U.S Secondary Hyperparathyroidism (SHPT) Treatment Market Size, Share & Industry Analysis, By Drug Class (Calcimimetics, Vitamin D Analogues, and Phosphate Binders), By Distribution Channel (Hospital & Retail Pharmacies, Online Channels, and Others), and Region Forecast 2019-2032

The U.S secondary hyperparathyroidism (SHPT) treatment market size was valued at USD 4.34 billion in 2018 and is projected to reach USD 9.88 billion by 2032, exhibiting a CAGR of 7.5% during the forecast period (2018-2032).

Release of excessive parathyroid hormone resulting from persistent elevations in levels of biochemical markers of mineral metabolism is known as secondary hyperparathyroidism (SHPT). Patients with chronic kidney disease (CKD), as well as people who require renal replacement therapy, are affected by secondary hyperparathyroidism. According to current estimates of Centers for Disease Control and Prevention (CDC), around 15% of U.S adults, i.e. 37 million people are estimated to have CKD. Additionally, CKD is found more common in people aged 65 years or older than in people aged 45-64 years. Rising patient pool is associated with increasing cost burden for the treatment of secondary hyperparathyroidism.

Medications are commonly prescribed for SHPT, but in complex situations where thyroid glands secrete high levels of PTH, surgery is recommended. Surgical treatments have shown greater treatment accuracy, but high cost and availability of effective drugs in the market makes surgical treatment less preferable. Medications of SHPT are covered under Medicare national insurance program of the U.S. Recently, in January 2018, medications for the treatment of SHPT were included in the Part B bundle of the Medicare Insurance. There are many non-profit associations in the U.S. that aid the uninsured and underinsured patients, further making the treatment of SHPT affordable to all. Though the government provide health coverage through public insurance, patients are incurring a considerable out-of-pocket expenses.

International & national organizations in the U.S. and working groups such as the National Kidney Foundation have published various clinical guidance documents to encourage best practices in managing SHPT. Therefore, considering the above market analysis, increasing prevalence of SHPT in U.S., launch of secondary hyperparathyroidism drugs, rise in burden of SHPT treatment, and establishment of government guidelines for the secondary hyperparathyroidism treatment management are projected to drive the U.S. secondary hyperparathyroidism (SHPT) treatment market during the forecast period.

MARKET DRIVERS

“Consistent Rise in the Burden of SHPT due to Increased Patient Pool for Dialysis is likely to Propel the Secondary Hyperparathyroidism Treatment (SHPT) Market”

One of the crucial and significant driver for the market growth is the rising burden of SHPT due to increased patient pool for dialysis. A significant increase in the incidence rate of renal complications among the U.S. population is drawing attention to its associated accompanying disorders. Individuals with Chronic Kidney Disease (CKD) and End-stage Renal Disease (ESRD) are at high risk of developing secondary hyperparathyroidism. Significant rise in the prevalence of chronic diseases such as diabetes is a key indicator for the rising patient pool for renal disorders. In the U.S., diabetes is a major cause for the development of nephropathy. Over 9.4% of the population in the U.S. is diabetic. Owing to the fact that roughly 40% of the patients with diabetes develop nephropathy, the diabetes patients in the U.S. constitute around 12 million patients of CKD.

Moreover, SHPT develops in combination with vitamin D deficiency. OPKO Health, Inc. says that over 97% of the patients with ESRD shows symptoms of vitamin D insufficiency, which is a major indicator of SHPT development in a patient. Thus, increase in the prevalence of chronic disorders owing to the adoption of sedentary lifestyle is projected to drive the SHPT treatment market in the U.S.

“Establishment of Guidelines for the Improvement in Treatment Regimen to Drive the Secondary Hyperparathyroidism Treatment (SHPT) Market Worldwide”

Another critical driving factor for the U.S. secondary hyperparathyroidism (SHPT) treatment market is the government initiative for establishment of guidelines in order to improvise secondary hyperparathyroidism treatment management. The aim of SHPT treatment is to manage the biochemical markers of bone and mineral metabolism, which are directly linked to cardiovascular events and bone fractures by extensive epidemiologic evidence. Such complications aggravate the heavy financial costs associated with dialysis. Thus, various public & private organizations recommend the initiation of SHPT treatment at the start of stage 3 of CKD.

International & national organizations in the U.S. and working groups such as the National Kidney Foundation have published various clinical guidance documents to encourage best practices in managing SHPT. Increasing awareness about SHPT in physicians, as well as clinical specialists, have improved the treatment regimen for its management. The earlier identification and assessment of SHPT is hence improving the mineral metabolism in CKD & ESRD and reduce its associated complications. Such improved regimen for the management of SHPT is anticipated to propel the uptake of secondary hyperparathyroidism medications such as Calcimimetics, vitamin D analogues, and phosphate binders at an early stage of the disease.

SEGMENTATION

By Drug Class Analysis

“The Calcimimetics Segment Would Ensure to Generate the Highest Growth Rate During the Forecast Period”

On the basis of drug class, the secondary hyperparathyroidism treatment market can be segmented into calcimimetics, Vitamin D analogues, and phosphate binders.

The Vitamin D analogues segment dominated the U.S. market in 2018 with a value share of 48.9%. The segment is anticipated to remain leading during the forecast period, attributable to improved diagnosis of vitamin D insufficiency with the help of advanced vitamin D testing tools in the country. According to OPKO Health, Inc., one of the leading manufacturer of vitamin D analogue Rayaldee for SHPT, the test volume of vitamin D in the U.S. was 70 million in 2016. On the other hand, Calcimimetics accounted for the second-largest share in terms of revenue in 2018 and is likely to expand with relatively significant CAGR during 2019-2026. 

Factors contributing to the high growth of the calcimimetics segment are green signal by USFDA for numerous generic substitutes of Cinacalcet in the U.S. to cater to the rising demand for potent and specific therapy for the treatment of SHPT. For instance, the use of Cinacalcet has increased from 23% to 31% between 2014 and 2017, according to a national survey conducted by American Journal of Kidney Diseases. Moreover, eight generic substitutes of Sensipar have received approval by USFDA till now, out of which a few companies have launched their drugs. Such positive scenario for the uptake of Cinacalcet is expected to propel the expansion of Calcimimetics segment during the forecast period.

By Distribution Channel Analysis

“Hospital and Retail Pharmacies are Projected to Hold the Highest Market Share During the Forecast Period”

On the basis of distribution channel, the secondary hyperparathyroidism treatment (SHPT) market can be segmented into hospital & retail pharmacies, online channel, and others. The hospital & retail pharmacies segment holds the highest market share in the secondary hyperparathyroidism market. Hospital & Retail Pharmacies is estimated to be a leading distribution channel for secondary hyperparathyroidism therapeutics in the U.S., attributable to the consistent rise in the number of dialysis facilities in the country and availability of SHPT therapeutics with significant discounts in hospital pharmacies. There were over 152 dialysis facilities per 1,000 patients in Midwest region of the U.S., and around 14.3 facilities per 1,000 patients in North Dakota State of the Midwest region, in 2016.

The online channel segment in the secondary hyperparathyroidism treatment (SHPT) is anticipated to grow at a faster CAGR. This is primarily due to the surge in the investment by key distributors for the improvement of e-pharmacy network in the U.S. This is driving the uptake of secondary hyperparathyroidism drugs from online channels. In the U.S., around 8% of patients were on home dialysis in 2017. Rising number of patients preferring dialysis services at home is projected to increase the use of online channels for SHPT therapeutics in the U.S. Others segment consists of clinics, government tender systems, etc. Increasing patient pool for dialysis and introduction of generic therapeutics is likely to boost the growth of segment in the coming years.

REGIONAL ANALYSIS

Geographically, the U.S. SHPT treatment market is categorized into West, Midwest, South, and Northeast regions. South region generated a revenue of USD 1.93 Billion in 2018 and is anticipated to emerge dominant in the U.S. market during the forecast period. The dominance of South region is attributable to the availability of significant number of dialysis facilities with strategic presence of leading dialysis clinic networks such as Fresenius Care, DaVita, etc. in the region. Also, the southern region in the U.S. has the highest prevalence of secondary hyperparathyroidism owing to presence of elderly population with kidney diseases.

Significant prevalence of patients diagnosed with SHPT in states such as Iowa and South & North Dakota is a key factor for the second leading position of Midwest region in the U.S. SHPT treatment market. According to Centers for Disease Control and Prevention (CDC), 90% of the patients with stage-5 CKD (ESRD) suffer from SHPT in Midwest region. This significant patient pool is projected to boost the growth of SHPT treatment market during forecast period.

The Northeast region in the U.S. SHPT market is anticipated to grow with a higher CAGR during the forecast period. Improved reimbursement scenario in the U.S. with the coverage of major treatment options under part B Medicare is projected to augment the growth of West and Northeast region.

INDUSTRY KEY PLAYERS

“Amgen, Inc. has Strengthened its Market Position Across the Globe”

The secondary hyperparathyroidism treatment (SHPT) market is consolidated by Amgen Inc., having around 40% market share due to its strong product portfolio and key strategic decisions. Amgen provides blockbuster therapy Sensipar (Cinacalcet) for the treatment of SHPT. Recently, the market is witnessing an emergence of generic manufacturers, owing to the patent expiration of therapies. Companies such as Teva Pharmaceutical Industries Ltd., Abbvie, Sandoz, among others are players operating in the market. Growing competitive landscape between generic manufactures is also likely to drive the market growth of SHPT during the forecast period.

List Of key Companies Covered:

• Amgen Inc.


• Teva Pharmaceutical Industries Ltd.


• Genzyme Corporation (Sanofi)


• AbbVie Inc.


• Cipla Inc.


• Dr. Reddy’s Laboratories Ltd.


• OPKO Health, Inc.


• Other Prominent Players

REPORT COVERAGE

The increased demand for effective SHPT and establishment of guidelines for improvising treatment is expected to increase the U.S. secondary hyperparathyroidism treatment market growth. 

Along with this, the report provides an elaborative analysis of the U.S. market dynamics and competitive landscape. Various key insights presented in the report are the prevalence of secondary hyperparathyroidism, distribution of secondary hyperparathyroidism patients by treatment type – surgery, drugs and others, key industry developments, pipeline analysis, reimbursement scenario, cost burden of secondary hyperparathyroidism, competitive landscape, and company profiles.

Report Scope & Segmentation

INDUSTRY DEVELOPMENT:

• July 2019: LUPIN received approval from US health regulatory body for the generic Cinacalcet tablets used in the treatment of excess parathyroid hormone.


• May 2019: Cipla Inc. and its subsidiary Cipla USA Inc. announced the launch of generic form of Cinacalcet hydrochloride tablets in USA.


• February 2017: Amgen Inc. announced the USFDA approval of Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD).