Developments in IPV Vaccines to Drive Revenue Growth

IPV Vaccines

Expanding IPV Vaccine Coverage Globally

As polio nears global eradication, health organizations are working to transition all countries from using oral polio vaccine (OPV) to inactivated polio vaccine (IPV) exclusively. IPV does not carry the rare risk of vaccine-derived polio cases that can occur with OPV. To complete polio eradication and ensure the world is protected once OPV use stops, the World Health Organization (WHO) recommends all countries introduce at least one dose of IPV into their routine immunization schedules by end of 2015. Achieving global IPV introduction represents a major opportunity for vaccine manufacturers to access new markets.

Several developing countries have recently introduced IPV or have plans to do so in the coming years. India introduced IPV in 2015 with support from vaccine partners and Gavi, the Vaccine Alliance. Pakistan and Nigeria are also working towards IPV introduction. Gavi recently announced it will provide funding support to help 73 countries transition from trivalent to IPV. Wider IPV use in developing countries will require vaccine suppliers to scale up production capacity and lower per-dose costs to meet subsidized prices. Those able to expand access in low-income markets stand to significantly grow their IPV revenue.

Transition to IPV Poses Supply Challenges

Transitioning all OPV-using countries to IPV presents infectious disease organizations and vaccine suppliers with major supply chain and production challenges over the next several years. Current global IPV manufacturing capacity of around 100 million doses per year is far below the estimated long-term demand of over 600 million annual doses once all countries introduce IPV. Potential shortages could delay immunization schedules if additional capacity is not brought online in time.

The two main suppliers - Sanofi Pasteur and GSK - have plans to expand but scaling up IPV production is complex given the extensive safety testing and regulatory approvals required for vaccines. Both are building or upgrading existing IPV production facilities with expectations of doubling or tripling their respective capacities by 2018-2020. Other manufacturers including Bharat Biotech and Bio-Med are also developing IPV vaccines but on smaller scales for domestic and regional markets. Those who can deliver on expanding capacity while maintaining quality and low prices stand to capture more market share as IPV demand surges globally.

New IPV Presentations in Development

With the looming switch from trivalent to IPV, manufacturers are working to develop new, easy-to-administer vaccine presentations that could improve uptake and cost-effectiveness in routine programs. Sanofi Pasteur recently received approval for its easy-to-administer IPV injector device in Australia, providing a model for introduction in developing countries. The one-dose, single-use injector eliminates the need for mixing and loading syringes, reducing the skill level needed and risk of contamination compared to vials. Other new formats in development could include lyophilized IPV Vaccines  versions that stay stable without refrigeration.

New IPV combination vaccines are also being tested which may offer public health benefits. For example, trials are underway for an IPV-hepatitis B vaccine. Combining IPV with proven and widely used vaccines like pentavalent could enhance immunization schedules in developing nations and improve the positive impact of Gavi's IPV funding. Manufacturers who deliver IPV in novel, easy-to-use and combination presentations stand to increase the accessibility and adoption of IPV globally as the market transitions in the coming years.

Changes in Polio Eradication Strategy Impact Market Demand

The polio vaccination landscape has fundamentally changed with the new endgame eradication strategy adopted by the Global Polio Eradication Initiative (GPEI) in 2012. In addition to the IPV switch, campaigns are shifting to using bivalent oral polio vaccine (bOPV) which protects against only types 1 and 3 rather than the full trivalent formulation. This greatly reduces the risk of vaccine-derived polio cases from type 2. With IPV and bOPV deployment, total polio vaccine market demand is expected to rise significantly before declining over the long term as wild polio is eliminated.

Vaccine suppliers are closely monitoring GPEI’s strategic plans and adapting accordingly. While production of trivalent OPV will cease, bOPV demand is surging. Manufacturers expanding bOPV capacity like Sanofi Pasteur have captured more campaign supply contracts. Transition activities themselves including synchronized bOPV and IPV introduction campaigns represent a major revenue opportunity over the next 3-5 years. Those able to reliably deliver sufficient volumes of all three polio vaccines – IPV, bOPV, tOPV – as eradication strategies change hold a strategic advantage in the shrinking but lucrative polio vaccine market.

 

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