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Main Subject - How Do I Build a Winning Business Plan? - Part 2
Competitor Analysis - Keep it Real
Failure to identify competitors in your business plan is a warning sign to potential investors that e
Failure to identify competitors in your business plan is a warning sign to potential investors that e
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
ither:- you've not done enough research; you haven't acknowledged the competition you face; or that actually the market is not large enough to su
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
port any competition. You're not going to find anyone to invest in your business if the latter is true.
It is much better if you acknowledge rea
It is much better if you acknowledge rea
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
istic strengths and weaknesses of your closest competitors, and how you will address those with your business model. It also acts as evidence to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
he potential investor - as mentioned above - that the market is large enough to support a number of businesses. A perceived margin of safety that
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
there's business there for the taking.
Competitive Analysis - Prove your barriers to entry
In the part in your business plan which addre
Competitive Analysis - Prove your barriers to entry
In the part in your business plan which addre
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
ses competition, you must cover the area known as competitive barriers.
Some businesses naturally have barriers that prevent upstart competitors
Some businesses naturally have barriers that prevent upstart competitors
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
from getting a look in.
Take the oil industry for example. The nature of the business is such that development costs are prohibitive and the lic
Take the oil industry for example. The nature of the business is such that development costs are prohibitive and the lic
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nses for exploring viable sites are already in the ownership of the oil majors. This acts as a significant barrier for anyone fancying to start u
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
business in the oil industry.
This does not mean that new companies do not start, rather they are few and far between because the resources and
This does not mean that new companies do not start, rather they are few and far between because the resources and
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
expertise required to compete are high.
In your business plan you must identify exactly what the barriers to entry into your business are and kn
In your business plan you must identify exactly what the barriers to entry into your business are and kn
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
wing these how you will prevent any actual or potential competitors from taking a large part of your customers away from you.
Some examples of c
Some examples of c
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
mpetition barriers include no availability of prime sites (take supermarkets for example), legal restrictions, import duties, expensive plant and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
machinery, exclusive distribution licenses etc.
It is also important to consider the situation very seriously if you identify few or no barriers
It is also important to consider the situation very seriously if you identify few or no barriers
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
to entry. This may jeopardize the future growth or even viability of your business. How could you make it more difficult for competitors to take
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
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
our customers. What kinds of things could you do. Could you sign them up to longer term contracts for example? Can you protest legitimately at ev
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ry planning application of new competitors etc.
Competitive Analysis - Demonstrate your advantage
It is convenient whilst analysing the
Competitive Analysis - Demonstrate your advantage
It is convenient whilst analysing the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ompetition, to turn the spotlight of analysis on yourself, and demonstrate how your competitive edge is truly razor sharp, to the point of being
.
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
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
nfair.
The typical kinds of assets that show strong competitive advantage include patented technologies and processes, proven management record
The typical kinds of assets that show strong competitive advantage include patented technologies and processes, proven management record
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
f success, exclusive contracts with suppliers and customers that make it difficult if not impossible for competitors to compete on the same terms
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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