Biologics Contract Manufacturing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Afri

Biologics Contract Manufacturing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

The global biologics contract manufacturing market is set for remarkable growth, with worldwide revenue anticipated to increase from USD 16.01 billion in 2024 to an impressive USD 36.3 billion by 2031. Projected to grow at a CAGR of 12.4%, this surge reflects heightened demand for innovative biologic and biosimilar products, as companies increasingly leverage contract manufacturing to streamline R&D and commercialization.

The biologics contract manufacturing market's expansion is fueled by the growth of the biopharmaceutical contract manufacturing organization (CMO) sector. Industry players are focusing on consolidation, adopting inorganic growth strategies, and developing integrated end-to-end solutions to offer comprehensive services. Biopharmaceutical CMOs with advanced technological capabilities are well-positioned to capitalize on this expanding market, driven by rapid scientific advancements in the field.

Drivers of Market Growth

1.Growing Demand for Biologics and Biosimilars: Rising demand for biologics and biosimilars is driving contract manufacturing services growth.

2.R&D Outsourcing: Companies are increasingly outsourcing R&D to CMOs and CDMOs (contract development and manufacturing organizations) to reduce costs and improve operational efficiency.

3.Scientific and Technological Advancements: Innovations like single-use bioreactors and cell & gene therapy capabilities are bolstering market growth. For instance, Lonza Group AG's acquisition of Shire plc’s facility expanded mammalian manufacturing operations, and AGC Biologics’ acquisition of Molecular Medicine S.p.A. strengthened its gene therapy capabilities.

Business Opportunities

The evolving CDMO business model supports high-potency drug development and biopharmaceuticals, enabling companies to achieve efficiency across the value chain by outsourcing clinical development stages. CMOs and CDMOs optimizing manufacturing technologies are also driving long-term profitability through scalable, cost-effective solutions.

Region Analysis
• United States: In North America, the U.S. dominates, capturing around 89.9% of the market in 2023. Robust biologics pipelines, substantial venture capital investment in biotechnology R&D, and a strong presence of leading manufacturers bolster its position.
• Germany: With 33.7% of Europe’s market share in 2023, Germany emerges as a key market, driven by increased biopharmaceutical research and clinical trials. Companies outsource research activities to reduce costs, further propelling market demand.
• China: Commanding an 18.2% market share in East Asia, China benefits from global-local collaborations. The rising presence of pharmaceutical and biopharmaceutical companies in China is unlocking growth opportunities for contract manufacturing.

Impact of Regulatory Dynamics

The biologics contract manufacturing market faces challenges from evolving regulatory policies, cGMP compliance mandates, and supply chain security complexities in emerging markets. Entry barriers for SMEs are high due to significant financial requirements. Additionally, the biotech industry in many countries lags behind the U.S. due to shortages of skilled professionals and funding.

Competitive Analysis

Leading players are expanding service portfolios and focusing on emerging markets to harness growth opportunities. Major companies in the biologics contract manufacturing market include:
• BioXcellence (Boehringer Ingelheim)
• Lonza Group AG
• Samsung Biologics
• Fujifilm Diosynth Biotechnologies
• AbbVie CM (AbbVie Inc.)
• WuXi Biologics (Cayman) Inc.
• AGC Biologics
• Patheon N.V. (Thermo Fisher Scientific Inc.)
• Emergent BioSolutions Inc.
• Ajinomoto Bio-Pharma
• Avid Bioservices, Inc.
• KBI Biopharma
• Rentschler Biotechnologie GmbH
• Merck KGaA
• Catalent Inc.
• Therapure Biopharma Inc.
• Novasep
• Abzena plc.
• ProBioGen AG

Biologics Contract Manufacturing Market Segmentation

Product:
• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Insulin
• Interferons
• Growth Factors
• Others

Platform:
• Mammalian
• Microbial

Therapeutic Area:
• Oncology
• Autoimmune Disease
• Metabolic Disease
• Ophthalmology
• Cardiovascular Disease
• Infectious Disease
• Neurology
• Respiratory Disorder
• Others

Application:
• Commercial
• Clinical

Region:
• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa


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