Hospital Infection Therapeutics Market to Reach US$14.7 Billion by 2033 | Astute Analytica
Astute Analytica’s latest report reveals that the clinical pipeline for hospital infection therapeutics exposes key innovation gaps and emerging opportunities for investment across antibiotic and antifungal segments.
Chicago, Oct. 21, 2025 (GLOBE NEWSWIRE) — The global hospital infection therapeutics market was valued at US$ 10.5 billion in 2024 and is anticipated to reach US$ 14.7 billion by 2033, growing at a CAGR of 3.8% over the forecast period from 2025 to 2033.
The global hospital infection therapeutics market is undergoing a period of significant transformation. Fueled by a surge in regulatory approvals and a pipeline of innovative treatments, the landscape is shifting rapidly. Stakeholders are witnessing unprecedented opportunities driven by the urgent need to combat antimicrobial resistance (AMR). An analysis of recent data from 2024 and 2025 reveals a market poised for substantial growth. New therapies are emerging. Advanced diagnostics are reshaping treatment protocols. Consequently, the dynamics of patient care and pharmaceutical development are being redefined for the foreseeable future.
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A flurry of regulatory actions in 2024 has invigorated the hospital infection therapeutics market. As per the FDA, the approval of the new antibiotic Zevtera (ceftobiprole) in April 2024 was a landmark event. Zevtera was approved for three distinct indications. These include Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). The agency also granted Zevtera three special designations: Priority Review, Fast Track, and Qualified Infectious Disease Product, signaling its importance. In another key development, the FDA approved Pivya (pivmecillinam) in April 2024, the first new oral antibiotic for uncomplicated urinary tract infections in two decades.
Furthermore, the momentum continued throughout the year. In February 2024, the FDA approved Exblifep (cefepime and enmetazobactam) for treating complicated urinary tract infections. The agency also provided marketing authorization for the Sepsis ImmunoScore in 2024, representing the first AI/machine learning diagnostic tool for sepsis. Looking ahead, Pfizer received an FDA Fast Track designation in October 2024 for a novel broad-spectrum injectable antibiotic. The new agent specifically targets carbapenem-resistant Enterobacteriaceae. These regulatory milestones are creating fresh commercial avenues for market players.
Key Findings in Hospital Infection Therapeutics Market
| Market Forecast (2033) | US$ 14.7 billion |
| CAGR | 3.8% |
| Largest Region (2024) | North America (Largest) |
| By Drug Type | Antibiotics Drugs (72%) |
| By Application | Bloodstream Infections (Dominant) |
| Top Drivers |
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| Top Trends |
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| Top Challenges |
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Clinical Pipeline Reveals Innovation Gaps and Opportunities for Investment
The research pipeline provides a critical view of the future hospital infection therapeutics market. As of 2025, the global clinical pipeline for antibacterial agents contained 90 candidates. However, a WHO analysis revealed a significant innovation gap, with only 15 of these 90 candidates qualifying as innovative. The pipeline is composed of 50 traditional antibacterial agents and 40 non-traditional agents, such as phages and antibodies. A 2024 review identified 28 small molecules specifically in development for Gram-negative bacteria, along with 20 non-traditional products targeting these challenging pathogens.
Despite these developments, the pace of innovation remains a concern. Since mid-2017, only 17 new antibacterial agents have received marketing authorization. Of these recent approvals, only two represent a completely new chemical class. The data underscores a pressing need for novel mechanisms of action to combat evolving resistance. The decrease in total pipeline candidates from 97 in 2023 to 90 in 2025 further highlights the challenges in bringing new drugs to market, creating opportunities for targeted investment in truly innovative research programs.
Robust Clinical Trial Data Underpins New Therapeutic Market Entries
The strength of new entrants in the hospital infection therapeutics market is backed by extensive clinical data. For instance, the pediatric trial supporting Zevtera’s approval for CABP included 138 subjects. Similarly, the foundational research for the Sepsis ImmunoScore tool was substantial. It involved approximately 2,000 patients initially. The Prenosis biobank, crucial for the AI tool’s development, now houses an impressive collection of over 100,000 blood samples. These samples were meticulously collected from more than 25,000 patients, with data initially built from three Illinois hospitals.
In parallel, academic research continues to generate valuable insights that inform clinical development. A 2024 sepsis study conducted at Lund University analyzed 1,364 plasma samples. Within that large cohort, 1,073 patients were confirmed to have an infection. Ultimately, 913 of those individuals were diagnosed with sepsis. Such detailed clinical investigations provide the robust evidence base required for regulatory approval and physician adoption. The data also helps in building confidence and driving the uptake of new therapeutic and diagnostic solutions.
Substantial Global Funding Initiatives Drive Antimicrobial Resistance Research Forward in the Hospital Infection Therapeutics Market
Governments worldwide are recognizing the critical threat of AMR and are allocating significant funds to combat it. In 2024, the UK’s ODA Challenge-Oriented Research Grants will support five promising research projects on Antimicrobial Resistance. This important UK grant program supports researchers in at least 12 eligible developing countries. In the United States, public health organizations recommended substantial funding for fiscal year 2024. The recommendations included $608 million for AMR Research at the NIAID and $175 million for the Advanced Molecular Detection Initiative.
Moreover, a recommendation of $100 million was made for the National Healthcare Safety Network for its FY2024 activities. The U.S. also provides AMR-related technical assistance to 30 countries through a global health division. Further funding recommendations included $330 million for BARDA’s Broad Spectrum Antimicrobials program and CARB-X. An additional $200 million was suggested for the Project BioShield Special Reserve Fund to combat AMR. From fiscal years 2016 through 2024, the U.S. CDC awarded over $57 million to fight AMR via Broad Agency Announcements, showcasing a sustained financial commitment.
Private Sector Investment and Partnerships Fuel Next-Generation Antibiotic Development
The private sector is playing a crucial role in advancing the hospital infection therapeutics market. In July 2024, Merck invested $100 million in a biotech startup that utilizes AI for antibiotic discovery. In 2025, Omnix Medical successfully raised $25 million in Series C financing. The funding will advance its lead compound, OMN6, for treating drug-resistant infections. These investments highlight a growing confidence in the commercial viability of novel antimicrobial agents. The public-private partnership CARB-X has also scheduled two funding cycles for 2025 to support new antimicrobial products.
Strategic collaborations are also shaping the future of antibiotic development in the hospital infection therapeutics market. In June 2024, the Global Antibiotic Research and Development Partnership (GARDP) announced a collaboration with one company, Bugworks Research Inc. The partnership aims to develop a new broad-spectrum antibiotic. Meanwhile, the U.S. NIAID has listed three research initiatives focused on AMR for which awards will be made in fiscal year 2025. The agency has planned four distinct research initiatives for AMR in fiscal year 2026, indicating a long-term strategy to foster innovation through sustained funding and partnerships.
Competitive Landscape Shifts Toward Specialized Biotech and Novel Drug Patents
The competitive environment of the hospital infection therapeutics market is evolving. Large pharmaceutical companies are retreating, while smaller, specialized biotech firms are stepping in to innovate. The number of large pharmaceutical companies actively working on antibiotics has shrunk to approximately four as of 2025. A number represents a significant drop from the roughly 20 large pharma companies involved in antibiotic R&D in 2000. Globally, there are 232 active preclinical programs for antibacterial agents. These programs are being conducted by 148 distinct groups and companies, demonstrating a more fragmented but highly focused research landscape.
Intellectual property is a key battleground in this specialized market. In late 2024, Telum Therapeutics announced the filing of one new patent for a novel family of antimicrobial peptides. These peptides are effective against Gram-negative bacteria. In 2025, Blacksmith Medicines was granted one U.S. Patent (No. 12,187,754) covering its LpxC inhibitor antibacterial compounds. Similarly, Dr. Matibur Zamadar at Stephen F. Austin State University received one U.S. patent in 2024 for a new type of antibiotic medication. The patent follows two international patents previously secured by the same researcher for a different invention, underscoring the value of novel scientific discoveries.
Targeted Therapies Address Urgent Need for Hospital-Acquired UTI Solutions
Hospital-acquired urinary tract infections (HAUTIs) represent a significant segment of the hospital infection therapeutics market. Recent approvals have specifically targeted this area of high unmet need. The approval of Pivya in April 2024 was particularly noteworthy, marking the first new oral antibiotic for uncomplicated UTIs in two decades. Additionally, Exblifep, approved in February 2024, is indicated for complicated UTIs. It is effective against five susceptible microorganisms. The standard intravenous administration course for Exblifep is seven days.
The treatment flexibility of these new agents is a key advantage. For patients with concurrent bacteremia, the treatment duration with Exblifep can be extended up to 14 days. The innovation continued later in the year. In October 2024, one new oral penem antibiotic, Orlynvah, was approved. Its primary indication is to target resistant strains of bacteria causing UTIs. These targeted therapies provide clinicians with much-needed new options to treat challenging hospital-acquired urinary tract infections, improving patient outcomes and addressing a critical area of AMR.
Epidemiological and Surveillance Data Underscore Growing Infection Control Challenges in the Hospital Infection Therapeutics Market
Recent epidemiological data reveals the persistent and growing challenge of healthcare-associated infections (HAIs). In 2024, Long-Term Care (LTC) facilities in Pennsylvania, USA, submitted 26,501 healthcare-associated infection reports over 24.4 million resident days. The state’s reporting system tracks 14 distinct subtypes of HAIs. Concerningly, 13 of these subtypes saw an increase in the number of reports submitted in 2024. The largest increase was for Influenza, with 795 more reports filed. All six administrative regions of Pennsylvania saw an increase in the LTC infection rate in 2024.
According to a November 2024 CDC report, nine U.S. states performed better on at least four different HAI types in 2023, while two states performed worse on two or more HAI types in the hospital infection therapeutics market. A separate 2024 CDC publication highlighted that six specific bacterial hospital-onset infections showed a combined increase during the COVID-19 pandemic. Global surveillance systems are expanding to meet these challenges. The 2024 European Antimicrobial Resistance Surveillance Network (EARS-Net) metadata set consists of eight technical variables and 28 epidemiological variables. The network also added four new antibiotic codes to its reporting list. As per WHO, its GLASS platform will present resistance data across eight common pathogens and 22 antibiotics in its 2025 report, with 104 countries now participating in the system.
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Advanced Diagnostics and Systemic Burdens Shape Future Therapeutic Demand
The future trajectory of the hospital infection therapeutics market will be heavily influenced by advancements in diagnostic technology and the systemic burden of infections. The AI-powered Sepsis ImmunoScore diagnostic test, which was named by TIME magazine as one of the best inventions of 2024, delivers critical results within a 30 to 60-minute window. Such rapid diagnostics enable earlier, more targeted therapeutic interventions, which can improve patient outcomes and optimize antibiotic stewardship. The ability to quickly identify sepsis and its likely cause will directly impact prescribing patterns and the demand for specific therapeutics.
Beyond the direct costs of treatment, the non-monetary burden on healthcare systems underscores the need for effective therapies. The average length of stay for patients in Long-Term Acute Care Hospitals (LTACHs) is more than 25 days. The statistic indicates a patient population with complex needs that is highly susceptible to infections. Reducing infection rates in such settings through effective therapeutics can free up bed capacity, reduce staff workload, and improve overall healthcare efficiency. These systemic pressures create a strong, ongoing demand for innovative solutions in the hospital infection therapeutics market.
Hospital Infection Therapeutics Market Major Players:
- Actavis plc
- AstraZeneca plc
- Bayer AG
- Bristol-Myers Squibb Company
- Cipla
- Cubist Pharmaceuticals, Inc.
- F. Hoffmann-La Roche AG
- GlaxoSmithKline plc
- Johnson & Johnson
- Melinta Therapeutics
- Merck & Co.
- Merck & Co., Inc.
- Paratek Pharmaceuticals Inc
- Pfizer, Inc.
- Sanofi S.A.
- Spero Therapeutics Inc
- Teva Pharmaceutica
- Other Prominent Players
Key Market Segmentation:
By Drug Type
- Antibiotics Drugs
- Antifungal Drugs
- Antiviral Drugs
- Others
By Applications
- Pneumonia
- Bloodstream Infections
- Gastrointestinal Disorders
- Surgical Site Infections
- Urinary Tract Infections
- Others
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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