U.S. Sterile Injectables Market is Estimated to Witness High Growth Owing to Strong Demand for Cancer Therapeutics and Rising Preference for Biologics
The U.S. sterile injectables market is estimated to be valued at USD 155.46 Bn in 2024 and exhibit a CAGR of 9.6% over the forecast period (2024-2031). Furthermore, rising prevalence of chronic diseases such as cancer and diabetes in the U.S. is expected to drive the demand for sterile injectable drugs over the coming years.
Market Dynamics:
Strong demand for cancer therapeutics: The increasing incidence of cancer has significantly boosted the demand for sterile injectable drugs in cancer treatment in the U.S. Sterile injectables play a vital role in delivering anti-cancer therapeutics directly into the patient's bloodstream. Chemotherapy drugs and biologics used for treating various cancers like lung cancer, breast cancer, etc. dominate the U.S. sterile injectables market.
Rising preference for biologics: The biologics segment under sterile injectable drugs is witnessing high demand owing to the benefits offered such as high specificity and targeted drug delivery. Biologics have revolutionized the treatment of chronic diseases. Moreover, the development of advanced delivery mechanisms, such as controlled release injectables, is expected to further support the growth of the biologics U.S. sterile injectables market during the forecast period.
Increasing Prevalence of Chronic Diseases is Driving Growth in the U.S. Sterile Injectables Market
One of the key drivers of the U.S. sterile injectables market is the rising prevalence of chronic diseases across the country. In 2022, according to the Centers for Disease Control and Prevention (CDC), six in 10 Americans live with at least one chronic disease like cancer, heart disease, stroke, diabetes or arthritis. Chronic diseases are also responsible for seven out of 10 deaths each year in the U.S. As the incidence of chronic illnesses continues to grow due to an aging population and increasing risk factors like obesity, there is a corresponding rise in demand for long-term disease management therapies including sterile injectable drugs. Areas like oncology, rheumatology, infectious diseases, and neurology heavily rely on sterile injectables to treat chronic conditions. This sustained need for injectable medication administration delivers a steady stream of revenue to players in the U.S. sterile injectables market.
Increased Adoption of Biologics is Driving the Market Growth
Another driver for the U.S. sterile injectables market is the increased adoption of biologics for the treatment of various diseases. Biologics, such as monoclonal antibodies, have revolutionized the treatment of conditions like cancer, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. Their ability to precisely target disease pathways with greater efficacy and fewer side effects than conventional drugs has led to widening use across indications. Furthermore, the expiration of patents has enabled the approval of cheaper biosimilar products, improving patient access. This growing biologic sector continues to bolster demand for sterile injectables as the delivery method. Manufacturers are subsequently expanding their portfolios to include more complex biologics and specialty sterile injectable drugs.
Supply Shortages Pose a Challenge for Market Growth
One key restraint affecting the U.S. sterile injectables industry is the frequent occurrence of drug shortages. The production of sterile injectables is a complex process requiring adherence to stringent quality standards and regulatory guidelines for sterile facilities and equipment. Any breakdowns or compliance issues can potentially disrupt manufacturing output. Additionally, a majority of sterile injectable production takes place overseas in countries like India and Ireland due to lower costs. This reliance on an international supply chain leaves the market vulnerable to delays, especially during times of high global demand. The short supply of vital sterile injectables, including critical care, anesthesia and oncology drugs, creates treatment challenges for healthcare providers and patient anxiety. Resolving drug shortages remains an ongoing priority.
Complex Manufacturing Adds to Cost Burden
Another challenge faced by manufacturers in the U.S. sterile injectables market pertains to the inherently complex production process that leads to higher costs. Sterile injectable formulations must be prepared aseptically to guarantee sterility, with multiple filtration and filling steps conducted under strictly controlled ISO-classified cleanroom conditions. Additionally, newer biologic injectables require advanced capabilities like lyophilization. Maintaining such optimized manufacturing infrastructures entails substantial capital investments and operating expenses. This cost burden is inevitably passed on to customers in the forms of higher drug prices. As healthcare expenditures remain a significant policy issue in the U.S., high injectable drug costs could potentially limit market opportunities.
Growth of Biosimilars Offers Commercial Opportunities
One major opportunity area for companies in the U.S. sterile injectables market stems from the increasing approval and uptake of biosimilar drugs. Biosimilars provide more affordable treatment alternatives to originate biologics whose patents have expired. However, to gain widespread adoption, they still need to convince physicians of their safety and efficacy relative to reference products. Sterile injectable drug makers can engage in educational initiatives and real-world evidence programs to endorse biosimilars. This helps expand the market by enabling cost-conscious healthcare providers and payers to prescribe these interchangeable biologic options. It also enhances the revenue potential from biosimilar product portfolios. Their positioning as lower-cost substitutes capable of capturing a share of the large biologics market bodes well for future growth.
Aging Demographics Presents Expanding Commercial Prospects
Another key opportunity arising for participants in the U.S. sterile injectables industry relates to demographic trends. The proportion of older adults aged 65 years and above continues rising in the country. This aging population has greater requirements for specialty injectable treatments across a range of therapy areas as age-related health issues like cancer, diabetes, and arthritis increase in prevalence. Their reliance on healthcare will correspondently drive volume demand for self-administered injectable drugs and physician-administered injectables used in hospitals and clinics.
Link: https://www.coherentmarketinsights.com/market-insight/us-sterile-injectables-market-4961
Key Developments:
- On June 26, 2024, Sharp Services, a global leader in clinical supply chain services and contract pharmaceutical packaging, announced expansion in Pennsylvania, U.S. to facilitate growth in the sterile injectables market. The expansion aims to increase its production capacity for sterile injectables secondary packaging
- On April 11, 2024, Baxter, a global leader in injectables, anesthesia and drug compounding, announced the continued expansion of its Pharmaceuticals portfolio with five injectable product launches in the U.S. Product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include Norepinephrine Bitartrate in 5% Dextrose Injection, Vasopressin in 0.9% Sodium Chloride Injection, Vancomycin Injection, USP in 5% Dextrose in new 1.25 g/250 mL and 1.5 g/300 mL strengths, Ropivacaine Hydrochloride Injection, and others.
- In June 2023, Hikma Pharmaceuticals PLC, a global pharmaceutical company, launched Dobutamine Injection, USP, in a 250mg/20mL vial in the U.S. This product is indicated for short-term inotropic support in adults experiencing cardiac decompensation due to reduced contractility from organic heart disease or surgical procedures.
Key Players:
Baxter, AstraZeneca, Merck & Co., Inc., Novartis AG, Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, Recipharm AB, Hikma Pharmaceuticals PLC, and Eli Lilly and Company
