Small molecule API (Active Pharmaceutical Ingredient) has shown versatility and are moving towards more orphan drugs or targeted therapies. This is due to the requirement for contract manufacturers to be able to produce from kilograms to hundreds of metric tons of APIs in order to fulfill the demand for wide variety. Moreover, it is important for Contract manufacturing organizations (CMOs) to offer a wide range of manufacturing options to cover life-cycle of the drug from the introduction to maturity. Hence small molecule API will be the key focus of CMOs, emerging as the backbone of the pharmaceutical industry.
According to the latest report by Future Market Insights (FMI), the global small molecule API market is projected to register 4.9% CAGR during 2017-2027. The higher growth rate in HPAPI and investment in infrastructure to raise in-house production are some of the factors driving the demand for small molecule API market. APEJ is expected to be the fastest growing market, registering 5.8% growth rate during 2017-2027. The large population consuming non-controlled drugs is resulting in higher consumption of API in APEJ. Moreover, India is the leading country in DMF filing. Hence, most of the manufacturing contracts from the companies in the U.S. are expected to be awarded to companies in India.
The small molecule API market in APEJ is anticipated to exceed $52 billion by 2027 end. The biggest reason for this growth is increasing outsourcing. Meanwhile, owing to the limited regulatory requirement, the production in India and China is also increasing.
Next-gen technology to drive efficiency and quality of small molecule API
For CMOs the rising demand for small molecule API presents new business opportunities. However, there are various challenges where CMO market is highly competitive and only new technology can make a difference. CMOs are also focusing on technologies that meet the specific need of the particular drug. Manufacturers are also investing and accruing expertise in order to handle projects. It can be challenging to develop new facility from scratch, hence, a lot of mergers and acquisitions are taking place.
For instance, WuXi AppTech’s Pharmaceutical Development Division recently merged with STA Pharmaceutical. On basis of this merger, STA Pharmaceutical plans to provide fully integrated small molecule API and drug product solutions to its global clients. It will also result in seamless CMC working process. The merger will facilitate STA to advance from pre-clinical stage to New Drug Application (NDA). This will also enhance STA to full-service CDMO. The WuXi AppTech’s Pharmaceutical Development Division offers development, formulation, clinical trial material, manufacturing, packaging and labeling.
Many technological innovations are also in the pipeline. For example, Peptron’s SmartDepot is ultrasonic spray drying technology to prepare Sustained Release (SR) injectable microsphere formulation of the drug. Due to the high cost of developing new medicines, pharmaceutical companies are getting attracted towards this next-gen technology. Moreover, SmartDepot is also highly applicable to small molecule drug, enabling mass production and ensuring quality aspects. SmartDepot features release profiles from one week to 6 months. Peptron has already used SmartDepot to develop SR once monthly anti-prostate cancer drug, under the trade name of Luphere Depot. It is also considered to be the world’s first technology using ultrasonic spray drying process.