世界の高トリグリセライド血症市場パイプライン

Report Overview

KEY FINDINGS
Hypertriglyceridemia (HTG) is a condition marked by high triglyceride levels in the blood. Triglycerides, a type of fat, are sourced from dietary intake and produced by the body.

高トリグリセリド血症 (HTG) は、血中のトリグリセリド濃度が高いことを特徴とする状態です。脂肪の一種であるトリグリセリドは、食事から摂取され、体内で生成されます。

Elevated triglyceride levels pose risks for cardiovascular diseases like heart disease and stroke.
Additionally, hypertriglyceridemia correlates with obesity, poorly controlled diabetes, hypothyroidism, liver or kidney disease, and specific genetic disorders. Lifestyle factors such as high-fat diets, excessive alcohol consumption, and physical inactivity can elevate triglycerides. Treatment includes dietary changes, weight management, regular exercise, and medication as necessary.

MARKET INSIGHTS
Key growth enablers of the global hypertriglyceridemia market:
• Heightened awareness of hypertriglyceridemia
• Growing prevalence of hypertriglyceridemia
• Widening range of treatment options
o Hypertriglyceridemia can be managed through lifestyle changes such as reducing fat and carbohydrate intake, limiting alcohol, quitting smoking, and regular exercise.
o Moreover, therapeutic approaches such as statins and fibrates are employed to reduce triglyceride (TG) levels. Currently, statins and fibrates represent the main pharmacological therapies for hypertriglyceridemia (HTG). However, certain patients may be ineligible for or may not respond to these treatments.
o To address this gap, companies are developing new therapeutic approaches aimed at more effectively reducing triglycerides in the bloodstream and mitigating the impact of HTG. Notably, approaches targeting apolipoprotein C-III and ANGPTL are being extensively explored.
o In parallel, emerging drugs based on apolipoprotein C-III have shown promising results and are expected to reach the market in the near future. The anticipated launch of these innovative treatments could significantly advance HTG management, providing improved options for patients resistant to current therapies.
Key growth restraining factors of the global hypertriglyceridemia market:
• Setbacks in new treatment development
o Drug and product development for HTG is facing a high rate of clinical trial failures, occurring in the early phases and the later stages of development.
o In line with this, Pfizer and Ionis recently discontinued the Phase III drug Vupanorsen after Phase II results did not justify continuing the clinical development program.
o Similarly, other pharmaceutical companies have faced significant setbacks in late-stage clinical trials, even after promising outcomes in earlier stages.
o Failures can arise at any stage during the development of emerging drugs. Initial clinical trial outcomes are not always indicative of later-stage results, and they can vary significantly across different patient cohorts. Hence, these setbacks with emerging therapies represent a significant barrier to market growth.
• Obstacles in gaining regulatory approval
• Recommendation for lifestyle and dietary changes
• Suboptimal results from clinical trials
Hypertriglyceridemia | Disease Overview
• Introduction
• Symptoms
• Causes
o The causes of hypertriglyceridemia can be divided into genetically based disorders (primary disorders) and secondary disorders caused by other conditions.
o Lipoprotein lipase (LPL) deficiency and Apolipoprotein (Apo) C-II deficiency are two well-characterized genetic forms of HTG occurring in infancy as chylomicronemia syndromes, leading to early childhood HTG. In adults, severe HTG is often indicated by extremely high fasting levels of chylomicrons, very low-density lipoproteins (VLDL), and remnants.
o Among the most common secondary causes of HTG are obesity, untreated diabetes mellitus, alcohol consumption, pregnancy, and various medications. Many of these secondary causes are associated with abnormalities in insulin responsiveness.
• Diagnosis
o Hypertriglyceridemia (HTG) is diagnosed via a fasting lipid panel. As per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines, HTG is classified based on triglyceride levels: mild (150-199 mg/dL), high (200-499 mg/dL), and very high (≥500 mg/dL).
o When triglycerides exceed 400 mg/dL, LDL-C levels are often estimated using the Friedewald equation, which may underestimate LDL-C. Alternatively, non-HDL-C (total cholesterol minus HDL cholesterol) or direct LDL-C measurement can be considered.
o Assessing LDL size or density is not considered beneficial for managing cardiovascular events in HTG. Apo B and Lp(a) levels may assist in assessing cardiovascular risk. Therapeutic options include effectively lowering Apo B levels, while niacin and estrogen may reduce Lp(a). However, evidence does not conclusively support that reducing Lp(a) prevents atherosclerotic cardiovascular disease.
o High Lp(a) levels correlate with premature cardiovascular disease, warranting aggressive LDL management when Lp(a) levels are elevated. Hepatic steatosis or non-alcoholic steatohepatitis (NASH) often coexists with HTG due to insulin resistance. Elevated aminotransferases in liver function tests suggest further evaluation, including liver ultrasound.
• Treatment

COMPETITIVE INSIGHTS
Major players in the global hypertriglyceridemia market:
• Arrowhead Pharmaceuticals Inc
• Ionis Pharmaceuticals Inc
• 89Bio Inc
• Rivus Pharmaceuticals Inc
• Regeneron Pharmaceuticals Inc
• MediciNova Inc
• Matinas BioPharma Holdings Inc
Arrowhead Pharmaceuticals Inc (Arrowhead) is a biotechnology company specializing in the development and commercialization of gene silencing therapeutics. The company employs RNA chemistries and its proprietary TRiM platform to target and silence genes that cause diseases. Arrowhead’s product pipeline includes ARO-AAT, GSK4532990, ARO-ANG3, ARO-APOC3, ARO-PNPLA3, ARO-C3, ARO-ENaC2, ARO-MUC5AC, ARO-RAGE, ARO-COV, ARO-DUX4, ARO-MMP7, JNJ-3989, ARO-SOD1, HZN-457, and Olpasiran. These therapeutics address various conditions, including hypertriglyceridemia, dyslipidemia, facioscapulohumeral muscular dystrophy, complement-mediated diseases, and muco-obstructive or inflammatory pulmonary conditions. They also target liver disease, idiopathic pulmonary fibrosis, gout, cardiovascular disease, and chronic hepatitis B. Moreover, Arrowhead operates laboratory facilities in San Diego, California, and Madison, Wisconsin, with its headquarters located in Pasadena, California, United States.
The company is developing Plozasiran, a drug designed to reduce the production of Apolipoprotein C-III (apoC-III). ApoC-III is a key component of triglyceride-rich lipoproteins (TRLs) such as VLDL and chylomicrons, and it is fundamental in regulating triglyceride metabolism. The company anticipates that reducing hepatic production of apoC-III could potentially decrease VLDL synthesis and assembly, enhance the breakdown of TRLs, and improve the clearance of VLDL and chylomicron remnants. Plozasiran is presently undergoing Phase II clinical trials for treating severe hypertriglyceridemia.
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Frequently Asked Questions (FAQs):
• Can children have hypertriglyceridemia?
A: Yes, children can also develop hypertriglyceridemia, especially if they have a family history of lipid disorders or if they lead sedentary lifestyles and consume unhealthy diets. Early detection and intervention are crucial to prevent long-term health complications.

• Is hypertriglyceridemia the same as high cholesterol?
A: No, while related, hypertriglyceridemia specifically denotes elevated levels of triglycerides in the bloodstream. High cholesterol typically refers to elevated levels of LDL (low-density lipoprotein) cholesterol, commonly known as bad cholesterol, which also poses a risk factor for cardiovascular disease.

Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. HYPERTRIGLYCERIDEMIA: SUMMARY
3. OVERVIEW
3.1. INTRODUCTION
3.2. CLASSIFICATION OF HYPERTRIGLYCERIDEMIA (HTG)
3.3. METABOLISM OF TRIGLYCERIDE-RICH LIPOPROTEINS
3.4. ETIOLOGY AND RISK FACTORS
3.5. CLINICAL SIGNS AND SYMPTOMS
3.6. DIAGNOSIS
3.6.1. DIFFERENTIAL DIAGNOSIS
3.7. TREATMENT AND MANAGEMENT
4. MARKET DYNAMICS
4.1. KEY DRIVERS
4.1.1. HEIGHTENED AWARENESS OF HYPERTRIGLYCERIDEMIA
4.1.2. GROWING PREVALENCE OF HYPERTRIGLYCERIDEMIA
4.1.3. WIDENING RANGE OF TREATMENT OPTIONS
4.2. KEY RESTRAINTS
4.2.1. SETBACKS IN NEW TREATMENT DEVELOPMENT
4.2.2. OBSTACLES IN GAINING REGULATORY APPROVAL
4.2.3. RECOMMENDATION FOR LIFESTYLE AND DIETARY CHANGES
4.2.4. SUBOPTIMAL RESULTS FROM CLINICAL TRIALS
5. PIPELINE THERAPEUTICS
5.1. CURRENT PIPELINE OVERVIEW
5.2. COMPARATIVE ANALYSIS: PRODUCTS IN VARIOUS PHASES
6. THERAPEUTIC ASSESSMENT: ACTIVE PRODUCTS
6.1. EVALUATION BY ROUTE OF ADMINISTRATION
6.2. EVALUATION BY STAGE AND ROUTE OF ADMINISTRATION
6.3. EVALUATION BY MOLECULE TYPE
6.4. EVALUATION BY STAGE AND MOLECULE TYPE
7. LATE-STAGE PRODUCTS (PHASE III)
7.1. COMPARATIVE ANALYSIS
7.2. OLEZARSEN: IONIS PHARMACEUTICALS INC
7.2.1. PRODUCT DESCRIPTION
7.2.2. RESEARCH AND DEVELOPMENT
7.3. MND 2119: MOCHIDA PHARMACEUTICAL
7.3.1. PRODUCT DESCRIPTION
7.3.2. RESEARCH AND DEVELOPMENT
7.4. PEGOZAFERMIN: 89BIO
7.4.1. PRODUCT DESCRIPTION
7.4.2. RESEARCH AND DEVELOPMENT
7.4.3. SAFETY AND EFFICACY
8. MID-STAGE PRODUCTS (PHASE II)
8.1. COMPARATIVE ANALYSIS
8.2. PLOZASIRAN: ARROWHEAD PHARMACEUTICALS
8.2.1. PRODUCT DESCRIPTION
8.2.2. RESEARCH AND DEVELOPMENT
8.2.3. SAFETY AND EFFICACY
8.3. EVINACUMAB: REGENERON PHARMACEUTICALS
8.3.1. PRODUCT DESCRIPTION
8.3.2. RESEARCH AND DEVELOPMENT
8.3.3. SAFETY AND EFFICACY
8.4. SEFA-1024: NORTHSEA THERAPEUTICS
8.4.1. PRODUCT DESCRIPTION
8.4.2. RESEARCH AND DEVELOPMENT
8.5. HU-6: RIVUS PHARMACEUTICALS
8.5.1. PRODUCT DESCRIPTION
8.6. MAT-9001: MATINAS BIOPHARMA
8.6.1. PRODUCT DESCRIPTION
8.6.2. RESEARCH AND DEVELOPMENT
8.6.3. SAFETY AND EFFICACY
8.7. MN-001: MEDICINOVA
8.7.1. PRODUCT DESCRIPTION
8.7.2. RESEARCH AND DEVELOPMENT
8.8. INV-202: NOVO NORDISK
8.8.1. PRODUCT DESCRIPTION
8.8.2. RESEARCH AND DEVELOPMENT
8.8.3. SAFETY AND EFFICACY
8.8.4. PRODUCT DEVELOPMENTAL ACTIVITIES
8.9. HTD1801: HIGHTIDE BIOPHARMA
8.9.1. PRODUCT DESCRIPTION
8.10. MET-3: NUBIYOTA
8.10.1. PRODUCT DESCRIPTION
9. EARLY-STAGE PRODUCTS (PHASE I/II)
9.1. COMPARATIVE ANALYSIS
9.2. MAR-001: MAREA THERAPEUTICS
9.2.1. PRODUCT DESCRIPTION
9.2.2. RESEARCH AND DEVELOPMENT
10. EARLY-STAGE PRODUCTS (PHASE I)
10.1. COMPARATIVE ANALYSIS
10.2. LY 3875383: ELI LILLY AND COMPANY
10.2.1. PRODUCT DESCRIPTION
10.2.2. RESEARCH AND DEVELOPMENT
10.3. VSA-003: VISIRNA THERAPEUTICS
10.3.1. PRODUCT DESCRIPTION
10.3.2. RESEARCH AND DEVELOPMENT
10.4. GC 304: GENECRADLE THERAPEUTICS
10.4.1. PRODUCT DESCRIPTION
10.4.2. RESEARCH AND DEVELOPMENT
10.5. TLC-2716: ORSOBIO INC
10.5.1. PRODUCT DESCRIPTION
10.5.2. RESEARCH AND DEVELOPMENT
10.5.3. PRODUCT DEVELOPMENTAL ACTIVITIES
10.6. LIPISENSE: LIPIGON PHARMACEUTICALS
10.6.1. PRODUCT DESCRIPTION
10.6.2. RESEARCH AND DEVELOPMENT
10.6.3. SAFETY AND EFFICACY
11. PRECLINICAL-STAGE PRODUCTS
11.1. COMPARATIVE ANALYSIS
11.2. STP125G: SIRNAOMICS
11.2.1. PRODUCT DESCRIPTION
11.3. IMBP 001: IMETABOLIC BIOPHARMA
11.3.1. PRODUCT DESCRIPTION
11.3.2. PRODUCT AND DEVELOPMENTAL ACTIVITIES
11.4. STP251G: SIRNAOMICS
11.4.1. PRODUCT DESCRIPTION
11.5. STP237G: SIRNAOMICS
11.5.1. PRODUCT DESCRIPTION
11.6. SEFA 6131: NORTHSEA THERAPEUTICS
11.6.1. PRODUCT DESCRIPTION
11.7. VK1430: VIKING THERAPEUTICS
11.7.1. PRODUCT DESCRIPTION
12. DISCOVERY-STAGE PRODUCTS
12.1. COMPARATIVE ANALYSIS
12.2. ANGPTL3/8 ANTIBODY PROGRAM: KYTTARO
12.2.1. PRODUCT DESCRIPTION
12.2.2. PRODUCT DEVELOPMENTAL ACTIVITIES
12.3. IMBP 150: IMETABOLIC BIOPHARMA
12.3.1. PRODUCT DESCRIPTION
13. INACTIVE PRODUCTS
13.1. COMPARATIVE ANALYSIS
14. STRATEGIC DEVELOPMENTS
14.1. MERGERS & ACQUISITIONS
14.2. PARTNERSHIPS & AGREEMENTS
15. UNMET NEEDS

List of Tables

LIST OF TABLES
TABLE 1: PRIMARY (GENETIC) DISORDERS CAUSING SEVERE HTG
TABLE 2: TOTAL ACTIVE PRODUCTS IN HYPERTRIGLYCERIDEMIA PIPELINE
TABLE 3: PRODUCTS IN VARIOUS PHASES
TABLE 4: EVALUATION BY ROUTE OF ADMINISTRATION
TABLE 5: EVALUATION BY MOLECULE TYPE
TABLE 6: LATE-STAGE PRODUCTS (PHASE III)
TABLE 7: CLINICAL TRIALS DESCRIPTION: OLEZARSEN
TABLE 8: GENERAL DESCRIPTION: OLEZARSEN
TABLE 9: CLINICAL TRIALS DESCRIPTION: MND 2119
TABLE 10: GENERAL DESCRIPTION: MND 2119
TABLE 11: CLINICAL TRIALS DESCRIPTION: PEGOZAFERMIN
TABLE 12: GENERAL DESCRIPTION: PEGOZAFERMIN
TABLE 13: MID-STAGE PRODUCTS (PHASE II)
TABLE 14: CLINICAL TRIALS DESCRIPTION: PLOZASIRAN
TABLE 15: GENERAL DESCRIPTION: PLOZASIRAN
TABLE 16: CLINICAL TRIALS DESCRIPTION: EVINACUMAB
TABLE 17: GENERAL DESCRIPTION: EVINACUMAB
TABLE 18: CLINICAL TRIALS DESCRIPTION: SEFA 1024
TABLE 19: GENERAL DESCRIPTION: SEFA 1024
TABLE 20: GENERAL DESCRIPTION: HU-6
TABLE 21: CLINICAL TRIALS DESCRIPTION: MAT-9001
TABLE 22: GENERAL DESCRIPTION: MAT-9001
TABLE 23: CLINICAL TRIALS DESCRIPTION: MN-001
TABLE 24: GENERAL DESCRIPTION: MN-001
TABLE 25: CLINICAL TRIALS DESCRIPTION: INV-202
TABLE 26: GENERAL DESCRIPTION: INV-202
TABLE 27: GENERAL DESCRIPTION: HTD1801
TABLE 28: GENERAL DESCRIPTION: MET-3
TABLE 29: EARLY-STAGE PRODUCTS (PHASE I/II)
TABLE 30: CLINICAL TRIALS DESCRIPTION: MAR001
TABLE 31: GENERAL DESCRIPTION: MAR001
TABLE 32: EARLY-STAGE PRODUCTS (PHASE I)
TABLE 33: CLINICAL TRIALS DESCRIPTION: LY3875383
TABLE 34: GENERAL DESCRIPTION: LY3875383
TABLE 35: CLINICAL TRIALS DESCRIPTION: VSA003
TABLE 36: GENERAL DESCRIPTION: VSA003
TABLE 37: CLINICAL TRIALS DESCRIPTION: GC304
TABLE 38: GENERAL DESCRIPTION: GC304
TABLE 39: CLINICAL TRIALS DESCRIPTION: TLC-2716
TABLE 40: GENERAL DESCRIPTION: TLC-2716
TABLE 41: GENERAL DESCRIPTION: LIPISENSE
TABLE 42: PRECLINICAL-STAGE PRODUCTS
TABLE 43: GENERAL DESCRIPTION: STP125G
TABLE 44: GENERAL DESCRIPTION: IMBP 001
TABLE 45: GENERAL DESCRIPTION: STP251G
TABLE 46: GENERAL DESCRIPTION: STP237G
TABLE 47: GENERAL DESCRIPTION: SEFA 6131
TABLE 48: GENERAL DESCRIPTION: VK1430
TABLE 49: DISCOVERY-STAGE PRODUCTS
TABLE 50: GENERAL DESCRIPTION: ANGPTL3/8 ANTIBODY PROGRAM
TABLE 51: GENERAL DESCRIPTION: IMBP 150
TABLE 52: INACTIVE-STAGE PRODUCTS
TABLE 53: LIST OF MERGERS & ACQUISITIONS
TABLE 54: LIST OF PARTNERSHIPS & AGREEMENTS

List of Figures

LIST OF FIGURES
FIGURE 1: CLASSIFICATION OF HTG BASED ON SERUM TG LEVEL
FIGURE 2: KEY STEPS INVOLVED IN THE METABOLISM OF TRIGLYCERIDE-RICH LIPOPROTEINS
FIGURE 3: METABOLISM OF TRIGLYCERIDE-RICH LIPOPROTEINS (TGRL)
FIGURE 4: CAUSES OF HTG
FIGURE 5: THE INTERTWINED CONTRIBUTING FACTORS AND CLOSE INTERACTIONS BETWEEN HTG, TYPE II DIABETES, AND ACUTE PANCREATITIS
FIGURE 6: SIGNS AND SYMPTOMS OF HTG
FIGURE 7: PRODUCTS IN VARIOUS PHASES
FIGURE 8: EVALUATION BY ROUTE OF ADMINISTRATION
FIGURE 9: EVALUATION BY STAGE AND ROUTE OF ADMINISTRATION
FIGURE 10: EVALUATION BY MOLECULE TYPE
FIGURE 11: EVALUATION BY STAGE AND MOLECULE TYPE
FIGURE 12: LATE-STAGE PRODUCTS (PHASE III)
FIGURE 13: MID-STAGE PRODUCTS (PHASE II)
FIGURE 14: EARLY-STAGE PRODUCTS (PHASE I/II)
FIGURE 15: EARLY-STAGE PRODUCTS (PHASE I)
FIGURE 16: PRECLINICAL-STAGE PRODUCTS
FIGURE 17: DISCOVERY-STAGE PRODUCTS
FIGURE 18: INACTIVE STAGE PRODUCTS

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