|
|
 |
|
Viewing report
|
|
|
|
Global Biosimilars Industry
Taiyou Research, Aug 2011, Pages: 315
'Biosimilars' is a term used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. In 2009 alone, the total market in the US and five major European nations for biosimilars was $150.4 million and this expanded to $198 million in the 12 months which followed. It is also greatly anticipated that by 2015 the market worth of biosimilars is going to reach up to $51 billion.
Even after the sanction of its pathways in the US, the EU and Japan and its growing capitalization, all of which help drive the uptake of biosimilars, there still remain many detrimental factors for it to achieve commercial success in developed markets. The exigency for cost-effective treatments still remains an issue to deal with. Concerns revolving comparability, brand loyalty, dearth of substitutes and competition from second generation brands are the crucial matters of contention for the biosimilar market. Taking into account the emerging markets in countries such as Brazil, Russia, India and China, low purchasing power teamed with high proportion of out-of-pocket expense and not to mention brand loyalty, all hamper the growth of the biosimilar market.
It is because of their intricacy, cost, and development risks that the manufacturing and commercialization in developed markets remains centered amongst a bunch of pharma companies, all of which are established generics corporations. These companies are now looking to accelerate the market for biosimilars by going into partnerships. With a solid foundation of reputation lodged, these corporations are hoping to take the marketing of biosimilars to new heights. There is hardly any doubt that these companies ought to accomplish their goals as they have been dominating the market ever since its establishment.
Meanwhile in the emerging markets, home-grown pharmaceutical companies dictate the biologics market and have launched numerous products which are a hindrance for international corporations entering the sector. Companies such as Biocon and Dr. Reddy's are looking forward to expanding themselves through partnerships and upholding their revenues. With the accessing of biosimilar products readily growing globally, it looks set to rise by leaps and bounds in the coming years.
The “Global Biosimilars Industry” report covers the following:
- The emergence of biosimilars – the role of the Biologics Price Competition and the Innovation Act, and the issue of data exclusivity and how this has led to the emergence of biosimilars.
- An industry definition, including the specific nature of biosimilars, categories of biologics, importance of biosimilars, a comparison of biosimilars with generics, and the branded product business model in the industry.
- An overview of the biopharmaceutical industry is necessary in order to place the growth of the biosimilars industry. The biopharmaceutical manufacturing process is also discussed.
- Moving onto the actual analysis of the global biosimilars industry, the report analyzes the market through market size, market overview, market value of branded biologics that are facing upcoming patent expiries, the operating margin for biosimilar manufacturers, investor concerns with regards to biosimilars, and the commercial impact of the biosimilars industry in Europe.
- The report analyzes the key success factors for biosimilars. This section looks at the importance of having a well thought out strategy, along with the knowledge of what competitors in the business are up to. Development of biomanufacturing competencies and clinical capabilities are also discussed.
- Factors having an impact, be it positive or negative, on the global biosimilars market are analyzed. Factors analyzed include the growth of the industry in developed countries and BRIC countries, the high cost of biologics, the use of branded biologics, approval pathways, unfavorable tendering processes, lack of incentives, ease of market entry in the BRIC countries, and many others.
- Also analyzed are the factors driving the growth of biosimilars worldwide, including the need to lower healthcare costs, the lower development costs of biosimilars, lower treatment cost with biosimilars, amongst others. Challenges barring the growth of biosimilars are also analyzed, including the high cost of development and manufacturing of biosimilars as compared to generic drugs, the high entry barriers to the industry, and many others.
- Regulations have a major role to play in the uptake of biosimilars around the world. In the report, an in-depth analysis of the regulatory framework impacting the biosimilars industry in Europe, Japan, and the US is carried out. Current position of governments on biosimilars, approval pathways, and the various regulations are all discussed.
- For the growth of the biosimilars industry, new players need to keep entering the market. There are many factors which determine market entry in the global biosimilar industry and these factors are analyzed in the report,. Some of the factors analyzed include approval pathways, long drawn-out clinical development timeline for biosimilars, issues with patents, strategic partnerships in the industry, and many others.
- The section on competitive landscape analyzes the key players and markets in the global biosimilar industry analyzes the key industry players, key industry suppliers, generic drug producers and the role they have to play in the biosimilars industry. It looks at major stakeholders in the industry, developed versus emerging markets, biosimilars launches expected in the coming years, and a market analysis. The markets analyzed in this section include Australia, BRIC countries, European Union, Japan, and the United States.
- The report analyzes the major biosimilars on the market presently. These include epoetin, filgrastim, and somatropin.
- Upcoming patent expiries and the opportunities they present for the global biosimilars market are analyzed, followed by the strategies used by Big Pharma in the face of rising competition from biosimilars.
- The biosimilar market is then analyzed by country. Markets analyzed in-depth in this section include France, Germany, India, Italy, Japan, Spain, the UK, and the US.
- As the report is wrapped up, the major players in the global biosimilars industry are analyzed. All the players have been analyzed through a company overview, analysis of business segments, presence in the biosimilars market, and a SWOT analysis. For the smaller market players, only an overview of their performance in the biosimilars market is included.
- Market outlook for the global biosimilars industry includes an overall industry forecast, forecast for biosimilar sales, forecast by market including the US biosimilars market, European biosimilars market, and the Japanese biosimilars market. Forecast for the industry is also broken down into an outlook for some particular types of biosimilars. These include biosimilars for mAb against cancer, EPO biosimilars market, hGh biosimilar markets, G-CSF biosimilars markets, insulin and insulin analogs biosimilars, Interferon alfa and beta biosimilars, and the TNF alfa inhibitor biosimilar market.
The “Global Biosimilars Industry” is a comprehensive and detailed coverage of the industry – including a statistical as well as strategic view of the complete market.
|
|
|
|
