Infectious Disease Therapeutics Market Size, Share

Infectious Disease Therapeutics Market

Global Infectious Disease Therapeutics market size is anticipated to be worth USD 50996.16 million in 2024, projected to reach USD 71124.91 million by 2033 at a 3.7% CAGR.

The infectious disease therapeutics market is experiencing a rapid transformation driven by increased incidence rates of communicable diseases and the emergence of new pathogens. As of 2024, over 1.6 billion individuals globally are affected by one or more infectious diseases annually, with tuberculosis accounting for 10.6 million cases, HIV for 39 million cases, and hepatitis B and C for 296 million and 58 million cases respectively. The growing threat of antimicrobial resistance (AMR) further complicates treatment protocols, prompting urgent advancements in therapeutic options.

The market is also influenced by surging global immunization programs. WHO-supported campaigns have led to 81% immunization coverage for diphtheria-tetanus-pertussis globally. In response, over 100 vaccine candidates are currently under clinical trials, with at least 45 in Phase III as of early 2024. Biopharmaceutical manufacturers are focusing heavily on recombinant DNA technologies and monoclonal antibodies. Moreover, infectious disease outbreaks such as the COVID-19 pandemic highlighted critical gaps in therapeutic preparedness, leading to increased public-private collaborations.

Key Findings

Top Driver Reason: The key driver for the infectious disease therapeutics market is the increasing global disease burden, with over 1.3 million deaths from tuberculosis and 650,000 deaths from influenza recorded annually.

Top Country/Region: The United States leads the market due to high therapeutic consumption, with over 42 million antibiotic prescriptions filled in the first quarter of 2024 alone.

Top Segment: The drugs segment dominates the market, representing over 78% of all therapeutic interventions for infectious diseases globally.

Infectious Disease Therapeutics Market Trends

The infectious disease therapeutics market is undergoing transformation due to advancements in biotechnology, a surge in novel pathogen outbreaks, and the global emphasis on pandemic preparedness. As of 2024, over 700 million people were treated with anti-infective drugs annually, including antivirals, antibiotics, antifungals, and antiparasitics. Biologic therapies are seeing significant attention, with 32% of all infectious disease drug approvals in 2023 categorized as biologics.

Monoclonal antibodies have become a focal point in therapeutic development. In 2023, over 20 monoclonal antibody-based therapies entered clinical trials for infectious diseases, especially targeting respiratory syncytial virus (RSV), HIV, and Ebola. Furthermore, companies launched 8 new antiviral combinations for hepatitis C and HIV in the last 12 months, reducing treatment duration from 12 weeks to 8 weeks in over 65% of patients.

The resurgence of vector-borne diseases like malaria and dengue in subtropical regions has influenced product pipelines. More than 300 million malaria cases were treated globally in 2023, and 48 countries reported outbreaks. This has led to the accelerated approval of artemisinin-based combination therapies (ACTs) and mRNA-based malaria vaccine candidates.

Diagnostics and therapeutics integration has emerged as a key trend, with 70% of infectious disease treatment strategies now guided by real-time PCR and molecular diagnostics. In Asia-Pacific alone, diagnostic-guided therapy usage increased from 48% in 2022 to 63% in 2024, enhancing targeted drug deployment.

Telehealth platforms have begun playing a role in infectious disease treatment. Over 120 million virtual consultations in 2023 included prescription of anti-infectives, streamlining patient access and improving early intervention. This trend is particularly visible in urban areas, where tele-prescriptions increased by 37% year-on-year.

Infectious Disease Therapeutics Market Dynamics

DRIVER

Rising demand for pharmaceuticals.

The demand for pharmaceuticals to treat infectious diseases continues to increase due to growing population density, international travel, and antimicrobial resistance. As of 2024, over 140 new drug candidates are in development targeting diseases such as HIV, tuberculosis, and influenza. Hospitals in high-density urban zones reported a 15% increase in infectious disease hospitalizations year-over-year. The global immunization rate for infectious diseases such as measles and hepatitis B remains below 90%, resulting in sustained therapeutic demand. Moreover, emerging zoonotic diseases have driven 42% of new therapeutic development projects over the past two years, demonstrating an urgent push to mitigate viral outbreaks.

RESTRAINT

High development costs of novel therapies.

The development of new infectious disease therapeutics involves extensive R&D, with average drug development costs exceeding $1.2 billion per drug. Biopharmaceutical companies report a 19% increase in R&D expenditure over the past five years, largely attributed to the need for clinical validation across multiple strains and patient demographics. Delays in clinical trials due to limited patient enrollment in rare infectious conditions, as seen in trials for Marburg virus and Nipah virus, also impact timelines. Regulatory approval processes for infectious disease drugs take an average of 3.4 years globally, with an additional 2.1 years for commercialization, leading to slow market penetration.

OPPORTUNITY

Growth in personalized medicines.

Personalized medicine in infectious disease therapeutics is gaining traction, with over 45% of new trials incorporating genomic or biomarker-based targeting. The rise in precision therapies for hepatitis B and HIV includes tailored drug combinations based on patient-specific viral load and resistance profiles. In 2023, over 3 million patients globally were treated with genotype-guided antivirals. Asia-Pacific countries like Japan and South Korea are leading in these initiatives, integrating pharmacogenomic testing in over 65% of infectious disease cases in top hospitals. These trends enable better clinical outcomes, reduce treatment failures, and lower the risk of resistance development, increasing adoption of such therapeutics.

CHALLENGE

Rising costs and expenditures.

Therapy costs for infectious diseases remain a significant challenge, particularly in low-income and middle-income countries. On average, antiviral treatment courses cost over $900 per patient for chronic infections such as hepatitis C. For drug-resistant tuberculosis, treatment duration extends up to 20 months with associated drug costs surpassing $4,000 per patient. Budget limitations within public healthcare systems prevent large-scale deployment of advanced biologics and vaccines. Additionally, patent protection laws and exclusivity rights restrict market access for biosimilars and generics in emerging economies, creating affordability gaps that hinder equitable access to essential medicines.

Infectious Disease Therapeutics Market Segmentation

The infectious disease therapeutics market is segmented by type and application to assess product usage across therapeutic areas. By type, the market comprises drugs and vaccines. By application, the market is segmented into HIV/AIDS, influenza, hepatitis, malaria, tuberculosis, and others. Each segment plays a critical role in addressing disease-specific needs, with high utilization across developing and developed regions.

By Type

Drugs: Drug-based therapies account for approximately 78% of the total infectious disease treatment landscape. In 2023, more than 820 million prescriptions were filled globally for antibiotics, antivirals, antifungals, and antiparasitics. Anti-HIV drugs remain the largest segment, with over 28 million people on antiretroviral therapy. Novel small molecule inhibitors for RSV and Ebola have entered Phase III trials, and over 90% of U.S. hospitals reported active inventory management of second-generation antivirals. Fixed-dose combinations for hepatitis C achieved over 90% cure rates in trials spanning 12 countries. Drug resistance remains a concern, prompting more than 35 biopharma companies to invest in resistance-breaking agents.
Vaccines: Vaccines contribute approximately 22% of the therapeutic volume but have higher population coverage. In 2023, over 3.5 billion vaccine doses were administered globally, with measles, polio, and hepatitis B vaccines accounting for the majority. Emerging vaccines for dengue, chikungunya, and Lassa fever are under trial, with 12 candidates in Phase II and III stages. Pediatric vaccines are routinely administered in over 190 countries, achieving immunization rates above 85% for diseases like diphtheria and tetanus. The global shift toward mRNA and vector-based platforms is evident, with 24% of pipeline candidates for infectious diseases being mRNA vaccines.

By Application

HIV/AIDS: As of 2024, over 39 million people live with HIV, with 75% of them receiving antiretroviral therapy. New integrase strand inhibitors and long-acting injectables have improved adherence rates, with over 4 million patients using monthly injectable regimens. More than 23 drugs are in advanced clinical trials targeting multi-drug resistant HIV strains. Countries in sub-Saharan Africa reported a 35% decline in HIV-related deaths since 2015 due to expanded access to combination therapies.
Influenza: Seasonal influenza affects an estimated 1 billion people annually, leading to 290,000–650,000 respiratory deaths. Neuraminidase inhibitors remain the primary therapy, while newer antiviral agents such as baloxavir marboxil are increasingly adopted, with over 10 million prescriptions in 2023. Global stockpiling initiatives by WHO have increased, with 450 million doses of influenza vaccines secured for future outbreaks.
Hepatitis: Hepatitis B and C impact nearly 354 million individuals globally. Direct-acting antivirals (DAAs) for hepatitis C achieve over 95% cure rates in as few as 8 weeks. Over 1.1 million patients started hepatitis C treatment in 2023. New subcutaneous therapies for hepatitis B are under trial, with over 9 novel agents targeting viral clearance pathways.
Malaria: Malaria causes 247 million cases globally each year, with 619,000 deaths in 2022. Artemisinin-based therapies remain standard treatment, but resistance in Southeast Asia has prompted the development of triple-drug combinations. A new vaccine, RTS,S/AS01, was introduced in African countries, with over 1 million children immunized in 2023. Pediatric mortality has decreased by 18% in vaccine-covered regions.
Tuberculosis: Tuberculosis continues to be a global health concern with 10.6 million cases reported in 2023. Multidrug-resistant TB affects over 500,000 individuals annually. Bedaquiline and pretomanid are increasingly used in resistant cases. Over 19 TB vaccine candidates are under development, with Phase III trials underway in India and South Africa.
Others: Emerging infectious diseases like Zika, Ebola, and Nipah are increasingly targeted. Over 75% of new viral outbreaks in 2023 were zoonotic. Therapeutics for Ebola, such as monoclonal antibody-based drugs, achieved survival rates above 70%. Zika-related research is expanding with 6 vaccine candidates in active trials.

Infectious Disease Therapeutics Market Regional Outlook

The global infectious disease therapeutics market shows strong geographic variation in treatment adoption, government initiatives, R&D funding, and product availability. Developed regions lead in pharmaceutical innovations and clinical trials, while developing regions account for the majority of disease burden, requiring scalable and cost-effective therapeutic solutions. Geopolitical health risks and healthcare infrastructure also significantly influence market potential across regions.

North America

North America remains the largest regional market for infectious disease therapeutics, with the United States leading in consumption and innovation. In 2023, over 42 million prescriptions for anti-infectives were written in the U.S. alone. The region houses more than 60% of the world's clinical trials for infectious disease drugs and vaccines. Canada’s national immunization strategy resulted in 90% measles and hepatitis B coverage among children. The U.S. FDA approved 18 new anti-infective drugs in 2023, including 7 biologics. Government funding for antimicrobial resistance research reached $1.3 billion in 2024, supporting academic and private R&D. Telemedicine integration in infectious disease care grew 42% year-over-year.

Europe

Europe has a high rate of antimicrobial resistance surveillance and treatment standardization. Germany, France, and the UK collectively conducted over 3 million molecular diagnostic tests for infectious diseases in 2023. The European Medicines Agency (EMA) approved 14 new therapies targeting HIV, influenza, and multi-drug resistant tuberculosis last year. Vaccination campaigns in the EU reached over 85% of children under 5 for polio, diphtheria, and hepatitis B. The region recorded over 23 million influenza infections and administered more than 150 million flu vaccine doses in 2023. Public-private initiatives in the EU support more than 35 ongoing antimicrobial development projects.

Asia-Pacific

Asia-Pacific is the fastest-expanding region in terms of infectious disease therapeutic uptake. China, India, and Japan dominate the regional landscape. In India, over 2.4 million new TB cases are reported annually, making it a critical market for TB therapeutics. China administered over 850 million vaccine doses in 2023 across pediatric and adult populations. Japan has one of the highest adoption rates for diagnostic-guided therapy, with 68% of patients tested before antibiotic prescription. Southeast Asia reported the highest number of dengue cases globally, prompting vaccine development initiatives. Regional governments are increasing funding for mRNA vaccine development and drug repurposing strategies.

Middle East & Africa

This region has a significant unmet need due to high prevalence of HIV, malaria, and TB. Sub-Saharan Africa accounts for over 67% of global HIV cases, with over 25 million individuals living with the virus. South Africa treated more than 5 million patients with antiretroviral therapy in 2023. Nigeria and Ethiopia reported over 12 million malaria cases combined, with ACTs as the standard treatment. The RTS,S malaria vaccine rollout in Ghana and Kenya reached 1.2 million children. Access to advanced biologics remains limited, but multinational collaborations are increasing. Local pharmaceutical production capacity is expanding in countries like Egypt and South Africa.

List of Top Infectious Disease Therapeutics Market Companies

Novartis AG
Gilead
GlaxoSmithKline plc
Janssen Pharmaceutical Inc.
Hoffmann-La Roche Ltd.
BioCryst Pharmaceuticals Inc.
Merck & Co. Inc.
Boehringer Ingelheim GmbH

Top Two Companies with Highest Share

Gilead: Gilead remains a dominant player in the infectious disease therapeutics market, particularly for its HIV and hepatitis portfolio. Over 12 million patients globally are treated with Gilead's antiretroviral therapies. In 2023, Gilead’s long-acting HIV drug formulations were used in 38 countries and achieved adherence rates above 90%. The company has 9 pipeline drugs for hepatitis B, dengue, and HIV variants in Phase II and III trials.

GlaxoSmithKline plc (GSK): GSK leads the vaccine segment, with over 800 million doses distributed globally in 2023, including for rotavirus, influenza, and shingles. GSK’s RTS,S malaria vaccine has been administered to over 1 million children in Africa. The company also holds a strong position in antibiotic manufacturing and respiratory antivirals. GSK supports over 50 active infectious disease clinical programs, primarily in Europe and Asia-Pacific.

Investment Analysis and Opportunities

Investments in infectious disease therapeutics have risen sharply in recent years due to pandemic preparedness strategies and global surveillance initiatives. In 2023 alone, biopharmaceutical companies allocated over $12 billion toward infectious disease R&D, including vaccines, diagnostics, and drug repurposing. Public and private sector collaborations have increased dramatically, with over 180 formal agreements signed globally in the past 18 months, particularly targeting diseases such as COVID-19, hepatitis, RSV, and Zika.

One of the most promising areas for investment is mRNA technology. Over 24 mRNA-based vaccine candidates are in development for infectious diseases like Lassa fever, chikungunya, and Ebola. Governments in Asia-Pacific and North America are funding local mRNA manufacturing capabilities, with Japan investing $2.1 billion and South Korea $1.7 billion in domestic infrastructure.

Antimicrobial resistance (AMR) presents both a threat and opportunity. Approximately 1.27 million deaths are attributed annually to AMR globally, leading to increased investment in resistance-breaking therapeutics. Over 75 new antibiotic molecules are under development targeting Gram-negative pathogens. Funding programs in Europe such as the ENABLE-2 initiative support at least 14 of these projects through late-phase clinical trials.

New Product Development

The infectious disease therapeutics sector has seen a surge in new product development across biologics, small molecules, and vaccines. In 2023, over 30 new drugs and vaccines received regulatory approvals globally, with at least 60 more in Phase III trials targeting HIV, hepatitis, tuberculosis, and tropical diseases.

Among the most notable developments is the launch of long-acting injectable HIV therapies. These formulations offer once-monthly dosing, replacing daily oral regimens. Clinical trials in 19 countries showed a 96% adherence rate among over 5,000 patients. These injectables are now approved in over 25 countries and being fast-tracked in 12 more.

In the vaccine segment, significant innovation includes mRNA-based and viral vector vaccines targeting dengue, Zika, chikungunya, and RSV. The world’s first mRNA-based dengue vaccine entered Phase III trials in 2023, showing 85% efficacy in a cohort of 1,200 participants across Brazil and Thailand. GSK’s RTS,S malaria vaccine, already in use, is being adapted for broader pediatric application with the next-generation version (R21/Matrix-M) showing enhanced efficacy in early trials.

Novel antibiotic classes are in development targeting drug-resistant pathogens. A new β-lactam-β-lactamase inhibitor combination has shown success against carbapenem-resistant Enterobacteriaceae (CRE), which cause over 19,000 deaths annually in the U.S. alone. Trials involving 1,400 patients demonstrated over 88% success rates with minimal side effects.

Monoclonal antibody therapies for Ebola and respiratory syncytial virus (RSV) are also expanding. One of the most successful candidates, palivizumab, is being followed by next-generation formulations with broader age indications. Over 6 million children are targeted for these therapies across Europe and North America in 2025.

Five Recent Developments

Gilead Sciences: launched its long-acting injectable HIV drug in 25 new countries by Q4 2023, expanding global access to over 3 million patients.
GlaxoSmithKline: began mass deployment of its RTS,S malaria vaccine across Ghana and Kenya, reaching 1.2 million children by early 2024.
Novartis: announced a Phase III trial for its oral combination drug for multi-drug resistant TB with results expected by late 2024.
BioCryst: Pharmaceuticals advanced its antiviral drug for Marburg virus into Phase II trials, enrolling 500 patients in central Africa.
Merck & Co.: received emergency use approval for its next-generation influenza antiviral, showing 79% reduction in hospitalization rates.

Report Coverage of Infectious Disease Therapeutics Market

This report offers an exhaustive evaluation of the infectious disease therapeutics market, encompassing drug and vaccine development, therapeutic applications, and geographic distribution. It covers core therapeutic categories including antivirals, antibiotics, antifungals, antiparasitics, and biologics, with segmentation by type, application, and region. Analysis includes 7 core applications—HIV/AIDS, influenza, hepatitis, tuberculosis, malaria, and other emerging diseases.

The report integrates qualitative and quantitative data derived from clinical trials, government health databases, and pharmaceutical R&D activity. Over 180 clinical pipeline agents are assessed, and performance metrics such as patient uptake, dosage frequency, therapeutic efficacy, and treatment adherence are included. Comparative metrics for biologics versus small molecules, and pediatric versus adult applications, are detailed.

The regional analysis includes in-depth reviews of North America, Europe, Asia-Pacific, and Middle East & Africa. It details national healthcare spending, disease prevalence, immunization rates, and therapeutic penetration. For instance, the Asia-Pacific section emphasizes rising adoption of personalized medicines and mRNA platforms, while the Europe section highlights antibiotic resistance management.

The report also profiles 8 leading companies, benchmarking them on market share, product innovation, global footprint, and regulatory pipeline. Gilead and GlaxoSmithKline emerge as the dominant players, with robust product pipelines and high treatment penetration across multiple continents.