Bioibérica SA

DUBLIN, March 26, 2024 /PRNewswire/ -- The "Chondroitin Sulfate for Pet Supplements Market - Forecasts from 2024 to 2029" report has been added to ResearchAndMarkets.com's offering. Chondroitin sulfate, a natural compound present in cartilage, the protective tissue surrounding bones in joints, is a prevalent ingredient in pet supplements aimed at promoting joint health, particularly for dogs and cats grappling with osteoarthritis (OA). Pet owners often turn to daily joint supplements when addressing bone and joint diseases in their pets. These supplements, known as chondroprotective, also find use in mitigating inflammation in various bodily areas, particularly those exposed to fluids or mucus. For instance, pets with frequent urination due to an irritated bladder lining can benefit from formulations containing glucosamine and chondroitin. Many pet owners prefer chondroprotective like glucosamine and chondroitin due to their holistic approach, promoting overall pet well-being rather than merely alleviating symptoms. Additionally, these supplements tend to have few side effects and enable pets to rely less on prescription medications. Importantly, chondroprotective supplements are generally considered safe for long-term use, potentially for a pet's lifespan. It is advisable to administer chondroitin supplements in response to joint injuries, initiating joint supplements early in a pet's life is also recommended as a preventive measure. Market Drivers Rise in Pet Ownership Worldwide, there is a growing trend of integrating pets into changing lifestyles, with pets becoming integral companions across the globe. The COVID-19 pandemic witnessed an upswing in pet adoption, notably in the United States, where the percentage of households with at least one dog increased from 38% to 45% between 2016 and 2020, and cat ownership experienced a steady rise from 25% to 29% in 2022. In China, 74 million households own dogs, the United States has 85 million dog owners, and the European Union boasts 92 million dog owners. These figures underscore the global significance of pets and their impact on the chondroitin sulfate market. Growing awareness of the significance of chondroitin sulfate Chondroitin sulfate is gaining popularity in the pet supplement sector as awareness grows regarding its potential advantages for enhancing joint health in dogs and cats. Faced with concerns about possible side effects, pet owners are increasingly inclined toward natural methods to address their pet's well-being. Chondroitin sulfate, sourced from natural origins such as cartilage and shellfish, aligns with this preference, presenting a potentially safer alternative. Pet caregivers are becoming increasingly cognizant of the adverse impact of osteoarthritis (OA) on their pets' quality of life. Market Challenges Regulatory challenges posing a hurdle Navigating regulatory challenges poses an obstacle in the realm of pet supplements. At present, AAFCO exclusively oversees the labelling of supplements categorized as "food-type". Despite a growing body of scientific information on veterinary pet supplements and nutraceuticals, there persists a scarcity of quality control, safety, and efficacy data for the majority of these marketed substances and the corresponding products available for purchase. Despite this evidence gap, the utilization of veterinary supplements and nutraceuticals is on the rise. It is imperative for veterinarians and pet owners alike to advocate for enhanced enforcement of regulations governing these products and to call for manufacturers to collaborate more closely with researchers for the betterment of pets as well as the market. By pet type, chondroitin sulfate for the pet supplements market is divided into dogs and cats The chondroitin sulfate for the pet supplement market is segmented into two categories, i.e, dogs and cats- In the United States, 65.1 million households consider dogs integral family members. The feline companionship is also cherished, as revealed by the 46.5 million households that own a cat, according to the American Pet Products Association (APPA). Notably, the APPA highlights that a significant portion of pet owners in the U.S. are millennials, underscoring the growing importance of pets in the lives of this demographic. Europe is anticipated to hold a notable share of the chondroitin sulfate for pet supplements Europe is projected to account for a notable share of the chondroitin sulfate for pet supplements owing to the people's huge ownership of pets in these regions. As the FEDIAF Facts & Figures states the expanding landscape of pet ownership in Europe, indicates that 90 million households in the European Union have embraced the companionship of a pet, representing 46% of households. The breakdown of this pet population reveals approximately 110 million cats, 90 million dogs, 50 million birds, 30 million small mammals, 15 million aquariums, and 10 million terrariums, showcasing the diverse array of pets that contribute to the rich tapestry of European households. Market Segmentation By Purity Level 99% Level Others By Pet Type Cat Dog By Geography North America USA Others Europe, Middle East, And Africa UK Germany France Others Asia Pacific China Japan South Korea Others Companies Profiled Unibridge Shandong Haiyu Biological Co., Ltd ZPD A/S Shandong Runxin Biotechnology Co., Ltd Bioiberica S.A.U. For more information about this report visit 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. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

“CPHI is always a fantastic opportunity to connect with customers – new and old – but the excitement has been taken up a notch this year as we welcome key stakeholders from across the global pharmaceutical landscape to our hometown, Barcelona,” said Luis Solera, CEO at Bioiberica. The life science company says it is committed to ‘improving the health and well-being of people, animals and plants’ and is excited to participate in the event. It will be showcasing its investment in scientific research, sustainable development and strategic partnerships for a more resilient future, it says. Alongside its active pharmaceutical ingredient (API) portfolio, the company will present the latest research for its mobility, digestive and skin health branded ingredients. Attendees will also have the opportunity to explore Bioiberica’s newfound focus on advanced wound care which is describes as ‘a captivating area of research in the medical nutrition arena’. Also under the spotlight for the first time, Bioiberica will share scientific data set to unlock a new world of co-innovation possibilities. Essential APIs The company will exhibit its essential APIs ​ – chondroitin sulfate and glucosamine for the symptomatic treatment of osteoarthritis, thyroid for endocrinology and its flagship ingredient, Heparin. Visitors to the company’s stand will get the chance to see the latest research supporting the efficacy of its branded ingredients – Collavant n2 (native (undenatured) type 2 collagen), Mobilee (hyaluronic acid matrix ingredient) for joint health and mobility, Dermial (hyaluronic acid matrix ingredient) for skin health and DAOgest (diamine oxidase enzyme) for histamine intolerance. googletag.cmd.push(function () { googletag.display('text-ad1'); }); With sustainability top of the agenda for the pharmaceutical industry, Bioiberica will highlight the potential of its latest sustainability initiatives and how they’re helping to enhance its customers’ green credentials in the face of mounting pressures. Climate neutrality Attendees can connect with Bioiberica’s experts to learn more about its circular bioeconomy model, targets to obtain 100% renewable electricity by 2024 and 30% less GHG emissions by 2030, and ambitious plans to achieve climate neutrality by 2050. Solera added: “Progression in the healthcare space hinges on three key pillars: science, sustainability and strategic partnership. CPHI offers us a platform to highlight the substantial strides we’ve made to strengthen these foundations and showcase how we’re supporting our customers in addressing some of the most pressing challenges facing the pharmaceutical industry. Visitors are warmly invited to our booth where we look forward to fostering innovative ideas together.” Meet Bioiberica at CPHI on stand 7P20 to learn more about the company's APIs and ingredients for human health.

Spanish heparin and API manufacturer Bioiberica is still not in the clear as far as the FDA is concerned, with a new warning letter related to contamination concerns. The US regulator initially issued a Form 483 to the Spanish drugmaker’s manufacturing plant in Palafolls, north of Barcelona. In an FDA inspection between Jan. 31 and Feb. 4 this year, the regulator found several major issues related to cleaning and contamination and a lack of control procedures among other observations. The agency has now issued a warning letter concerning significant deviations in cGMP for active APIs at the facility. The letter , dated June 30, acknowledges that Bioiberica had responded to the Form 483, but the FDA was not satisfied. First, the FDA had concerns over Bioiberica’s failure to establish written procedures to monitor the progress and control the performance of processing steps. The initial inspection saw around 23 batches of APIs needing to be reworked in 2020 and 2021 due to microbiological contamination. Bioiberica responded that they agreed that there was inadequate control and monitoring of processes, and committed to validating the microbiological contamination reduction process, however, the FDA found this response inadequate. “The use of equipment that is not part of the validated manufacturing process is considered rework. In addition, you failed to provide interim measures to ensure your manufacturing process can adequately reduce microbiological contamination.” the letter said. Bioiberica also failed to provide corrective action to address a lack of process controls. The letter demands a response for an assessment of its API manufacturing process, including rework activities performed, to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability. Bioiberica must also provide timelines for completing process performance qualification studies and a comprehensive, independent assessment of the design and control of its manufacturing operations, with a detailed and thorough review of all microbiological hazards. The FDA also noted that the company failed to ensure that reworked batches were subjected to evaluation and stability testing as none of the company’s reworked batches were placed on stability to ensure they were of the same quality. The company’s response committed to developing impurity profile parameters and stability-indicating analytical methods but failed to provide interim measures until those methods are installed and need to show to the FDA. Additionally, the reworked batches currently on the market have not been evaluated. The company also does not have an adequate program for monitoring process controls as well. The letter recommends that Bioiberica engage a cGMP consultant and further investigate any other issues. Any continued failures and the FDA may withhold approval of new applications or supplements listing it as a drug manufacturer until any deviations are addressed and in compliance. The FDA may also re-inspect as well. Failure to address any of these issues may also result in the FDA refusing admission of articles manufactured at Bioiberica. The company, which did not immediately respond to a request for comment, had 15 days from June 30 to respond to the letter.