Biologics Contract Manufacturing Market Size, Share & Trends Analysis Report By Product (MABs, Recombinant Protein), By Indication (Oncology, CVDs), By Region (Europe, APAC),- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The global biologics contract manufacturing market size was exhibited at USD 16.20 billion in 2023 and is projected to hit around USD 52.61 billion by 2033, growing at a CAGR of 12.5% during the forecast period 2024 to 2033.

Key Takeaways:

• North America dominated the market in 2023 and accounted for the maximum share of more than 43.00% of the global revenue.
• The MABs segment dominated the global market in 2023 and accounted for the maximum share of more than 60.00%.

Biologics Contract Manufacturing Market Report Scope

There was unparalleled growth in 2020 due to the COVID-19 pandemic. The main drivers for this growth were the rise in investments by the government and prominent players in the biopharmaceutical market to increase productivity and efficiency. Biotechnology outsourcing of biologics has become a new trend. Biotech contract manufacturing is witnessing an increase in inquiries as well as orders, mostly related to coronavirus vaccines and therapeutics. Currently, Lonza has received over 40 inquiries about projects related to COVID-19. The COVID-19 pandemic has resulted in the disruptions in the supply chain.

However, supply chains have proven to be robust and supplies, manufacturing as well as services associated with biologics, have remained largely unaffected around the globe. Many organizations are attempting to speed up their productivity to meet the growing demand. Such companies are, therefore, appointing CDMOs to speed up their production processes. The worldwide effort to develop a vaccine against COVID-19 has created the greatest opportunity for many large CDMOs. Continuous advancements in biotechnology and biomedical science techniques have dramatically enhanced the process of biologics development for the management of several chronic conditions.

These advancements are aimed at a better understanding of cell-line production & protein identification and expression & engineering. Several biotechnology approaches for the production of self-adjuvanting antigen-adjuvant fusion protein subunit vaccines have been introduced in recent years. The development of new vaccines is observed to be aided by the availability of characterized platforms of new adjuvants. Furthermore, the use of nanosystems has increased in recent years as they help address the delivery challenges pertaining to the application of mRNA therapeutics in the treatment of diseases.

Several factors, such as a robust pipeline of biologics, an increase in the rate of FDA NDA/BLA approvals, a rise in patent expiration, as well as limited manufacturing capacity, and the need for realization of cost savings, have prompted the market players to opt for contract manufacturing services for biologics development to stay competitive in the market. Contract Manufacturing Organizations (CMO) play an important role in reshaping the biologics market as they can support startups and small-scale & emerging players.

Segments Insights:

Indication Insights

On the basis of indications, the global market has been further categorized into oncology, immunological disorders, Cardiovascular Disorders (CVDs), hematological disorders, and others. The oncology indication segment dominated the global market in 2023. The segment accounted for the largest share of more than 49.8% of the overall revenue in the same year. It is estimated to remain dominant throughout the forecast period. The segment growth can be attributed to the high costs of drug development, rising cancer cases, and FDA regulations to accelerate the biologics drug development.

Despite the challenges related to COVID-19, the FDA approved 30 new drugs & biologics agents, 45 supplementary drugs, and 1 biosimilar application in oncology. On the other hand, the immunological disease segment is expected to witness the fastest CAGR over the forecast period. Biologics targeting autoimmune diseases have made a positive impact on the management of diseases, such as Rheumatoid Arthritis (RA), psoriasis, and other immunological disorders. Several biologics have been developed to attenuate common autoimmune diseases, and they target various pathological stages that occur during the development of immunological diseases.

Product Insights

On the basis of products, the global market has been further sub-segmented into Monoclonal Antibodies (MABs), recombinant proteins, and others. The MABs segment dominated the global market in 2023 and accounted for the maximum share of more than 60.00%. The segment is projected to expand further at the fastest CAGR maintaining its leading position during the forecast period. The high growth of the segment can be attributed to the extensive usage of the products made by MABs in different therapeutic areas. The drugs produced by MABs are used for the treatment of cancer, chronic Hepatitis B (HBV) infection, infectious diseases, and autoimmune diseases including rheumatoid arthritis.

For instance, in November 2023, Lonza Group AG entered into a manufacturing agreement with BlueJay, a developer of innovative therapeutics, for the development of BJT-778 monoclonal antibody for treating chronic HBV infection. Monoclonal antibodies are one of the most powerful tools in modern medicine and more than 100 of them have been licensed over the last 30 years. In addition, the MABs are relatively more effective than earlier available therapies and are also often better tolerated and easier to deliver.

Regional Insight

On the basis of geographies, the global market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the market in 2023 and accounted for the maximum share of more than 43.00% of the global revenue. The regional market is estimated to expand further at a steady CAGR retaining its leading position over the forecast period. This growth is mainly attributed to the increasing outsourcing activities in North America. The region has a strong presence of several key players competing to capture higher market shares by introducing cost-efficient and high-quality work.

The development and manufacturing of advanced therapy in the region are also expected to boost the market growth over the years to come. On the other hand, Asia Pacific is projected to be the fastest-growing regional market during the forecast period. The regional growth can be attributed to the alteration in the clinical trial evaluation standards by regulatory organizations of biologics according to the global requirements. In addition, the costs of conducting clinical trials are low in Asia Pacific as compared to other regions. Thus, these factors are expected to augment the regional market growth over the forecast years.

Some of the prominent players in the Biologics contract manufacturing market include:

• Wuxi Biologics
• Abzena Ltd.
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Boehringer Ingelheim GmbH
• Lonza
• SamsungBiologics
• Abbvie
• Catalent
• Bioreliance
• Thermo Fischer (Patheon)
• Eurofins CDMO

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2023 to 2033. For this study, Nova one advisor, Inc. has segmented the global biologics contract manufacturing market.

Product

• MABs
• Recombinant Protein
• Others

Indication

• Oncology
• Immunological Disorders
• Cardiovascular Disorders (CVDs)
• Hematological Disorders
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)