U.S. Vaccines Market Size, Share & COVID-19 Impact Analysis, By Type (Live Attenuated, mRNA, Viral Vectors, Toxoid, and Others), By Route of Administration (Parenteral and Oral), By Disease Indication (Viral Diseases {Hepatitis, Influenza, Human Papillomavirus, Herpes Zoster, and Others}, and Bacterial Diseases {Meningococcal Disease, Pneumococcal Disease and Others}), By Age Group (Pediatrics and Adults), By Distribution Channel (Hospital & Retail Pharmacies, Government Suppliers, and Others), and Country Forecast, 2023-2030

The U.S. vaccines market size was worth USD 34.37 billion in 2022 and is projected to grow at a CAGR of 8.2% during the forecast period.

Vaccines refer to a pharmaceutical or a biological preparation that is administered to enable immunity against a malignant or infectious disease. According to the World Health Organization (WHO), vaccination prevents an estimated 3.5-5 million deaths per year from diseases such as measles, influenza, tetanus, and others. The growing incidence of infectious diseases in the country is one of the predominant factors raising the demand for effective vaccines. Furthermore, rising awareness among the population regarding immunization, and growing government efforts to increase vaccination rates are increasing the demand for vaccination, thereby propelling market growth. 

• According to the 2023 data published by the Centers for Disease Control and Prevention (CDC), approximately 8,916 and 34,945 new cases of tuberculosis and Lyme disease were reported in the U.S. in 2019.

In addition, the rising investment by key players in research and development for the development and launch of new products, increasing funding by the government and non-government organizations to support the development of products, proper reimbursement scenarios in the country, and others are a few factors contributing to the market’s growth.

The COVID-19 pandemic had a positive impact on the vaccines market. All the manufacturing companies shifted their focus to developing products to combat the pandemic. Furthermore, emergency authorizations of the COVID-19 vaccines and mass vaccination programs spiked the uptake of products, thereby augmenting the growth of the U.S. vaccines market during the COVID-19 pandemic.

U.S. Vaccines Market Trends

Shifting Preference toward mRNA-Based Products

Manufacturers are shifting their preferences toward developing mRNA-based products. These vaccines have various benefits, such as shorter manufacturing time and no risks of developing side effects when compared to other vaccines. The government of the country is investing extensively in the development of mRNA-based products. In addition, key players are developing mRNA-based products for various infectious diseases apart from COVID-19, which is leading to the U.S vaccines market growth.

• For instance, in February 2023, Pfizer Inc. and BioNTech commenced phase 1/2 of the clinical trial to study the immunogenicity, safety, and tolerability of its mRNA vaccine against shingles.

U.S. Vaccines Market Growth Factors

Large Production of Products Coupled with New Approvals and Launches to Propel Market Growth

Rising awareness and campaigns have led to an increasing demand for products among the patient population. To cater to the rising demand, the manufacturers are increasing their vaccine production capacity, which is anticipated to bolster the market growth during the forecast period.

• According to the CDC 2023 report, the vaccine manufacturers in the U.S. will manufacture and supply an estimated 156 million to 170 million doses of influenza vaccine in the country for the 2023-2024 season.

In addition, a conducive environment for the research and development of products and their approval further promotes U.S. vaccines market growth.

• For instance, in July 2023, Emergent BioSolutions received the U.S. FDA approval for Cyfendus, an adjuvant anthrax vaccine for use in patients aged 18 years to 65 years.

According to an article published by the CDC in 2023, the total number of reported cases in the U.S. suffering from hepatitis A infection in 2021 was 5,728. The state with the highest rate of reported hepatitis A cases was Arkansas (15.5 cases per 100,000 population).

RESTRAINING FACTORS

Long Production Cycle Coupled With High Cost of Production May Hinder Market Growth

Despite the rising burden of infectious diseases, certain factors, such as the long duration required for developing and launching new products and the high cost of vaccines, are a few factors likely to limit the vaccine market growth. Manufacturing a vaccine is a critical and complex process, generally taking 10 to 15 years.

Furthermore, meeting regulatory requirements, such as quality, safety, and clinical efficacy, requires a long timeframe for vaccine development, which makes it a lengthy process. In addition, the high cost of per dose products in the country is likely to hamper the adoption of vaccine supplies and market growth.

• According to the 2023 CDC updated vaccine price list, the private sector cost per dosage of Respiratory Syncytial Virus (RSV) vaccine is USD 495.0.

U.S. Vaccines Market Segmentation Analysis

By Type Analysis

Based on type, the market is segmented into recombinant/conjugate/subunit, inactivated, live attenuated, mRNA, viral vectors, toxoid, and others.

The recombinant/conjugate/subunit segment dominated the market in 2022. Recombinant vaccines are able to induce a more specific and stronger immune response when compared to other traditional products. In addition, they are safer as they do not contain attenuated or live organisms, which raises their demand among the population.

Furthermore, the government of the country is providing a conducive environment to research, develop, and launch new recombinant products for various diseases, thereby increasing their adoption and is expected to continue the growth of the market.

• For instance, in July 2021, GSK plc. received the U.S. FDA approval for its recombinant, adjuvanted zoster vaccine, Shingrix. The vaccine is indicated to prevent shingles in adults aged 18 years and above.

By Route of Administration Analysis

Based on route of administration, the market is categorized into parenteral and oral.

The parenteral segment accounted for the largest share of the U.S. vaccines market in 2022. Most of the products are based on the parenteral route of administration. Through the parenteral route, the drugs bypass the liver's first-pass metabolism and are easily absorbed quickly and have a faster onset of action.

Furthermore, the increase in vaccine procurement by government agencies is anticipated to raise the demand for parenteral doses of products. To meet the growing demand, manufacturers are developing products based on the parenteral route of administration, which is expected to result in high revenue generation in the forthcoming years.

By Disease Indication Analysis

Based on disease indication, the market is classified into viral diseases and bacterial diseases.

The bacterial diseases segment accounted for the largest U.S. vaccines market share in 2022 due to the rising prevalence of various diseases caused by bacteria. Moreover, increasing vaccination coverage for bacterial diseases is raising the demand for the product, thereby contributing to the segment’s growth.

• For instance, according to the Centers for Disease Control and Prevention 2022 data, around 23.9% of adults aged 18 years and above at increased risk of pneumococcal disease in the U.S. had received pneumococcal vaccination.

By Age Group Analysis

On the basis of age group, the market is categorized into pediatrics and adults.

The pediatrics segment accounted for the lion’s share in 2022. The rising number of infectious diseases among the small age group, the rising emphasis of key players on launching vaccine products specific to younger age groups, and the increase in pediatric vaccination rate, among others, are a few factors supporting the segment growth.

• According to the American Academy of Pediatrics 2022, the immunization rate of DTaP is 81.6% in Oregon, 86.4% in North Carolina, and 84.9% in Florida.

Furthermore, the launch of new products indicated for pediatrics and the increase in research and development expenses by the government of the country to launch vaccines for pediatric patients also support the segment growth.

By Distribution Channel Analysis

Based on distribution channel, the market is classified into hospital & retail pharmacies, government suppliers, and others.

The hospital & retail pharmacies segment dominated the market in 2022. These pharmacies are most often conveniently located and allow easy access to medicines, thus becoming a popular distribution channel among patients. Furthermore, new partnerships among these pharmacies to make vaccines accessible to patients also promote the segment growth.

• For instance, in February 2021, the U.S. government launched the Federal Retail Pharmacy Program (FRPP), a public-private partnership among 21 national pharmacies to help and expand COVID-19 vaccine access among the population.

List of Key Companies in U.S. Vaccines Market

The U.S. vaccines market is highly consolidated with the presence of a few players such as Pfizer, Inc., Merck & Co., Inc., GSK plc., and others. The presence of a strong product portfolio, rising initiatives by the companies to expand their product portfolio by launching new products, and shifting focus toward inorganic business activities to strengthen the geographical presence, among others, are a few factors contributing to the market share of these companies.     

• For instance, in June 2022, Merck & Co., Inc. received the U.S. FDA clearance for VAXNEUVANCE, a pneumococcal 15-valent conjugate vaccine, to prevent infants and children from invasive pneumococcal disease.

Some other players, such as Emergent BioSolutions, Inc., Inovio Pharmaceuticals, Inc., and others, are also present in the market. The growing investment by these players to seek approval for novel products and shifting focus to mergers, acquisitions, and collaborations is strengthening their market position.

LIST OF KEY COMPANIES PROFILED:

• GSK plc. (U.K.)


• Sanofi (France)


• Pfizer Inc.  (U.S.)


• Merck & Co., Inc. (U.S.)


• Novartis AG (Switzerland)


• Emergent BioSolutions, Inc. (U.S.)


• CSL Limited (Australia)


• Inovio Pharmaceuticals, Inc. (U.S.)


• Bavarian Nordic (Denmark)


• Mitsubishi Tanabe Pharma Corporation (Japan)

KEY INDUSTRY DEVELOPMENTS:

• October 2023: Sanofi entered an agreement with Janssen Pharmaceuticals, Inc. to develop and commercialize a phase III vaccine product indicated against extraintestinal pathogenic E. coli.


• March 2023: CSL Limited established a new state-of-the-art vaccine R&D center in Massachusetts. The R&D facility is equipped with 54,000 square feet of lab space, comprising BSL-3 safety level.


• October 2022: GSK plc. received approval from the U.S. FDA for its vaccine, Menveo, with single vial presentation for individuals suffering from invasive meningococcal disease. The vaccine is intended for patients aged 10 years to 55 years.

REPORT COVERAGE

The U.S. vaccines market research report provides a detailed analysis of the market. It focuses on key aspects such as market dynamics, leading companies, vaccine type, and route of administration. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation