Vaccines are one of the most powerful and cost effective health interventions available. Yet preventable diseases still cost millions of lives each year. Vaccine companies are a key link in the chain to each successful vaccination.
In 2017, the Access to Medicine Foundation mapped how vaccine companies are responding to global calls to increase immunisation coverage for the first time. Published on 6 March 2017, the Foundation's Access to Vaccines Index finds that eight vaccine companies approach access to vaccines in differing ways, generally linked to whether their businesses are focused more on developing new vaccines or on marketing existing ones, or on both.
Figure 4: Access to Vaccines Index - Overall performance
Some companies have portfolios of highly profitable vaccines and small vaccine pipelines: here, companies’ access considerations mainly relate to pricing, registration and supply. Other companies have small portfolios but larger pipelines supported by proportionally high investments in vaccine R&D. For these companies, the access-to-vaccines focus is on ensuring vaccines in development will meet global health needs and on putting measures in place to ensure that successful vaccines will be accessible. Of the six companies evaluated across all areas of assessment, GSK performs the best, with Sanofi also performing well across the board. Of the eight companies evaluated in Research & Development, GSK also leads, followed closely by Johnson & Johnson. The other companies demonstrate mixed performances across the different areas evaluated.
Research & Development
The potential public health benefits of developing new effective vaccines are immense. Further benefits can be achieved by adapting existing vaccines to make them more suitable for resource-limited settings. Yet vaccine R&D involves high costs, technical complexity and high risk of failure, while there are limited incentives to stimulate engagement. Without heavy investments, by companies and donors, few vaccines will make it to market. When companies do develop vaccines, it is important they consider the future accessibility of the product.
Scope of this research area:
- R&D investments: companies’ investments in vaccine R&D for the 69 diseases and pathogens in scope, compared to global vaccine revenues.
- Vaccine pipelines: where companies are focusing vaccine R&D.
- Types of vaccine R&D: whether companies are developing new vaccines, adapting existing ones, and/or developing technologies for vaccine packaging and delivery.
- Access provisions: actions companies take during vaccine R&D to ensure rapid uptake of approved vaccines by populations in need.
Outcomes in Research & Development
GSK and Johnson & Johnson lead in this research area, with strong yet differing approaches. GSK has the largest pipeline, while Johnson & Johnson makes the largest R&D investments as a proportion of vaccine revenue. Both companies aim to address high-need vaccine gaps, and both have access plans in place for over half their late-stage vaccine candidates.
Figure: GSK and Johnson & Johnson lead in R&D with strong yet differing approaches
In total, the eight companies evaluated have 89 projects in the pipeline for 35 of the 69 diseases in scope. Many of the 34 unaddressed diseases currently have no vaccines. Six dis- eases/pathogens receive the most attention: pneumococcal disease (9 projects), HPV and seasonal influenza (6 each), meningococcal disease and RSV (5 each), and dengue (4). Almost one-third of projects target diseases highly prioritised by WHO for vaccine R&D. The 89 projects in the pipeline are relatively evenly split between developing new vaccines on the one hand and adapting existing ones on the other (52% and 48% respectively). Both types of vaccine R&D are critical for facilitating widespread immunisation. Over half of late- stage projects have one or more measures in place to ensure the vaccine’s future accessibility. Company investment in vaccine R&D varies, with investments ranging from less than 10% to 253% of a company’s global vaccine revenue.
Looking ahead in Research & Development
To ensure the long-term relevance and sustainability of their vaccine businesses, companies must invest sufficient vaccine profits into vaccine R&D. This also entails responding to R&D gaps prioritised by global health stakeholders, designing vaccine characteristics to address specific access barriers, and making clear plans to ensure rapid uptake where needed. While commercial market incentives drive vaccine R&D for some diseases, for others – in particular those that predominantly affect populations in low- and middle-income countries – potential profitability is low: alternative external incentives may be necessary to support this work where traditional incentives are lacking.
Pricing & Registration
Vaccines for routine immunisation are generally purchased by governments or through pooled-procurement systems aiming to lower prices. There are three main organisations involved in these systems: the United Nations International Children’s Emergency Fund (UNICEF), the Pan American Health Organization (PAHO) Revolving Fund, and Gavi, the Vaccine Alliance. The vaccine market is consolidated, with four companies accounting for the majority of vaccine revenues (GSK, Merck & Co., Inc., Pfizer and Sanofi). There is also a growing number of vaccine manufacturers based in emerging markets which focus on manufacturing traditional, lower-priced vaccines.
Scope of this research area:
- Vaccine pricing decisions: whether and how companies consider affordability in pricing strategies for public sectors in low- and middle-income countries.
- Price trends: how prices of key new vaccines for Gavi-eligible countries have changed over time.
- Transparency in pricing: whether companies are transparent around the factors they consider in their pricing strategies and whether they support vaccine price transparency.
- Availability: how widely companies file to register vaccines in low- and middle-income countries.
Outcomes in Pricing & Registration
In Pricing & Registration, GSK leads, followed by Merck & Co., Inc. and Sanofi with equal total scores. GSK’s pricing strategy for vaccines is the most sensitive to each country’s ability to pay, relative to peers’ strategies. GSK and Merck & Co., Inc. lead in transparency, publishing their complete pricing strategies and reporting that they do not prohibit governments from publishing manufacturer prices. Sanofi is the leader in registration, filing to register most of its relevant vaccines in 30-50% of both low- and lower-middle-income countries in scope.
Figure: GSK leads, followed by Merck & Co., Inc. and Sanofi with equal total scores for Pricing & Registration
The six companies evaluated each consider multiple factors when setting vaccine prices, the combination of which is unique to each company and dependent on their portfolio. Across all companies, the most frequently considered factor is whether a country is eligible for Gavi support. This is followed by Gross National Income per capita, which is considered by four companies for at least some low- and middle-in- come countries. Some companies publish their complete pricing strategies online for all vaccines, yet in general, the transparency of pricing strategies varies. Most companies state that they do not include clauses in government contracts that prevent manufacturer prices being published. Vaccines are not being led for registration widely: for the 91 vaccines that qualify for analysis, the registration process has begun in less than a quarter of low-income countries and lower-middle income countries within the scope of the Index.
Looking ahead in Pricing & Registration
When pricing vaccines, companies need to address affordability systematically – especially for countries that receive no support from Gavi and do not participate in pooled procurement via PAHO or UNICEF. Companies can form and share clear pricing strategies for all low- and middle-income countries. Companies should also enable global information sharing about vaccine prices to promote a more competitive environment, facilitate negotiations and help ensure that prices are fair. There is also a gap in certain countries regarding vaccine registration: companies need to file to register vaccines according to public health need. In turn, governments and procurers must invest sufficiently in national regulatory systems and immunisation programmes in low- and middle-in- come countries.
Manufacturing & Supply
To achieve their full potential, immunisation programmes must be effectively implemented. National as well as international stakeholders share the same goal here: an uninterrupted supply of high-quality vaccines, from the manufacturer to the clinic, school or home. This shared interest requires cooperation and coordination at each step of the vaccine supply chain: implementation can be hindered by many factors, including insufficient vaccine supply, inadequate distribution systems and limited local capacity to store, handle and administer vaccines.
Scope of this research area:
- Aligning supply and demand: the steps and processes companies use that help prevent vaccine shortages.
- Capacity building: companies’ capacity building activities in countries in scope for vaccine manufacturing.
- Distribution and administration: how companies have adapted or developed vaccine presentations, packaging and delivery technologies that help simplify distribution and administration.
Outcomes in Manufacturing & Supply
In Manufacturing & Supply, GSK and Sanofi score highest. Both demonstrate strong processes and commitments to help ensure vaccine production meets demand. They further support global vaccine supply through capacity building in manufacturing. The two companies have also implemented vaccine presentations and packaging that help to overcome local access barriers (e.g., vaccines that are easier for health workers to administer).
Figure: GSK and Sanofi score highest for Manufacturing & Supply
The six companies evaluated are taking steps to align supply and demand at a global level, increasing the likelihood that some potential vaccine shortages are being detected, mitigated or prevented. Companies generally implement multiple internal processes to improve alignment between supply and demand; many also make commitments around continuing supply of needed vaccines. Companies are building vaccine manufacturing capacity in some countries in scope: a relatively small number of middle-income countries with established vaccine production capacities. All companies take steps to ensure certain vaccines have packaging, presentations or features intended to help overcome barriers to access on the ground.
Looking ahead in Manufacturing & Supply
The existence of ongoing vaccine shortages shows that communication and coordination between the industry, procurers and other stakeholders can be further improved. The industry must continue to monitor demand and improve approaches for preventing shortages. This is especially important – nationally and on a global level – where demand suddenly spikes, such as with disease outbreaks. To support access on the ground, companies can also ensure that vaccine presentations pose minimal challenges to local supply chains and health systems. There is further progress to be made in this area: partnerships with stakeholders who understand local needs and can put incentives in place for private-sector involvement may be useful here.
What does the industry look like?
The Index has compared key characteristics of each company included in the Index scope (see figure 2). The companies evaluated in the Access to Vaccines Index have diverse business models, which are reflected in their vaccine pipelines, portfolios, revenues and number of doses sold globally.
The industry is highly consolidated: the “big four” – GSK, Merck & Co., Inc., Pfizer and Sanofi – represent a large proportion (around 80%) of global vaccine revenues. While all companies within this group have very high vaccine revenues, there are also important differences between them: GSK and Sanofi have a large number of vaccines in their diverse portfolios, a relatively wide geographic spread and larger-than-average pipelines. Merck and Co., Inc. and Pfizer have smaller pipelines and portfolios, and sell fewer doses globally.
Figure 2: The vaccine industry is highly consolidated; business models are diverse
Serum Institute of India is also a major player of global public health importance, especially in terms of the number of vaccine doses produced and its wide geographic reach: its lower revenue reflects its high-volume, low-cost model. For Johnson & Johnson, vaccines currently represent a smaller part of the business – its revenue is low compared with other companies evaluated – but a promising vaccine pipe-line supported by a very high proportion of R&D investments (compared to revenue) indicates an increasing focus on vaccines in the future. Daiichi Sankyo and Takeda are smaller players that are important to the domestic Japanese vaccine market, with growing vaccines businesses. Neither currently markets vaccines in other countries, but the pipelines and R&D investments of both companies show potential and interest in contributing to the global vaccines market.
Figure 3: Looking beyond revenue: variations in portfolio and pipeline size signal potential for decreasing consolidation
Pipeline and portfolio analysis: where is the industry focusing? When it comes to vaccines, companies clearly concentrate on diseases with larger global markets: for example, the diseases with the most vaccines on the market are meningococcal disease, polio, seasonal influenza and viral hepatitis; the largest pipelines are for pneumococcal disease, seasonal influenza, HPV, meningococcal disease and RSV.
For the full portfolio and pipeline analysis, download the Index report.