Be it the prevalence of chronic diseases, increasing population of geriatrics, or governmental push to provide adequate care to their citizens – the healthcare industry is on the rise and with that, the pharmaceutical industry is gaining traction. For the manufacturers of drugs, active pharmaceutical ingredients (APIs) are of great essence as their quality defines the effectiveness of the products. However, not all pharmaceutical companies possess in-house API manufacturing capabilities and it is not feasible for a single company to produce all the APIs required for their formulation offerings. This makes for an opportune situation wherein the bulk manufacturers and suppliers of these ingredients stand to gain from. According to this business intelligence study, the demand in the global active pharmaceutical ingredients market will multiply at a CAGR of 6.4% during the forecast period of 2017 to 2023. In terms of revenue, the active pharmaceutical ingredients market is estimated to attain a valuation of US$219,601.9 by the end of 2023, mounting from the market’s evaluated worth of US$151,591.7 as of 2017.
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Apart from increased healthcare expenditure by the urban populations across the world and rapid increment people aged over 60 years, the global API market stands to gain addition traction from the increase in drug master file (DMF) filing from Indian companies. On the other hand, adverse regulatory policies are foreseen as a restraint that will curtail the progress of the API market. That being said, patent expiry of lucrative biological drugs is expected to open new opportunities in this market over the course of the aforementioned forecast period.
Based on drug type, the active pharmaceutical ingredients market has been segmented into branded, generic, and over the counter (OTC). Among these, branded prescription drugs are the most profitable segment, promising to generate a revenue of US$164,481.9 million by the end of 2023. On the other hand, the generic prescription drugs segment is expected to grow at the highest rate among all counterparts in the forecast period of 2017 to 2023. With the rising cost of healthcare, governments and payers are pushing for increasing generics consumption over branded drugs, and thus driving growth of the generic APIs market. Additionally, several major pharmaceutical companies are also focusing on generic drugs along with branded drugs due to eroding product pipeline and patent expirations.
API market segmentation by manufacturing process: captive and contract. In 2017, the captive manufacturing segment generated a revenue of US$100,476.0 million. And, although the demand for the same is expected to expand at a lower than the average CAGR of 6.1% during 2017 to 2023, the segment will hold onto its leading position. The captive API manufacturing market segment includes the ingredients that are produced for internal consumption of a pharmaceutical company, and is usually preferred in cases involving sensitive or patent-protected drugs. The captive or in-house API manufacturing segment, once dominated by Europe, is steadily shifting toward Asia-Pacific where low cost of manufacturing as well as demand from generic manufacturers is huge. By the end of 2023, the segment is estimated to be worth US$143,042.2 million.
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On the basis of API type, the report bifurcates the market into synthetic chemicals and biological. While the synthetic chemical API segment is expected to remain the most profitable category, promising to generate a demand worth of US$144,838.9 million by 2023, the biological API segment is showcasing stronger growth potential. Presently, most of the biologics are manufactured in-house due to intellectual property concerns and quality issues. However, the manufacturing of biological APIs is a very complex and challenging process. Hence, innovator companies are outsourcing the segment to contract manufacturing companies who have biological production expertise.
The report has also determined the potential of demand that will be forthcoming from the therapeutic areas of diseases pertaining to cardiovascular, oncology, NSAIDs, musculoskeletal, neurological, metabolic, and others. Among these, cardiovascular, neurological, and metabolic disorders have been identified as the prominent therapeutic areas, collectively providing for more than half of the total demand in the global active pharmaceutical ingredients market.
Region-wise, North America is currently most profitable and is primed to remain so until 2023 too, when it will generate a demand worth of US$69,396.6 million. North America is the leading consumer of APIs; hence, API exporters consider it the most attractive market. India and China are the major suppliers of APIs to North America due to low production and labor costs. Biologics have become one of the top-selling drugs in North America in the recent past. Thus, the expected market entry of biosimilars with flexible regulatory process would boost the API market in the region. Country-wise, although the U.S. API market is showing a sluggish growth rate, it will remain more profitable than any other across the globe, having generated a revenue of US$44,940.9 million as of 2017.
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BASF, Bayer, DuPont, and Dow Chemicals are some of the most prominent players currently operating in the global active pharmaceutical ingredients market.
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