Ajinomoto Bio-Pharma Services

DUBLIN--( BUSINESS WIRE )--The "U.S. Small Molecule Innovator API CDMO Market Size, Share & Trends Analysis Report by Stage Type (Preclinical, Clinical, Commercial), Customer Type, Therapeutic Area, Region, and Segment Forecasts, 2024-2030" report has been added to ResearchAndMarkets.com's offering. The U.S. small molecule innovator API CDMO market size is anticipated to reach USD 12.60 billion by 2030 and is projected to grow at a CAGR of 6.17% from 2024 to 2030. A growing outsourcing trend among pharmaceutical companies, increasing demand for small molecule drugs, and surge in clinical trials are anticipated to influence the U.S. market positively. Small molecules continue to play an important role in developing new treatments globally. Specialty medicines are increasingly driving U.S. pharmaceutical growth, particularly in developed markets, with small molecule applications accounting for over half of specialty sales. In addition, enhanced efficiency serves as another pivotal driver for pharmaceutical outsourcing. With mounting pressure on pharmaceutical companies to expedite the introduction of new drugs to the market, outsourcing emerges as a solution to accelerate the drug development process. Leveraging their expertise, experience, and cutting-edge equipment, CDMOs facilitate the swift & efficient production of high-quality drugs, enabling pharmaceutical firms to adhere to their development schedules. The pharmaceutical/biotechnology companies increasingly opt for CDMO services to leverage their expertise. CDMOs offer flexibility & scalability in manufacturing capacity, allowing pharmaceutical companies to adapt to changing market demands and accelerate time to market for new therapies. In addition to providing extended expertise and assisting in improved cash flow management, outsourcing brings significant manufacturing advantages, including reducing investment risks. In the context of early-stage technologies and products, establishing expensive in-house capabilities entails substantial risks across the product development phases. At the same time, outsourcing serves as a risk-averse alternative. The preference for outsourcing small molecule API has grown as an effective strategy until market demand for products becomes well-established and understood. For instance, in May 2022, Piramal Pharma Limited's Pharma Solutions business, a CDMO, inaugurated a new API facility at its site in Aurora, Ontario. This state-of-the-art plant has commenced operations & has completed its initial production runs. U.S. Small Molecule Innovator API CDMO Market Report Highlights Based on stage, the clinical segment led the market with the largest revenue share of 54.79% in 2023. The segment growth can be attributed to the rising clinical trial (Phase I-III) activities, growing small molecule development pipeline, and increasing availability of expertise Based on the customer type, the pharmaceutical segment held the market with the largest revenue share of 91.89% in 2023, attributing to rising funding for drug development is propelling segment growth Based on therapeutic area, the oncology segment accounted for the largest revenue share of 42.05% in 2023. The segment is driven by increasing prevalence of cancer in U.S. In addition, high R&D investments in advanced therapeutics to minimize cancer disease burden are expected to boost segment growth West Group dominated the U.S. market with the largest revenue share of 33.19% in 2023. The presence of various factors, such as increasing prevalence of chronic diseases, demand for APIs & CDMO services and improving healthcare infrastructure is expected to drive market significantly Companies Featured Lonza Group Ltd. Novo Holdings (Catalent, Inc.) Thermo Fisher Scientific, Inc. Siegfried Holding AG Recipharm AB CordenPharma International Samsung Biologics Labcorp Ajinomoto Bio-Pharma Services Piramal Pharma Solutions Jubilant Life Sciences (Jubilant Biosys Limited) WuXi AppTec Co., Ltd. Key Attributes: Report Attribute Details No. of Pages 150 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $8.2 Billion Forecasted Market Value (USD) by 2030 $12.6 Billion Compound Annual Growth Rate 6.1% Regions Covered United States Key Topics Covered: Chapter 1. Methodology and Scope Chapter 2. Executive Summary 2.1. Market Outlook 2.2. Segment Outlook 2.3. Competitive Insights Chapter 3. U.S. Small Molecule Innovator API CDMO Market Variables, Trends & Scope 3.1. Market Lineage Outlook 3.1.1. Parent market outlook 3.1.2. Ancillary Market outlook 3.2. Market Dynamics 3.2.1. Market driver analysis 3.2.1.1. Increasing Demand for Small Molecule Drugs 3.2.1.2. Increasing Outsourcing Trends Among Pharmaceutical Companies 3.2.1.3. Surge in Number of Clinical Trials 3.2.2. Market restraint analysis 3.2.2.1. Compliance Issues While Outsourcing 3.3. Technology Landscape 3.3.1. Integration Of AI in U.S. Small Molecule Innovator API CDMO Market 3.3.1.1. Current Dynamics and Future Trends 3.3.1.1.1. Drug Discovery and Design 3.3.1.1.2. AI-Assisted Drug API Synthesis 3.3.1.1.3. Process Optimization 3.3.1.1.4. Supply Chain Management 3.3.1.1.5. Clinical Trial Optimization 3.3.1.1.6. Regulatory Compliance 3.4. Total Number of Clinical Trials in U.S. (2021-2023) 3.4.1. Total Number of Clinical Trials by Phase (2021-2023) 3.4.2. Total Number of Clinical Trials by Therapeutic Area (2021-2023) 3.5. U.S. Small Molecule Innovator API CDMO Market: Regulatory Scenario /Framework 3.6. U.S. Small Molecule Innovator API CDMO Market: Analysis Tools 3.6.1. Porter's Five Forces Analysis 3.6.2. PESTEL Analysis 3.7. Impact of COVID-19 on Small Molecule Innovator CDMO Market 3.8. COVID-19 Impact Analysis Chapter 4. U.S. Small Molecule Innovator API CDMO Market: Stage Type Estimates & Trend Analysis 4.1. Segment Dashboard 4.2. U.S. Small Molecule Innovator API CDMO Market Movement Analysis 4.3. U.S. Small Molecule Innovator API CDMO Market Size & Trend Analysis, by Stage Type, 2018 to 2030 (USD Million) 4.3.1. Preclinical 4.3.1.1. Market estimates and forecast 2018 to 2030 (USD Million) 4.3.2. Clinical 4.3.2.1. Market estimates and forecast 2018 to 2030 (USD Million) 4.3.2.2. Phase I 4.3.2.3. Phase II 4.3.2.4. Phase III 4.3.3. Commercial Chapter 5. U.S. Small Molecule Innovator API CDMO Market: Customer Type Estimates & Trend Analysis 5.1. Segment Dashboard 5.2. U.S. Small Molecule Innovator API CDMO Market Movement Analysis 5.3. U.S. Small Molecule Innovator API CDMO Market Size & Trend Analysis, by Customer Type, 2018 to 2030 (USD Million) 5.3.1. Pharmaceutical 5.3.1.1. Market estimates and forecast 2018 to 2030 (USD Million) 5.3.1.2. Small 5.3.1.3. Medium 5.3.1.4. Large 5.3.2. Biotechnology 5.3.2.1. Market estimates and forecast 2018 to 2030 (USD Million) 5.3.2.2. Small 5.3.2.3. Medium 5.3.2.4. Large Chapter 6. U.S. Small Molecule Innovator API CDMO Market: Therapeutic Area Estimates & Trend Analysis 6.1. Definitions and Scope 6.2. Therapeutic Area Market Share, 2023 & 2030 6.3. Segment Dashboard 6.4. U.S. Small Molecule Innovator API CDMO Market Movement Analysis 6.5. U.S. Small Molecule Innovator API CDMO Market Size & Trend Analysis, by Therapeutic Area, 2018 to 2030 (USD Million) 6.5.1. Cardiovascular Diseases 6.5.1.1. Market estimates and forecast 2018 to 2030 (USD Million) 6.5.2. Oncology 6.5.3. Respiratory Disorders 6.5.4. Neurology 6.5.5. Metabolic Disorders 6.5.6. Infectious Diseases 6.5.7. Others Chapter 7. U.S. Small Molecule Innovator API CDMO Market: Regional Estimates & Trend Analysis by Product, Workflow, & Application 7.1. Regional Market Dashboard 7.2. Global Regional Market Snapshot 7.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030: 7.4. Northeast 7.4.1. Market estimates and forecast, 2018-2030 (USD Million) 7.4.2. New Jersey 7.4.2.1. Competitive Scenario 7.4.2.2. Market estimates and forecast, 2018-2030 (USD Million) 7.4.3. New York 7.5. Midwest 7.5.1. Market estimates and forecast, 2018-2030 (USD Million) 7.5.2. Illinois 7.5.3. Missouri 7.6. West Group 7.6.1. Market estimates and forecast, 2018-2030 (USD Million) 7.6.2. California 7.6.3. Washington 7.7. South 7.7.1. Market estimates and forecast, 2018-2030 (USD Million) 7.7.2. Texas 7.7.3. Florida Chapter 8. Competitive Landscape 8.1. Market Participant Categorization 8.2. Service Heat Map Analysis (a comparative analysis of the players together) 8.3. Company Profiles 8.3.1. Strategy Mapping 8.3.2. Expansion 8.3.3. Partnerships 8.3.4. Acquisitions 8.4. Vendor Landscape 8.4.1. Key company market share analysis, 2023 For more information about this report visit https://www.researchandmarkets.com/r/k3068l 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.

Partnership will include cGMP manufacturing services for AFTX-201, Affinia's investigational gene therapy medicine for BAG3 dilated cardiomyopathy WALTHAM, Mass. and COLUMBUS, Ohio, Nov. 13, 2024 /PRNewswire/ -- Affinia Therapeutics ("Affinia"), an innovative gene therapy company with a pipeline of rationally designed adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, and Forge Biologics ("Forge"), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an agreement to tech transfer and manufacture clinical trial material under Current Good Manufacturing Practice (cGMP) standards to help advance Affinia's pipeline of development candidates into clinical trials. The scope includes Affinia's investigational medicine program, AFTX-201 for BAG3 dilated cardiomyopathy, a devastating monogenic heart disease affecting more than 70,000 patients in the U.S., Europe, and U.K. regions. "We're proud to support Affinia's vision of bringing hope to patients affected by cardiomyopathy through their innovative gene therapy," said John Maslowski, President and CEO of Forge. "Forge's comprehensive AAV development and manufacturing services, including our robust tech transfer capabilities, were designed to empower partners like Affinia as they work to deliver transformative therapies to patients worldwide." Affinia's pipeline of rationally designed gene therapies incorporate the company's novel tissue-tropic AAV capsids validated in single-clonal nonhuman primate studies and the company's proprietary plasmid design system validated across a range of novel and conventional capsids and payloads. These innovations confer unique properties that enable the targeted delivery of genetic payloads to tissues of interest, improving efficacy, safety, and cost of goods, as well as the potential treatment of prevalent diseases with first-in-class or best-in-class therapies. The company's initial programs are intended to help patients affected by devastating cardiovascular or neurological diseases. "We are pleased to enter into this tech transfer and manufacturing partnership with an initial focus on AFTX-201 utilizing our proprietary cardiac capsid and plasmid design," said Rob May, Affinia's Chief Technical Operations Officer. "We are delighted with Forge's expertise, strong collaboration, and industry-leading capabilities that were evident during the tech transfer process. We look forward to advancing our innovative pipeline of rationally designed gene therapies toward the clinic jointly with Forge." Through this partnership, Forge will provide tech transfer services, process and analytical development, toxicology, and cGMP manufacturing services to Affinia. All tech transfer, development, and manufacturing activities will occur at the Hearth, Forge's 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio. About Affinia Therapeutics Affinia Therapeutics is pioneering a shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics' pipeline of first-in-class or best-in-class product candidates in cardiovascular and neurological diseases leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit . About Forge Biologics Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge's 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge's end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit . SOURCE Affinia Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

COLUMBUS, Ohio--( BUSINESS WIRE )--Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced it will be the adeno-associated virus (AAV) development and manufacturing partner for the Muscular Dystrophy Association’s (MDA) Kickstart Program. MDA is the leading nonprofit focused on accelerating research, advancing care, and advocating for the support of people living with muscular dystrophy, ALS, and related neuromuscular diseases. The MDA Kickstart Program is a new research program developed as a strategy to lower commercial barriers and de-risk development of gene therapies for ultra-rare neuromuscular diseases. “Collaborating with the MDA embodies our mission at Forge to help deliver potentially life-changing treatments to patients suffering from rare disease,” said John Maslowski, Chief Commercial Officer at Forge Biologics. “We are excited to support the MDA Kickstart Program and help advance these critical projects to the next stage of development.” Forge will provide process and analytical development manufacturing services, and the partnership will leverage Forge’s platform process, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio. "Forge has proven to be a trusted partner to gene therapy innovators, advancing many critical programs for rare diseases. We look forward to embarking on this manufacturing partnership, leveraging their deep expertise and robust platform to propel our Kickstart Program's goal of accelerating the delivery of treatments and cures to patients with ultra-rare neuromuscular diseases," said Sharon Hesterlee, Ph.D., Chief Research Officer at the Muscular Dystrophy Association. About Forge Biologics Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 200,000L of manufacturing capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com .