all report title image
  • Published On : Sep 2022
  • Code : CMI5249
  • Industry : Pharmaceutical
  • Pages : 245
  • Formats :

Fabry disease is an unusual genetic disorder initiated by a defective gene i.e., the Galactosidase Alpha (GLA) gene in the body. The defect in the gene causes a lacking amount of the enzyme alpha-galactosidase A. This enzyme is essential for the everyday breakdown of a fatty substance in the body called globotriaosylceramide (GL-3/GB-3). When proper breakdown of this lipid and other similar lipids does not occur, GL-3 gathers in the majority of cells throughout the body which leads to cell damage. The cell damage is an origin for a wide range of indications including potentially life-threatening consequences such as kidney failure or heart failure.

  • Symptoms of fabry disease include extreme pain during physical activity, heat or cold intolerance, burning or pain in the hands or feet, dizziness, hearing loss or ringing in ears, swelling in the legs, ankles or feet, etc.
  • Tests to diagnose fabry disease includes Enzyme assay, Genetic testing, Newborn screenings, etc.
  • Fabry disease is treated by therapies such as Enzyme Replacement Therapy, Chaperone Therapy, Gene Therapy, Substrate Reduction Therapies, etc.

LATAM Fabry Disease Market - Impact of the Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic is expected to hamper growth of the LATAM fabry disease market, owing to negative impact on supply chain during the COVID-19 pandemic. For instance, according to data published by United Nations Office on Drugs and Crime, there was impact of the actions implemented to control the spread of the COVID-19 on drug supply chain, in the destination markets. Many countries have reported an overall shortage of numerous types of drugs at the retail level. The COVID-19 restriction had limited the distribution of drugs in market, at retail level.

Increasing price of the drugs during COVID-19 pandemic might have a negative impact on growth of the fabry disease market in Latin America. For instance, according to data published by United Nations Office on Drugs and Crime, complete lockdown was implemented in many countries worldwide during COVID-19 pandemic which resulted into disturbance in the transport of drugs from one country to other, which has caused price increase of the drugs globally which is expected to hamper growth of the LATAM fabry disease market.

LATAM fabry disease market is estimated to be valued at US$ 81.330 Mn in 2022 and is expected to exhibit a CAGR of 6.7% over the forecast period (2022-2030)  

Figure 1: LATAM Fabry Disease Market Share, (%), Analysis, By Therapy Type, 2022

LATAM Fabry Disease  | Coherent Market Insights

Development of consensus document for the diagnosis of fabry disease by Brazilian Society of Nephrology, is expected to drive the market growth of the LATAM fabry disease market, over the forecast period.

Development of consensus documents for fabry disease by health care community is expected to drive the market growth of the LATAM fabry disease market, over the forecast period. For instance, according to data published in June, 2022 by Brazilian Journal of Nephrology, Committee for Rare Diseases - Brazilian Society of Nephrology, developed a consensus document to standardize recommendations related to kidney involvement in fabry disease in the areas of diagnosis, screening, and treatment of adult and pediatric patients. The development of the consensus statement aims to assists physicians and patients regarding the results of the treatment for fabry disease.  

Increasing research and development for drug development by key players present in Latin America is expected to drive growth of the LATAM fabry disease market, over the forecast period.

Increasing research and development for drug development by key players present in Latin America is expected to drive growth of the LATAM fabry disease market, over the forecast period. For instance, on October 23, 2019, Amicus Therapeutics, a biotechnology company, successfully completed a Phase III clinical trial for fabry disease. The study was conducted to evaluate the long-term safety and efficacy of Migalastat Hydrochloride Monotherapy in patients with fabry disease. The study reported 0.00% mortality of the patients who participated in clinical trials and about 30.95% patients have been reported with adverse effects.

CMI table icon

LATAM Fabry Disease Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 81.330 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 6.7% 2030 Value Projection: US$ 136.890 Mn
Geographies covered:
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
Segments covered:
  • By Therapy Type: Enzyme Replacement Therapy (Agalsidase Beta (Fabrazyme), Agalsidase Alfa (Replagal), Pegunigalsidase Alfa (PRX-102, Phase III)), Chaperon Therapy (Migalastat (Galafold Phase III)), Substrate Reduction Therapy (Lucerastat (Phase III), Venglustat (Phase III))
  • By Route of Administration: Oral, Parenteral
  • By Distribution Channel: Hospitals Pharmacies, Online pharmacies, Retail Pharmacies
Companies covered:

Amicus Therapeutics, Inc., Sanofi-Aventis U.S. LLC, GlaxoSmithKline plc, Mendelics, Takeda Pharmaceuticals U.S.A., Inc, Teva pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, Moderna Therapeutics Inc, and Resverlogix

Growth Drivers:
  • Development of consensus document for the diagnosis of fabry disease
  • Granting of approvals by the regulatory bodies for the marketing of drugs
  • Increasing prevalence of patients with fabry disease
Restraints & Challenges:
  • Lack of proper treatment for fabry disease

LATAM Fabry Disease Market – Restraints

Lack of proper treatment for fabry disease in countries of Latin America is expected to hamper growth of the LATAM fabry disease market, over the forecast period. For instance, according to an article published on February 10, 2021, by National Center for Biotechnology Information, Brazil is at the risk for the availability of the treatments such as enzyme replacement therapy, for the patiens with Fabry disease. Brazil is one of the populated country in Latin America and lack of proper treatment for the patients with fabry disease is expected to hamper growth of the LATAM fabry disease market.

LATAM Fabry Disease Market – Country Analysis

On the basis of Country, the LATAM fabry disease market is segmented into Brazil, Mexico, Argentina and Rest of Latin America.

Among Country, Argentina fabry disease market is expected to hold a dominant position during the forecast period, owing to increasing prevalence of patients with fabry disease. For instance, according to an article published on March, 2018, by National Center for Biotechnology Information, A team of researcher estimated the prevalence of fabry disease in Argentina of young adults who had stroke and reported that 3% of patients were identified with fabry disease.

Furthermore, Brazil is also estimated to witness significant growth in the LATAM fabry disease market, owing to increasing research and development by research institutes in collaboration with key market players. For instance, according to the source clinicaltrials.gov University of Sao Paulo General Hospital in collaboration with Pfizer Inc., a pharmaceutical company, on September 9, 2020 had started clinical trials for Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Two-dimensional Shear Wave Elastography) in Patients With Amyloidosis and Fabry Disease to evaluate the diastolic myocardial elasticity in patients with Fabry disease and compare it with the transthyretin amyloidosis group with cardiac involvement.

Figure 2: LATAM Fabry Disease Market (US$ Bn), by Country, 2022

LATAM Fabry Disease  | Coherent Market Insights

LATAM Fabry Disease Market – Competitive Landscape

Major players operating in the LATAM fabry disease market include Amicus Therapeutics, Inc., Sanofi-Aventis U.S. LLC, GlaxoSmithKline plc, Mendelics, Takeda Pharmaceuticals U.S.A., Inc, Teva pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, Moderna Therapeutics Inc, and Resverlogix.

Fabry disease is an inherited disorder which is caused by accumulation for globotriaosylceramide, a type of fat, in the body’s cells. Fabry disease symptoms affect body parts which include a decreased ability to sweat, events of pain in hands and feet, difficulties with the gastrointestinal system, etc. Diagnosis for fabry disease includes test such as Deoxyribonucleic acid sequence analysis, enzyme assay analysis, etc.

Treatment for fabry disease includes intravenously administered enzyme replacement therapy or oral chaperone therapy, along with this it may also need lifestyle modifications and prophylactic medications. Sometimes doctors also refer drugs to relieve pain, medicine for stomach problems, blood thinners or other drugs for an irregular heartbeat or other heart problems, blood pressure medicine, which also helps to protect kidneys. If fabry disease has caused serious kidney damage, dialysis or a kidney transplant is needed for treatment.

Market Dynamics

Survey regarding achievements or learning about fabry disease, is expected to drive growth of the LATAM fabry disease market. For instance, according to data published on June 20, 2022, by Orphanet Journal of Rare Diseases, a team of researchers had done 20 years of Fabry Outcome Survey that focused to broaden the understanding of fabry disease such as to know about the insights, achievements, and learning more about the development of fabry disease, effects of treatment, etc. according to same Route of Administration population suffering from fabry disease has reported cardiovascular problem and it was more common type of problem reported in male and female in with fabry disease in Latin America.

Updated guidelines by regulatory bodies for the development of drugs used in the treatment of fabry disease is expected to drive the LATAM fabry disease market growth. For instance, in August, 2019, the U.S. Food and Drug Administration announced the availability the draft guidance for the industries, to develop drugs for the treatment of fabry disease. This draft guidance describes the FDA’s current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints to be used in clinical development programs of investigational drugs to treat fabry disease.

Key features of the study:

  • This report provides in-depth analysis of the LATAM fabry disease market, and provides market size (US$ Mn) 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 LATAM fabry disease market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Amicus Therapeutics, Inc., Sanofi-Aventis U.S. LLC, GlaxoSmithKline plc, Mendelics, Takeda Pharmaceuticals U.S.A., Inc, Teva pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, Moderna Therapeutics Inc, and Resverlogix.
  • 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 LATAM fabry disease 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 LATAM fabry disease market

Detailed Segmentation:

  • LATAM Fabry Disease Market, By Therapy Type:
    • Enzyme Replacement Therapy
      • Agalsidase Beta (Fabrazyme)
      • Agalsidase Alfa (Replagal)
      • Pegunigalsidase Alfa (PRX-102, Phase III)
    • Chaperon Therapy
      • Migalastat (Galafold Phase III)
    • Substrate Reduction Therapy
      • Lucerastat (Phase III)
      • Venglustat (Phase III)
  • LATAM Fabry Disease Market, By Route of Administration:
    • Oral
    • Parental
  • LATAM fabry disease market, By Distribution Channel:
    • Hospitals Pharmacies
    • Retail Pharmacies
    • Online pharmacies
  • LATAM Fabry Disease Market, By Country:
    • Brazil
      • By Distribution Channel
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online pharmacies
    • Mexico
      • By Distribution Channel
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online pharmacies
    • Argentina
      • By Distribution Channel
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online pharmacies
    • Rest of Latin America
      • By Distribution Channel
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online pharmacies
  • Company Profiles
    • Amicus Therapeutics, Inc. *
      • Company Overview
      • Material Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Sanofi-Aventis U.S. LLC
    • GlaxoSmithKline plc
    • Mendelics
    • Takeda Pharmaceuticals U.S.A., Inc.
    • Teva pharmaceutical Industries Ltd
    • Pfizer Inc.,
    • Novartis AG
    • Moderna Therapeutics Inc
    • Resverlogix

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

Frequently Asked Questions

LATAM fabry disease market is expected to exhibit a CAGR of 6.7% during the forecast period (2022-2030).
LATAM fabry disease market is estimated to be valued at US$ 81.330 Mn in 2022.
Amicus Therapeutics, Inc., Sanofi-Aventis U.S. LLC, GlaxoSmithKline plc, Mendelics, Takeda Pharmaceuticals U.S.A., Inc, Teva pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, Moderna Therapeutics Inc, and Resverlogix are some of the prominent players operating in the market.
The market is expected to be valued at US$ 136.890 Mn in 2030.
Argentina is the prominent country in the market.
Enzyme Replacement Therapy is the prominent segment among the therapy segment in the market.

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