United States In Vitro Monoclonal Antibodies Market 2025: Industry Developments, Future Growth, Share & Industry Insights | GlaxoSmithKline plc, Novartis AG, Pfizer Inc., Sanofi, Merck & Co., Inc.

Global In Vitro Monoclonal Antibodies Market reached US$ 5.41 billion in 2023 and is expected to reach US$ 8.4 billion by 2031, growing at a CAGR of 5.7% during the forecast period 2024-2031.

According to DataM Intelligence Comprehensive Report has released its latest report on the "In Vitro Monoclonal Antibodies Market Size 2025," providing a detailed analysis of market trends, key growth drivers, competitive landscape, and regional insights. The report includes market size (value and volume), CAGR projections, and emerging opportunities that help businesses identify growth areas and build effective strategies. Backed by data-driven insights and future outlook, this study serves as a valuable resource for companies looking to stay competitive and capitalize on market potential.

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USA - Industry Latest News 2025:

✅ 09 Jun 2025 - FDA approves Merck's RSV monoclonal antibody Enflonsia (clesrovimab) for infant RSV prevention.

✅ 23 Jan 2025 - Nipocalimab (J&J) pivotal Phase-3 findings published / FDA Priority Review announced for generalized myasthenia gravis.

✅ 26 Jun 2025 - Invivyd publishes positive full Phase 1/2 clinical data for its monoclonal candidate VYD2311 (COVID-19 mAb program).

✅ Jul 2025 - Sanofi's investigational mAb SAR446523 received U.S. FDA orphan-drug designation (multiple myeloma).

Japan - Industry Latest News 2025:

✅ 27 Mar 2025 - Genmab / partner: Japan MHLW approves TIVDAK® (tisotumab vedotin) (antibody-based ADC) for specified indications in Japan.

✅ 15 Jul 2025 - Otsuka Pharmaceutical agrees to acquire worldwide rights/assets to Cantargia's IL-1RAP antibody program CAN10 (asset acquisition).

Korea - Industry Latest News 2025:

✅ 13 Jan 2025 - Samsung Biologics announces a >$1.4 billion contract-manufacturing agreement (large mAb/biologics manufacturing deal) with a Europe-based pharma partner.

✅ 2025 (Conference calendar) - BIO KOREA 2025 / industry updates highlight continued strong pipeline activity and presentations featuring monoclonal and bispecific antibody programs.

✅ 2025 (company news) - BioXCell (Korea site news) releases new panels of murine monoclonal antibodies (research-use product launches).

Europe - Industry Latest News 2025:

✅ 16 Jun 2025 - Roche advances monoclonal antibody prasinezumab into Phase III for early-stage Parkinson's (major clinical development).

✅ 20 Mar 2025 - Sanofi to acquire Dren Bio (bispecific/myeloid-engager assets) - strategic M&A expanding antibody/immunology pipeline.

✅ 03 Feb 2025 - BioNTech completes acquisition of Biotheus (expanding biologics/antibody development capabilities).

✅ Feb 19, 2025 - Celltrion secures EU approvals / expands biosimilar monoclonal antibody portfolio (regulatory approvals and Europe commercial roll-outs).

Market Geographical Share:

North America holds the dominant share, driven by advanced biopharmaceutical infrastructure, high R&D investment, and strong regulatory frameworks supporting antibody production. The U.S. leads the region due to extensive clinical research activities and large-scale biologics manufacturing capabilities.

Asia-Pacific is the fastest-growing regional market, propelled by expanding biotechnology sectors in China, India, Japan, and South Korea. Government support for biopharma innovation, growing contract manufacturing organizations (CMOs), and increasing adoption of in vitro antibody testing are fueling regional expansion.

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Market Drivers:

✅ Rising Demand for Targeted Therapies: Increasing prevalence of chronic diseases such as cancer and autoimmune disorders is boosting the need for monoclonal antibodies that offer high specificity and reduced side effects compared to conventional therapies.

✅ Technological Advancements in Antibody Engineering: Innovations in hybridoma technology, recombinant DNA methods, and phage display are enhancing antibody affinity and production efficiency, driving in vitro antibody development.

✅ Growth in Biopharmaceutical Research: Expanding investments in biologics research and the growing pipeline of antibody-based drugs are stimulating market growth.

✅ Increasing Use in Diagnostics and Therapeutics: In vitro monoclonal antibodies play a vital role in diagnostic assays, biosensors, and biomarker identification, broadening their applications beyond therapeutics.

✅ Expansion of Contract Research and Manufacturing Services: Outsourcing to specialized CROs and CMOs is rising as biopharma companies seek cost-effective production and testing solutions.

✅ Regulatory Support and Biosimilar Development: Evolving regulatory pathways for biosimilars and biobetters are encouraging more players to enter the market, fostering competition and innovation.

Segments Covered in the Beverage Premix Market:

By MAB Functionality - Naked Monoclonal Antibodies, Conjugated Monoclonal Antibodies, Bispecific Monoclonal Antibodies

By MAB Structure - Murine, Chimeric, Humanized, Human

By Technology - Hybridoma technology, Phage display, Single B-cell antibody technology, Recombinant antibody production

Regional Analysis for Beverage Premix Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Major Key Players: Amgen Inc., Biogen, Bristol-Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, GlaxoSmithKline plc, Novartis AG, Pfizer Inc., Sanofi, Merck & Co., Inc.

✅ Amgen Inc. - Amgen is a top biopharma with large 2024 product sales (~US$33.4B) and a meaningful biologics/mAb footprint (products such as Vectibix and adalimumab biosimilar Amjevita contribute materially to its biologics revenue), positioning Amgen as a major seller in the mAb space.

✅ Biogen - Biogen (full-year 2024 revenues roughly in the high single-digit billions) relies on specialty biologics (e.g., Tysabri and other biologic therapies); while smaller in total revenue than the largest mAb-centric firms, Biogen remains an important specialist player in neurological biologics.

✅ Bristol-Myers Squibb (BMS) - BMS's growth portfolio (including major mAb oncology/immuno-oncology products such as Opdivo) makes it one of the leading contributors to global mAb sales; BMS reported strong full-year revenues in 2024, reflecting the commercial scale of its mAb franchises.

✅ Eli Lilly and Company - Lilly reached record overall revenues in 2024 (growth to the tens of billions driven by newer products); while historically more diversified across modalities, Lilly's recent investments and approvals (including antibody therapeutics like donanemab) mean it is rapidly increasing its share of the therapeutic-antibody market.

✅ Hoffmann-La Roche Ltd (Roche) - Roche remains one of the largest and most mAb-centric companies (Ocrevus, Hemlibra, Xolair, Phesgo, Vabysmo, etc.), with pharmaceuticals sales that make Roche a dominant market share holder in monoclonal antibodies globally. Roche's 2024 financials show continued double-digit contributions from these mAb drivers.

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