Global Sterile Injectables Market – Insights
Injectables are chemical substances that are administered in the body through intravenous (IV) route of administration using needles and syringes. Sterile injectables are made up of small and large molecules (biologics).
The global sterile injectables market was valued at US$ 357.4 billion in 2018, and is expected to exhibit a CAGR of 7.3% over the forecast period (2019 – 2027).
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Global Sterile Injectables Market: Drivers
Increasing investment in business expansion is expected to boost growth of the global sterile injectables market. For instance, in July 2019, Nexus Pharmaceuticals invested US$ 250 million for expanding its facility in Wisconsin, U.S. This new facility is expected to focus on production and supply of sterile injectable drugs to therapeutic areas such as anesthesia, oncology, cardiovascular, and neurology. In April 2019, Chr. Hansen Holding A/S, a global bioscience company, and Lonza AG, a pharma contract manufacturing company, received approvals from anti-trust regulators (it is a law in the U.S. to prevent large business corporations (trust)), to establish the 50/50 joint venture for live biotherapeutics products. Furthermore, in August 2016, Fresenius Kabi invested around US$ 250 million to expand the company’s Melrose Park site located in Illinois, U.S., where it manufactures generic and sterile injectable pharmaceuticals.
Global Sterile Injectables Market: Restraints
However, product recall due to sterility failure in injectables is a major factor hindering growth of the global sterile injectables market. For instance, in August 2019, the U.S. Food and Drug Administration (FDA) issued a warning against Emcure Pharmaceuticals after investigating the batches of sterile injectables, where microbial growth was observed in the batch of amikacin sulfate and schizophrenia drug prochlorperazine edisylate sterile injectables.
Global Sterile Injectables Market – Competitive Landscape
Key players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in June 2019, Lyophilization Services of New England (LSNE), a contract development and manufacturing organization (CDMO), acquired sterile injectables manufacturing facility located in León, Spain. The acquisition is expected to help expand existing manufacturing capabilities of LSNE in Europe. Moreover, in February 2014, Lupin Limited acquired Nanomi BV – a Netherland-based injectables company that has around 38 products in pipeline targeting branded and generic injectables market.
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Global Sterile Injectables Market – Regional Analysis
North America is expected to account for the largest market share in the global sterile injectables market over the forecast period. This is attributed to high presence of major market players in the region such as Baxter International Inc., and Pfizer Inc. Moreover, increasing M&A and investment activities are also expected to boost growth of the market in North America. For instance, in July 2017, Baxter acquired Claris injectables Ltd. (a subsidiary of Claris Lifesciences Limited) and gained complete access to the Claris Injectables product portfolio and pipeline and three manufacturing plants of Claris injectables Ltd. In 2018, Pfizer Inc. invested US $800 million to expand its sterile injectables business and planned for an additional investment of US$ 1.4 billion in manufacturing capabilities of sterile injectables.
Increasing business expansion activities are expected to boost growth of the market in Asia Pacific. For instance, in August 2019, Neopharma—a pharmaceutical company based in United Arab Emirates- bought sterile injectables plant and drugs in Japan from Lupin’s Japanese subsidiary Kyowa.
Global Sterile Injectables Market: Competitive Landscape
Major players operating in the global sterile injectables market include, Novartis AG, Johnson & Johnson Services, Inc., Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., JHP Pharmaceuticals, Gilead Sciences, Inc., Pfizer Inc., Fresenius Kabi Ag, CordenPharma, and Hikma Pharmaceuticals PLC.
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