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Non-Aqueous Form Is Expected to be the Dominant Segment In the Sterile Active Pharmaceutical Ingredients Says Fact.MR Report

Rising acceptance of biologics and preventive medicines is expected to propel the demand for sterile active pharmaceutical ingredients. Significant accessibility to drugs, growing pharmaceutical spending, and rising demand for targeted therapy drugs are factors boosting sterile active pharmaceutical ingredients market growth. China and India are the prominent suppliers of sterile active pharmaceutical ingredients, globally. Manufacturers are focusing on the expansion of their manufacturing plants in these countries owing to low-cost production and cheap labor. On this premise, the overall sales of sterile active pharmaceutical ingredients was valued at US$53 Bn in 2018 and will witness dexterous growth through 2029.

 “Increasing investments for sterile fill-finish capabilities expansion and inclination towards in-house sterile API production as a cost reduction strategy by pharmaceutical manufacturers are anticipated to favor the global sterile active pharmaceutical ingredients market growth.” says the Fact.MR Analyst.

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Key Takeaways of Sterile Active Pharmaceutical Ingredients Market Study

  • By product type, monoclonal antibodies accounted for prominent market value share in the sterile active pharmaceutical ingredients market. This is primarily attributed to growing need for biologics and targeted therapies for treatment of chronic disorders such as cancer.
  • South Asia and East Asia collectively hold over 33% of the sterile active pharmaceutical ingredients market share owing to expansion of sterile active pharmaceutical ingredients manufacturing facilities for small API molecules in these regions.
  • Aqueous form is expected to be the dominant segment in the sterile active pharmaceutical ingredients market attributed to the ability to provide great solubility for non-water-soluble drugs.

Emphasis on Manufacturing Capability, Key Strategy Followed by Market Players

Sterile active pharmaceutical ingredients manufacturers are focusing on the expansion of manufacturing facilities and adopting advanced aseptic processing techniques. For instance, in October 2017, Corden Pharma GmbH announced a strategic investment of US$ 4 million in small molecule API development capacity in its Corden Pharma Switzerland facility. With growing investments for infrastructural and technological advancements, manufacturers are also focusing on the opening up of new production plants for sterile active pharmaceutical ingredients in emerging countries. For instance, in October 2018, Sun Pharmaceutical Industries Ltd. opened a new cGMP production line in Guwahati, India to enhance the manufacturing capacity of sterile products.

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Key Segments of the Sterile Active Pharmaceutical Ingredients Market

Fact.MR’s study on the sterile active pharmaceutical ingredients market offers information divided into four important segments-product type, form and region. This report offers comprehensive data and information about the important market dynamics and growth parameters associated with these categories.

Product Type

  • Monoclonal Antibodies
  • Immunoglobulin
  • Cytokines
  • Insulin
  • Peptide Hormones
  • Blood Factors
  • Peptide Antibiotics
  • Vaccines
  • Small Molecule Antibiotics
  • Highly Potent Active Pharmaceutical Ingredients (HPAPI)
  • Others


  • Aqueous
  • Non-Aqueous Liquid
  • Dry Powder

Explore All Opportunities of Sterile Active Pharmaceutical Ingredients Industry


  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa

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The research study on the sterile active pharmaceutical ingredients market by Fact.MR incorporates an unbiased assessment of key demand-driving factors and trends, which have shaped the landscape of the sterile active pharmaceutical ingredients market over 2014 – 2018 and includes a detailed assessment of key parameters that are anticipated to exert influence during 2019 – 2029. Market statistics have been presented on the basis of product type (monoclonal antibodies, immunoglobulin, cytokines, insulin, peptide hormones, blood factors, peptide antibiotics, vaccines, small molecule antibiotics, highly potent active pharmaceutical ingredients (HPAPI), and others), and form (aqueous, non-aqueous liquid and dry powder) across seven major regions.

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Last Updated: 24-Aug-2021