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According to new report, first time, UK has become leading market for outs

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

ourcing. The UK has overtaken US to become the top national market for new outso

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

Examples of combination products may in

rcing contracts. According to TPI, UK represented 37% of the market for major

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

outsourcing contracts awarded worldwide in this year. UK is followed by US - 25% and

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

Asia-Pacific with 4%. However, it is understood that, UK will not continue its leadi

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

Combination pro

ng position as majority of the outsourcing chunk is because of deals by Reuters and

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

T. Even in this quarter, without Reuters and BT, UK would have been second largest n

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

tional market.

However, Europe still dominates market and accounted for over

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

50% of the new contracts worldwide. According to Duncan Aitcheson, Tip’s Managing Di

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

rector, International:

“While some may argue that Europe’s ?2.4 billion mega

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

deal – the Reuters/BT contract – skews the results for this first quarter, Europe st

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

Following aspects would a

ll accounted for well over half (57%) of new contracts worldwide – a high point for

dd to the challenges in developing combination products:

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

b>European outsourcing.”

Also, so-called big six suppliers in the outsourcing m

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

arket which are - Accenture, ACS, CSC, EDS, HP an

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

IBM have seen their combined market share to fall by 57% in the first quarter of 20

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

5. 60% of the senior management in UK companies are looking at big Indian outsour

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing providers who are providing outsourcing services like their western counterp

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

arts but at low cost. This growing confidence in Indian outsourcing companies will f

.

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

rther allow increase in their market share and decrease in the market share of big s

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

Companies that provide selfless information through particip

x and other western consulting companies. This also gives a wider choice for clients

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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