New drug research and development needs to accelerate the release of pharmaceutical outsourcing industry to welcome new opportunities
With the increasing difficulty and cost of new drug research and development year by year, as well as the increasingly fierce competition among pharmaceutical companies, pharmaceutical companies have continuously increased their product investment in the field of new drug research and development, and the development of innovative new drugs has become the focus of attention of pharmaceutical companies. The agency believes that with the gradual release of my country's demand for new drug research and development, the reform of the pharmaceutical industry will increase. In the next few years, my country's pharmaceutical research and development outsourcing industry will usher in new development opportunities and become an important link in the pharmaceutical research and development industry chain.
The outsourcing service of pharmaceutical research and development contract mainly includes the design and consultation of clinical trial plan and case report form, data management, statistical analysis and the writing of statistical analysis report, which is a kind of outsourcing service with high professional requirements. The pharmaceutical R & D outsourcing industry mainly relies on undertaking new drug R & D outsourcing contracts from large pharmaceutical companies to achieve profitability. The scope of services basically covers all stages and fields of new drug research and development. For most pharmaceutical companies, part or all of the entrusted pharmaceutical R & D outsourcing company is the inevitable choice of modern professional division of labor, will be more professional, more effective and reduce pharmaceutical costs.
As the most developed region in the pharmaceutical R & D outsourcing market, Europe and the United States occupy a major share of the global pharmaceutical R & D outsourcing market. Nine of the world's top 10 pharmaceutical R & D outsourcing companies are from Europe and the United States. According to BCG and ICON estimates, the pharmaceutical R & D outsourcing market in 2013 was $28 billion, with R & D outsourcing accounting for 47% of the industry's market share. It is estimated that the market size will reach 40 billion billion US dollars in 2020, and the penetration rate is expected to exceed 55%.
At present, China has surpassed India to become the first choice for R & D outsourcing in Asia. With the intensification of cost pressure, pharmaceutical R & D outsourcing has become an important element of competition among large pharmaceutical companies. In recent years, in order to reduce the cost of drug development, pharmaceutical companies have accelerated the transfer of biomedical (2349.89,0.000,0.00) research to emerging markets in Asia. In the next few years, the growth rate of emerging markets in Asia will continue to increase, which is expected to bring huge development opportunities to our country.
The development of the pharmaceutical R & D outsourcing market depends on the demand for new drug research and development. China's pharmaceutical R & D outsourcing started late, the drug market is dominated by generic drugs, and the power of new drug R & D is insufficient. With the continuous increase of support policies, the pharmaceutical research and development outsourcing industry is expected to usher in rapid development. In March this year, the general office of the State Council issued the opinions on the consistency evaluation of the quality and efficacy of generic drugs, making arrangements for the "consistency evaluation" of the quality and efficacy of generic drugs that have been approved for listing. On March 28, the State Food and Drug Administration formulated the "Working Procedures for the Consistency Evaluation of the Quality and Efficacy of Generic Drugs (Draft for Solicitation of Comments)" and "Requirements for the Application of Consistency Evaluation of Oral Solid Preparations of Chemical Drugs (Draft for Solicitation of Comments)". The development of "consistency evaluation" will enhance the overall level of China's pharmaceutical industry, promote the upgrading and structural adjustment of the pharmaceutical industry, improve the innovation ability of China's pharmaceutical industry, and bring incremental demand for the pharmaceutical R & D outsourcing industry.
With the rapid release of China's demand for innovative drug research and development, it is expected that by 2018, the scale of China's pharmaceutical research and development outsourcing market will exceed 60 billion yuan. The agency believes that China's pharmaceutical R & D outsourcing industry will enhance the degree of service specialization, open up upstream and downstream links, expand the scope of business to achieve vertical integration. In the future, the industry will form large-scale and professional pharmaceutical R & D outsourcing companies through mergers and acquisitions. In the integration of resources, pharmaceutical R & D outsourcing companies that have occupied market resources will be the first to benefit.