Northbrook, IL 60062 -- (SBWIRE) -- 12/04/2023 -- Biotechnology Contract Manufacturing Market by Service (Manufacturing, Fill Finish, Packaging), Type (Drug Substance, Drug Product), Scale, Source (Mammalian), Therapy Area (Oncology), Molecule Type (mAbs, ADC, CGT, Vaccines) - Global Forecasts to 2028", is estimated to reach USD 24.8 billion by 2028 from USD 16.6 billion in 2023, at a CAGR of 8.3% during the forecast period of 2023 to 2028. The growth of this market is driven by the rising demand for biologics and biosimilars, increasing outsourcing of biologics manufacturing among biopharmaceutical companies, growing focus on personalized medicine, increasing collaborations between pharmaceutical companies and biologics contract manufacturers, and advancements in manufacturing technologies. Additionally, the rising demand for cell & gene therapies and the expansion of biologics manufacturing capacities by CMOs will provide growth opportunities in the biotechnology contract manufacturing market.

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Key Market Players:

Key players in the biotechnology contract manufacturing market include Lonza (Switzerland), Thermo Fisher Scientific Inc. (US), Catalent, Inc. (US), Samsung Biologics (South Korea), WuXi Biologics (China), Boehringer Ingelheim International GmbH (Germany), FUJIFILM Holdings Corporation (Japan), AbbVie, Inc. (US), Eurofins Scientific (Luxembourg), GenScript Biotech Corporation (US), AGC Inc. (Japan), Merck KGaA (Germany), JSR Corporation (Japan) and among others.

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Biotechnology Contract Manufacturing Market Dynamics:

Drivers:

1. Rising demand for biologics and biosimilars
2. Increasing outsourcing of biologics manufacturing among biopharmaceutical companies
3. Growing focus on personalized medicine
4. Increasing collaborations between pharmaceutical companies and biologics CMOs
5. Advancements in manufacturing technologies

Restraints:

1. Intellectual property rights issues

Opportunities:

1. Rising demand for cell and gene therapies
2. Significant growth opportunities offered by emerging countries
3. Expansion of biologics manufacturing capacities by CMOs
4. Strong emphasis on drug development

Challenge:

1. Complying with regulatory reforms

The monoclonal antibody segment accounted for the largest share by molecule type in the biotechnology contract manufacturing market in 2022.

By molecule type, the biotechnology contract manufacturing market has been further categorized as monoclonal antibodies, cell therapy & gene therapy, antibody-drug conjugates, vaccines, therapeutic peptides & proteins, and other molecule types. The monoclonal antibodies segment held the largest share of the global biotechnology contract manufacturing market in 2022. This can be attributed to the growing demand for targeted therapies in the treatment of chronic diseases, increasing government initiatives for the development of monoclonal antibody drugs, and the growing number of mAb product candidates currently in development.

The mammalian expression segment accounted for the largest share of the biotechnology contract manufacturing market by source in 2022.

Based on the source, the global biotechnology contract manufacturing market has been segmented into mammalian expressions and non-mammalian expressions. The mammalian expression segment held the largest market share in 2022. The large share of this segment can be attributed to the high sensitivity of this system, its wide usage in the manufacturing of biopharmaceuticals, the growing number of approved biologics based on mammalian expression systems, and the expansion of mammalian-based cell culture capacity by CMOs.

North America region accounted for the dominant share of the biotechnology contract manufacturing market in 2022.

The biotechnology contract manufacturing market in North America has experienced significant growth in recent years. The strong pharmaceutical and biotech industry, the presence of a well-established pharmaceutical industry, the rising demand for biosimilars and biologics, and the increasing outsourcing of manufacturing services by pharmaceutical & biopharmaceutical companies contribute to the growth of the biotechnology contract manufacturing market in the North American region. Additionally, the presence of highly advanced manufacturing technologies makes this region an attractive market for contract manufacturing organizations (CMOs).

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Biotechnology Contract Manufacturing Market Advantages:

- Cost Efficiency: Biotech companies can reduce capital expenses by outsourcing manufacturing processes to specialized contract manufacturing organizations (CMOs), avoiding the need for large-scale infrastructure and equipment investments.
- Expertise and Specialization: CMOs often possess specialized knowledge and expertise in bioprocessing techniques, ensuring high-quality and compliant production, which can be challenging for smaller biotech firms to achieve on their own.
- Scalability: CMOs have the capacity to scale production quickly in response to changing market demands, allowing biotech companies to adapt to fluctuating production requirements without significant lead times or investment.
- Faster Time to Market: Outsourcing manufacturing to CMOs can significantly accelerate drug development timelines, enabling biotech companies to bring their products to market more swiftly and gain a competitive edge.
- Risk Mitigation: Biotech firms can reduce risks associated with manufacturing, regulatory compliance, and quality control by partnering with experienced CMOs, who navigate regulatory hurdles and quality standards on their behalf.
- Focus on Core Competencies: By delegating manufacturing responsibilities, biotech companies can concentrate their resources and efforts on research, development, and innovation, enhancing their ability to bring novel therapies and products to market.
- Global Reach: CMOs often have a global presence, enabling biotech companies to access diverse markets and benefit from regional expertise and regulatory knowledge.
- Cost Transparency: Contract manufacturing agreements often provide cost transparency, allowing biotech firms to plan their budgets more effectively and avoid unexpected expenses.
- Regulatory Compliance: CMOs stay up-to-date with evolving regulatory requirements and quality standards, reducing the regulatory burden on biotech companies and ensuring compliance throughout the manufacturing process.
- Flexibility and Customization: CMOs can tailor their services to meet the specific needs of biotech clients, providing customized solutions for a wide range of biopharmaceutical products.

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