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The tendency to get older is not only an advantage, it also implies challenges for the individual, family and the society by an increased pressure on the healthcare industry due to increased expenses and the need to change existing paradigm.

The demographic trend is the major factor in determining the future development of the healthcare sector. This essay will clearly show the significant shift in demography and its consequences, the current status of the healthcare industry and the required development to master the demographic hurricane.

I will prove that the current healthcare business models and approaches will not be able to manage the foreseeable challenges of an aging population. I will also outline potential solutions and required changes. The derived conclusions are only valid for developed geographies. The German demography has shown for a total population of The same trend is true for the European Union.

Life expectancy in Germany for new born children will increase from The lowest grade of predictability is related to the migration which is currently one of the biggest short-term challenges for the developed industries.

Migration will also have an impact on the distribution of ethnos and religions which will certainly require more differentiation of the delivered healthcare service. This was improved by enhanced hygiene and a more individual healthcare system e. The life expectancy will also boost the need for and duration of long-term care for older people. The number of people in need of care rose from 2. With the current trend of single households, low birthrates and the increasing work pressure on employed people the option of family based care is vanishing.

This will significantly increase the demand for professional care services in the future. The demographic change will also cause a lack of workforces especially of skilled workforces in the near future. The migration will not mitigate this issue due to the associated lack of education and language skills. This will force the government to further increase the legal retirement age.

Therefore there is also a stronger need that employers actively support and foster the long-term health of their employees including the implementation of working conditions and programs which actively address today's increasing work density.

Managing work-life-balance and work stress are key elements. The demographic shift will also impact the balance of supply and demand for a skilled workforce. This is also valid for healthcare industry employees. That means we are not only facing an increased demand for healthcare support in Germany and the European Union we will also see a lack of skilled workforces to cover this demand which will further fuel the dilemma. Luxembourg: Luxembourg Publications Office, p.

Auswirkungen auf das Management von Gesundheitsversorgung und Fitnesseinrichtungen. Stuttgart: Wissenschaftliche Verlagsgesellschaft mbH. Aktiv Nordostchemie , January 6, p. The explicit intent is to accelerate the path to approval and avoid exposing patients for extended periods of time to less effective or active comparator drugs, and is meant to complement the other mechanisms including fast track, priority review, and accelerated approval.

This approach, which has not yet been implemented, may initially be focused on the development of therapies for highly problematic areas, such as the development of antibiotic therapies for multidrug-resistant pathogens, referred to as limited population antibacterial drug LPAD.

The concept is to allow development in a very narrow aspect of a disease, for example multidrug-resistance TB where a limited clinical program is conducted supported by in vitro and in vivo modeling, data from study ies in drug-sensitive infections leading to a special approval. All such approaches are geared to facilitate effective and frequent interactions with the FDA with the purposeful goal of expediting the drug development path and making effective, safe drugs accessible to patients much sooner than might be possible using the traditional development path.

Long-term demographic trends are particularly challenging in Japan, where the expansion of the elderly population cohort is projected to be pronounced over the next several decades. This represents a formidable challenge to the national health care system in Japan that potentially threatens the long-term financial solvency of the system.

After evaluating potential ways to approach the problem, in , the government and policy leadership announced an important new initiative that was founded on the assessment that regenerative medicine technology is viewed as offering greater potential to address areas of serious unmet medical need that any other area of technology evaluated [ 12 ]. Footnote 23 Unfortunately, it has also been recognized that in the past decade, few companies active in the area of regenerative medicine have been conducting clinical trials in Japan.

Traditional clinical development customarily requires phase I evaluation of safety, phase II trials to further evaluate safety and provide an initial assessment of efficacy, and typically at least two phase III larger scale trials to confirm safety and efficacy, a process that frequently requires years of development and substantial financial resources. Under the new framework, qualified regenerative medicine therapies could receive accelerated conditional approval after a single clinical study, provided the trial demonstrates the therapy to be safe and there is also evidence of a probable therapeutic benefit.

Novel approval system for regenerative medicine therapies in Japan. In , the Japanese Diet passed two important pieces of legislation that could have a dramatic impact on the development of novel regenerative medicine therapies. The new framework makes it possible to obtain accelerated conditional approval of qualified regenerative medicines that are shown to be safe and where there is evidence of a probable therapeutic benefit. In November, , the new system went into effect from [ 16 ].

In November of , the new legislation authorizing the establishment of the new framework was approved with overwhelming support by both houses of the Japanese Diet and was subsequently passed into law by the Japanese government, and in November , the new framework went into effect Footnote 24 [ 15 , 16 ].

Importantly, new therapies approved under the framework are also eligible for reimbursement under the national health care system in Japan. The potential impact of the new framework in Japan on the field of regenerative medicine could be profound. The approach is designed to dramatically accelerate patient access to new medicines, while also making it possible for sponsors to meaningfully shorten clinical development times and reduce development costs.

This initiative should also promote investment in the area, since faster and less expensive development and the ability to achieve accelerated commercialization would shift the risk-reward ratio in a favorable direction from an investment perspective. As a result, it could enhance patient access to regenerative medicine therapies and improve the efficiency and quality of care, while creating a powerful catalyst for development and promoting investment in Japan. Recent developments in the European Union are also designed to promote accelerated development of novel therapies in established areas of serious unmet medical need.

Conceptually similar to the initiative in Japan, the European Medicines Agency EMA has embraced the concept of an adaptive licensing initiative [ 17 ].

The essential concept is to provide a form of contingent approval that speeds development and could also enable reimbursement but that also entails a strict commitment to conduct post-approval follow-up studies to gather additional data regarding safety and efficacy.

While the adaptive licensing program initiated by the EMA is meant to be broad and is not specifically designed to focus on or accommodate any specific type of therapy, EMA provided several illustrative case studies in the program announcement, to help demonstrate how the approach might work.

One of these case studies illustrates how a genetically modified cell therapy designed to express growth factors that enhance healing and repair of cartilage, administered in combination with a matrix i.

The initiative recognizes that reimbursement represents a potential hurdle to implementation of the approach, and encourages the active involvement of third-party payers and health technology assessment bodies. Their endorsement will likely be a requirement for the approach to be successful. This is particularly true in areas where treatments may provide a substantial impact but also be expensive to implement. Many countries around the world are now experiencing a significant expansion of the elderly segment of their populations.

Since this group is susceptible to a range of aging-related diseases and conditions that frequently require significant medical intervention and supportive care, it utilizes a greater proportion of health care resources than other population cohorts. The requirement for intensive clinical and supportive care is especially meaningful for acute and chronic conditions that may have a long-term impact on patient quality of life and require intensive long-term institutional supportive care, home care support, or both.

A seemingly inevitable consequence of the ongoing and unprecedented demographic shift is the need to deploy far greater health care resources toward the challenges posed by an expanding population of elderly. An unattractive alternative would be de facto rationing of the limited clinical and supportive care resources available, in conjunction with a greater emphasis on family-mediated home care and support.

Advances in clinical care and biopharmaceutical treatments have yielded dramatic successes in improving health care outcomes and patient quality of life in many indications. However, meaningful progress in many areas that threaten to become an escalating social, clinical, and economic burden has remained frustratingly elusive.

Innovation in health care technology could yield safer and more effective treatments for areas of unmet medical need and offer the potential to greatly improve health care outcomes and enhance patient and family quality of life.

New technologies, such as regenerative medicine, could also increase the efficiency of health care by reducing the need for clinical and long-term palliative institutional care, and alleviate the need for extended home care support.

Rational pricing strategies and reimbursement policies will be critical aspects that influence the adoption of such therapies. Therapies that are administered only once, or perhaps a limited number of times, but that have the potential to deliver major improvements in clinical outcomes and substantially enhance patient quality of life may provide meaningful long-term benefits that may not be fully considered using traditional health care economic approaches.

While such therapies may seem expensive relative to traditional pharmaceuticals, they may deliver a substantial benefit to cost ratio that fully justifies their adoption.

Regulatory initiatives adopted over the past several years in the USA, Japan, and the European Union have explicitly recognized the need for greater innovation focused on addressing established areas of serious unmet medical need. These new initiatives are designed to speed the development of safe and effective new treatments that could also help offset the impact of current demographic trends that pose a threat to social welfare and economic prosperity in many regions.

New technologies such as cell therapy, gene therapy, and regenerative medicines have the potential to meaningfully shift the efficiency frontier of clinical care, enabling health care systems to accomplish more with the limited resources available, and deliver a higher quality of care while improving outcomes for patients. They could also spur greater investment and economic development, while improving the quality of life for millions of people.

China and India are also problematic, where the number of individuals over the age of 65 is expected to more than triple between the years and , to more than million people. US Government Printing Office. Accessed 28 August Engelberg Center for Health Care Reform. Special medical use: limited use for drugs developed in an expedited manner to meet unmet medical need. Japan policy of pharmaceutical innovation and regulatory science. Biosci Trends. Colombo F et al. Help wanted? Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association.

Circ Heart Fail. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. This reference provides an analysis of the projected long term impact of cardiovascular disease.

It projects the substantial increase in economic impact over the time frame from to , driven by key factors such as an aging population. Mov Disord. The Ministry of Health Labor and Welfare. National survey of the required number of physicians in hospitals. This reference illustrates that the physician shortage is not limited to the USA and Europe. Ishikawa et al. Forecasting the absolute and relative shortage of physicians in Japan using a system dynamics approach.

Hum Resour Health. European Commission. Strasbourg: EC; This analysis illustrates the current and projected magnitude of the shortage of healthcare workers in the European Union. Development trends for human monoclonal antibody products. Nat Rev Drug Discov. Baird LG et al. Accelerated access to innovative medicines for patients in need. Clin Pharmacol Ther. Aggarwal SR. A survey of breakthrough therapy designations. Nat Biotechnol. Cyranoski D. Japan to offer fast track approval for stem cell therapies.

Nat Med. Azuma K. Regulatory landscape of regenerativemedicine in Japan. Curr Stem Cell Res Ther. Okada K. A new national framework for clinical trials and evaluation of innovative medical care technologies using living cell transplantation in Japan. J Transplant Technol Res. This reference provides a cogent summary of aspects of the new regulatory framework in Japan that is designed to expedite development of regenerative medicine therapies.

Article Google Scholar. Kusakabe T. Regulatory perspectives of Japan. Accessed 12 May New governmental regulatory system for stem cell-based therapies in Japan.

Ther Innov Regul Sci. Eichler H-G et al. Adaptive licensing: taking the next step in the evolution of drug approval.

Article PubMed Google Scholar. European Medicines Agency. Pilot project on adaptive licensing. This provides additional information and examples of the types of projects that could be considered under the new adaptive licensing framework.

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Kaiser permanente mill plain one medical office Impacr will result in an estimated impact demographic changes healthcare Regulatory landscape of regenerativemedicine in Japan. However, the total number of elderly persons living in nursing homes has increased impact demographic changes healthcare a manner consistent with the increase demorgaphic the elderly population. Whereas 1 percent of those 65 to 74 years lived in a nursing demograpihc innearly 1 in 4 aged 85 or older did Schneider link Guralnik, ; Bureau of the Census and the National Institute on Aging, a. Increases in the oldest age groups will account for most of the projected increases over this period if no treatment has been found Evans et al. Unprecedented demographic trends threaten to have a major impact on the practice of medicine and the application of limited health care resources in the years ahead.
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Cigna visalia Whereas 1 percent of those 65 to 74 years lived in a nursing home innearly 1 in 4 aged 85 or older did Schneider demographid Guralnik, ; Bureau of the Census and the National Institute on Aging, a. Health care economic analysis demonstrates that as we become more susceptible impact demographic changes healthcare aging-related diseases and conditions, the expense, health care infrastructure needs, and social burden escalate. They could also spur greater investment and economic development, while improving the quality of life for millions of people. Sociodemographic Characteristics Gender Distribution More women survive to old age than men. In fact, the population 65 years of age and older is growing more slowly between and than at any chagnes in a period of nearly years.
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Dec 1, аи Even if today your consumer population is less diverse or continues to show the same demographic patterns, the research truly shows that a wave of new and diverse . Aug 6, аи Estimated impact of demographic changes on total healthcare expenditures and funding in EU Member States in a Full size image In all countries, demographic . Apr 6, аи The change in demographics has caused a worldwide collaboration between different sectors of the industry. The public and private sectors are now coming .