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The Affluent Market Tracking Study #8, the just released Fall 2005 report in a continuing series of twice-yearly surveys by The American Affluence Research Center (A

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

ARC), reveals several important changes in the 12- month economic outlook and spending plans of the wealthiest 10% of Americans, the 11 million households representi

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

Examples of combination products may in

g about half of all consumer income and spending and a third of the total US economy.

While the affluent still have a somewhat positive outlook toward current busin

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

ss conditions, their outlook for future economic conditions is now neutral. This may reflect concern about the potential negative economic consequences of the Gulf c

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

ast hurricanes (risk of increased inflation, higher interest rates, and a recession) that dominated the news media in September, when the survey was conducted.

The

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

Combination pro

ffluent are far less positive than they were six months ago, continuing a decline that began in Spring 2004 after reaching a record high in the Fall 2003 survey. The

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

composite Affluent Consumer Expectations (ACE) index for economic conditions 12 months from now had set a record low this past spring at 116 and has now dropped furt

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

her to the neutral level of 100.

The affluent also indicated modest declines in their plans for major purchases and their expected changes in spending for 17 differ

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

nt products and services. Their projected $57 billion in expenditures for holiday gifts (25% of the estimated total holiday gift market) is 1.6% below 2004 spending

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

evels. This contrasts with a 5% increase projected in an early October survey of the total adult population for the National Retail Federation.

There is some indica

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

ion of a reduction in the plans for major expenditures in the next 12 months, with 44% of respondents reporting no such plans. Plans for home remodeling, cruises, an

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

Following aspects would a

acquisition of vacation residences declined from their Spring 2005 record highs. Plans to acquire motor vehicles and boats showed slight increases, while plans to

dd to the challenges in developing combination products:

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

urchase an existing home as a primary residence increased to a record high.

The AARC surveys track spending plans over the next 12 months for 17 categories of good

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

and services, including major appliances, home computers, furniture/furnishings, entertainment equipment, casual and upscale dining out, entertainment, recreation,

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

domestic and international travel, designer and non-designer apparel, collectibles, fine jewelry, and political and charitable contributions.

Of the 17 future spen

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

ing indexes, only four are at positive levels. Of the 13 categories with negative indexes, 11 declined from their Spring 2005 level. The Future Spending Index averag

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

Professional from academic institutions, pharmaceutical industries, health care indust

(91.8) is at its lowest level since tracking began in Fall 2003.

Approximately two-thirds of the respondents expect to spend the same amount for holiday gifts this

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

year as last year. The number who expect to spend “less” (21%) this year is about double the number who expect to spend “more” (11%).

This information is based on a

.

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

national survey of 448 men and women in the wealthiest 10% of American households. The survey participants have an average income of $308,000 and an average net wor

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

Companies that provide selfless information through particip

h of $2.7 million. The survey has a 5% margin of error at the 95% confidence level.Highlights of the survey can be found at the AARC website www.affluenceresearch.or

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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