Medical science has come up with newer wonders in the treatment of various incurable diseases by making their treatment easy and more manageable than before. Most conventional prescription drugs target a complete system or tissue organization causing collateral damage to healthy tissue. Biological drugs or biologics have pinpoint accuracy and can search out the diseased organs or cells that need to be treated. These are the drugs of the future and are composed of sugars, proteins, or nucleic acids, or a combination of these substances.
Most biological drugs today are monoclonal antibodies and are part of the immune system of normal healthy individuals. In immune-compromised people, monoclonal antibodies find diseased cells so well that they make it possible for patients to have safe and effective treatments with fewer side effects. A biologic is manufactured in a living medium such as a cell, microorganism, plant or animal. Many biologics are produced using recombinant DNA technology.
Living systems are extremely sensitive to external stimulus and the smallest changes in the manufacturing set-up can destroy complete batches of the drug thus making them very expensive to make. To ensure that a manufacturing process remains the same over time, biologics manufacturers control all stages stringently from starting materials, equipment, sensors for physiological parameters and employ hundreds of protocols to ensure identical quality every time.
Biological drugs currently have a market size worth approximately US$ 100 billion and from January 1995 to 2008 European and U.S regulators have approved approximately 174 biological drugs. The recognition of the potential benefits of these drugs has put them on the fast track for FDA approval.
Today more than 25 biological drugs are approved for the treatment of various diseases including Rheumatoid arthritis, irritable bowel disease, asthma, and cancer. The top segments catered by biological drugs include Rheumatoid Arthritis and Enbrel continues to be the leading choice. ARMD (Age-related macular degeneration) and DR (Diabetic Retinopathy) are the leading segments for Avastin and Lucentis.
Since the route of administration for these drugs is injection or intravenous infusion the common side effects seen with these drugs include: pain and rashes at the site of injection. There are approximately 20 leading biologics – including Avastin (Roche), Enbrel (Amgen), Humira (Abbott), Herceptin (Roche), Remicade (Johnson & Johnson) and Lucentis (Roche/Novartis).
The sales of Lantus (Sanofi) and Humira (Abbott) have increased by the growth of approximately 20%. In March 2015, the U.S. FDA approved the country’s first biosimilar drug Zarxio (filgrastim-and). The advent of biosimilars will pose a significant challenge to existing biologics since biosimilars are available for a fraction of their cost.
North America holds a lion share of almost 60% of the global market for biologics followed by Europe and Japan. In the coming decade, the Asia Pacific is expected to record a high growth rate in this market as an outcome of improved government healthcare support, ever-increasing population and affordability enhancement. The report covers the market for other geographies namely, Latin America, Middle-East and Africa.
This report intends to provide qualitative analysis for market segmentation, treatment algorithms, drivers and inhibitors, opportunities (organic and non-organic), pipeline analysis and the competitive landscape of the market. Along with this quantitative analysis will be provided for treatment by disease segments and geography.
The below mentioned quantitative and qualitative analysis is subject to enhancement and refinement during the course of research.
The report analyses and estimates the market by:
- Product Segment/Sub-segment Types
- Market Share Analysis – segments, players, geographies
- Geographic Analysis
° North America
° Latin America
° Middle East
- Market Segmentation
- Drivers & inhibitors in the market
- Opportunities in the market
- Reimbursement scenario – Region-specific
- Pipeline developments – by phases
- Competitive landscape – recent strategic developments