Main Subject - Business

To complete a comprehensive competitive analysis, you must know the competitive landscape. You must know who your competitors are. Prepare

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

an overview of your competitors, their strengths and weaknesses. Position each competitor’s product against your products. Understand the

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

Examples of combination products may in

ustomer needs and preferences that are you competing to meet.

When you consider your competitors, determine what are the similarities and d

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

fferences between their products and yours. You must also consider how their prices compare to yours and how well they are doing. You must

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

have a specific plan to compete. For example, you can offer better quality services, lower prices, more support, or easier access to servic

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

Combination pro

s. You must address the following basic issues:

• Define your target market.

• Determine the size of the target market.

• Drill down to

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

your specific segment within the target market.

• Define the size and the revenue opportunity that your segment represents.

• Determine ho

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

fast the overall market and your specific segment are growing.

• Learn what factors are most important to your customers such as price, te

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

hnology, ease of use, or new uses.

• You must know the most important characteristics in your industry. Is is driven by high or low volume

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

Is it capital or labor intensive? Is it seasonal?

• Identify and profile your targeted customers by their consumer budgets and by how th

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

y make decisions to buy a product.

• Identify your direct and indirect competitors and understand their impact on you.

• Identify the feat

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

Following aspects would a

ures that differentiate your product from the competitors’.

In order to address the basic issues, you must know where to find competitive a

dd to the challenges in developing combination products:

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

d industry information. Information is available from the Federal Commerce Department online or in the library. You can review Edgar Onlin

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

and business websites to obtain required financial filings. Look for an industry trade association and industry publications. Go to Hoove

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

s Online or Bacon’s to look for business publications in your industry. You can also check online for www.usdata.com or for North American

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

ndustry Classifications www.naics.com.

After all basic issues have been addressed and your competitive research is completed, you should be

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

Professional from academic institutions, pharmaceutical industries, health care indust

able to describe all of your competitors and their strengths and weaknesses. You should be able to clearly articulate what is different ab

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

ut your product and why customers will choose your product rather than the competitors’. You should also be able to describe your target ma

.

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

ket and target customer and what will motivate them to purchase your product. Finally, your should be able to explain how you will gain and

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

Companies that provide selfless information through particip

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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Main Subject - Important Factors to Consider in Competitive Analysis

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