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Τετάρτη 23 Νοεμβρίου 2011

Big Pharma productivity still shaky as R&D costs escalate


Clinical News | November 22, 2011


Leading research-based pharmaceutical companies have seen the average number of compounds in their late-stage development pipelines fall by 22% this year, while R&D costs have ballooned by more than 25%, a new study has found.

According to the latest annual review of pharma R&D value by Deloitte and Thomson Reuters, Measuring the Return from Innovation, the average cost of bringing a new product successfully to market among the top 12 research-based pharmaceutical companies worldwide increased by 26.3% from US$830 million in  2010 to US$ 1,048 million in 2011.
Over the same period, the number of late-stage compounds in development dropped from 23 on average per company to 18 per company. Moreover, the average R&D Internal Rate of Return (IRR) among the companies analyzed was down from 11.8% in 2010 to 8.4% this year.
In a study released late last year, Deloitte and Thomson Reuters suggested that, against a backdrop of declining productivity, pharmaceutical companies should be setting performance targets and driving R&D strategy around output-based measures such as IRR. Historically, that study noted, pharmaceutical companies had relied on input-based measures for R&D investment, such as expenditure as a percentage of sales revenue.

At the time, the Deloitte/Thomson Reuters analysis found that the top 12 research-based pharmaceutical companies by R&D investment should be generating a positive IRR, ranging from 8.4% to 18.4%, from the investment required to develop each of their late-stage product portfolios. These returns were all above the estimated Weighted Average Cost of Capital of 7% for the basket of pharma leaders. 

Cause for optimism

Despite the declines in average IRR and the number of compounds in late development, as well as R&D cost escalation in 2011 versus 2010, the latest Deloitte/Thomson study found some cause for optimism.
For example, nearly two thirds of the 12 companies reviewed managed to realise more value from product commercialization than they had lost as a result of late-stage pipeline failures. And non-R&D costs across the 12 companies have eased, lifting operating margins and helping to free up cash flow that could be reinvested in R&D, Deloitte/Thomson observed.

Innovation through collaboration

Innovating through collaboration has already proved a fruitful strategy, said Julian Remnant, head of Deloitte’s European R&D advisory practice.
“The walls of secrecy are coming down in some cases and there are increasing numbers of players within the industry forming alliances and joint ventures to pool research knowledge in particular disease area or indication,” he commented.  
Companies are also making efforts to work more closely with payers at an earlier stage of drug development, so they can ensure investments in innovation are directed at therapies and propositions that are attractive to the payer community.

All the same, Remnant cautioned, the pharmaceutical R&D sector “can do more to work together, for example, sharing knowledge on the science behind failed molecules and studies will help improve success rates and ultimately bring down the cost to develop new medicines”. In future, he envisages R&D organizations joining forces to simplify and share capabilities in non-competitive areas of R&D, thereby reducing costs. “Shared drug development models will remove duplication, maximize capacity utilization, and drive scale economies within service providers,” Remnant predicted. “We see R&D leaders beginning to raise their level of ambition and take the lead in this type of cross-company collaboration.”

Role to play

A return-on-investment simulation for a typical pharmaceutical company in the annual review showed that all corporate functions have a role to play in helping R&D earn back its investment, Deloitte/Thomson noted. Simulating the impact on R&D IRR of improvements in gross profit margin, for example, illustrated that “even modest” efforts to improve manufacturing efficiency “would, over time, have a profound effect on R&D returns”.  

With a tighter focus on the economics of pharmaceutical R&D, Remnant believes, “we’re likely to see companies establishing centers of excellence which bring together value analytics, simulation and modeling expertise, and finance and portfolio management capabilities to inform capital allocation decisions during drug development”. Successful adoption and implementation of these capabilities will better position R&D leaders to make the case for investment in “the business of R&D”, while continuing to develop medicines for the benefit of patients and society, Deloitte/Thomson suggest.  

Πέμπτη 17 Νοεμβρίου 2011

Sanofi will replace Pfizer as the world’s biggest drug maker by revenue next year, according to new forecasts.

Pfizer’s nine-year reign at the top has been driven by sales of its anti-cholesterol drug Lipitor, which made $13.4 billion in peak annual sales.
But Lipitor will go off patent in the US this month and in Europe early next year – a process that will shrink revenue from the drug to just $2 billion a year by 2016.   
Sanofi is now expected to take its place at the top, followed by Novartis, Pfizer and GlaxoSmithKline, according to industry analysts at EvaluatePharma.

Sanofi strength

EvaluatePharma (EP) are projecting annual sales growth of 4% over the next four years for Sanofi, meaning the French firm will be capable of holding on to the top spot. 
EP says the strength for Sanofi is the culmination of a decade of mega-mergers starting with the 1999 acquisition of Synthélabo in a deal worth around $30 billion, and later its $63 billion deal with Aventis in 2004.  

The $20 billion takeover of Genzyme earlier this year has cemented its future success, and EP believes that sales of its new biotech’s enzyme replacement therapies should be enough to keep Sanofi at the top of the table until at least 2016. 
Genzyme’s drugs will also help offset the loss of revenues from its anticoagulant Plavix, which loses US patent protection next year, and ongoing generic erosion of anticoagulant Lovenox and chemotherapy Taxotere. 

Novartis will also remain firmly in second place for the coming years based on the predicted strength of its MS pill Gilenya and blood cancer treatment Tasigna - these should be enough to help offset the loss of by blood pressure drug Diovan, which has been bringing in over $6 billion in peak annual sales. 
Its recent $48 billion acquisition of eye specialist Alcon will also help the group’s top-line sales outside of drug products, illustrating the strength of diversification for the firm.
Merck to struggle
Merck, which is currently in fourth position, will drop to sixth next year. Despite buying Schering-Plough for $41 billion in 2009, the US firm will struggle to expand its drugs business over the next four years, according to EP, letting faster growing companies GlaxoSmithKline and Roche climb ahead. 

Teva reaches top 10

A notable entrant to the top ten next year will be the Israeli generics drug maker Teva, which is predicted to post strong 7% annual sales growth over the period with both its generic and branded drug segments expanding.
This has been achieved largely through an aggressive acquisition policy that has seen the company make five multi-billion dollar deals in the last seven years, including its recent $6.5 billion purchase of US biopharmaceutical firm Cephalon. 

Firm
Rank: 2011
2012
2014
2016
Rx/OTC sales: 2011
2012
2014
2016
Sanofi
3
1
1
1
$48bn
$52bn
$55bn
$58bn
Novartis
2
2
2
2
$50bn
$50bn
$52bn
$55bn
Pfizer
1
3
3
3
$54bn
$50bn
$50bn
$52bn
GSK
5
6
5
4
$39bn
$41bn
$46bn
$51bn
Roche
6
4
4
5
$39bn
$44bn
$46bn
$49bn
Merck
4
5
6
6
$42bn
$42bn
$41bn
$43bn
J&J
8
8
7
7
$25bn
$27bn
$29bn
$32bn
AZ
7
7
8
8
$32bn
$29bn
$28bn
$26bn
Teva
12
10
10
9
$17bn
$20bn
$23bn
$24bn
Abbott*
9
9
9
10
$22bn
$24bn
$24bn
$24bn
*Abbott has recently announced that it will split into two separate firms - one focusing on pharma products and other on medical devices and diagnostics

Source: EvaluatePharma