WHO Releases Global Influenza Vaccine Market Study in 2024

WHO Releases Global Influenza Vaccine Market Study in 2024

Background and Rationale

In 2022, the World Health Organization (WHO) updated its recommendations on the use of seasonal influenza vaccines based on advice from the Strategic Advisory Group of Experts on Immunization (SAGE).

The updated recommendations state that all countries should consider implementing seasonal influenza immunization programs and should consider vaccinating the following target groups: healthcare workers, individuals with comorbidities and underlying conditions, the elderly, and pregnant women.

Countries may consider vaccinating other groups such as children and can determine priority groups based on local circumstances.

In line with the requirements of the Global Immunization Agenda 2030, the use of seasonal influenza vaccines contributes to strengthening immunization throughout the life course and is a key component of the WHO’s Global Influenza Strategy 2019-2030 to address influenza pandemics.

In the aftermath of the COVID-19 pandemic, there is an increased focus on influenza pandemic preparedness and an expectation that the seasonal influenza vaccine market will change, hence the need for a deeper understanding of market dynamics to support global, regional and country decision-making.

Many influenza vaccines are in development that have the potential to be improvements over existing seasonal influenza vaccines.

The impact and public health value of existing and improved seasonal influenza vaccines will be summarized in the WHO’s “Full Value Assessment of Improved Influenza Vaccines” and will help inform future decisions on influenza vaccine policy and use. Market dynamics assessment plays a key role in this assessment.

This study provides the latest insights into global trends and drivers of seasonal influenza vaccine supply and demand to ensure equitable access to seasonal influenza vaccines for all countries, all regions and all income groups.

Market Background

National policies guiding the use of influenza vaccines vary. As of November 2023, 123 (63%) countries reported implementing influenza vaccination policies through the WHO/UNICEF Joint Reporting Table. This includes 96 countries (85%) classified by the World Bank as high-income (HIC) or middle-income (MIC) countries. Among countries with policies in place, 74 countries (60%) recommend vaccination for all WHO priority groups, and 41 countries (33%) report their policies exceed WHO recommendations, covering the entire population. In contrast, only 27 low-income (LIC) and middle-income (LMIC) countries (34%) have policy recommendations in place to support public financing, procurement or use of seasonal influenza vaccines, highlighting the uneven use of seasonal influenza vaccines across different income groups and therefore the opportunity for increased demand.

This leads to a high concentration of seasonal influenza vaccine consumption. In 2022, high-income and middle-income countries consumed 97% of global seasonal influenza vaccine production, with 92% of that consumption coming from the Americas, Europe, and the Western Pacific regions (Figure 1). Vaccine use is also concentrated in five countries, with these countries accounting for 55% of global consumption. Adult QIV accounted for 65% of global seasonal influenza vaccine consumption. The use of improved seasonal influenza vaccines is still limited and is mainly concentrated in high-income countries.

Market Dynamics

The continuous evolution of influenza viruses requires the influenza strains in vaccines to be updated every two years to match the circulating influenza viruses. To accommodate the seasonality of influenza transmission, vaccine production and vaccination are timed to meet the needs of both the Northern and Southern Hemispheres, resulting in a biannual cycle of supply and demand. In 2022, seasonal influenza vaccines produced using Northern Hemisphere circulating influenza strains accounted for 64% of global production, seasonal influenza vaccines produced using Southern Hemisphere circulating influenza strains accounted for 20% of global production, and countries using vaccines produced using both Northern Hemisphere and Southern Hemisphere circulating influenza strains accounted for 15% of global production. Since 2012, seasonal influenza vaccines have consisted of two influenza A virus strains and one influenza B virus strain in TIV, with the addition of the B/Yamagata strain in QIV. The two most common types of seasonal influenza vaccines are: 1) inactivated vaccines produced in eggs or cell cultures and 2) live attenuated vaccines (LAIV), which accounted for 98% and 2% of global seasonal influenza vaccine production in 2022, respectively.

There are at least 122 seasonal influenza vaccines on the market, produced by 42 companies, with 12 companies only performing vaccine filling and finishing. Twenty vaccines from 10 manufacturers have received WHO prequalification. Some countries utilize improved vaccines for specific target groups, including those containing adjuvants, a higher antigen content, or made with recombinant antigens. Only 10% of existing vaccines are considered improved, and these are offered by four major manufacturers.

In September 2023, the WHO recommendation stated that “the B/Yamagata antigen is no longer necessary as a component of influenza vaccines and all efforts should be made to phase it out as soon as possible.” This recommendation has the potential to change current market dynamics, as it is expected that QIV may be phased out, reverting to the exclusive use of TIV. National regulatory bodies and vaccine manufacturers will play a critical role in implementing the WHO recommendation.

Global Demand (Projected Vaccine Dose Requirements)

Global forecasts for seasonal influenza vaccine demand from 2023-2034 were prepared based on historical procurement data on national seasonal influenza vaccine use and the latest available information. A baseline scenario was established based on current national influenza vaccination policies and vaccination coverage for each target group. This scenario assumes:

1. Existing national influenza vaccination policy recommendations will remain unchanged.
2. No new countries will adopt and implement seasonal influenza vaccination programs.
3. Target group coverage remains constant throughout the forecast period.

Under this scenario, by 2024, the total global seasonal influenza vaccine program demand (PDR) is expected to reach approximately 850 million doses. This is due to increased historical consumption in 2022-2023, including high-volume countries like China, following policy changes. Between 2024 and 2034, demand is projected to slowly increase, reaching approximately 920 million doses by the end of the period, driven by the projected growth of the elderly population (one of the WHO’s focus groups).

Limited expansion of seasonal influenza vaccine policy and use in low-income and middle-income countries is anticipated, with PDR expected to remain concentrated in high-income and middle-income countries (around 95% by the end of the forecast period).

To assess the potential evolution of seasonal influenza vaccine demand under different planning and policy conditions, including increased use in low-income and middle-income countries, different scenarios were modeled (Figure 3). Each scenario builds upon the baseline scenario demand forecast.

• Scenario 1: Pandemic Preparedness – Assessed the impact of vaccinating all healthcare workers in all countries with seasonal influenza vaccine; due to the smaller population size of healthcare workers compared to existing seasonal influenza vaccine demand requirements, the short-, medium-, and long-term PDR is similar to the baseline scenario.

• Scenario 2: Life Course Vaccination Scenario – Evaluated the evolution of vaccinating pregnant women in all countries with seasonal influenza vaccine. The additional PDR required to support this change is slightly higher than the baseline scenario (approximately 20 million doses annually).

• Scenario 3: Policy Expansion Scenario – Provided insights into the impact of expanding seasonal influenza vaccine use in high-income and middle-income countries if they vaccinated all WHO-recommended priority groups beyond those vaccinated in the baseline scenario. This scenario leads to the second-highest PDR growth among the scenarios assessed, with required doses stabilizing at around 1 billion annually by 2029.

• Scenario 4: Global Priority Vaccination Scenario – Simulated the availability of a vaccine that meets the WHO’s Preferred Product Characteristics (PPC) for improved influenza vaccines, resulting in all countries vaccinating all WHO priority vaccination groups. This scenario would result in a long-term increase in global PDR of around 50%, reaching approximately 1.4 billion doses annually.

Providing seasonal influenza vaccines to all WHO-recommended priority groups, many of whom are not included in routine childhood immunization programs, is a significant challenge for many countries. Establishing and/or strengthening sustainable approaches to adult immunization are crucial to support more countries implementing seasonal influenza vaccination according to WHO recommendations. Multivalent vaccines targeting multiple respiratory pathogens also have the potential to support increased seasonal influenza vaccine use by simplifying planning requirements and reducing delivery costs. In resource-constrained settings, scientific planning for existing vaccines and local registration of seasonal influenza vaccines might also influence future adoption decisions. Securing access to local influenza epidemiological data and funding amidst competing priorities is essential for establishing and/or expanding seasonal influenza vaccination programs.

Global Supply (Commercially Available Supply)

Consultations with manufacturers and experts, along with a review of publicly available information on seasonal influenza vaccines, provided the basis for assessing the current and future global commercially available supply (ASC) of seasonal influenza vaccines.

As of November 2023, there were 29 seasonal influenza vaccines in the clinical development phase, with 27 considered improved vaccines (Figure 4). Twenty of these vaccines are based on nucleic acid (NA) technology, some as standalone influenza vaccines and others as combination vaccines targeting influenza and other respiratory pathogens. Adjuvanted vaccines, high-dose vaccines, vaccines with innovative delivery systems, and recombinant vaccines represent the improved vaccines in the development pipeline. Vaccines considered to have universal and broad protection against influenza viruses have been excluded, as their market availability within the timeframe covered by this study is highly unlikely.

Among the 29 seasonal influenza vaccines in development, 21 are being developed by 9 new manufacturers, which has the potential to increase market supply. Two of these manufacturers are responsible for developing 12 pipeline vaccines. The remaining 8 pipeline vaccines are being developed by 4 existing seasonal influenza vaccine manufacturers. New vaccines developed by existing seasonal influenza vaccine manufacturers are likely to replace currently produced vaccines, and therefore are unlikely to significantly increase ASC.

Nucleic acid-based vaccines account for 69% of influenza vaccines in clinical development. One potential benefit of nucleic acid-based vaccines is their ability to be produced relatively quickly, potentially shortening the time gap between strain selection and vaccination, and therefore theoretically improving effectiveness by ensuring a better match between circulating influenza strains and the strains included in the vaccine. To achieve this potential benefit, revisions to the global strain selection system would be necessary.

As of 2023, the ASC stands at 1.2 billion doses of trivalent influenza vaccine. A baseline scenario modeled a moderate increase in ASC from current manufacturers and entry of pipeline vaccines, resulting in a long-term ASC that is 1.8 times higher than the current ASC. To assess a range of future supply scenarios, we developed various scenarios to simulate the impact of market exits, increased production from existing manufacturers, and pipeline products entering the market at different rates.

• Low Scenario Model: Limited market exits, minimal ASC increase from current manufacturers, and limited success of pipeline vaccine supply leads to a short-term decrease in ASC by 1.6 times.

• High Scenario Model: No market exits, moderate ASC increase from existing manufacturers, and optimistic outlook on clinical development progress of pipeline vaccines. Long-term ASC would increase by 3 times, with accelerated uptake of nucleic acid-based vaccines potentially leading to an ASC increase by as much as 4 times. Significant increases in all medium- and long-term service costs would only be realized if there is a substantial demand increase, requiring careful coordination and planning.

• Very Low Scenario Model: This unlikely worst-case scenario assumes a few current manufacturers exit the market, also resulting in a 2-fold decrease in ASC in the short term; in the long term, without increased ASC from remaining manufacturers or new market entrants, the ASC would still be lower than the current ASC in the baseline scenario.

For manufacturers supplying both hemispheres and producing both TIV and QIV vaccines, their ASC can be adjusted to some extent based on the proportion of TIV or QIV and Northern or Southern Hemisphere influenza vaccines provided each year.

Supply and Demand Balance

For seasonal influenza vaccines, under the baseline scenario, the current ASC is sufficient and surpasses demand, not indicating a risk of supply-demand imbalance. In the medium and long term, ASC is likely to continue exceeding global demand across all scenarios (Figure 5). Aside from the Low Scenario, ASC is projected to exceed PDR. The excess ASC in seasonal influenza may be advantageous for responding to an influenza pandemic due to the risk of pandemics occurring. While ASC might exceed PDR, if there is significant demand from low-income and middle-income countries, it would necessitate manufacturers registering vaccines in these countries, providing vaccines that align with program requirements, and making them readily available at sustainable prices.

The extent to which the estimated ASC is substitutable and readily available for countries not currently using vaccines and for immediate access before the influenza transmission season (i.e., locally registered, readily orderable) remains unclear.

Pricing

Prices reported by countries for seasonal influenza vaccines have remained stable over time, with no clear price trends between different vaccine types or procurement approaches (Figure 6). QIV and TIV vaccines, accounting for over 80% of global sales, also exhibit significant price differentials across income groups, with up to an 8-fold and 10-fold difference between the highest and lowest prices for adult QIV and TIV vaccines across different income groups. Across all income groups, the median price for adult QIV consistently remains higher than the median price for adult TIV, with the smallest disparity seen with the Pan American Health Organization Revolving Fund (PAHO

Conclusion

The WHO’s “Global Influenza Vaccine Market Study, January 2024” provides valuable insights into the current state and future projections for seasonal influenza vaccine supply and demand. Here’s a summary of the key findings:

• Demand: Global demand for seasonal influenza vaccines is expected to rise moderately, driven by factors like increasing elderly populations and potential policy changes to include more priority groups.
• Supply: Current commercially available supply (ASC) exceeds demand and is likely to increase further due to new vaccines in development, particularly those based on nucleic acid technology.
• Supply and Demand Balance: The projected ASC surpasses projected demand across all scenarios, suggesting no immediate risk of supply shortages. This excess ASC could be advantageous for responding to potential influenza pandemics.
• Challenges: Ensuring equitable access, particularly for low-income and middle-income countries, remains a critical challenge. Lower-priced vaccines alongside streamlined registration processes and improved availability are crucial to address this gap.
• Pricing: Despite remaining relatively stable, significant price variations exist between income groups and vaccine types. More transparency and efforts towards affordable pricing are needed for broader vaccine access.

The Road Ahead

The study findings highlight the importance of several key actions to optimize the global seasonal influenza vaccine market and ensure equitable access:

• Strengthening Policy and Planning: Encouraging countries to adopt and implement WHO-recommended influenza vaccination policies for priority groups.
• Promoting Innovation: Supporting the development and introduction of improved seasonal influenza vaccines with broader coverage and potential for faster strain matching.
• Expanding Access: Facilitating vaccine registration in low-income and middle-income countries, promoting affordable pricing strategies, and strengthening vaccine delivery infrastructure.
• Enhancing Collaboration: Encouraging collaboration between stakeholders, including governments, manufacturers, and public health organizations, to address supply chain vulnerabilities and improve overall market efficiency.

By implementing these recommendations, we can move towards a future where seasonal influenza vaccines are readily available and accessible to all, ultimately contributing to a world with fewer influenza-related illnesses and deaths.

Disclaimer: This is a summarized version of the WHO report and may not encompass all details included in the original document.