Biopharmaceutical Manufacturing Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global biotechnology contract manufacturing market growth forecasted to transform from USD 16.6 billion in 2023 to USD 24.8 billion by 2028, driven by a CAGR of 8.3%. The growth of biopharmaceutical manufacturing market is majorly driven by factors like increasing approvals of monoclonal antibodies and, in other targeted therapies, rising approvals of biosimilars. Increasing investments for the expansion of production capacities among the contract manufacturers will support the growth of the market in the future. Moreover, factors like increasing investments for research in novel therapeutics like cell and gene therapy and antibody drug conjugates are likely to support the market growth.

Biologics Contract Manufacturing Market - Global Forecast to 2028

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Biotechnology Contract Manufacturing Market Dynamics

DRIVER: Increasing biologics manufacturing outsourcing trend among biopharmaceutical companies

The increasing popularity of biologics in medicine has led to a significant rise in outsourcing manufacturing. Biologics contract manufacturers have the know-how and setup to make these complex therapies effective while ensuring the meeting of strict quality rules and regulations. Such contract manufacturers have a deep understanding of protein chemistry, cell culture, downstream process, and the impact of process conditions on yield and protein structure while proceeding from lab to GMP scale. Therefore, biopharmaceutical companies prefer to opt for a highly efficient way to accelerate development and manufacturing by partnering with CDMOs, and CMOs have strong expertise in biologics, chemistry manufacturing control, and commercial manufacturing. Further, biopharmaceutical companies outsource clinical and commercial biomanufacturing to reduce the cost and associated risk with in-house development and manufacturing. This, in turn, supports the biopharmaceutical contract manufacturing market growth.

RESTRAINT: Intellectual property rights issues

Intellectual property protection is the most vital part of contract manufacturing. An innovator company has to share the complete details of its patented drug with the contract manufacturer to allow it to manufacture the drug. It includes the risk of using the information in an unauthorized manner and duplicating the products and the risk associated with infringements. Recently, the outsourcing of basic manufacturing activities is emerged as an upcoming trend in the industry. For example, pharmaceutical firms are outsourcing the manufacturing of complex biologics as it requires the expertise and infrastructure to manufacture them in a manner that meets individual patient requirements. For this trend to continue in the biopharmaceutical contract manufacturing market, it is necessary to maintain an honest relationship between the pharmaceutical companies and the CMOs to ensure the protection of intellectual property.

OPPORTUNITY: Rising demand for cell therapies and gene therapies

Cell and gene therapies are highly specific and have the potential to address unmet medical needs associated with treating untouched disorders by small molecule drugs and other biologics. Their promising therapeutic potential has led many pharmaceutical companies to focus on developing and commercializing these therapies. This has led to increased demand for cell and gene therapy development and manufacturing. As of April 2022, more than 20 cell & gene therapies have been approved by the US FDA. The growing number of cell and gene therapy candidates, along with their progression through the various phases of clinical development and their complex manufacturing process, has increased the demand for facilities that offer manufacturing services for these therapies. This is likely to provide growth opportunities for the contract manufacturing of these therapies.

CHALLENGE: Challenges to meet reformed regulations

FDA regulations outline that the manufacturer needs to strictly follow the guidelines defined by the respective regulatory authority. The CMOs face the task of seeking regulatory approvals from different regions for the same molecule, tailoring their submissions based on specific client requirements. This process becomes complex due to variations in regulations and submission criteria across different countries. Mistakes in this complex attempt can pose significant obstacles for innovators aiming to access regulated markets. This challenge is deepened by the need to align manufacturing practices with the latest regulatory reforms. Thus making it challenging for CMOs to consistently meet evolving standards across diverse regions and countries.

Biopharmaceutical Manufacturing Market Ecosystem

The global biopharmaceutical contract manufacturing market is a complex ecosystem involving various stakeholders, including the supply side, i.e., companies providing contract manufacturing services, and the demand side, i.e., pharmaceutical companies and biotechnology companies, among others.

Several key companies provide services for contract manufacturing. For example, Lonza (Switzerland) is a leading provider of contract manufacturing services for biologics, including cell and gene therapies, viral vectors, and plasmid DNA. Other service providers include Thermo Fisher Scientific, Inc. (US), AbbVie, Inc. (US), Catalent Inc. (US), Wuxi Biologics (China), and others.

The manufacturing segment dominated the biotechnology contract manufacturing industry by service.

The manufacturing segment held the largest share of the global biotechnology contract manufacturing market in 2022. The manufacturing of biopharmaceuticals includes processes like upstream manufacturing and downstream manufacturing. As the manufacturing of biologics involves complex processes, the process design, optimization, and deployment of enhanced protocols and procedures to obtain purity is still an ongoing challenge for biopharmaceutical companies. Biologic manufacturers can fulfill their production goals while staying ahead of ever-changing trends and technologies, supporting the trend for outsourced manufacturing.

The biologic drug substance manufacturing segment dominated the biotechnology contract manufacturing industry by type.

The biologic drug substance manufacturing segment held the largest share of the global biopharmaceutical contract manufacturing market in 2022. The large share of drug substance manufacturing is attributed to the growing research in the field of novel therapies to treat chronic diseases.  As the marketed drugs are moving toward the patent cliff, there is an increasing demand for newer targeted therapies like monoclonal antibodies, cell therapies, and gene therapies. Whereas the manufacturing of these complex drug substances requires highly sophisticated equipment and manufacturing technologies. The innovator companies prefer to outsource the manufacturing of these biological drug substances, in turn supporting the market growth.

Asia Pacific region of the biotechnology contract manufacturing industry is estimated to register the highest CAGR during the forecast period.

Asia Pacific offers lucrative growth potential for the biotechnology contract manufacturing market. This can be attributed to the increasing pharmaceutical R&D spending in the region, the growing trend of outsourcing manufacturing services, and increasing government initiatives for healthcare research. One significant growth driver for the market in the Asia Pacific region is the increasing investment in healthcare infrastructure and R&D activities. Further, the growing prevalence of chronic diseases and the large population in the region are also facilitating the demand for novel therapies for treatment, supporting the demand for biologic drugs and their outsourced manufacturing. Also, the favorable regulatory guidelines for drug approval in the region are expected to drive biopharmaceutical contract manufacturing market growth.

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Key players in the biologics 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 Holding Corporation (Japan), AbbVie, Inc. (US), Eurofins Scientific (Luxembourg), GenScript Biotech Corporation (US), AGC, Inc. (Japan), Merck KgaA (Germany), JSR Corporation (Japan), among others.

Scope of the Biopharmaceutical Manufacturing Market

This report categorizes the Biotechnology contract manufacturing market to forecast revenue and analyze trends in each of the following submarkets:

By Service

• Manufacturing
• Formulation and Fill-Finish
• Packaging and Labeling
• Other services

By Type

• Biologic Drug Substance Manufacturing
• Biologic Drug Product Manufacturing

By Scale of Operation

• Commercial Operations
• Clinical Operations

By Source

• Mammalian Expression Systems
• Non-Mammalian Expression Systems

By Molecule

• Monoclonal Antibodies
• Cell Therapy & Gene Therapy
• Antibody-Drug Conjugates (ADCs)
• Vaccines
• Therapeutic Peptides & Proteins
• Other Molecule Types

By Therapeutic Area

• Oncology
• Autoimmune Diseases
• Cardiovascular Diseases
• Metabolic Diseases
• Infectious Diseases
• Neurology
• Other Therapeutic Areas

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
  • Brazil
  • Rest of Latin America
• Middle East and Africa (MEA)

Recent Developments of Biologics Contract Manufacturing Market

• In January 2023, WuXi Biologics entered into a licensing agreement with GSK plc for using WuXi Biologics’ proprietary technology platforms. Under this, GSK was granted an exclusive global license for the research, development, manufacturing, and commercialization of bispecific antibodies in the WuXi Biologics plan.
• In October 2022, Samsung Biologics partnered with GSK plc for the manufacturing of GSK’s monoclonal antibody and products, including lupus treatments like Benlysta.

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