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Market Overview

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The global biopharmaceutical contract manufacturing market is expected to experience a Compound Annual Growth Rate (CAGR) of 14.37% from 2022 to 2027. It is projected to surpass $25.20 billion by 2027, compared to $11 billion in 2021. Several factors contribute to the growth of this market, including the increased uptake of branded biologics and biosimilars, mandatory immunization programs for newborns and children to prevent diseases, and ongoing global COVID-19 vaccine programs aimed at curbing the pandemic.

The biopharmaceutical contract manufacturing market consists of companies involved in advanced technology, scientific advancements, and complex research and development (R&D) activities. These organizations, known as Contract Manufacturing Organizations (CMOs) or Contract Development and Manufacturing Organizations (CDMOs), provide drug development and manufacturing services to the pharmaceutical industry. Outsourcing manufacturing processes allows pharmaceutical and biopharmaceutical manufacturers to focus on their core competencies and improve process efficiency, thereby driving the growth of the biopharmaceutical contract manufacturing market.

Cell and gene therapies are emerging as dynamic fields with increasing research and development activities. Many vendors and research organizations are engaged in the R&D of these therapies, particularly in the United States, which offers untapped potential. Factors such as rising product approvals, increased investment in regenerative medicines and biologics, and growing demand for cell and gene therapies contribute to the overall growth of the biopharmaceutical contract manufacturing market.

The biosimilars pipeline continues to expand, with numerous approvals and launches in recent years. The number of biosimilars in development has significantly increased, along with the number of marketed biosimilars. This growth has positively impacted the biopharmaceutical contract manufacturing market. Additionally, the European Union has approved more than 40 biosimilars as of 2018.

Gene therapies have also seen a rising trend in the biopharmaceutical industry. Biopharma companies and the FDA have shown support for gene therapy development. Due to the time and cost involved in developing and manufacturing gene therapies, many biopharmaceutical companies are turning to CMOs to reduce operational risks and manufacturing time. Outsourcing to established CMOs allows these companies to leverage expertise, facilities, and regulatory knowledge, further contributing to the growth of the biopharmaceutical contract manufacturing market in the gene therapy sector.

The biopharmaceutical manufacturing market helps address challenges faced by the industry, such as high R&D spending, declining return on investment, regulatory pressures, and the need for improved productivity. Outsourcing manufacturing operations allows pharmaceutical companies to enhance operational efficiency, expand their geographic reach, and access specialized services. While larger companies outsource established products to focus on new developments, small and medium-sized enterprises (SMEs) rely on contract manufacturing for product commercialization.

The decision of pharmaceutical and biotechnology companies to outsource manufacturing directly impacts the biopharmaceutical contract manufacturing market. Virtual companies often outsource all production as part of their overall strategy, while companies with in-house manufacturing may employ different strategies based on their specific situations. As a result, the market continues to grow, driven by both virtual companies and those with organic production capabilities.

CMOs and CDMOs are investing in expanding their manufacturing capacity to meet future demand. The total manufacturing capacity is projected to increase by 60% over the next three years, primarily focused on mammalian cell cultures. Despite this expansion, capacity utilization rates are expected to remain in the low 70% range. To meet future needs, CMOs are also investing in services, research centers, and improvements related to the manufacturing of cell and gene therapies.

Several vendors in the biopharmaceutical contract manufacturing market are focused on developing and marketing single-use bioprocessing products to remain competitive and expand their market presence. R&D activities and product launches contribute to market growth, and vendors such as Boehringer Ingelheim GmbH, AbbVie Inc., Lonza, AGC Biologics, Catalent, Samsung Biologics, and WuXi Biologics have significant market shares due to their continuous innovation and product launches. Product approvals and launches between 2015 and early 2021 have positively influenced the market.

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Market Segmentation

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The market is segmented based on various factors, including product, biologics, expression system, scale of operations, company size, and geography.

Segmentation by Product Type
Finished Dosage Form (FDF)
Active Pharmaceutical Ingredients (APIs)

Segmentation by Biologics
Monoclonal Antibodies (mAbs)
Vaccines
Others

Segmentation by Expression System
Mammalian
Non-Mammalian

Segmentation by Scale of Operations
Commercial
Research (Clinical & Preclinical)

Segmentation by Company Size
Large & Very Large Companies
Small & Mid-Sized Companies

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain, Switzerland
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico
Middle East & Africa – South Africa, Saudi Arabia, Turkey, UAE

The global biopharmaceutical contract manufacturing market can be categorized based on product type, with Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) as the main segments. In 2021, the FDF segment accounted for the majority share of around 50.52%. This is because the FDF stage is critical in the product life cycle and requires high-standard manufacturing facilities either within the pharmaceutical company or through outsourced manufacturing.

There has been a significant increase in demand for biologics in the global biopharmaceutical contract manufacturing market. Among the biologics sector, monoclonal antibodies (mAbs) have reported a substantial market share. The mAbs segment is expected to grow further due to the entry of various companies, including big pharma, small biotech, and generic participants, into the global biosimilars development. This growth will significantly boost the market.

In the impression system category, the mammalian segment holds a higher global biopharmaceutical contract manufacturing market share. This is because the development of biopharmaceuticals made from transgenic mammalian cell lines remains a central pillar of the biotechnology and pharmaceutical industry. Moreover, mammalian-expressed biopharmaceuticals constitute a significant proportion of candidates in the biopharmaceutical pipeline.

Among different scales of operation, the commercial segment holds the largest market share. The commercial segment is driven by the increasing prevalence of infectious diseases, epidemics, and pandemics, which demand the production of billions of doses of biotechnology products within a short span of time. Small-scale manufacturing for clinical trials and large-scale drug substance and product manufacturing face limitations, making commercial contract manufacturing crucial in meeting these demands.

Large-sized companies dominate the biopharmaceutical contract manufacturing market, accounting for a significant share of approximately 58.66%. Large biopharmaceutical companies rely on contract manufacturing organizations (CMOs) for large-scale biologics production. With a focus on drug development rather than manufacturing, these companies rely on CMOs to provide access to capacity without investing in facilities.

In terms of regional distribution, North America is the leading market, accounting for a revenue share of 37.21%, followed by Europe. The APAC region is experiencing the fastest growth due to emerging countries such as China and Japan, which offer low labor costs and increased outsourcing of biologics manufacturing.

North America’s dominance in the biopharmaceutical contract manufacturing market can be attributed to its well-established position, with prominent biopharmaceutical manufacturing companies based in the region. The increasing demand for cell and gene therapy, as well as the presence of key companies, contributes to this market dominance. Particularly, the U.S. is a major revenue contributor in North America.

In Europe, the growth of the biopharmaceutical contract manufacturing market is driven by factors such as the increasing elderly population, prevalence of autoimmune diseases, respiratory disorders, cancer, and the expanding biopharma and biotech industry. Government bodies’ high focus on research and development across European regions also leads to significant investments and drives the biopharmaceutical outsourcing market.

Latin America shows potential for growth in the biopharmaceutical contract manufacturing market due to increasing expenditure on regenerative medicine development and clinical trials. The rise in clinical trials related to cell and gene therapies further stimulates the growth of manufacturing companies in the region, triggering the development of the biopharmaceutical contract manufacturing market.

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Competitive Landscape

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The biopharmaceutical contract manufacturing market is characterized by high levels of competition, with numerous global, regional, and local companies engaged in the manufacturing of various biopharmaceutical products on a contract basis. These companies vie for market share based on the breadth of services offered, pricing, quality, and their ability to scale up production.

Key players in this market include well-established companies such as Samsung Biologics, Lonza, and Boehringer Ingelheim GmbH. These companies have a significant presence and influence in the market. Additionally, there are emerging players like AbbVie, Inc., Catalent, Emergent BioSolutions, FUJIFILM Diosynth Biotechnologies, Merck KGaA, Pfizer CentreOne, Serum Institute of India, and WuXi biologics that also hold substantial market shares and actively seek expansion opportunities in the biopharmaceutical contract manufacturing sector. The presence of these companies adds to the competitive intensity of the global market.

Samsung Biologics, for instance, has made substantial investments to enhance its manufacturing capacity. It has allocated approximately USD 2 billion towards the development of a super plant in Incheon, South Korea, which will have a production capacity of 256,000 liters.

To stay ahead in the market, vendors in the biopharmaceutical contract manufacturing industry engage in strategic acquisitions and collaborations. These activities allow them to develop proprietary technologies, strengthen their capabilities, and enhance their brand image. Catalent, for example, expanded its early development capabilities through the acquisition of Pharmatek Laboratories, showcasing its commitment to growth and advancement in the industry.

Key companies profiled in this report include Boehringer Ingelheim, Lonza, Samsung Biologics, AbbVie, Catalent, Emergent BioSolutions, FUJIFILM, Merck KGaA, Pfizer, Serum Institute of India, WuXi Biologics, AGC Biologics, Ajinomoto, Albany Molecular Research (AMRI), Asymchem, Biocon, Cobra Biologics, Charles River Laboratories, Goodwin Biotechnology, KBI Biopharma, Sanofi, Bavarian Nordic, Wacker Biotech B.V, Jubilant HollisterStier, National Resilience, Novasep, Kemwell Biopharma, Midas Pharma, Alcami, Cambrex, Pharmaceutics International, Singota Solutions, Thermo Fisher Scientific, Binexc, Canton Biologics, ChemPartner, Cytovance Biologics.

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Key Questions Answered

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What is the size of the global biopharmaceutical contract manufacturing market?

The global biopharmaceutical contract manufacturing market was valued at USD 11.30 billion in 2021 and is expected to reach USD 25.30 billion by 2027.

What is the projected growth rate of the global biopharmaceutical contract manufacturing market?

The global biopharmaceutical contract manufacturing market is expected to grow at a compound annual growth rate (CAGR) of 14.37%.

Which companies are key players in the biopharmaceutical contract manufacturing market?

Key companies in the biopharmaceutical contract manufacturing market include Samsung Biologics, Lonza, and Boehringer Ingelheim GmbH.

What are the trends driving the growth of the global biopharmaceutical contract manufacturing market?

Some significant trends driving the growth of the global biopharmaceutical contract manufacturing market include mergers and acquisitions among biopharmaceutical manufacturers and the increased manufacturing of gene therapies by contract manufacturing organizations (CMOs).

Which region has the largest market share in the global biopharmaceutical contract manufacturing market?

North America holds the largest market share in the global biopharmaceutical contract manufacturing market. The region has experienced a significant increase in demand for biopharmaceutical contract manufacturing due to a rise in drug development activities.