Cancer Vaccine Developments to 2013

The launch of Sanofi Pasteur MSD' s Gardasil and GSK' s Cervarix has propelled cancer vaccines from research obscurity to a key area of commercial and clinical interest. But can the sector capitalise on these gains and really fulfil its promise?

By 2010, the global cancer market is expected to generate sales in excess of US$60 billion due to growth in the sales of existing innovative products and the launch of nearly 60 new products which will account for around 30% of total drug launches.

But where do cancer vaccines fit into this outlook? At present, prophylactic vaccines dominate the cancer vaccine sector following the recent launches of Sanofi Pasteur MSD' s Gardasil and GlaxoSmithKline' s Cervarix. We expect that sales of these vaccines will break through US$4 billion by 2011. While there is no therapeutic vaccine market, so to speak of, at present, it has the potential to mirror the growth seen in the monoclonal antibody market, and reach sales in excess of US$5 billion by 2012. This prediction may be optimistic and is highly dependent on vaccines being approved for major cancer indications - no small challenge taking the development history of the sector.

While no new therapeutic cancer vaccine has been approved recently the product pipeline has changed substantially, shifting from one filled with vaccines at the Phase I and II stage, to a more mature pipeline reflecting a shift in development towards the later stages. This is a consequence, not only of the age of the pipeline, but of the difficulties and pitfalls that therapeutic cancer vaccine development faces. Many vaccines have fallen by the wayside for one reason or another. Indeed the rush to join this area of research has waned slightly with the realisation that products are harder to bring to market than first anticipated.

Cancer vaccine research is coming to fruition, with a number of products now in Phase III trials and 15 therapeutic cancer vaccines realistically expected to launch by 2013

Despite the challenges faced by the sector, we predict that by 2010, there will be six new therapeutic cancer vaccine approvals, led by Favrille' s FavId for B-cell non-Hodgkin' s lymphoma. This number looks set to increase quickly with the possibility of 21 vaccines being launched by the end of 2013, although 15 seems a more realistic scenario given the historic failure rate for therapeutic cancer vaccines in Phase III development. These products look set to target some of the "big" cancers, with launches for vaccines against renal cell carcinoma, melanoma, prostate, non-small cell lung and colorectal cancer.

But there are many challenges ahead

It is still not clear how best to use cancer vaccines with respect to disease stage and in combination with other therapies. How should clinical trials be designed so that the endpoints reflect the actions of the vaccines? It looks likely that when therapeutic cancer vaccines finally make their way on to the market and into clinical use it will be alongside current therapies as part of combination regimens that keep cancer in check. The current vaccines in development do not seem to be the "magic bullet" for cancer that many had hoped they would be. Instead they look set to occupy a much needed place in the growing choice of treatments that are needed to keep cancer under control.

The problems faced by the sector are illustrated by Dendreon' s Provenge. Everything was right: a biotech company getting a vaccine approved for a major indication in a large market. However, this was not to be, as the FDA ruled that additional survival data was needed, signalling another setback for a sector that has seen its fair share of failures and false dawns.

But it was also a timely reminder for developers that the path to market for therapeutic cancer vaccines is not going to be an easy one. Companies must now focus on conducting well-designed trials with achievable but robust endpoints in suitable patient populations, and perhaps even consider combination trials with other therapies.

Who are the players and products in the race to launch? This report critically assesses the candidates in their wider market context

This insightful and data-rich management report Cancer Vaccine Developments to 2013, fully evaluates the products and their developers. In more than 180 pages, the report provides a complete review of the market and its likely development to 2013.

Cancers covered

• Brain
• Breast
• Gastrointestinal
• Genito-urinary
• Gynaecological
• Haematological
• Lung
• Melanoma/Sarcoma

Types of cancer vaccine

• Antigen/adjuvant vaccines
• Whole-cell tumour vaccines
• Dendritic cell vaccines
• Viral vectors and DNA vaccines
• Idiotype vaccines

The report answers key questions...

• Who' s developing what, and with whom?
• What are the prospects for Gardasil achieving US$1.6 billion sales by 2011?
• Which products are likely to launch in 2009 and 2010?
• Why do some cancer vaccines fail?
• Which company is leading the race to develop a breast cancer vaccine?
• What cancer vaccines are there in Phase II/III for lung, breast, prostate and colorectal cancer?
• What unique regulatory hurdles must cancer vaccines overcome?

Incorporating information from Espicom' s extensive cancer databases, case studies and direct contact with developers, the report provides unique insight, forecasts, product launch predictions and much, much more. Essential reading for investors, developers and industry professionals!