A Small molecule Active Pharmaceutical Ingredient (API) is a low molecular weight organic compound, which may help to control biological process, with a size on the order of 1 nm. Most of the small molecule can be administered orally and are most likely to be absorbed by the body. Owing to its small size it has properties of rapid diffusibility to reach at intracellular site of action.
Small Molecule API Market – Dynamics
The small molecule API market is witnessing rapid growth due to increasing number of corporate agreements. For instance, BASF Pharma will sell its OMEGA 3 manufacturing facility in Norway to Marine Ingredients. The Highly Potent Active Pharmaceutical Ingredients (HPAPI) is projected to witness high growth rate, owing to easy access to the people for medication in emerging economies. The rising prevalence of diseases such as cancer, cardiovascular, and infectious diseases is expected to propel demand for manufacturing of small molecule APIs. According to the National Center for Biotechnology Information (NCBI) report, in 2014, out of 570,341 deaths 29.4% were due to cancer and 27.1% were due to cardiovascular disease. Increasing consumer awareness, benefits of small molecule API, expiry of patents covering the top-selling pharmaceuticals, and technological advancement in manufacturing sector are expected to drive the market growth over the forecast period. Increasing adoption of generic drugs has resulted into affordable healthcare expenditure, which is expected to increase production of small molecule API’s, in turn driving the global small molecule API market growth. According to the Indian Brand Equity Foundation (IBEF), in 2018, India is largest producer of generic medicines, which supplies 50% of vaccines and 40% of drugs to the U.S. and 25% of drugs to the U.K.
Small Molecule API Market – Regional insights
North America held the largest market share for small molecule API registering for 38.84% in 2017, due to high adoption rate of accelerated regulatory review of innovative medicines. Asia Pacific excluding Japan (APEJ) market is estimated to witness rapid growth in market, owing to high adoption of over the counter (OTC) drugs by large patient population coupled with growing healthcare and pharmaceutical industry and strong research and development in API. According to IBEF, investment in research and development by Indian pharmaceutical companies increased (in term of sales) from 5.3% to 8.5% from 2012 to 2018.
Small Molecule API Market – Competitive landscape
The major player operating in global small molecule API market include ALLERGAN, Aurobindo Pharma, Cambrex Corporation, Albemarle Corporation, D.r. Reddy’s Laboratories Ltd. The other key players in market are Johnson Matthey, Siegfried Holding AG, Pfizer, Sanofi S.A., Novartis AG, Johnson & Johnson, Bristol-Myers Squibb, Bachem Holding AG, Boehringer Ingelheim GmbH, F. Hoffmann-La Roche Ltd, GlaxoSmithKline PLC, GILEAD Science Inc., Albany Molecular Research Inc., Sun Pharmaceuticals, AstraZeneca, Merck & Co, Inc., BASF SE, and Teva Pharmaceuticals. In March 2012, the FDA approved Ilumya (Tildrakizumab-asmn) developed by Sun Pharmaceuticals used for Plaque Psoriasis.
Global Small Molecule API - Market Taxonomy
A small molecule Active Pharmaceutical Ingredient (API) is a low molecular weight organic compound, which may help to control biological process. Most of the small molecules can be administered orally and are most likely to be absorbed by the body. Owing to its small size it has properties of rapid diffusibility to reach the intracellular site of action.
Growing expansion of small molecule API manufacturers in the Asia Pacific region is a major factor driving the small molecule API market growth. For instance, BASF is planning to build a new specialty amines plant at its existing site in Nanjing Chemical Industry Park, China. This new multi-product plant will be able to manufacture 21,000 metric tons of amines year, and it extends BASF’s amines portfolio at the specialty amines complex in Nanjing. The plant is scheduled to stream by 2019. Moreover the small molecule API manufacturers have planned to add global sales and business development staff, followed by quality, regulatory, and project management teams, which have positively influenced growth of the market.
However, stringent regulatory policies for API manufacturing may hinder the market growth. Stringent global regulatory policies on quality assessments of small molecule API manufacturing, facility certification, and increased supply chain security issues across emerging countries have a large impact on the cost of final small molecule API products. The new entrants willing to enter into small molecule API manufacturing are facing financial challenges, owing to aforementioned factors.
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