Cases - Business

Currently, there is an estimated 40,000 multinational corporation’s world wide in and approximate

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

ly 250,000 overseas collaborations running cross-continental operations. Globalization has allowe

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

Examples of combination products may in

d access to markets via technology and has reduced distribution, lower internal coordination cost

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

s. It has also allowed for networking of specialized services and products in support of corporat

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

e functions through business process outsourcings (BPO’s) whether within the companies’ internal

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

Combination pro

operations or its external activities.

With the current communications and management technologi

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

es available, more companies are able to make the most out of international trade liberalization.

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

Today, multinational corporations are expanding themselves to increase their markets, increase br

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

and presence and image and benefit from inexpensive raw materials and labor. As mentioned, the ma

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

jor reason for multinational expansion is accessing a wider market.

Though there has been some s

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

etbacks because of international financial crises and recession, trends in Asia, particularly Chi

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

Following aspects would a

na and India, have been able to sustain interests. Among the developments that are being consider

dd to the challenges in developing combination products:

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

ed as return of Coca-Cola to India, the ranking of Asia as the most attractive foreign direct inv

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

estment region and the growing success on BPO’s in India and the Philippines. The opening up of t

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

e banking industry in China December 2006 is a good example of this motivation. It has been one o

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

f the most anticipated developments in the global market. The sheer size of the Chinese market re

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

Professional from academic institutions, pharmaceutical industries, health care indust

mains to be the greatest attraction to most prospective new entrants.

Other benefits for compani

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

es include reduced labor, materials or overall operation costs. A significant benefit of going gl

.

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

obal is establishing brand and product presence. Many companies have also benefited from the mark

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

Companies that provide selfless information through particip

et variation that globalization has provided them increasing product efficiency and marketability

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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