<img src="https://ml.globenewswire.com/Resource/Download/908fb457-7f8e-4a08-9081-5565e3dfb3d7?size=2" nborder="0" align="left" hspace="5" vspace="5" title="22157.jpg" alt="Company Logo"/>Aging populations, chronic disease pipelines and high capex are driving biologics outsourcing. Opportunities span integrated services, fill-finish, analytics, microbial platforms and Asia-Pacific.<div style="float:right;padding:0 0 15px 20px;margin:15px 0 20px 20px;width:300px">
 Biologics Contract Development And Manufacturing Organization Cdmo Market Pharmaceutical Sales By Region In U S D Billion Global 2017 2021
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</div>Dublin, Aug. 20, 2026 <a href="https://www.globenewswire.com" target="_blank">(GLOBE NEWSWIRE)</a> -- The <a href="https://www.researchandmarkets.com/reports/5185247/biologics-cdmo-market-share-analysis-industry?utm_source=GNE&amp;utm_medium=PressRelease&amp;utm_code=jjllrh&amp;utm_campaign=2330950+-+Biologics+CDMO+(2026-2031)+-+Growing+Biologics+Pipeline+Drives+Demand+for+Outsourced+Development+and+Manufacturing&amp;utm_exec=clshmsai" rel="nofollow" target="_blank" title="Biologics CDMO - Market Share Analysis, Industry Trends &amp; Statistics, Growth Forecasts (2026-2031)">"Biologics CDMO - Market Share Analysis, Industry Trends &amp; Statistics, Growth Forecasts (2026-2031)"</a> report has been added to ResearchAndMarkets.com's offering. <img alt="" height="302" src="//www.researchandmarkets.com/content-images/313/313640/1/1655389442982_reseller_biologics-contract-development-and-manufacturing-organization-cdmo-market_Pharmaceutical_Sales_By_Region_In_USD_Billion_Global_2017-2021_original.png" width="600" /> USD 38.29 Billion by 2031, Growing at a 7.14% CAGR The global biologics contract development and manufacturing organization (CDMO) market was valued at USD 25.32 billion in 2025 and is projected to increase from USD 27.13 billion in 2026 to USD 38.29 billion by 2031. The market is expected to register a compound annual growth rate (CAGR) of 7.14% during the 2026-2031 forecast period, supported by expanding biologics pipelines, rising demand for outsourced manufacturing, and continued investment in advanced production capacity. Aging Population and Chronic Disease Pipelines Support Market Growth Longer life expectancy and the increasing prevalence of oncology, autoimmune, and metabolic disorders are strengthening long-term demand for advanced biologic therapies. The global population aged 60 and older is expected to reach 2.1 billion by 2050, increasing pressure on healthcare systems and accelerating the development of targeted treatments. Pharmaceutical and biotechnology companies are responding by securing reliable manufacturing capacity for high-volume injectable therapies. Novo Nordisk's USD 4.1 billion investment in a U.S. fill-finish facility illustrates the growing emphasis on supply continuity. Partnerships with biologics CDMOs enable drug developers to accelerate product launches, access specialized expertise, and reduce the capital risks associated with building and operating in-house facilities. Capital-Intensive Biologics Manufacturing Drives Outsourcing Advanced facilities for antibody-drug conjugates, multispecific antibodies, and other complex biologics can require investments exceeding USD 1 billion. These substantial costs are encouraging pharmaceutical companies to transfer development and manufacturing activities to CDMOs with established Good Manufacturing Practice capacity and scalable infrastructure. Samsung Biologics has secured approximately USD 13 billion in long-term manufacturing contracts with 16 of the world's 20 largest pharmaceutical companies, highlighting demand for integrated development and production services. Rising material costs, including inflation affecting single-use equipment, are also reinforcing the financial advantages of outsourced biologics manufacturing. Small and mid-sized biotechnology companies remain particularly reliant on asset-light partnerships. Continuous bioprocessing and flexible production technologies are creating additional opportunities, although persistent capacity constraints may continue to extend project lead times. Regulatory Requirements Increase Demand for Quality and Analytical Services Updated U.S. Food and Drug Administration guidance on batch uniformity and evolving European regulations are increasing validation, documentation, and quality assurance requirements. CDMOs may allocate 12% to 15% of revenue to quality assurance, substantially above traditional pharmaceutical industry levels. Greater scrutiny of biosimilar comparability could lengthen development schedules, but it is also creating demand for experienced partners with strong regulatory and analytical capabilities. Fill-Finish Services Maintain a Leading Market Position Fill-finish and packaging services accounted for 34.96% of the biologics CDMO market in 2025. Their leading position reflects the stringent sterility, quality, and regulatory requirements associated with final drug-product preparation. Major investments, including Lonza's CHF 500 million facility in Switzerland, demonstrate the strategic importance of this segment. Analytical and quality control services are forecast to grow at a 12.24% CAGR through 2031 as sponsors seek faster testing, product release, and regulatory support. Integrated CDMOs are increasingly combining process development, GMP manufacturing, analytical testing, and regulatory services to reduce operational handoffs and shorten development timelines. Eurofins BioPharma's network of 45 GMP laboratories reflects the shift toward geographically diversified testing capabilities. Mammalian Platforms Lead While Microbial Systems Gain Momentum Mammalian production platforms represented 61.68% of the biologics CDMO market in 2025, driven by their critical role in producing monoclonal antibodies and other glycosylation-dependent therapies. Samsung Biologics' expansion to 784,000 liters of production capacity underscores continued investment in large-scale mammalian cell culture manufacturing. Microbial production systems are projected to expand at an 8.22% CAGR through 2031, supported by cost advantages and streamlined processing. Single-use fermentation technologies can reduce contamination risks and improve facility turnaround times, broadening microbial applications across peptide and oligonucleotide therapeutics. These capabilities are particularly attractive to emerging biotechnology companies seeking efficient early-stage production. North America Leads the Global Biologics CDMO Market North America generated 34.12% of global market revenue in 2025, supported by established biotechnology clusters, advanced manufacturing infrastructure, and regulatory support for innovative production methods. FDA guidance on continuous processing and expedited review pathways is encouraging early technology adoption, while major projects such as Novo Nordisk's USD 4.1 billion North Carolina facility are expanding regional capacity. Europe remains a significant biologics manufacturing center, led by Germany, the United Kingdom, and Switzerland. Lonza's fill-finish investment in Stein, Switzerland, and Biosynth's bioconjugation expansion in Germany reflect demand for specialized, high-value services. Updated European Medicines Agency guidelines are also supporting technology transfers and cross-border manufacturing programs. Asia-Pacific is forecast to be the fastest-growing regional market, with a projected CAGR of 10.48% through 2031. Capacity expansion, government incentives, and streamlined regulatory procedures are attracting global drug development programs. Samsung Biologics' scale-up and SK pharmteco's USD 260 million project in Sejong demonstrate South Korea's ambition to strengthen its position in global biologics manufacturing. Regulatory reforms in China and infrastructure grants in India are expected to generate further opportunities for biologics CDMO providers across the region. Key Topics Covered: 1 INTRODUCTION 1.1 Study Assumptions and Market Definition 1.2 Scope of the Study 2 RESEARCH METHODOLOGY 3 EXECUTIVE SUMMARY 4 MARKET LANDSCAPE 4.1 Market Overview 4.2 Market Drivers 4.2.1 Aging population and chronic-disease pipeline expansion 4.2.2 Capital-intensive biologics innovation driving outsourcing 4.2.3 SME biotech preference for asset-light CDMO partnerships 4.2.4 Continuous bioprocessing accelerates flexible capacity 4.2.5 Single-use technologies compress CAPEX and timelines 4.2.6 Cell and gene therapy manufacturing spill-over to biologics CDMOs 4.3 Market Restraints 4.3.1 Evolving global GMP and comparability requirements 4.3.2 Persistent capacity bottlenecks lengthen lead-times 4.3.3 Captive facility expansion by big pharma reduces outsourcing 4.3.4 Resin and single-use component supply fragility 4.4 Supply-Chain Analysis 4.5 Regulatory Landscape 4.6 Technological Outlook 4.7 Porter's Five Forces Analysis 4.7.1 Bargaining Power of Suppliers 4.7.2 Bargaining Power of Buyers 4.7.3 Threat of New Entrants 4.7.4 Threat of Substitutes 4.7.5 Intensity of Competitive Rivalry 5 MARKET SIZE AND GROWTH FORECASTS (VALUE) 5.1 By Service Type 5.1.1 Process Development 5.1.2 GMP Manufacturing 5.1.3 Fill-Finish and Packaging 5.1.4 Analytical and QC Services 5.1.5 Other Service Type 5.2 By Type 5.2.1 Mammalian 5.2.2 Microbial 5.3 By Product Type 5.3.1 Biologics 5.3.1.1 Monoclonal Antibodies 5.3.1.2 Recombinant Proteins 5.3.1.3 Vaccines 5.3.1.4 Antisense / Molecular Therapy 5.3.1.5 Other Biologics 5.3.2 Biosimilars 5.4 By Scale 5.4.1 Pre-clinical and Clinical 5.4.2 Commercial 5.5 By End-user 5.5.1 Small / Mid-size Biotech 5.5.2 Large Pharma 5.6 By Geography 5.6.1 North America 5.6.1.1 United States 5.6.1.2 Canada 5.6.1.3 Mexico 5.6.2 Europe 5.6.2.1 Germany 5.6.2.2 United Kingdom 5.6.2.3 France 5.6.2.4 Italy 5.6.2.5 Spain 5.6.2.6 Russia 5.6.2.7 Rest of Europe 5.6.3 Asia-Pacific 5.6.3.1 China 5.6.3.2 India 5.6.3.3 Japan 5.6.3.4 South Korea 5.6.3.5 Australia and New Zealand 5.6.3.6 Rest of Asia-Pacific 5.6.4 Middle East and Africa 5.6.4.1 Middle East 5.6.4.1.1 United Arab Emirates 5.6.4.1.2 Saudi Arabia 5.6.4.1.3 Turkey 5.6.4.1.4 Rest of Middle East 5.6.4.2 Africa 5.6.4.2.1 South Africa 5.6.4.2.2 Nigeria 5.6.4.2.3 Egypt 5.6.4.2.4 Rest of Africa 5.6.5 South America 5.6.5.1 Brazil 5.6.5.2 Argentina 5.6.5.3 Rest of South America 6 COMPETITIVE LANDSCAPE 6.1 Market Concentration 6.2 Strategic Moves 6.3 Market Share Analysis 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments) 6.4.1 Lonza Group 6.4.2 Samsung Biologics 6.4.3 WuXi Biologics 6.4.4 Boehringer Ingelheim BioXcellence 6.4.5 Catalent 6.4.6 Fujifilm Diosynth Biotechnologies 6.4.7 AGC Biologics 6.4.8 Thermo Fisher Scientific (Patheon) 6.4.9 AbbVie Contract Manufacturing 6.4.10 Rentschler Biopharma 6.4.11 Celonic 6.4.12 Binex 6.4.13 Sandoz 6.4.14 Parexel 6.4.15 ICON plc 6.4.16 Recipharm - Arranta Bio 6.4.17 Toyobo 6.4.18 Emergent BioSolutions CDMO 6.4.19 Porton Biologics 6.4.20 Just-Evotec Biologics 6.4.21 Grifols Contract Manufacturing 7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK For more information about this report visit <a href="https://www.researchandmarkets.com/reports/5185247/biologics-cdmo-market-share-analysis-industry?utm_source=GNE&amp;utm_medium=PressRelease&amp;utm_code=jjllrh&amp;utm_campaign=2330950+-+Biologics+CDMO+(2026-2031)+-+Growing+Biologics+Pipeline+Drives+Demand+for+Outsourced+Development+and+Manufacturing&amp;utm_exec=clshmsai" rel="nofollow" target="_blank" title="">https://www.researchandmarkets.com/r/lnp8ac</a> 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. 
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Biologics CDMO (2026-2031) - Growing Biologics Pipeline Drives Demand for Outsourced Development and Manufacturing

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