Seikagaku Corp.

DUBLIN--( BUSINESS WIRE )--The "Pharmaceutical Analytical Testing Outsourcing - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. The global market for Pharmaceutical Analytical Testing Outsourcing was estimated at US$10.3 Billion in 2023 and is projected to reach US$16.3 Billion by 2030, growing at a CAGR of 6.8% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The growth in the pharmaceutical analytical testing outsourcing market is driven by several factors, each contributing to the increasing reliance on external service providers. One of the key drivers is the rising complexity of drug molecules, particularly in the biologics and biosimilars sector. These drugs require more sophisticated analytical testing methods to ensure their safety, purity, and efficacy, which often necessitates the use of highly specialized equipment and expertise that pharmaceutical companies may lack internally. This has prompted the outsourcing of these tasks to CROs that possess the technological capabilities and regulatory know-how to handle complex biologics testing. Another critical factor fueling growth is the cost-saving potential that outsourcing offers pharmaceutical companies. By outsourcing analytical testing, companies can avoid significant capital investment in expensive equipment and infrastructure while also reducing the costs associated with staffing and maintaining in-house laboratories. This is especially appealing to smaller biotech firms or start-ups that may lack the resources to develop in-house testing capabilities but require access to high-quality analytical services to advance their drug candidates. Regulatory pressures are also driving the demand for outsourcing, as pharmaceutical companies face increasingly stringent requirements from regulatory agencies worldwide. CROs with expertise in regulatory compliance offer a distinct advantage by ensuring that testing processes meet global standards, mitigating the risk of delays or rejections during the approval process. Additionally, the growing trend toward globalization in drug development means that pharmaceutical companies are working across multiple geographic regions, each with its own regulatory requirements. This further increases the reliance on CROs that have a global footprint and the ability to navigate complex regulatory landscapes. Lastly, the rapid advancements in digital technologies and data analytics have made outsourcing an attractive option for pharmaceutical companies looking to optimize their R&D processes. CROs that offer advanced data analytics capabilities can provide deeper insights into testing results, accelerating decision-making and improving the overall efficiency of drug development. These factors, combined with the growing demand for personalized and specialized medicines, ensure that the pharmaceutical analytical testing outsourcing market will continue to experience robust growth in the years to come. What Are the Key Market Trends Driving Outsourcing in Pharmaceutical Analytical Testing? Another major trend influencing the market is the rising regulatory scrutiny in drug development. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are enforcing stricter guidelines on drug safety, quality, and efficacy, prompting pharmaceutical companies to seek out CROs that can provide expertise in regulatory compliance and high-quality testing. This includes testing for impurities, stability, and degradation, as well as ensuring that manufacturing processes adhere to Good Manufacturing Practices (GMP). The increasing prevalence of specialty and personalized medicines is also driving the need for more specialized testing services. Personalized therapies, particularly those based on genetics or rare diseases, often require highly specific analytical methods, which many pharmaceutical companies may not have the in-house capability to perform. As a result, these companies are increasingly outsourcing their testing needs to CROs that specialize in niche areas of drug development. Additionally, the shift toward virtual pharma models, where companies focus exclusively on drug development and outsource all other functions, has further accelerated the demand for comprehensive analytical testing services. 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 Pharmaceutical Analytical Testing Outsourcing Market such as Bioreliance, Boston Analytical, Charles River Laboratories International, Inc., Dalton Pharma Services, Eurofins Scientific 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 Bioanalytical Testing Service segment, which is expected to reach US$6.4 Billion by 2030 with a CAGR of a 8.0%. The Method Development & Validation Service segment is also set to grow at 6.8% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, estimated at $2.8 Billion in 2023, and China, forecasted to grow at an impressive 6.2% CAGR to reach $2.5 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 93 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $10.3 Billion Forecasted Market Value (USD) by 2030 $16.3 Billion Compound Annual Growth Rate 6.8% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Influencer Market Insights World Market Trajectories Global Economic Update Pharmaceutical Analytical Testing Outsourcing - Global Key Competitors Percentage Market Share in 2024 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E) MARKET TRENDS & DRIVERS Rising Complexity of Drug Development and Regulatory Compliance Drives Demand for Outsourced Pharmaceutical Analytical Testing Services Increasing Stringent Regulatory Requirements from Global Health Authorities, Including FDA and EMA, Fuels Growth in Analytical Testing Outsourcing Growing Focus on Cost Efficiency and Speed-to-Market in Drug Development Spurs Demand for Outsourcing Analytical Testing Services Technological Advancements in Analytical Testing, Including High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry, Enhance Testing Accuracy Expansion of Biologics and Biosimilars Development Strengthens Demand for Specialized Analytical Testing Outsourcing Increased Adoption of Outsourcing in Emerging Markets Drives Growth of Analytical Testing Services in Asia-Pacific and Latin America Rising Focus on Quality Control and Assurance in Drug Manufacturing Propels Demand for Outsourced Stability and Microbial Testing Growing Need for Advanced Testing Capabilities in Pharmaceutical Packaging, Including Extractables and Leachables Testing Emerging Use of Outsourced Analytical Testing for Preclinical and Clinical Trials Fuels Growth in Early-Stage Drug Development Rising Demand for Analytical Testing Outsourcing in the Development of Personalized Medicine and Gene Therapies Technological Innovations in Automation and AI-Powered Analytical Testing Solutions Enhance Efficiency and Data Accuracy Expansion of Contract Research Organizations (CROs) Offering End-to-End Analytical Testing Services Drives Market Growth Growing Use of Outsourced Analytical Testing in Generic Drug Development and Approval Processes FOCUS ON SELECT PLAYERS: Some of the 42 companies featured in this Global Pharmaceutical Analytical Testing Outsourcing market report Bioreliance Boston Analytical Charles River Laboratories International, Inc. Dalton Pharma Services Eurofins Scientific Exova Halo Pharma Intertek Group PLC Pace Analytical Services, LLC Pharmaceutical Product Development, LLC SGS SA Toxikon, Inc. West Pharmaceutical Services, Inc. WuXi AppTec, Inc. For more information about this report visit https://www.researchandmarkets.com/r/lrn1tt 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.

PARSIPPANY, N.J.--( BUSINESS WIRE )--Ferring Pharmaceuticals and its clinical development partner, Seikagaku Corporation (Seikagaku), today announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold a meeting on January 10, 2025, to review data supporting the biologics license application (BLA) for SI-6603 (generic name: condoliase), an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation (LDH) in adults. “ Treatment options for the millions of Americans who suffer from radicular leg pain associated with lumbar disc herniation each year are currently limited to conservative pain management and physical therapy or surgery, ” said Brent Ragans, President, Ferring Pharmaceuticals, U.S. “ This represents a significant unmet patient need, and Ferring, in partnership with Seikagaku, is working to address this treatment gap. ” The FDA will live stream the advisory committee meeting and a webcast of the meeting will also be available on the FDA website. About Lumbar Disc Herniation About 9 million adults in the U.S. suffer from lumbar disc herniation each year. A disc herniation is a displacement of the gel-like inner core of the intervertebral disc, called the nucleus pulposus, through its external membrane (annulus fibrosus) due to wear and tear, aging or sudden injury. As a result of this displacement, the disc presses on the spinal nerve, often producing pain. 1,2 About SI-6603 SI-6603, which contains condoliase as its active pharmaceutical ingredient, is an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation in adults via a single, direct intradiscal injection. SI-6603 (condoliase) is designed to reduce nerve root compression and thereby the radicular leg pain. SI-6603 was developed by Seikagaku. Marketing approval for SI-6603 in Japan was obtained from the Japanese Ministry of Health, Labour and Welfare in March 2018 and SI-6603 has been marketed in Japan only as HERNICORE ® 1.25 units for intradiscal injection through Seikagaku's Japanese sales partner Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan) since August 1, 2018. 3 Alliance with Seikagaku Seikagaku and Ferring entered into a license agreement for SI-6603 in August 2016. Ferring plans to commercialize the product in the United States upon FDA approval and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees. For more information, please visit www.ferringusa.com , call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn and X (Twitter) . References: Vialle LR, Vialle EN, Suárez Henao JE, Giraldo G. Lumbar Disc Herniation. Rev Bras Ortop . 2015 Nov 16;45(1):17-22. doi: 10.1016/S2255-4971(15)30211-1. PMID: 27019834; PMCID: PMC4799068. Herniated Disk in the Lower Back. OrthoInfo. American Academy of Orthopaedic Surgeons. Available at: https://orthoinfo.aaos.org/en/diseases–conditions/herniated-disk-in-the-lower-back/ . Accessed May 23, 2023. Press Release. Seikagaku and Kaken Announce the Launch of HERNICORE® 1.25 Units for Intradiscal Injection in Japan. July 31,2018. Available at: https://www.seikagaku.co.jp/en/news/news-6617037418084939174/main/0/link/20180731-e.pdf . Accessed May 24, 2023.

PARSIPPANY, N.J.--( BUSINESS WIRE )--Ferring Pharmaceuticals and its clinical development partner, Seikagaku Corporation (Seikagaku), today announced the presentation of data from two Phase 3 trials evaluating the efficacy and safety of SI-6603 (generic name: condoliase), an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation (LDH). The podium presentation at the North American Spine Society’s (NASS) Annual Meeting included results from one study conducted in the U.S. and one in Japan. In addition, The Spine Journal has published the results of the pivotal U.S. Phase 3 study. NASS Presentation In the double-blind, sham or placebo controlled Phase 3 studies, patients with LDH were randomized to receive either a single intradiscal injection of SI-6603 1.25 Units or control (sham injection for U.S. study; placebo injection for Japanese study) followed by 52 weeks of observation. The modified intention-to-treat population in the U.S. study included 341 participants (SI-6603 n=169; sham n=172), and the study population in Japan included 163 participants (SI-6603 n=82; placebo n=81). The studies met their primary endpoint, showing significantly greater change from baseline (CFB) in worst leg pain at Week 13 compared to sham (U.S.) / placebo (Japan) (least squares mean [LSM] difference: -7.5 [p=0.0263] for the U.S. study and -15.2 [p=0.001] for the Japan study). “ Treatment for radicular leg pain associated with lumbar disc herniation is currently limited to conservative pain management and physical therapy or surgery. The data from these two Phase 3 studies further support the potential of SI-6603 as a therapeutic option for the millions of Americans suffering from the debilitating impact of this condition, ” said Kee Kim, MD, University of California, Davis. The most common treatment-emergent adverse events (TEAEs) in the U.S. trial were spinal magnetic resonance imaging abnormalities (SI-6603 28.1%; sham 9.2%) and back pain (SI-6603 19.2%; sham 12.6%). In the Japan trial, the most common TEAEs were back pain (SI-6603 36.6%; placebo 33.3%) and leg pain (SI-6603 25.6%; placebo 35.8%). There were no treatment-related serious adverse events (SAEs) with SI-6603 in the U.S. study, and in the Japan study, one SAE (back pain) was considered potentially related to SI-6603. About the Phase 3 Trial in the U.S. In this randomized double-blind, sham-controlled, parallel Phase 3 study — known as the Discovery 6603 clinical trial (NCT03607838) — participants were randomized 1:1 to receive either SI-6603 (1.25 U) or sham injection followed by 52 weeks of observation. The primary endpoint was defined as the CFB to Week 13 in worst leg pain during the past 24 hours averaged over the previous seven days, as assessed by Visual Analogue Scale, a pain rating score from 0 – 100 with a higher score indicating greater pain intensity. Key secondary endpoints included the CFB in average worst leg pain at 52 weeks, percentage of participants with negative straight leg raise test, and 50% responder rates for worst leg pain and Oswestry Disability Index (ODI). Since the key secondary endpoint of change in average worst leg pain at Week 52 was not significant, the serial gatekeeping testing algorithm dictated that there were no significant group differences for Week 13 herniation volume or ODI score regardless of their p-values. Endpoints were assessed using a mixed model for repeated measures (MMRM) analysis of the modified intention-to-treat population (mITT). The trial included U.S. participants ages 30 to 70 years old who had contained posterolateral LDH with the chief complaint being unilateral radiculopathy/radicular leg pain and inadequate improvement in pain despite more than six weeks of conservative treatment. Among 352 randomized participants, 341 constituted the mITT population (SI-6603 n=169; sham injections n=172). About the Phase 3 Trial in Japan In this randomized, double-blind, placebo-controlled study, participants were randomized 1:1 to receive either a single injection of SI-6603 (1.25U) or placebo injection, followed by 52 weeks of observation. The primary endpoint was the CFB to Week 13 in average worst leg pain during the past 24 hours over the previous seven days, as assessed by Visual Analogue Scale, a pain rating score from 0 – 100 with a higher score indicating greater pain intensity. Secondary endpoints included CFB up to Week 52 in average worst leg pain, herniation volume and ODI score. Endpoints were assessed using an analysis of covariance model. About Lumbar Disc Herniation About 9 million adults in the U.S. suffer from lumbar disc herniation each year. A disc herniation is a displacement of the gel-like inner core of the intervertebral disc, called the nucleus pulposus, through its external membrane (annulus fibrosus) due to wear and tear, aging or sudden injury. As a result of this displacement, the disc presses on the spinal nerve, often producing pain. 1,2 About SI-6603 SI-6603, which contains condoliase as its active pharmaceutical ingredient, is an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation via a single, direct intradiscal injection. SI-6603 (condoliase) is designed to reduce nerve root compression and thereby the radicular leg pain. SI-6603 was developed by Seikagaku. Marketing approval for SI-6603 in Japan was obtained from the Japanese Ministry of Health, Labour and Welfare in March 2018 and SI-6603 has been marketed in Japan only as HERNICORE ® 1.25 units for intradiscal injection through Seikagaku's Japanese sales partner Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan) since August 1, 2018. 3 Alliance with Seikagaku Seikagaku and Ferring entered into a license agreement for SI-6603 in August 2016. Ferring plans to commercialize the product in the United States upon FDA approval and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees. For more information, please visit www.ferringusa.com , call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn and X (Twitter) . References: Vialle LR, Vialle EN, Suárez Henao JE, Giraldo G. Lumbar Disc Herniation. Rev Bras Ortop . 2015 Nov 16;45(1):17-22. doi: 10.1016/S2255-4971(15)30211-1. PMID: 27019834; PMCID: PMC4799068. Herniated Disk in the Lower Back. OrthoInfo. American Academy of Orthopaedic Surgeons. Available at: https://orthoinfo.aaos.org/en/diseases–conditions/herniated-disk-in-the-lower-back/ . Accessed May 23, 2023. Press Release. Seikagaku and Kaken Announce the Launch of HERNICORE ® 1.25 Units for Intradiscal Injection in Japan. July 31,2018. Available at: https://www.seikagaku.co.jp/en/news/news-6617037418084939174/main/0/link/20180731-e.pdf . Accessed May 24, 2023.