Vaccine developments will bolster interest and market growth in the infectious diseases space, says GlobalData

Looking to the horizon for 2020, Michael Breen, Associate Director of Infectious Diseases, and Philipp Rosenbaum, Infectious Diseases Analyst, at leading data and analytics company GlobalData, comment on the key trends and events shaping the vaccines space in 2020.

Expansion into new patient segments and geographies

Breen says: “Merck’s Gardasil franchise has proven to be one of the greatest success stories not just in terms of vaccines, but across the entire pharmaceutical industry. Its efficacy is remarkable, with many anticipating that human papillomavirus (HPV) associated cancers, due to the serotypes covered in the vaccine, may soon be a thing of the past.

“In the first three quarters of 2019, Gardasil/Gardasil 9 saw sales of $3.04bn, up from $2.3bn in the same time period of 2018. What is truly remarkable is that there is still room for significant growth of this franchise. Upon release, HPV vaccine use was limited to adolescent females, however as time has gone on, the label and recommended groups that should receive HPV vaccines has been expanded to include males, and in the US the age limit has been raised to 45 years.

“Expansion into new patient segments is one driver of the Gardasil franchise’s growth, but the launch and uptake into new markets will also be key, particularly as the franchise sees uptake in China, which has remained an untapped market for many pharmaceutical products which have seen success in other geographies.”

Addressing manufacturing limitations

Breen commented: “GSK’s shingles vaccine, Shingrix, boasts efficacy data that was frankly surprising, it is that good. However, the limitation with Shingrix is with its availability, there have been shortages since its approval in the US in late 2017. GSK has made strides to accommodate demand, with growth seen in every quarter since its launch, and nearly $700m in sales in Q3 in the US in 2019.

“Those figures suggest that Shingrix will be one of few vaccines, including Merck’s Gardasil franchise and Pfizer’s Prevnar franchise, to record annual sales of over $3bn. It is noteworthy that at present, those figures only represent US sales, the aforementioned supply shortages have constrained Shingrix’s global rollout. When Shingrix does indeed reach all intended markets, it could be the best-selling vaccine globally.”

Vaccines for respiratory virus infections

Breen continued: “We’re going to continue to hear about development for viruses associated with respiratory infection, in particular, respiratory syncytial virus (RSV) and influenza. RSV is notable as no prophylactic vaccines are licensed for this pathogen, though it is not for lack of trying, but failure has remained the rule for vaccines for RSV for over 50 years. At present, advances in vaccine development and technology suggest that a vaccine for RSV is imminent, although the potential efficacy of such a product remains murky at best.”

Rosenbaum commented: “Seasonal influenza vaccines will see a transition away from egg-based towards cell-, plant-based, and recombinant vaccines to improve vaccine efficacy and thus hopefully decrease hesitancy for the annual immunization. Seqirus’ cell-based vaccine Flucelvax and Sanofi’s recombinant vaccine Flublok are becoming more popular in the US, and launches in Europe will further propel the shift towards this next generation of influenza vaccines. Medicago’s plant-based virus-like particle vaccine MDG-2271 is set to launch in the US in 2021, while universal influenza vaccines that promise multi-season and multi-strain protection are 6-8 years away from approval.”

Vaccines for developing markets

Breen says: “In late 2019 Merck’s Ervebo received both EMA and FDA approval, and while the vaccine will likely see little if any use in these markets, the approvals pave the way for rollout in other countries with less defined paths to market, such as countries where Ebola outbreaks occur.

“We’ll also continue to see advancement of TAK-003, a Dengue fever vaccine being developed by Takeda which demonstrated strong efficacy data in Phase III studies released in early 2019. The continued launches of vaccines such as TAK-003 and Ervebo will help support the development of vaccines for indications where significant unmet need persists, such as malaria, and in geographies which are typically considered to be lower profit than development markets.”

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