Vaccines: Hot 'new' business for drugmakers

NEW YORK (CNNMoney.com) -- The once-sluggish vaccine industry is anything but these days.

The vaccine market was once "very small and fraught with the inability to price effectively," said Anthony Butler, analyst for Lehman Brothers.

But now, with fewer manufacturers hawking new products, the business is expected to grow rapidly the next few years, with fast-growing vaccines like Wyeth's (down $0.55 to $57.22, Charts, Fortune 500) Prevnar and Merck's (down $1.24 to $52.16, Charts, Fortune 500) Gardasil helping drive growth.

"I expect [the vaccine industry] to more than double" by 2010, said Butler, noting he expects Merck and Wyeth will sell some $10 billion worth of vaccines a year by 2010, accounting for a growing chunk of their total business.

This is welcome news for vaccine makers that put up with years of sluggish growth or wild swings in demand when the market was focused on vaccines for hepatitis and seasonal flu.

"There has been a renewed emphasis and interest in the vaccine business, but a lot of firms had exited the business in the last 10 years or so," said Joe Tooley, analyst for A.G. Edwards. "Only a few remain. It's a tough business to get into, but those stayed in it are in a better position now."

Prevnar, Wyeth's second-biggest seller, is the leader of the pack. This fast-growing vaccine, for the immunization of infants and toddlers against pneumonia, meningitis and infections of the ear and blood stream, totaled nearly $2 billion in 2006 sales, up 30 percent from 2005. And growth is accelerating, with first quarter sales of $617 million, a 43 percent surge from a year earlier.

Prevnar was launched years ago and first hit billion-dollar blockbuster status in 2004. Barbara Ryan, analyst for Deutsche Bank North America, believes the vaccine will total $2.5 billion in 2007 sales.

But a new entry has rekindled interest in the vaccine market and helped prop up the stock for its maker: Merck's Gardasil, a vaccine to prevent sexually transmitted viruses that cause cervical cancer.

Gardasil, on the market for nearly a year, is the potential blockbuster that helped the New Jersey-based Merck pull out of its Vioxx withdrawal blues. Since the Food and Drug Administration approved Gardasil last June, Merck's stock has surged 57 percent, outperforming S&P gains of 21 percent.

Gardasil sales totaled $365 million in the first quarter of 2007, helping Merck reach nearly $1 billion in total vaccine sales for the quarter, more than triple vaccine sales from a year earlier. Analyst projections have ranged up to $4 billion in annual sales for Gardasil, assuming the government mandates widespread vaccinations for girls.

Merck launched two other vaccines in 2006 - Zostavax, for the prevention of shingles, and Rotateq, for the prevention of a rotavirus that causes diarrhea in infants. Les Funtleyder, analyst for Miller Tabak, estimates that these vaccines could reach hundreds of millions of dollars in annual sales.

"Merck showed that you can make quite a bit of money with vaccines, and I think that got a lot of people's attention," said Funtleyder.

Gardasil could get some competition from British drugmaker GlaxoSmithKline (up $0.40 to $52.46, Charts), which has filed the cervical cancer vaccine Cervarix with the FDA. Glaxo CEO J.P. Garnier said in a March interview that he hopes to get the vaccine on the U.S. market this year.

The two vaccines are similar, but Gardasil has the advantage of getting to the U.S. market first. Gbola Amusa, former analyst for Sanford C. Bernstein, has projected peak annual sales of $2.5 billion for Gardasil and $1.5 billion for Cervarix.

Even the Novartis (up $0.09 to $56.23, Charts)-dominated industry for flu vaccines - which is subject to seasonal fluctuations and doesn't include any blockbusters - is expected to grow. The research firm Datamonitor projects that worldwide flu vaccine sales will more than double by 2016 from last year's $2.2 billion.

In the meantime, companies including the Dutch biotech Crucell (down $0.30 to $22.58, Charts) are developing faster ways to produce vaccines. Vaccines are traditionally produced in chicken eggs, but the U.S. government has urged companies to come up with more efficient methods to deal with the potential threat of a potential bird flu pandemic.

Back in 2005, the U.S. government awarded the French company Sanofi-Aventis (up $0.21 to $47.54, Charts) nearly $100 million to come up with a better way to make vaccines sans oeufs. Sanofi is licensing technology from Crucell to make grow vaccines inside steel bioreactors containing cell cultures at its plant in Swiftwater, Penn. Hemispherx BioPharma of Philadelphia and Vical Inc. of San Diego are also developing ways to develop vaccines in DNA or cell-based cultures.

But analysts say that finding another vaccine blockbuster could be difficult with no apparent candidates in Big Pharma's pipelines. Unless, they say, Merck completes its quest to develop the Holy Grail of worldwide healthcare: an HIV vaccine.

"There's nothing in anyone's model for an HIV vaccine," said Butler of Lehman Brothers, referring to the models that analysts use to project future drug sales. "But who knows?"