In the context of global economic development, the biopharmaceutical industry has been working to improve Bioprocessing technology to reduce costs and increase productivity. Targeted and improved production technology can not only reduce operating costs, but also improve the weak R&D of the company, especially for pharmaceutical companies in developing countries. According to BioPlan Consulting's 14th annual report and biopharmaceutical production capacity and production survey, biopharmaceutical key areas show strong growth trends, while the market is further subdivided, requiring technological advancement to meet global market demand and future development prospects. .

Currently, many large biopharmaceutical companies are increasing their research and development of biopharmaceuticals compared to small molecule drugs. In fact, a number of research data show that biopharmaceuticals account for 40% to 50% of the R&D investment of most organizations. In order to promote the development of biopharmaceuticals, major biopharmaceutical companies are striving to maintain this R&D investment and increase product productivity through innovation. Innovation can also speed up the drug discovery process, increase R&D options, and reduce costs and productivity.

4 trends affecting the production of biopharmaceuticals

The development of biopharmaceuticals has broad prospects: new technologies, biosimilars, cellular and gene therapy are developing rapidly, and the rise of emerging markets has also brought opportunities. Based on the above innovation platform, the biopharmaceutical field will continue to improve production technology.

图1 2014-2017年生物药领域关注的4种发展趋势

In the 15 major trends in the development of the biopharmaceutical industry in 2017, this paper summarizes the main trends currently affecting biopharmaceutical production, including the characteristics of many key trends. For example, from the annual report, the most influential trend is production efficiency (16.4%), which has been among the best in recent years as “the single most important impact on biopharmaceutical production trends”. Second, the productivity gains from downstream bioprocesses and the reduced cost of ongoing production processes have become the second largest trends affecting the biopharmaceutical industry. Although these technologies are not being developed, in most cases, commercial-scale applications have not yet been implemented. The third major factor is the reduction in production costs (11.6%), which can help reduce healthcare costs by lowering production costs, making it easier for underdeveloped economies to access expensive biological products, and can also help to open biosimilars. Within the global market.

BioPlan's annual survey data and other studies confirm that bioprocess efficiency and productivity will continue to rise steadily. At the same time, in order to improve the production process, drug developers and biopharmaceutical companies have to spend more time and energy to evaluate and improve existing technology, process development areas and production options. Especially for CMO companies, it should ensure that the customer's low cost and product quality attributes are met.

With the opening of the US biosimilar drug market, the development trend of biosimilar drugs in the world seems to be accelerating. The FDA has approved a number of biosimilars, including monoclonal antibodies, demonstrating the feasibility of developing biosimilars in accordance with FDA standards, and we look forward to the development of more cost-driven biologics. It is expected that the biopharmaceutical industry will continue to improve the global biologics processing and production environment by hiring technicians and combining technological advancements to improve and increase the production of biologics, small molecule drugs, biosimilars and other formulations.

Meeting changing supplier needs

It should also assess how current bioprocess trends affect the technical requirements and purchasing patterns of bioprocess end users. By assessing the current and future needs of bioprocess end users, it is possible to better predict the direction of the supplier's investment.

When asked what technologies will be needed in the future, more than half (53.8%) of industry respondents believe that bioprocesses will need to use more closed system technologies. Figure 2 shows that 40% of suppliers agree to continue developing one-off system technology. Based on analysis in China and other emerging markets, it has been found that single-use platforms have been used on a large scale in clinical facilities. Most new entrants, especially those seeking rapid access to CGMP manufacturing, will choose to use a one-time system technology strategy. In addition, nearly one-third of respondents (30.8%) believe that Continuous Bioprocessing (CBP) is a key area for the development of suppliers and innovators. Although CBP accounts for only 12% of the important trends affecting production (see above), it still puts some pressure on suppliers and innovators, because CBP often involves complex operations and large-scale supply challenges. Not ready for widespread use in commercial use.

图2 生物制造的未来——终端用户期望的技术要求

As shown above, the industry continues to explore and develop new biotechnology technologies. As the industry matures, many existing biotechnology technologies and facilities are increasingly unable to meet demand. Coupled with the recent slowdown in bioprocess innovation, the industry's suppliers are under greater pressure to build better and more efficient platforms. To meet the industry's need for innovation, some of the larger suppliers have created innovation centers and established customer-centric, collaborative R&D new product approaches. For smaller suppliers, they can continue to innovate and seek development partners, so the industry's innovation situation still has a sufficient foundation.

Biotechnology has been developed in recent years, but downstream technologies and production capacity still lag behind upstream biotechnology. The biopharmaceutical industry has been working to increase productivity, save costs and improve product quality. According to survey data, the 2018 trend is no exception.

China and India increase productivity, and the global competition is obvious

Global competition has always been a trend and will continue to follow this trend in 2018. Biosimilars (and in international markets where biosimilars are less and unregulated) are attracting many new players into the biopharmaceutical industry. As the main location for biopharmaceutical research and development, the United States remains the country with the largest number of biosimilar drugs. Soon, biosimilars will become one of the largest markets for biopharmaceuticals. At the same time, Asian countries such as China and India are introducing new facilities and technologies to increase production capacity and enter the biosimilar market.

in conclusion

In the past 20 years, biopharmaceuticals and their suppliers have continued to grow at a rate of about 14%; currently, sales of biotherapeutics have exceeded $200 billion. With the improvement of innovative product channels and the growth of international sales, industry revenues are expected to grow steadily. According to the survey, the most important trend in the biopharmaceutical field in 2017 is that the industry should pay attention to the trend in 2018: to improve production efficiency to meet growing demand, reduce costs, and improve the overall quality of products. The survey data also shows that improving biopharmaceutical continuous production processes and reducing production costs, especially those associated with single use, is a top priority in biopharmaceutical management. In addition, the increasing number of facilities and the popularity of biosimilars on the market means that companies should pay close attention to new technologies in 2018 while ensuring that skilled employees are retained to serve potential expansion businesses.

references:

[1] 14th Annual Report and Survey Biopharmaceutical Manufacturing Capacity and Production, April 2017, BioPlan Associates, Inc., Rockville, MD,http://bioplanassociates.com/14th/