Clinical Trial Supplies Market: Overview
A safe clinical trial presupposes a robust supply chain management of the study drugs, consistent with various regional and global regulations and available infrastructures. Clinical trial supplies management is imperative for avoiding overproduction, inventory expiration, and oversupply. With the escalating costs of drug discovery, clinical trial supplies is gaining more significance. In addition, the implementation of stricter handling requirements for a variety of biopharmaceutical products entering clinical trials, clinical trial supplies strategy needs to be constantly overhauled. This also calls for integrating several third-party vendors across all stages of clinical development.
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Sponsors and contract research organizations partaking drug discovery initiatives have realized the role of clinical trials logistics and end-to-end solutions for respecting the desired study timelines. Stringent handling requirements pertaining to the handling requirements such as good manufacturing practices (GMP) are essential for the manufacture, storage, and distribution of investigational medicinal products (IMPs), essentially for clinical trials being conducted in developed regions such as Europe and North America. Activities related to import and distribution of IMPs and Non Investigational Products (NIMPs) also mandate an extensive clinical trial supplies planning for adhering to require trial protocols. These also include standardized return and destruction procedures. The increasing prevalence of chronic diseases such as various cancer types and the growing popularity outsourcing of drug discovery services, in several developing and developed nations, is expected to bolster the demand for clinical trial supplies services. In addition, the rising need for determining the level of toxicity in the early stages of drug discovery is a crucial factor catalyzing the clinical trial supplies market.
Clinical trials are research studies that discover whether a medical treatment, strategy, or device is effective and safe for humans. There are four stages of clinical trials: phase Ι, phase ΙΙ, phase ΙΙΙ, and phase ΙV. Identification of pharmacological actions and tolerability is done in phase I. Phase ΙΙ evaluates drug safety and efficacy. Phase III involves the evaluation of risk benefit ratio and determination of dosage interval. Epidemiological data, efficacy, and safety within large diverse populations and pharmacoeconomics are identified in phase IV.
Clinical trials are complex activities that require synchronization of several different functions and processes. A pharmaceutical manufacturer’s primary goal in any clinical study is to optimize clinical trial supplies so that packaged investigational materials are distributed to patients enrolled in a clinical trial on time. These activities include, but are not limited to, project management, clinical packaging, randomization generation, labeling, supply chain logistics, blinding, distribution, return drug accountability, and destruction.
The clinical trial supplies market can be segmented based on products and services, therapeutic area, and region. In terms of products and services, the market can be categorized into manufacturing, packaging, logistics, and distribution. Based on therapeutic area, the clinical trial supply market can be segmented into oncology, cardiovascular diseases, neurological diseases, respiratory diseases, orthopedics, and others. In terms of end-user, the market can be segregated into contract research organizations, pharmaceutical & biotechnology companies, academic & research institutes, and others. In terms of region, the market can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
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The global clinical trials supplies market is witnessing strong growth due to the increasing prevalence of chronic diseases such as cancer, epilepsy, and HIV; rising demand for outsourcing of drug discovery services, and increased emphasis on determining toxicity level in early stages of drug discovery. Additionally, increasing number of life sciences research in various countries and rising government funding for the development of new drugs are likely to propel the clinical trial supplies market. New entrants are focusing on new technologies and launch of new products in the market. However, shortage of trained professionals and lack of infrastructure are expected to hamper the growth of the market.
North America accounted for the largest share of the clinical trial supplies market due to high number of research and development activities in the area of drug discovery, advanced health care infrastructure, and presence of multinational pharmaceutical and biotechnology companies that carry out clinical trials. Europe accounted for the second largest share in terms of revenue owing to high health care investment and rising government funding. Asia Pacific is also witnessing significant growth due to rising unmet health care needs and increased government funding to research activities. Moreover, major pharmaceutical companies are outsourcing their drug development services to various countries such as China, Singapore, Malaysia, and India, which is propelling the growth of the clinical trial supplies market in the region. Middle East and Latin America are expected to be the prospective markets due growing access to information, high cancer burden, improving patient education, and access to new drugs for research centers. However, long timeline for regulatory approval, lack of training, lack of economic investment, and lack of personnel participating in clinical research in Latin America and Middle East are expected to restrain the clinical trial supplies market.
Key players operating in the clinical trial supplies market are Alamc Group Ltd., Amatsigroup, ADAllen Pharma, Durbin plc, Biocair, Catalent Pharma Solutions, Inc., KLIFO A/S, Movianto, Rubicon Research Pvt. Ltd., PCI Services, Patheon, Inc., PAREXEL International Corporation, and Sharp Packaging Services.
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