Latest news with #biologics
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2 days ago
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AbCellera Biologics Secures Patent Validity Affirmation for Microfluidic Cell Culture Technology
AbCellera Biologics Inc. (NASDAQ:ABCL) is one of the best Canadian stocks with huge upside potential. Earlier in May, AbCellera Biologics announced that the US Court of Appeals for the Federal Circuit/CAFC issued a Rule 36 Order, which affirmed the validity of its US Patent No. 10,087,408 ('the '408 Patent'). The patent specifically covers microfluidic devices and their application in culturing and selectively recovering cells. Previously, Bruker Cellular Analysis Inc., which is a subsidiary of Bruker Corporation (NASDAQ:BRKR), had challenged the claims of the '408 Patent. Bruker argued for the patent's invalidity based on allegations of anticipation and obviousness in light of prior art. However, the US Patent Trial and Appeal Board/PTAB rejected all of Bruker's arguments. The CAFC's recent decision further confirms the validity of all claims within AbCellera's '408 Patent. A research team analyzing data on a computer screen, uncovering details about the antibody discovery platform. The 408 Patent is an integral part of ongoing multi-patent infringement litigation between AbCellera and Bruker, which is currently pending in the US District Court for the Northern District of California. AbCellera intends to continue defending its intellectual property portfolio and looks forward to proving its infringement case against Bruker in the District Court. AbCellera Biologics Inc. (NASDAQ:ABCL) discovers and develops antibody-based medicines for indications with unmet medical needs in the US. Bruker Corporation (NASDAQ:BRKR) develops, manufactures, and distributes scientific instruments and analytical and diagnostic solutions. While we acknowledge the potential of ABCL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
3 days ago
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AGC Biologics Expands Cell Therapy Development Operations to Asia to Serve Growing Market Need
TOKYO, June 26, 2025--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, will commence cell therapy process development and clinical manufacturing services on July 1, 2025, at AGC Inc.'s Yokohama Technical Center, marking the latest step in the global expansion of the company's Global Cell and Gene Technologies Division. The improved geographical footprint allows AGC Biologics to better serve customers requiring autologous and allogeneic products across all markets, with cell therapy manufacturing now available in three continents (Milan, Italy – Longmont, Colorado, U.S. – Yokohama, Japan). This new site precedes the opening of a new AGC Biologics Yokohama manufacturing facility on schedule to be operational in 2027 with pre-clinical through commercial services for mammalian-based protein biologics, cell therapies, and messenger RNA. The Yokohama location will provide process transfer and manufacturing services for pre-clinical and clinical trials to serve an expanding global cell therapy market. Its core technologies include induced pluripotent stem cells, mesenchymal stem cells, hematopoietic stem cells, and CAR-T cell therapies. AGC Biologics Cell and Gene Technology Center of Excellence in Milan, with its nine product approvals by the EMA and FDA, hundreds of batches manufactured, and 30-year track record, will support and enable the successful ramp up of operation in the new Yokohama site. "In a cell and gene therapy market of high volatility and witnessing consolidation of CDMOs, AGC Biologics is among the few experiencing significant growth and success. We are now building on this success to complete the vision of having a truly global offering," said Luca Alberici, Executive Vice President of Global Cell and Gene Technologies at AGC Biologics. "Now Asian developers can benefit from having a local supply within one of the best global infrastructures on the market for cell therapy. Moreover, customers can continue to leverage the offering of viral vector central supply in our Milan facility, which supplies around a third of the ex vivo gene therapy product approved for commercialization. AGC Biologics, through its proprietary ProntoLVV and BravoAAV platforms, aims to offer viral vectors at a sustainable cost for its clients targeting less than 1,000€ per CAR-T patient." "Our team of friendly experts in Milan have a strong reputation for collaboration and working side-by-side with customers to achieve clinical, late-phase, and commercial successes," said Jun Takami, Senior Vice President and General Manager, Japan Region and Yokohama Facility. "As part of this next major phase for cell therapy in the region, our Yokohama team is ready to support partners in accelerating drug development timelines while maintaining the highest quality standards in the industry." AGC Biologics is a part of AGC Inc.'s Life Science Company. The Life Science company operates over 10 facilities worldwide focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. The AGC Inc. Yokohama Technical Center, built in 2020, is dedicated to advancing AGC Inc.'s research and development capabilities in materials science, chemical processes, and biotechnology. Please visit to learn more about AGC Biologics' global network of services for protein biologics and cell and gene therapies. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. View source version on Contacts AGC Inc. Corporate contact:info-pr@ AGC Biologics Media Contact:Kati Sillsksills@ +1 (425) 652-1182 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
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FDA Regulatory Compliance for Drug and Biotech Products - 2 Day Virtual Training Course, July 16-17, 2025: Enhance Compliance Skills with Expert-Led Training and Resources
Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act and GMP regulations in drug manufacturing and testing. Attendees receive presentation slides, a participation certificate, a Q&A session, and free compliance handouts. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Products (ONLINE EVENT: July 16-17, 2025)" training has been added to offering. Enhance your knowledge of Regulatory Compliance with this specialized live seminar focused on the essential practices mandated by the Federal Food, Drug, and Cosmetic Act. Dive into the practical applications necessary for ensuring adherence to FDA regulations in biologics and drug development, a critical component for both sponsors and regulatory agencies. This seminar offers an insightful exploration of the graded approach in compliance, vital for pharmaceutical and biotechnology companies striving to meet Good Manufacturing Practice (GMP) regulations effectively. This includes the meticulous management needed in manufacturing, testing, and controlling clinical supplies, as well as overseeing commercial product outputs. This live training Seminar includes the following for each registered attendee: A copy of the presentation slides by download A certificate of participation for attendee training records Q/A Session Free Handouts on FDA Regulatory Compliance This course will benefit professionals involved in working with pharmaceutical and Biotech products and management involved in drug development and FDA Regulatory Compliance: QA/QC analytical chemists QA/QC directors, managers Investigators in QA/QC Manufacturing/Production Research and Development Project management Manufacturing personnel CROs analysts Technical liaison Regulatory affairs personnel CMC specialists Senior quality managers Quality professionals Regulatory professionals Compliance professionals Quality auditors Document control specialists New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. Course Agenda: Day 1 FDA and its Statutory and Regulatory Requirements FDA's Structure and Purpose The Federal Food, Drug and Cosmetic Act The Code of Federal Regulations Guidane, Policy Documents and Compliance Manuals The Evolution of FDA Law Brief Overview: The Products FDA Regulates and Their Pathways to Market Drugs Medical Devices Food & Dietary Supplements Cosmetics Tobacco Veterinary Products Universal Requirements Establishment Registration, Product Listing, User Fees, etc. FDA Drug Development and Approval Process Considerations Statutory and Regulatory Provisions Citizen Petitions Approvals and Clearances The Drug IND, NDA, ANDA and Orphan Designation Biologic's BLA Medical Device 510(k) and PMA Combination Products Veterinary INAD, NADA, ANADA, MUMS FDA Drug Approval Process Case Study # 1: Suitability Petitions Case Study #2: Paragraph IV Certification Post Approval Submissions QbD product development and design Key elements of IND, NDA/ANDA applications and FDA expectations Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway) Post approval changes to process, methods etc. Regulatory Filings Risk analysis Statutory and Regulatory Compliance The Concepts of "Adulteration" and "Misbranding" Identifying Non-Compliance Product Label and Labeling The Internet Approval and Clearance Facility Inspections Adverse Events Recalls Trade Complaints and Anonymous Tips FDA's Compliance Options, Historical Case Examples & FDA's Website Form 483s Untitled Letters Warning Letters Import Alerts Seizures Recalls Consent Decrees Temporary and Permanent Injunctions Civil and Criminal Prosecution The Park Doctrine Other Compliance Bodies DOJ, FTC, EPA, the States, NAD Management's Role and Responsibilities in Compliance Communication, Implementation and Decision Making Quality Policy and Resourcing Personnel Training Escalation of issues to upper management Corrective and Preventive Actions (CAPA) Gap Analysis Facility Audits and Inspections Internal Company Audits Training the Employees Use of Third-Party Auditors Auditor qualifications understanding Learn Key critical audit areas Internal auditing procedures and schedule Supplier and Customer Audits FDA Inspections Foreign Inspections The FDA Form 483 Strategies for Successfully Responding to a Form 483 including Inspection Observations and Violations The Written Response Communication with FDA Disagreements with Form 483 Observations When the Form 483 Becomes a Warning Letter Course Agenda Day 2 Manufacturing and Quality Controls for Drug Products Management's Role and Involvement Complying with Good Manufacturing Practices "cGMPs" Laboratory Quality Controls Standard Operating Procedures What Makes a Good SOP How to Write an Adequate SOP Strategies for Drafting Recalls and Market Withdrawals FDA Jurisdiction and Authority Stock Rotations Corrections Market Withdrawals Recalls Recall Classifications How to Conduct a Product Recall Customer Communication FDA Communication Documentation Strategies for Mitigating the Chances of a Recall Pharmacovigilance Definitions of Significant and Serious Adverse Events Recording, Investigating and Reporting Complaints FDA Communication Strategies for Dealing with Complaints Customs, Detentions and Import Alerts The Process Holds and Detentions Seizure and Destruction Remediating The Import Alert Rx Drug Promotion and Advertising Risk Considerations "Fair Balance" Elements & Considerations Brief Summary Boxed Warning Important Safety Information False and Misleading Claims Fair Balance Superiority Claims Testimonials Market Research Quality of Life Data Other Considerations Enforcement Action Examples Emerging Compliance Trends Counterfeit drug issues and growing concerns Drug shortage crisis Biosimilar approval pathways Others Other Compliance Issues Questions & Answers and Closing Thoughts For more information about this training visit About 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. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ 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
Yahoo
5 days ago
- Business
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Biosimilars Market Outlook, Growth Trends, Regulatory Landscape and Opportunities 2025–2034
Luton, Bedfordshire, United Kingdom, June 23, 2025 (GLOBE NEWSWIRE) -- Biosimilars Market Report: 2024–2025 Overview Foreword Biosimilars have emerged as a powerful tool in the global healthcare arsenal, delivering cost-effective alternatives to high-priced biologics and expanding patient access. As policymakers, payers, providers, and manufacturers align incentives around value, biosimilars are reshaping therapeutic landscapes and fueling generics-style competition in biologics. Download PDF Brochure: The biosimilars market is anticipated to reach a valuation of approximately $25 billion in 2024, driven by increasing demand for cost-effective biologic therapies and a growing prevalence of chronic diseases. The market is projected to expand significantly, with an estimated value of $60 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of around 9% during the forecast period from 2025 to 2034. Segmentation By Product, Indication, and Region. BY PRODUCT Monoclonal Antibodies Infliximab Trastuzumab Rituximab Adalimumab Other Insulin Granulocyte Colony-Stimulating Factor Erythropoietin Recombinant Human Growth Hormone Etanercept Follitropin Teriparatide Interferons Enoxaparin Sodium Glucagon Calcitonin BY INDICATION Oncology Inflammatory & Autoimmune Disorders Chronic Diseases Blood Disorders Growth Hormone Deficiency Infectious Diseases Others BY REGION North America Europe Asia Pacific South America Middle East and Africa As one health policy expert remarked during a POLITICO Focus roundtable: > 'Experts explored the pivotal role that biosimilars play in strengthening the nation's health care system…' Scientific and regulatory leaders also emphasize mitigating biases and reinforcing confidence. Professor Schellekens notes: > 'Biosimilars often have even a higher quality than the reference products.' Additional insights from industry leaders underline the ongoing transformation: - Sarah Yim (FDA): 'Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.' - Adam Fein (Drug Channels): 'For 2025, the three largest pharmacy benefit managers… have again each excluded hundreds of drugs from their standard formularies… creating an increasingly confusing and crowded biosimilar marketplace.' - Alex Brill (Matrix Global Advisors): 'Is the biosimilar market a failure with respect to these pharmacy benefit drugs like Humira? Maybe in March it was, but in April it's starting to look functional again.' - Jon Martin (Organon): 'That's what gives us some optimism,' referring to expectations that biosimilars can gain ~50% share over time, as seen with Remicade. - AMCP 2025 Reports: 'High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US.' - Sandoz Spokesperson: 'Misaligned incentives across the US healthcare system have led to meaningful delays and barriers to biosimilar adoption, resulting in significant missed opportunities for healthcare savings.' Browse full Report - Market Size & Segmentation Global Valuation & Growth: USD 18.65 billion (2024), rising to 21.95 billion in 2025. Estimated CAGR: 17.7% to USD 42.16 billion by 2029. Other projections suggest growth from USD 40.4 billion (2025) to USD 176 billion by 2034 at 17.8% CAGR. Segmentation: By Therapeutic Area: Oncology, autoimmune diseases, metabolic disorders. By Molecule Type: Monoclonal antibodies, G-CSF, insulin, epoetins. By Application: Chronic and acute care. By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa. Key Players Established Leaders: Amgen, Novartis/Sandoz, Samsung Bioepis, Pfizer, Celltrion, Biogen, Coherus, Merck & Co., Dr. Reddy's, Biocon, Intas. Emerging Names: CVS/Cordavis, Alvotech, Kashiv BioSciences, Fresenius Kabi. Key Market Events (2024–2025) FDA Approvals: Over 60 biosimilars approved in the U.S. as of late 2024. Ustekinumab Biosimilars Launch: Products like Wezlana, Pyzchiva, and Imuldosa began sales in Q1 2025. CVS Cordavis x Sandoz: Hyrimoz launched as a private-label biosimilar for Humira in the U.S. (Apr 2024). Humira Dynamics: Despite biosimilar competition, Humira retained over 80% U.S. market share in 2024 due to PBM rebates. India Rule Overhaul: Indian regulators revised biosimilar manufacturing and quality frameworks (May 2025). Recent Company Developments: Adalimumab Biosimilars (2024–2025) 1. Amgen – Amjevita Key 2025 Development: Listed as a preferred biosimilar on the Optum Rx formulary, which is one of the largest pharmacy benefit managers (PBMs) in the U.S. This significantly improves market access. Real-World Evidence (RWE): Amgen has emphasized clinical performance data and safety outcomes to support payer decisions. The strong RWE backing is helping Amjevita remain competitive despite the influx of newer biosimilars. Market Insight: Despite being the first biosimilar launched in the U.S. (January 2023), initial uptake was slow due to high WAC pricing. However, Amgen's subsequent pricing strategies and improved payer contracts have revitalized adoption. 2. Boehringer Ingelheim – Cyltezo Milestone Achievement: Cyltezo remains the only FDA-approved interchangeable biosimilar to Humira that is available in both high- and low-concentration formulations. Market Differentiation: Interchangeability status is a key competitive edge as it allows automatic substitution at the pharmacy level (subject to state laws), improving prescription volume. Strategic Positioning: Being early to achieve interchangeability has helped Boehringer establish trust among prescribers and pharmacists, especially in rheumatology and gastroenterology. 3. Sandoz – Hyrimoz Recent Development: Though initially launched with multiple dosage strengths (including citrate-free and high-concentration options), Hyrimoz faced formulary exclusion in 2025 from several key PBMs. Market Impact: This exclusion impacted Sandoz's market share, pushing the company to focus on institutional sales and non-PBM-aligned providers. Commercial Focus: Sandoz is working on reinforcing relationships with IDNs (Integrated Delivery Networks) and specialty clinics to maintain uptake. 4. Coherus BioSciences – Yusimry Remarkable Market Share: By early 2025, Yusimry had captured ~33% of the rheumatology market, becoming a major player. Cost Leadership Strategy: Coherus pursued an aggressive low-cost model, offering Yusimry at a 70–85% discount to branded Humira. Retail Success: Coherus partnered with Mark Cuban's Cost Plus Drug Company, making Yusimry directly accessible to consumers at discounted prices, thereby bypassing traditional PBMs. 5. Biocon Biologics / Viatris (Mylan) – Hulio Key Update: In June 2025, Hulio received FDA interchangeability designation, allowing it to be substituted for Humira at the pharmacy level. Competitive Edge: This places Hulio in a more favorable reimbursement tier, potentially improving market access in the latter half of 2025. Partnership Model: Now solely marketed by Biocon (after acquiring Viatris' biosimilar business), Hulio's commercialization is focused on cost competitiveness and institutional penetration. 6. Pfizer – Abrilada Launch Recap: Though approved earlier, Pfizer launched Abrilada in late 2023. By 2024–2025, it secured strong placement in major PBM formularies, including CVS Caremark. Advantages: Abrilada benefits from Pfizer's established distribution network and payer negotiation strength. Clinical Support: Pfizer's robust clinical trial data and real-world validation helped in promoting Abrilada among conservative prescribers. 7. Organon / Samsung Bioepis – Hadlima Dosing Options: Hadlima is unique in offering multiple administration options, including autoinjectors and prefilled syringes with both high- and low-concentration versions. Evolving Formulary Position: While not the first-mover, Hadlima is gradually gaining access across PBMs and health systems by undercutting competitors on pricing and offering flexibility in administration. Target Market: Focused on dermatology and GI segments due to its versatility and delivery mechanisms. 8. Celltrion – Yuflyma High-Concentration Formulation: One of the few biosimilars that mimic the high-concentration, citrate-free version of Humira, preferred by many patients due to reduced injection volume and discomfort. Interchangeability Status: Expected by late 2024, this could significantly enhance Yuflyma's market access through automatic substitution pathways. Commercial Strength: Celltrion's U.S. entry has been backed by a direct sales force and aggressive discounting. 9. Fresenius Kabi – Idacio Institutional Play: Idacio is marketed primarily in low-concentration injectable form, making it attractive for hospital and outpatient clinic use. Strategic Niche: Rather than competing head-on in retail, Fresenius is targeting group purchasing organizations (GPOs) and long-term care facilities. Moderate Uptake: While slower in market penetration, its institutional strategy is ensuring a steady adoption curve. 10. Alvotech – Simlandi Key Approval: In February 2024, Alvotech's Simlandi became the first high-concentration Humira biosimilar to gain FDA approval with interchangeability. Significance: This combination (high concentration + interchangeability) makes Simlandi a major competitive threat to both Amjevita and Yuflyma. Commercial Expansion: Alvotech is partnering with Teva for U.S. commercialization and focusing on payer contracts and formulary inclusion throughout 2025. Buy Now: Key Funding Deals (2024–2025) Biocon Biologics: Continued global expansion and investment. Bio-RIDE Scheme (India): $1.2B biotech initiative supporting biosimilar development. Cloudsek (APAC threat analytics): $19M funding round relevant to regulatory compliance and digital oversight. Government Initiatives & Regulations U.S. FDA Biosimilars Action Plan: Ongoing efforts to improve biosimilar approvals, labeling, and interchangeability. BPCI Act: Continues to guide abbreviated regulatory pathway for biosimilar market entry. Bio-RIDE Scheme (India): Supporting local biotech infrastructure and biosimilar manufacturing. EU and UK Regulatory Expansion: EU's centralized procedure and NHS guidance help drive biosimilar uptake. Most Sold Biosimilars by Region USA: - High-volume products: Filgrastim (Zarxio), Pegfilgrastim, Rituximab, Bevacizumab, Infliximab, Ranibizumab. - 2024 Adoption Trend: Humira biosimilars like Amjevita, Hyrimoz, Cyltezo, Simlandi began capturing 20%+ share. Europe: - Dominant biosimilars: Adalimumab (Amgevita, Hulio), Infliximab (Remsima, Inflectra), Etanercept (Benepali), Aflibercept, Ustekinumab. APAC: - Top products: Truxima, Remsima, Herzuma (Infliximab biosimilars); Yuflyma, Cadalimab (Adalimumab). - Usage Drivers: Broad use in India, China, South Korea; strong domestic production. LATAM: - Common imports: Remsima, Amgevita, Benepali. - Adoption via: Public tenders in Brazil, Mexico, and Argentina. Volume-Based Rankings & Sales Figures USA: - Filgrastim: ~88% volume share. - Pegfilgrastim: ~82% share. - Rituximab: ~76% share. - Bevacizumab: ~64% share. - Infliximab: ~49% share. - Ranibizumab: ~42–51% share. - Humira Biosimilars: USD 1.54B in 2025, forecast to USD 7.7B by 2032 (26% CAGR). EU: - IQVIA estimate: ~30–37% of total biologic volume from biosimilars. APAC: - Regional Revenue: USD 8.43B (2023), forecast to USD 46B by 2033. LATAM: - Limited data: Highest volume for infliximab, adalimumab via EU imports. The biosimilars market is rapidly advancing toward USD 90–176 billion by 2034, propelled by patent cliffs (e.g., Humira, Stelara), policy reforms, payer cost pressures, and improved trust in biosimilar interchangeability. As stakeholders navigate volume penetration, pricing battles, and rebate challenges, success will rely on clear clinical guidance, supply chain localization, and educational outreach. This report compiles key data for manufacturers, investors, regulators, and health systems to strategize entry, pricing, policy, and growth in biosimilars across therapeutic classes and global markets. Request Sample Pages: More Research Finding – Golimumab Simponi Market The global market for Golimumab (Simponi) is valued at approximately $3.5 billion, driven by increasing prevalence of autoimmune diseases such as rheumatoid arthritis, ulcerative colitis, and psoriasis. The market is projected to reach $5.2 billion by 2034, reflecting a robust demand for biologics in immunotherapy. Ranibizumab Market The global Ranibizumab market is projected to reach a value of approximately $10.5 billion in 2024, driven by increasing prevalence of retinal diseases such as age-related macular degeneration (AMD) and diabetic retinopathy. During the forecast period from 2025 to 2034, the market is expected to grow significantly, with a projected value of around $16.2 billion by 2034, translating to a Compound Annual Growth Rate (CAGR) of 4.5%. Aflibercept Biosimilars Market The global market for Aflibercept biosimilars is valued at approximately $1.2 billion, reflecting a surge in demand driven by increasing prevalence of retinal diseases and rising healthcare costs associated with novel therapies. The market is projected to reach around $4.6 billion by 2034, demonstrating robust expansion in a landscape characterized by an influx of biosimilar entrants and heightened competition within the pharmaceutical sector. Procarbazine Market The global procarbazine market is estimated to hold a value of approximately $120 million in 2024, driven by its critical application in treating various types of cancer, including Hodgkin's lymphoma. As awareness of cancer treatment advancements rises and with ongoing clinical trials exploring new applications, the market is projected to reach around $180 million by 2034. This growth reflects a Compound Annual Growth Rate (CAGR) of about 4.3% during the forecast period from 2025 to 2034. U.S. Generic Injectables Market The U.S. generic injectables market is estimated to reach a value of approximately $55 billion in 2024, buoyed by the increasing demand for cost-effective alternatives to brand-name drugs and a growing prevalence of chronic diseases. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of around 7% from 2025 to 2034. Understanding Growth Hormone Deficiency Market The global growth hormone deficiency (GHD) market is valued at approximately $4.8 billion, driven by increasing prevalence rates, advances in recombinant human growth hormone therapies, and greater awareness of GHD among healthcare professionals. The market is expected to grow significantly, achieving a projected value of $7.2 billion by 2034, indicating a robust expansion trajectory. Insulin Biosimilars Market The global insulin biosimilars market is valued at approximately $5.8 billion in 2024, driven by an increasing prevalence of diabetes and the rising demand for cost-effective therapeutic options. The market is projected to grow to around $13.2 billion by 2034, representing a robust Compound Annual Growth Rate (CAGR) of 8.5% during the forecast period from 2025 to 2034. Human Insulin Market The human insulin market is expected to grow at 6.14 % CAGR from 2021 to 2029. It is expected to reach above USD 40.45 Billion by 2029 from USD 23.05 Billion in 2020. Bioprocess Technology Market The bioprocess technology market is expected to grow at 15.2% CAGR from 2022 to 2029. It is expected to reach above USD 61805.63 million by 2029 from USD17296.4 million in 2022. Autoimmune Monoclonal Antibodies Market The market for autoimmune monoclonal antibodies is currently valued at approximately $160 billion in 2024, driven by increasing prevalence of autoimmune diseases and advancements in biopharmaceutical technology. The demand for targeted therapies is expected to fuel a robust growth trajectory, with a projected market value of $290 billion by 2034. This growth reflects a Compound Annual Growth Rate (CAGR) of around 6.3% during the forecast period from 2025 to 2034. Recombinant Insulin Analogue Market The recombinant insulin analogue market is poised for significant growth, currently valued at approximately $24.5 billion in 2024. This market is projected to reach around $45 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period of 2025–2034. Lymphopenia Therapeutics Market The global lymphopenia therapeutics market is valued at approximately $3.2 billion, driven by increasing awareness of immune disorders and advancements in biologics and immunotherapies. The market is projected to grow significantly, reaching an estimated $6.8 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of around 8.1% during the forecast period of 2025 to 2034. Demyelinating Diseases Therapeutics Market The global market for demyelinating diseases therapeutics is valued at approximately $25 billion in 2024, with projections indicating substantial growth, reaching an estimated $45 billion by 2034. This reflects a robust Compound Annual Growth Rate (CAGR) of around 6.3% during the forecast period from 2025 to 2034. SOX2 Antibody Market The global SOX2 antibody market is valued at approximately $250 million in 2024 and is projected to reach around $450 million by 2034. This indicates a robust growth trajectory, with a compound annual growth rate (CAGR) of about 6.5% during the forecast period from 2025 to 2034. VDAC1 Antibody Market The VDAC1 antibody market is poised for significant growth, anticipated to reach a value of approximately $220 million in 2024. Projections suggest that the market could expand to around $480 million by 2034, reflecting the increasing prevalence of chronic diseases and the rising demand for targeted therapies. This trajectory indicates a Compound Annual Growth Rate (CAGR) of about 8.1% during the period from 2025 to 2034. Anti-Olig2 Antibody Market The global market for Anti-Olig2 antibodies is estimated to reach approximately $150 million in 2024, driven by increasing research activities in neurodegenerative diseases and developments in cancer immunotherapy. During the forecast period from 2025 to 2034, the market is projected to grow at a compound annual growth rate (CAGR) of 6.5%, potentially reaching around $325 million by 2034. CONTACT: Irfan Tamboli (Head of Sales) Phone: + 1704 266 3234 Email: sales@
Yahoo
20-06-2025
- Business
- Yahoo
5 Insightful Analyst Questions From West Pharmaceutical Services's Q1 Earnings Call
West Pharmaceutical Services' first quarter results drew a negative market response, despite the company surpassing Wall Street's revenue and non-GAAP profit expectations. Management attributed the flat year-over-year sales to continued destocking in biologics components and a shift in demand to specific manufacturing sites, creating short-term supply constraints. CEO Eric Green highlighted that 'solid contributions from GLP-1s and a reduced impact from industry-wide destocking' were positive factors, but also pointed to ongoing mix challenges. Outgoing CFO Bernard Birkett noted improved operating efficiencies and cost controls, partially offsetting the effects of changes in product and segment mix. Is now the time to buy WST? Find out in our full research report (it's free). Revenue: $698 million vs analyst estimates of $684.5 million (flat year on year, 2% beat) Adjusted EPS: $1.45 vs analyst estimates of $1.23 (18.1% beat) Adjusted EBITDA: $165 million vs analyst estimates of $150.6 million (23.6% margin, 9.6% beat) The company lifted its revenue guidance for the full year to $2.96 billion at the midpoint from $2.89 billion, a 2.4% increase Management raised its full-year Adjusted EPS guidance to $6.25 at the midpoint, a 2.5% increase Operating Margin: 15.3%, down from 17.7% in the same quarter last year Market Capitalization: $15.66 billion While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Paul Knight (KeyBanc): asked about utilization rates at the new Dublin site and margin improvements. CEO Eric Green explained utilization is low but ramping, and Birkett attributed margin gains to operational efficiencies and lighter SG&A spending. Larry Solow (CJS Securities): questioned the drivers behind softer high-value product growth and the impact of government spending reductions. Birkett noted supply constraints and slightly weaker pricing, while Green said no macroeconomic or policy changes have significantly affected demand. Justin Bowers (Deutsche Bank): inquired whether increased demand would spill into 2026 and how tariffs impact sourcing. Green confirmed some demand could shift to next year, and Birkett said tariffs affect both components and finished goods, with mitigation efforts ongoing. David Windley (Jefferies): asked about margin offsets from product mix and the economics of AnnexOne, as well as leadership transitions. Birkett said efficiencies and AnnexOne upgrades help margins, and Green described management changes as a natural evolution. Patrick Donnelly (Citi): focused on the high-value component ramp and tariff pass-through. Green reported improving order trends and destocking relief, while Birkett said tariff cost offsets are not yet embedded in guidance. Looking ahead, our team will monitor (1) the pace of biologics demand recovery and the trajectory of high-value component orders, (2) progress on efficiency gains and automation, particularly with the SmartDose platform, and (3) management's ability to mitigate tariff headwinds through cost pass-throughs or operational adjustments. Execution on new contract manufacturing wins and expansion in AnnexOne projects will also be critical signposts. West Pharmaceutical Services currently trades at $218.87, in line with $217.68 just before the earnings. Is there an opportunity in the stock?The answer lies in our full research report (it's free). Donald Trump's victory in the 2024 U.S. Presidential Election sent major indices to all-time highs, but stocks have retraced as investors debate the health of the economy and the potential impact of tariffs. While this leaves much uncertainty around 2025, a few companies are poised for long-term gains regardless of the political or macroeconomic climate, like our Top 5 Growth Stocks for this month. This is a curated list of our High Quality stocks that have generated a market-beating return of 183% over the last five years (as of March 31st 2025). Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today.
