Biologics continue to outperform the global pharma market, driven by premium priced therapies for conditions that cannot be managed by conventional drugs.

The rapid penetration of novel biologics and the gradual expiry of their patents will create significant market opportunities for biosimilars developers through to 2016.

In the short term, biosimilar market growth will be driven by drug classes including erythropoietin, filgrastim, human growth hormone (hGH) and insulin.

This report examines the competitive landscape of the global biosimilars industry. The latest key issues and evolving business models in the biosimilars market are identified and the leading companies in this sector are profiled in detail.

This report also examines the portfolio sales performances, pipelines and growth strategies of each of the top 10 biosimilars companies. The opportunities and threats facing each of these leading players are also assessed.

It further examines the size, growth and major trends of the global biosimilars industry, in addition to providing to an assessment of leading biosimilars companies outside of the top 10.

Key findings:

The global biosimilars market reached $1bn in 2007, representing an increase of 5.9% over 2006. The increasing use of biologics in disease areas such as cancer, auto-immunity and orphan diseases, in addition to healthcare cost containment, has driven this growth.

Novartis (Sandoz) leads the global biosimilars market with a market share of 4.1% and sales of $23m in 1H 2008. The company is expanding its portfolio to exploit the opportunities arising from branded biologics going off-patent in the US and EU.

An estimated $25bn worth of biologics will lose patent protection by 2016, creating a significant market opportunity for biosimilars. Monoclonal Antibodies (mAb) such as Herceptin and Rituxan/Mabthera are among a number of major biologics going off-patent during this period.

Teva is the third largest company in the global biosimilars market, with a share of 2.1% based on sales of $12m in 1H 2008. The company is investing in R&D and manufacturing capabilities to accelerate biosimilar development.

The 2008 acquisition of Barr has substantially strengthened its market position, having provided access to Barr’s substantial expertise in the field.

Use this report to:

- Compare the performances of the top 10 players in the global biosimilars market with this report’s analysis of marketed product sales for Biocon, Bioton, Emcure (Gennova), Hospira, Intas Biopharma, LG Life Sciences, Novartis (Sandoz), Ranbaxy, Teva, Wockhardt

- Identify the market dynamics of the global biosimilars industry over the 2006-07 period, examine the drivers and resistors to industrial growth and understand the key trends that are shaping the future of the biosimilars market

- Assess the future prospects of the top 10 biosimilars companies with this report’s analysis of each firm’s strengths, weaknesses, opportunities and threats, in addition to an examination of their product pipelines and growth strategies

- Measure the progress of other leading biosimilars companies by evaluating the financial performances, marketed products and pipelines of 3SBio, Bharat Biotech, Dr Reddy’s, MJ Biopharm, Panacea Biotech, Pharmaclon, Shantha Biotech, Shenzhen Neptunus Interlong, Shreya Life Sciences and Stada.

Explore issues including:

The safety and efficacy of biosimilars: Technological and manufacturing complexities make it difficult to produce exact replicas of biologics, raising concerns over the safety/efficacy of biosimilars. Such perceptions, combined with an unwillingness to switch from sophisticated branded biologics, mean that the market acceptance of biosimilars is likely to be slow.

The erosion of biosimilar price differentials: The cost of biosimilar development is rising due to regulatory agencies seeking additional clinical studies to ensure patient safety. This is reducing the price advantage of biosimilars against their reference drug. Price discounts are subsequently expected to amount to only 25%-35% initially, due to high costs and limited competition.

Significant regulatory hurdles to overcome: The complex structure of biosimilars demands stringent regulation to ensure patient safety. Europe was the first among regulated pharma markets to create a biosimilars approval pathway in 2006. This legislation provides 10 years of patent protection to biologics against biosimilars and hybrids, and calls for extensive testing to ensure safety. The difference between a similar biological medicinal product and the reference product must be justified with appropriate studies and clinical trials on a case-by-case basis, in addition to post-marketing monitoring.

Discover:

- Which major trends are currently shaping the global biosimilars market?

- Who are the top 10 players in the market?

- What is the market share of each of the global leaders by company?

- What are the key growth strategies of leading companies?

- What are the strengths and weaknesses of the industry’s top players?

- Which factors are considered when creating biosimilar regulations across Europe, the US, Canada, India and China?

- How are the dynamics of the biosimilars market different from generics?



Table of Contents



167 pages

Publication Date : April 2009