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10 Predictions for Pharma in 2015

What does 2015 hold in store for the pharmaceutical industry? Pharma-iQ asked a cross-section of industry insiders, professors and experts for their predictions.

January 2015

10 Predictions for Pharma in 2015. What does 2015 hold in store for the pharmaceutical industry? Pharma-iQ asked a cross-section of industry insiders, professors and experts for their predictions. IMA LAB


What do the experts forecast for the pharmaceutical industry in 2015? Pharma IQ – an international online community focused on pharmaceutical essays and analysis – put the question to a number of key industry insiders, professors and sector experts. What follows is a synthesis of the resulting White Paper published by Pharma iQ.

Market Priorities For 2015
2014 was a highly successful year for pharmaceuticals and biotechnology, thanks to robust demand for key products, a series of successful phase 3 outcomes and the launch of various significant specialist products.

Over the next 12 months, the industry is likely to see real-world evidence, personalized medicine, immunotherapy, combination treatments, regenerative medicine and companion diagnostics as constituting the key trends driving the marketplace.

In 2015 the industry will probably see important advances in a number of areas, including lung, prostate and breast cancers and melanomas, infectious diseases, ophthalmology,
HCV and neurodegenerative conditions such as Alzheimer’s disease. Drug-drug (including novel-novel) combinations will grow in importance, as will diagnostics, particularly biomarkers.
2014 saw a huge increase in the number of innovative products coming from small research-based pharmaceutical and biotechnology firms, on the one hand and, on the other,
reduced research and development from the larger top 10 pharmaceutical firms. This means that 2015 may well see further acquisitions and mergers.
2015 will also see more drugs come off patent and consequently the launch of more biosimilar products, which will certainly have an impact on pricing policies for biologics.

The companies likely to perform best in terms of market access will be those who recognize the growing importance of the payer and adopt new ways of working together with them. Payers also need to see real-world value, which comes from real-world evidence, and 2015 is likely to see increasing numbers of patient registries.
 


Integrated healthcare industry
The role of charities and public funds will take on greater significance in seeding early innovation. Medium-sized niche-based companies will play increasingly important roles.
Larger Pharma will make choices about how they will generate revenue and a new, more productive integrated healthcare industry will emerge, offering healthcare solutions combining pharmacology, technology and life style changes in order not only to treat the patient but also to keep them well.
 


More Accurate Models
Among the many exciting developments taking place in cell biology, one of the most interesting is the tailoring of stem cell-based hepatocyte systems to model human physiology 'in a dish'. These models are profoundly enabling and in particular allow us to study human biology using somatic cells derived from karyotpyically stable founder cells from known genetic origin. Such models have huge potential for the future. This is an area on which the pharmaceutical industry needs to focus strongly, in order to boost the sophistication – and ultimately the accuracy – of stem cell-based models.

 

Real-world Evidence
One of the most promising new areas is that of Real-world Evidence (RWE), a scientifically credible, anonymized patient-level data base, founded on millions of patient experiences in the real world and accessible around the globe.

Concerning all the announced projects on gaining new insights into pharma therapeutics in terms of their efficacy in a real world setting, the hope is that a significant number of these will actually be carried out… and carried out successfully. Quite probably this will start from areas like oncology, where this approach is no novelty and where there is already a lot of work being done to broaden and focus the evidence base and to improve outcomes.

 

Serialization
The launch of the European Union’s pharmaceutical serialization initiatives will represent the biggest change in 2015, when the European Commission will be announcing the delegated acts. Once these have been published and finally approved, the pharma companies will then have 36 months to make their product packaging comply with the traceability and anti-falsified medicines directive.

 

Data Security and Privacy
The handling of ever greater masses of data and personal details calls for initiatives that focus on data security… both for governments and consumers.
The increasing use of the cloud, plus the fact that many previously analogue systems are now going digital, could potentially raise security risks  which will cause increasing concern among consumers. In 2015 it will be important for any pharma company which provides a digital service to be able to reassure the public over security.

 

Clinical Trials
One of the most passionate battles in recent years has been fought about release obligations concerning clinical trial data which previously remained  unpublished.
Successful campaigns by organizations such as AllTrials have succeeded in completely shifting industry opinion on this subject, and many companies that previously opposed compulsory data sharing are now on board with the campaign. Numerous vocal opponents continue to fight in the press and in the courts, but since January 1st 2015, the European Medicines Agency has begun releasing data submitted as part of marketing applications.

 

Social Media
In recent years, Social Media have transformed the way most businesses conduct their marketing and their user feedback and customer experience functions.
This trend initially left pharma behind: there were no solid guidelines on how pharma should conduct its online presence and consequently – in fear of finding itself on unsteady ground – pharma companies barely exerted any presence in social media. In June 2014, however, the FDA finally issued its guidance on the subject, giving pharma a clearer idea of what the rules will be in the online world. Time to catch up!

 

Mergers and acquisitions
In the first six months of 2014, mergers and acquisition deals totaling $317.4 billion took place… an amount approximately equal to the GDP of Denmark.
This trend will certainly continue in 2015, especially relating to small companies with promising assets in areas such as regenerative medicine and immunotherapy.
This process will be guided above all by two general trends: firstly, increasing streamlining and specialization – many firms are focusing down onto one particular therapeutic area – and secondly, and perhaps most importantly, increasing tax inversion, aimed at minimizing a company’s tax burden.

 

Mobility
The pharmaceutical industry has an enormous, technology-reliant, mobile workforce. There are more than half a million pharma employees in Europe alone.
They perform numerous different tasks and functions, all of which can be hugely streamlined with available technology, but their jobs very rarely involve them sitting behind a computer all day: they also need to move. Integrating mobile technologies into the pharma workflow, therefore, promises to unlock the huge potential of the pharma industry.
With the mobility market set to grow at over 25% in 2015, pharma companies will hopefully realize the value of getting on board sooner rather than later.




Reference:

Pharma-iQ white paper