Biopharmaceuticals Contract Manufacturing Market Size To Hit USD 31.92 Bn By 2032

According to the latest research by nova one advisor, the global biopharmaceuticals contract manufacturing market size was exhibited at USD 19.89 billion in 2023 and is projected to hit around USD 31.92 billion by 2032, growing at a CAGR of 5.4% during the forecast period 2023 to 2032.

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Growing biopharmaceutical pipeline and lack of adequate manufacturing capabilities are two key factors that are driving partnership between large molecule manufacturers and Contract Manufacturing Organizations (CMOs). Contract manufacturers are engaged in broadening their service portfolio to meet the companies’ demands with respect to regulatory standards and new services. The pandemic has, however, also had some negative knock-on effects as budgets and resources are diverted to “COVID products” at the expense of other biologics projects in development for other therapeutic areas.

The reliance of companies on CMOs for the production of biologics and biosimilars is expected to rise during the forecast period as a consequence of changes adopted by the CMOs. This is evident through growing investment in collaborations of companies with CMOs as well as continuous efforts taken up for expanding the service portfolio. The supply chain of biopharmaceuticals remained robust and was largely unaffected worldwide during the coronavirus outburst. Also, biopharmaceutical contract manufacturers are observing increased demand related to COVID-19 vaccine and therapeutics. Thus, the future holds numerous opportunities for the market. For instance, in 2020, AstraZeneca and Oxford Biomedica signed a one-year clinical and commercial supply agreement for the manufacturing of AstraZeneca’s COVID-19 vaccine candidate, AZD1222.

The future growth of the market is highly dependent on the promising opportunities offered by the biopharmaceutical industry, bioprocessing industry, and contract service industry. Expansion of fill-and-finish services and increasing robustness of venture capital investments for the life science sector are two important opportunities that are anticipated to drive the market. For instance, in 2019, Shanghai HaiHe Biopharma Co. Ltd. raised USD 146.6 million as venture capital for its large cancer drug portfolio, which it shall utilize along with its outsourcing partner Zhejiang Jiuzhou Pharmaceutical Co., Ltd.

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Biopharmaceuticals Contract Manufacturing Market Report Highlights

• Mammalian-based biopharmaceutical contract manufacturing captured the largest market share about 60.9% in 2022 owing to the high penetration of mammalian expression systems for biologics development
• Out of all the services offered in this market, process development contributed to the largest share of 34.7% in 2022, owing to high capital investment, especially in downstream process
• Biologics contract manufacturing dominated its counterpart segment owing to higher demand for biologics production. However, the biosimilar segment is growing with a lucrative CAGR of 8.3% due to cost-saving advantages associated with biosimilars development
• The presence of an effective regulatory framework for biologics development in the U.S. has resulted in a large share of the North America market of 34.0% in 2022
• However, Asia Pacific is expected to emerge as the fastest-growing regional market with a CAGR of 5.8% from 2022 to 2032, owing to developing economies such as India and China incorporating developments to sustain the competition.

Biopharmaceuticals Contract Manufacturing Market Trends

1. Increased Outsourcing: Biopharmaceutical companies are increasingly outsourcing manufacturing activities to contract manufacturing organizations (CMOs) due to the complexity and high capital costs associated with biologics production. This trend is driven by the desire to focus on core competencies such as research and development while leveraging the expertise and infrastructure of CMOs for manufacturing.
2. Biologics Dominance: The market for contract manufacturing of biologics, including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies, continues to expand rapidly. Biologics represent a significant portion of the pharmaceutical pipeline, and outsourcing their manufacturing to CMOs allows companies to access specialized facilities and expertise required for bioprocessing.
3. Emergence of Biosimilars: The increasing demand for biosimilars, driven by patent expirations of originator biologics, is fueling growth in contract manufacturing. CMOs are playing a crucial role in the development and manufacturing of biosimilars, offering cost-effective solutions for companies seeking to enter or expand their presence in the biosimilars market.
4. Flexible Manufacturing Platforms: CMOs are investing in flexible manufacturing platforms that enable the production of multiple biologic products with varying scales and complexities. Flexible facilities equipped with single-use bioreactors, modular cleanrooms, and flexible downstream processing capabilities allow CMOs to accommodate the diverse needs of their clients and respond quickly to changes in demand.
5. Globalization of Manufacturing: The contract manufacturing market for biopharmaceuticals is becoming increasingly globalized, with CMOs expanding their presence in key regions such as North America, Europe, Asia-Pacific, and emerging markets. This global footprint enables CMOs to offer proximity to clients, access to diverse regulatory environments, and cost-effective manufacturing solutions.
6. Strategic Partnerships and Alliances: Collaboration between biopharmaceutical companies and CMOs through strategic partnerships and alliances is becoming more prevalent. These partnerships facilitate technology transfer, process optimization, and risk-sharing arrangements, enabling both parties to accelerate product development and commercialization timelines.
7. Quality Assurance and Regulatory Compliance: Ensuring product quality, safety, and regulatory compliance is paramount in biopharmaceutical manufacturing. CMOs adhere to stringent quality standards and regulatory requirements set forth by agencies such as the FDA, EMA, and other regulatory bodies worldwide. Robust quality management systems, good manufacturing practices (GMP), and comprehensive quality assurance programs are integral to CMO operations.
8. Focus on Innovation and Technology: CMOs are continuously innovating and adopting advanced technologies to improve efficiency, productivity, and product quality. This includes the implementation of process analytical technologies (PAT), continuous manufacturing, advanced analytics, and automation to enhance process control, reduce costs, and accelerate time to market for biopharmaceutical products.

Source Insights

The mammalian source segment led the market in 2022 and accounted for the highest share of 60.9%. Based on the source, the market is dived into mammalian and non-mammalian-based contract manufacturing. The intensive investigation that is being carried out on the usage of various sources and species for biopharmaceutical development is expected to drive market growth. The main objective of these investigations is to enhance the productivity and efficiency of biopharmaceutical manufacturing. Mammalian-based biomanufacturing contributed to a higher revenue share owing to the higher cost associated with obtaining products from these sources. Companies engaged in providing contract services using mammalian cell culture include AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals Gmbh, and Catalent Pharma Solutions.

In addition to this, a major percentage of biopharmaceutical products that are in pipeline are mammalian expressed, hence expecting to maintain the dominance over the forecast period as well. Consequently, companies like Lonza and Charles River are making significant investments in the expansion of their mammalian cell culture manufacturing facilities for biologics and biosimilar development. For instance, in October 2017 Lonza acquired a clinical-stage mammalian manufacturing site in the United States from Shire plc. The plant is equipped with single-use bioreactors of 1,000L and 2,000L capacities, coupled with downstream purification capabilities.

Non-mammalian cell line -E. Coli is recognized as the widely adopted non-mammalian cell culture for biopharmaceutical production owing to its rapid access and cost-effective cultivation. The development of a transgenic non-mammalian expression system holds a great promise for the significant growth of this segment throughout the forecast period. Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion are a few companies working as CMOs using microbial cultures.

Service Insights

Process development services led the global market in 2022 and accounted for a share of about 34.7%. This is due to high capital expenditure in downstream processing. Moreover, downstream operations demand vigorous attention for final product recovery and purification steps to maintain product quality and prevent wastage. CMOs have provided biopharma players with a wide array of services ranging from cell cultivation to the final packaging of the product. The manufacturing services offered by CMOs are process development, fill & finish operations, analytical & QC studies, and packaging.

Process development services dominated in 2022 with respect to revenue with downstream processing leading the market. This is due to high capital expenditure in downstream processing. Moreover, downstream operations demand vigorous attention for final product recovery and purification steps, to maintain product quality and prevent wastage. With growing quality concerns and regulatory changes for biopharmaceutical development, analytical & QC studies are expected to grow lucratively during the forecast period. New regulations are being introduced for the production of biologics by CMOs in compliance with regulatory standards to maintain product purity and safety.

Product Insights

The biologics product segment led the market in 2022 with a share of over 82.7%. Contract manufacturers have played a vital role in the success of both biologics and biosimilars. This is majorly due to the huge commercial success of biologics, which is depicted through the presence of a large number of FDA-approved biologics in the market.

Among all the biologics, Monoclonal Antibodies (MAb) have captured the largest share in 2022. A high capital requirement for the construction of a MAb plant has accelerated the uptake of contract services for Mab production, thereby contributing to the major share of this segment.

However, biosimilars production is considered one of the key strategies for business expansion in comparison with biologics because investment in biosimilars manufacturing helps in the fast market reach of the biopharmaceuticals. Moreover, biosimilars have supported the biopharmaceutical CMO industry with respect to cost-saving advantages.

Regional Insights

With a high number of biomanufacturing facilities in the U.S., North America dominated with the largest revenue share of 35% in 2022. Furthermore, revenue from biopharmaceutical-based R&D activities held a major percentage of the total R&D carried out in various sectors in the U.S. Furthermore, interventions & conferences conducted in the region for pertinent technologies and issues in the application of biologics for the treatment of various chronic conditions are anticipated to positively influence regional growth.

However, Asian countries are expected to emerge as the attractive outsourcing location for the biomanufacturing of large molecules. Low manufacturing and operating cost offered by countries, like China & India, is one key factor driving the Asian market. Faster growth in the Korean market is expected to boost revenue generation from the APAC region.

Some of the prominent players in the Biopharmaceuticals Contract Manufacturing Market include:

• Boehringer Ingelheim GmbH
• Lonza
• Inno Biologics Sdn Bhd
• Rentschler Biotechnologie GmbH
• JRS PHARMA
• AGC Biologics
• ProBioGen
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Toyobo Co. Ltd.
• Samsung BioLogics
• Thermo Fisher Scientific, Inc.
• Binex Co., Ltd.
• WuXi Biologics
• AbbVie, Inc.
• Novartis AG
• ADMA Biologics, Inc.
• Catalent, Inc
• Cambrex Corporation
• Pfizer Inc.
• Siegfried Holding AG

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 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global Biopharmaceuticals Contract Manufacturing market.

By Source

• Mammalian
• Non-mammalian

By Service

• Process Development
  • Downstream
  • Upstream
• Fill & Finish Operations
• Analytical & QC studies
• Packaging

By Product

• Biologics
  • Monoclonal antibodies (MABs)
  • Recombinant Proteins
  • Vaccines
  • Antisense, RNAi, & Molecular Therapy
  • Others
• Biosimilars

By Therapeutic Area

• Oncology
• Autoimmune Diseases
• Metabolic Diseases
• Cardiovascular Diseases
• Neurology
• Infectious Diseases
• Others

By Region

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

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