On the economy side, governments and payers faced with the rapid escalation of health care costs, the inefficiency in the system, the ever increasing prices of medical technologies, relative to the scarcity of resources, increase their intervention and through regulation exercise policies to increase transparency, to hold or reduce technology prices, to attain greater value for money, to mitigate risks, and to maintain the sustainability of the system.
Globalisation has made life science business more rewarding but because of referencing, mobility and trade wars far more complex. In emerging economies in Asia and Latin America, improvements in the scope, breadth and depth of coverage, in the context of tight budgets, put additional strains and challenges. Many opportunities are emerging in these economies but are still many challenges and issues to be resolved.
In the largest market in the world, in the USA, health and pharmaceutical care is also undergoing significant changes, in an effort to improve coverage and hold price and cost inflation and increase transparency. European markets as well are under enormous pressure as their health and medical technology expenditure has reached alarming levels.
On the regulation side, in the authorisation in Europe and the USA, accelerated - fast track approvals, adaptive pathways, early benefit assessments and new trial designs such as umbrella or basket trials, reflect the objective of regulators to increase efficiency, speed up access, manage risks and capture additional determinants of value. Moreover, regulators collaborate in between them and also with health technology assessment and payer agencies for early benefit assessments.
New regulations are now available for assessing MedTech products in Europe, altering the landscape in this field. These are contrasted with the situation in emerging markets where there are varying standards in the authorisation and production of medical technologies, creating complex and uneven competitive dynamics in between local and international players.
The market access landscape is very dynamic and becomes more complex over time. Value based pricing interconnects price with the perceived value delivered by a new technology. Reference pricing means that there are spill over effects in between countries and reduced abilities for differential pricing. Rebates, contracting, tendering, pay backs, claw backs, discount agreements mean that there is significant indirect on top of direct pricing. Along the above, combinational medical products, companion diagnostics, accelerated approvals, disruptive technologies and ultra-rare disease technologies with huge up front or significant life time price tags, medical technologies with significant impacts on hospital care, are making pricing a very sophisticated and challenging endeavour with significant business opportunities.
Health technology assessment and the proof of comparative and real word value to multiple audiences within and across health care systems, make technology reimbursement a more laborious, data driven and uncertain, process. Real word data and evidence play an constantly increasing role in value proof. Coverage with evidence generation, risk-sharing, managed-entry, performance-based reimbursement means that access is driven by complex mechanisms and goes far long beyond launch. Emerging value-assessment frameworks imply that beyond payers and technology assessment agencies, other stakeholders wish to evaluate and maximise the value for money attained. Moreover patient centricity and patient experience and new disruptive medical and other technologies and supporting services force the reimbursement landscape to new avenues.
In Europe complexity due to the diversity of thinking and practices amongst different agencies is being emphasised due to supranational collaboration of health technology assessment agencies as well as from the collaboration with the authorisation agencies. In the USA the fragmented and complex landscape will be made more complex due to reforms and the emergence of a new organisation which is geared to assess new technologies based on the incremental cost per quality adjusted year delivered. Such value assessment paradigms and mechanisms are now spreading across the globe and health technology assessment is used in most of the emerging economics I many different ways and decision-making settings.
Health care provision and financing is also in the dawn of value-based health care, which implies a shift of emphasis in digitaliation and more health information technology, integration of care in specialised units, early diagnosis and community based management, application of treatment pathways, time based activity costing, bundle payments, patient centricity and outcomes based reimbursement. This new wave gets a momentum amongst health care providers and payers in the USA and amongst some pharmaceutical and MedTech firms and is now also reaching European jurisdictions. In emerging markets the most dominant force is the shift towards universal coverage, which improves access and the appetite for technology, but pushes health care cost upwards and raises issues of affordability and sustainability.
Medical technology re-evolution represents the most significant and impactful driving force in health care delivery today and has multiple implications for access and cost. Cell and gene therapies, monoclonal antibodies, nucleotide therapies, nanotech, cancer vaccines, digital-software therapeutics, companion diagnostics, biosimilars and combinational drugs represent some cases of disruptive and transformational new medical technologies.
In the field of MedTech and digital technologies and the internet of medical things m-health; e-health, drones, 3d printing, robotics, cloud, and blockchain technologies are or will soon have profound impacts. Big data, real world data, social media data and omics, together with artificial intelligence, machine learning, predictive analytics, free language processing, affective computing, deep learning, neuroscience, quantum computing, will also affect any aspect of health care provision and health technology development, from discovery, to development, authorisation, market access, sales and marketing.
Hence, health care becomes a more complex, regulated, fast moving, multi-player, promising, uncertain, global, data driven, growing, personalised, commercialized, digitalized, consumerized, business and unprecedended skills in analysis, strategy and execution needed for success. Amid escalating costs, quality challenges, uneven access, continued economic challenges, and ongoing healthcare reforms, life science companies must continue reassessing how best to serve and succeed in the market.
Higher life expectancy and longevity reshape the population pyramid, which in turn weakens the system financial basis, whilst it increases the prevalence of multiple chronic diseases, pushes the demand for medical services and technologies and inflates related costs.
Social behaviours are driven by higher expectations for wider coverage, timely access, and better quality of care, consumerism, unhealthy lifestyles, cultural sclerosis, greater access to information, higher mobility, stronger dependence on social networks and greater use of the internet and smart devices with their accompanying applications.
In terms of research and development, digitalisation, health information technology, smart devices and applications, alongside the generation of real-world data, are having a profound impact in the design and execution of clinical trials. Virtual trials, synthetic comparative arms based on real word or meta-analysed data, pragmatic trials, trials patient reported outcomes, trials combined with observational studies and registries, are notable examples of how the field is evolving. Moreover, the innovators and the innovation profile is now changing with significant number of new technologies coming from emerging biotechnology, small medtech, digital or information technology firms. Many technologies are very disruptive, such as for instance software therapeutics, and are more and more focusing in ultra-rare, chronic and malignant diseases.