The MAH system has brought unprecedented opportunities and challenges to the Chinese pharmaceutical industry. Combined with the current development of the world's biopharmaceutical industry, the article will take you to understand the development pattern and current situation of the pharmaceutical CDMO industry, and understand the background of the CDMO industry development driven by policies and dividends.
01
Introduction to CDMO Industry Services
The CDMO (Contract Development Manufacture Organization) business model includes the entire supply chain system from preclinical research, clinical trials to commercial production, including R&D, procurement, and production. It provides innovative process R&D and large-scale production services for pharmaceutical companies. Technology output with higher added value replaces pure capacity output.
02
Global CDMO Market Status, Scale
01 The global CDMO market size is nearly 100 billion US dollars
In 2019, the global CDMO market size is nearly 80 billion US dollars, of which it is mainly for small molecule CDMO business services, with a market size of 58.3 billion US dollars. The annual growth rate of the global CDMO industry from 2012 to 19 is 11.95%, which is much higher than the 4.9% annual growth rate of the global pharmaceutical market in the same period; 5.7%. The market size of cell and gene therapy CDMO services in 2017 was only US$1.2 billion, but the growth rate is also very fast. It is expected to reach US$3.6 billion in 2022, with an annual growth rate of 24%.
02 Global CDMO Industry Distribution
(1) The development of CDMO industry emerges from Europe and shifts to Asia-Pacific
Before 1996, there were few companies engaged in CDMO business. APIs and intermediates were mainly produced by pharmaceutical companies themselves or provided by chemical companies, mainly distributed in Europe. From 1997 to 2007, it was 10 years when the CDMO industry emerged. Several important CDMO companies achieved rapid development at this stage, laying the foundation for their development as leading companies in the CDMO field: Pathon began to enter the pharmaceutical CRO field and Vigorously deploy the European and North American markets; Catalent entered the oral drug business from the packaging and potting business, and became independent from the parent company; the current biopharmaceutical CDMO leader Lonza officially entered the biopharmaceutical field in 1996 and began a series of layout expansions for the future. Development laid the foundation.
At this stage, CDMO has been able to develop rapidly. The reason can be attributed to the fact that a large number of patented drugs have expired, resulting in idle production capacity of pharmaceutical companies. In order to reduce operating costs, pharmaceutical companies sold idle production capacity to CDMO companies to make them grow stronger. At the same time, early biotech companies entered a period of rapid development, including Celgene, Gilead, Shire, etc. These companies were generally established in the 1970s and 1980s. After entering the 1990s, some products were approved for the market, and some of them have not yet established large-scale production lines. , thus promoting the development of outsourcing production business. In the third aspect, clinical CRO companies such as Covance and Quintiles have achieved success in this stage, and have begun to establish long-term relationships with large biopharmaceutical companies, making the form of pharmaceutical outsourcing services gradually recognized by the market. Another option in R&D.
From 2007 to 2018, the assistant industry for accelerated approval of new drugs developed rapidly again. After the financial crisis, the industry began to pick up. According to the news released by pharmaTech, the CDMO industry has grown by 10-15% since 2013, and the small molecule API business has grown rapidly, mainly due to the increase in the approval of innovative drugs and the frequent emergence of blockbuster drugs; In 2017, the number of new drug approvals and the five-year sales situation, in terms of quantity, the number of new drug approvals increased after 2010, and increased rapidly from 2014 to 2015, reaching 51 and 56 respectively; GBI Health released "2017 According to the report, the number of imported drugs approved in 2017 reached 39, and the number of domestic Class 1 new drug applications was 174, both hitting the highest in the past 10 years.
03
Situation and Development Trend of Domestic CDMO Market
Although the CDMO industry in Europe and the United States occupies a very important market share in the world, due to cost pressure factors such as environmental protection and R&D in recent years, the European and American pharmaceutical outsourcing service industry is gradually shifting to emerging markets with engineer dividends and greater market potential. Taking into account the multiple advantages of talents, costs, policies, etc., my country has become an important target country to undertake industrial transfer. At the same time, the dust settlement of the MAH system has also pushed the domestic CDMO industry into the harvest period.
01 Domestic CDMO development status and scaleAccording to Evaluate Phama data, in 2019, the scale of the global CDMO industry was 79.8 billion yuan, a year-on-year increase of 13.19%. growth in global market size. At present, the leading CDMO companies in China mainly include Stapharma, WuXi Biologics, Asymchem, Proton, and Apeloa.
(1) Business upgrade: extending to high value-added business
Compared with overseas CDMO leading companies, domestic companies still have huge room for growth in business extension and development.
(2) Transfer and undertaking: China has benefited significantly from the transfer of CDMO business in Europe and the United States to the Asia-Pacific region
(3) Favorable policies: policy support creates opportunities for the development of the domestic CDMO industry
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