Main Subject - Business

Strategy making process for business existing in a particular industry involves the study of many

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

factors in the industry. These factors, when studied together, shape up an overall context for a

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

Examples of combination products may in

organization in an industry. To determine strategy for existence and profitability of an organiz

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

ation, the management should analyze the industry and its structure and how they change with the

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

hanging environment.

Analysis of bargaining power of customers or buyers determines how much buy

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

Combination pro

rs can influence the demand/supply function, prices, profit margins and the quality of products.

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

Customers can exercise such power when they are in large number or they use to buy a product in l

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

rge quantities.

The suppliers can exercise their bargaining power when they have large number of

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

customers but they are fragmented. In some cases where the suppliers are aware of the fact that

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

upplies or the input product have no substitute, they easily demand high prices for the supplie

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

.

An industry normally exists with a number of producers producing a particular type of product

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

Following aspects would a

for a market. Therefore an environment of competition forms between these producers and their mar

dd to the challenges in developing combination products:

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

et shares are affected with the performance of their competitors.

Alternative products or servic

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

es offering the same or higher benefits to the customer are known as substitutes. Customers tend

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

o switch to substitutes products when there is cost to benefit ratio for the substitute product i

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

high than the current product used by that customer. New entrants can easily enter an industry

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

Professional from academic institutions, pharmaceutical industries, health care indust

and distort the existing distribution of market share and price equilibrium if there lesser barri

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

rs to entry.

The development of the corporate strategy can be done in accordance to exploit the

.

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

structure and variables of an industry so as to decide about the entry an exit to any market, cho

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

Companies that provide selfless information through particip

se between products and services to offer, maximization of profitability, growth and market share

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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The first task is to select a shortlist of companies with in-depth knowledge of the industry, a good reputation and a proven track record.

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