Brazil Orphan Diseases Drugs Market Analysis

Brazil Orphan Diseases Drugs Market Analysis


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Brazil's Orphan Diseases Drugs Market is projected to grow from $3.870 Bn in 2022 to $9.114 Bn by 2030, registering a CAGR of 11.30% during the forecast period of 2022-2030. In Brazil, there is a significant population affected by rare diseases, with estimates suggesting that around 8 Mn Brazilians suffer from one of the more than 7,000 rare diseases currently known. The most common types of rare diseases in Brazil include genetic disorders, neurological conditions, and blood disorders. The key players in the Brazil orphan diseases drugs market include Pfizer, Roche Holding, Sanofi, Novartis International, Merck, and Amgen.

ID: IN10BRPH019 CATEGORY: Pharmaceuticals GEOGRAPHY: Brazil AUTHOR: Shivam Zalke

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Brazil Orphan Diseases Drugs Market Executive Summary

Brazil's Orphan Diseases Drugs Market is projected to grow from $3.870 Bn in 2022 to $9.114 Bn by 2030, registering a CAGR of 11.30% during the forecast period of 2022-30.

The Brazil orphan drugs market is a growing market with increasing demand for treatments for rare diseases. This market is expected to grow due to the increasing incidence of rare diseases, growing awareness among patients and healthcare providers, and favorable government policies promoting the development and access to orphan drugs. However, the market faces challenges such as high costs of treatments and limited access for patients due to inadequate reimbursement policies. The market is dominated by international pharmaceutical companies, with a small presence of local companies.

An orphan disease, also known as a rare disease, is a condition that affects a small number of individuals and is therefore not a priority for pharmaceutical companies to develop treatments for. In Brazil, there is a significant population affected by rare diseases, with estimates suggesting that around 8 Mn Brazilians suffer from one of the more than 7,000 rare diseases currently known. The most common types of rare diseases in Brazil include genetic disorders, neurological conditions, and blood disorders. Despite the high number of people affected, the limited availability of treatments and lack of public policies and resources dedicated to rare diseases remains a challenge in Brazil.

brazil orphan diseases drugs market

Market Dynamics

Market Drivers

The key drivers of the Brazil orphan diseases drugs market are:

  1. Increasing incidence of rare diseases: The rising incidence of rare diseases in Brazil is driving demand for treatments and boosting the growth of the orphan drugs market
  2. Growing awareness among patients and healthcare providers: Greater awareness of rare diseases and their treatments is leading to increased demand for these drugs
  3. Favorable government policies: The Brazilian government has implemented policies to promote the development and access to orphan drugs, which is driving growth in the market
  4. Advances in medical technology: Technological advancements in the medical industry are leading to the development of new and improved treatments for rare diseases, which is driving growth in the market
  5. Increased investment by pharmaceutical companies: Pharmaceutical companies are investing more in the development of orphan drugs, which is driving growth in the market
  6. Improving healthcare infrastructure: The improvement of healthcare infrastructure in Brazil is providing more opportunities for the diagnosis and treatment of rare diseases, which is driving growth in the market

Competitive Landscape

Key Players

The key players in the Brazil orphan diseases drugs market include:

  • Pfizer
  • Roche Holding
  • Sanofi
  • Novartis International
  • Merck
  • Amgen
  • Biogen
  • AbbVie
  • Alexion Pharmaceuticals
  • Gilead Sciences

These companies hold a significant share of the market and offer a range of treatments for rare diseases. However, the market also has a presence of local pharmaceutical companies that specialize in the development and production of orphan drugs for the Brazilian market.

Healthcare Policies and Regulatory Landscape

The healthcare policies and regulatory landscape in Brazil play a crucial role in shaping the orphan diseases drugs market. The Brazilian government has implemented several policies and initiatives to promote the development and access to treatments for rare diseases. Some of these policies include tax incentives for companies developing orphan drugs, fast-track regulatory approval for orphan drugs, and reimbursement programs to provide access to treatments for patients with rare diseases.

The regulatory landscape in Brazil is governed by the Brazilian National Health Surveillance Agency (ANVISA), which is responsible for the regulation of drugs and medical devices in the country. ANVISA classified "rare diseases" as illnesses with an incidence of up to 65 instances per 100,000 people in Resolution RDC No. 205/2017. The existing regulations in Brazil don't give an explicit description of an "Orphan Drug". ANVISA implements strict regulations to ensure the safety and efficacy of orphan drugs in the market. The agency also has specific regulations for the development, authorization, and pricing of orphan drugs in the country.

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Orphan Diseases Drugs Market Segmentation

Therapeutic area

  • Cancer
  • Neurological condition
  • Cardiovascular condition
  • Musculoskeletal condition
  • Hematologic condition
  • Others

Route of administration

The injectable segment dominated the market and is expected to witness significant growth during the forecast period. This can be attributed to the launch of novel injectables for the treatment of rare diseases.

  • Oral
  • Injectable
  • Others

Drug Type

Biologics dominated the market and is expected to witness significant growth during the forecast period. The advancement in biotechnology and research techniques has facilitated the development of novel biologics. High target specificity and potential of biological drugs revolutionizing the treatments of several rare diseases are expected to fuel the segment growth.

  • Biologics
  • Biosimilars  
  • Small molecule

Distribution Channel

The specialty pharmacy segment dominated the market. The dominance can be attributed to strategic initiatives undertaken by key players, such as the acquisition of specialty pharmacies for the distribution of their products.

  • Hospital Pharmacy
  • Specialty Pharmacy
  • Online Pharmacy

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

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Last updated on: 14 June 2023
Updated by: Keta Vora

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