Nephrology and Urology Devices Market Outlook in Brazil to 2017 - Incontinence Devices, Renal Dialysis Equipment and Others
- Published: March 2011
- Region: Brazil
Regulations and Patent Expirations Challenge Brazilian Laboratories
This research service considers the biologics market in Brazil. It covers the market’s move toward greater regulation and outlines the impact of specific patent expirations. An analysis of monoclonal antibodies, blood factors, insulin, filgrastim, interferon, growth hormones, and erythropoietin is provided. This service also highlights key market drivers and restraints in addition to breaking down the current and forecasted competitive scenario. The base year of the study is 2010, and the forecast period is 2011 to 2017.
Biologics are medicines obtained by a biological source or through a biological process. They can be derived from genetically modified or the natural cultivation of bacteria or cells to produce the active ingredient of interest. Because ingredients are produced from living organisms, the medicine has a complex molecular structure with a heterogeneous active component. The medicine is developed to meet the specific molecules of the immune system that are responsible for causing a disease.
Raw materials have two origins:
- They are either extracted from microorganisms or from organs and tissues of plant or animal origin.
- Or, they are of biotechnological origin, which means that, in general, they are proteins produced by genetically modified cells.
Biosimilars, or “follow-on biologics,” are medicines whose production is based on reference biologics after the patents for these biologics expire. These medicines must undergo several tests to prove their similarities to the original drugs in terms of quality, safety, and efficacy. However, biosimilars cannot be considered “generics” because they are not identical copies of the reference medicine. SHOW LESS READ MORE >
Introduction to Biologics
- The Complex Manufacturing and Testing Process
- Differences Between Biosimilars and Generic Drugs
The Global Biologics Market
- Global Market Overview
- Issue Regarding Biosimilars
- Key Biologic Patents Expiring in 2012–2016
The Brazilian Biologics Market
- Market Overview
- The Evolution of the Generic Market in Brazil
- Key Biologics Market Segments
- Market Engineering Measurements
- Industry Challenges
- Industry Challenges in Order of Impact
- Challenges Explained
- Biologics Market: Drivers and Restraints
- Key Drivers Ranked in Order of Impact
- Drivers Explained
- Key Restrains Ranked in Order of Impact
- Restraints Explained
- Competitive Scenario Overview
- Key Companies Selling Biologics in the Brazilian Market
- Market Size of Brazilian Biologics Market: Revenue Forecast
- Market Representation per Segment
- Market Share Analysis
Key Market Segments
- Market Highlights - Blood Agents
- Main Brands Available on the Market - Blood Agents
- Market Highlights- Insulin
- Main Brands Available on the Market-Insulin
- Market Highlights - Erythropoietin (EPO)
- Main Brands Available on the Market - Erythropoietin
- Market Highlights - Interferon
- Main Brands Available on the Market - Interferon
- Market Highlights - Granulocyte colony stimulating factor (G-CSF)
- Main Brands Available on the Market - Granulocyte colony stimulating factor
- Market Highlights - Growth Hormone
- Main Brands Available on the Market - Growth Hormone
- Market Highlights - Monoclonal Antibodies
- Main Brands Available on the Market - Monoclonal Antibodies
- Brazilian Regulation for Biologics
- The New Resolution for Biologic Products
Profile of Key Industry Participants
Conclusions and Recommendations
The Frost & Sullivan Story
LIST OF FIGURES
Biologics Market: Key Biologic Patents Expiring, Global, 2012–2016
Biologics Market: Industry Challenges in Order of Impact, Brazil, 2011
Biologics Market: Key Drivers Ranked in Order of Impact, Brazil, 2011–2017
Biologics Market: Key Restraints Ranked in Order of Impact, Brazil, 2011–2017
Biologics Market: Key Companies Selling Biologics, Brazil, 2011
Biologics Market: Revenue Forecast, Brazil, 2010–2017
Biologics Market: Main Blood Agents Brands Available on the Market, Brazil, 2011
Biologics Market: Main Insulin Brands Available on the Market, Brazil, 2011
Biologics Market: Main Erythropoietin Brands Available on the Market, Brazil, 2011
Biologics Market: Main Interferon Brands Available on the Market, Brazil, 2011
Biologics Market: Main Granulocyte Colony Stimulating Factor (G-CSF) brands Available on the Market, Brazil, 2011
Biologics Market: Main Growth Hormone Brands Available on the Market, Brazil, 2011
Biologics Market: Main Monoclonal Antibodies Brands Available on the Market, Brazil, 2011
LIST OF CHARTS
Biologics Market: Key Biologics Segments, Brazil, 2011
Biologics Market: Market Engineering Measurements, Brazil, 2010
Biologics Market: Key Industry Challenges, Brazil, 2011–2017
Biologics Market: Key Drivers and Restraints, Brazil, 2011–2017
Biologics Market: Revenue Forecasts, Brazil, 2010–2017
Biologics Market: Market Representation per Segment, Brazil, 2010
Biologics Market: Company Market Share by Revenue, Brazil, 2010
In 2010, the total Brazilian biologics market was worth $x,xxx.x million. The market is in a development stage and is likely to grow at a compound annual growth rate (CAGR) of xx.x percent from 2010 to 2017, reaching $x,xxx.x million by 2017.
Biologic drugs are significantly advancing the treatment of serious diseases such as Alzheimer's, Rheumatoid Arthritis, different types of cancer (for example, breast and renal cancers as well as leukemia), Multiple Sclerosis, Lupus, and Leprosy.
Discovering, manufacturing, and testing biologic drugs can sometimes take more than ten times the cost and five times the development time of synthetic drugs. Because they are made by living organisms, the manufacturing process for biologic drugs requires a high degree of technology to stabilize complex
molecular structures. Any small deviation in the production process can change the effect of the drug.
Thus, regulations regarding biologic drugs must be strict. Brazil has already taken steps to establish a highly regulated market given December 2011’s regulation changes, but the country is still far from European regulation levels.
Public programs, such as the National List of Essential Medicines (RENAME) and Farmacia Popular, are important drivers of the market. For some biologic segments, such as insulin and blood agents, the government provides the population with free biologic drugs, which ensures demand because most of
the population cannot afford the expensive costs of biologics without this assistance.
The Brazilian market is dominated by big multinational companies. Their brands and drugs are already established on the market, and in all segments they have the largest shares.
Local production for biologics is still very low. Of the 26 main brands of biologics, only 8 are Brazilian, and their products do not have the same market penetration as the multinational companies.
For market share in Brazilian biologics, Roche, Novo Nordisk, and Eli Lilly are the top three vendors.
Monoclonal antibodies are the most lucrative segment, with revenue of $767.7 million in 2010 and a CAGR of 25.0 percent until 2017.