Summary

The 7 major galactosemia markets reached a value of US$ 341.0 Million in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 501.7 Million by 2034, exhibiting a growth rate (CAGR) of 3.57% during 2024-2034.

The galactosemia market has been comprehensively analyzed in IMARC's new report titled "Galactosemia Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Galactosemia refers to a rare genetic disorder that affects the body's ability to process galactose, a sugar found in milk and other dairy products. Some of the common symptoms of the ailment are failure to thrive, poor weight gain, jaundice, liver damage, vomiting, diarrhea, feeding difficulties in infants, etc. Cataracts, which can impair vision, are a characteristic feature of galactosemia and can occur in infancy or childhood. Various other potential indications include developmental delays, intellectual disabilities, speech difficulties, tremors, hypoglycemia, ovarian failure in females, etc. The condition is diagnosed through a combination of clinical evaluation, biochemical testing, and genetic analysis. Newborn screening programs play a crucial role in identifying infants with galactosemia shortly after birth by analyzing elevated levels of galactose or its metabolites in the blood. Confirmatory diagnostic testing involves further analysis of enzyme activity, such as measuring GALT or other relevant enzyme levels in red blood cells. Genetic testing can also be performed to identify specific gene mutations associated with galactosemia. Additionally, clinical evaluation and assessment of symptoms, along with family history, contribute to the diagnosis.

The increasing cases of inherited disorders, which lead to reduced or absent enzyme activity on account of gene variations, are primarily driving the galactosemia market. Besides this, the widespread adoption of prebiotics like galacto-oligosaccharides and probiotics for improving digestion and overall gastrointestinal health in patients is acting as another significant growth-inducing factor. Furthermore, the escalating usage of pharmacological chaperones, since they offer a convenient and non-invasive treatment option for individuals with galactosemia, is also bolstering the market growth. These agents bind to the defective enzyme, which is responsible for galactose metabolism, and help in preventing its degradation by increasing the stability. Additionally, several key players are making extensive investments in R&D activities to introduce compounds that inhibit galactose production and promote the removal of toxic metabolites. This, in turn, is further creating a positive outlook for the market. Moreover, the emerging popularity of mRNA therapies that boost the production of deficient enzymes and potentially restore the body's ability to metabolize galactose is expected to drive the galactosemia market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the galactosemia market in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report the United States has the largest patient pool for galactosemia and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario and unmet medical needs, etc. have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the galactosemia market in any manner.

Time Period of the Study

Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the galactosemia market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the galactosemia market
Reimbursement scenario in the market
In-market and pipeline drugs
Competitive Landscape:
This report also provides a detailed analysis of the current galactosemia marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:
Market Insights

How has the galactosemia market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the galactosemia market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the galactosemia market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (2018-2034) of galactosemia across the seven major markets?
What is the number of prevalent cases (2018-2034) of galactosemia by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of galactosemia by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with galactosemia across the seven major markets?
What is the size of the galactosemia patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of galactosemia?
What will be the growth rate of patients across the seven major markets?

Galactosemia: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for galactosemia drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the galactosemia market?
What are the key regulatory events related to the galactosemia market?
What is the structure of clinical trial landscape by status related to the galactosemia market?
What is the structure of clinical trial landscape by phase related to the galactosemia market?
What is the structure of clinical trial landscape by route of administration related to the galactosemia market?

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Table of Contents

​1 Preface

2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Galactosemia - Introduction
4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence

5 Galactosemia - Disease Overview
5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 Patient Journey

7 Galactosemia - Epidemiology and Patient Population
7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
7.2.1 Epidemiology Scenario (2018-2023)
7.2.2 Epidemiology Forecast (2024-2034)
7.2.3 Epidemiology by Age (2018-2034)
7.2.4 Epidemiology by Gender (2018-2034)
7.2.5 Diagnosed Cases (2018-2034)
7.2.6 Patient Pool/Treated Cases (2018-2034)
7.3 Epidemiology Scenario - United States
7.3.1 Epidemiology Scenario (2018-2023)
7.3.2 Epidemiology Forecast (2024-2034)
7.3.3 Epidemiology by Age (2018-2034)
7.3.4 Epidemiology by Gender (2018-2034)
7.3.5 Diagnosed Cases (2018-2034)
7.3.6 Patient Pool/Treated Cases (2018-2034)
7.4 Epidemiology Scenario - Germany
7.4.1 Epidemiology Scenario (2018-2023)
7.4.2 Epidemiology Forecast (2024-2034)
7.4.3 Epidemiology by Age (2018-2034)
7.4.4 Epidemiology by Gender (2018-2034)
7.4.5 Diagnosed Cases (2018-2034)
7.4.6 Patient Pool/Treated Cases (2018-2034)
7.5 Epidemiology Scenario - France
7.5.1 Epidemiology Scenario (2018-2023)
7.5.2 Epidemiology Forecast (2024-2034)
7.5.3 Epidemiology by Age (2018-2034)
7.5.4 Epidemiology by Gender (2018-2034)
7.5.5 Diagnosed Cases (2018-2034)
7.5.6 Patient Pool/Treated Cases (2018-2034)
7.6 Epidemiology Scenario - United Kingdom
7.6.1 Epidemiology Scenario (2018-2023)
7.6.2 Epidemiology Forecast (2024-2034)
7.6.3 Epidemiology by Age (2018-2034)
7.6.4 Epidemiology by Gender (2018-2034)
7.6.5 Diagnosed Cases (2018-2034)
7.6.6 Patient Pool/Treated Cases (2018-2034)
7.7 Epidemiology Scenario - Italy
7.7.1 Epidemiology Scenario (2018-2023)
7.7.2 Epidemiology Forecast (2024-2034)
7.7.3 Epidemiology by Age (2018-2034)
7.7.4 Epidemiology by Gender (2018-2034)
7.7.5 Diagnosed Cases (2018-2034)
7.7.6 Patient Pool/Treated Cases (2018-2034)
7.8 Epidemiology Scenario - Spain
7.8.1 Epidemiology Scenario (2018-2023)
7.8.2 Epidemiology Forecast (2024-2034)
7.8.3 Epidemiology by Age (2018-2034)
7.8.4 Epidemiology by Gender (2018-2034)
7.8.5 Diagnosed Cases (2018-2034)
7.8.6 Patient Pool/Treated Cases (2018-2034)
7.9 Epidemiology Scenario - Japan
7.9.1 Epidemiology Scenario (2018-2023)
7.9.2 Epidemiology Forecast (2024-2034)
7.9.3 Epidemiology by Age (2018-2034)
7.9.4 Epidemiology by Gender (2018-2034)
7.9.5 Diagnosed Cases (2018-2034)
7.9.6 Patient Pool/Treated Cases (2018-2034)

8 Galactosemia - Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 Galactosemia - Unmet Needs

10 Galactosemia - Key Endpoints of Treatment

11 Galactosemia - Marketed Products
11.1 List of Galactosemia Marketed Drugs Across the Top 7 Markets
11.1.1 Drug Name – Company Name
11.1.1.1 Drug Overview
11.1.1.2 Mechanism of Action
11.1.1.3 Regulatory Status
11.1.1.4 Clinical Trial Results
11.1.1.5 Sales Across Major Markets

Kindly note that the complete list of marketed drugs has been provided in the report.

12 Galactosemia - Pipeline Drugs
12.1 List of Galactosemia Pipeline Drugs Across the Top 7 Markets
12.1.1 AT-007 - Applied Therapeutics
12.1.1.1 Drug Overview
12.1.1.2 Mechanism of Action
12.1.1.3 Clinical Trial Results
12.1.1.4 Safety and Efficacy
12.1.1.5 Regulatory Status

Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.

13. Galactosemia - Attribute Analysis of Key Marketed and Pipeline Drugs

14. Galactosemia – Clinical Trial Landscape
14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 Galactosemia - Market Scenario
15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
15.2.1 Galactosemia - Market Size
15.2.1.1 Market Size (2018-2023)
15.2.1.2 Market Forecast (2024-2034)
15.2.2 Galactosemia - Market Size by Therapies
15.2.2.1 Market Size by Therapies (2018-2023)
15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
15.3.1 Galactosemia - Market Size
15.3.1.1 Market Size (2018-2023)
15.3.1.2 Market Forecast (2024-2034)
15.3.2 Galactosemia - Market Size by Therapies
15.3.2.1 Market Size by Therapies (2018-2023)
15.3.2.2 Market Forecast by Therapies (2024-2034)
15.3.3 Galactosemia - Access and Reimbursement Overview
15.4 Market Scenario - Germany
15.4.1 Galactosemia - Market Size
15.4.1.1 Market Size (2018-2023)
15.4.1.2 Market Forecast (2024-2034)
15.4.2 Galactosemia - Market Size by Therapies
15.4.2.1 Market Size by Therapies (2018-2023)
15.4.2.2 Market Forecast by Therapies (2024-2034)
15.4.3 Galactosemia - Access and Reimbursement Overview
15.5 Market Scenario - France
15.5.1 Galactosemia - Market Size
15.5.1.1 Market Size (2018-2023)
15.5.1.2 Market Forecast (2024-2034)
15.5.2 Galactosemia - Market Size by Therapies
15.5.2.1 Market Size by Therapies (2018-2023)
15.5.2.2 Market Forecast by Therapies (2024-2034)
15.5.3 Galactosemia - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
15.6.1 Galactosemia - Market Size
15.6.1.1 Market Size (2018-2023)
15.6.1.2 Market Forecast (2024-2034)
15.6.2 Galactosemia - Market Size by Therapies
15.6.2.1 Market Size by Therapies (2018-2023)
15.6.2.2 Market Forecast by Therapies (2024-2034)
15.6.3 Galactosemia - Access and Reimbursement Overview
15.7 Market Scenario - Italy
15.7.1 Galactosemia - Market Size
15.7.1.1 Market Size (2018-2023)
15.7.1.2 Market Forecast (2024-2034)
15.7.2 Galactosemia - Market Size by Therapies
15.7.2.1 Market Size by Therapies (2018-2023)
15.7.2.2 Market Forecast by Therapies (2024-2034)
15.7.3 Galactosemia - Access and Reimbursement Overview
15.8 Market Scenario - Spain
15.8.1 Galactosemia - Market Size
15.8.1.1 Market Size (2018-2023)
15.8.1.2 Market Forecast (2024-2034)
15.8.2 Galactosemia - Market Size by Therapies
15.8.2.1 Market Size by Therapies (2018-2023)
15.8.2.2 Market Forecast by Therapies (2024-2034)
15.8.3 Galactosemia - Access and Reimbursement Overview
15.9 Market Scenario - Japan
15.9.1 Galactosemia - Market Size
15.9.1.1 Market Size (2018-2023)
15.9.1.2 Market Forecast (2024-2034)
15.9.2 Galactosemia - Market Size by Therapies
15.9.2.1 Market Size by Therapies (2018-2023)
15.9.2.2 Market Forecast by Therapies (2024-2034)
15.9.3 Galactosemia - Access and Reimbursement Overview

16 Galactosemia - Recent Events and Inputs From Key Opinion Leaders

17 Galactosemia Market - SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 Galactosemia Market – Strategic Recommendations

19 Appendix