Human Combination Vaccines Market Size, Share & Growth Analysis by 2035

Human Combination Vaccines (HCV) Market Overview

The Human Combination Vaccines market was valued at USD 10.28 billion in 2024 and is expected to reach USD 33.71 billion by 2035, at a CAGR of 11.4% between 2025 and 2035.

The Human Combination Vaccines Market is experiencing significant growth, driven by increasing awareness of immunization benefits, rising prevalence of infectious diseases, and the convenience of combination vaccines, which reduce the number of injections required. These vaccines protect against multiple diseases with a single shot, improving compliance rates, particularly in pediatric populations.

The market is segmented based on type, including inactivated and live attenuated vaccines. Inactivated combination vaccines dominate due to their stability and safety profile, although live attenuated vaccines offer strong immune responses with longer-lasting protection.

Geographically, North America leads the market owing to robust healthcare infrastructure, high vaccination rates, and supportive government policies. Europe follows, supported by similar factors and strong research and development (R&D) capabilities. The Asia-Pacific region is poised for substantial growth due to increasing healthcare expenditure, improving vaccine coverage, and growing awareness about immunization programs.

Key players in the market include GlaxoSmithKline, Sanofi Pasteur, Merck & Co., and Pfizer, which focus on strategic collaborations, mergers, acquisitions, and extensive R&D activities to maintain their competitive edge. Innovations in vaccine formulations and delivery methods, such as needle-free injectors and oral vaccines, are anticipated to further drive market growth.

Market Dynamics And Factors For Human Combination Vaccines Market

Drivers:

Rising Prevalence of Infectious Diseases & Increase in Novel Vaccines by Manufacturers

• The rapid rise in the prevalence of infectious diseases as well as the increasing pediatric population are the major factors driving the huge growth of the human combination vaccines market. Since babies do not have a fully developed immune system during their early stages of life they are more vulnerable to many infectious diseases. For instance, the Centres for Disease Control and Prevention (CDC) reported that approximately 3.1% of the children population in the age group 5-11 years was in fair or poor health in the U.S in 2018. This thereby leads to an increase in the demand for combination vaccines thus propelling the market growth. Also, an increase in antiviral drug resistance has changed the market trend toward combination vaccines as these vaccines help reduce the problem of drug resistance.
•  For instance, according to a review article published in Nature, a scientific journal in 2021, appropriate utilization of vaccines reduces the spread of antimicrobial drug resistance as they are used specifically for a given infectious antigen. Moreover, the growing interest of manufacturers in developing novel vaccines to target a wide range of diseases drives the growth potential of the human combination vaccine market. For instance, in December 2017, the Government of Bangladesh collaborated with WHO (World Health Organization), Gavi the Vaccine Alliance, and UNICEF (United Nations Children’s Emergency Fund) for the need to launch a diphtheria vaccination campaign for young children in the age group 6 weeks to 6 years.
• Further, The Serum Institute of India donated 300,000 pentavalent vaccine doses to the Government of Bangladesh for this vaccination campaign in 2017. Additionally, many countries have brought out immunization policies wherein they follow a fixed immunization schedule in order to immunize every newborn against any type of common infectious diseases such as diphtheria, polio, hepatitis, and tetanus which increase the demand for vaccines. For instance, in the U.S, the Advisory Committee on Immunization Practices (ACIP) recommended vaccination schedules for adults & children based on previous epidemiological studies. According to the National Conference of State Legislatures, the childhood vaccination rate for the year 2019 in the U.S. was approximately 95% and is thus expected to grow rapidly.

Restraints:

The Threat of Bioterrorism & Crucial Side Effects

• The threat of bioterrorism and stringent regulatory policies for the approval of novel combination vaccines are the key factors that are hindering the growth of the human combination vaccine market. Bioterrorism refers to the use of biological agents such as fungus, bacteria, and viruses to disrupt human life. Since these biological agents are hard to predict, it is very difficult to control them. Bioterrorism can easily spread through the route of vaccines hence; regulatory authorities scrutinize the vaccine development process to avoid any mishaps. For instance, the U.S Food and Administration authority has been directed by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to protect the public against bioweapons associated with vaccines, diagnostic tools, and drugs in the U.S. The U.S. FDA has set out a multistep & complex process for assessing the safety, immunogenicity, as well as efficiency of the vaccine before approval of licensure for a particular vaccine, followed by post-approval surveillance. Some combinations of vaccines are associated with unfavorable side effects which hamper the human combination vaccine market growth.
• For instance, in 2020, the Com-Cov study led by the University of Oxford, U.K revealed that when both the doses of AstraZeneca and Pfizer COVID-19 vaccines were mixed a higher proportion of the users experienced side effects such as fever, headache, and fatigue.
• Moreover, factors such as poor healthcare infrastructure, lack of awareness, and facilities in low- and middle-income countries such as India, Vietnam, Nigeria, and Brazil hinder the market growth of human combination vaccines. For instance, according to a survey by the World Health Organization in 2018, nearly 19.4 million pediatric population in the world were without vaccination in recommended immunization schedule, and among these 60% population were recorded to be from low- and middle-income countries such as Pakistan, Indonesia, India, etc.

Opportunities:

New Approaches in Testing and Development are Estimated to Boost Protective and Durable Response

• Increasing understanding of the human immune response to immunization has boosted the development of more efficacious products in the human vaccines market. Furthermore, strides made in computational and systems biology, coupled with the rapidly expanding scope of bioinformatics and machine learning in vaccine clinical trials, are enriching the landscape of the human vaccines market, thereby creating huge growth opportunities. New approaches that consist of system immunology are essential for improving the success rates and can act as a growth opportunity for the human combination vaccines market. Novel approaches help in augmenting protective and durable response, wherein the impact of psychosocial and cultural factors along with the overall biology plays a vital role. Some of the key product types propelling sales in the human vaccines market are conjugate, recombinant, inactivated, combination, and attenuated vaccines.

Segmentation Analysis Of Human Combination Vaccine Market

Type Insights:

• The Inactivated attenuated vaccine segment dominates the growth in the human combination vaccines market. Major Vaccine manufacturers are working toward the advancement of existing vaccines as well as the development of novel vaccines which is giving rise to the growth of the human combination vaccines segment. Inactivated vaccine segment is further anticipated to grow rapidly over the projected period owing to its high adoption and acceptance as an efficient human combination vaccine. Additionally, the stability of inactivated vaccine makes it more suitable to be used for the treatment of infectious diseases as it can be stored and transported easily in lyophilized form. For instance, according to the Global Vaccine Market report by World Health Organization, in 2017 the global demand for the D&T vaccine (Diptheria and Tetanus) was approximately 945 million doses wherein DTwP-HepB-Hib vaccine accounted for 33% of the total D&T vaccine.

Regional Analysis Of Human Combination Vaccines Market

• The Human Combination vaccines market is growing largely in the Asia-Pacific region. The Asia-Pacific region is accounted for the largest market share all across the globe. But in the forecast period, due to the high demand from the regions like China, Japan, Australia, and India, Asia-Pacific is expected to continue its rapid growth. The high mortality and morbidity of infectious diseases in the non-industrialized world, as well as industrialized nations, is a key driver of extensive R&D in the human vaccines market. For instance, nationwide immunization programs along with a pneumococcal conjugate vaccine (PCV7) in children have helped reduce the incidence of invasive pneumococcal disease. The fast growth is also due to the rise in the pediatric population and the increasing prevalence of infectious diseases such as tetanus, whooping cough, polio, diphtheria, chickenpox, measles, and smallpox. For instance, according to the Our World in Data report-2017, South Asia accounts for a majority of new tetanus cases. In 2019, the World Health Organisation merely reported that in South East Asia around 52% of deaths under the age of five happen during the neonatal period.
•  A boost in R&D activities and increasing technological advancements propel the market growth of human combination vaccines in North America. For instance, in 2019 three licensed DTaP combinations were readily available in North America for offering immunity against tetanus, diphtheria, and whooping cough (acellular pertussis) in children. These combination vaccines include Infanrix manufactured by GlaxoSmithKline, and Tripedia and Daptacel manufactured by Sanofi Pasteur. Also, booster combination vaccines Boostrix and Adacel are highly available for use in adults in the North American region which boosts the combination vaccine market growth in this region. Additionally, the U.S government has been actively involved in vaccine awareness initiatives which is another key factor that cushions the growth of human combination vaccines. Expanding understanding of infectious disease epidemiology has further helped companies develop a human vaccine that has played a crucial role in decreasing the global burden of infectious diseases.

Major Key Players Considered in the Market

• Sanofi (France)
• GlaxoSmithKline (GSK) (United Kingdom)
• Merck & Co. (United States)
• Pfizer (United States)
• AstraZeneca (United Kingdom)
• Johnson & Johnson (United States)
• Novartis (Switzerland)
• Serum Institute of India (India)
• CSL Limited (Australia)
• Bharat Biotech (India)
• Moderna (United States)
• Sinovac Biotech (China)
• Sinopharm (China)
• Inovio Pharmaceuticals (United States)
• BioNTech (Germany)
• Valneva (France)
• Medicago (Canada)
• Astellas Pharma (Japan)
• Takeda Pharmaceutical Company (Japan)
• Emergent BioSolutions (United States)

Key Industry Developments in the Human Combination Vaccines Market

• In March 2024, Moderna, Inc. announced at its fifth Vaccines Day event clinical and program updates demonstrating the advancement and acceleration of its mRNA pipeline. The updates include data readouts in the Company's respiratory and latent and other vaccine portfolios, as well as commercial, manufacturing and financial announcements for its vaccine business.
• In June 2024, Moderna, Inc. announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial.