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An international recovery is underway led by the Caribbean, which could see bareboat activity reach 2001

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

peaks within two years if the markets continue to grow at a rate of 6-8%.

While the average size of a ba

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

reboat fleet has been reduced by 8% over the last two years, there has been a 50% increase in charter cus

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tomers since 2001 which now represents $75 million in annual turnover.

However, it is the Caribbean and

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

principally the Virgin Islands, which lead this recovery with a 6% gain since 2001, and remarkably this m

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

eans it has captured an additional 3% of the international marketplace at the expense of the United State

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

s, Europe and other areas. It now owns 56% of the international bareboat arena.

In fact, the Caribbean h

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

as for the first time exceeded the historic highs of 2001 and looks set to grow by an additional 6-8% nex

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

t year.

The Virgin Islands in particular, outstrip its closest rival, The Pacific NW/California, by near

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ly 60%. Together these two areas account for nearly 80% of international bareboat charters.

Again, the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

bulk of international customers are choosing to take their sailing vacations during the summer months wit

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

h 2005 activity now outstripping 2004.

However, it is not all doom and gloom for the United States, whic

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

h has still seen a healthy 4%, increase in bareboat activity.

But it increasingly looks like some of the

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ir traditional customers are heading to The British Virgin Islands.

It is worth noting that its stronges

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

t lynchpin, the Pacific NW/California, while edging up, is still 13% off 2001 levels and actually recorde

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

d a slight drop over 2004 levels. It is starting to look like the poor cousin of the BVI!

A dark horse

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

in the international marketplace is Europe, which is the only region to show positive gains each year sin

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ce 2001 quietly posting a 60% increase in bareboat activity. However, it still represents only a fraction

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

of the international pie.

Mexico also shows modest gains but is slightly off the pace of 2004.

For mor

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e information please visit http://www.catamarans.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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