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The Pharmaceutical Market: USA
Management Report
Published: January 2010
Pages: 84
Tables: For full details, please email keithw@cmsinfo.com
From: GBP 595.00 Buy Now!
Research from: Espicom
Sector: Prescription Medicines
Espicom’s in-depth pharmaceutical market reports are ideal for executives wanting to understand the key drivers in pharmaceutical markets and have access to a wealth of statistical data. Each report opens with an outlook section that provides analysis of the market, 5-year market forecasts, national data projections, market outlook and key developments such as regulation, pricing/reimbursement, intellectual property, health facilities and government policy. The report also provides extensive background information, population trends, health status, health expenditure, organisation & administration, hospital services, medical personnel, healthcare development, market access information, trade data for raw materials and finished products and essential industry contacts. Included with the report are 3 free quarterly updated outlook reports, enabling you to keep up to date with market developments for a year.
The USA has the highest health expenditure in the world, but costs need to be contained. It is also the only major industrial country where the provision of medical services and insurance is not unified by a central national strategy. The USA is also unique in that it does not guarantee health coverage to all citizens. A key aspect of President Obama’s policies has been to overhaul the healthcare system; this is something promised, tried and largely failed by previous Democrat Presidents. The loss of the Senate’s seat in Massachusetts to the Republican candidate Scott Brown in January 2010 is a blow to Barack Obama’s agenda and the healthcare reform is now in doubt. Options are being considered but it is not clear that a stripped-down bill can be approved soon.
The effect of the healthcare reform would be difficult to measure but pharmaceutical sales could be boosted in the long-term. R&D investments are large but growth has slowed down. Around 85.0% of the USA's pharmaceutical requirements are domestically manufactured. A number of companies have made significant cutbacks, making reductions to sales forces. There have been a number of plant closures and scaling back of investment plans. For companies traditionally reliant on chemical drugs, there is an increasing interest in moving into the biologic field. This is seen as more lucrative as it has greater scope for the development of innovative products and is less susceptible to generic competition. With their acquisitions in 2009, Pfizer and Merck have diversified and enter the biologic sector, whilst Roche is specialising in biologics and diagnostics.
The OTC sector is expected to increase by a low CAGR between 2010 and 2015. Nevertheless, the sector is attractive and market concentration continues. In December 2009, sanofi-aventis agreed to acquire 100.0% of the outstanding shares of Chattem. The transaction will create the world's fifth-largest consumer healthcare company. The modern generic sector is shaped by the Hatch Waxman legislation of 1984. As a result, generics are widely-used and well-accepted in the USA. This is because generics are usually far cheaper than branded drugs, with the advent of generic competition leading to rapid price falls. The sector is expected to increase by a moderate CAGR between 2010 and 2015. The leading player is the Israeli company Teva Pharmaceuticals but competition is increasing; Watson completed the acquisition of Arrow in December 2009.
As part of the healthcare reform, Congress was looking at ways to create a regulatory system for biosimilars, or ‘generic’ versions of biologic drugs. While there was widespread agreement on the need for such a system, there was a considerable dispute over the details. Brand-name producers were trying to limit biosimilar competition by lobbying for long data exclusivity. The most likely outcome was around 12 years, which had widespread support in Congress, and it would have been similar to the 11 year term established in Europe. Pfizer believes that legislation will be approved in the future. Therefore, the company, via its Established Products Business Unit, is already preparing to enter the biosimilar market within five years. Meanwhile, Teva has asked the FDA to approve XN02. Effectively, this is a biosimilar to Amgen’s Neupogen but Teva is asking the court to rule that XN02 will not violate Amgen’s patent rights; technically, it is a new drug.
The effect of the healthcare reform would be difficult to measure but pharmaceutical sales could be boosted in the long-term. R&D investments are large but growth has slowed down. Around 85.0% of the USA's pharmaceutical requirements are domestically manufactured. A number of companies have made significant cutbacks, making reductions to sales forces. There have been a number of plant closures and scaling back of investment plans. For companies traditionally reliant on chemical drugs, there is an increasing interest in moving into the biologic field. This is seen as more lucrative as it has greater scope for the development of innovative products and is less susceptible to generic competition. With their acquisitions in 2009, Pfizer and Merck have diversified and enter the biologic sector, whilst Roche is specialising in biologics and diagnostics.
The OTC sector is expected to increase by a low CAGR between 2010 and 2015. Nevertheless, the sector is attractive and market concentration continues. In December 2009, sanofi-aventis agreed to acquire 100.0% of the outstanding shares of Chattem. The transaction will create the world's fifth-largest consumer healthcare company. The modern generic sector is shaped by the Hatch Waxman legislation of 1984. As a result, generics are widely-used and well-accepted in the USA. This is because generics are usually far cheaper than branded drugs, with the advent of generic competition leading to rapid price falls. The sector is expected to increase by a moderate CAGR between 2010 and 2015. The leading player is the Israeli company Teva Pharmaceuticals but competition is increasing; Watson completed the acquisition of Arrow in December 2009.
As part of the healthcare reform, Congress was looking at ways to create a regulatory system for biosimilars, or ‘generic’ versions of biologic drugs. While there was widespread agreement on the need for such a system, there was a considerable dispute over the details. Brand-name producers were trying to limit biosimilar competition by lobbying for long data exclusivity. The most likely outcome was around 12 years, which had widespread support in Congress, and it would have been similar to the 11 year term established in Europe. Pfizer believes that legislation will be approved in the future. Therefore, the company, via its Established Products Business Unit, is already preparing to enter the biosimilar market within five years. Meanwhile, Teva has asked the FDA to approve XN02. Effectively, this is a biosimilar to Amgen’s Neupogen but Teva is asking the court to rule that XN02 will not violate Amgen’s patent rights; technically, it is a new drug.