Cushing’s Disease Treatment Market to Witness an Outstanding Growth by 2017 – 2025

Cushing disease is caused by tumour in the pituitary gland which leads to excessive secretion of a hormone called adrenocorticotrophic (ACTH), which in turn leads to increasing levels of cortisol in the body. Cortisol is a steroid hormone released by the adrenal glands and helps the body to deal with injury or infection. Increasing levels of cortisol increases the blood sugar and can even cause diabetes mellitus. However the disease is also caused due to excess production of hypothalamus corticotropin releasing hormone (CRH) which stimulates the synthesis of cortisol by the adrenal glands.

The condition is named after Harvey Cushing, the doctor who first identified the disease in 1912. Cushing disease results in Cushing syndrome. Cushing syndrome is a group of signs and symptoms developed due to prolonged exposure to cortisol.

Signs and symptoms of Cushing syndrome includes hypertension, abdominal obesity, muscle weakness, headache, fragile skin, acne, thin arms and legs, red stretch marks on stomach, fluid retention or swelling, excess body and facial hair, weight gain, acne, buffalo hump, tiredness, fatigue, brittle bones, low back pain, moon shaped face etc.

Symptoms vary from individual to individual depending upon the disease duration, age and gender of the patient.  Disease diagnosis is done by measuring levels of cortisol in patient’s urine, saliva or blood. For confirming the diagnosis, a blood test for ACTH is performed. The first-line treatment of the disease is through surgical resection of ACTH-secreting pituitary adenoma, however disease management is also done through medications, Cushing disease treatment market comprises of the drugs designed for lowering the level of cortisol in the body. Thus patients suffering from Cushing disease are prescribed medications such as ketoconazole, mitotane, aminoglutethimide metyrapone, mifepristone, etomidate and pasireotide.

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Cushing’s disease treatment market revenue is growing with a stable growth rate, this is attributed to increasing number of pipeline drugs. Also increasing interest of pharmaceutical companies to develop Cushing disease drugs is a major factor contributing to the revenue growth of Cushing disease treatment market over the forecast period. Current and emerging players’ focuses on physician education and awareness regarding availability of different drugs for curing Cushing disease, thus increasing the referral speeds, time to diagnosis and volume of diagnosed Cushing disease individuals. Growing healthcare expenditure and increasing awareness regarding Cushing syndrome aids in the revenue growth of Cushing’s disease treatment market. Increasing number of new product launches also drives the market for Cushing’s disease Treatment devices. However availability of alternative therapies for curing Cushing syndrome is expected to hamper the growth of the Cushing’s disease treatment market over the forecast period.

The Cushing’s disease Treatment market is segment based on the product type, technology type and end user

Cushing’s disease Treatment market is segmented into following types:

By Drug Type

  • Ketoconazole
  • Mitotane
  • Aminoglutethimide
  • Metyrapone
  • Mifepristone
  • Etomidate
  • Pasireotide

By End User

  • Hospital Pharmacies
  • Retail Pharmacies
  • Drug Stores
  • Clinics
  • e-Commerce/Online Pharmacies

Cushing’s disease treatment market revenue is expected to grow at a good growth rate, over the forecast period. The market is anticipated to perform well in the near future due to increasing awareness regarding the condition. Also the market is anticipated to grow with a fastest CAGR over the forecast period, attributed to increasing investment in R&D and increasing number of new product launches which is estimated to drive the revenue growth of Cushing’s disease treatment market over the forecast period.

Depending on geographic region, the Cushing’s disease treatment market is segmented into five key regions: North America, Latin America, Europe, Asia Pacific (APAC) and Middle East & Africa (MEA).

North America is occupying the largest regional market share in the global Cushing’s disease treatment market owing to the presence of more number of market players, high awareness levels regarding Cushing syndrome. Healthcare expenditure and relatively larger number of R&D exercises pertaining to drug manufacturing and marketing activities in the region. Also Europe is expected to perform well in the near future due to increasing prevalence of the condition in the region.

Asia Pacific is expected to grow at the fastest CAGR because of increase in the number of people showing the symptoms of Cushing syndrome, thus boosting the market growth of Cushing’s disease treatment market throughout the forecast period.

Some players of Cushing’s disease Treatment market includes CORCEPT THERAPEUTICS, HRA Pharma, Strongbridge Biopharma plc, Novartis AG, etc. However there are numerous companies producing branded generics for Cushing disease. The companies in Cushing’s disease treatment market are increasingly engaged in strategic partnerships, collaborations and promotional activities to capture a greater pie of market share.

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Day 14, Cushing’s Awareness Challenge 2016

Way back when we first got married, my husband thought we might have a big family with a lot of kids.  He was from a family of 6 siblings, so that’s what he was accustomed to.  I am an only child so I wasn’t sure about having so many.

I needn’t have worried.

In January, 1974 I had a miscarriage.  I was devastated. My father revealed that my mother had also had a miscarriage.  I had no idea.

At some point after this I tried fertility drugs.  Clomid and another drug.  One or both drugs made me very angry/depressed/bitchy (one dwarf I left off the image)  Little did I know that these meds were a waste of time.

Eventually,  I did get pregnant and our wonderful son, Michael was born.  It wasn’t until he was seven that I was finally, actually diagnosed with Cushing’s.

When I had my early Cushing’s symptoms, I thought I was pregnant again but it was not to be.

I’ll never forget the fall when he was in second grade.  He was leaving for school and I said goodbye to him.  I knew I was going into NIH that day for at least 6 weeks and my future was very iffy.  The night before, I had signed my will – just in case.  He just turned and headed off with his friends…and I felt a little betrayed.

Michael wrote this paper on Cushing’s when he was in the 7th grade. From the quality of the pages, he typed this on typing paper – no computers yet!

Click on each page to enlarge.

When Michael started having headache issues in middle school, I had him tested for Cushing’s.  I had no idea yet if it could be familial but I wasn’t taking any chances.  It turned out that my father had also had some unnamed endocrine issues.  Hmmm…

I survived my time and surgery at NIH and Michael grew up to be a wonderful young man, if an only child.  🙂

After I survived kidney cancer (Day Twelve, Cushing’s Awareness Challenge 2015) Michael and I went zip-lining – a goal of mine after surviving that surgery.  This photo was taken in a treetop restaurant in Belize.

For the mathematically inclined, this is his blog.  Xor’s Hammer.  I understand none of it.  He also has a page of Math and Music, which I also don’t understand.

I know it doesn’t fit into a Cushing’s awareness post but just because I’m a very proud mama – Michael got a PhD in math from Cornell and his thesis was Using Tree Automata to Investigate Intuitionistic Propositional Logic

 

proud-mom

 

Preclinical Data for ALD1613 at ENDO 2016

Alder BioPharmaceuticals, Inc. (“Alder”) (NASDAQ:ALDR), today announced that preclinical data on ALD1613, its anti-adrenocorticotropic hormone (ACTH) antibody for the treatment of congenital adrenal hyperplasia (CAH) and Cushing’s disease, were presented today by Andrew L. Feldhaus, Ph.D., in a poster presentation at ENDO 2016, the Endocrine Society’s 98th Annual Meeting in Boston, Mass. The presentation entitled “A Novel Anti-ACTH Antibody (ALD1613) Neutralizes ACTH Activity and Reduces Glucocorticoids in Rats and Nonhuman Primates” was presented as a late-breaking abstract.

Key Points:

  • In vitro, ALD1613 inhibits ACTH-induced cortisol secretion in a mouse adrenal cell line.
  • ALD1613 administration in rats with artificially elevated ACTH and corticosterone levels resulted in a rapid and durable reduction of plasma corticosterone levels.
  • In non-human primates, ALD1613 demonstrated stable and durable reductions in plasma cortisol levels by >50%.

Quote:

Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, “Existing therapeutic options for patients with congenital adrenal hyperplasia and Cushing’s disease comprise treatments that provide limited disease control and involve significant side effects. We believe these limitations indicate a clear need for new therapies such as ALD1613, which targets ACTH to diminish the overproduction of cortisol. The data presented today demonstrate the capacity of ALD1613 to reduce corticosteroid levels in preclinical settings. We intend to use these studies as part of an IND filing that we plan to submit to the FDA in the second half of 2016.”

From https://globenewswire.com/news-release/2016/04/03/825231/0/en/Alder-Presents-Preclinical-Data-for-ALD1613-at-ENDO-2016.html

Novartis Pharmaceuticals Health Policy Monthly Update : October

Presidential Candidates Release Proposals to Impact Drug Prices

Democratic candidates for President Hillary Clinton and Sen. Bernie Sanders introduced separate proposals that would impact pharmaceutical pricing and potentially inhibit innovation. The proposals include providing Medicaid-level rebates in Medicare Part D; allowing importation of drugs from other countries; reducing the exclusivity period for biologics; requiring negotiation with the federal government for Part D rebates; preventing certain patent settlements between innovator and generics companies; requiring pharmaceutical companies to invest a specific percentage of revenue in R&D; removing tax deductions for direct-to-consumer advertising; and pushing drug companies to price based on the value of treatments assessed via comparative effective analysis.
 
House Speaker Resigns, Government Shutdown Averted

John Boehner, Speaker of the House of Representatives, announced that he will resign from Congress, effective October 31. With his resignation, Speaker Boehner was able to put forth a bill to avert a partial government shutdown that would have begun October 1, 2015 if Congress had not passed legislation to provide funding to keep the government functioning. Previously, Speaker Boehner had faced threats to his leadership position if he put forward the bill, which included funding for Planned Parenthood. On September 30, legislation providing funding for the government until December 11 was passed by both the House and Senate and was signed by President Obama.
 
NCQA Releases Health Plan Ratings

The National Committee for Quality Assurance (NCQA) released a new health plan rating system, using a 1.0 to 5.0 scale with 5.0 indicating higher performance. This new rating system replaces their previous health plan ranking system. Evaluating more than 1,000 plans, including commercial, Medicaid, and Medicare Part D plans, the new rating system assesses three major performance categories, consumer satisfaction, prevention, and treatment and it provides a simple way for consumers to gauge the quality of care being provided by a health plan. The new plan rating system shows that Maine, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island, Vermont, Michigan, Minnesota, and Wisconsin had the highest percentage of plans receiving a 4.5 or 5.0 rating.

 
CMS Announces Medicare Advantage Value-Based Insurance Design

On September 1, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the Medicare Advantage Value-Based Insurance Design (VBID) Model, which will test the hypothesis that giving Medicare Advantage plans flexibility to offer targeted extra supplemental benefits or reduced cost sharing to enrollees who have specified chronic conditions can lead to higher quality and more cost-efficient care. The VBID Model will begin January 1, 2017 and run for five years. CMS will test the model in seven states: Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania, and Tennessee. Upon approval from CMS, eligible Medicare Advantage plans in these states can offer varied plan benefit design for enrollees who fall into the following clinical categories: diabetes, congestive heart failure, chronic obstructive pulmonary disease (COPD), past stroke, hypertension, coronary artery disease, and mood disorders.
 
Medicare Advantage and Part D Markets Largely Stable from 2015-2016

On September 21, 2015, CMS announced that premiums for Medicare Advantage (MA) plans will remain stable in 2016. CMS estimates that the average MA premium will decrease by $0.31 next year, from $32.91 on average in 2015 to $32.60 in 2016. Enrollment in MA is projected to increase to approximately 17.4 million enrollees, which represents about 32 percent of the Medicare population. Earlier this year, CMS announced that the average basic Medicare prescription drug plan premium in 2016 is projected to remain stable at $32.50 per month. The Annual Election Period for Medicare health and drug plans begins on October 15, 2015 and ends December 7, 2015.
 
CMS Announces the Enhanced Medication Therapy Management Model

On September 28, 2015, the Center for Medicare and Medicaid Innovation (CMMI) announced a five-year model to test approaches to improve Medicare Part D beneficiary medication use. The Part D Enhanced Medication Therapy Management (MTM) Model will test whether changes to the Part D program can help to better align the interests of plan sponsors with those of the federal government. Eligible basic stand-alone prescription drug plans (PDPs), upon approval from CMS, can vary the intensity and types of MTM items and services based on beneficiary risk level and seek out a range of strategies to individualize beneficiary and prescriber outreach and engagement. An initial five-year performance period will begin January 1, 2017 in five Part D regions spanning 11 states: Region 7 (Virginia), Region 11 (Florida), Region 21 (Louisiana), Region 25 (Iowa, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Wyoming), and Region 28 (Arizona).

 
HHS Releases Latest Exchange Enrollment Numbers

The U.S. Department of Health and Human Services (HHS) has released their latest enrollment numbers for both the federal and state exchanges. As is to be expected, actual enrollment is down slightly from the March report. Almost 9.9 million people had paid their first month’s premium as of June 30, slightly above the projected enrollment of 9.1 million people. Of those paying their premiums, 84%, or 8.3 million, received premium tax credits and 5.5 million people also received cost sharing subsidies. Premium tax credits averaged $270 a month. Approximately 423,000 people had their 2015 coverage terminated for failure to provide the necessary documentation of citizenship or legal immigrant status. More than 6.7 million people enrolled in a silver tiered plan, 2.1 million enrolled in bronze or catastrophic, almost 700,000 selected a gold tier and 332,000 picked platinum. In early September, CMS reported that Medicaid and CHIP enrollment had reached 72 million. The increase in both public and private insurance programs has dropped the national uninsured rate to below 10%.

 
HHS Issues Proposed Rule Regarding ACA’s Non-discrimination Provisions

HHS issued a draft rule providing clarity to the Affordable Care Act’s prohibition on discrimination in insurance coverage on the basis of race, color, age, national origin, sex, and disability. The proposed rule covers consumers’ rights under the ACA, obligations of covered entities, the inclusion of gender identify discrimination as a form of sex discrimination, requirements for effective communication to those with disabilities, and language assistance for those with limited English proficiency. Discriminatory practices in benefit plan design, marketing and cost sharing are prohibited. The proposed regulations apply to health insurers participating in the federal and state-based exchanges, Medicare Advantage and Medicaid programs. These protections are extended to all individual and group products sold by a participating insurer. As drafted, the proposed regulations are a step forward in eliminating discriminatory practices that prevent patients with chronic conditions from accessing necessary medication but opportunities for more specific language in the final regulations remain.

Pituitary ACTH Hypersecretion (Cushing’s Disease)

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Summary

This report provides comprehensive information on the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and special features on late-stage and discontinued projects.

Report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Request Sample Report:  Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H1 2015

Scope

– The report provides a snapshot of the global therapeutic landscape of Pituitary ACTH Hypersecretion (Cushing’s Disease)

– The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

– The report reviews key players involved in the therapeutics development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and enlists all their major and minor projects

– The report summarizes all the dormant and discontinued pipeline projects

– A review of the Pituitary ACTH Hypersecretion (Cushing’s Disease) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

– Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

– A detailed assessment of monotherapy and combination therapy pipeline projects

– Coverage of the Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline on the basis of target, MoA, route of administration and molecule type

– Latest news and deals relating related to pipeline products

Reasons to buy

– Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

– Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

– Develop strategic initiatives by understanding the focus areas of leading companies

– Identify and understand important and diverse types of therapeutics under development for Pituitary ACTH Hypersecretion (Cushing’s Disease)

– Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

– Devise corrective measures for pipeline projects by understanding Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline depth and focus of Indication therapeutics

– Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

– Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline”

 

 

From http://www.medgadget.com/2015/10/pituitary-acth-hypersecretion-cushings-disease-pipeline-review-h1-2015-by-reportbazzar.html

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