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Kalorama Information Reports 7 "Take Notice" Trends in the Pharmaceutical Market

ROCKVILLE, Md., July 13, 2017 /PRNewswire/ -- New York City-based market research firm Kalorama Information notes seven trends that watchers of pharmaceutical markets should be aware of.  From new products to new costs, to the threat of generic biologics.  These trends are detailed in a recently completed study, Potential Pipeline Disruptors.

Among them are the following:

1.  Age-Driven Growth - True Impact Moment Arriving  

For years, we have been aware of the impact the growing population and, to a more extreme extent, the aging population will have on chronic diseases.  Despite the ongoing awareness, companies must keep pace with the shift in demographics and how it continues to impact certain markets.  From 2010 to 2050, global population growth is forecast to be 0.8% annually on average, growing from 6.9 billion in 2010 to 9.4 billion in 2050.  In comparison, aging populations for the same period will increase by 2.7% annually, reaching 1.6 billion people in 2050 compared to 533 million in 2010.  The aging population will account for 16.7% of the global population by 2050, as compared to 7.8% in 2010.

2.  Expect Disruptive Products

The pharmaceutical market is fluid and at times can defy predictions of observers of today's pipelines. In recent years, several 'disruptors' have hit the market and pushed aside the current standard treatment protocols. Consider these two cases: Gilead Sciences has turned the Hepatitis C (HCV) treatment market upside down, for its competitors at least. In 2013, Gilead began to rollout its new therapies for HCV, of which the company claimed were superior products to the established market. A bold claim considering it was going up against some of the biggest names in biopharmaceutical participation - mainly Merck and Roche. The market showed favor for Gilead's products, which began to erode sales for Merck and Roche's HCV products. By 2015, Gilead had a solid hold on the market with about 80% market share. In December 2014, Bristol-Myers Squibb was granted approval for its PD-1 monoclonal antibody Opdivo (nivolumab). Opdivo was originally granted approval for advanced melanoma; by the end of 2016, lung cancer, renal cell carcinoma, lymphoma, and head & neck cancer were also approved. Approvals continue to be pursued and granted for 2017. 

3.  Outcomes-Based Reimbursement Changes Game

The changing landscape for reimbursement of medical therapies is forcing developers to show benefits of new therapies.  As the market shifts to an outcomes-based reimbursement system, developers will have to stay ahead of the changing landscape and focus on data in clinical results that show significant benefits over current therapies, particularly if a higher price is to be pursued.  As a whole, the medical industry is moving toward a system of documented outcomes and proven benefits of treatments.  This is the major driver for new patient monitoring technologies, electronic medical records systems, and similar technologies.  Although the approach is a bit different with therapies, the basis of the topic is the same.  Without solid documentation and 'proof' of benefits and outcomes, reimbursement is at risk. 

4.  Disease-Modifying Therapies for Alzheimer's Disease  

The highly-anticipated development of an effective Alzheimer's disease treatment that focuses on modifying the progression of disease is coming closer to fruition.  There are six therapies in advance stages that have been reviewed by Kalorama Information and are expected to move to market.  A market estimate for these therapies is part of Kalorama's Pipeline Disruptors Report. 

5.  Era of No-Fail Drug Development is a Real Threat to New Innovation

Developers are finding more disease targets using advanced research techniques, but if the therapies fail in late-stage trials, it is usually very expensive. If better disease targets are selected from the start, companies expect to develop more effective therapies and waste less in lost R&D investment.  Several projects have failed in the last stages of development, failing to meet primary endpoints, failing to show any significant benefits.  Developing advanced targets, whether small or large molecules, takes an enormous investment in both financial and human resources.  Companies, with advanced development technologies combined with the number of projects in development, can push R&D spending budgets to billions of dollars and 15-20% of revenues each year.  In 2014, the Tufts Center for the Study of Drug Development put the average cost of developing a drug at $2.6 billion ($1.4 billion in out-of-pocket costs, $1.2 billion in time costs).  This is up from about $800 million reported in 2001 by the Tufts Center.    Companies are finding more disease targets using advanced research techniques, but if the therapies fail in late-stage trials, it is usually very expensive. Selecting the right disease target from the start, may lead to the development of more effective therapies and waste less in lost R&D investment.

Promising therapies that failed late in the development process include Roche's lebrikizumab for asthma; AbbVie's veliparib for breast and lung cancers; Otsuka and Lundbeck's LU AE58054 for Alzheimer's disease; Boehringer Ingelheim's volasertib for leukemia; and AstraZeneca's selumetinib for lung cancer.

6.  Three Key Chronic Diseases Will Affect Markets

Chronic disease is the leading cause of death worldwide, representing approximately 60% of all deaths.  In 2015, 56.4 million deaths were recorded worldwide - equal to 7.79 deaths/1,000 population; 108 deaths per minute or 1.8 deaths every second. 

Alzheimer's disease will increase by 5,000 new cases annually worldwide.  This moves the number affected from about 44 million to more than 80 million over the next decade, taking into account new cases and mortality rates.  As the population ages the number affected by Alzheimer's will climb.  About 11% of people over the age of 65 have Alzheimer's disease; in the over 85 age group, 32% of people have Alzheimer's.  Asthma currently affects about 300 million people worldwide.  Several factors are contributing to the expected increase to about 400 million by 2025, these include environmental factors, an increase in respiratory infections and conditions, occupational irritants and, even though tobacco consumption is lower than a decade ago, it is still a concern as a contributor to asthma.  Cancer as a whole will impact future markets with increasing incidence and a growing demand for effective therapies.  Lung cancer, in particular, is expected to see an increase in incidence by 2.8% annually.  Considering the poor prognosis associated with the disease, effective treatments fulfil an unmet need.  Increases in breast cancer incidence will be slower, yet significant.  There will likely be an increase in breast cancer incidence equal to about 1.8-1.9% annually.  Lymphoma and leukemia will also increase at about a rate of 2.5% annually.  New methods of detection at an earlier stage, changes in guidelines for prevention and an aging population are all contributors to the growing incidences.

7.  Biosimilar Development Will Cut into Sales for Original Therapies

Development activities of biosimilar therapies targeting Avastin, Herceptin, and Rituxan are currently at full speed.  Development efforts are on pace to reach market penetration by 2018 and are expected to be strong performers, upsetting original therapy performance.  The changing legislative environment and new healthcare reform should be carefully observed to adapt strategies and adjust development plans.  In the area of biosimilars, the changes will likely continue to support additional activity in development and adoption as the industry as a whole looks to cost-saving strategies while continuing to provide access to vital therapies.

What are Pipeline Disruptors?

Pipeline Disruptors are innovative therapies that impact current therapies with significant competition and alter the course of treatment.  For the purpose of this study, it may affect current therapies that were also considered disruptor innovations at one time  or involves a new innovation that is expected to displace other treatments.  In recent years, several 'disruptors' have hit the market and pushed aside the current standard treatment protocols.  Gilead and Bristol-Myers Squibb have produced innovative therapies that are classified as pipeline disruptors.  Kalorama Information's report Potential "Pipeline Disruptors" - New Products That Will Drive The Future Pharmaceutical Market can be found at:

About Kalorama Information

Kalorama Information, a division of, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on and

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website.  

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