The Business of Cancer Diagnostics and Therapeutics

Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Overall costs of the disease are $126 billion annually. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects.

Since 1950, the overall mortality rate has remained the same. [1] There is a pressing need for more sensitive, accurate, and cost-effective methods for detecting and treating cancer. With their unique optical, thermal, and electromagnetic properties, nanoparticle-biomaterial composites have tremendous potential in novel methods for detection, characterization, and therapy of cancer. [2]

According to a recent study (link), the worldwide market for in vitro cancer diagnosis will reach the $7.4 billion mark by 2009, as the demand for such tests will continue to increase as new cancer cases soars toward the 10 million mark.

Cancer, with its high prevalence and mortality rate, continues to rank among the world's deadliest and most costly diseases. According to the World Health Organization, (WHO), in 2003, about 25 million people live with cancer and nearly 11 million new cases are diagnosed each year.

The report also predicted the demand for more sophisticated diagnostics continues to grow and synergies between tests and new therapeutics emerge. IVD tests for cancer will continue to see a 13 per cent annual growth. Despite the high price tag and hesitation by payer groups, both private and government based, to accept these newer diagnostic modalities, the sheer number of cases threaten to overwhelm these arguments.

Successful commercialization of these tests carries a price tag, with quotes from $350.00 to $3500.00. There is considerable scepticism over the ability of health care systems, worldwide, to pay for these new tests, which so far have shown little effect on patient outcomes.  Second, the 1990s tremendous strides were made in cancer management using more traditional tests including tissue biopsies and serum assays, which means that penetrating the existing clinical market will be challenging.

Cancer drug research is gradually shifting from traditional cytotoxic chemotherapies toward higher specificity immunological and biological approaches that target unique biochemical receptors and signaling pathways.  These new drugs will be more cancer- and patient-specific and will have the potential for slowing cancer growth and inhibiting disease progression, with fewer adverse effects on the patient.  As these drugs come to market, in vitro diagnostics will become critical to matching drug to cancer and to patient and then the monitoring of the drug's action on the disease.

According to another recent study,  entitled "Early Diagnosis And Targeted Therapy To Address Unmet Need In European Breast Cancer Therapeutics Market," released Nov 7, 2007:

The greatest unmet need of all breast cancer patients is a cure. A variety of drugs are used to treat breast cancer in stages III and IV. However, they only act to control the progression of the disease and can be associated with side effects that can cause significant disruption to patients' quality of life. In those who respond, the tumor can be controlled for many years. However, in most cases, survival is not greatly extended. This situation is creating a real and immediate need for effective, targeted therapeutics.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), European Markets for Breast Cancer Therapeutics, finds that the market earned revenues of $1.72 billion in 2006 and estimates this to reach $2.9 billion in 2013.

"Fifteen per cent of breast cancer cases are detected at a metastatic stage and approximately 50 per cent of those detected at an early stage will progress to stages III and IV," states Frost & Sullivan Research Analyst Sriram V. "In the advanced stages of the disease, the chances of being cured with the current therapies are bleak, opening up opportunities for improved diagnostic techniques and development of breast cancer therapeutics with a good safety profile."

Chemotherapeutic side effects present a significant challenge to the breast cancer therapeutics market. Biologics are considered to be the alternative, with a host of products anticipated to enter the market post 2008. However, clinical trials and their lengthy duration are a concern that companies should address before determining the timing of their product launch.

At present, the only commercially available offering in the biologics sector is Herceptin. A huge barrier to the widespread adoption of biologics will be the high cost of treatment. Pressure on margins and high prices due to the high cost of development may not continue for long, as prescribing trends are subject to governmental regulations and available literature.

"A single Herceptin injection is estimated to cost $3,500, while a whole course over a nine month period may cost up to $60,000 comments Sriram. "This challenge will have a limited effect in the early stages of the market, since only one biologic is currently available, but is anticipated to have a greater impact after 2008, as more biopharmaceutical products enter the global breast cancer therapeutics market."

Cancer therapeutics are the most expensive to bring to market, owing mostly to the costs involved in administering clinical trials. A potential strategy to counteract this challenge will be to attract commercial partners to support drug development and marketing. Large multinationals are comparatively receptive to such proposals if the product shows promise in the pre-clinical stages.

Pagilarulo, et al. Journal of Clinical Oncology 24,18, 2735-2741, June 2006, emphasizes the importance of early detection in prostate cancer. In his paper, of the patients who received primary treatment for prostate cancer, the portion of patients with cancer-free diagnosis were 57%.  Of those, 37% were misdiagnosed and were not cancer free.  Of those, 98% of these patients died within ten years. 

Currently imaging methods such as MRI, PET, and Mammography require one billion cancer cells as the lower level of detection.  This is the size of a pencil eraser. New methods, such as ours, have the capability to detect 10,000 cancer cells.

 

[1] Brigger, I., et al., Adv. Drug Delivery Rev. (2002) 54, 631

[2] Kreibig, U., and Vollmer, M., Optical Properties of Metal Clusters, Springer, Berlin,
(1995), 25