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Reportlinker Adds Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify

NEW YORK, April 28, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify


Healthcare expenditure is growing fast in all markets, driven by aging populations, a growing prevalence of chronic diseases, expanding government healthcare coverage, use of expensive drugs. Also, as a result of the economic downturn, healthcare funding is under increased scrutiny by governments in developed markets looking to pay down their debts.

Features and benefits

* An overview of healthcare expenditure in the 12 major markets

* Insight into the major reforms of healthcare systems in the developed and developing markets

* An assessment of the regulatory issues that are affecting global pharma markets.

* Analysis of the key pricing and reimbursement controls that are affecting pharma


As a result, healthcare reforms in EU and Japan focus on containing costs, without impacting quality of service. Ongoing measures include pricing and reimbursement cuts, bolstering generic usage, as well as other cost cutting tools, with the outcome largely negative for branded pharma.

Although the US health reform law may well result in extended health insurance coverage and increase government involvement in healthcare, costs are expected to escalate. In the short-term though, discounts and rebates implemented as part of the reform are expected to result in drop in US sales.

Reforms in the emerging markets concentrate on improving the quality and coverage of healthcare, providing opportunities for pharma, particularly for generics manufacturers. Nevertheless, as healthcare access expands and quality improves, funding pressures increase, leading to the Introduction of cost-containment.

Your key questions answered

* Evaluate key factors driving healthcare expenditure as well as measures implemented by governments strategies implemented to contain further growth.

* Gain insight into the impact of healthcare reforms in the developed and emerging markets and their impact on pharma.

* Assess pharma's responses to the increasingly tough regulatory and reimbursement environment.

Executive Summary


Strategic scoping and focus

Key findings

Key growth drivers and resistors facing healthcare payers and pharma

Healthcare expenditure

Healthcare reforms

Regulatory issues

Pricing and reimbursement

Related Reports

Upcoming related reports


Healthcare expenditure is growing fast

There are several factors driving up healthcare expenditure across the markets analyzed:

The proportion of public contribution to healthcare is greater in the developed as compared to the emerging markets

However, despite improving economies, the emerging markets like the developed markets, are under pressure to contain costs, leading to implementation of strategies such as price cuts that are impacting pharma companies operating in such markets.

Pharmaceutical expenditure is increasing in all markets


Healthcare reforms focus on improving access and cutting costs

The main aim of healthcare reforms in the EU and Japan is to contain costs

France is reforming hospital management to reduce costs

Germany is transferring cost of healthcare onto individuals to rein in spending

Italy has been engaged in a raft of healthcare reforms

Spain's recent healthcare reforms have focused on pricing and reimbursement issues

UK primary care trusts will be phased out

An aging population has necessitated cost-containment measures in Japan

Healthcare reforms in emerging markets will positively impact pharma

Key aims of healthcare reforms in emerging markets include the following:

India plans to expand healthcare services

Healthcare continues to be a priority for Brazil's government

Russia rolls out its 2020 healthcare plan

China is making strides in improving health insurance coverage

Healthcare reforms in the US will largely have a neutral impact on pharma

Healthcare reform has already had an impact on pharma in 2010

Will the healthcare reform law be repealed?

Potential impact of healthcare reform on pharmaceutical sales

Healthcare systems globally are converging towards a similar model

Closes payer-pharma relationships set to evolve

Disease management will become central to payer decisions

Pharma will need to manage both patient and payer expectations

Several key markets are decentralizing healthcare decision-making to increase efficiency

UK's decentralization strategy has raised concerns regarding inequality of access to healthcare services

Italy has already devolved many powers to regions causing inequality in access to care and treatments

Brazil, Russia, and China are also engaging in decentralization strategies


Regulatory changes have a largely negative impact on pharma

Heightened safety concerns continue to impact pharma

Collaboration between the FDA and EMA is intensifying

EU ban on direct-to-patient communication guidelines partially relaxed

Developed markets exhibit a stable intellectual property environment

It is generally easier to secure patent protection in the US than in the EU

The EU follows the 8+2+1 rule

Japan gives branded pharma companies 8 years of data exclusivity through re-evaluation requirement

Springboarding allows generics manufacturers to access branded drug data in Australia

Loss of Plavix exclusivity in Germany is thought to be an exception

The EU's move to a single patent has been held up

The intellectual property environments in the emerging markets are seen as inadequate

Russia's intellectual properly environment is characterized by corruption

Patent reviews are slow in Brazil

Indian law does not contain statutory data protection

China is not yet affording adequate data protection for new chemical entities


Key global pricing and reimbursement controls

Pricing controls

Reimbursement controls

Pricing and reimbursement cuts were key elements included in austerity measures in many developed markets

Patent-protected drugs are spared by Italian price cuts but off-patent and generic drugs suffer

Austerity measures in France impact both prices and reimbursement rates

Spain's price cuts impact both branded and generic medicines

Germany's new law focuses on containing the growth of spending on patent-protected drugs

Australia's changing reimbursement landscape puts pressure on local generics sector

Japan continues to focus on drug price cutting as its main cost-containment measure

US pharma companies are impacted by higher rebates and discounts, but escape Medicare drug price negotiation

Pharma shows a strong reaction to price cuts in certain markets

Pricing pressures are also felt in the emerging markets

Brazil is widening free access of drugs to patients

China introduces tighter pricing controls on foreign pharmaceuticals

Russia has increased its drug price controls

India threatens to expand drug pricing controls

Branded pharma adopts flexible pricing strategies to capture emerging markets growth

Raised cost-effectiveness barriers lead to reimbursement restrictions

The UK is a difficult market to access for expensive therapies

It is becoming increasingly difficult to obtain a high price for new drugs in France

Achieving premium drug pricing in Japan is difficult

Germany is using cost-effectiveness in its drug evaluations

Comparative effectiveness analysis is starting to be used even in the US

Risk-sharing is becoming a viable option for both payers and industry, particularly in Europe

UK is one of the leaders in risk-sharing agreements

Italy has a number of performance-based risk-sharing schemes for oncology drugs

Risk-sharing schemes are also appearing in the US but in a fragmented manner

Australia's risk-sharing agreements lack transparency

Risk-sharing agreements with individual sickness funds are used to boost market share in Germany

Price negotiation may be the way of the future

Value-based pricing in the UK to be introduced in 2014

Germany introduces drug price negotiation


Publications and online articles

Datamonitor reports


Exchange rates used in this report

To order this report:

: Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify

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Nicolas Bombourg



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