The biosimilar market is still immature. The return on investment is difficult to guarantee.

In 2009, the size of the world's biological products market exceeded US$125 billion, accounting for 17% of the total pharmaceutical and biopharmaceutical market. In the coming years, this proportion is expected to increase significantly. It is estimated that the top three products for global sales in 2014 will be biologics, and the three sales are expected to reach US$25.4 billion.

There are few listed products

In the next 10 years, the United States will have many blockbuster biopharmaceutical patents expired, such as Genentech and Roche's bevacizumab, Amgen's etanercept, and Eli Lilly's cetuximab. And Abbott’s adalimumab. Even with such potential, biosimilars achieved sales of only US$89 million in 2009, of which Novartis Group's Santoro’s recombinant human growth hormone Omnitrope accounted for 33% of them, which was in 2008. Sales from June to June 2009 doubled. Sandoz is the leader in the global biosimilar market and the only company with more than two approved biosimilar products. Teva and Hospira are also developing a large number of biosimilar products. It can be seen that the biosimilar market is not yet a mature market.

Europe is currently the world's largest biosimilar market. Since November 2005, a total of 13 biosimilars such as the recombinant human growth hormone Omnitrope, alfa ibustine and recombinant human granulocyte colony-stimulating factor have been approved in Europe. The review procedures for biosimilars have not yet been established. The drafting of relevant regulations is expected to be approved by the Obama administration. Santoz’s recombinant human growth hormone Omnitrope is the only biosimilar approved in the United States but its indications Restrictions; the Ministry of Health, Labor, and Welfare of Japan issued the final guidelines for biosimilars in March 2009. The first biosimilar approved in Japan is the recombinant human growth hormone Omnitrope; Australia is a biological product. Under the management of drugs, Omnitrope has been approved for listing in the country; Malaysia and South Korea in the Asia Pacific region issued guidelines in August 2008 and May 2009 respectively.

As the only region in the world that implements a special biosimilar drug policy, Europe has very few listed products. Currently, due to differences in usage habits, medical systems such as drug reimbursement policies, doctors' influence, and product prices, the market penetration of biosimilar drugs in European countries varies greatly, among which Germany has the largest market share in the European market.

The legal provisions do not permit the substitution of biosimilar drugs for original research products. This is a special reason for restricting the market penetration of biosimilar drugs, which limits the use of biosimilar drugs to new patients and short-term indications. However, cost control using biosimilars is still significant. In markets where regulatory approaches have not yet been established (including the United States), the exclusivity of patents, the requirements of clinical trials, and the substitutability of products are the three decisive factors for the success of products in the market. From the current status of the biosimilar market, it can be predicted that in the next few years, there will be no more competitors in the biosimilar market than in the traditional chemical generic market.

The return on investment is difficult to guarantee

Global drug costs are rising, with biological products accounting for a large proportion. To control costs, the paying party must break through the barriers of biosimilars. At present, many listed biological products are facing patent expiration, which has led some generic companies to shift their future growth potential to biotechnology products. In addition, due to the decline in sales of blockbuster brand drugs, some R&D pharmaceutical companies, such as Merck, have also targeted biosimilars as an opportunity for future development. The sales of biosimilar drugs need to be clinically promoted, which is exactly what R&D pharmaceutical companies are good at.

Although many companies have begun technical cooperation and licensing trade in the field of biosimilars, only those companies with independent research and development capabilities can succeed. Due to the high cost of mergers and acquisitions in this area and the limited market penetration of biosimilars, it is difficult to ensure the return on investment in the short and medium term.

Due to the ambiguous classification of biosimilars, manufacturers’ direct sales to consumers, pricing policies for original research products, bidding and contract prices, and other factors have caused biosimilar sales to be difficult to predict. It is predicted that sales will be driven by 2008. The US$0.66 billion has risen to US$2.3 billion in 2015, and there are forecasts that its 2013 sales will exceed US$5.6 billion. Regardless of the forecast, the market potential of 50 billion U.S. dollars is existent, but whether the potential can be transformed into real market consumption also depends on the relevant laws and regulations, the substitution of products, and the original manufacturer's strategy.