Clinical Trial Supply And Logistics Market Size, Share & Trends Analysis Report By Service (Logistics & Distribution, Storage & Retention), By Phase, By End-user, By Therapeutic Area, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global clinical trial supply and logistics market size was valued at USD 3.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.1% from 2021 to 2028. The market growth is attributed to the increasing R&D expenditure by pharmaceutical and biopharmaceutical firms and the rising number of clinical trials conducted globally. Furthermore, the market is mostly driven by technological advancements in the supply chain. The growing complexity in clinical studies and increased competition among players are factors responsible for the adoption of new technologies in supply chain management. The Covid-19 pandemic introduced logistical challenges to the clinical trial market, and sponsors faced numerous challenges last year. With the rapid and widespread adoption of the remote trial approach, the conventional supply chain has seen significant changes. Direct-to-patient approaches were used to manage the various logistical constraints of remote trials. With decentralized trials, global reach is more easily achievable for sponsors. The pandemic has boosted the acceptance of such trials, but demand would continue to be high long after Covid-19.

Besides, Britain's departure from the European Union (EU) has caused a slew of logistical issues for clinical trials. These are connected to customs and borders, VAT management, and the need for sites and suppliers to obtain Exporter of Records Identification (EORI) numbers. Companies contracting U.K.-based CDMOs are likely to face these complications. For now, they have to continue using U.K. companies due to specific Investigational Medicinal Product Dossier (IMPD) or Clinical Trial Authorization (CTA) from regulatory bodies, which requires them to keep the same manufacturing and packaging addresses. They also have to handle VAT reclaims and additional qualified person (QP) releases in Europe. This takes time and money, and it necessitates collaboration with other supply-chain partners.

Clinical studies have become increasingly complex and expensive. Drug developers are relying on third-party service providers to procure clinical study materials and deliver them to investigator sites and patients. Further, reliance on outsourcing for all clinical trial supply and logistics tasks would drive strong growth in the market, which involves storage, logistics, and transport of clinical trial materials including investigational drugs, ancillary supplies, and biological specimens to and from clinical sites or patient’s homes directly.

Clinical supplies are becoming more prominent as pharmaceutical companies strive to standardize and harmonize their commercial and clinical supply chain processes.  Silos of information make accurate planning difficult and add unnecessary costs and barriers. In terms of actual inventory at clinical facilities, inbound and outbound shipments, actual patients, and dispensing schedules, companies are suffering a lack of visibility along the end-to-end clinical supply chain. However, also there is a lack of integration between many partners in the clinical supply chain industry.

In the near future, when clinical studies become more agile and diversified, the industry would require IT solutions that are flexible enough to support such changes. New umbrella, basket, or platform trials needed to be handled, supplies must be pooled, and more complex logistics and shelf-life issues are to be factored into clinical preparation. Different collaboration models are required in the future such as o-boarding of various clinical supply chain partners, IRT/RTMS, or cold-chain solution vendors (logistical service providers, contract manufacturers, and others) is required, and detailed information to be shared. 

Service Insights

The logistics and distribution segment led the market and accounted for a revenue share of over 20.0% in 2020. The segment is also anticipated to register the fastest growth rate throughout the forecast period. This is due to the globalization of clinical trials, an increase in the number of trials involving temperature-sensitive products, and the highly regulated structure of the industry.

Technological developments are positively impacting the global market, both on the inbound and outbound sides. As additional Point of Care (POC) diagnostic tools are developed, there would be a trend toward performing more and more local analyses and transferring less blood, tissue, urine, and other samples to a central site for examination in the future. As the number of expensive biologic drugs in development has expanded, the value of outbound shipments has increased considerably. Some of these drugs take up to two years to manufacture and are extremely difficult to replicate.

Advances in smart packaging solutions, such as active and passive thermo-regulated products, ensure that shipments stay within suitable temperature ranges while en-route and in storage, protecting the contents of the shipment. SENTRY and other GPS-enabled devices track a shipment's position and condition in real-time, including motion, shock, battery life, and light exposure, all while sending SMS notifications about any deviations or excursions.

Phase Insights

The phase III segment held the largest revenue share of over 40.0% in 2020. This is primarily due to a rise in the number of patients enrolled in phase III trials. Investigators in phase III studies compare the novel treatment's safety and efficacy against the current standard of care. Most phase III clinical trials involve a large number of patients, at least several hundred.

Phase II clinical trials had the highest number of projects in 2020 and this trend is expected to continue owing to increasing investments in R&D by industry and non-industry sponsors. According to a clinical trial logistics survey by Nice System, in 2017, 60.0% of trials in phase II are outsourced, which accounts for the highest number of outsourced clinical trials in all phases. The rising number of drugs in phase II is expected to increase the complexities in supply chain and logistics, which is further anticipated to increase the demand for effective supply chain and logistics, thereby contributing to the growth of the market.

Therapeutic Area Insights

The cardiovascular diseases segment held the largest revenue share of over 25.0% in 2020. This is due to the large and growing number of cardiovascular research studies and the growing number of companies focused on bringing innovative drugs to the market. Due to the high incidence of cardiovascular diseases, healthcare systems across the globe are focusing on minimizing the burden of heart attacks and strokes by implementing new diagnostic and therapeutic approaches.

The oncology segment held the second-largest share in 2020. This is due to the high prevalence of cancer. In 2018, cancer was the second biggest cause of death around the world, accounting for 9.6 million fatalities, or one in every six deaths. Considering these factors, many pharmaceutical firms are investing in the development of novel cancer treatments.

End-user Insights

Based on end-user, the pharmaceuticals segment led the market and accounted for over 40.0% share in 2020. This is due to the increased number of clinical studies conducted by pharmaceutical companies and R&D investments by these companies. Besides, the globalization of clinical trials is supporting market growth.

The biologicals segment is projected to expand at the fastest growth rate of 7.3% over the forecast period. This may be largely attributed to the increasing demand for biological products, such as cell and gene therapies, and vaccines and the growing investments in product development. Furthermore, the Covid-19 pandemic contributed to the market growth due to the surge in global demand for vaccines. 

Regional Insights

North America led the global market with a share of over 35.0% in 2020. An increase in the number of clinical trials conducted by pharmaceutical companies drives the market in the region. According to ClinicalTrials.gov, the U.S. performs the highest number of clinical trial operations per year. The regional growth is also credited to the presence of a significant number of participants in the market.

Asia Pacific is anticipated to register the fastest growth rate of7.8% throughout the forecast period. The region has access to a large and diversified patient pool, cheaper recruitment costs, and favorable policies that make Asia Pacific desirable for clinical studies. Researchers are shifting their attention from developed countries like Japan, Australia, South Korea, and Singapore toward emerging markets like Thailand, China, the Philippines, and Vietnam. 

Key Companies & Market Share Insights

Market players are implementing a range of strategic activities, such as new partnership agreements, collaborations, and geographic expansion, with the aim of strengthening their services. For instance, in July 2021, Paraxel has announced the opening of a new clinical trial supplies depot in China to help clinical sites and patients get supplies and drugs faster as China remains a significant growth market for clinical trials and Parexel.

Besides, the players are playing an important role in the Covid-19 pandemic by providing direct-to-patient/direct-from-patient services. For instance, Marken offers in-home clinical trial services such as DTP delivery and collection of biological samples. Marken's direct-to-patient services establish a supply chain that allows drugs to be delivered to the patient instead of the site. For both its direct-to-patient services and its traditional supply chain, the company's supply chain uses controlled room temperature facilities, refrigerators and freezers, and packaging materials with GPS and remote temperature monitoring devices to provide cold chain, ultra-cold chain, and ambient temperature shipping. Some prominent players in the global clinical trial supply and logistics market include:

• Piramal Pharma Solutions

•  UDG Healthcare

• DHL

• FedEx

•  Movianto

• Packaging Coordinators Inc.

• Thermo Fisher Scientific (Patheon)

• Catalent, Inc.

• Parexel

• Almac Group

• Marken

Clinical Trial Supply And Logistics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global clinical trial supply and logistics market report on the basis of service, phase, end-user, therapeutic area, and region:

• Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Logistics & Distribution

  • Storage & Retention

  • Packaging, Labeling, and Blinding

  • Manufacturing

  • Comparator Sourcing

  • Other Services (Solutions, Ancillary Supply)

• Phase Outlook (Revenue, USD Million, 2016 - 2028)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• End-user Outlook (Revenue, USD Million, 2016 - 2028)

  • Pharmaceuticals

  • Biologicals

  • Medical Device

• Therapeutic Area Outlook (Revenue, USD Million, 2016 - 2028)

  • Oncology

  • Cardiovascular Diseases

  • Respiratory Diseases

  • CNS and Mental Disorders

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Iran

    • Israel