Clinical Trial Supply & Logistics Market by Services, Type, Phase, Therapeutic Area, End User

Description

List of Tables

[196 Pages Report] The Clinical Trial Supply & Logistics Market size was estimated at USD 24.33 billion in 2023 and expected to reach USD 26.20 billion in 2024, at a CAGR 7.75% to reach USD 41.04 billion by 2030.

Clinical trial supply & logistics encompasses the planning, management, storage, and distribution of clinical trial materials (CTMs) needed to conduct clinical studies. These materials include investigational medicinal products (IMPs), placebos, patient kits, ancillary supplies, and labeling services. The main objective of CTSL is to ensure that clinical trials are conducted efficiently and in compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines while maintaining product quality and integrity. The prevalence of chronic disorders and increasing government investments in pharmaceutical research & development process drives the use of clinical trial supply & logistics. On the contrary, the cost-intensive nature of clinical trials and the limited availability of trained professionals hinders market growth. However, growing interest in drug development projects coupled with outsourcing clinical trials is expected to increase its usage in the coming years.

KEY MARKET STATISTICS
Base Year [2023]	USD 24.33 billion
Estimated Year [2024]	USD 26.20 billion
Forecast Year [2030]	USD 41.04 billion
CAGR (%)	7.75%

Services: Continuous advancements in cold chain distribution services with growing demand

Comparator sourcing is a crucial aspect of clinical trials where supply chain management companies source the required drugs and other materials from reliable and approved sources, which involves procuring investigational and reference products. The process ensures that standardized supplies are maintained throughout the trial period across different sites and countries. Comparator sourcing helps maintain consistency in trial results while avoiding any potential disruptions due to variations in products or their quality. Logistics & distribution encompasses the management of transportation and delivery of clinical trial materials to multiple research sites across various regions. This includes coordinating with customs clearance procedures, monitoring regulatory compliance requirements for each country, and ensuring cold chain storage is maintained if necessary. Manufacturing refers to the production of clinical trial materials, including active pharmaceutical ingredients (APIs), excipients, drug products, and placebo formulations. Manufacturing processes must adhere to strict Good Manufacturing Practices (GMP) guidelines set by regulatory authorities to ensure high-quality products are produced consistently throughout the entire study period. Packaging, labeling, and blinding services deal with preparing the final clinical trial materials for shipment to research sites. Packaging involves creating unit dose packs or bulk packaging according to specific protocol requirements while maintaining appropriate environmental conditions during transport. Labeling includes printing accurate information on packages, such as dosage strength, storage instructions, expiry date(s), and unique identification codes. Blinding refers to the process of concealing treatment allocations from trial participants, investigators, and site staff to avoid any potential biases in the results. Storage & retention services cover the secure housing of clinical trial materials throughout their entire lifecycle, from initial arrival at storage facilities until final destruction, including maintaining appropriate temperature-controlled environments, adhering to regulatory guidelines on material handling, and ensuring that limited access is granted to authorized personnel.

Type: Surging utilization of small molecules in the pharmaceutical sector

In clinical trial supplies & logistics, biological drugs, medical devices, and small molecules present unique advantages tailored to specific medical needs and treatment objectives. Biologic drugs, or biopharmaceuticals, developed through living organisms, are preferred for their precise ability to target diseased cells. They offer effective treatments with minimal side effects for conditions where traditional therapies fall short despite their need for complex manufacturing and cold chain management. Medical devices include simple tools, advanced systems, such as MRI machines, favored for their non-invasive diagnostics and treatment options, with industry giants supported by logistic companies. Small molecules, characterized by their low molecular weight and ease of penetration into cells, are pivotal for their versatility and ease of administration. The selection among biologics, devices, or small molecules hinges on the specific health condition being addressed, the goals of treatment or research, and logistical considerations, highlighting the diverse and complementary roles they play in advancing patient care and clinical research.

Phase: Increasing scope of supply & logistics services in phase 3 clinical trials

Bioavailability studies determine the rate and extent to which the active ingredient or therapeutic compound is soaked and becomes available at the site of action. Bioequivalence studies compare the bioavailability between two pharmaceutical products. These studies are crucial in the development of generic drugs. Phase 1 trials are the initial infusion of a new drug into humans, typically conducted with a few healthy volunteers. The primary goal is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Phase 2 trials test the efficacy of a drug and continue to evaluate its safety. The study population typically includes patients with the condition or disease being studied. Phase 3 trials involve large groups of patients and aim to confirm a drug's efficacy, monitor side effects, compare it to typically used treatments, and gather information that allows the drug to be used safely. Phase 4, or post-marketing surveillance, involves the ongoing study of a drug after it has been approved for consumer sale. It aims to detect rare or long-term adverse effects and compare the drug's effectiveness in general use.

Therapeutic Area: Proliferating private and public sector investments and research activities in oncology

In clinical trial supply & logistics for blood disorders, meticulous coordination is essential to handle sensitive biological materials, such as blood samples. These trials often require specialized storage and timely transportation to ensure sample integrity for accurate trial outcomes. Supply chain management for cardiovascular disease trials necessitates rigorous control and monitoring of investigational medicinal products. Trials are extensive and require scalable logistics solutions to manage trial component distribution efficiently, considering the high prevalence of these diseases. Clinical trials in the CNS and mental disorder domain necessitate innovative logistic solutions owing to the sensitive nature of investigational drugs. These include controlled substances requiring specialized handling, distribution protocols, and stringent regulatory compliance. Trials involving dermatological disorders often necessitate diverse product forms, including topicals and orals, requiring customized logistics strategies. Quick and precise distribution is vital to maintain the efficacy of these products across various climates and regions. For digestive disorder trials, the supply chain should be adept at handling various investigational products, from enzymes to probiotics, with special attention to maintaining product stability and integrity under different storage conditions. Supply logistics for ENT disease trials focus on the distribution of specialized devices and medication, ensuring timely delivery to trial sites. It's crucial to adhere to specific storage instructions to preserve the effectiveness of these items. Immunology trials often involve biologics that require cold chain logistics and advanced monitoring to guard against degradation. The global nature of these trials adds complexity to shipping and requires robust systems for tracking and temperature management. Trial supply logistics are focused on rapid scalability and distribution with the need for new treatments in infectious diseases, especially in pandemic situations. Secure and quick transport mechanisms for such therapeutics are critical for moving sensitive materials between labs and trial sites.

Clinical trials for metabolic disorders require handling a broad spectrum of investigational products, often necessitating personalized logistics solutions. Attention to detail in shipping and storage conditions is paramount to ensure the integrity of these compounds. Given the importance of dose accuracy and timing in nephrology-related trials, ensuring the precise management of medications and devices with advanced tracking and logistical planning is essential. Oncology trials are among the most complex, requiring highly specialized treatments often tailored to individual patients. This necessitates a flexible and responsive logistics system that handles sensitive materials, including live cells, under strict conditions.

Moreover, clinical trials for rare diseases present unique supply chain challenges due to the often-limited patient population and scattered geographical distribution. Tailored logistics solutions are essential to address these trials' specific needs and urgency. Furthermore, in trials for respiratory disorders, logistical systems must accommodate a range of investigational products, including inhalers and nebulizers, requiring precise temperature control and swift distribution channels to ensure product efficacy upon delivery.

End User: Rising use of clinical trial supply & logistics by pharmaceutical & biotechnology companies

Contract research organizations (CROs) rely on clinical trial supply & logistics services to provide end-to-end support throughout all stages of clinical trials. Through partnerships, CROs can access flexible supply chains, ensuring timely delivery of investigational medicinal products (IMP), ancillary materials, and devices to trial sites. Moreover, these services help CROs manage temperature-sensitive shipments through controlled environments and monitor real-time inventory levels at depots worldwide. Medical device companies utilize clinical trial supply & logistics services to manage their complex supply chain requirements efficiently. Medical device companies can maintain proper storage conditions during transportation, adhere to import/export regulations, and reduce risks associated with global device distribution by leveraging specialized logistics providers' expertise. Pharmaceutical & biotechnology companies heavily depend on clinical trial supply & logistics services for their clinical trial needs, and these services assist in managing the entire supply chain of investigational biopharmaceutical products, including manufacturing, packaging, labeling, distribution, storage, and destruction. Pharmaceutical & biotechnology companies require specialized logistics solutions to maintain product stability during transportation owing to biopharmaceutical products' fragile and sensitive nature. Furthermore, these services help pharmaceutical & biotechnology companies optimize their supply chains by utilizing demand forecasting tools and implementing just-in-time (JIT) strategies to minimize wastage and reduce prices associated with overstocking or stockouts.

Regional Insights

In the Americas region, North America has considerable utilization of clinical trial supply & logistics, with the United States leading the growth with its robust pharmaceutical industry and extensive investment in research and development (R&D). Furthermore, numerous leading pharmaceutical companies conducting clinical trials and strong government support for R&D activities drive market expansion. South America also contributes to increasing clinical trial supply & logistics usage due to its developing healthcare infrastructure and growing focus on clinical research. The Asia-Pacific region's clinical trial supply & logistics market is growing rapidly due to its rapidly evolving pharmaceutical industry in China, India, South Korea, Taiwan, Indonesia, and Vietnam, among others. Moreover, many multinational pharmaceutical companies have established their R&D centers or collaborations with local partners in this region due to resource availability at competitive prices. Within the EMEA region, Europe has been traditionally considered a stronghold for the global clinical trial supply & logistics market due to the presence of numerous pharmaceutical and biotechnology companies. The European Union (EU) has a well-established framework for conducting clinical trials across its member states that ensures the safety, efficacy, and quality of investigational medicinal products (IMPs). In addition, Middle East & Africa are emerging markets within the EMEA region due to increasing healthcare expenditure by governments, expansion of multinational pharmaceutical companies into these markets to tap a larger patient pool for testing their investigational drugs/devices, continuous development of healthcare infrastructure and availability of skilled workforce due to their investments in education.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trial Supply & Logistics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Clinical Trial Supply & Logistics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Clinical Trial Supply & Logistics Market, highlighting leading vendors and their innovative profiles. These include Acnos Pharma GmbH, ADAllen Pharma Ltd, Almac Group Limited, Ancillare, LP, Avantor, Inc., Beroe Holdings Inc., Biocair International Limited, Calyx, Catalent, Inc., Clinical Services International LTD, Clinigen Group PLC, COREX LOGISTICS LIMITED, DHL Group, Eurofins Scientific SE, Experic, LLC, FedEx Corporation, ICON PLC, Inceptua S.A., Infosys Limited, IPS Pharma, KLIFO A/S, Lonza Group AG, Marken Limited by United Parcel Service, Inc., Microsoft Corporation, Myonex, Inc., N-SIDE SA, NUVISAN GmbH, OCT Clinical GmbH, Octalsoft, Parexel International Corporation, PCI Pharma Services, PHOENIX Pharmahandel GmbH & Co KG, Piramal Pharma Limited, Recipharm AB, SAP SE, Sharp Services, LLC, Signant Health, SIRO Clinpharm Private Limited, Thermo Fisher Scientific Inc., Tower Cold Chain Solutions, Uniphar PLC, Walden Group, and Zuellig Pharma Pte Ltd by Interpharma Investments Limited.

Market Segmentation & Coverage

This research report categorizes the Clinical Trial Supply & Logistics Market to forecast the revenues and analyze trends in each of the following sub-markets:

Services
- Comparator Sourcing
- Logistics & Distribution
  - Cold Chain Distribution
  - Non-Cold Chain Distribution

Manufacturing
Packaging, Labeling, & Blinding
Storage & Retention

Type
- Biologic Drugs
- Medical Devices
- Small Molecules

Phase
- BA/ BE studies
- Phase 1
- Phase 2
- Phase 3
- Phase 4

Therapeutic Area
- Blood Disorders
- Cardiovascular Diseases
- CNS & Mental Disorders
- Dermatological Disorders
- Digestive Disorders
- ENT Diseases
- Immunology
- Infectious Diseases
- Metabolic Disorders
- Nephrology
- Oncology
- Rare Diseases
- Respiratory Disorders

End User
- Contract Research Organisations
- Medical Devices Companies
- Pharmaceutical & Biotechnology Companies

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - Massachusetts
    - Minnesota
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Clinical Trial Supply & Logistics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trial Supply & Logistics Market?

3. What are the technology trends and regulatory frameworks in the Clinical Trial Supply & Logistics Market?

4. What is the market share of the leading vendors in the Clinical Trial Supply & Logistics Market?

5. Which modes and strategic moves are suitable for entering the Clinical Trial Supply & Logistics Market?

Product Code: MRR-501246436315

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising government funds to strengthen pharmaceutical R&D activities across economies with increasing incidence of chronic diseases
  - 5.1.1.2. Globalization of clinical trials and harmonization of regulations
- 5.1.2. Restraints
  - 5.1.2.1. Problems associated with technology integration and data management
- 5.1.3. Opportunities
  - 5.1.3.1. Integration of artificial intelligence and machine learning for predictive analytics in supply chain optimization
  - 5.1.3.2. Increasing partnership activities between pharmaceutical manufacturers and CDMOs
- 5.1.4. Challenges
  - 5.1.4.1. Concerns associated with the operations within clinical trial supply and logistics
5.2. Market Segmentation Analysis
- 5.2.1. Services: Continuous advancements in cold chain distribution services with growing demand
- 5.2.2. Type: Surging utilization of small molecules in the pharmaceutical sector
- 5.2.3. Phase: Increasing scope of supply & logistics services in phase 3 clinical trials
- 5.2.4. Therapeutic Area: Proliferating private and public sector investments and research activities in oncology
- 5.2.5. End User: Rising use of clinical trial supply & logistics by pharmaceutical & biotechnology companies
5.3. Market Trend Analysis
- 5.3.1. Strong pharmaceutical production capability and integration of advanced technologies in the supply chain across the Americas
- 5.3.2. Expanding healthcare sectors coupled with supportive government initiatives augmenting clinical trial logistics across APAC region
- 5.3.3. Robust presence of market players and continuous focus on advancing pharmaceutical supply chain across EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis
5.8. Client Customization
- 5.8.1. Catalent, Inc. : Active participation in webinars and conferences to promote innovative solutions and services in clinical trial supply and logistics
- 5.8.2. Infosys Limited: Focus on penetration pricing strategy to provide solution at a low price while ensuring high precision and quality
- 5.8.3. Almac Group: Launch of new marketing campaign by Marken Limited to promote clinical drug product storage and distribution
- 5.8.4. Eurofins Scientific Group: Eurofins Scientific Group's focus on conferences and fairs for effective product marketing
- 5.8.5. Lonza Group AG: Significant digital marketing strategies by Lonza Group AG to enhance their global reach
- 5.8.6. Biologic Drugs: Utilisation of digital technologies to streamline the supply chain, enhance transparency, and improve communication with stakeholders
- 5.8.7. Medical Devices: Disseminating educational content addressing stakeholders' pain points
- 5.8.8. Small Molecules: Need to address intense competition and regulatory complexities
- 5.8.9. Adoption of diverse marketing strategies for clinical trial supply & logistics services

6. Clinical Trial Supply & Logistics Market, by Services

6.1. Introduction
6.2. Comparator Sourcing
6.3. Logistics & Distribution
6.4. Manufacturing
6.5. Packaging, Labeling, & Blinding
6.6. Storage & Retention

7. Clinical Trial Supply & Logistics Market, by Type

7.1. Introduction
7.2. Biologic Drugs
7.3. Medical Devices
7.4. Small Molecules

8. Clinical Trial Supply & Logistics Market, by Phase

8.1. Introduction
8.2. BA/ BE studies
8.3. Phase 1
8.4. Phase 2
8.5. Phase 3
8.6. Phase 4

9. Clinical Trial Supply & Logistics Market, by Therapeutic Area

9.1. Introduction
9.2. Blood Disorders
9.3. Cardiovascular Diseases
9.4. CNS & Mental Disorders
9.5. Dermatological Disorders
9.6. Digestive Disorders
9.7. ENT Diseases
9.8. Immunology
9.9. Infectious Diseases
9.10. Metabolic Disorders
9.11. Nephrology
9.12. Oncology
9.13. Rare Diseases
9.14. Respiratory Disorders

10. Clinical Trial Supply & Logistics Market, by End User

10.1. Introduction
10.2. Contract Research Organisations
10.3. Medical Devices Companies
10.4. Pharmaceutical & Biotechnology Companies

11. Americas Clinical Trial Supply & Logistics Market

11.1. Introduction
11.2. Argentina
11.3. Brazil
11.4. Canada
11.5. Mexico
11.6. United States

12. Asia-Pacific Clinical Trial Supply & Logistics Market

12.1. Introduction
12.2. Australia
12.3. China
12.4. India
12.5. Indonesia
12.6. Japan
12.7. Malaysia
12.8. Philippines
12.9. Singapore
12.10. South Korea
12.11. Taiwan
12.12. Thailand
12.13. Vietnam

13. Europe, Middle East & Africa Clinical Trial Supply & Logistics Market

13.1. Introduction
13.2. Denmark
13.3. Egypt
13.4. Finland
13.5. France
13.6. Germany
13.7. Israel
13.8. Italy
13.9. Netherlands
13.10. Nigeria
13.11. Norway
13.12. Poland
13.13. Qatar
13.14. Russia
13.15. Saudi Arabia
13.16. South Africa
13.17. Spain
13.18. Sweden
13.19. Switzerland
13.20. Turkey
13.21. United Arab Emirates
13.22. United Kingdom

14. Competitive Landscape

14.1. Market Share Analysis, 2023
14.2. FPNV Positioning Matrix, 2023
14.3. Competitive Scenario Analysis
- 14.3.1. PCM Trials acquires Netherlands-based Clinical Trial Service
- 14.3.2. Piramal Pharma Solutions Commemorates Opening of its ADC Manufacturing Expansion in Grangemouth, Scotland
- 14.3.3. Biocair Announces the U.S. Expansion as Part Of Global Growth Strategy
- 14.3.4. Vaxcyte and Lonza Sign New Commercial Manufacturing Agreement for PCVs
- 14.3.5. Piramal Pharma Solutions Launches In-Vitro Biology Capabilities at Ahmedabad Discovery Services Site
- 14.3.6. Signant Health Launches Signant Biotech to Accelerate and Streamline Clinical Development for Emerging Biopharmaceutical Organizations
- 14.3.7. N-SIDE Introduces Lighthouse, Innovative Software to Shape the Future of Worldwide Clinical Trial Supply Management
- 14.3.8. Zuellig Pharma and GSK establish vaccine distribution hub in Singapore
- 14.3.9. Ariceum Therapeutics and Eurofins CDMO Sign a Pharmaceutical Multi-Project Agreement
- 14.3.10. Vial Announces Strategic Partnership with Royale International Group
- 14.3.11. Biocair Partners with TrakCel to Improve Visibility in the Supply Chain
- 14.3.12. IDEAYA Expands Clinical Trial Collaboration and Supply Agreements with Pfizer
- 14.3.13. Catalent Starts Construction of USD 20M Expansion at Clinical Supply Facility in Germany
- 14.3.14. Eurofins BioPharma Product Testing ENCO Expands the U.S. Capabilities Footprint
- 14.3.15. Calyx Introduces New Clinical Trial Supply Forecasting Service
- 14.3.16. Catalent Completes Expansion of Singapore Clinical Supply Facility for Increased Temperature-Controlled Capabilities
- 14.3.17. Parexel Opens Clinical Trial Supplies and Logistics Depot in Suzhou, China

15. Competitive Portfolio

15.1. Key Company Profiles
15.2. Key Product Portfolio