The market for sterile injectables is expected to expand due to the demand for biologics and the rising prevalence of chronic illness. Disease-modifying biologics, such as monoclonal antibodies are being used more frequently to treat a range of chronic and life-threatening conditions, such as cancer and autoimmune diseases. This indicates a rising dependence on these therapies for effectively managing serious health challenges. In addition, there is also an increase in the number of elderly people, which raises the prevalence of chronic disorders across the globe. Thus, creating more requirements for the use of sterile injectables for better control of diseases.
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Market Trends:
Greater usage of prefilled syringes: The prefilled syringes offer higher safety and precision in dosing as well as ease in administration. As a result, their adoption is increasing for injectable drug delivery. This is expected to push the growth of the sterile injectables market during the forecast period.
Development in the manufacturing processes: The leading companies are investing in the improvement of manufacturing processes in order to enhance the sterilization methods and reduce the risk of contamination in injectable pharmaceuticals production. This is likely to lead to increased volumes of sterile injectable drug production which will spur the growth of the market
Sterile Injectables Market Report Coverage
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Report Coverage |
Details |
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Market Revenue in 2024 |
$586.1 billion |
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Estimated Value by 2031 |
$984.1 billion |
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Growth Rate |
Poised to grow at a CAGR of 7.7% |
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Historical Data |
2019–2023 |
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Forecast Period |
2024–2031 |
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Forecast Units |
Value (USD Million/Billion) |
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Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
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Segments Covered |
By Molecule Type, By Drug Type, By Disease Indication, By Route of Administration |
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Geographies Covered |
North America, Europe, Asia Pacific, and Rest of World |
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Growth Drivers |
• Rising Prevalence of Chronic Diseases • Increasing Biologics Uptake |
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Restraints & Challenges |
• Stringent government regulations • Supply chain and inventory issues |
Market Opportunity:
Surge Segment: Large molecules such as monoclonal antibodies, cytokines, and peptide hormones have been shown to effectively treat cancer and autoimmune diseases. These treatments are beneficial for various health conditions. Global economics is resulting in increased instances of chronic illness which is creating a demand for these biologics. Moreover, the patent expiration of blockbuster products has caused pharmaceutical companies to seek large molecules with good prospects. It is anticipated that this segment will grow somewhere in the range of 8.2% during the forecasted period.
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Oncology Type Drug: The growing burden of cancer across various regions in the world combined with the faster registration and marketing of new drugs is expected to drive the sterile injectable oncology therapeutics market. Moreover, the launch of biosimilars has made cancer treatment more accessible. In order to get a larger market share, wide pharmaceutical companies are aiming the production of enhanced sterile injectable formulations of checkpoint inhibitors, antibody-drug conjugates, and other biologics. It is anticipated that this segment will have the highest CAGR of about 9.1% till 2031.
Key Market Takeaways:
The sterile injectables market size is estimated to reach USD 986.1 Billion by 2031, expanding at a CAGR of 7.7% during the forecast timeline. The growing prevalence of chronic diseases, rising geriatric population, faster U.S. FDA approvals and launches are contributing to the market growth.
By molecule type, the large molecule segment is expected to dominate the market owing to the high efficacy of monoclonal antibodies and biologics in treatments.
Based on drug type, the oncology drug segment will remain the highest revenue generator due to the increasing cancer burden worldwide and development of novel injectable therapeutics.
On the basis of route of administration, the intravenous segment accounts for the major share as it allows for rapid delivery of drugs into systemic circulation.
Regionally, North America dominates the market due to the advanced healthcare infrastructure and presence of key pharma companies in the U.S. and Canada.
Key Players Insights
- Pfizer Inc.
- Merck & Co., Inc.
- Johnson & Johnson
- Baxter International Inc.
- Novartis AG
- Sanofi S.A.
- GlaxoSmithKline plc (GSK)
- AstraZeneca PLC
- Gilead Sciences, Inc.
- Amgen Inc.
- AbbVie Inc.
- Teva Pharmaceutical Industries Ltd.
- Bayer AG
- Fresenius SE & Co. KGaA (Fresenius Kabi)
- Becton, Dickinson and Company (BD)
- F. Hoffmann-La Roche Ltd
- Eli Lilly and Company
Recent Developments:
In April 2024, Pfizer Inc. announced the approval of a new sterile injectable formulation for a widely used cancer treatment, enhancing patient access and treatment options.
In March 2024, Merck & Co., Inc. launched a new sterile injectable vaccine aimed at preventing infectious diseases, further expanding its portfolio in immunization.
In February 2024, Johnson & Johnson received U.S. FDA approval for a new sterile injectable medication for treating chronic pain, aimed at improving patient outcomes and compliance.
In January 2024, Baxter International Inc. introduced an advanced sterile injectable solution designed for critical care settings, enhancing safety and efficacy in drug delivery.
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