Future Pharmaceutical Industry Trends:

In recent years, Pharma has begun to adapt its business model in response to growing industry constraints and the decline of the primary-care focused blockbuster therapy. This process of change has recently been disrupted by unprecedented challenges caused by the global economic downturn, and by President Obama's planned overhaul of the US healthcare system.
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EXECUTIVE SUMMARY

Scope of the report
Key findings

STRATEGIC & FUTURE TRENDS AFFECTING PHARMA

Strategic and future trends in the branded pharmaceutical market
Corporate trends and strategies
Sales and marketing trends and strategies
R&D trends and strategies
External trends and resultant company strategies

Strategic and future trends in the generic pharmaceutical market
Corporate trends and strategies
R&D trends and strategies
Sales and marketing trends and strategies
External trends and resultant company strategies

PRESIDENT OBAMA’S REFORMS

President Obama – time for change!
Current issues with US healthcare
President Obama sets out to provide quality, affordable and portable healthcare insurance to all US citizens
Obama’s healthcare reform ambitions – how realistic are they?
Good news for Pharma
Bad news for Pharma
The uncertain news for Pharma

GENERICS & BIOSIMILARS

The need for cost-containment will drive generic and biosimilar uptake

Generics growth begins to slow
Global march towards a commodity generics market gathers pace
Increasing scrutiny of innovator-generic company deals
Promotion of generics uptake gains momentum

Biosimilars uptake set to grow
First biosimilars in Europe have yet to make a splash
Lessons from the EU
The US outlook

FINANCE & THE ECONOMY

The global economic downturn is set to exacerbate Pharma’s problems
Greater focus on Pharma spending
The Biotech financing crisis – no sign improvement for Biotech
Growing uninsured population – patients even less able to cover the costs of healthcare including pharmaceuticals
Pharma may struggle to justify the costs of expensive prescription drugs

STRATEGIC GROWTH DRIVERS & RESISTORS

Unprecedented industry pressures will affect future growth potential

Key drivers
Emerging markets set to drive future growth for Pharma
From blockbusters to personalized medicine
Niche markets offer growth potential for Pharma

Key resistors
Growing regulatory pressures are set to restrict Pharma
Pharma needs to reassess its R&D strategies
Regulatory pricing pressures and limited payer healthcare spend impact Pharma sales

REGULATORY PRESSURES & CHANGES

Heightening regulatory pressure restricts Pharma’s options

Drug safety regulations set to intensify
Drug safety takes center stage
Manufacturers in breach of Good Manufacturing Practice
FDA’s failing oversight

FDA – expansion will be a challenge without industry funding
Funding the FDA’s expansion is vital to the implementation of President Obama’s reforms
Tighter regulations for Pharma marketers in 2009
Until a new FDA commissioner is appointed reforms will stall
FDAAA is up and running forcing Pharma to adjust its internal processes to comply
Developing a REMS adds between 3 and 9 months to the FDA approval process
REMS slow down generic approvals
Companies to submit all bioequivalence studies in ANDA applications

EU approvals to become faster and more tailored to specialty products

US direct to consumer advertising is waning as EU relaxes rules
FDA’s direct to consumer oversight is lacking
Drug advertisements falling foul of the FDA
Pharma moving away from direct-to-consumer advertising
EU direct to consumer communication guidelines partially relaxed

Security and supply dominate drug distribution
Contrasting distribution trends in Germany and the UK
Securing the drug supply chain
Pound’s depreciation turns UK into parallel exporter

Evolving pricing and reimbursement set to restrict pharma further
US – President Obama’s cost-cutting strategies will drive down drug prices
Japans NHI drug pricing system reforms will balance innovation with cost-containment
Germanys healthcare reforms will create difficult market conditions for branded Pharma
UK – introduction of the PPRS is not all bad news for Pharma
France, Italy and Spain – continue to implement cost cutting strategies through greater generic use

Evolution of a payer centric sales and marketing model
Sales force cuts will intensify in 2009
Pharma discloses physician fees to enhance public perception
Internet-based approaches in reaching key stakeholders will intensify

BIBLIOGRAPHY

Publications and online articles

Datamonitor resources

Conference Literature
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Table: Omnitrope sales and market share in the US and 5EU, year to June 2008
Table: Epoetin biosimilars in the German market, Q4 2007—Q1 2008
Table: G-CSF biosimilars with European market authorization
Table: Recent shifts in R&D and manufacture to emerging markets
Table: The blockbuster market has matured and decline is imminent
Table: Compound 12-month growth of drugs in the US hospital and retail markets (MAT H2 2003 & H12004 to MAT H2 2007 & H12008)
Table: Most popular targets in for drugs in development, 2009
Table: GMP deviations
Table: FDA foreign drug facility inspection outposts
Table: Pharma cost-cutting strategies, 2007–09
Table: Exchange rates, 2009
Table: US new molecular entity and new biological approvals by the FDA, 2008

Figure: Traditional Pharma Business Model Evolution
Figure: Traditional Pharma Business Model Evolution
Figure: The top 20 Pharma could increase profits by $202 billion to 2013 simply by cutting costs
Figure: Sales force effectiveness – sales efficiency over effectiveness
Figure: Optimization of pharmacovigilance strategies
Figure: The underlying need for collaboration in R&D
Figure: Niche, specialty care markets offer Pharma the greatest growth potential
Figure: Pharma set to face harsher regulatory pressures in the future
Figure: Regulatory pressures and company responses impacting Pharma’s return on investment
Figure: Global generics company ranking, 2008
Figure: President Obama’s healthcare reforms, 2009
Figure: Demographics of the 47 million uninsured citizens in the US, 2007
Figure: The need for cost-containment drives uptake of generics and biosimilars
Figure: The global generics continuum
Figure: Fosamax sales erosion in the US, 2007–08
Figure: Branded-generic final settlements in the US, FY 2004–07
Figure: Innovator strategies that delay generic entry
Figure: Strategies to promote generic uptake in Japan
Figure: Impact of the hospital-retail divide on biosimilars uptake
Figure: US biosimilars pathway bills to date
Figure: Factors depressing future global sales growth for top 20 Pharma
Figure: Pharma will forgo forming partnership agreements, prioritizing M&A
Figure: Healthcare consequences of growing unemployment
Figure: US citizens cutting back on prescriptions in tough financial times
Figure: Drug spending has accelerated considerably in the US
Figure: Although US Pharma sales continue to increase, the growth rate is declining fast
Figure: Key drivers and resistors facing Pharma
Figure: Emerging market overview
Figure: Global pharmaceutical sales, 2007–2012
Figure: Big Pharma’s emerging market presence, 2001–2013
Figure: Growth in the proportion of producers of active pharmaceutical ingredients for export, 2004–08
Figure: Drivers and resistors of personalized medicine
Figure: Proportion of pipeline oncology drugs that are targeted and have biomarkers, 2001–10
Figure: The proportion of branded sales attributed to the hospital branded drug market has grown by 2% between Q3 2003 and Q2 2008
Figure: Regulatory pressures and company responses impacting Pharma’s return on investment
Figure: The R&D process is failing somewhere between initial innovation and market approval
Figure: Optimizing return on clinical R&D
Figure: Pharma set to face harsher regulatory pressures in the future
Figure: Regulatory issues impacting on drug safety
Figure: Number of drug related deaths in the US, Q2 2006–Q2 2008
Figure: Spending on direct-to-consumer advertisements in the US, 2002–08
Figure: The creation of more targeted communications in pharma advertising
Figure: Trends in drug distribution
Figure: Pharma companies which have moved to a restricted distribution system in the UK, 2007–09
Figure: Origin of counterfeit drug seizures in the EU, 2007
Figure: Distributor licensing and pedigree requirements for the pharmaceutical supply chain in the US, 2008
Figure: Timetable for UK Pharmaceutical Price Regulation Scheme (PPRS) 2008
Figure: France, Spain and Italy pricing and reimbursement update, 2009
Figure: Sales and marketing will involve cross-functional co-operation
Figure: Drivers and resistors to eDetailing, 2009
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