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Invigorated by heightening demand for injectable drugs, global sterile active pharmaceutical ingredients (APIs) market is poised for robust growth at 5.3% CAGR over 2019-2029. The revenues are projected to expand 2X by 2029 end. Moreover, rapid globalization, prevalent chronic diseases, and ageing population are some of the key drivers of sterile APIs market growth, as suggested by a new report published by Fact.MR.

“Prominent companies in sterile APIs market are targeting Europe and North America through new launches and strategic collaborations. Moreover, developing nations such as India have gained a stronghold in market owing to the presence of major drug manufacturers. Low production costs further assist market growth in such economies,” says Fact.MR.

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sterile active pharmaceutical ingredients market share analysis

Sterile Active Pharmaceutical Ingredients Market: Key Takeaways

  • Vaccines and monoclonal antibodies (mAbs) will account for approximately 48% market share by 2029.
  • Insulin is projected to witness noteworthy CAGR during the forecast period.
  • Aqueous form of sterile APIs will continue to occupy major market share.
  • Gains in global sterile active pharmaceutical ingredients market will remain concentrated in North America.
  • Sterile APIs market in East Asia will register profuse growth through 2029.

Key Driving Factors

  • Outsourcing of highly potent APIs is projected to stimulate the market growth.
  • Chronic disease prevalence, particularly in elderly population, is accentuating the need for sterile APIs.
  • Capacity expansion by major manufacturers is accelerating market growth in developing countries.
  • Substantial demand for injectable drugs is supplementing the growth of sterile APIs market.
  • Low production costs and population explosion in developing economies continue to be a significant booster to sterile APIs market.

Key Constraints

  • SMEs continue to face regulatory pressures, which in turn hampers the growth of market in developing economies.
  • High operational costs remain a major impediment for manufacturers, thereby restricting the growth of sterile APIs market.
  • Supply chain security concerns continue to influence the cost-competitiveness of final products, limiting market growth.
  • Fragmentation of the competitive landscape will primarily hinder the final product margins and market profitability of leading players.

Explore 30 tables and 58 figures in the study. Request ToC of the report at:

Competition Landscape

The competitive landscape of sterile active pharmaceutical ingredients market is fragmented, and the report offers a deep-dive analysis of the same. Some of the leading players profiled in Fact.MR’s study include, but are not limited to, Aurobindo Pharma Limited, Corden Pharma GmbH, Sun Pharmaceutical Industries Ltd., Sanofi S.A., Dalton Pharma Services, and Teva Pharmaceutical Industries Ltd. The chief expansion strategy adopted by industry leaders is acquisition of established regional players. Aurobindo Pharma USA Inc. recently announced the acquisition of Apotex, a prominent pharma player, to broaden the access to Apotex’s operations in Spain, the Netherlands, Czech Republic, Belgium and Poland.

About the Report

This 170-page study offers readers with comprehensive market forecast on the sterile active pharmaceutical ingredients market. Global, regional and country level analysis of the latest industry trends impacting the sterile active pharmaceutical ingredients market are covered in this Fact.MR study. The report offers compelling insights on sterile active pharmaceutical ingredients market on the basis of drug class (monoclonal antibody, immunoglobulin, cytokines, insulin, peptide hormones, blood factors, peptide antibiotics, vaccines, small molecule antibiotics, and highly potent active pharmaceutical ingredients), form (aqueous, non-aqueous liquid, and dry powder) across seven regions (North America, Latin America, Europe, South Asia, East Asia, Oceania, Middle East & Africa).

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