January 15, 2007 (Vol. 27, No. 2)

Cancer researchers have long struggled to recruit the body’s immune system to attack tumors while leaving healthy cells alone. The vaccine approach can offer huge improvements over traditional chemotherapy and radiation, which kill healthy and diseased cells indiscriminately and carry harsh side effects.

In the past decade, repeated attempts to find a cancer vaccine have failed, largely because scientists had a crude understanding of the molecular mechanics of the immune system and cancer cells. But recently, good progress has been made, and it is the general consensus of scientists that cancer vaccines will become a reality, representing a market that could become highly competitive within just a few years.

Although technically not a therapeutic cancer vaccine in the traditional sense, the highly visible advertising of Merck’s Gardasil™ prophylactic vaccine has raised awareness of cancer vaccines to a new level, which could have a positive impact on both the prophylactic and the potential therapeutic vaccine markets.

Gardasil prevents infection with the two types of human papillomavirus (HPV)—HPV 16 and 18—that together cause 70% of cervical cancer cases worldwide. The FDA approved Gardasil for use in females ages 9 to 26 last June. Merck’s(www.merck.com) ad campaign “One Less” features girls and young women engaged in empowering activities with the message that the embracing of its vaccine could yield one less case of cervical cancer.

According to Kalorama Information’s research, the cancer vaccine industry is well poised to piggyback off this awareness and take advantage of better understanding of molecular biology technology to reach a total market of up to $700 million in potential new cancer vaccine revenue by 2008 and $8.4 billion by 2012.

The increasing incidence and mortality of many cancers provides a conceivable setting for a cancer vaccine market. Worldwide, cancer affects more than 10 million people each year. This number is expected to increase by 2.4% annually to 15 million people each year by 2020. The aging population has made a considerable impact on the cancer incidence and mortality and is expected to have even more of an effect with each passing year. As the elderly tend to be the highest population for new incidence, it is expected that these rates will reach new records.


The development pipeline of cancer vaccines also presages strong market conditions. Several promising vaccines are in late-stage development and are preparing for regulatory review. It is expected that the market will see as many as five approvals by 2008, and, by 2012, eight additional approvals are possible.

Many of the products with potential approval status over the coming years are already in Phase III development, have orphan drug status, SPA status, or Fast-track status. This could indicate a promising future for other vaccine products. Additionally, some products in international regions have been granted compassionate-use status, which is significant in evaluating need on a patient-by-patient basis.

Several cancer areas are positioned with strong potential vaccines. Approvals are expected to have increased competition, with more than one competitor in many of these areas. For example, in the prostate cancer area, Cell Genesys(www.cellgenesys.com) and Dendreon(www.dendreon.com) are both expected to offer new vaccines and have comparable revenues by 2008.

Both products are in a Fast-track status with the FDA and have shown positive clinical data. The intensifying competition in this marketplace reflects the favorable clinical trial results, the likely FDA approvals over the next five years, and a growing acceptance of cancer vaccines by both healthcare professionals and patients.

The areas expected to display the highest competition include melanoma, lymphoma, and cervical and prostate cancer. These areas have a wide range of research and development activities brewing from preclinical to Phase III trials. Specifically in the areas of prostate and lung cancers, the demand for vaccines is highly motivating for developers since the incidence of these cancers continues to hold strong, displaying steady increases each year, and there are limited efficacious options among current treatment protocols.

There are some obstacles along the way that can interfere with the advancement of cancer vaccines, however. Education and advancement of methods to detect cancer early are paramount to the success of these therapies. Political and social resistance to vaccinations in general and the oncology community’s traditionally conservative environment are realities that may slow implementation. Also, there is the challenge of reimbursement. Manufacturers must demonstrate that the new vaccine is superior to other products on the market, a particularly difficult task given that designing trials around patients with early-enough stage cancers has met with resistance.

Near-term prospects for therapeutic vaccines may appear speculative. However, parallels between the emerging therapeutic vaccines industry and the history of the monoclonal antibodies industry can be seen. In the case of monoclonal antibodies, their eventual, long-awaited success was driven by technology evolution from murine to chimeric and, ultimately, humanized and fully human antibodies. Now the industry has exceeded $10 billion in annual sales and is expected to continue to grow rapidly to over $20 billion by 2012.

Technological evolution should ultimately enable therapeutic cancer vaccines to make similar commercial breakthroughs, after their initial disappointments. This is a promising area of medicine, which will continue to assist in the fight against cancer. Given the need for more effective and less intrusive therapies for cancer, the robust pipeline, and expected publicity, we believe cancer vaccines represent a market to watch with excellent potential.

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