FUJIFILM Holdings Corp.

By August or September of this year, Fujifilm Diosynth's CEO expects “basically half” of the company’s $8 billion in manufacturing investments to be “in operation,” calling 2025 the “biggest year” yet for the CDMO's expansion progress. While Fujifilm Diosynth Biotechnologies isn’t immune to the challenges facing the broader CDMO industry, the company’s long-running expansion journey—and its ability to snare high-profile pharma clients—has blunted many of the pressures met by its peers.Following major progress updates across its manufacturing network late last year, Fujifilm Diosynth’s focus in 2025 will be to get its “first large investments up and running” and to execute a previously disclosed plan to double the size of its biomanufacturing plant in Hillerød, Denmark, Lars Petersen, the CDMO’s president and CEO, said in a recent interview.Since 2011, Fujifilm Diosynth has laid out more than $8 billion in a bid to bulk up its global biomanufacturing network, the company noted in a November press release. That cash has been used to fuel the buildout of multiple modular facilities, with the CDMO placing particular emphasis on the Denmark site and a growing biologics campus in Holly Springs, North Carolina.By August or September of this year, Petersen said he expects “basically half” of the company’s $8 billion in manufacturing investments to be “in operation,” calling 2025 the “biggest year” yet for Fujifilm Diosynth’s expansion progress.The CEO was quick to point out that his company has “several more projects in the making,” as well. Fujifilm Diosynth in early November said that the first phase of its expansion at the Hillerød plant was ready to roll, thanks to the addition of six new mammalian cell bioreactors, for a total of 12 now operating at the site.The next phase of the growth strategy, backed by an investment of $1.6 billion, will bring another eight bioreactors and two downstream processing streams online, the company said last year.Fujifilm expects to kick off fill-finish work at the site by the middle of this year, with plans for the full expansion to be in operation by 2026. All told, the move will grow the site’s footprint to 51,500 square meters (about 554,341 square feet) and create up to 2,200 jobs.As for the Holly Springs facility, where Fujifilm Diosynth laid out an additional $1.2 billion last April, construction is poised to wrap up shortly before summer, Petersen said. The entire facility is slated to open in the fall, he added.In total, the company plans to go from six bioreactors in Holly Springs as of last October to 20 in about a year’s time, essentially tripling its capacity at the site, per Petersen. Fujifilm Diosynth is standing tall among several other CDMOs like Samsung Biologics and Lonza that have managed to buck the downturn the industry suffered following the contracting highs of the COVID-19 pandemic. Petersen acknowledged that slump, attributing it to several years of inflation and interest rate increases, coupled with skittishness on the part of small biotech investors.And while the company’s large-scale business performed “very well” in 2024, the CEO said, “We do, like the rest of the industry, have our struggles in more of the cell therapy area.”In fact, last April, Fujifilm Diosynth said it was restructuring a recently unveiled small-scale business unit after suffering the effects of “short-term impacts of reduced venture capital investment into early-stage research projects.” At the time, the company noted that the issue was particularly pronounced among cell and gene therapy investments.Fujifilm Diosynth is sticking with its cell therapy business, “but it’s, of course, something we need to watch out for,” Petersen said.“I still think, like many others, that this is the future,” the CEO said of the personalized medicine boom, though he added as a caveat that the field currently faces many challenges around issues like cost.Overall, Fujifilm Diosynth has been “more fortunate” than many of its peers amid the industry’s slump, Petersen said, given that it was already undergoing a multiyear journey to increase its large-scale business and capture more big pharma clients.While small biotechs may be struggling, the larger pharma contracting business is in good shape, the CEO added.“My take is that a lot of the large pharma companies, they didn’t want to invest themselves, so they prefer to outsource more,” Petersen said. 

Atara said it has discussed and agreed with the FDA “upon the actions necessary to release the clinical holds”. Image credit: Shutterstock / Lamar Belina. Atara Therapeutics’ pipeline has hit another obstacle after the US Food and Drug Administration (FDA) halted clinical trials evaluating two of the company’s T-cell immunotherapies, after receiving a complete response letter (CRL) last week. The clinical hold by the FDA is on active investigational new drug applications for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) treatment Ebvallo (tabelecleucel), and ATA3219, a candidate for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus. Screening and enrolment of new participants in both programmes have been halted, whilst those who have the potential to gain clinical benefit from the drugs may continue treatment. Shares in the US company were down 4.1% at market open on 21 January following the announcement and closed a further 3.8% lower at market close. Atara has a market cap of $34.8m. Atara stated that the FDA’s decision was based on an inspection of a third-party manufacturing site conducted as part of a pre-licence inspection for Ebvallo. The FDA found there were inadequately addressed good manufacturing practice (GMP) compliance issues at the third-party facility. Whilst ATA3219 drug product is manufactured at a separate facility, the drug was still implicated in the clinical hold because its starting materials are affected by the compliance issues at the same third-party facility. Atara said it has discussed and agreed with the FDA “upon the actions necessary to release the clinical holds”. Atara’s CEO Cokey Nguyen said: “We intend to work closely with the FDA to address these issues as expeditiously as possible. “We are encouraged with ongoing correspondence with the agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programmes.” Atara reassured concerns over its other third-party manufacturer – Fujifilm Diosynth Biotechnologies – whose facility in California is unaffected by the issues which caused the CRL and clinical hold. This site was recently approved by the European Medicines Agency (EMA) to manufacture Ebvallo, which was approved in Europe in December 2022. Atara’s shares also took a hit last week when the FDA rejected the approval of Ebvallo for EBV+ PTLD in the US. Atara reiterated that the CRL was solely due to the issues at the third-party manufacturing site and not related to clinical safety or efficacy. Given as an injection over several 35-day cycles, Ebvallo became the first allogenic T-cell immunotherapy following its European approval. The treatment is forecast to become a blockbuster drug by 2028 and could generate $1.5bn in sales by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology . Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

"AI in clinical and molecular diagnostics uses artificial intelligence to analyze medical data, such as lab tests and genetic information, more quickly and accurately. BCC Research Highlights Explosive Growth in AI-Driven Clinical and Molecular Diagnostics, Projecting Market Expansion from $2.6 Billion in 2024 to $8.9 Billion by 2029 BOSTON, Jan. 9, 2025 /PRNewswire/ -- According to the latest study from BCC Research AI in Clinical and Molecular Diagnostics Market is expected to grow from $2.6 billion in 2024 and is projected to reach $8.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 27.6% during the forecast period of 2024 to 2029. This report provides an overview of the global market for AI in clinical and molecular diagnostics, covering market size, growth trends, and key applications such as medical imaging, genomics, and lab testing. It focuses on the factors driving AI adoption, challenges, and opportunities, along with profiles of leading companies and regional insights. Emerging trends in personalized medicine and telehealth are also discussed, making this report a valuable resource for healthcare providers, tech developers, and policymakers. Interesting and surprising facts: Two Powerful Ways AI is Revolutionizing Healthcare Diagnostics Predicting Disease Before Symptoms Appear AI can analyze your genetic data to identify potential health risks, even before you show any symptoms. This means doctors can take preventive measures to keep you healthy. Unlocking Hidden Insights in Medical Records AI's language processing abilities allow it to read and understand doctor's notes, extracting valuable information that might have been overlooked. This helps doctors make more accurate diagnoses, develop personalized treatment plans and improve patient care. Factors contributing to the growth include: Investment in the AI health sector.: Investment in the AI health sector involves funding AI technologies that help doctors diagnose diseases quicker, and improve treatments and healthcare efficiency. Companies, governments, and organizations are investing more in AI to boost patient care and lower costs. Increasing prevalence of chronic and infectious diseases.: The rising number of chronic diseases (such as diabetes and heart disease) and infectious diseases (such as flu and COVID-19) is putting stress on healthcare systems, creating a greater demand for improved treatments and prevention methods. Introduction of software with AI.: The introduction of AI-powered software means that new programs can learn from data, make decisions, and perform tasks such as analyzing medical images or diagnosing diseases more accurately and efficiently, making processes faster and smarter. Opportunities in developing markets.: Opportunities in developing markets refer to the potential for businesses to grow in countries with expanding economies, especially in sectors such as healthcare and technology. Companies can invest by offering products or services, such as AI in healthcare, to meet growing demand and improve living standards in these regions. Sample Copy of the AI in Clinical and Molecular Diagnostics Market Report Report Synopsis This report addresses the following key questions: What is the projected size and growth rate of the global market for AI in clinical and molecular diagnostics? The market is projected to grow from $2.6 billion in 2024 to $8.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 27.6% during the forecast period. Which market segments are covered in the report? The AI in clinical and molecular diagnostics market is segmented based on type, component, and region. By type, which segment will dominate the market by the end of 2029? By type, molecular diagnostics is expected to contribute the highest share of the market by the end of 2029. Which component is growing fastest? Software is the fastest growing component. Leading companies in the market include: Atomwise Inc. F. Hoffmann-La Roche Ltd. Fujifilm Holdings Corp. GE Healthcare Illumina Inc. Koninklijke Philips N.V. Medtronic Microsoft Corp. Siemens Healthineers AG Thermo Fisher Scientific Inc. Butterfly Network Inc. Enlitic Intel Corp. Merative Nvidia Corp. Qure.Ai Synapsica Healthcare Pvt Ltd. Directly purchase a copy of the report from BCC Research. For further information on these reports or to purchase one, please contact [email protected]. About BCC Research BCC Research market research reports provide objective, unbiased measurement and assessment of market opportunities. Our experienced industry analysts' goal is to help readers make informed business decisions, free of noise and hype. Contact Us Corporate HQ: 50 Milk St. Ste 16, Boston, MA 02109, USA Email: [email protected], Phone: +1 781-489-7301 For media inquiries, email [email protected] or visit our media page for access to our market research library. Any data and analysis extracted from this press release must be accompanied by a statement identifying BCC Research LLC as the source and publisher. Logo: SOURCE BCC Research LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED