eClinical Solutions – Cutting Costs In Clinical Trials

12 August 2008 – 6:53 pm

Life sciences companies worldwide are devising ways to cut costs in their drug development programmes. The clinical trials of a drug account for a major part of the drug development costs and time. The costs are between 50-70 per cent of the total spending on bringing a new drug to market. Clinical trials generate a lot of paper work and documentation adding up to the costs. Clinical trial paperwork alone costs US$ 12-17 million a year for life sciences companies, according to a new report released by Datamonitor.

The report, In Pursuit of the Paperless Clinical Trial: A Look at EDC and CTMS, states that life sciences companies can expect to save around US$ 10-15 million every year using eClinical solutions. Considering the time it takes—on an average 10 years—to complete the clinical trials, the savings are substantially huge.

With pharmaceutical companies under immense pressure to improve their efficiencies, eClinical solutions could provide a solution to contain the costs. Adaptive trials which are expected to accelerate drug development process can also benefit from eClinical solutions. The solutions can offer the flexibility, continuous analysis, monitoring and allow the changes in trial design in a better fashion.

While Electronic Data Capture systems have been in place for over 20 years, interoperability has been a major issue. The report envisages that an eClinical solution built on an interoperable platform can provide better access to all the departments and stakeholders involved in the process than any other solution. The report however, warns that unless the stakeholders in the clinical trial process realise the benefits and switch to eClinical solutions, the uptake of the solutions will remain sluggish. It further adds that the adoption of EDC and clinical trial management systems will be rapid through the year 2012.

Posted in Clinical Trials, Information Technology, Market Insights | No Comments »

Biotech’s Growth Pangs

24 June 2008 – 8:44 pm

The global biotech market clocked sales worth US$75 billion in the year 2007 and grew at double the rate of the pharmaceutical industry (6.7 per cent), according to the recent report from market intelligence company IMS Health. However, it is the lowest growth rate for the biotech market since 1998. The biotech market grew around 18 per cent in the period 2004-06.

Murray Aitken, Senior Vice president of Healthcare Insight, IMS cautioned that “Loss of exclusivity and competition from biosimilars, crowded therapy areas with weaker sales growth, payers showing more reluctance to fund innovative drugs without compelling value propositions, and safety concerns for some therapies will all contribute to a more moderate growth environment through 2012.” He also added that, “The biotech sector will remain to be one of the most robust segments of the marketplace with a continued strong flow of innovative products to the market.”

It is interesting to note that the biotech industry has seen the number of blockbusters grow from six in 2003 to 22 in 2007 and also generate sales exceeding US$1 billion. Amgen, Roche, Johnson & Johnson, Novo Nordisk and Elli Lilly occupy the top five spots accounting for nearly US$46 billion in sales. Pfizer does not figure in the top ten. Biotech products and therapies for Diabetes, Oncology and Vaccines represented the major portion of the growth and the market. U.S. leads the other regions contributing 59 per cent to the sales of biotech products.

The report also outlined the key market dynamics that can influence future market growth:

• Around 25 percent of the pharmaceutical pipeline is represented by biotech products and they are expected to further boost the pipeline in the coming years.
• Though the growth has been good, the biotech products nevertheless are being subjected to intense scrutiny by both payers and healthcare agencies to assess the safety and efficacy issues and also justify their usage over cheaper alternatives.
• Product safety issues will continue to have a greater impact.
• Competition among biotech products and from alternatives will play a major role in deciding the future direction of the market.
• Like pharma, the biotech industry’s growth prospects could be hampered by follow-on biologics. Though the impact from them has not been very significant till now, loss of exclusivity can change the scenario.

Posted in Biotech Industry, Drug R&D, Market, Market Insights, Pharmaceutical Industry | No Comments »

Welcome

23 June 2008 – 11:49 pm

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Posted in Market Insights | 1 Comment »