The infectious disease sector is a study in contradictions.
Despite overall growth, the number of key infectious disease players seems to be shrinking, with just a handful of companies dominating the field. And although Pfizer scored a huge approval in May with Paxlovid, the first oral antiviral pill approved by the FDA to treat COVID-19 in adults, the COVID market isn’t as lucrative as it’s been in previous years.
“[T]he long-term shrinking prospects of an uncertain seasonal, variant-specific market have curbed this appeal, contracting the pipeline,” Charlotte Holmes, senior analyst at Citeline, told PharmaVoice via email. “Even Pfizer … announced a planned re-evaluation of resources directed towards COVID research as [it] transitioned out of the profitable pandemic phase.”
“Pfizer’s dominance in the COVID-prevention market has been cited by some developers as one of the major reasons for pipeline attrition in the first couple of years of the pandemic."
Charlotte Holmes
Senior analyst, Citeline
Treatments and vaccines for respiratory diseases have gotten the lion’s share of infectious disease attention in the wake of the pandemic, even among the space's biggest players. However, these companies are still heavily investing in disease mainstays like HIV, HPV and hepatitis C.
Meanwhile some big players in the space are scaling back their work. Among them is Johnson & Johnson, which said it was shuttering several parts of its vaccine R&D division after dropping its RSV shot and discontinuing a phase 3 HIV vaccine trial.
“With Pfizer and GSK further ahead in the race, J&J seemingly decided the competition was too fierce in this segment and decided to pull out of the running, citing ‘strategic R&D reasons,’” said Natasha Boliter, senior analyst at Citeline, via email.
Still, the infectious disease market is growing. The research firm GlobalData predicts a compound annual growth rate of 5.7% through 2029, and sales reaching $150 billion annually by the end of the decade.
How three companies dominate the sector
Today, just three major players are generating the majority of growth in the market: Pfizer, Gilead and GSK, collectively are forecasted to generate 62% of total infectious disease drug sales between 2023 and 2029, according to GlobalData.
Their dominance in certain diseases have discouraged rivals from competing. J&J abandoning its RSV program before GSK’s first-to-market success for Arexvy is just one example. Holmes also pointed to Gilead’s success in the hepatitis C vaccine (HCV) market.
“Gilead and AbbVie’s dominance in HCV with pan-genotypic direct-acting antiretrovirals has shrunk the market as developers can no longer recoup R&D costs in a shrinking patient population,” Holmes said.
Pfizer’s COVID-19 strength had the same effect.
“Pfizer’s dominance in the COVID-prevention market has been cited by some developers as one of the major reasons for pipeline attrition in the first couple of years of the pandemic,” she said.
The consolidated control among the three companies will likely continue as they develop new drugs and seek additional approvals. Boliter points to Pfizer’s current focus on dual combination vaccines, as well as its leadership in the pneumococcal disease market, thanks to Prevnar 20. It’s also competitive in RSV with Abrysvo.
The same is true for GSK.
“GSK also has a key vaccine in RSV with Arexvy and is now pursuing an approval in adults aged between 50-59 years,” Boliter said.
Meanwhile, Gilead’s HIV prevention and treatment portfolio secured it “approximately 60% of the lucrative HIV treatment market in 2023,” Holmes said.
“The main driver behind this unrivaled supremacy is the widely prescribed INSTI-based regimen [integrase strand transfer inhibitors] Biktarvy, which profits from an excellent efficacy and safety profile, generating blockbuster sales of [more than] $10 billion,” she added.
The race to combo jabs
Although J&J pulled out of the RSV race, respiratory diseases represent a hot market.
“RSV is getting a lot of focus, as it is a major cause of morbidity in immunosuppressed adults and the elderly as well as affecting young children, with almost all children becoming infected with RSV within the first two years of life, and with approximately 0.5% to 2.0% of infections resulting in hospitalization,” Boliter said. “It is set to become a very lucrative market.”
She pointed to Sanofi, which already leads the market in influenza vaccines, as a key RSV player thanks to the treatment Beyfortus, which it developed with AstraZeneca.
Additionally, Merck & Co., which dominates the HPV market, is hot on Beyfortus’s heels with the phase 3 RSV treatment MK-1645.
Sanofi is also developing an RSV vaccine, while “Moderna’s mRNA-1345 is set to become the third approved vaccine for RSV, which will compete directly with GSK’s Arexvy and Pfizer’s Abrysvo,” Boliter said.
Other companies and diseases are worth watching, too.
Vaxcyte is developing VAX-24, a pneumococcal conjugate vaccine which received a breakthrough designation from the FDA.
“It has shown robust immune responses versus Prevnar 20,” Boliter said.
Analysts also point to pan-respiratory seasonal vaccines as a key development focus going forward, with Moderna, Novavax and Pfizer leading the way.
While the early focus has been on combining COVID-19 and influenza jabs, there could be a future for combining even more, and at least one company, Moderna, is already looking in that direction.
“A triple combination targeting COVID-19, influenza and RSV would have clear logistical advantages to healthcare systems compared to delivering three separate annual boosters,” Boliter said. “Patient compliance would also be expected to be higher for a single vaccine.”
