PHARMACEUTICALS
‣ The Ministry of Health , Labour & Welfare released the strategic ‘ Pharma Industry Vision 2021 ’ report in September 2021 , eight years after the previous vision was formulated . 2 The report focused on changing business circumstances in recent years , such as drug discovery using genome technology and Big Data , market penetration by generic drugs and the globalisation of the drug market . Based on the external trends surrounding the industry , the report advocated a policy that supports innovative drug discovery by the development of genome data infrastructure and the vitalisation of collaboration between academia and start-ups throughout the pharmaceutical ecosystem .
Small molecule revival
One recent remarkable trend in pharmaceutical R & D is the revival of the investigation of small molecule drugs . This is particularly obvious in the field of oncology . 3 The US FDA approved 53 new drugs in 2020 , 40 small molecules and 13 biological drugs . Chemotherapeutic agents accounted for 23 new approvals , including 13 new chemical entities . Small molecules represent approximately 75 % of all drugs approved by the FDA and they are expected to continue to play a key role in innovative treatments . Owing to an increased development of small molecule drugs , the global production capacity for small molecules in CDMOs is becoming tighter . 4 A report from the Office of Pharmaceutical Industry Research , a Japanese think tank for the pharmaceutical industry , reviewed the nationality of the innovators of novel molecular entities worldwide in 2020 . 5 The proportion of Japanese companies in the nationalities of project owners was only 3 % for antibody drugs but approximately 10 % for small and medium-sized molecule ( DNA and RNA ) drugs ( Figure 1 ). This indicates that a credible and sustainable cycle has been realised in Japan in which strong demand for small and medium-sized molecule projects has revitalised the CDMO business . This in turn has helped the development of new drugs by pharmaceutical companies , including start-ups .
CDMOs in Japan
When ‘ Western ’ drugs were first introduced to Japan in the 19th century , API sourcing depended upon the import from foreign pharmaceutical companies . During the strong economic recovery in the 1950s , many pharmaceutical companies were established with the aim of manufacturing APIs in Japan . At that time , API manufacturers focused on the production of antibiotics and antihistamines , which became big markets in Japan . Juzen Chemical was established in 1950 to produce diphenhydramine . In the 1960s , GMP for pharmaceutical production was enacted in the US and other countries followed suit . The manufacturing standards in Japan were established approximately a decade later . Since its establishment in 1975 , the Japan Bulk Pharmaceutical Manufacturing Association ( JBPMA ) has been working on the introduction and improvement of GMP systems
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