Reflecting the growing depth of understanding of mechanisms behind cancer progression, presently there is a raise in the number of new drugs and therapeutics reaching clinical trials. Also, over the past few years, research and development efforts for new cancer therapeutics have witnessed many new directions such as development of new, targeted therapies for prolonging the life of cancer patients. The main reason for the increased research activities on this segment can be the new selective therapies ability to offer disease relief without debilitating side effects. Therefore, from the patient's point of view, the treatment offers months or years of high quality life, even if there is a relapse.

In this context, there have been significant advancements in the development of biotech drugs, including therapeutic monoclonal antibodies in the area of oncology. Although there are a number of monoclonal antibodies already in the market, the oncology market is largely untapped and holds significant potential.

Presently in phase III clinical trials of the oncology biotech pipeline, nearly 50 per cent of products are monoclonal antibodies. Monoclonal antibodies target and bind to a specific antigen on the surface of cancer cells. Apart, monoclonal antibodies are designed to have a cytotoxic effect on them through various different mechanisms. Monoclonal antibodies are mainly being developed for treating cancer. Clinical trials are often being conducted in key areas like non- Hodgkin's lymphoma, colorectal cancer, head and neck cancer, ovarian cancer and small cell lung cancer. There has been growing approvals in this area. Some examples include Erbitux, Herceptin, Avastin, Humira and Xolair.

There has been a good acceptance of monoclonal antibodies by patients and the healthcare community, which is reflected in growing sales. Monoclonal antibodies have established their efficacy and safety profile in treating cancer. The next generations of monoclonal antibodies have also evolved with the radiolabelling of monoclonal antibodies with radioactive agents. This forms a potent combination of targeted attack on the cancer cells.

Vaccines and gene therapy are heavily dominant in phases I and II compared to phase III. These products, which are scheduled to be launched 10 years from now, are expected to hit the market in the medium term horizon. Cancer vaccines are emerging technologies that are likely to create the next wave of growth in the biotechnology industry because of better safety profiles and minimal side effects.

The National Cancer Institute and many biotech companies are involved in the research and development of cancer vaccines. The initial success of cancer treatments with monoclonal antibodies is likely to be fortified with the launch of cancer vaccines. However, the main advantage of monoclonal antibodies over cancer vaccines commercially is that they have now started to receive approvals for multiple indications. Vaccines however target only specific tumors and would be more narrowly focused. This may actually limit the market opportunity for vaccines.

Cancer forms a major area of research for gene therapy products and there are large numbers of drugs under trials addressing this area. This technology could actually be a potential competitor to vaccines. The companies developing gene therapy products are mostly small research-based companies. However, there are many more challenges in the development of gene therapy compared to the other technologies.

Gene therapy involves modification of the genetic material within cells resulting in a beneficial outcome. Currently hundreds of experiments are being conducted that seek to alter cancer genes throughout a tissue. These experiments have helped define the cellular responses to each specific alteration, as well as the susceptible target cells. Through this approach enormous knowledge has been gained about the basic mechanisms that give selective advantages to tumor cells.

In the future we will see biotech companies exploiting the array of unmet medical needs in the market. There will be a higher success rate for biologics compared to small molecules, paving the way towards more targeted therapies for patients and exciting opportunities for manufacturers.

(The author is programme leader, Pharmaceuticals and Biotechnology - Healthcare Practice with Frost & Sullivan)