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By PharmaCompass
2025-12-11
Impressions: 194
The global market for antibiotics has been witnessing several challenges. First, there is growing recognition of the harm overuse and misuse of antibiotics can do to human health. Antimicrobial resistance (AMR) is considered a silent and rapidly growing pandemic.
Second, inadequate treatment of pharmaceutical wastewater poses significant environmental risks and contributes to rising AMR. This has led to higher expectations and regulations around sustainable and compliant manufacturing. Third, we are witnessing increased guidelines around the use of certain antibiotics, such as the use of fluoroquinolones.
And fourth, supply chain issues have taken centerstage post Covid, as much of APIs used in manufacturing antibiotics come from China and India. This structural vulnerability is reshaping procurement strategies around the world.
Despite these headwinds, antibiotics remain indispensable to public health, and their demand is growing at a healthy pace. According to Grand View Research, the global antibiotics market is set to reach US$ 74.07 billion by 2033, growing at a compound annual rate of 3.71 percent from 2025 to 2033.
Major players in the antibiotics space include Pfizer, GSK, Centrient Pharmaceuticals, Merck & Co, Abbott Laboratories, Bristol-Myers Squibb, Century Pharmaceuticals, Teva Pharmaceutical Industries, Sun Pharmaceutical Industries, Hisun Pharmaceutical, Aurobindo Pharma, Novartis AG, and Sanofi. Players like Lupin Limited, Dr Reddy’s Laboratories, Cipla, Fresenius Kabi are known for their cost-efficient generics and specialized formulations.
FDA approves GSK’s Blujepa for uncomplicated UTIs, Pfizer-AbbVie’s Emblaveo for intra-abdominal infections
This year, two new antibiotics bagged the approval of the US Food and Drug Administration (FDA).
In February this year, FDA approved Emblaveo (aztreonam and avibactam), developed jointly by AbbVie and Pfizer, for the treatment of complicated intra-abdominal infections in adults who have limited or no alternative treatment options.
Emblaveo is the first and only fixed-dose, intravenous, combination antibiotic. It is approved in combination with metronidazole for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections, including those caused by escherichia coli, klebsiella pneumoniae, klebsiella oxytoca, enterobacter cloacae complex, citrobacter freundii complex, and serratia marcescens. The European Commission granted marketing authorization to Emblaveo in April 2024.
Another notable approval was granted to GSK’s Blujepa (gepotidacin). It was approved by the FDA in March this year for treating uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years and older. This marks the first approval of a new class of oral antibiotics for uUTIs in nearly 30 years. Blujepa’s dual-action approach drastically reduces the likelihood of developing AMR. The drug was approved in the UK in August.
This month, FDA accepted Wockhardt’s new drug application (NDA) for its antibiotic Zaynich (a combination of cefepime and zidebactam) under its fast track approvals pathway. This is the first NDA for a new chemical entity filed by an Indian drugmaker that has been accepted by the FDA. Zaynich is developed for treating multi drug-resistant infections. Wockhardt has said the market opportunity could be worth up to US$ 7 billion.
GSK shutters Ulverston site in UK; EU Council agrees on Critical Medicines Act to strengthen supply chain
The Covid-19 pandemic had exposed deep-seated weaknesses in antibiotic supply chains across the US and Europe. In July 2020, when supply chain disruptions were at their peak, Austria had teamed up with Novartis to strengthen antibiotic manufacturing. Sandoz, Novartis’ generic unit, and the Austrian government had agreed to invest €150 million (US$ 175 million) over five years to improve antibiotic manufacturing at Novartis’ plant in Kundl, Austria.
In March 2024, Sandoz inaugurated a new automated production facility increasing its antibiotic production capacity by 20 percent. However, in a recent report, Richard Saynor, CEO of Sandoz, warned that the “last remaining 6-APA manufacturing site in any European or North American country – operated by Sandoz in Kundl, Austria – faces an increasingly precarious economic situation, which has worsened significantly in recent years due to a series of major geopolitical shocks.”
The UK is facing similar challenges. In June, GSK confirmed the closure of its Ulverston site, the country’s last major antibiotic fermentation facility. The site, which began operations over 75 years ago, had been producing the antibiotic Zinnat (cefuroxime axetil) for Sandoz. The contract ended earlier this year, and GSK plans to demolish the antibiotic factory.
In March, the European Commission had proposed a framework to secure the availability of critical medicines. The Council of the European Union has now agreed on the Critical Medicines Act, aimed at strengthening the EU's supply of essential medicines, including antibiotics, insulin and painkillers, by improving security of supply and availability in the EU.
Lyfius Pharma, Boryung set up penicillin manufacturing facilities; Centrient earns second AMR-risk certification
Drug shortages have prompted companies across the world to increase capacities. South Korea’s Boryung Pharmaceutical is setting up an oral penicillin antibiotic production facility in Ansan (South Korea). Once completed, this facility will more than double the annual production of oral penicillin capacity.
More than 60 percent of global penicillin API capacity and over 80 percent of penicillin intermediate production remain concentrated in China. Similarly, in cephalosporins (antibiotics that inhibit bacterial cell wall synthesis), only two intermediate-production sites operate worldwide, one of them being Centrient’s facility in the Netherlands. The other one is in China.
Headquartered in the Netherlands, Centrient Pharmaceuticals is a global B2B leader in sustainable, enzymatic antibiotics, next-generation statins and antifungals. The company recently secured its second independent Minimized Risk of AMR certification for its antibiotic production. Only four other manufacturers have AMR certification in Europe.
The US currently has no domestic antibiotic API production facility, and is relying heavily on APIs imported from China and finished dosage forms from India.
In March this year, US-based specialty drugmaker Avenacy launched a suite of five antibiotic products — ampicillin for injection, ampicillin and sulbactam for injection, nafcillin for injection, penicillin G potassium for injection, piperacillin and tazobactam for injection.
In India, Syschem is setting up a new factory to manufacture cloxacillin, dicloxacillin, and flucloxacillin sodium. It is also expanding its existing amoxicillin unit. The total investment is estimated to be around Rs 150 to Rs 200 million (US$ 1.67 million to US$ 2.22 million).
Similarly, Lyfius Pharma is investing Rs 25 billion (US$ 278 million) through the Indian government’s Production Linked Incentive Scheme for its state-of-the-art penicillin-G manufacturing facility, at Kakinada, Andhra Pradesh.
Our view
The market for antibiotics is navigating a complex mix of AMR risks, supply chain vulnerabilities and cost pressures. The approval of GSK’s Blujepa signals scientific progress. But a lot more needs to be done to build resilient supply chains, and to address the rising menace of AMR.
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Image Credit : ANTIBIOTIC MARKET UP DESPITE SUPPLY ISSUES by PharmaCompass license under CC BY 2.0
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