The global clinical trial supplies market size was valued at USD 2.13 billion in 2022. It is estimated to reach USD 3.47 billion by 2031, growing at a CAGR of 5.6% during the forecast period (2023–2031). The expansion of clinical trial sites and the growing R&D in biologics and biosimilars boost the market.
Clinical trial supplies encompass a range of materials and resources essential for successful clinical trials. The investigational products, drugs, biologics, and medical devices under investigation are at the core of these supplies. These investigational products are carefully selected based on their potential therapeutic benefits and undergo rigorous testing and evaluation before being used in clinical trials. The trial sponsor or manufacturer typically provides them and must meet quality, safety, and efficacy regulatory requirements. In addition to the investigational products, clinical trial supplies include placebos, inactive substances designed to resemble the active investigational product. Placebos are used in controlled trials to assess the specific effects of the investigational product and distinguish them from any placebo effects. Placebos are critical for establishing the true efficacy of the investigational product and ensuring unbiased results.
Furthermore, clinical trial supplies may include various ancillary materials such as labeling and packaging, randomization kits, study-specific forms and documents, and laboratory supplies for sample collection and analysis. These supplies are essential for ensuring accurate documentation, maintaining product integrity, and facilitating the smooth operation of the clinical trial. Quality and regulatory compliance are of utmost importance in clinical trial supplies. They must adhere to good manufacturing practices (GMP) and other relevant guidelines to ensure high-quality supplies are contamination-free and accurately labeled. Strict inventory management is crucial to maintain proper control and accountability of clinical trial supplies throughout the trial.
|Market Size||USD 3.47 billion by 2031|
|Fastest Growing Market||Europe|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
The majority of clinical trials are currently being conducted in developing economies. The increasing cost of clinical trials and complications in the recruitment of patients have encouraged biopharmaceutical companies to outsource clinical trials to regions such as Asia Pacific, Latin America, Central and Eastern Europe, and the Middle East. Disease variation in developing economies further aids biopharmaceutical companies in performing clinical trials on rare diseases. Some regions, such as Asia-Pacific, also provide greater economic benefits to biopharmaceutical companies, as governments in Singapore and China allocate funds to promote biomedical research. In Latin America, patient recruitment is easy due to reduced language barriers, which can help obtain informed consent easily, resulting in a faster clinical trial process.
There has been a significant rise in biologics and temperature-sensitive drugs in clinical trials. Currently, 38.0% of pharmaceutical drugs are temperature-sensitive, and 35.0% of late-phase pharmaceutical drugs are biologics. This number is expected to increase as the demand for biologics is growing owing to lesser adverse effects than traditional ties for storing temperature-sensitive drugs. Hence, the rise in biologics in clinical trials is expected to increase the demand for cold chain facilities. It is estimated that eight of the top ten biopharmaceutical products will require cold chain facilities by 2022. The high demand for biosimilars in developing and developed economies is expected to boost the cold chain supply further, thereby contributing to the clinical trial supplies market growth over the forecast period.
The biggest challenge to the global market is the varying regional regulations and ethical dilemmas. Each country has its requirements for shipments. In addition, each drug company has different storage requirements for testing drugs. For instance, FDA approval is required before any drug shipment can enter the U.S. Each country's shipping and customs requirements are also different, making it a complicated affair to conduct clinical trials in different countries. Recently, there has been a paradigm shift in the clinical trials market, as most trials are now being conducted in developing economies, where researchers may not be properly trained or unaware of regulations governing clinical trials.
The global market presents significant opportunities for outsourcing and streamlining clinical trial management processes. Pharmaceutical and biotechnology firms increasingly turn to outsourcing as a strategic approach to decrease the financial burden and accelerate drug discovery. This trend creates opportunities for specialized clinical trial supply companies and contract research organizations (CROs) to provide comprehensive services and solutions for managing multiple clinical trials. Outsourcing clinical trial supplies and management offers several advantages. First, it allows pharmaceutical and biotechnology firms to focus on their core competencies, such as research and development, while relying on specialized service providers for clinical trial logistics, packaging, labeling, and distribution. By outsourcing these activities, companies can optimize their resources, reduce operational costs, and enhance efficiency.
Moreover, outsourcing enables access to specialized expertise and infrastructure. Clinical trial supply companies and CROs possess extensive knowledge and experience in managing the complex regulatory requirements, quality standards, and logistical challenges associated with clinical trials. They have established relationships with vendors, storage facilities, and distribution networks, ensuring timely and compliant delivery of supplies to trial sites globally.
Based on region, the global clinical trial supplies market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global clinical trial supplies market shareholder and is estimated to grow at a CAGR of 5.4% over the forecast period. North America accounts for the highest number of clinical trials conducted among all regions, a major driver for the growth of this region's clinical trial supplies market. An increase in the number of clinical trials and players in the market and the availability of advanced technology are among the elements responsible for the dominance of this region. Most clinical trials are conducted in countries like the U.S. and Canada in the region. English is a widely used language in this region, which reduces the language barrier.
Hence, North America is preferred for conducting clinical trials. Most CROs and biopharmaceutical companies are present in this region, and with technological advancements, the demand for effective supplies is increasing. Hence, this region is expected to witness considerable growth in the clinical trial supplies market over the forecast period.
Europe is anticipated to exhibit a CAGR of 5.8% over the forecast period. Europe is one of the leading markets for clinical trial supplies owing to advancements in technology, increasing clinical trials in this region, and innovative biopharmaceutical companies and CROs. According to the Outsourcing Survey by Nice Insights, in 2016, there was a 3.0% rise in projects outsourced to Western Europe from 11.0% to 14.0%. This can be attributed to biopharmaceutical companies prefer conducting research in established markets, such as Europe and North America, than emerging markets due to well-established healthcare infrastructure. Emerging economies such as Eastern Europe are expected to exhibit rapid growth in the clinical trials outsourcing market owing to faster processes and cost-effectiveness.
Asia-Pacific is expected to be one of the fastest-growing global clinical trial supply market regions. The tremendous growth in clinical research is anticipated to assess the growth of the market in the nation, thereby contributing to the expansion of the global market. The primary factors driving the growth of clinical research in these regions include low cost per patient in Asia-Pacific countries and a diverse group of patients that are easy to recruit.
Latin America is one of the places with the most growth. In terms of the number of clinical trial sites owing to its diverse population, ease of access to patients, proximity to North America, and relatively low transportation cost. These factors are driving the market for clinical trials in this region. Colombia, Peru, Chile, Argentina, Mexico, and Brazil accounted for 90.0% of the total clinical trials in Latin America. Recent regulatory reforms to reduce the clinical trial application approval period in Brazil, China, and Argentina are expected to boost the market.
Middle East and Africa is one of the emerging markets for conducting clinical trials owing to increased demand for quality care, a diverse population, and ease in patient recruitment. In addition, this region offers logistic benefits as European pharmaceutical companies are located in proximity to African regions than Latin America.
The global clinical trial supplies market is bifurcated into phase, product and services, end-use, and therapeutic use.
Based on phase, the global market is bifurcated into phase I, phase II, phase III, and others.
The phase I segment dominates the global market and is projected to exhibit a CAGR of 6.1% over the forecast period. Phase I clinical trials are mostly outsourced, with more than 60.0% of trials being outsourced to research centers, CROs, and academic institutions. The presence of a small sample population and high capital investment are major factors responsible for outsourcing most clinical trials. The increase in the number of phase I clinical trials being outsourced and the globalization of clinical trials are expected to drive the market for clinical trial supplies for phase I.
Major therapeutic areas, such as cardiovascular diseases, central nervous system, infectious diseases, and oncology, have the largest number of phase I projects. This high volume of activity is expected to increase the complexities in the supply chain of clinical trials, thereby increasing the demand for global clinical trial supplies.
Based on products and services, the global market is bifurcated into manufacturing, storage, and distribution, and supply chain management.
The manufacturing segment dominates the global market and is projected to exhibit a CAGR of 5.7% over the forecast period. The manufacturing segment includes drug and placebo manufacturing, comparator sourcing, and labeling and packaging. The rise in clinical trials has resulted in high demand for material supplies, increasing the demand for quality drugs. Complex molecules and high demand for biologics are expected to boost the manufacturing segment of the global market. Most material supplies are outsourced, which drives the demand for efficient clinical trial supplies. Outsourcing in manufacturing can be attributed to the introduction of new technologies to manufacture complex molecules and increasing demand for developing cost-efficient products.
Based on end use, the global market is bifurcated into pharmaceuticals, biologics, and medical devices.
The pharmaceuticals segment dominates the global market and is projected to exhibit a CAGR of 5.6% over the forecast period. There has been a steady decrease in pharmaceutical drugs in the R&D pipeline as it has been substituted by biological drugs, which is expected to impact segment growth during the forecast period negatively. The number of pharmaceutical drugs in the top 10 innovative drugs has decreased drastically and is expected to be replaced by biologics. Although pharmaceutical drugs account for the most drugs in the clinical trial segment, the growing number of biological drugs will likely impact this number.
Based on therapeutic use, the global market is bifurcated into oncology, central nervous system (CNS) disorders, cardiovascular, infectious disease, metabolic disorders, and others.
The oncology segment dominates the global market and is projected to exhibit a CAGR of 6.5% over the forecast period. Oncology clinical studies are made to help find, treat, and control cancer and its symptoms. In oncology, clinical study materials come in two types of packaging: main and secondary. The main goal of packing is to get patients to take their medicine as prescribed. 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.