November 2024
The comparator drug sourcing market size was estimated at US$ 1.16 billion in 2023 and is projected to grow to US$ 2.24 billion by 2034, rising at a compound annual growth rate (CAGR) of 6.15% from 2024 to 2034. The increasing number of clinical trials, new drug development research, and increasing investments drive the market.
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Comparator drug sourcing is a strategic operation for storing, repackaging, and distributing comparator drugs to clinical trial sites. A comparator drug is a marketed product or placebo used as a standard or reference in a clinical trial to compare its efficacy and safety with the investigational drug. It also refers to investigational medicinal products when the drugs are repurposed for novel indications. Comparator drugs include several branded and generic drugs, specialty medications, and over-the-counter medications. Comparator drug sourcing offers consistent, timely, and secure supply chain operations from manufacturers to consumers.
The increasing number of clinical trials due to growing research and development activities augments the market. Comparator drug sourcing is beneficial for large, complex, and multi-phase clinical trials since they require huge quantities of drugs. Such services implement regulatory specifications for the import/export of drugs and maintain consistency and integrity in the storage and supply of comparator drugs.
The advent of advanced technologies helps in revolutionizing the healthcare sector. Technologies like artificial intelligence (AI) and machine learning (ML) streamline the supply chain of comparator drugs. It can allow companies to search for comparator suppliers based on specific locations and products within minutes. The supply chain can be automated using AI and ML, from automated inventory management systems for comparator drugs to sophisticated tracking and monitoring tools. AI can also help find the best logistics route based on the particular need for shipment. AI can also precisely monitor and maintain the temperature of the comparator drugs throughout the supply. Additionally, AI can help mitigate several risks associated with comparator drug sourcing, such as the identification of poor-quality goods, drug shortages, excessive inventory, supplier risk assessment, and predictive analytics. Hence, AI and other advanced technologies can improve the resilience and efficiency of the comparator drug sourcing.
The major challenge for comparator drug sourcing is compliance with regulatory variation. For larger and more complex clinical trials conducted at multiple locations globally, it becomes difficult for comparator-sourcing companies to fulfill the stringent regulatory requirements of multiple countries. Another major challenge includes the maintenance of the quality of comparators obtained from different suppliers.
North America dominated the comparator drug sourcing market in 2023. The increasing number of clinical trials, the presence of key players, regulatory standards, state-of-the-art research and development, and favorable government policies drive the market. As of January 2024, around 20,465 clinical trials were recruiting patients in the US. According to the WHO International Clinical Trials Registry Platform (ICTRP), the US conducted the highest number of clinical trials globally, accounting for 168,520 trials from 1999 to 2022, whereas Canada conducted around 34,041 clinical trials. The market is also driven by new drug discoveries in the U.S. and Canada. The clinical trials for new drugs require comparators as reference molecules. In 2023, the Center for Drug Evaluation and Research approved 55 novel drugs to be marketed in the U.S.
Asia-Pacific is estimated to grow fastest in the comparator drug sourcing market during the forecast period. The growing research and development activities, increasing number of clinical trials, new drug approvals, and increasing investments & collaborations drive the market. According to China’s National Medicines and Pharmaceutical Administration (NMPA), 87 novel drugs were approved by China in 2023. In India, 27 new drugs were approved by the Central Drugs Standard Control Organization (CDSCO) in 2023. In Japan, a total of 776 new drugs were approved from 2004 to 2023. China, India, and Japan are also among the top five countries that conducted the highest number of clinical trials from 1999 to 2022.
By type, the central sourcing segment held a dominant presence in the comparator drug sourcing market in 2023. Central sourcing utilizes the largest commercial markets to provide complicated supply chains with worldwide testing. Larger and more complex clinical trials require central sourcing for comparators. The increasing demand for centralized procurement and the rising number of phase III trials potentiates market growth.
The local sourcing segment is predicted to witness notable growth in the comparator drug sourcing market over the forecast period. Local sourcing is widely preferred by companies due to the ease of product availability, eliminating the need to import comparators from other countries. Additionally, local sourcing can offer timely delivery and be economically compliant.
By application, the drug producers/manufacturers segment accounted for a considerable share of the comparator drug sourcing market in 2023. The drug producers or pharmaceutical companies are the major suppliers and consumers of comparator drugs. Many branded and generic drugs required as comparators are manufactured by the drug producers. Also, most clinical trials globally are conducted by pharmaceutical companies. The novel drug discovery by these companies leads to the conduction of clinical trials, necessitating the demand for comparator sourcing.
The CMO segment is anticipated to grow with the highest CAGR in the comparator drug-sourcing market during the studied years. Contract manufacturing organizations (CMOs) are the organizations that are given contracts for manufacturing particular drugs by pharmaceutical companies that do not have the relevant facilities. Comparator drugs are supplied through CMOs as they even manufacture small or desired quantities of drugs for clinical trials.
By Type
By Application
By Region
November 2024
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Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y. Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.
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