Dublin, Feb. 03, 2026 (GLOBE NEWSWIRE) -- The "Pharmaceutical Contract Development and Manufacturing Organization (CDMO) - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" report has been added to ResearchAndMarkets.com's offering.The Pharmaceutical contract development and manufacturing organization (CDMO) market is expected to grow from USD 258.88 billion in 2025 to USD 275.27 billion in 2026 and is forecast to reach USD 374.68 billion by 2031 at 6.33% CAGR over 2026-203 ...

Core Insights - Catalent, Inc. has unveiled a new corporate brand that emphasizes its commitment to customer service and supporting important missions in healthcare [1][2] - The rebranding comes after Catalent's transition to private ownership under Novo Holdings in December 2024, and coincides with the establishment of its new global headquarters in Tampa, Florida [2] Company Strategy - The new branding reflects Catalent's dedication to putting patients first and providing tailored solutions with exceptional service [3] - The company aims to align its identity with the unique experiences that differentiate it in the market [3] Operational Highlights - Catalent has supported the development and manufacture of products that account for half of all FDA approvals over the past decade [3] - The company produces over 60 billion doses annually and manages over 1,000 active development programs at any given time [3] - Catalent collaborates with a diverse range of customers, from small organizations to large global companies, adapting its approach to meet specific program needs [3]

Core Insights - Catalent, Inc. has launched a new corporate brand that signifies a strategic evolution in its operations [1] - The rebranding emphasizes the company's commitment to exceptional customer service and supporting important missions in the pharmaceutical, biotech, and consumer health sectors [1] - The new approach aims to assist clients in delivering life-enhancing and life-changing solutions [1] Company Focus - The rebranding reflects Catalent's dedication to its customers in the pharmaceutical and biotech industries [1] - The company positions itself as a champion for its clients' missions, indicating a strong focus on partnership and collaboration [1] - Catalent aims to enhance its service offerings to better meet the needs of its customers [1]

Core Insights - Lisata Therapeutics Inc has entered a collaboration with Catalent to leverage its lead molecule, certepetide, across various cancer types and treatment modalities [1] Revenue Potential - The Catalent deal is described as having "unlimited revenue potential," particularly in the rapidly growing antibody-drug conjugate (ADC) class in oncology [2] - Major players in the industry are actively developing ADCs and seeking ways to enhance their efficacy [2] Partnership Details - The arrangement with Catalent is non-exclusive, allowing Lisata to partner with other companies in the ADC space [3] - This partnership introduces a new therapeutic modality, as certepetide has not been tested specifically with ADCs prior to this collaboration [4] Validation of Technology - The collaboration marks the first instance of a third party using a certepetide-related molecule conjugated to another molecule, validating the hypothesis of co-administration or conjugation benefits [5] Strategic Vision - The strategic vision for certepetide is to exploit its broad applicability across various cancers and treatment modalities, primarily through partnerships [6] - Collaborating with a well-established company like Catalent is seen as a significant advancement for Lisata, which recognizes its limitations as a small company [7] Future Partnerships - Lisata is actively seeking additional partnerships to further exploit the applicability of certepetide and is open to evaluating different transaction types [8]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The news team covers key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2][3] Group 2 - The team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4][5] - All content published by Proactive is edited and authored by humans, ensuring adherence to best practices in content production and search engine optimization [5]

Core Viewpoint - The U.S. FDA issued a Complete Response Letter (CRL) for Scholar Rock's apitegromab Biologics License Application (BLA) due to observations from a routine inspection of Catalent Indiana LLC, which is not specific to the drug itself [1][2]. Group 1: FDA Response and Observations - The CRL did not raise any concerns regarding the efficacy and safety data of apitegromab or the third-party drug substance manufacturer [2]. - Catalent Indiana submitted a comprehensive response to the FDA's observations in early August 2025 and is actively working on corrective actions [4]. - Scholar Rock plans to resubmit the apitegromab BLA following Catalent Indiana's remediation of the FDA observations [4]. Group 2: Market Authorization and Future Plans - Outside the U.S., the apitegromab marketing authorization application (MAA) is under review by the European Medicines Agency, with a decision expected by mid-2026 [5]. - The European launch of apitegromab is anticipated in the second half of 2026, with Germany expected to be the first market for patient access [5]. Group 3: Related Industry Developments - Regeneron Pharmaceuticals anticipates delays in regulatory approvals for its EYLEA HD applications due to observations from an FDA inspection at Catalent Indiana, which also affects Scholar Rock [6]. - Scholar Rock's stock price increased by 1.24% to $32.99 following the news [7].

Market Overview - The Asia-Pacific Pharmaceutical Contract Manufacturing Organization (CMO) Market is projected to grow from an estimated USD 59.97 billion in 2025 to USD 91.18 billion by 2030, reflecting a compound annual growth rate (CAGR) of 8.74% [2] - The market landscape is highly fragmented, with large pharmaceutical firms increasingly outsourcing production to CMOs for cost efficiency and expertise [6] Regional Insights - China's competitive advantage in the CMO market is attributed to low labor costs, tax incentives, and favorable currency valuation, which help reduce manufacturing expenses [3] - India is attracting Japanese pharmaceutical investments through favorable foreign direct investment policies, enhancing its domestic manufacturing landscape [8] - Japan's CMO sector has experienced a 30% growth due to regulatory changes that separate manufacturing from sales [8] - Australia faces challenges due to pricing and reimbursement volatility but benefits from its geographical proximity to South Asian markets [8] Market Dynamics - The demand for injectable drugs, particularly for rapid-acting oncology treatments, presents significant growth opportunities within the market [8] - Prolific late-stage clinical trials, especially in cancer therapies, are expected to drive market growth, with anti-cancer drugs making up nearly half of the developmental pipeline [8] - Outsourcing of biologic formulations to CMOs is common as major pharmaceutical companies focus on discovering and developing new drug modalities [8] Industry Developments - Recent expansions by companies such as Jubilant Biosys in India and Boehringer's capacity increase in China highlight strategic collaborations aimed at enhancing market share [6] - New policies in India allowing certain drug studies without late-stage clinical trials lead to considerable cost savings, further strengthening its appeal for pharmaceutical production [8] Challenges - The COVID-19 pandemic has disrupted global supply chains, necessitating strategic responses to inventory management, particularly as China is a key supplier of essential raw materials [8] - Increasing lead times and logistics costs, along with stringent regulatory requirements, pose challenges for the CMO market [14]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive has bureaus and studios in key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Group 2 - The company is focused on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4] - Automation and software tools, including generative AI, are used, but all content is edited and authored by humans [5]

Core Viewpoint - Catalent, Inc. reported a first-quarter fiscal 2025 adjusted loss per share of 13 cents, which was wider than the Zacks Consensus Estimate of a loss of 11 cents per share, although the GAAP loss per share improved significantly from the previous year [1][6]. Revenue Performance - Total revenues for the quarter reached $1.02 billion, reflecting a year-over-year increase of 4.2%, but fell short of the Zacks Consensus Estimate by 5.3% [2]. - Excluding COVID-related revenues, net revenues increased by 13% year over year, driven by growth in the Biologics and Pharma and Consumer Health segments [3]. - The Biologics segment reported revenues of $461 million, up 2.9% year over year, while the PCH segment saw revenues of $563 million, an increase of 5.4% [4]. Geographic Performance - Revenue from the United States was $658 million, a 2% increase year over year, while Europe experienced a significant growth of 20.8% to $331 million. However, revenues from the Other region declined by 22.7% to $68 million [5]. Operational Update - Gross profit rose by 7.1% to $181 million, with gross margin expanding by 48 basis points to 17.7%. However, selling, general, and administrative expenses increased by 22.9% to $252 million, leading to an adjusted operating loss of $71 million [6]. Financial Update - At the end of the first quarter of fiscal 2025, Catalent had cash and cash equivalents of $335 million, up from $289 million at the end of fiscal 2024. Total debt increased slightly to $4.93 billion from $4.91 billion [7]. Guidance - The company will not provide any outlook due to a pending transaction with Novo Holdings [8]. Overall Assessment - Catalent showed solid year-over-year improvement in overall top-line results, with notable revenue growth in both segments and most geographic regions. The strength in Zydis commercial products and gene therapy offerings is a positive indicator, along with gross margin expansion [9]. - However, the lower-than-expected results and declining revenues from the Other region were disappointing, compounded by rising operating costs [10].

Financial Performance - Net revenue for the three months ended September 30, 2024, was $1,023 million, an increase of $38 million or 4% compared to $982 million in the same period of 2023[144]. - Gross margin increased by $11 million or 7%, reaching $181 million, with a gross margin percentage of 17.7% for the three months ended September 30, 2024, compared to 17.2% in the prior year[148]. - The operating loss for the three months ended September 30, 2024, was $67 million, a significant improvement from a loss of $726 million in the same period of 2023, reflecting a 91% decrease in losses[145]. - The company reported a net loss of $129 million for the three months ended September 30, 2024, compared to a net loss of $759 million in the same period of 2023, marking an 83% improvement[145]. - EBITDA from operations for the three months ended September 30, 2024, was $56 million, a significant improvement from a loss of $627 million in the same period of 2023[161]. Revenue Segments - Organic revenue growth for the same period was 4%, driven by increased demand for prescription products and gene therapy offerings[146]. - The Biologics segment net revenue increased by $11 million, or 3%, to $461 million, driven by growth in gene therapy offerings, despite a decline in COVID-19 related programs[162]. - The Pharma and Consumer Health segment net revenue increased by $27 million, or 5%, to $563 million, primarily due to increased revenue from prescription products and demand for Zydis commercial products[164]. Expenses and Costs - Selling, general, and administrative expenses rose by $47 million or 23%, totaling $252 million, primarily due to acquisition costs related to the pending Novo merger[149]. - Other operating expenses increased by $12 million, primarily due to a rise in restructuring charges and fixed-asset impairment charges[152]. - Unallocated costs for the three months ended September 30, 2024, totaled $109 million, a decrease from $777 million in the same period of 2023, reflecting restructuring and special items[159]. Cash Flow and Liquidity - Cash provided by operating activities was $61 million for the three months ended September 30, 2024, compared to cash used in operations of $70 million for the same period in 2023, reflecting a year-over-year change of $131 million[168]. - Cash used in investing activities decreased to $34 million for the three months ended September 30, 2024, from $84 million in the same period of 2023, primarily due to a decrease in acquisition of property and equipment[169]. - The company had $1.09 billion in available borrowing capacity under its revolving credit facility as of September 30, 2024[165]. - The company expects its cash on hand, cash from operations, and available borrowings to be adequate to meet liquidity needs for at least the next 12 months[166]. - As of September 30, 2024, the company held consolidated cash and cash equivalents of $335 million, with foreign subsidiaries holding $277 million[178]. Debt and Interest Rates - The company has $919 million of euro-denominated debt outstanding as of September 30, 2024, which qualifies as a hedge of a net investment in European operations[181]. - The variable portion of the applicable interest rate on $500 million of the U.S. dollar-denominated term loan is effectively fixed at 0.9431% due to the 2023 Rate Swap[180]. - The applicable rate for the U.S. dollar-denominated term loan was LIBOR plus 2.00% as of September 30, 2024, prior to the interest-rate swap agreement[179]. Mergers and Acquisitions - A merger agreement with Novo Holdings was approved by stockholders, with the merger expected to close towards the end of calendar year 2024[136]. - The company announced a definitive agreement to sell its oral solids development and small-scale manufacturing facility in Somerset, New Jersey, expected to close in early 2025[133]. Internal Controls and Risks - The company has identified a material weakness in internal control over financial reporting related to inventory costing and valuation at its Bloomington, Indiana facility[189]. - A comprehensive remediation plan is being developed to address the material weakness, including hiring additional personnel and updating processes[190]. - The company's disclosure controls and procedures were deemed not effective as of September 30, 2024, due to the identified material weakness[187]. - As of September 30, 2024, there has been no material change in the company's quantitative and qualitative disclosures about market risks[185]. - The company maintains no material off-balance sheet arrangements as of September 30, 2024[183]. - The company does not currently use any forward foreign currency exchange contracts but continues to evaluate hedging opportunities for foreign currency in the future[182].