Biosimilar Entry to Inhibit Growth in the US and European Biopharmaceutical Markets

"According to Imarc’s latest research report, “Global Biopharmaceutical Market Report (2010-2015)”, the combined sales of biopharmaceuticals in the United States and top five European Markets (Germany, France, Italy, Spain and United Kingdom) reached nearly US$ 68 Billion in 2009, growing at a CAGR of more than 11% during the last five years. One of the key reasons for the strong historical growth rates was the fact that these drugs were immune to generic erosion even after their patent expiry. The last two-three years, however, have seen major changes in the dynamics of these markets: burdened by the high healthcare costs and sluggish growth in their overall economies, regulators in both the US and Europe are establishing guidelines to approve biosimilars or “generic versions of biopharmaceuticals” in their respective markets.


Biosimilars for Erythropoietins and Colony Stimulating Factors are already available in Europe, and those for Growth hormones are available in both the US and Europe. By 2020, Imarc expects 17 biopharmaceuticals to face biosimilar erosion. The total combined 2009 sales of these products were worth more than US$ 32 billion in the US and nearly US$ 13 billion in the five major European markets.


Despite the huge potential, however, the findings from the report suggest that launching biosimilars for generic manufacturers will not be as easy as launching traditional small molecule generics. The entry barriers for manufacturing biosimilars are much higher than that of traditional small molecule generics. As per the research, biopharmaceuticals are manufactured using live cells, and are significantly larger and more complex than small molecule drugs. Biosimilar manufacturers would require to have their own process that could produce the same efficacy, safety and tolerability in biosimilars as are found in their branded counterparts. This is extremely difficult in case of biopharmaceuticals unlike small molecule drugs. Moreover, the cost of developing a biosimilar is estimated at US$100 Million - US$200 Million, compared with US$1 Million - US$ 5 Million for a normal generic. Only a small number of manufacturers will be able to meet these criteria and the resulting volume and price erosion will not be as high as seen in cases of small molecule drugs.

Despite the above limiting factors, IMARC expects biosimilars to cause a significant price and volume erosion in some of the biopharmaceutical classes. A good example would be the case of Erythropoietin alpha products in Germany. Between September 2007 and April 2010, biosimilar Erythropoietin alpha products in Germany eroded around 61% of the total branded sales volume. Thus Imarc expects some of the biopharmaceutical manufacturers to face difficult times ahead in their key markets.

IMARC’s new report “Global Biopharmaceutical Market Report (2010-2015)” gives a deep insight into the global biopharmaceutical market. The research study serves as an analytical as well as a statistical tool to understand the strengths, weaknesses, opportunities, threats, market trends, geographical structure, therapeutic structure, competitive structure and the outlook of the global biopharmaceutical market till 2015.

Table of Contents

1. Market Definitions & Research Methodology
2. Analyst Briefing
3. Introduction to Biopharmaceuticals
4. Global Biopharmaceutical Market: Industry Analysis
4.1 Strengths
4.1.1 High Efficacy and Target Oriented Attack
4.1.2 Strong Potential to Achieve Blockbuster Status
4.1.3 Limited Generic Threat
4.1.4 Approval Success Rates are Higher than Small Molecule Drugs
4.2 Weaknesses
4.2.1 Inconvenient Drug Delivery Coupled with Short Half Lives
4.2.2 Second Line of Therapy
4.2.3 Huge Cost of Therapy
4.2.4 High Incidence of Unfavorable Side Effects
4.3 Opportunities
4.3.1 Diseases with High Unmet Needs
4.3.2 Expanding the Patient Pool by Approval into Additional Indications
4.3.3 Emerging Markets
4.3.4 Increasing New Approvals and a Strong Pipeline
4.4 Threats
4.4.1 Biopharmaceutical Drug Development is a Very Risky Venture
4.4.2 Biosimilars
4.4.3 Limited and Conditional Reimbursement
4.4.4 Uncertainties in the Economic Environment
5. Global Biopharmaceutical Market: Industry Performance
5.1 Market Performance & Forecast
5.2 Market Segmentation by Region
5.3 Market Segmentation by Indication
5.4 Market Segmentation by Class
5.5 Competitive Landscape
6. North America
6.1 US
6.1.1 Market Performance (2005-2009)
6.1.2 Market Segmentation by Class
6.1.3 Performance of Top Players
6.1.4 Market Forecasts (2010-2015)
6.2 Canada
6.2.1 Market Performance (2005-2009)
6.2.2 Market Segmentation by Class
6.2.3 Performance of Top Players
6.2.4 Market Forecasts (2010-2015)
7. Latin America
7.1 Mexico
7.1.1 Market Performance (2005-2009)
7.1.2 Market Segmentation by Class
7.1.3 Performance of Top Players
7.1.4 Market Forecasts (2010-2015)
7.2 Brazil
7.2.1 Market Performance (2005-2009)
7.2.2 Market Segmentation by Class
7.2.3 Performance of Top Players
7.2.4 Market Forecasts (2010-2015)
7.3 Argentina
7.3.1 Market Performance (2005-2009)
7.3.2 Market Segmentation by Class
7.3.3 Performance of Top Players
7.3.4 Market Forecasts (2010-2015)
8. Europe
8.1 Germany
8.1.1 Market Performance (2005-2009)
8.1.2 Market Segmentation by Class
8.1.3 Performance of Top Players
8.1.4 Market Forecasts (2010-2015)
8.2 France
8.2.1 Market Performance (2005-2009)
8.2.2 Market Segmentation by Class
8.2.3 Performance of Top Players
8.2.4 Market Forecasts (2010-2015)
8.3 Italy
8.3.1 Market Performance (2005-2009)
8.3.2 Market Segmentation by Class
8.3.3 Performance of Top Players
8.3.4 Market Forecasts (2010-2015)
8.4 Spain
8.4.1 Market Performance (2005-2009)
8.4.2 Market Segmentation by Class
8.4.3 Performance of Top Players
8.4.4 Market Forecasts (2010-2015)
8.5 UK
8.5.1 Market Performance (2005-2009)
8.5.2 Market Segmentation by Class
8.5.3 Performance of Top Players
8.5.4 Market Forecasts (2010-2015)
8.6 Russia
8.6.1 Market Performance (2005-2009)
8.6.2 Market Segmentation by Class
8.6.3 Performance of Top Players
8.6.4 Market Forecasts (2010-2015)
8.7 Turkey
8.7.1 Market Performance (2005-2009)
8.7.2 Market Segmentation by Class
8.7.3 Performance of Top Players
8.7.4 Market Forecasts (2010-2015)
9. Asia Pacific
9.1 Japan
9.1.1 Market Performance (2005-2009)
9.1.2 Market Segmentation by Class
9.1.3 Performance of Top Players
9.1.4 Market Forecasts (2010-2015)
9.2 China
9.2.1 Market Performance (2005-2009)
9.2.2 Market Segmentation by Class
9.2.3 Performance of Top Players
9.2.4 Market Forecasts (2010-2015)
9.3 Australia
9.3.1 Market Performance (2005-2009)
9.3.2 Market Segmentation by Class
9.3.3 Performance of Top Players
9.3.4 Market Forecasts (2010-2015)
9.4 South Korea
9.4.1 Market Performance (2005-2009)
9.4.2 Market Segmentation by Class
9.4.3 Performance of Top Players
9.4.4 Market Forecasts (2010-2015)
9.5 India
9.5.1 Market Performance (2005-2009)
9.5.2 Market Segmentation by Class
9.5.3 Performance of Top Players
9.5.4 Market Forecasts (2010-2015)
9.6 Indonesia
9.6.1 Market Performance (2005-2009)
9.6.2 Market Segmentation by Class
9.6.3 Performance of Top Players
9.6.4 Market Forecasts (2010-2015)

To get the full version of “Global Biopharmaceutical Market Report (2010-2015)” please get in touch with us by emailing us at sales@imarcgroup.com or by calling us on +91-11-43095788"

"For more than 5 years, the International Market Analysis Research and Consulting Group has been a leading advisor on management strategy and market research worldwide. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

IMARC's information products include major market, scientific, economic and technological developments for business leaders in pharmaceutical, industrial, and high technology organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverage, travel and tourism, nanotechnology and novel processing methods are at the top of the company's expertise.
"

IMARC Group
15-a, International Commercial Centre, Mayur Vihar Phase-1 Extension
Delhi-110096
India
contact@imarcgroup.com
91-11-43095788
http://www.imarcgroup.com

This release was published on openPR.