Pharmaceutical giant Eli Lilly is hoping for dramatically increased sales and profits in Asia.

The increasing demand in China for diabetes drugs is fueling a significant portion of this growth. Specifically, Eli Lilly anticipates that revenues in China will grow 500% by the year 2015, to nearly $1 billion.

The company hopes the growth in sales of its drugs in Asia will help mitigate the anticipated losses in sales of drugs that will lose their U.S. patent protection over the next several years.

Additionally, according to Lorenzo Tallarigo, president of international operations, Eli Lilly is also considering to outsource their Asian manufacturing in India.

“No doubt India has great capability when it comes to manufacturing,” Tallarigo said. “We don’t have anything concrete to discuss but that is definitely something we’re going to look at.”

Pharmaceutical companies are now looking to test their upcoming blockbuster drugs in Asia. According to drug industry experts, this will shorten the time it takes for new pharmaceutical drugs to be available for sale in the U.S. market.

Because of dramatically lower costs in Asia, and because there are much larger populations there, drug manufacturers can speed up the whole drug-approval process. A report by AT Kearney, a management consulting firm, suggests that clinical trials in China can cost half of what a trial would cost in the United States.

According to the Tufts Center for the Study of Drug Development in Boston, the number of pharmaceutical companies that conduct clinical trials overseas increased to almost 1,800 last year, up from 956 in 1997.

Also, 86% of clinical trials were done in U.S. in 1997; that figure has now dropped to 57%… and 30% of total clinical trials are now performed in countries other than Europe and the U.S.

Additionally, the FDA is looking to increase the number of drugs it approves. Among potential blockbuster drugs to receive approval next year is the diabetes drug Galvus, manufactured by Novartis.

However, despite the potential savings, many industry experts worry that these new cost-saving measures could put U.S. consumers at increased health risks.

“There is concern among physicians over whether the clinical data gathered overseas can be generalized to patients in the U.S.” says Ken Getz, a research fellow at the Tufts Center for Drug Development.

“There will be greater discussion about whether a guideline should be created that restricts the proportion of patients abroad tested for drugs that will be introduced on the U.S. market.”

Major manufacturers of diabetes drugs faced major market setbacks as a result of diabetes drugs that were discontinued (Avandia, Actos, Exubera, etc.).

The inhaled insulin product, Exubera, was discontinued in the third quarter of 2007 as a result of lacklustre sales… and Pfizer took a $2.8 billion charge. During the same quarter, GlaxoSmithKline’s sales of Avandia declined 38% because of growing concerns over heart failure risks.

Diabetes and obesity rates just keep climbing at an alarming pace. On November 5, 2007 the United Health Foundation reported that a quarter of the people in the United States is obese, compared with less than half that figure, or 11.6% in 1990.

And according to Medco Health Solutions, a benefit management company, diabetes drugs were one of the biggest drivers of health-care costs in 2006, as overall diabetes treatments increased 5.1%. From 2001 to 2006 the number of people with Type II diabetes climbed 16.9%.

The oral diabetes treatment market is currently at $5 billion annually.

The Indian Diabetes Prevention Programme recently published a study in Diabetes Care, which promotes lifestyle modifications and long-term treatment with metformin, alone or in combination, as cost-effective measures for preventing Type II Diabetes in individuals who are at risk for this disease.

According to Dr. Ambady Ramachandran of the India Diabetes Research Foundation, Chennai, and his co-investigators, India is facing a diabetes epidemic with around 35 million diabetics suffering from the disease, with approximately 30% of these likely being undiagnosed cases.

Ramachandran and his team studied 531 adults aged 35-55 years with impaired glucose tolerance, and divided them into four groups:

1. a group that received 250 mg metformin tablets twice a day;
2. a lifestyle modification group which was directed to exercise every day for a minimum of 30 minutes, plus given dietary instruction;
3. a group that was given both of the above interventions (metformin and lifestyle modification); and
4. a control group that was given standard health-care advice.

The study participants were monitored at regular intervals, over a 3-year period.

The study revealed that “Lifestyle modification was the most cost-effective intervention, followed by metformin.”

However, this “prevention” approach merely postponed the onset of diabetes, rather than prevent it, according to Ramachandran.

A far better approach is to simply solve the underlying cause of diabetes, since this has been proven to not merely postpone the disease, but to completely reverse it in over 80% of diabetics.

Unfortunately, such a strategy doesn’t seem to fit the current medical paradigm of “treating” or “controlling” diabetes. Could this be because it’s far more profitable to keep treating the ongoing symptoms of diabetes for the rest of the diabetic’s (dramatically shortened) life?!