Infectious Disease Clinical Trials Global Market Report 2025

The infectious disease clinical trials market size has grown strongly in recent years. It will grow from $14.14 billion in 2024 to $15.1 billion in 2025 at a compound annual growth rate (CAGR) of 6.7%. The growth in the historic period is driven by the emergence of novel pathogens, globalization and increased travel, limited access to sanitation in developing regions, rising incidence of antimicrobial resistance, and government vaccination initiatives.

The infectious disease clinical trials market size is expected to see strong growth in the next few years. It will grow to $19.83 billion in 2029 at a compound annual growth rate (CAGR) of 7%. The growth in the forecast period can be connected to growing investment in rapid diagnostic technologies, expansion of genomic surveillance systems, increasing development of novel vaccine platforms, rising collaborations between pharma and biotech companies, and demand for point of care infectious disease testing. Major trends in the forecast period include use of artificial intelligence in outbreak prediction, adoption of telehealth for infectious disease management, integration of wearable health monitoring devices, focus on one health approaches linking human and animal health, and expansion of digital epidemiology using big data.

The rising healthcare infrastructure is expected to support the growth of the infectious disease clinical trials market going forward. Healthcare infrastructure refers to the physical facilities, medical equipment, technologies, and trained workforce that enable the delivery of healthcare services and support effective disease prevention, diagnosis, and treatment. The development of healthcare infrastructure is increasing due to the growing demand for advanced medical services, the rising burden of emerging and complex diseases, and the need for well-equipped facilities and skilled healthcare professionals to provide timely diagnosis, treatment, and preventive care. Healthcare infrastructure strengthens clinical trial capacity by offering advanced medical facilities, specialized equipment, and improved research capabilities essential for conducting comprehensive infectious disease studies. For instance, in January 2025, according to the American Hospital Association, a United States-based nonprofit organization, the total number of hospitals in the country was 6,090 in 2021 and is projected to reach 6,093 by 2025, indicating modest growth in healthcare facilities nationwide. Therefore, the rising healthcare infrastructure is supporting the growth of the infectious disease clinical trials market.

Leading companies in the infectious disease clinical trials market are emphasizing the development of advanced research programs, such as phase 3 trials of antibiotic candidates, to identify rare side effects and determine optimal dosage levels. A phase 3 trial of antibiotic candidates represents a late-stage clinical study conducted on a large patient population to assess the drug’s safety, efficacy, and comparative performance against existing treatments before regulatory approval. For example, in May 2025, Roche, a Switzerland-based pharmaceutical firm, initiated a Phase 3 clinical trial for zosurabalpin, an innovative tethered macrocyclic peptide antibiotic developed to target CRAB, a major cause of severe hospital-acquired infections globally. Zosurabalpin features a unique mechanism of action that inhibits the transport of lipopolysaccharide required for constructing the bacterial outer membrane, with no observed resistance to date. The international trial will include about 400 patients to assess its safety and efficacy relative to standard therapies. Preliminary findings have demonstrated strong activity against multidrug-resistant bacteria, high tolerability, and favorable pharmacokinetic characteristics, positioning zosurabalpin as a potentially transformative solution to the growing threat of antibiotic resistance.

In February 2025, Flourish Research LLC, a US-based multi-site clinical trial organization, acquired Diablo Clinical Research LLC for an undisclosed amount. Through this acquisition, Flourish Research LLC aims to broaden its geographic presence and diversify its therapeutic area expertise to further enhance its clinical trial capabilities. Diablo Clinical Research LLC is a US-based company that conducts infectious disease clinical trials.

Major players operating in the infectious disease clinical trials market are GlaxoSmithKline plc (GSK), Pfizer Inc, Moderna Inc, Novartis AG, Sanofi S.A., AstraZeneca plc, Merck & Co Inc, Gilead Sciences Inc, AbbVie Inc, Eli Lilly and Company, Bristol Myers Squibb Company, Roche Holding AG, Bayer AG, Takeda Pharmaceutical Company Limited, CSL Limited, Regeneron Pharmaceuticals Inc, Biogen Inc, Amgen Inc, Inovio Pharmaceuticals Inc, Dynavax Technologies Corporation, Valneva SE, Emergent BioSolutions Inc, Vir Biotechnology Inc, International AIDS Vaccine Initiative, VBI Vaccines Inc, Otsuka Pharmaceutical Co Ltd, Daiichi Sankyo Company Limited, Shionogi & Co Ltd, Astellas Pharma Inc, Eisai Co Ltd, Sun Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Ltd, Bharat Biotech International Limited, Laurus Labs Limited, Sarepta Therapeutics Inc, Alnylam Pharmaceuticals Inc, Intellia Therapeutics Inc, Sangamo Therapeutics Inc, Excision BioTherapeutics Inc, Atara Biotherapeutics Inc, Adaptive Biotechnologies Corporation, ImmunityBio Inc, Enanta Pharmaceuticals Inc, Iterum Therapeutics plc, Spero Therapeutics Inc, Venatorx Pharmaceuticals Inc, Vaxart Inc, Immunovant Inc, Tonix Pharmaceuticals Holding Corp, Genentech Infectious Diseases Unit.

North America was the largest region in the infectious disease clinical trials market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the infectious disease clinical trials market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

The infectious disease clinical trials market research report is one of a series of new reports that provides infectious disease clinical trials market statistics, including infectious disease clinical trials industry global market size, regional shares, competitors with a infectious disease clinical trials market share, detailed infectious disease clinical trials market segments, market trends and opportunities, and any further data you may need to thrive in the infectious disease clinical trials industry. This infectious disease clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Infectious disease clinical trials refers to the structured research studies that evaluate the safety, efficacy, and optimal use of drugs, vaccines, or therapies targeting infectious diseases. These trials follow carefully designed protocols to monitor participants’ responses and collect clinical data under controlled conditions. The findings contribute to advancing medical knowledge and supporting the development of effective treatments and preventive measures against infectious diseases.

The main phases of infectious disease clinical trials include phase I, phase II, phase III, and phase IV. Phase I infectious disease refers to the initial stage of clinical trials for a new drug or vaccine, rather than the infection itself. The key indications include human immunodeficiency virus, hepatitis, influenza, tuberculosis, malaria, coronavirus disease of 2019, and others. The types of studies conducted include randomized controlled trials, open label studies, double blind studies, observational studies, and cohort studies. The various drug types include antibiotics, antivirals, antifungals, vaccines, and combination therapies, which are utilized by pharmaceutical companies, biotechnology firms, contract research organizations, academic institutes, and other research entities.

The countries covered in the infectious disease clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The infectious disease clinical trials market consists of revenues earned by entities by providing services such as patient recruitment and enrolment, data collection and management, laboratory testing and analysis, monitoring and safety oversight and regulatory compliance support. The market value includes the value of related goods sold by the service provider or included within the service offering.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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