#Secondary Hyperparathyroidism epidemiology

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Secondary Hyperparathyroidism Market, Epidemiology, Clinical Trials and FDA Approvals by DelveInsight | Amgen, OPKO Health, AbbVie, Shire, Roche, Sanofi, Kyowa Hakko Kirin, Astellas Pharma, Leo Pharma

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Secondary Hyperparathyroidism Market, Epidemiology, Clinical Trials and FDA Approvals by DelveInsight | Amgen, OPKO Health, AbbVie, Shire, Roche, Sanofi, Kyowa Hakko Kirin, Astellas Pharma, Leo Pharma

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Medullary carcinoma of the thyroid (MTC) accounts for less than 5% of thyroid cancer. MTC arises from the C cells of the thyroid, which do not accumulate radioiodine, and it secretes calcitonin (Ctn), which is used as a tumor marker. Sporadic, or isolated, MTC accounts for 75% of cases and the remaining 25% are part of multiple endocrine neoplasia type 2 (MEN2), an autosomal-dominant syndrome caused by germline-activating mutations in the RET proto-oncogene. [1] These features allow early recognition of sporadic MTC using Ctn screening in patients with thyroid nodules and preclinical diagnosis of patients with MEN2 by RET gene analysis. Outcome depends on extent of disease, nature of tumor biology, and overall efficacy of surgical treatment.

Advances in genetic testing in have revolutionized the management of this disease, by allowing risk stratification of patients with inherited mutations and identifying molecular targets for therapy. Prophylactic thyroidectomy is indicated for patients who carry mutations that put them at risk for aggressive MTC.

Surgery remains the standard of care for localized disease and for oligometastatic disease. Several tyrosine kinase inhibitors are approved for use in progressive, metastatic MTC, and a variety of agents have entered clinical trials. External beam radiotherapy is used in certain situations.

Medullary thyroid cancer (MTC) is usually diagnosed on physical examination as a solitary neck nodule. Early spread to regional lymph nodes is common. Distant metastases occur in the liver, lung, bone, and brain.

Sporadic MTC usually is unilateral. MTC in association with multiple endocrine neoplasia (MEN) syndromes is always bilateral and multicentric, with presentation earlier in life. MTC typically is the first abnormality observed in both MEN 2A and 2B syndromes.

In addition to producing calcitonin, MTC cells can produce several other hormones, including corticotropin, serotonin, melanin, and prostaglandins. Moreover, paraneoplastic syndromes (eg, carcinoid syndrome, Cushing syndrome) can occur in these patients.

Etiology

Sporadic MTC occurs in 75% of patients, and inherited MTC constitutes the rest. MTC is the dominant component of the multiple endocrine neoplasia (MEN) type 2 syndromes, MEN2A and MEN2B. MEN2A accounts for 95% of the cases. The following four variants have been recognized:

Classical MEN2A - The most common variant. MTC is uniformly present; pheochromocytoma, primary hyperparathyroidism, or both occur less frequently.

MEN2A with cutaneous lichen amyloidosis (CLA) - CLA may present in young patients, before the onset of clinically evident MTC

MEN2A with Hirschsprung disease

Familial medullary thyroid carcinoma (FMTC) - MTC only, in the absence of a family history of pheochromocytoma or hyperparathyroidism

Mutations in RET, a transmembrane proto-oncogene located on chromosome 10q11.2, are responsible for MEN2. Although its function is still unknown, the protein produced by RET is critical during embryonic development of the enteric nervous system and kidneys. RET consists of 3 domains, including a cysteine-rich extracellular receptor domain, a hydrophobic transmembrane domain, and an intracellular tyrosine kinase catalytic domain.

RET germline mutations are present in virtually all patients with MEN2A and MEN2B, and somatic RET mutations are present in approximately 50% of sporadic MTCs. In sporadic MTC that is RET mutation–negative, mutations in genes involving the RAS pathway—HRAS, KRAS, or (rarely) NRAS—are often found.

Epidemiology

Thyroid cancer represents approximately 3% of new malignancies occurring annually in the United States, with an annual incidence of approximately 14 per 100,000. Of these cancer diagnoses, 2% to 3% are medullary thyroid carcinoma (MTC), which translates into approximately 1080-1620 new diagnoses per year. Unlike the rising incidence rates of papillary thyroid cancer and other differentiated thyroid cancers, incidence rates for MTC (as well as follicular) thyroidcancers have remained relatively stable over the past 30 years.The incidence rate of MTC in Europe is 0.11 per 100,000 person-years, with no noted substantial differences by race/ethnicity and sex. Peak incidence of isolated MTC occurs in the fifth or sixth decade of life. The peak incidence of MTC associated with multiple endocrine neoplasia (MEN) 2A or 2B occurs during the first to third decade of life.

Prognosis

Prognosis depends on patient age, histologic grade, and status of surgical resection. Patients with a worse prognosis tend to be older, have higher-grade lesions, and have undergone incomplete surgical resection of the lesion. The 5-year relative survival for stages I to III is about 93% compared to 28% for stage IV. [6]Isolated medullary carcinoma of the thyroid (MTC) typically demonstrates a relatively indolent biologic progression. While regional lymph node metastases are possible, the lesion may not spread outside of the cervical region until several months later. MTC associated with multiple endocrine neoplasia (MEN) syndromes may have a more aggressive course, which also depends on associated comorbidity (eg, pheochromocytoma).

Despite advances in genetic screening for the RET proto-oncogene, preliminary population studies have yet to show a definitive impact on disease prognosis.

A study by Rohmer et al concluded that disease-free survival (DFS) in younger patients (>21 y) with hereditary MTC was best predicted by TNM staging and preoperative basal CT level of less than 30 pg/mL. Basal CT findings, class D genotype, and age were the key factors in deciding peroperatively timely surgery.In a meta-analysis of 27 studies involving 984 MTC patients who underwent reoperation, Rowland and colleagues found that normalization of calcitonin after reoperation occurred in 16.2% of patients overall. Patients who underwent targeted selective lymph node removal procedures showed normalization of calcitonin in 10.5% of cases, while normalization was seen in 18.6% of those who underwent compartment-oriented procedures.

Permanent hypoparathyroidism and recurrent laryngeal nerve palsy reportedly occur in less than 2% of virgin neck dissections. Reoperation is associated with a considerably higher risk of these injuries.

Clinical picture

A specific constellation of symptoms of medullary thyroid carcinoma (MTC) is not usually noted; however, one or more of the following symptoms may be observed:

Patients may describe a lump at the base of the neck, which may interfere with or become more prominent during swallowing

Patients with locally advanced disease may present with hoarseness, dysphagia, and respiratory difficulty

Although uncommon, patients may present with various paraneoplastic syndromes, including Cushing or carcinoid syndrome

Diarrhea may occur from increased intestinal electrolyte secretion secondary to high plasma calcitonin levels

Distant metastases (eg, lung, liver, bone) may result in weight loss, lethargy, and bone pain

Physical Examination

Physical examination may demonstrate a dominant thyroid nodule at the base of the neck. Palpable cervical lymphadenopathy signifies disease that has progressed locally. Icterus, and rarely, bone tenderness may occur in patients with systemic metastases.

Cutaneous lichen amyloidosis in MEN 2A patients manifests as multiple pruritic, hyperpigmented, lichenoid papules in the scapular area of the back. Men2B patients may have a marfanoid habitus with mucosal neuromas.

Labile hypertension may be seen in those with an associated pheochromocytoma.

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From the UpToDate article on hypovitaminosis D:

The optimal serum 25-hydroxyvitamin D (25[OH]D) concentration for skeletal health and extraskeletal health is controversial, and it has not been rigorously established for the population in general or for specific ethnic groups. We favor maintaining the serum 25(OH)D concentration between 20 and 40 ng/mL (50 to 100 nmol/L). (See 'Defining vitamin D sufficiency' above.)

●There are several causes of vitamin D deficiency, including decreased intake or absorption, reduced sun exposure, increased hepatic catabolism, decreased endogenous synthesis (via decreased 25-hydroxylation in the liver or 1-hydroxylation in the kidney), or end-organ resistance to vitamin D (table 1). (See "Causes of vitamin D deficiency and resistance".)

●The clinical manifestations of vitamin D deficiency depend upon the severity and duration of the deficiency. The majority of patients with serum 25(OH)D between 12 and 20 ng/mL (37.5 and 50 nmol/L) are asymptomatic. With prolonged severe vitamin D deficiency, there is reduced intestinal absorption of calcium and phosphorus and hypocalcemia occurs, causing secondary hyperparathyroidism, which leads to phosphaturia, demineralization of bones, and, when prolonged, osteomalacia in adults. (See 'Clinical manifestations' above and "Clinical manifestations, diagnosis, and treatment of osteomalacia".)

●The approach to testing and replenishment is based upon an initial assessment of a patient's risk for having a low serum 25(OH)D level. For low-risk adults, we suggest not routinely screening individuals for vitamin D deficiency (Grade 2C). Rather than screen, we suggest intake of 600 to 800 international units (15 to 20 micrograms) of vitamin D daily (Grade 2B). (See 'Optimal intake to prevent deficiency' above.)

●For high-risk adults in whom there is a clinical suspicion that the usual doses are inadequate (eg, older homebound or institutionalized individuals, those with limited sun exposure, obesity, dark skin, osteoporosis, malabsorption), measurement of serum 25(OH)D concentrations is useful to ensure that supplementation is adequate. (See 'Groups at high risk' above and 'Candidates for 25(OH)D measurements' above.)

●The majority of healthy adults with serum 25(OH)D in the range of 12 to 20 ng/mL (30 to 50 nmol/L) do not require any additional evaluation. Patients with serum 25(OH)D levels <12 ng/mL are at risk for developing osteomalacia. In such patients, we measure serum calcium, phosphorus, alkaline phosphatase, parathyroid hormone (PTH), electrolytes, blood urea nitrogen (BUN), creatinine, and tissue transglutaminase antibodies (to assess for celiac disease). Some UpToDate editors also measure similar tests in patients with serum 25(OH)D between 12 and 20 ng/mL, particularly if the level is 12 to 15 ng/mL (30 to 37.5 nmol/L) and there is clinical concern for a secondary cause of vitamin D deficiency (eg, malabsorption, celiac disease). Radiographs are necessary only in certain settings, such as the presence of bone pain. (See 'Evaluation' above.)

●For high-risk adults with serum 25(OH)D levels <20 ng/mL (50 nmol/L), we recommend vitamin D repletion (Grade 1A). (See 'Defining vitamin D sufficiency' above.)

For patients with serum 25(OH)D <12 ng/mL (30 nmol/L), one common approach is to treat with 50,000 international units (1250 micrograms) of vitamin D2 or D3 orally once per week for six to eight weeks, and then 800 international units (20 micrograms) of vitamin D3 daily thereafter. (See 'Dosing' above.)

For individuals with serum 25(OH)D levels in the range of 12 to 20 ng/mL (30 to 50 nmol/L), many clinicians supplement initially with 800 to 1000 international units (20 to 25 micrograms) daily. (See 'Dosing' above.)

●For individuals with serum 25(OH)D levels of 20 to 30 ng/mL (50 to 75 nmol/L), 600 to 800 international units (15 to 20 micrograms) of vitamin D3 daily may be sufficient to maintain levels in the target range. (See 'Dosing' above.)

●We suggest cholecalciferol (vitamin D3), when available, rather than ergocalciferol (vitamin D2) for vitamin D supplementation (Grade 2C). (See 'Preparations' above.)

●Follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved. (See 'Monitoring' above.)

●All patients should maintain a daily total calcium intake (diet plus supplement) of 1000 mg (for ages 19 to 70 years) to 1200 mg (for women ages 51 through 70 years and all adults 71 years and older). (See 'Calcium' above.)

These recommendations assume that the patient is not vitamin D resistant (see "Hypophosphatemia: Causes of hypophosphatemia", section on 'Vitamin D deficiency or resistance' and "Epidemiology and etiology of osteomalacia"). Such patients need a higher dose of vitamin D.

Vitamin D supplementation for patients with inflammatory bowel disease or celiac disease (many of whom have osteoporosis) is discussed elsewhere. (See "Metabolic bone disease in inflammatory bowel disease" and "Management of celiac disease in adults".)

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Secondary Hyperparathyroidism Market Analysis, Leading Companies, Emerging Drugs and Epidemiology Forecast

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Secondary Hyperparathyroidism Market Analysis, Leading Companies, Emerging Drugs and Epidemiology Forecast

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Chronic Kidney Disease (Chronic Renal Failure) Market Scenario

Chronic kidney disease (CKD) is a syndrome where there are persistent alterations in kidney structure, function, or both with implications on the health of the individual. Examples of structural abnormalities include cysts, tumors, malformations and atrophy, which are evident on imaging. By contrast, kidney dysfunction can manifest as hypertension, edema, changes in output or quality of urine and growth delay in children, these changes are most often recognized by increased serum levels of creatinine, cystatin C, or blood urea nitrogen. The most common pathological manifestation of CKD, regardless of the initiating insult or disease, is some form of renal fibrosis. 

DelveInsight’s ‘Chronic kidney disease (CKD) - Market Insights, Epidemiology and Market Forecast-2030" report delivers an in-depth understanding of the disease, historical &forecasted epidemiology as well as the market trends of CKD in the United States, EU5 (Germany, Spain, Italy, France and United Kingdom) and Japan.

The Report provides the current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted market size of Chronic kidney disease (CKD) from 2017 to 2030 segmented by seven major markets. The Report also covers current treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assess underlying potential of the market.

Geography Covered

• The United States

• EU5 (Germany, France, Italy, Spain and the United Kingdom)

• Japan

Study Period: 2017–2030

Chronic kidney disease (CKD) Treatment Algorithm

Several aspects need to be considered when managing patients with CKD, including controlling further nephron injury, normalizing single-nephron hyperfiltration, controlling CKD-related complications and preparing the patient for kidney replacement therapy. At the core of these is the principle of ‘the earlier, the better’, which is the effort to reduce the progression to ESRD and optimize renal outcomes. 

Chronic Kidney Disease Diagnosis

The clinical presentation of CKD depends on the underlying disorder and the severity of renal impairment. Patients with early stages of CKD (G1–G2) are usually asymptomatic, but from CKD G3 onwards, patients may experience weakness related to anemia and polyuria. CKD can be detected during a routine periodic health assessment, during the evaluation of individuals at risk of CKD, as a consequence of the incidental finding of abnormal laboratory values in connection with another acute or chronic illness, during an investigation of symptoms and/or signs relating to the kidneys or urinary tract (such as hematuria) or after the discovery of abnormal laboratory values in a population-based screening program.

Chronic Kidney Disease Treatment 

It covers the details of conventional and current medical therapies available in the Chronic Kidney Disease market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithm across the United States, Europe and Japan. 

The DelveInsight Chronic Kidney Disease market report gives a thorough understanding of CKD by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides CKD treatment algorithms and treatment guidelines in the US, Europe, and Japan. 

Request for sample pages: https://www.delveinsight.com/sample-request/chronic-kidney-disease-chronic-renal-failure-market

Chronic kidney disease Epidemiology

The Chronic kidney disease (CKD) epidemiology division provide the insights about historical and current patient pool and forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings 

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology (Diagnosed Prevalent cases of CKD, Prevalent cases of CKD by stage, Prevalent cases of CKD by etiologies, Comorbidities associated with CKD, Dialysis dependency in CKD) scenario of Chronic kidney disease (CKD) in the 7MM covering United States, EU5 countries (Germany, Spain, Italy, France and United Kingdom) and Japan from 2017–2030. According to DelveInsight, the total number of prevalent cases of Chronic kidney disease (CKD) in 7 MM was found to be 122,704,658 in the year 2017.

Chronic kidney disease Drug Chapters

This segment of the Chronic Kidney Disease report encloses the detailed analysis of marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details and the latest news and press releases.

The chronic kidney disease (CKD) drugs market is categorized on the basis of drug class such as Erythropoietin stimulating agents (ESA), Angiotensin-converting-enzyme inhibitors and Angiotensin receptor blockers (ACE-I and ARBs), Antidiabetics, Secondary Hyperparathyroidism Treatment (SHPT), and Urate Lowering Therapies.

Chronic kidney disease Marketed Drugs

Aranesp (darbepoetin alfa): Amgen 

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. It is a synthetic form of erythropoietin that stimulates erythropoiesis (increases red blood cell levels) and is used to treat anemia, commonly associated with chronic renal failure and cancer chemotherapy and works similar like endogenous erythropoietin

Products detail in the report…

Chronic kidney disease Emerging Drugs

Daprodustat: GlaxoSmithKline

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. The product is being developed by GlaxoSmithKline and company has filed the application to the Japan authorities for the treatment of Anemia Associated with Chronic Kidney Disease.

Products detail in the report…

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Chronic Kidney Disease Market Outlook

The Chronic kidney disease market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted trend of the market by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology. 

This segment gives a through detail of market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the market of chronic kidney disease in 7MM is expected to undergo a major positive shift during the course of the study period (2017–2030). Among the 7MM, the United States accounts for the largest market size of CKD, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan. As per DelveInsight's analysis the market size for CKD is expected to increase with a CAGR of 5.9% during the forecast period for 7MM.

Key Findings

This section includes a glimpse of the Chronic Kidney Disease market in 7MM.

The United States Market Outlook

This section provides the total Chronic Kidney Disease market size and market size by therapies in the United States.

EU-5 Countries: Market Outlook

The total Chronic Kidney Disease market size and market size by therapies in Germany, France, Italy, Spain and the United Kingdom is provided in this section.

Japan Market Outlook 

The total Chronic Kidney Disease market size and market size by therapies in Japan is also mentioned. 

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