Comparator Drug Sourcing Market to Climb USD 2.24 Bn by 2034

Comparator Drug Sourcing Market Companies, Trends and AI Impact

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 Market: Bridging the Gap

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.

Comparator Drug Sourcing Market Trends

• In July 2024, Catalent announced the completion of the expansion of its clinical supply facility in Schorndorf, Germany. The 32,000 sq. ft. facility provides comprehensive clinical supply services at controlled room temperatures between 15 and 25 degrees Celsius.
• In April 2022, Yourway announced an expansion of its controlled ambient capabilities in Allentown, Pennsylvania. The expansion was made to meet the growing demand for long-term, temperature-controlled storage and accommodate 5,000 pallets of clinical trial supplies.
• The consolidated revenue of McKesson Corporation for fiscal 2024 was $309 billion, an increase of 12% from fiscal 2023. The cash flow from operations was $4.3 billion, and the Free Cash Flow was $3.6 billion.

Artificial Intelligence: Future of the Comparator Drug Sourcing Market

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.

Regulatory Compliance Hinder the Comparator Drug Sourcing Market

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.

Regional Insights

Rising Number of Clinical Trials Dominated North America

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.

New Drug Approvals Promote the Asia-Pacific Market

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.

Segmental Insights

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.

Recent Developments in the Comparator Drug Sourcing Market

• In April 2024, BAP Pharma opened its new US headquarters in Somerset, N.J. The new state-of-the-art 28,000 sq. ft. facility includes a 24-hour temperature-controlled and monitored warehouse, in-house label design and print, clinical secondary packaging, and just-in-time/on-demand labeling.
• In December 2023, World Courier, a part of Cencora, opened transport stations in three new markets in the US, expanding its presence and capacity to deliver specialized logistics support as the specialty pharmaceutical market continues to grow.

Top Companies in the Comparator Drug Sourcing Market

• BAP Pharma
• Catalent, Inc.
• Cencora
• ClientPharma
• Clinigen
• Euromed Pharma
• McKesson Corporation
• Myonex
• NewLife Medicals, Inc.
• Sharp Services
• Thermo Fisher Scientific
• Yourway – The Biopharma Services Company

Segments Covered in the Report

By Type

• Central Sourcing
• Local Sourcing
• Others

By Application

• Drug Producers/Manufacturers
• CMO
• Academic and Research Institute
• Others

By Region

• North America
  • US
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait