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Pharmaceutical Processing News
News Release from: ARC Advisory Group | Subject: ARC Pharmaceutical Industry
Edited by the Processingtalk Editorial
Team on 21 November 2003
Pharmaceuticals needs new manufacturing
systems
ARC Pharmaceutical industry plant-level expenditures worldwide outlook report: many drug manufacturers are ill prepared for the coming pressures, they need to shorten development times
Capital spending in the pharmaceutical industry is driven primarily by new drug development, along with pressure to maintain financial performance, shorten time-to-market, and improve quality Drug makers are also investing in the technologies and infrastructures necessary to achieve and demonstrate compliance with current and future regulatory requirements
This article was originally published on Processingtalk on 6 Jan 2004 at 8.00am (UK)
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The pharmaceutical industry is still a low volume, high-margin business, but this is gradually changing as the industry begins to face pressures for which many drug manufacturers are ill prepared.
These pressures are driven by weak development pipelines, crowding of therapeutic categories, new generic competition, new FDA responses, increasing socio-political price pressures, and new drug delivery systems requirements.
The most consistently profitable drug companies will be those that succeed in shortening development times and terminating unpromising drugs earlier in the development cycle.
The US Food and Drug Administration (FDA) has traditionally led the pack with its strict policing of the industry and the move to electronic records and signatures.
Compliance with regulations will become even more expensive with the introduction of new European Union legislations.
Global Pharmaceutical Industry.
The US, Japan, and Europe are the key markets for the international pharmaceutical industry and make up the great majority of global pharmaceutical sales.
However, during the last decade there have been major differences in the manner in which the healthcare systems in these countries have developed.
This has affected the way in which pharmaceutical companies invest in R and D in these regions.
The pharmaceutical industry believes that its ability to discover and develop innovative new drugs depends on the competitive nature of the markets in which it operates and the availability of scientific talent.
The recent WTO agreement regarding the manufacture of drugs under patent for use in developing countries will accelerate the growth of drug manufacturing in both developed and developing countries for export to underdeveloped regions of the world.
In many countries, law controls the prices of pharmaceutical products.
Governments may also influence the prices of pharmaceutical products through their control of national healthcare organizations, which may bear a large part of the cost of supplying such products to consumers.
In some countries, such as France and Japan, the prices of individual products are regulated.
In the UK, prices are controlled by reference to limits upon the overall profitability, measured by the rate of return on capital employed, of sales of products supplied under the National Health Service.
In the US, debate over the reform of the healthcare system has also resulted in an increased focus on pricing.
Additional information on this study can be found on our website.
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