Viral Vaccines Market Size, Share & COVID-19 Impact Analysis, By Form (Liquid and Lyophilized), By Container Format (Vials and Prefilled Syringes), By Biosafety Level Type (Biosafety Level 1, Biosafety Level 2, Biosafety Level 3, and Biosafety Level 4), and Regional Forecast, 2023-2030

The viral vaccines market size was valued at USD 94.95 billion in 2022 and is projected to grow from USD 52.42 billion in 2023 to USD 70.99 billion by 2030, exhibiting a CAGR of 4.4% during 2023-2030. Asia Pacific dominated the global market with a share of 29.08% in 2022. Moreover, the U.S. viral vaccines market size is projected to grow significantly, reaching an estimated value of USD 26.14 billion by 2030, driven by growing number of initiatives to rollout vaccination plans for the prevention of viral diseases.

Viral vaccines are considered to be one of the most effective prevention measures against infections caused by viral agents. Viruses cause several familiar infectious diseases, such as common cold, flu, and warts, along with other severe viral diseases, such as Human Immunodeficiency Virus (HIV/AIDS), Ebola, influenza, COVID-19, and many more. The incidence of these viral diseases varies from region to region as well as from season to season, which often causes fluctuations in the demand for these products across the globe. For instance, as per an article published by Physiopedia in 2022, Japanese encephalitis is the most common cause of encephalitis in Asia due to favorable conditions offered by this region for the growth of this virus. Some other viruses that need geographical and seasonal variation for growth include dengue virus, Enterovirus (EV71), rabies, Nipah virus, herpes simplex, West Nile virus, mumps, and many more.

Over decades, the range and availability of viral vaccines have been expanding globally, with the development of new products against viral diseases, such as hepatitis E, dengue fever, Ebola, and many more, that primarily affect lower-income countries. The outbreak of the COVID-19 pandemic has proved that vaccines can be developed even faster in a short time span through significant public investments, joint planning of clinical development, regulations, and manufacturing capacity. Organizations, such as the Coalition for Epidemic Preparedness Innovations (CEPI), Serum Institute of India, and many more are leveraging innovative platforms by supporting research projects to develop products against emerging diseases. These factors are anticipated to drive the growth of the viral vaccines market during the forecast period.

COVID-19 IMPACT

Decline in Immunization Programs during COVID-19 Outbreak Slowed Market Growth

The COVID-19 pandemic impacted health service delivery, including immunization programs across the globe, as a reduction in vaccination coverage and decline in the total number of vaccines administered were observed. This decline led to children missing out on their vaccine doses, thereby declining the demand for these products. Governments across the world attempted to regulate the outbreak by implementing population-wide lockdowns, closing borders, and halting mass gatherings, which disrupted the progress of various programs, including immunization campaigns. Moreover, the WHO issued guidelines to temporarily suspend the operations of mass immunization programs across the globe to mitigate the impact of the COVID-19 pandemic.

• According to the data collected by the WHO in 2020, the United Nations Children’s Fund (UNICEF), the Global Alliance for Vaccines and Immunizations (GAVI), and the Sabin Vaccine Institute reported that the suspension of vaccination services in over 68 countries had placed at least 80 million children under the age of one at risk.

However, the pandemic also accelerated companies' R&D activities and manufacturing capacity to introduce a vaccine against the COVID-19 virus. At the end of 2020, viral vaccines against COVID-19 were introduced, which is boosting the demand for viral vaccines across the globe.

• According to the 2021 Global Vaccine Market report of the WHO, COVID-19 and seasonal influenza vaccines and Oral Polio Vaccine (OPV) used in Supplemental Immunization Activities (SIAs) had the largest volumes in 2021. There was an increase of 4% in the market size from 2019 to 2021, mostly driven by the introduction of COVID-19 vaccines that accounted for more than double the volume and value of all other vaccines distributed in 2021.  

In 2022, the market witnessed robust growth due to the continuation of the vaccination drive against COVID-19 along with the resumption of everyday activities, ease of pandemic restrictions, and slow resumption of immunization programs.

Some of the positive results from the ease in restrictions included an increase in the number of approvals by key regulatory agencies, including the U.S. FDA and European Medicines Agency (EMA).

• In July 2023, Moderna, Inc. submitted a marketing authorization application for its investigational RSV vaccine, mRNA-1345, to the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia.

These factors cumulatively have led several prominent and emerging companies to increase their engagement in R&D initiatives to develop these products to fulfill the demand and drive the global viral vaccines market growth at a steady rate during the forecast period.

Viral Vaccines Market Trends

Gradual Shift from Vials to Prefilled Syringes to Determine Market Growth

One of the most prevailing trends witnessed in this market is the inclination of market players to manufacture these products in Prefilled Syringe (PFS) form rather than in vial form owing to the benefits the former offers. Compared to vials, PFS offers various advantages in terms of speed, disposal, wastage, and patient safety as it contains premeasured and accurate doses that reduce dosing errors and risk of microbial contamination. These factors have continued to gain favor among vaccine manufacturers and healthcare providers for creating Prefilled Syringes (PFS).

• In July 2022, Novavax entered an agreement with SK Bioscience to develop and commercialize a version of the COVID-19 vaccine containing the Omicron variant in prefilled syringes.

This gradual shift of manufacturers from vials to prefilled syringes due to the benefits the latter provides to the healthcare provider in terms of accuracy in delivering vaccines to patients is expected to favor the market growth during the forecast period.

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Viral Vaccines Market Growth Factors

Increasing Incidence of Viral Infections to Propel Market Growth

A key market driver is the increasing incidence of viral infections globally. These infections are caused by viruses whose frequency and distribution vary from region to region. A few notable examples that have gathered the attention of the public health community and the population at large include COVID-19, Ebola, SARS, influenza, Zika, yellow fever, Human Immunodeficiency Virus (HIV/AIDS), Human Papillomavirus (HPV), viral gastroenteritis, varicella, and viral hepatitis.

• According to the European Centre for Disease Prevention and Control 2023 data, 3 million new cases of hepatitis B and C are registered per year globally, while in the EU/EEA there are approximately 6 million people living with chronic hepatitis B and C infections.

Some of the chronic viral infections create a severe public health problem, as they significantly increase the risk of chronic diseases, such as cancer.

• As per a report published by the HPV Information Center in 2021, HPV infection is a well-established cause of cervical cancer, and HPV types 16 and 18 are responsible for about 70% of all cervical cancer cases worldwide. The annual number of cervical cancer cases caused by HPV in India was 123,907 in 2021, and this number varies from country to country. An increase in the incidence of these viral infections will boost the demand for viral vaccines as a preventive measure, driving the market growth during the forecast period.

Surge in Initiatives by Government Authorities for Immunization to Drive Market Growth

Globally, government authorities are actively focused on the introduction of new programs to eradicate and prevent certain viral diseases. The promotion of vaccination drives is one of the key effective measures to combat these viral diseases.

• In April 2022, the Global Polio Eradication Initiative (GPEI) raised the urgency to renew eradication strategy for polio at a virtual event. The new strategy, if fully funded, will witness the vaccination of 370 million children annually for the next five years and the continuation of global surveillance activities for polio and other diseases in 50 countries. Such initiatives by various regulatory bodies will lead to the adoption of early preventive measures and eventually eliminate highly infectious diseases.

RESTRAINING FACTORS

Stringent Pricing Control to Hinder Market Growth

Despite the increasing demand for viral vaccines in the global market, the stringent regulatory control over the prices of these products is a substantial restraining factor for the market’s growth. This may prevent many established biopharmaceutical companies from investing in this market to avoid financial loss.

• For instance, in Japan, the pharmaceutical industry is subject to government-mandated annual price reductions of pharmaceutical products, including certain vaccines. Furthermore, the government can order re-pricings for specific products defined under applicable re-pricing rules if it determines that the use of such products will exceed certain thresholds. Such restrictions from government bodies may negatively influence market players' interest to invest further in this market to prevent business loss, thereby restricting the market’s growth.

Moreover, several pharmaceutical companies have introduced vaccines against Coronavirus during the pandemic, out of which only a few were approved, which led to a significant difference in pricing across various regions.

• According to an article published by Reuters in October 2022, Pfizer expressed plans to roughly quadruple the price of its COVID-19 vaccine to about USD 110 – USD 130 per dose after the U.S. government’s current purchase programs expire. These pricing pressures and market access challenges continue to vary, which may slow down the growth of the global market during the forecast period.

Viral Vaccines Market Segmentation Analysis

By Form Analysis

Liquid Vaccines to Gain Traction Due to Low Manufacturing Cost

On the basis of form, the market is divided into liquid and lyophilized.

The liquid segment dominated the global market in 2022 due to various benefits, such as the requirement for lesser processing and handling time. Moreover, as it incurs minimal manufacturing cost, many viral vaccines are commercialized in liquid form. According to an article published by the MDPI (Pharmaceuticals) in June 2023, it was concluded that even though the cold chain requirements of the lyophilized formulations were significantly lower than those of the liquid formulations, the process requirements of the latter were relatively lower than those of the lyophilized one, which makes liquid formulations more suitable for early clinical use.

The lyophilized segment is estimated to record a robust CAGR due to its longer shelf life and better stability than liquid form. As per an article published by the European Pharmaceutical Review in January 2022, U.S.-based scientists from the University of Massachusetts Lowell (UMass Lowell) were granted USD 930,000 to develop a freeze-drying technique for mRNA-based COVID-19 vaccines. These products can be transported and stored at room temperature. The benefits provided by lyophilized form of vaccines are expected to drive the segment’s growth during the forecast period.

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By Container Format Analysis

Cost-Effectiveness of Conventional Vials to Propel Their Use

Based on container format, the market is bifurcated into vials and prefilled syringes.

The vials segment will hold the maximum global viral vaccines market share throughout the forecast period due to its cost-effectiveness over prefilled syringes. This has significantly influenced the focus of market players in terms of the manufacturing and commercialization of these products in vial form. These factors will contribute to the segment’s growth in the global market. For instance, in June 2022, GSK plc received the U.S. FDA approval for Priorix (Measles Mumps and Rubella Vaccine, Live) for 12 months and older individuals. In the market, the vaccine is commercialized in the vial format with a subcutaneous route of administration. Such new product launches in the market will propel the segment’s growth.

The Prefilled Syringes (PFS) segment will register the highest CAGR during the forecast period as it offers multiple advantages over the conventional vial format, such as simplified vaccine administration and reduction in dosage errors. It also minimizes the potential for microbial cross-contamination and pathogen transmission, which can happen when multiple doses are withdrawn from a single vial.

By Biosafety Level Type Analysis

Introduction of COVID-19 Vaccine to Boost Launch of Biosafety Level Type 3 Vaccines

By biosafety level type, the market is classified into biosafety level 1, biosafety level 2, biosafety level 3, and biosafety level 4.

The biosafety level 3 segment generated the highest revenue in 2022, and the growth is majorly driven by the surge in COVID-19 vaccinations across the globe from 2020 onwards. According to an article published by the CATO INSTITUTE in January 2023, roughly 655 million doses of COVID-19 vaccines were rolled out, which were enough for covering 80% of the population. Through 2022, COVID-19 vaccination efforts in the U.S. prevented more than 18 million hospitalizations and 3 million additional deaths. Such huge utilization of COVID-19 vaccines strongly contributed to the segment’s growth.

The biosafety level 2 segment is anticipated to record a significant CAGR during the forecast period. The segment includes products that offer protection against viral diseases, such as chickenpox, measles, mumps, rotavirus, hepatitis, influenza, and many more. The rising incidence of these diseases will increase the demand for these vaccines during the forecast period.

Biosafety level 1 and biosafety level 4 segments accounted for a comparatively smaller market share in 2022 and are estimated to grow steadily during the forecast period. This is owing to increased focus of key players on introducing novel products by accelerating the research and development of their pipeline candidates.

REGIONAL INSIGHTS

In terms of region, the global market is studied across North America, Europe, Asia Pacific, and the rest of the world.

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Asia Pacific viral vaccines market size was valued at USD 27.62 billion in 2022 and is likely to remain dominant throughout the forecast period. The rising prevalence of major viral diseases, such as hepatitis, HIV, HPV, COVID-19, and many more is a key factor for market’s growth. In addition, the growing support of government bodies through the introduction of vaccination drives to control the incidence rate and eradicate the disease eventually is strongly contributing to the market’s growth across the region. For instance, in December 2021, the government of Japan announced a USD 4.3 million grant for the procurement of essential oral polio vaccines as part of its continued support to Pakistan. The latest grant will be utilized to procure 24 million oral doses of these products.

North America held the second-largest share of the market in 2022. The robust usage of viral vaccines and growing number of initiatives to roll out vaccination plans for viral diseases are expected to drive the market’s growth in this region. For instance, in October 2022, Ottawa Public Health launched an annual influenza vaccination campaign for the general public.

Europe held a significant market share owing to the rising R&D initiatives for these vaccines and growing government expenditure for preventing these infectious diseases. According to an article published by the National Institutes of Health (NIH) in 2022, it was observed that the acceptance of vaccination programs against the COVID-19 infection was increasing. Furthermore, it also states that France, which is amongst the world’s most vaccine-hesitant countries, were opting for COVID-19 vaccines. The rising adoption rate among the general population will augment the regional market’s growth.

The rest of the world is estimated to record a comparatively lower CAGR, including Latin America, the Middle East, and Africa. Some factors lowering the adoption rate of viral vaccines are the limited supply and lack of manufacturers in low-income countries, such as Iran, Iraq, and Kenya. According to an article published by the United Nations International Children's Emergency Fund (UNICEF), Iraq received 336,000 doses of AstraZeneca COVID-19 vaccine in March 2021 through the COVAX facility.

List of Key Viral Vaccines Market Companies

Strong COVID-19 Vaccine Sales by Pfizer, Inc. to Pivot Company to Peak Position

In terms of the competitive landscape, the market is consolidated, with a few market players holding a majority share of the market. Pfizer, Inc. has a dominant market position owing to the strong sales of its COVID-19 vaccine, Comirnaty, which received regulatory approvals from the U.S. FDA in August 2021. Moderna, Inc. also held a substantial share of the global market in 2022 owing to the high sales of its Spikevax vaccine for treating COVID-19.

Merck & Co. Inc. is one of the major players in the market due to its diversified range of products to treat prolonged long-term viral infections, such as hepatitis, seasonal influenza, measles, mumps, rubella, human papillomavirus, chicken pox, and herpes zoster. Sanofi and GSK plc also had a considerable market share owing to their strong portfolio and robust pipeline of candidates.

Other prominent players in the market include AstraZeneca, Johnson & Johnson, CSL SEQIRUS, Novavax, Bavarian Nordic, and others. These companies are strongly focusing on introducing technologically advanced products, such as combination vaccines, which will contribute to the market growth.

LIST OF KEY COMPANIES PROFILED:

• Merck & Co., Inc. (U.S.)


• GSK plc (U.K.)


• Sanofi (France)


• Pfizer Inc. (U.S.)


• SEQIRUS (CSL Limited) (Australia)


• Moderna, Inc. (U.S.)


• AstraZeneca (U.K.)


• Johnson & Johnson Services, Inc. (U.S.)


• Novavax (U.S.)


• Dynavax Technologies (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• July 2023: GSK plc received authorization for Arexvy from the Medicines and Healthcare Products Regulatory Agency (MHRA).


• November 2022: The U.S. FDA granted a Priority Review for GSK’s Respiratory Syncytial Virus (RSV) older adult vaccine candidate.


• October 2022: Bavarian Nordic A/S entered an agreement to supply monkeypox vaccine in Latin America and the Caribbean.


• July 2022: CSL SEQIRUS entered a multi-year influenza research partnership with the University of Liverpool Pandemic Institute to advance influenza protection and pandemic preparedness.


• June 2022: Bavarian Nordic A/S entered a five-year contract with the Government of Canada to procure the IMVAMUNE smallpox vaccine.

REPORT COVERAGE

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The report provides qualitative and quantitative insights into the global market and a detailed analysis of the market size and growth rate for all possible segments. Along with this, it elaborates on the market opportunities, dynamics, and competitive landscape. Various key insights presented in the report include new product launches, key industry developments, such as mergers, acquisitions, and partnerships, epidemiology: key viral diseases in key countries, pipeline analysis, and the impact of COVID-19 on the global market.

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