Biosimilars market is not yet mature is difficult to guarantee return on investment

Biological products in 2009 worldwide market size more than 125 billion U.S. dollars, accounting for medicine and biology, 17% of the total pharmaceutical market in the next few years, this proportion is also expected to increase significantly. It is estimated that by 2014 global sales of the top three products will be of biological agents, the three 

Biological products in 2009 worldwide market size more than 125 billion U.S. dollars, accounting for medicine and biology, 17% of the total pharmaceutical market in the next few years, this proportion is also expected to increase significantly. It is estimated that by 2014 global sales of the top three products will be of biological agents, the three sales are expected to reach 25.4 billion. 

    Very few marketed products 

    The next 10 years, America will have a lot of blockbuster patent expirations of biological agents, such as Genentech and Roche's Avastin, Amgen, etanercept, Lilly cetuximab Abbott's monoclonal antibody and adalimumab. Even with such potential, 2009 biosimilars is only achieved 0.89 billion in sales, which Sandoz unit of Novartis Group, the company's recombinant human growth hormone Omnitrope which accounted for 33% of the product in 2008 In 6 months between June 2009 sales doubled. Sandoz is currently the world leader in bio-generics market and is the only company with more than two biosimilars approved products. Hospira, Inc. and Teva also is developing a large number of biosimilar products. Shows biosimilars market is not yet a mature market. 

    Europe is currently the world's largest bio-generics market, has been since November 2005, recombinant human growth hormone Omnitrope, A method according to Bo Ting, recombinant human granulocyte colony stimulating factor, etc. A total of 13 biosimilars approval in Europe; United States not established procedures for review biogenerics, the drafting of relevant laws and regulations by the Obama administration is expected to urge the passage of Sandoz's recombinant human growth hormone Omnitrope was approved in the United States is the only bio-generic drugs, but the adaptation license restrictions; Japanese Institutes of Health, Labor and Welfare Protection Division is released in March 2009 the final biological guidelines for generic drugs, first approved in Japan biosimilars is recombinant human growth hormone Omnitrope; Australia for biological products is managed by drugs, Omnitrope has been allowed to market in the country; Asia-Pacific region, Malaysia and South Korea in August 2008 and May 2009 published guidelines. 

    As the only current implementation of the European biosimilars a special policy area, the listed products are few. At present the use of habit, the health care system such as drugs reimbursement policy, the impact of doctors and product prices are different, biosimilars market penetration in European countries vary widely, with Germany in the European market, the largest market share. 

    The law does not allow generic drugs to replace the original use of biological research products, which is currently limited market penetration of bio-generics is a special reason, which makes the application of bio-generics limited and short-term indications of new patients on. However, the use of biosimilars in cost control or significant. Regulatory approach has not been established in the market (including the United States), patent exclusivity, clinical trial requirements and product substitutability, is the product on the market success of the three decisive factors. By the status of biosimilars market can predict the next few years, biosimilars market competitors are not more than the traditional chemical generics market. 

    Difficult to guarantee return on investment 

    Rising drug costs worldwide, of which a large proportion of biological products. Pay for the cost side, we must break through biological barriers to generic drugs. Currently, many biological products have been listed on the face patent expiration, making a number of generic drug companies will turn to the future growth potential of biotechnology products. In addition, because sales of blockbuster branded drugs down, some R & D based pharmaceutical companies such as Merck & Co., also aimed at the bio-generic drugs, and as future development opportunities. Sales of biogenerics clinical need, which is the R & D based pharmaceutical companies are good at. 

    While many companies have begun to generics in the field of bio-technical cooperation and licensing, but only those with independent research and development capacity of the company to be successful. 

Since the high acquisition costs in this area, coupled with biosimilars market penetration is currently limited, short-term and medium-term return on investment is difficult to be ensured. 

    Since the classification of biosimilars fuzzy, manufacturers of consumer direct sales, original research products, pricing policies, tendering and contract price and other factors, led to sales of biosimilars is difficult to predict, there are forecasts that its sales by 2008 0.66 billion U.S. dollars up to 2015 to 23 billion U.S. dollars, also forecast that its 2013 sales will exceed 5.6 billion. No matter how the forecast 500 billion market potential exists, but the potential market can translate into real consumption, but also on relevant laws and regulations, products, manufacturers of alternative strategies and original research.