all report title image
  • Published On : Nov 2022
  • Code : CMI5329
  • Industry : Pharmaceutical
  • Pages : 190
  • Formats :

Congenital Hyperinsulinism (CHI) is a condition that causes abnormal high level of insulin in an individual, insulin is the hormone that controls blood sugar level. There are different subdivisions of congenital hyperinsulinism which includes Diffuse KATP HI, exercised induced HI, focal KATP HI, GDH HI or HI/HA , GK HI, HNF4A/HNF1A HI, SCHAD. Excessive disregulation in insulin secretion from pancreatic beta cells may cause permanent brain damage and severe lifelong neurodisability. There are various subtypes and classification of congenital hyperinsulinism which includes Focal HI, Diffuse HI, K-ATP mutated HI, Transient HI, Persistent Hi, etc. There are certain immediate treatment goal to stabilize the level of insulin by certain methods like glucagon treatment, continuous infusions of glucagon, etc.

The global congenital hyperinsulinism treatment market is estimated to be valued at US$ 206.0 million in 2022 and is expected to exhibit a CAGR of 5.7% during the forecast period (2022-2030).

Figure 1. Global Congenital Hyperinsulinism Treatment Market Share (%), by Distribution Channel, 2022

Congenital Hyperinsulinism Treatment  | Coherent Market Insights

Global Congenital Hyperinsulinism Treatment Market- Drivers

Growing awareness of congenital hyperinsulinism among the population is expected to drive the global congenital hyperinsulinism treatment  global market. For instance, Congenital Hyperinsulinism International, a voluntary, non-profit organization focused on providing support such as disease diagnosis and disease management to the patient with CHI, and raising awareness among the people suffering from CHI. On 16 August 2022, the organization held a family conference where well renowned researchers, physicist, doctors, and patients of congenital hyperinsulinism with their family were featured. The conference were held to share the experience of patients and their family, to get the awareness about the disease and to know all the aspects of disease and its treatments.

Rise in research & development activities for the development of congenital hyperinsulinism drugs are expected to drive the market growth during the forecast period. For instance, in October 2021, Hanmi Pharm.Co., Ltd., a Pharmaceutical company initiated Phase 2 Clinical trial for HM15136 to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136, a Glucagon analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker, used as add-on therapy in subjects with CHI with persistent hypoglycemia and the trial is expected to be completed on March 2025.

CMI table icon

Congenital Hyperinsulinism Treatment Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 206.0 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 5.7% 2030 Value Projection: US$ 319.9 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Disease Type: KATP-HI, GDH-HI, GK-HI, Other (SCHAD HI, HNF4A/HNF1A, etc.)
  • By Drug Type: Diazoxide, Octerotide, Glucagon, Nifedepine, Other (Sirolimus, Chlorothiazide, etc.)
  • By Route of Administration: Oral, Parenteral
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies 
Companies covered:

Zealand Pharma A/S, Eli Lilly and Company, Xeris Pharmaceuticals, Inc., Rezolute, Inc., Hanmi Pharm.Co., Ltd., Fresenius Kabi AG, Eiger BioPharmaceuticals., 
Crinetics Pharmaceuticals, Inc., AmideBio,LLC, Jolly Healthcare, e5 Pharma,LLC, Merck & Co.,Inc., Novo Nordisk A/S, Amphaster Pharmaceuticals,Inc., USV Private Limited, Teva Pharmaceutical Industries Ltd

Growth Drivers:
  • Growing awareness about congenital hyperinsulinism disease as well as treatment
  • Rise in research & development activities for the development of novel therapies for the treatment of congenital hyperinsulinism 
Restraints & Challenges:
  • High treatment cost for congenital hyperinsulinism 

Figure 2.Global Congenital Hyperinsulinism Treatment Market Share (%), by Region, 2022

Congenital Hyperinsulinism Treatment  | Coherent Market Insights

Global Congenital Hyperinsulinism Treatment Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.

COVID-19 can affect the economy in three main ways: by directly affecting production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, U.A.E., Egypt, and others, are facing problems with regards to the transportation of drugs from one place to another.

Moreover, clinical trials of endocrinal disease therapies and treatments has negative effect of COVID-19. For instance, in September, 2020, an article was published by Nepal Journal of Epidemiology suggested that the COVID-19 pandemic had negative impact on the clinical trial activities of endocrinal diseases such as congenital hyperinsulinism. There was decrease in new patient/subject enrollment which was due to mitigation efforts such as self-isolation and inaccessibility of health care facilities during pandemic with all aspects of clinical trials at various levels. The observed decrease in new subject enrollment in clinical trials was 64% in March 2019 to march 2020, 91 % in April 2019 to April 2020, and 89% in May 2019 to May 2020.

Global Congenital Hyperinsulinism Treatment Market: Key Developments

Glucagon, one of the primary medication of congenital hyperinsulinism shows promising results in treating congenital hyperinsulinism. For instance, in March 16, 2022, Xeris Pharmaceuticals, Inc., a biopharmaceutical company, develop a therapy for patients populations in endocrinology, a GVOKE kit (Glucagon Injection), containing liquid stable glucagon which is used to treat congenital hyperinsulinism. GVOKE was evaluated in a clinical trial in 31 pediatric patients with type 1 diabetes 100% (30/30) of pediatric patients had their glucose levels raise to safe levels.

This kit is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.

Global Congenital Hyperinsulinism Treatment Market: Restraint

The major factors that hinder growth of the global congenital hyperinsulinism treatment market include high cost of total annual treatment of first line of therapy. For instance, according to the data published by BioMedCentral Journal, an Orphanet Journal of rare diseases, in July 2018, the total annual cost of first line therapy is substantially high for congenital hyperinsulinism because of lack of response that is the cost of illness of CHI patients was US$ 13,144,870 annually and average cost per patient was US$ 2,083.19. Cost distribution was skewed among CHI patients, with 5.9% of patients (95 patients in their first year of life) contributing to 61.8% (U.S$ 2105491) of total costs which is high as compared to first line therapies.

Global Congenital Hyperinsulinism Treatment Market: Key Players

Major players operating in the global congenital hyperinsulinism treatment market include Zealand Pharma A/S, Eli Lilly and Company, Xeris Pharmaceuticals, Inc., Rezolute, Inc., Hanmi Pharm.Co., Ltd., Fresenius Kabi AG, Eiger BioPharmaceuticals., Crinetics Pharmaceuticals, Inc., AmideBio,LLC, Jolly Healthcare, e5 Pharma,LLC, Merck & Co.,Inc., Novo Nordisk A/S, Amphaster Pharmaceuticals,Inc., USV Private Limited, Teva Pharmaceutical Industries Ltd.

Congenital hyperinsulinism(CHI) also called as hyperinsulinemic hypoglycemia, a rare endocrine condition that causes low blood glucose levels and occurs mainly in newborn babies, infants and children leading to permanent brain injury and is most frequent cause of severe hypoglycemia. Over secretion of insulin by beta cells in pancreas leads to gene mutation in KATP channel genes (ABCC8 and KCNJ11, HNF4A, HNF1A, HADH, and UCP2 or activating mutations of GLUD1, GCK, and SLC16A1) that cause congenital hyperinsulinism. There is significant risk of permanent brain damage in CHI, hence it is necessary to make a prompt diagnosis and obtain immediate management of the disease to prevent complications such as epilepsy, cerebral palsy and neurodevelopmental deficits. According to the National Organization for Rare Disorders database, approximately 1/25,000 to 1/50,000 HI births occurs in most of the countries including HI develop hypoglycemia during the first month of life. Irritability, sleepiness, excessive hunger, rapid heart rate are common symptoms that occurs while more severe symptoms, such as seizures and coma occur. There are many causes of congential hyperinsulinism based on different forms of the disease for example there are transient forms while some are due to genetic defects and persist for life. Prematurely born babies sometimes, develop hypoglycemia due to excessive insulin secretion. The cause of this inappropriate insulin secretion is still not clear, but it can last a few days to months.

Market Dynamics

Ongoing research for development of novel therapeutic options for the treatment of congenital hyperinsulinismby various key players such as Zealand Pharma A/S, Hanmi Pharm.Co., Ltd., Eli Lilly and Company is anticipated to drive the growth of global congenital hyperinsulinismtreatment market over the forecast period. For instance, in May 2019, Zealand Pharma A/S, a biotechnology company initiated Phase 3 clinical trial of Dasiglucagon. The study aims to assess the efficacy and safety of Dasiglucagon for the treatment of pediatric patients with congenital hyperinsulinism. The study is estimated to be completed by December 2022.  Dasiglucagon is a peptide analogue of glucagon consisting 7 amino acid substitutions engineered to eliminate fibril formation as well as peptide aggregation.

Key features of the study:

  • This report provides an in-depth analysis of the global congenital hyperinsulinism treatment market, and provides market size (US$ Million) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global congenital hyperinsulinism treatment market  based on the following parameters – company highlights, products portfolio, key highlights, financial performance, and strategies
  • Key companies covered as a part of this study are Zealand Pharma A/S, Eli Lilly and Company, Xeris Pharmaceuticals, Inc., Rezolute, Inc., Hanmi Pharm.Co., Ltd., Fresenius Kabi AG, Eiger BioPharmaceuticals., Crinetics Pharmaceuticals, Inc., AmideBio, LLC, Jolly Healthcare, e5 Pharma,LLC, Merck & Co.,Inc., Novo Nordisk A/S, Amphaster Pharmaceuticals,Inc., USV Private Limited, Teva Pharmaceutical Industries Ltd.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global congenital hyperinsulinism treatment market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global congenital hyperinsulinism treatment market

Detailed Segmentation:

  • Global Congenital Hyperinsulinism Treatment Market, By Disease Type:
    • KATP-HI
    • GDH-HI
    • GK-HI
    • Other (SCHAD HI, HNF4A/HNF1A, etc.)
  • Global Congenital Hyperinsulinism Treatment Market, By Drug Type:
    • Diazoxide
    • Octerotide
    • Glucagon
    • Nifedipine
    • Other (Sirolimus, Chlorothiazide, etc.)
  • Global Congenital Hyperinsulinism Treatment Market, By Route of Administration:
    • Oral
    • Parental
  • Global Congenital Hyperinsulinism Treatment Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies 
    • Online Pharmacies 
  • Global Congenital Hyperinsulinism Treatment Market, By Region:
    • North America
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Region/Country
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Hanmi Pharm.Co., Ltd.,
      • Company Highlights
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Zealand Pharma A/S
    • Eli Lilly and Company
    • Xeris Pharmaceuticals, Inc.,
    • Rezolute, Inc.,
    • Fresenius Kabi AG
    • Eiger BioPharmaceuticals.,
    • Crinetics Pharmaceuticals, Inc.,
    • AmideBio,LLC
    • Jolly Healthcare
    • e5 Pharma,LLC
    • Merck & Co., Inc.
    • Novo Nordisk A/S
    • Amphaster Pharmaceuticals, Inc.
    • USV Private Limited
    • Teva Pharmaceutical Industries

 “*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global congenital hyperinsulinism treatment market size is estimated to be valued at US$ 206.0 million in 2022 and is expected to exhibit a CAGR of 5.7% between 2022 and 2030.
Factors such as growing awareness of congenital hyperinsulinism among the people at global level, and ongoing clinical trial phase 2 and 3 studies of drugs on congenital hyperinsulinism are the major factors which drives the market.
Hospital Pharmacies is the leading distribution channel segment in the market.
The major factors hampering growth of the market include high treatment cost for congenital hyperinsulinism.
Major players operating in the market include Zealand Pharma A/S, Eli Lilly and Company, Xeris Pharmaceuticals, Inc., Rezolute, Inc., Hanmi Pharm.Co., Ltd., Fresenius Kabi AG, Eiger BioPharmaceuticals., Crinetics Pharmaceuticals, Inc., AmideBio,LLC, Jolly Healthcare, e5 Pharma,LLC, Merck & Co.,Inc., Novo Nordisk A/S, Amphaster Pharmaceuticals,Inc., USV Private Limited, Teva Pharmaceutical Industries Ltd.

Related Reports

EXISTING CLIENTELE

Joining thousands of companies around the world committed to making the Excellent Business Solutions.

View All Our Clients
trusted clients logo