STERILE INJECTABLES MARKET ANALYSIS

Sterile Injectables Market Insights

Injectables are a compounded medication containing sterile drug with therapeutic actions, which is administered in the body through intravenous (IV) route of administration with the help of needles and syringes. These 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).

Figure 1. Global Sterile Injectables Market Share (%), By Molecule Type, (2019 & 2027)

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Source: Coherent Market Insights Analysis (2019)

Manufacturers developing sterile injectables are adopting strategies such as mergers and acquisitions, in order to expand their sterile injectables product portfolio, which is expected to boost the global sterile injectables market growth over the forecast period. 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. Through this acquisition the site LSNE-León, will help LSNE to expand its existing manufacturing capabilities in Europe.

Moreover, Lupin Limited acquired Nanomi BV (Netherland-based injectable company) in February 2014. Nanomi BV has an injectable drug in the development pipeline and around 38 products in the development pipeline targeting branded and generic injectables market.

Increasing investment by manufacturers to expand their business through new manufacturing facility is expected to propel sterile injectables demand in global sterile injectables market

Sterile injectables manufacturers require major capital investment for the equipment and the production process. Many pharmaceutical companies due to lack of funding are approaching to other firms for investment in the U.S. and Europe. For instance, in July 2019, Nexus Pharmaceuticals invested US$ 250 million, for expanding its facility in Wisconsin, U.S. This new facility will support the company for production and supply of sterile injectable drugs to therapeutic areas such as anesthesia, oncology, cardiovascular, and neurology.

Moreover, 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. These factors are expected to support global sterile injectables market growth over the forecast period.

Global Sterile Injectables Market - Regional Analysis

Regional segmentation of the global sterile injectables market comprises North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Among regions, North America is expected to hold a dominant position in the global sterile injectables market over the forecast period, owing to presence of major players in the region such as, Baxter International Inc., Pfizer Inc., and others. These players focus on developing sterile injectables, in order to expand their product portfolio.

For instance, in July 2017, Baxter gained complete access to the Claris Injectables product portfolio and pipeline as well as three manufacturing plants of Claris after acquiring Claris injectables Ltd (a subsidiary of Claris Lifesciences Limited). Moreover Pfizer Inc., had made overall investment of US $800 million in 2018 to grow their sterile injectables bussiness, however, they had again planned for additional investment of US $1.4 billion in manufacturing capabilities of sterile injectables. These factors are expected to boost the sterile injectables market growth in North America over the forecast period.

Asia pacific is also expected to witness significant growth over the forecast period, owing to expansion of manufacturing facilities in the region. For instance, in August 2019, Neopharma (United Arab Emirates-based drugmaker) has bought sterile injectables plant and drugs in Japan from Lupin’s Japanese subsidiary Kyowa. Through this agreement Neopharma, has built its presence in Japan. Such expansion are expected to drive the global sterile injectables market growth in Asia Pacific region.

Figure 2: Global Sterile Injectables Market Share (%), By Region, (2019 & 2027)

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Source: Coherent Market Insights Analysis (2019)

Restraints

Factor restraining the global sterile injectables market growth include product recall, due to sterility failure in injectables. 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.

Key Players

Key players operating in the global sterile injectables market include Baxter International Inc., AstraZeneca plc, Merck & Co., Inc, Novartis AG, Johnson & Johnson Services, Inc., Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, and Hikma Pharmaceuticals PLC.