were in the development stage in 2022, which increased the number of trials that further contributed to the market's substantial market growth. Based on the phase type, phase III dominated the market with a revenue share of 43.5 % in 2023. Phase III trial is an essential stage for vaccine approval. Despite no or lesser incidences of COVID-19, manufacturers are still focusing on the new generation vaccine-manufacturing practices to prevent serious consequences of the disease shortly. As per clinicaltrial.gov, around 550 novel vaccines were in the development stage in 2022, which increased the number of trials that further contributed to the market's substantial market growth. According to a clinical trial logistics survey by Nice Insights, 35.0% of phase III clinical trials are outsourced, and the number is likely to increase owing to the growing number of investigational drugs advancing to the next phase.

The phase I segment is expected to grow at the fastest CAGR of 7.9% from 2024 to 2030. Phase I of clinical trials usually involves assessing a device's or drug's safety and evaluating the molecules' tolerability and pharmacokinetics. The increasing demand for drugs and clinical trials for assessing drugs are fueling the market growth over the forecast years.

Therapeutic Area Insights

Based on the therapeutic area, cardiovascular disease held the largest market share of about 30% in 2023 and is projected to grow at the fastest CAGR over the forecast period. This growth can be attributed to increased cardiovascular research projects and companies dedicated to bringing new medications to the market. As per CDC data, heart disease is a predominant cause of death in the U.S., and about 805,000 people in the United States have a heart attack per year. Considering this higher prevalence of cardiovascular disease, the demand for drugs is also increasing. An increase in demand for drugs further boosts the growth of the market.

The oncology segment is expected to grow at a CAGR of 7.6% from 2024 to 2030. This growth is driven by the increasing cancer incidences and the higher need for clinical trials conducted for cancer therapeutics. Clinical trial supplies in oncology include primary and secondary packaging. The primary objective of packaging is to improve patient compliance. Packaging must protect vials from leakage and gases from aerosolizing. Packaging should be done following the dosage requirement. According to the United Press International, hospitals in the U.S. are disposing of millions of cancer drug vials due to improper dosage.

Key U.S. Clinical Trials Supply And Logistics Company Insights

The key companies operating in the U.S. clinical trials supply and logistics include Catalent, Inc., PCI Pharma Service, Thermo Fisher Scientific, Inc., Marken, and Parexel International Corporation among others.

There is intense competition between key companies that are actively engaged in a high degree of innovation, the impact of regulations, mergers and acquisitions, and regional expansion.

Recent Developments

• In August 2023, Worldwide Clinical Trials announced the agreement of acquisition with Kohlberg & Company, LLC. This acquisition would lead to increased sales of Kohlberg& Company, LLC, and give a minority stake in the company.

• In June 2023, SkyCell announced a partnership with Marken to enhance pharmaceutical transport for clinical trials. This collaboration will provide Marken, the clinical trials logistics subsidiary of UPS Healthcare, with SkyCell containers designed for shipping critical and temperature-sensitive drugs. The partnership aimed at transporting and safeguarding temperature-sensitive clinical pharmaceutical supplies.

• In September 2022, Paraxel announced opening a new clinical trial supplies depot in China to help clinical sites and patients get supplies and drugs faster, as China remains a significant avenue for the growth of clinical trials.

• In March 2021, PCI Pharma Services announced the expansion of its Berlin facility's cold chain clinical supply storage and distribution capabilities through a significant investment that would give local clients access to the global market. Recent regulatory inspections that were necessary for these expansions at the Berlin facility were completed, and it is now fully functional.

• In January 2021, PAREXEL International announced the completion of the separation of its Informatics and Medical Imaging business. As part of this separation, Parexel Informatics was anticipated to become Calyx.

U.S. Clinical Trials Supply And Logistics Market Report Scope

U.S. Clinical Trials Supply And Logistics Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest trends and opportunities in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the U.S. clinical trials supply and logistics market based on service, phase, therapeutic area, and end-use:

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Logistics & Distribution

  • Storage & retention

  • Packaging, labeling, and blinding

  • Manufacturing

  • Comparator sourcing

  • Other services (solutions, ancillary supply)

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical

  • Biologics

  • Medical device

• Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • CNS & Mental disorders

  • Cardiovascular

  • Respiratory disease

  • Others