Clinical Trial Kits Market

Market Overview

The global clinical trial kits market size was valued at USD 1.56 billion in 2022. It is estimated to reach USD 3.17 billion by 2031, growing at a CAGR of 8.2% during the forecast period (2023–2031).

Globalization of clinical trials has led to increased investment in product development in emerging countries, positively impacting the overall clinical trials market. Clinical trial kits, also known as study kits or trial supply kits, are packages or collections of materials, supplies, and documentation specifically assembled and provided to participants or investigators involved in a clinical trial. These kits play a crucial role in facilitating the smooth conduct of the trial, ensuring standardized procedures, and supporting the collection of accurate and reliable data. The contents of clinical trial kits can vary depending on the specific requirements of the trial and the nature of the intervention being studied. However, they typically include items necessary for the trial's administration, monitoring, and documentation. These kits are carefully designed to meet the unique needs of each study and ensure that all participants and investigators have access to the necessary resources.

One key component of clinical trial kits is the investigational product, which refers to the test article or intervention being studied in the trial. This could include drugs, vaccines, medical devices, or other experimental treatments. The kit will include the required quantity of the investigational product for a specified period or treatment regimen, ensuring that participants receive the appropriate dosage per the study protocol. In addition to the investigational product, clinical trial kits contain instructions and protocol documents. These materials provide detailed guidelines and study-specific information to ensure that all participants and investigators adhere to standardized procedures. They include information on dosing, administration, storage, handling, and safety precautions related to the investigational product, ensuring consistency and accuracy in the trial implementation.

Market Dynamics

Global Clinical Trial Kits Market Drivers

Globalization of Clinical Trials

The geographical distribution of clinical trials shows the gradual shift from developed nations to emerging countries. The rising cost of clinical trials and difficulties in patient recruitment have led biopharmaceutical companies to move their operations to regions like Central and Eastern Europe, Asia Pacific, Latin America, and the Middle East for cost savings and easy patient recruitment. Emerging countries also possess a diverse disease variation compared to the West, where traditional diseases are rising. Disease variation in developing countries helps biopharmaceutical companies to perform clinical trials on rare diseases.

Furthermore, regions like Asia-Pacific also provide greater economic benefits to biopharmaceutical companies as governments in countries like Singapore and China allocate funds to promote biomedical research. Regions like Latin America, where the population only speaks Portuguese and Spanish, also offer fewer barriers to informed consent, which helps in easy patient recruitment and faster clinical trials. The Middle East is expected to be a potential clinical trial region due to increasing population, improving infrastructure, and greater disease variation. Globalization of clinical trials has led to increased investment in product development in emerging countries, positively impacting the overall clinical trials market.

Increasing Demand for Remote Services

There has been a decrease in the number of people going to laboratories for blood tests in the wake of the current pandemic. As a result, more people are opting for at-home blood sample collection. Numerous patients are delaying regular tests and medical care to reduce and prevent infection. Various labs are operating as much as a 40% decrease in phlebotomy appointments and blood test volumes. For instance, Quest Diagnostics reported a significant decrease in test volumes in the last two weeks of March 2020. These changes have encouraged health institutions to adopt novel practices and technologies that allow patients to collect their blood.

Moreover, care providers are utilizing telehealth, a virtual mode that supports virtual interaction between patients and healthcare providers during the pandemic to help reduce exposure to disease. A survey conducted on physicians in April 2020 stated that up to 85% of participants saw patients via video or phone. It also stated that 77% of the participating physicians supported the transition to telemedicine.

Global Clinical Trial Kits Market Restraints

Varying Regulations in Countries

The biggest challenges for the global clinical trial supplies market are the varying regional regulations and ethical issues. The requirements for shipments vary in each country. In addition, each drug company has different storage requirements for testing drugs. For instance, FDA approval is required before any shipment carrying drugs in the U.S. Each country's shipping and customs requirements are also different, making it challenging 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.

For instance, shipments in Vietnam need to be addressed to organizations, not individuals. If a shipment is not addressed properly, the individual may be liable for the package's duty and tax implications. In certain countries, clearing customs may take more time, depending on the number of shipments at a point in time. Due to the delay, the quality of the contents may deteriorate and affect the efficacy of clinical trials.

Global Clinical Trial Kits Market Opportunities

Special Temperature Requirement for Storing and Transporting Drugs and Biological Sample

The special temperature requirements for storing and transporting drugs and biological samples in clinical trials present significant global clinical trial kit market opportunities. Clinical trials often involve investigational drugs and biological samples sensitive to temperature fluctuations and requiring specific temperature conditions to maintain their stability and integrity. One opportunity lies in the development and provision of temperature-controlled packaging solutions.

There is a growing demand for innovative packaging options, such as insulated containers, refrigerated boxes, and temperature-monitoring devices, to ensure the safe storage and transportation of drugs and biological samples. Companies specializing in temperature-controlled packaging can capitalize on this demand by offering reliable and efficient solutions that meet the unique requirements of clinical trials.

Regional Analysis

North America Dominates the Global Market

Based on region, the global clinical trial kits 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 kits market shareholder and is estimated to grow at a CAGR of 7.2% over the forecast period. North America had the biggest market, with 41.1% in 2020. This can be attributed to the robust medical infrastructure. Due to the availability of necessary funds, several companies are being developed in this sector in North America, mostly to conduct research and design new, effective therapies through clinical trials. Furthermore, the adoption of technologically advanced products is driving the market in North America.

North America is one of the global leaders in healthcare cold chain logistics. The region's developed healthcare sector has adopted product automation, reducing the risk of human handling errors in the cold chain. Moreover, several cold chain logistics and transportation providers, including AmerisourceBergen and FedEx, have supported regional market expansion.

Europe is anticipated to exhibit a CAGR of 8.5% over the forecast period. Europe is one of the leading markets for clinical trial kits 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.

Additionally, a Pharma IQ and Clinical Supply Europe survey estimated that logistics and distribution are among the major outsourced clinical trial kits market functions. Western Europe is an established market for clinical trial supplies and is expected to be one of the major markets over the forecast period. Eastern Europe is also expected to exhibit significant growth owing to benefits such as cost-effectiveness and ease in the availability of a diverse patient population for recruitment.

The Asia-Pacific area has emerged as a hotspot for clinical trials due to the extreme ease of regulatory compliance, low study costs, a growing patient population, and a few elite clinical institutions serving as sites. For example, regulatory bodies in China are attempting to better the clinical trial process by shortening the total review and approval procedure. The region is rapidly becoming one of the most important locations for clinical trials, with the number of clinical trial sites established by biotechnology companies increasing by an average of 40% per year, compared to only 11% in the rest of the globe.

Latin America is a rapidly growing region 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 clinical trial supplies 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. For American companies, sourcing patients and providing clinical supplies would be more economically beneficial in African regions over Asia. Kenya, Jordan, Uganda, Israel, and Egypt spearhead over 12,000 active trials in African and Middle Eastern countries.

Segmental Analysis

The global clinical trial kits market is bifurcated into services and phases.

Based on services, the global clinical trial kits market is bifurcated into kitting solutions and logistics. 

The kitting solutions segment dominates the global market and is projected to exhibit a CAGR of 8.5% over the forecast period. It includes kits for sample collection as well as medicinal products. Biological samples' collection, storage, processing, and shipment integrity are essential for successful clinical trials. Various firms offering these services make it easy for companies to conduct clinical trials. They provide customized protocol-specific lab manuals and kits and simplify collection for clinical trials. The segment includes lab kits for blood and specimen collection, drug administration, ancillary supply, related services, training, and transport kits for time and temperature-sensitive specimens.

Based on phase, the global clinical trial kits market is bifurcated into Phase I, phase II, phase III, and Phase IV. 

The phase I segment dominates the global market and is projected to exhibit a CAGR of 7.2% over the forecast period. Phase I trials involve only a small number of people. This phase determines the welfare of the drug or treatment, its optimum dose, and the most efficient delivery (orally or intravenously). As the Phase I trial is the first to test the drug on humans, they carry higher risks, and people enrolled in the study are generally monitored very closely. For instance, urine and blood samples may be collected regularly. Phase I trials are very important for biotechnology and pharmaceutical companies as they test the safety of new drugs in patients.

These are crucial in the early phases of drug development. As they are the first tests to be carried out on human subjects, their results are of extreme significance for future commercialization. However, Phase I studies have operational challenges due to the need to monitor patients' safety closely. As the drug being tested on people is new, toxicity is a major concern, and patients must be supervised more carefully, which implies the dedication of additional resources.

Recent Developments

• January 2023- Thermo Fisher Scientific announced that it had acquired BMG Diagnostics. BMG Diagnostics is a provider of clinical trial kits for infectious diseases. The acquisition is expected to help Thermo Fisher Scientific expand its portfolio of clinical trial kits and meet the growing demand for these products.
• February 2023- Sartorius announced the launching of a new line of clinical trial kits for cell and gene therapy. The kits are designed to help researchers and clinicians conduct these complex and demanding trials.