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Research Reports

Specialty Active Pharmaceutical Ingredients (API) Market Players Scramble to Develop Low-cost Generics: FMI Study

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The global specialty Active Pharmaceutical Ingredients (API) market reached US$ 152.5 Bn in 2019, up by 8.5% in 2018. Increase in the prevalence of chronic diseases such as cancer, diabetes, and cardiovascular disease has boosted the demand for specialty active pharmaceutical ingredients (API).

Manufacturers are on continuous lookout to produce new small molecule APIs. This is expected to give an impetus to the specialty active pharmaceutical ingredients (API) market during the forecast period.

Increasing investments in the specialty active pharmaceutical ingredients (API) market by key players and new technology development for low-cost production of generic drugs are the major factors expected to drive the market growth.

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Key Takeaways of Specialty Active pharmaceutical ingredients (API) Market Study

  • Increasing demand in the production of generic drugs is likely to fuel demand for small molecules
  • Europe, followed by North America, is expected to be the most lucrative region and account for a notable revenue share of about 29% in the global specialty active pharmaceutical ingredients (API) market in 2020 and trend is expected to continue owing to large number of drugs going off-patent during forecast period. 

High patient population and growing pharmaceutical contract manufacturing organizations in Asian countries is expected to propel the growth of the specialty active pharmaceutical ingredients (API) market in the region

“Continuous focus on the development of low-cost specialty active pharmaceutical ingredients (API) and increasing incidence of infectious and metabolic diseases around the world are expected to propel the growth of the global specialty active pharmaceutical ingredients (API) market,” says an FMI Analyst.

Increasing Research Collaboration – Imperative Strategy for Market Players

Manufacturers are now focusing on discovering and developing new drug candidates through research collaborations and license agreements for the treatment of cardiovascular diseases, lung diseases and the other chronic diseases.

For instance, in March 2020, Bayer signed a research collaboration and license agreement with Indian drug discovery firm Curdev to discover novel drug candidates.

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Specialty API Market Witnessing a Paradigm Shift

Shift of Specialty API Market from Type I DMFs (Drug Master Files) to Type II DMFs is expected to further drive market growth. Type II DMF drug encloses drug substances, substance materials and intermediates used in drug product’s penetration.

Extensive DMF filings are reflected through API manufacturers envisaging the steep increase in demand for outsourcing intermediates or APIs. DMF filings could also be attributed to growing investments for enhancing production facilities on the part of manufacturers based in Asia Pacific.

Also, regulatory agencies such as SAHPRA, Brazilian Health Regulatory Agency, MHRA, TGA, and U.S. FDA are in a DMF approval mode; thereby acting as another driving factor.

Covid-19 to Stall Short-term Momentum

The outbreak of Covid-19 has not left any vertical untouched,  and specialty API market is no exception. Certain manufacturers are dependent on China for APIs. This influx has slowed down due to this ongoing pandemic. The trend is expected to continue at least for the next few months till manufacturers come up with an alternative to by in sync with the “new” normal.

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What else is in the report?

Future Market Insights offers a unique perspective and actionable insights on specialty active pharmaceutical ingredients (API) market in its latest study, presenting historical demand assessment from 2015 – 2019 and projections from 2020–2030 based on product type (small molecules, peptides, carbohydrate drugs and steroidal drugs), by consumption (in-house and outsourced) in seven key regions.

About the Healthcare Research Practice at Future Market Insights

Future Market Insights enables corporates, governments, investors, and associated audiences in the healthcare sector to identify and accentuate vital aspects applicable to product strategy, regulatory landscape, technology evolution, and other crucial issues to achieve sustainable success. Our unique approach to gathering market intelligence equips you to devise innovation-driven trajectories for your business. Know more about our sector coverage here.

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About Future Market Insights (FMI) 

Future Market Insights (FMI) is a leading provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in Dubai, and has delivery centers in the UK, U.S. and India. FMI’s latest market research reportsand industry analysis help businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. 



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