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Sterile Injectable Market Size, Share, Trends, and Growth 2019-2026


(, December 18, 2019 ) Market Overview

• Global Sterile Injectable Market is expected to grow at a CAGR of 9.1 % to reach a market value of USD XXXX million by 2026.

• An injectable compounded medication is a sterile drug to be administered into the body using a needle and syringe or an I.V. administration set and needle device.

• New FDA inspection protocols would improve the quality of Sterile Injectable Drugs considerably. The US Food and Drug Administration (FDA) is modernizing inspection programs with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs.

• The New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a more structured manner for more consistent facility oversight and faster and more efficient analyses. The contracts also include additional questions related to quality culture in facilities.

• For instance, in February 2017, FDA warned Pfizer’s Hospira sterile injectable site in Kansas, after finding visible particulates in their products.

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Market Drivers

• The rising prevalence of chronic diseases is driving the global sterile injectable market.

• According to the National Health Council, in 2016, chronic diseases affect approximately 133 million Americans, representing more than 40% of the total population of the country. By 2020, that number is projected to grow to an estimated 157 million, with 81 million having multiple conditions.

• The rising investment in technically advanced sterile injectable pharmaceutical production facilities will drive the global barren injectable market. For instance, in July 2018, Pfizer had increased its commitment to U.S. manufacturing with a USD 465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in Portage, Michigan.

• This U.S. investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients across the globe.

• The shortage of sterile injectable drugs is expected to hamper the growth of the global barren injectable market. The FDA has been paying increased attention to quality control, an especially critical issue for injectable drugs.

• Drug shortages do occur when an FDA enforcement action for non-compliance with current good manufacturing practices (cGMPs) causes the primary or sole manufacturer of a drug to halt or delay production.

• For instance, In May 2018, Pfizer, which is the world’s largest maker of sterile injectable drugs, had 370 products that are depleted or in limited supply, 102 of which the company has indicated will not be available until 2019. Due to which sterile injectable product portfolio of Pfizer has declined by 9% in developed markets, one reason Pfizer modestly narrowed its revenue expectations for 2018.

Market Segmentation

By Application

The global sterile injectable market is segmented based on an application which includes oncology cardiovascular diseases, infectious diseases, diabetes, and others. The use of injectable drugs in oncology is expected to grow at high rates in North America due to the increased cases of oncology. According to the National Cancer Institute, the cancer cases has increased at the rate of 13.1% from 2012 to 2016.

The expansion of production sites for oncology products will drive the global sterile injectable market.

For instance, in July 2017, Alembic Pharma introduced oncology site for injectable and lyophilized generics. The site has manufacturing capacity for 60 million tablets and capsules and approximately 20 million vials of liquid injectable and lyophilized concentrates. These cancer medicines will be marketed in the Middle East and North Africa as well as Australia, South Africa, and the LIS.

By geography

North America holds the dominant market share for sterile injectable in 2017, and it is expected to maintain the growth over the forecast period. It is due to the increase in production sites for generic sterile injectable.

For instance, in August 2017, Fresenius Kabi has invested USD 250 million to turn a U.S. site to showcase its sterile injectable capabilities.

Sterile Injectable Companies

The increasing in expansion of production sites, acquisition, and product launches are driving the global sterile injectable market.

For instance, in April 2018, Endo International plc. Acquired Somerset Therapeutics, LLC, a New Jersey-based specialty pharmaceutical company that develops and markets sterile injectable and ophthalmic drugs for the U.S. market.

In August 2018, Nevakar Inc., entered into an exclusive licensing agreement with Endo International plc’s subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the U.S. and Canada.

In May 2018, Mithra entered into a contract agreement with Midas Pharma for the development of a sterile injectable product at the Mithra CDMO.

In August 2017 Athenex, Inc. launched three previously disclosed sterile injectable molecules through its subsidiary Athenex Pharma Solutions (APS). They are Epinephrine, Norepinephrine, and Phenylephrine.

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