The specialty API market is expanding due to low-cost generics and chronic disease prevalence, with Europe and Asia seeing significant growth.
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
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.
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The article discusses the growth of the specialty API market driven by low-cost generics and increased investments.
How is Covid-19 affecting the specialty API market? The pandemic has slowed down production due to dependency on China for APIs.
What regions are leading the market? Europe and North America are expected to hold significant market shares.
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