According to Nova One Advisor, the global clinical trial supplies market size was estimated at USD 3.55 billion in 2023 and is projected to hit around USD 8.49 billion by 2033, growing at a CAGR of 9.11% during the forecast period from 2024 to 2033. North America dominated the clinical trial supplies Industry with the largest revenue share of 55.49% in 2023.
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Clinical trials play a pivotal role in the drug development process by assessing the safety and efficacy of new treatments before their approval for public use. The complexity of conducting clinical trials necessitates meticulous planning and organization, especially in managing clinical trial supply. Clinical trial supply encompasses the provision of essential materials, equipment, and medications required for trial execution, including the drugs under investigation and their associated packaging and labeling materials.
The clinical trial supplies market is rapidly expanding as it fulfills a crucial role in drug development, providing investigational products like drugs, medical devices, and biologic substances essential for evaluating safety and effectiveness in clinical trials. These supplies are meticulously managed to meet stringent quality standards and regulatory requirements, encompassing inventory software, labeling, packaging, logistics, temperature monitoring, and distribution services. Specialized companies collaborate closely with pharmaceutical and biotech firms to ensure safe and efficient trial conduct, offering expertise in drug packaging, labeling, and storage. With increasing global clinical trial activities and ongoing advancements in medical research, the clinical trial supplies sector anticipates sustained growth and innovation.
· In February 2024, FedEx strengthened its commitment to the clinical trial supply chain by launching the ‘FedEx Life Science Center’ in Mumbai
· In March 2024, Myonex acquired Creapharm’s Clinical Packaging & Distribution and Commercial Packaging business and bioservices
Clinical Trial Supplies Market Report Highlights
- Based on the clinical phase, the market is anticipated to be dominated by the Phase III trial segment with a 52.75% revenue share in 2023. The presence of a large number of molecules currently under Phase III makes it the primary factor responsible for this deduction
- Among services, the storage, and distribution segment is anticipated to witness the fastest growth at a CAGR of 6.8% during the forecast period. The rise in global biologics pipeline and temperature-sensitive drugs is expected to increase the complexities related to the logistics of clinical trial supplies
- Biologics are expected to witness the fastest growth at 6.7% CAGR during the forecast period owing to the increasing research in the field of genetics and biotechnology such as the development of nanoparticle-based drug delivery systems
- In terms of therapeutic use, oncology dominated the market with a revenue share of 40.9% in 2023. According to the United Press International, hospitals in the U.S. are disposing of billions of cancer drug vials due to improper dosage, thereby indicating the need for appropriate supply management
- Based on end use, the Pharmaceuticals accounted for the largest market share of 42.48% in 2023.
· North America led the market with the highest market share of 55.49% in 2023.
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U.S Clinical Trial Supplies Market Size and Growth 2024 to 2034
The U.S. clinical trial supplies market size was USD 1.38 billion in 2023, calculated at USD 1.57 billion in 2024 and is expected to reach around USD 3.35 billion by 2033, expanding at a CAGR of 8.77% from 2024 to 2033.
North America dominates the clinical trial supplies market, bolstered by initiatives enhancing diversity, equity, and inclusion in medical research. The American Heart Association, backed by Pfizer and Gates Ventures, recently awarded grants aimed at addressing these gaps, underscoring a commitment to fostering a representative healthcare and research landscape in the United States. Meanwhile, Health Canada plays a pivotal role as the federal regulator overseeing clinical trials involving human pharmaceuticals and biological drugs. Its rigorous review process for clinical trial applications across phases I to III ensures compliance with stringent regulatory standards, supporting the robustness and reliability of North America’s clinical trial infrastructure.
Asia Pacific is poised to exhibit the fastest Compound Annual Growth Rate (CAGR) in the upcoming forecast period within the clinical trials market. The region’s growth is bolstered by initiatives such as the Clinical Trials Registry-India (CTRI), hosted by the ICMR’s National Institute of Medical Statistics (NIMS). This platform serves as a comprehensive, free, and online public record system for registering clinical trials conducted in India, enhancing transparency and compliance in medical research. The Indian Clinical Trial and Education Network (INTENT) initiative aims to establish a network of research institutes focused on conducting large-scale, multi-centric clinical trials. These efforts underscore Asia Pacific’s commitment to addressing urgent health challenges with evidence-based and culturally sensitive solutions, positioning the region as a key hub for clinical trials and fostering robust growth in the sector.
Market Dynamics
Driver
- Regulatory Compliance
Navigating the complex global landscape of regulations is a critical driver in the clinical trial supplies market. Compliance with stringent standards such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) is mandatory to ensure that trial supplies are produced, handled, and distributed according to the highest standards. Adhering to these regulations is crucial for safeguarding patient safety and maintaining the integrity and validity of clinical trials. The robust regulatory framework provides assurance to stakeholders regarding the quality and reliability of trial supplies, thereby fostering growth and trust in the clinical trial supplies market.
Restraint
- Lack of Real-Time Visibility and Regulatory Variability
One of the significant challenges in the clinical trial supply chain is the lack of real-time visibility. The complexity of the supply chain, involving multiple stakeholders, often hinders the ability to track goods efficiently, resulting in delays and increased costs. Ensuring accurate packaging and labeling is critical to delivering the correct drugs to patients, yet this remains a persistent challenge, particularly in multi-country trials. Varying regulatory requirements across different countries further complicate packaging and labeling processes, leading to potential errors and operational setbacks. These factors collectively limit the growth potential of the clinical trial supplies market by impacting efficiency and increasing operational risks.
Opportunity
- Digital Supply Chain Innovations
The adoption of Digital Supply Chain (DSC) practices, defined by the integration of information systems and advanced technologies like augmented reality, big data analytics, and Blockchain, is enhancing the agility and integration of supply chains in the clinical trial sector. By focusing on stakeholders such as drug suppliers, sponsors, and patients, DSC reduces intra and inter-organizational costs while increasing organizational value. This approach improves visibility, robustness, resilience, and overall performance tracking, thereby creating significant opportunities for growth and innovation in the clinical trial supplies market.
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Report Highlights
By Phases
The phase III segment is set to dominate the clinical trial supplies market, marking a crucial stage in drug development. These trials involve larger populations across diverse regions and countries, representing the final step before regulatory submission for market approval. Phase III studies build upon earlier phases (phase I for safety and phase II for efficacy), focusing on confirming efficacy, monitoring adverse effects, and assessing the overall benefit-risk profile of new treatments. As the pivotal phase preceding regulatory approval, phase III trials play a vital role in determining the success and commercial viability of new drugs, driving significant demand for specialized clinical trial supplies and services globally.
By Services
Supply chain management stands out as a pivotal service sector within the market, encompassing the comprehensive oversight of goods or services from initial raw material sourcing through to final consumer delivery. This involves establishing a robust network of suppliers to facilitate the seamless flow of products across various stages of production and distribution. In the context of clinical trials, efficient supply chain management is essential for drug manufacturers to achieve their trial objectives. Key priorities include ensuring the accurate and timely delivery of drugs to patient sites, optimizing costs, and maintaining strict compliance with regulatory standards such as Good Manufacturing Practices (GMP). A well-executed supply chain strategy supported by effective IT infrastructure not only enhances operational efficiency but also plays a critical role in advancing clinical trial timelines and outcomes, thereby driving growth and competitiveness in the market.
By Therapeutic area
The oncology segment is anticipated to experience significant growth in the coming forecast period within the clinical trial market. Clinical trials in oncology play a pivotal role in testing innovative approaches to detect, prevent, and treat cancer. They are instrumental in advancing medical knowledge and enhancing the quality of life for cancer patients by exploring novel treatments and strategies to manage treatment-related side effects. Predominantly focusing on treatment studies, these trials evaluate the efficacy of new therapies or alternative uses of existing treatments, aiming to improve patient outcomes and survival rates. With ongoing advancements in oncological research and increasing investment in cancer therapies, the oncology segment represents a critical area driving innovation and expansion in the clinical trial landscape globally.
By End User
Pharmaceutical and biotechnology companies are prominent end users in the clinical trial supply market, driving significant demand for clinical supply services. These companies require a comprehensive range of materials and services essential for conducting clinical trials, including the precise management of investigational drugs, biological specimens, and study materials.
Services provided encompass 24-hour collection and delivery of critical supplies, expertise in permit applications such as import permits, and logistical support to ensure regulatory compliance. Clinical trials conducted by these companies yield crucial insights into the cost-effectiveness of treatments, the clinical utility of diagnostic tests, and improvements in patient quality of life. As leaders in innovation and drug development, pharmaceutical and biotech firms play a pivotal role in shaping the growth and advancement of the clinical trial supply market globally.
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Browse More Insights:
Clinical Trials Market Size and Forecast: The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% during the forecast period from 2024 to 2033.
Biologics Market Size and Forecast: The global biologics market size was estimated at USD 511.04 billion in 2023 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period from 2024 to 2033.
Biotechnology Market Size and Forecast: The global biotechnology market size was estimated at USD 1.54 Trillion in 2023 and is projected to hit around USD 5.68 Trillion by 2033, growing at a CAGR of 13.95% during the forecast period from 2024 to 2033.
Oncology Market Size and Forecast: The global oncology market size was estimated at USD 222.36 billion in 2023 and is projected to hit around USD 521.60 billion by 2033, growing at a CAGR of 8.9% during the forecast period from 2024 to 2033.
Pharmaceutical Market Size and Forecast: The global pharmaceutical market size was valued at USD 1,501.90 billion in 2023 and is projected to surpass around USD 2,717.72 billion by 2033, registering a CAGR of 6.11% over the forecast period of 2024 to 2033.
Oncology Clinical Trials Market Size and Forecast: The global oncology clinical trials market size reached USD 13.19 billion in 2023 and is projected to hit around USD 22.11 billion by 2033, expanding at a CAGR of 5.3% during the forecast period from 2024 to 2033.
Cell And Gene Therapy Clinical Trials Market Size and Forecast: The global cell and gene therapy clinical trials market size reached USD 11.62 billion in 2023 and is projected to hit around USD 47.40 billion by 2033, expanding at a CAGR of 15.09% during the forecast period from 2024 to 2033.
Immuno-oncology Clinical Trials Market Size and Forecast: The global immuno-oncology clinical trials market size was exhibited at USD 8.30 billion in 2023 and is projected to hit around USD 35.37 billion by 2033, growing at a CAGR of 15.6% during the forecast period 2024 to 2033.
U.S. Pharmaceutical Market Size and Forecast: The U.S. pharmaceutical market size was valued at USD 602.19 billion in 2023 and is projected to surpass around USD 1,093.79 billion by 2033, registering a CAGR of 6.15% over the forecast period of 2024 to 2033.
U.S. Clinical Trials Market Size and Forecast: The U.S. clinical trials market size was valued at USD 25.81 billion in 2023 and is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of 4.88% over the forecast period of 2024 to 2033.
U.S. Biotechnology Market Size and Forecast: The U.S. biotechnology market size was estimated at USD 552.49 billion in 2023 and is projected to hit around USD 1,794.11 billion by 2033, growing at a CAGR of 12.5% during the forecast period from 2024 to 2033.
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Some of the prominent players in the Clinical trial supplies market include:
- Almac Group
- Biocair
- Catalent Inc.
- KLIFO
- Movianto
- PCI Pharma Services
- Sharp Services, LLC
- Thermo Fischer Scientific Inc.
- Marken
- PAREXEL International Corporation
Recent Developments
- In February 2023, Catalent completed a USD 2.2 million expansion of its clinical supply facility in Singapore. This expansion has enlarged the site’s footprint to 31,000 square feet, providing room for installing 35 new freezers dedicated to ultra-low temperature (ULT) storage.
- In January 2023, ASLAN Pharmaceuticals and Thermo Fisher Scientific entered into a partnership to manufacture a high concentration formulation of Eblasakimab for upcoming studies. Thermo Fisher Scientific will contribute its expertise in biologic manufacturing and scale-up capacity to oversee a clinical supply of Eblasakimab for the anticipated Phase 3 studies.
- In July 2023, Almac Sciences announced the opening of a custom-built GMP warehouse and dispatch hub at Almac Group’s global headquarters in Craigavon, UK. The facility will support all the manufacturing and lab activities of Active Pharmaceutical Ingredients from development to their commercialization.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the clinical trial supplies market
Clinical Phase
- Phase I
- Phase II
- Phase III
- Phase IV
- BA/BE Studies
Product & Services
- Manufacturing
- Storage & Distribution
- Cold chain distribution
- Non-cold chain
- Supply chain management
- Comparator Sourcing
- Other Services (Solutions and Ancillary supplies)
End-use
- Pharmaceutical
- Biologics
- Medical device
- Others
Therapeutic Use
- Oncology
- CNS
- Cardiovascular
- Infectious disease
- Metabolic disorders
- Others
Regional
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa
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