American Regent, Inc.

DUBLIN--( BUSINESS WIRE )--The "Generic Injectables - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering. The global market for Generic Injectables was estimated at US$95.2 Billion in 2023 and is projected to reach US$206.8 Billion by 2030, growing at a CAGR of 11.7% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. One of the primary drivers is the increasing incidence of chronic diseases globally, which has led to a heightened demand for injectable therapies. Conditions such as diabetes, cancer, cardiovascular diseases, and autoimmune disorders often require long-term or rapid-response treatments, and injectables are a preferred delivery method in these cases due to their fast-acting nature. As chronic diseases rise, especially in aging populations, the demand for affordable injectable medications continues to grow. Another significant driver is the advancement in biologics and biosimilars, which has expanded the range of complex injectables available in the market. As more biologic patents expire, opportunities for the introduction of biosimilar injectables increase, providing a lower-cost alternative to expensive branded biologics. Moreover, technological innovations in drug delivery systems, such as the development of prefilled syringes and autoinjectors, have made injectables more accessible to patients. These innovations support the trend towards home-based care and self-administration, reducing the burden on healthcare facilities. The global shift towards cost-effective healthcare solutions, combined with government initiatives to increase the use of generics, has further boosted the demand for generic injectables. Why Are Generic Injectables Gaining Such Immense Popularity Across the Globe? Generic injectables have emerged as a vital component of modern healthcare systems, offering cost-effective alternatives to branded drugs while maintaining the same efficacy and safety standards. With the increasing burden of chronic diseases like cancer, cardiovascular disorders, and diabetes, the demand for injectables has soared, particularly for treatments requiring quick, potent delivery. Generic injectables, being lower-priced versions of branded injectables, allow healthcare systems to treat more patients efficiently without compromising quality. Hospitals, clinics, and emergency care centers have increasingly integrated these generics into their treatment protocols to manage both acute and chronic conditions. The ability to quickly administer life-saving drugs, particularly in critical care settings, has made generic injectables indispensable, with their global demand continuing to grow year on year. Furthermore, advancements in drug delivery systems, including prefilled syringes and ready-to-use vials, have bolstered the adoption of generic injectables across various healthcare settings. Prefilled syringes and other single-use formats provide an extra layer of safety by minimizing contamination risks and ensuring accurate dosing. With their increasing availability in oncology, anesthesia, anti-infective drugs, and immunotherapy, the role of generic injectables in both treatment and prevention is expanding. Their ability to provide cost savings to healthcare providers while ensuring that patient outcomes are not compromised is a major reason for their accelerated adoption. What Role Do Technological Innovations Play in Expanding the Generic Injectables Market? Technological advancements have played a transformative role in driving the growth of the generic injectables market. Improvements in manufacturing technologies, such as continuous production and advanced sterilization processes, have increased the efficiency and scalability of generic injectables production. These innovations have reduced manufacturing costs while ensuring that production meets stringent regulatory standards. Additionally, advancements in biotechnology have enabled the development of complex generic injectables, including biosimilars, which are increasingly used to treat autoimmune diseases and various cancers. The growing use of biologics in modern medicine has opened up new opportunities for generic injectables manufacturers to provide lower-cost alternatives in this high-demand segment. The rise of automation and robotics in injectable production is also a critical factor. Automated systems improve precision in production, reduce human errors, and streamline the manufacturing process, making it easier for pharmaceutical companies to meet global demand. Furthermore, advances in packaging technologies, such as prefilled syringes and autoinjectors, make injectables more user-friendly, facilitating home care administration and reducing hospital visits. As healthcare shifts towards more patient-centered models, the development of self-administrable injectables is gaining traction, contributing to the expansion of the market. Report Features: Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030. In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Company Profiles: Coverage of major players in the Global Generic Injectables Market such as American Regent, Inc., Ascendia Pharmaceuticals, Aurobindo Pharma Ltd., Baxter International, Inc., Biocon Ltd. and more. Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments. Key Insights: Market Growth: Understand the significant growth trajectory of the Vials segment, which is expected to reach US$109.9 Billion by 2030 with a CAGR of a 12.7%. The Ampoules segment is also set to grow at 11.2% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, estimated at $20.0 Billion in 2023, and China, forecasted to grow at an impressive 15.0% CAGR to reach $43.7 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific. Key Attributes: Report Attribute Details No. of Pages 602 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $95.2 Billion Forecasted Market Value (USD) by 2030 $206.8 Billion Compound Annual Growth Rate 11.7% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Efficacy and Cost Benefits Continue to Drive Growth in Global Generic Injectables Market Global Economic Outlook Generic Injectables - Global Key Competitors Percentage Market Share in 2024 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E) Generic Injectables: Product Overview Recent Market Activity Influencer/Product/Technology Insights MARKET TRENDS & DRIVERS A Look into Growing Shift Towards Injectables Complex Injectables and Small-Volume Parenterals: A Challenging but High-Value Market Upcoming Patent Expirations of Key Branded Injectable Drugs Throw the Spotlight on Generics as a Cost-Effective Alternative, Opening Up New Market Opportunities Increasing Demand for Cost-Effective Healthcare Solutions Propels Significant Growth in the Generic Injectables Market Regulatory Incentives and Fast-Track Approvals for Biosimilars Strengthen the Business Case for Expanding Generic Injectable Offerings Expanding Geriatric Population and Rising Incidence of Age-Related Diseases Drive Strong Adoption of Generic Injectable Medications Technological Advancements in Injectable Drug Delivery Systems, Including Prefilled Syringes and Auto-Injectors, Sustain Long-Term Growth of Generic Injectables Surge in the Prevalence of Chronic Diseases, Such as Diabetes and Cardiovascular Disorders, Spurs Increased Demand for Generic Injectable Treatment Options Rise in Incidence of Cancer and Associated High Treatment Costs Drives Demand for Generic Injectable Treatments Growing Availability of Complex Biologics and Biosimilars Expands the Addressable Market Opportunity for Generic Injectables, Increasing Market Penetration Growing Preference for Home-Based Healthcare Services and Self-Administration Drives Demand for Generic Injectable Auto-Injectors and Other Patient-Friendly Solutions Rise of Infectious Diseases Drive Demand for Injectables Long-Term Mental Health Management Drives Growth Prospects Rising Demand for Affordable Alternatives to Branded Injectable Drugs Growth in Healthcare Expenditure Driving Demand for Cost-Effective Treatments Increasing Adoption of Generic Injectables in Hospitals and Ambulatory Settings Expansion of Generic Injectable Offerings in Oncology and Chronic Disease Management Surge in Demand for Injectable Antibiotics and Critical Care Medications Technological Advancements in Injectable Formulations for Improved Efficacy Growth in Outsourcing Injectable Manufacturing to Reduce Production Costs Expansion of Generic Injectables in Emerging Markets with Expanding Healthcare Access Increased Focus on Biologics and Biosimilar Injectable Products Rising Adoption of Pre-Filled Syringes and Auto-Injectors in Drug Delivery Development of Generic Injectables to Address Supply Shortages of Critical Medications Growth in Research and Development of Complex Injectables FOCUS ON SELECT PLAYERS: Some of the 43 companies featured in this Global Generic Injectables market report include American Regent, Inc. Ascendia Pharmaceuticals Aurobindo Pharma Ltd. Baxter International, Inc. Biocon Ltd. Biological E. Ltd. Bristol-Myers Squibb Company Cipla Ltd. Cosette Pharmaceuticals, Inc. Dr. Reddy's Laboratories Ltd. For more information about this report visit https://www.researchandmarkets.com/r/h7y985 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

SHIRLEY, N.Y., July 2, 2024 /PRNewswire/ -- American Regent announces the launch and availability of Sodium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Sodium Phosphates .1 Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Continue Reading Sodium Phosphates Injection, USP is available in three presentations The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia. "An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Sodium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. This product is available for immediate shipment. Customers can order Sodium Phosphates Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706. Sodium Phosphates Injection, USP is supplied as follows: See the following Important Safety Information, in addition to the product's Full Prescribing Information. For additional information, please visit FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS INDICATIONS AND USAGE Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia. WARNINGS Sodium Phosphates Injection, USP 3 mM P/mL must be diluted and thoroughly mixed before use. To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. PRECAUTIONS Do not administer unless solution is clear and seal is intact. Discard unused portion. Phosphorus replacement therapy with sodium phosphate should be guided primarily by the serum phosphorus level and the limits imposed by the accompanying sodium (Na+) ion. Use with caution in patients with renal impairment, cirrhosis, cardiac failure, and other edematous or sodium-retaining states. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Pregnancy: Animal reproduction studies have not been conducted with sodium phosphate. It is also not known whether sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium phosphate should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness of sodium phosphate has been established in pediatric patients (neonates, infants, children, and adolescents). Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions and phosphorus are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ADVERSE REACTIONS Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany. OVERDOSAGE In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. For additional safety information, please see Full Prescribing Information . You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236, or to the FDA by visiting or by calling 1-800-FDA-1088. You are encouraged to report adverse drug events (ADEs) to American Regent: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit . About Daiichi Sankyo Group Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit: . All trademarks are the property of their respective owners. Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. Accessed April 12, 2024 . SOURCE American Regent Inc

AAHA research reveals importance of resources, awareness focused on early-onset disease. SHIRLEY, N.Y., Dec. 7, 2023 /PRNewswire/ -- A pivotal survey by the American Animal Hospital Association (AAHA), conducted in partnership with American Regent Animal Health and leading veterinary orthopedist Denis Marcellin-Little, DEDV, DACVS, DACVSMR, CCAT, has revealed a significant demand among participating veterinarians for a structured protocol to manage canine osteoarthritis, especially when it comes to early detection in younger dogs. Continue Reading "We should be talking about osteoarthritis when it's a non-issue—before it becomes a problem." —Denis Marcellin-Little Post this Key findings from a survey conducted by the American Animal Hospital Association and American Regent Animal Health show a clear need for a canine osteoarthritis management protocol for veterinarians. An overwhelming 95% of veterinarians agree that a canine osteoarthritis protocol would be beneficial, signaling an urgent need for standardized care procedures. "It's extremely rare that 95% of veterinarians would agree on anything," said Dr. Marcellin-Little, a professor at the University of California, Davis, School of Veterinary Medicine. "This consensus is a cry for help—a clear demand for more structure in managing osteoarthritis." The survey, which garnered responses from nearly 800 veterinarians, also sheds light on practitioners' self-assessment of their own knowledge. They gave themselves an average rating of 7/10 on understanding the onset of canine osteoarthritis—equivalent to a "C" grade, according to Dr. Marcellin-Little, who added, "We want them to all be 'A's." When it comes to managing osteoarthritis, the average rating rises slightly to 8/10. "There's a bit more confidence in management than in detection, which shows that we should be focusing on early onset," Dr. Marcellin-Little added. With veterinarians estimating that 45% of their patients have osteoarthritis, 47% are predisposed to it, and 26% have early-onset disease, the survey highlights a critical window of opportunity for early intervention. "A quarter to half of our patients may be in the early stages of osteoarthritis," explained Dr. Marcellin-Little. "This justifies a stronger emphasis on early detection." In addition, veterinarians say 75% of their clients know only "a little bit" about canine osteoarthritis, presenting an opportunity for better education and resources that boost understanding of what dog owners need to know about osteoarthritis. Still, despite the awareness gap, the survey revealed that less than 10% of veterinarians initiate discussions about osteoarthritis when they first begin a relationship with a dog and client. Dr. Marcellin-Little emphasized the importance of early conversations: "We should be talking about osteoarthritis when it's a non-issue—before it becomes a problem." The findings are a call to action for the veterinary community to prioritize early osteoarthritis detection and management in clinical practice. This research from American Regent, maker of Adequan® Canine (polysulfated glycosaminoglycan), and AAHA is the first step in supporting veterinarians with the resources and protocols necessary to enhance dogs' joint health and overall well-being. Dr. Marcellin-Little will be presenting more insights on the survey findings during a lunch session on Sunday, Jan. 14, 2024, during the VMX veterinary conference in Orlando, Florida. Media are invited to attend the session and also speak with Dr. Marcellin-Little individually during the event. For more information on canine osteoarthritis and resources for veterinarians, visit adequancanine.com. Adequan® Canine polysulfated glycosaminoglycan (PSGAG) INDICATIONS AND USAGE Adequan® Canine is recommended for intramuscular injection for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints. IMPORTANT SAFETY INFORMATION Adequan® Canine should not be used in dogs who are hypersensitive to polysulfated glycosaminoglycan (PSGAG) or who have a known or suspected bleeding disorder. It should be used with caution in dogs with renal or hepatic impairment. Adverse reactions in clinical studies (transient pain at injection site, transient diarrhea, and abnormal bleeding) were mild and self-limiting. In post approval experience, death has been reported in some cases; vomiting, anorexia, depression/lethargy and diarrhea have also been reported. The safe use of PSGAG in breeding, pregnant or lactating dogs has not been evaluated. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For additional safety information, please see Full Prescribing Information at adequancanine.com. About American Regent Animal Health American Regent Animal Health, a division of American Regent, Inc., is committed to advancing animal health with proven FDA-approved products like Adequan® (polysulfated glycosaminoglycan). The company's portfolio is anchored by the only FDA-approved polysulfated glycosaminoglycan products for horses and dogs, which have been relied on for nearly three decades by veterinarians. American Regent, Inc., a Daiichi Sankyo Group Company, manufactures and distributes human and veterinary pharmaceutical products and is committed to providing the ever-changing U.S. healthcare marketplace with a growing and diversified portfolio. For more information on American Regent Animal Health, visit ARAnimalHealth.com or call 1-800-458-0163. SOURCE American Regent Animal Health