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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)

Sterile Injectables  | Coherent Market Insights

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)

Sterile Injectables  | Coherent Market Insights

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.

An injectable is a compounded medication to be administered into the body via a needle and syringe by several route of administration such as Intravascular (IV), Subcutaneous (SC), Intramuscular (IM), and others. Sterile injectables are used for the treatment of several disorders and diseases such as (Cardio vascular diseases, Central nervous system disorder, metabolic disorders, and others).

Market Dynamics

Increasing preference of sterile injectables over conventional drugs due to high absorbability and quick therapeutic response in body is expected to increase demand for sterile injectables over the forecast period. This has encouraged the pharmaceutical industry to emphasize on biologics and develop more products. For instance, in June 2017, Baxter entered into an agreement with Dorizoe Lifesciences (a global contract research and development (R&D) organization), engaged in developing over 20 generic injectables products in pipeline, which includes anti-infective, oncolytics, and cardiovascular medicines. Under the agreement Dorizoe will perform certain product development activities with Baxter, and Baxter will hold worldwide manufacturing and commercialization rights. This partnership is expected to expand Baxter’s pipeline of generic injectables, and strengthen its portfolio with a broad range of high-quality essential medicines.

Growing prevalence of chronic illnesses such as cancer is expected to drive global sterile injectables market growth over the forecast period. For instance, according to the Cancer Research UK in 2018, around 17 million people suffered from cancer in Europe. Moreover, according to the World Health Organization (WHO) 2018, 18.1 million people globally suffered from cancer and 9.8 million were reported to die due to cancer. This increasing prevalence is expected to increase demand for sterile injectables, which is further expected to propel the global sterile injectables market growth over the forecast period.

Key features of the study:

  • This report provides in-depth analysis of the global sterile injectables market, which provides market size (US$ Billion) and cumulative annual growth rate (CAGR %) for the forecast period (2019 – 2027), considering 2018 as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or product approvals, regional outlook, and competitive strategies adopted by the leading players
  • It profiles leading players in the global sterile injectables market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies, and future plans
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and management authorities of companies to make informed decisions with respect to future product launches, end user upgrades, market expansions, and marketing tactics
  • The global sterile injectables market report caters to various stakeholders in this industry, including investors, device/system manufacturers, distributors and suppliers for sterile injectables system, research and consulting firms, new entrants, and financial analysts

Detailed Segmentation:

  • Global Sterile Injectables Market, By Molecule Type:
    • Large Molecules
    • Small Molecules
  • Global Sterile Injectables Market, By Drug Type:
    • Monoclonal Antibodies (mAbs)
    • Cytokines
    • Insulin
    • Peptide Hormones
    • Vaccines
    • Immunoglobulins
    • Blood Factors
    • Peptide Antibiotics
    • Others
  • Global Sterile Injectables Market, By Therapeutic Application:
    • Cancer
    • Metabolic Diseases
    • Cardiovascular Diseases
    • Central Nervous Systems Disorders
    • Infectious Disorders
    • Musculoskeletal Disorders
    • Others
  • Global Sterile Injectables Market, By Route of Administration:
    • Subcutaneous (SC)
    • Intravenous (IV)
    • Intramuscular (IM)
    • Others
  • Global Sterile Injectables Market, By Distribution Channel:
    • Hospitals Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • Global Sterile Injectables Market, By Region:
    • North America
      • By Molecule Type:
        • Large Molecules
        • Small Molecules
      • By Drug Type:
        • Monoclonal Antibodies (mAbs)
        • Cytokines
        • Insulin
        • Peptide Hormones
        • Vaccines
        • Immunoglobulins
        • Blood Factors
        • Peptide Antibiotics
        • Others
      • By Therapeutic Application:
        • Cancer
        • Metabolic Diseases
        • Cardiovascular Diseases
        • Central Nervous Systems Disorders
        • Infectious Disorders
        • Musculoskeletal Disorders
        • Others
      • By Route of Administration:
        • Subcutaneous (SC)
        • Intravenous (IV)
        • Intramuscular (IM)
        • Others
      •  By Distribution Channel:
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country
        • U.S.
        • Canada
    • Europe
      • By Molecule Type:
        • Large Molecules
        • Small Molecules
      • By Drug Type:
        • Monoclonal Antibodies (mAbs)
        • Cytokines
        • Insulin
        • Peptide Hormones
        • Vaccines
        • Immunoglobulins
        • Blood Factors
        • Peptide Antibiotics
        • Others
      • By Therapeutic Application:
        • Cancer
        • Metabolic Diseases
        • Cardiovascular Diseases
        • Central Nervous Systems Disorders
        • Infectious Disorders
        • Musculoskeletal Disorders
        • Others
      • By Route of Administration:
        • Subcutaneous (SC)
        • Intravenous (IV)
        • Intramuscular (IM)
        • Others
      •  By Distribution Channel:
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Molecule Type:
        • Large Molecules
        • Small Molecules
      • By Drug Type:
        • Monoclonal Antibodies (mAbs)
        • Cytokines
        • Insulin
        • Peptide Hormones
        • Vaccines
        • Immunoglobulins
        • Blood Factors
        • Peptide Antibiotics
        • Others
      • By Therapeutic Application:
        • Cancer
        • Metabolic Diseases
        • Cardiovascular Diseases
        • Central Nervous Systems Disorders
        • Infectious Disorders
        • Musculoskeletal Disorders
        • Others
      • By Route of Administration:
        • Subcutaneous (SC)
        • Intravenous (IV)
        • Intramuscular (IM)
        • Others
      •  By Distribution Channel:
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • By Molecule Type:
        • Large Molecules
        • Small Molecules
      • By Drug Type:
        • Monoclonal Antibodies (mAbs)
        • Cytokines
        • Insulin
        • Peptide Hormones
        • Vaccines
        • Immunoglobulins
        • Blood Factors
        • Peptide Antibiotics
        • Others
      • By Therapeutic Application:
        • Cancer
        • Metabolic Diseases
        • Cardiovascular Diseases
        • Central Nervous Systems Disorders
        • Infectious Disorders
        • Musculoskeletal Disorders
        • Others
      • By Route of Administration:
        • Subcutaneous (SC)
        • Intravenous (IV)
        • Intramuscular (IM)
        • Others
      •  By Distribution Channel:
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East
      • By Molecule Type:
        • Large Molecules
        • Small Molecules
      • By Drug Type:
        • Monoclonal Antibodies (mAbs)
        • Cytokines
        • Insulin
        • Peptide Hormones
        • Vaccines
        • Immunoglobulins
        • Blood Factors
        • Peptide Antibiotics
        • Others
      • By Therapeutic Application:
        • Cancer
        • Metabolic Diseases
        • Cardiovascular Diseases
        • Central Nervous Systems Disorders
        • Infectious Disorders
        • Musculoskeletal Disorders
        • Others
      • By Route of Administration:
        • Subcutaneous (SC)
        • Intravenous (IV)
        • Intramuscular (IM)
        • Others
      •  By Distribution Channel:
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Molecule Type:
        • Large Molecules
        • Small Molecules
      • By Drug Type:
        • Monoclonal Antibodies (mAbs)
        • Cytokines
        • Insulin
        • Peptide Hormones
        • Vaccines
        • Immunoglobulins
        • Blood Factors
        • Peptide Antibiotics
        • Others
      • By Therapeutic Application:
        • Cancer
        • Metabolic Diseases
        • Cardiovascular Diseases
        • Central Nervous Systems Disorders
        • Infectious Disorders
        • Musculoskeletal Disorders
        • Others
      • By Route of Administration:
        • Subcutaneous (SC)
        • Intravenous (IV)
        • Intramuscular (IM)
        • Others
      •  By Distribution Channel:
        • Hospitals Pharmacies
        • Retail Pharmacies
        • Online Pharmacies
      • By Country/Region:
        • Central Africa
        • South Africa
        • North Africa
  • Company Profiles
    • Baxter International Inc.*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
      • Strategies
    • AstraZeneca plc
    • Merck & Co., Inc
    • Novartis AG
    • Johnson & Johnson Services, Inc
    • Gilead Sciences, Inc.
    • JHP Pharmaceuticals
    • Pfizer Inc.
    • Fresenius Kabi Ag
    • CordenPharma
    • Hikma Pharmaceuticals PLC.

“*” marked represents similar segmentation in other categories in the respective section.

FAQ

Frequently Asked Questions

The global sterile injectables market is estimated to surpass US$ 673.8 Billion by 2027.
Major 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.
Product recall, due to sterility failure in injectables is one of the major factors that is expected to hamper growth of the market over the forecast period.
Increasing investments by manufacturers to expand their business through new manufacturing facility is one of the major factors that is expected to propel growth of the market over the forecast period.
The global sterile injectables market is estimated to exhibit a CAGR of 7.3% during the forecast period (2019-2027).
Among regions, North America is expected to hold dominant position in the global sterile injectables market over the forecast period.
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