Better diagnostic tests and pressure to lower healthcare costs may finally usher in the era of personalized medicine, in which patients get drugs tailored to their genetic makeup, a new report suggests.
Personalized medicine has been a researcher's dream since 2003 when scientists completed the Human Genome Project — a decade-long race to sequence all of the DNA in people.
Drug companies and regulators are now looking for tests that increase the odds a high-cost biotechnology drug will work. They are using biomarkers — such as specific proteins or genes — to design better and cheaper clinical trials, lowering the cost of drug development.
"The fruits of the Human Genome Project are finally going to give us better insights into what works, and doesn't work for people," said Dr. David Levy of PricewaterhouseCoopers, which released a report on Thursday predicting increasing alliances between drug and diagnostics firms.
Levy said many patients were prescribed drugs that may have no benefit at all. According to the report, the response rate to current drugs ranged from 20 to 75 percent, depending on the compound or condition.
"Potentially, we can be much more specific with respect to who should get a drug and who should not," he said.
The report said the diagnostics market could grow 5 percent a year to $50 billion by 2012. Sales of molecular diagnostics, which include tests that analyze DNA or the chemical messenger RNA, could double to $5 billion in 2012 from $2.6 billion in 2007.
Some of that growth is being driven by regulators.
The report noted that regulatory agencies including the U.S. Food and Drug Administration and the European Medicines Agency were now requiring the use of "companion diagnostics" — diagnostic tests patients must have before a certain medication can be prescribed.
So far, the FDA requires the use of companion diagnostic tests with Pfizer's HIV drug Selzentry or maraviroc; Bristol-Myers Squibb's Erbitux or cetuximab for colorectal cancer and its leukemia drug Sprycel or dasatinib; and Genentech and Roche's Herceptin or trastuzumab for breast cancer.
Last week, the FDA recommended genetic testing before AIDS patients take GlaxoSmithKline Plc's drug Ziagen.
In Europe, there are now 11 drugs — including Ziagen or abacavir for HIV and Novartis' leukemia drug Tasigna or nilotinib — that require the use of companion diagnostics.
Researchers at PricewaterhouseCoopers, a financial advisory and consulting firm, expect many more.
Diagnostics not only help ensure that patients who get drugs will benefit. Drug makers can use them to enrich clinical trials, cutting the costs of drug development, Tony Pillari, director of Healthcare Advisory Services at PricewaterhouseCoopers, said in a telephone interview.
"In drug development, time is money. If you can cut development times by even by a small percentage, it can result in huge cost savings," Pillari said.
"Diagnostics now make possible enriched clinical trials. Rather than picking a random population, you can segment the population to focus on the people who are most likely to respond," he said.