Comparator Drug Sourcing Market Size, Share & Growth [2032]

Report Description

Global Comparator Drug Sourcing Market Outlook 2032

The Global Comparator Drug Sourcing Market size was USD 1,160.2 Million in 2023 and is likely to reach USD 1,797.2 Million by 2032, expanding at a CAGR of 5.2% during 2023–2032. Globalization, the rising number of clinical trials, and the growing number of biologics & and biosimilar drugs in clinical trials are expected to drive the market.

Adoption of a supply chain management system is increasing, due to the rising pressure to reduce R&D expenditure and increase operational efficiency, as comparator drug sourcing accounts for a large share of the total R&D expenditure of biopharmaceutical companies. A significant rise has been registered in the number of biologics and temperature-sensitive drugs in clinical trials. As per WHO in 2020, 38.0% of pharmaceutical drugs are temperature-sensitive and 35.0% of late-phase pharmaceutical drugs are biologics.

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Moreover, most 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 various regions, such as Asia Pacific, Latin America, Central & and Eastern Europe, and the Middle East.

The COVID-19 pandemic impacted the comparator drug sourcing market in the following ways:

Globally, many nations have experienced significant strain on their economies and healthcare systems, due to the high transmission rate of COVID-19. Production facilities of all healthcare-related businesses were disrupted and transportation was severely hampered in both developed and developing countries during the COVID-19 pandemic.

Lockdowns, transportation restrictions, and disruptions in manufacturing operations led to a certain delay and shortages in the supply of comparator drugs, affecting clinical trials and research.

The urgency of COVID-19 vaccine and treatment development increased the demand for comparators, further straining supply chains and driving up prices.

Global Comparator Drug Sourcing Market Dynamics

Major Drivers: Increasing Number of Clinical Trials

Increasing number of clinical trials is driving the global comparator drug sourcing market. Pharmaceutical companies and research institutions are intensifying their efforts to develop drugs and therapies, thus boosting the number of clinical trials. These trials are essential for testing the safety and efficacy of potential medications. According to the Tufts Center for the Study of Drug Development (CSDD), the top 10 pharmaceutical companies together spend more than $20 million every year on comparator sourcing.

Clinical trials cover a wide range of therapeutic areas, including cardiology, neurology, oncology, and infectious diseases, among others. Each of these areas requires specific comparator drugs for accurate assessments. According to WHO, as of Jan 2024, nearly 479 thousand clinical studies were registered globally. The number of clinical studies has increased significantly, as 2,119 clinical studies were registered in 2000.

Major Drivers: Rising Drug Development

Rising drug development is driving the global comparator drug sourcing market. Many pharmaceutical companies focus on developing drugs and therapies, which is boosting the number of clinical trials. Regulatory authorities such as the FDA and EMA mandate that new drugs undergo rigorous testing in clinical trials before approval. Comparator drugs are necessary to establish the comparative effectiveness of the new drug against existing treatments, ensuring compliance with regulatory standards. Spending on drug development and R&D have increased in the past two decades.

 In 2019, the pharmaceutical industry spent USD 83 billion dollars on R&D. Changes to the design of clinical trials have made comparator sourcing a key enabler of R&D success. Between 2010 and 2019, the number of new drugs approved for sale increased by 60% as compared with the previous decade, with 59 new drugs approved in 2018.

Existing Restraints: High Cost of Drug Development

Pharmaceutical companies and research institutions often operate under strict budgets for drug development. High cost of sourcing comparator drugs strains these budgets, potentially leading to cost-cutting measures that affect the sourcing process. For companies working in North America, cost is the main challenge, reflecting the high prices of drugs in the US.

Cost of drug development totaled approximately one billion US dollars in the decade from 1990 to 1999; however, this expense has more than doubled in the years that have followed, reaching around 2.6 billion US dollars. Challenges in the early stages of clinical trials, leading to high failure rates, boosted the research and development (R&D) costs. Members of the trade group PhRMA (Pharmaceutical Research and Manufacturers of America) spent approximately 83 billion US dollars on R&D in 2019.

Emerging Opportunities: Increasing New Drug Development

Clinical trials for drug efficacy a key to drug development, mainly for disease treatment before launching the drugs into market for human consumption. Additionally, the new drugs need to meet license extensions and international standards before sale and distribution. Increasing prevalence and incidence of diseases and the rising patient numbers are boosting the trend of clinical trials for drug development in developing countries over the past period. Governments in emerging markets (China, Brazil, Mexico, Russia, India, and South Africa) reform public healthcare and grant access to medicine. These two factors enable market development and increased innovation in clinical research in emerging markets.

As of June 2023, Brazil accounted for the largest number of clinical trials in Latin America, with over 9,000 studies. Mexico ranked second, with nearly 5,000 clinical trials.

Scope of the Global Comparator Drug Sourcing Market Report

The market report includes an assessment of the market trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Vendor Type Segment Analysis

On the basis of vendor type, the global comparator drug sourcing market is segmented into clinical trial supplies vendors, specialist comparator sourcing vendors, and networks/consortia.

The clinical trial supplies vendors segment is experiencing substantial growth, due to increasing clinical trial activity. The growth of the pharmaceutical and biotechnology industries has led to a rise in the number of clinical trials. This surge in clinical trial activity has driven the demand for comparator drugs and services of clinical trial supply vendors. Moreover, the robust drug development pipeline, with numerous new drugs entering clinical trials, generates a continuous demand for comparator drugs and associated services.

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End-user Segment Analysis

On the basis of end-user, the global comparator drug sourcing market is split into drug manufacturers, CMOs, academic and research institute, and others.

The drug manufacturers segment is estimated to expand at a CAGR of 5.3% during the forecast period, as drug manufacturers have established reputations for producing safe and effective pharmaceuticals. Their involvement in comparator drug sourcing adds an element of trust and reliability to clinical trials. Moreover, the growing number of clinical trials, especially in areas such as oncology, rare diseases, and biologics, is driving the demand for comparator drugs. Drug manufacturers tap into this expanding market by supplying these drugs.

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Regional Outlook

On the basis of region, the global comparator drug sourcing market is divided into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa (MEA).

North America accounts for the largest number of projects in the Phase 2 trial in 2020, which led to high investments in R&D by industry and other out-of-industry sponsors. The clinical trials logistic survey in 2021 stated that about 60% of clinical trials in phase 2 are outsourced. A high concentration of pharmaceutical companies and innovative combinations of approved and novel treatments boosted the number of phase 2 trial studies.

Countries in Asia Pacific have diverse patient populations in terms of genetics, ethnicity, and disease prevalence. This boosts the requirement of a wide range of comparator drugs to ensure the relevance of clinical trial results. Moreover, the high incidence of chronic diseases in Asia is likely to contribute to the surge in the number of clinical trials in Asia. According to the World Health Organization (WHO), non-communicable diseases cause 55% of the total deaths, ~8 million every year, in the region. Additionally, pharmaceutical companies are likely to conduct drug trials for treating gastroesophageal or liver cancer in China or South Korea, respectively, as many patients in these countries are suffering from these diseases. Moreover, clinical trials in Asia cost ~30–40% less than in the US and the EU, as doctor visits and medical treatments and procedures are less costly.

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