Market Overview:

The global antibodies contract manufacturing market size was valued at USD 15.40 Billion in 2023 and it expect to reach a value of USD 47.39 Billion by 2032 at a compound annual growth rate (CAGR) of 13.3% during the forecast period.

The growth is mainly led by the growing interest of biopharmaceutical and biotechnology companies in the production of antibody therapies. These drugs work really well to treat conditions such as rheumatoid arthritis, cancer, and other serious illnesses. Therefore, the demand for therapeutic antibody production is growing rapidly, expanding this market. The use of monoclonal antibodies in the treatment of COVID-19 has also increased the demand for the production of antibodies. The COVID-19 pandemic that is strong till today has helped the market.

In the wake of the COVID-19 pandemic, mRNA vaccine technology and global manufacturing afterward represent a significant step forward in antibody production. The number of mRNA candidates under investigation is now around 220, and treatments and vaccinations based on nucleotides will gain more momentum. The pandemic has mainly focused the efforts of CDMO on accelerating production scale up toward commercial supply, but in fact, because of this new generation of molecules, there is an increasing demand for technology and outsourced early phase development services.

Critical players have been forming strategic alliances aimed at developing COVID-19 treatments. Lonza and Moderna, for example, announced in May 2020 a ten-year strategic collaboration deal to support production of the Spikevax COVID-19 vaccine and other Moderna products in the future.

Many biotechnology and pharmaceutical companies have increased their research and development activities to develop biologics, such as monoclonal antibodies. Biologics are the most targeted way of treatment for various lung conditions, such as lung cancer, asthma, and lung infections. Thus, R&D investment is an essential strategy for long-term business sustainability.

To achieve market dominance, several biotechnology and pharmaceutical companies are teaming up and establishing strategic collaborations. In January 2022, Fujifilm Diosynth Biotechnologies announced that the company would be acquiring Atara Bio therapeutics, Inc., a company producing cell therapy products, thereby expanding its product portfolio of advanced therapies. Players are also expanding their presence across the globe.

Manufacturing of biopharmaceuticals is recognized to have a significant potential for growth. A large majority of companies in the health sector believe that within the near future, this business will feature in the top 10 revenue generators. It is also anticipated that a surge in CMOs for the manufacture of biopharmaceuticals would be a natural aftermath of the market players' concerted efforts to build up this sector to meet the increasing needs for bio-based pharmaceuticals. Indeed, a strong pipeline of products has been developed thanks to the healthy industry expansion of the biopharmaceuticals.

As several corporations began outsourcing parts of their biopharmaceutical manufacturing to contract manufacturers based on understanding the cost-effectiveness associated with contract manufacturing, FDA has approved a large number of biopharmaceutical products, designed antibody-like biomolecules, and monoclonal antibodies and recombinant proteins. The number of approvals increased significantly during the pandemic by which U.S. FDA awarded Emergency Use Authorization, or EUA. For instance, the therapy involved in monoclonal antibodies, where EUA got approved to be administered for Imdevimab and Casirivimab.

Key Findings:

• In January 2024, WuXi Biologics announced that its Research Service Unit (R in CRDMO) has entered into a research service agreement with BioNTech SE, a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.
• In September 2023, Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a Bristol Myers Squibb commercial antibody cancer drug substance.

Market Drivers

Increasing Demand for Biologics

• The contract manufacturing of antibodies is primarily driven by the fast-growing demand for biologics, specifically monoclonal antibodies (mAbs). Biologics are sought after since they can take care of various health issues, such as cancer, autoimmune diseases, and infectious disease, due to the effectiveness of their mechanism of action. Being products of living systems, biologics, particularly mAbs, exhibit increased efficacy and fewer side effects as compared to conventional small molecule drugs.
• The fact that the number of patients prescribed biologic therapy is increasing due to awareness of the benefits contributes to the demand. The fact that biotechnology has been able to develop new antibodies with better therapeutic profiles and modes of action has also resulted in new products. This trend is further amplified by the emergence of personalised medicine, which uses biologics customised to meet the needs of specific patients. Pharmaceutical companies are investing very fast in research and development of novel antibody therapeutics due to the bright clinical trials results.
• This rise in demand calls for strong manufacturing expertise and pushes biopharmaceutical companies to collaborate with CMOs to scale up production safely. CMOs possess the knowledge and technical platform required to fulfil the regulatory and entry requirements into markets. Taking everything into consideration, the market for contract manufactured antibodies is propelled by the robust growth in the demand for biologics, pushing further investment and innovation in that area.

Key Findings:

• In April 2024, Labcorp, a leading global life sciences company that is a pioneer in innovative and comprehensive laboratory services, announced the strategic expansion of its precision oncology portfolio, further establishing its place in the pursuit of the advancement of cancer research and patient care on a global level.
• In February 2024, announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.

Market Opportunities

Growth in Biosimilars Market

• There is a good opportunity for the global antibody contract manufacturing market due to the surge in the biosimilars market. This is because the market for biosimilars—biologic treatments that are highly similar to previously approved reference products—is growing as patents on much of the original biologic therapeutics, such as monoclonal antibodies, expire.
• The need for cheaper alternatives to biologic therapy which reduces the healthcare cost sharply not only for patients but also for payers is driving this evolution. The increasing acceptance of these products on the part of regulatory agencies and healthcare providers further opens up commercial opportunities in biosimilars. As regulatory frameworks for biosimilars become more streamlined and established, ever more companies enter this market segment which requires strong manufacturing capabilities.
• Contract manufacturing companies are at an advantageous position because they have both the infrastructure and experience for producing high-quality biosimilars that would meet legal standards. CMOs will benefit from the opportunity by revenue generation and through diversified service offerings, especially if the pharmaceutical companies would be interested in developing biosimilars.
• Biosimilars are highly demanded by expanding the focus on patient access to reasonably priced therapies. This field must be further resourced and developed, as this market in due course would offer a lot of opportunities for CMOs and biopharmaceutical firms, thereby stimulating competition and innovation in the area of contract manufacture of antibodies.

Market Restraining Factors

High Cost of Antibody Manufacturing

• The high cost of the synthesis of antibodies is a significant restraint on the global market for antibodies contract manufacturing. Cell line generation, running of bioreactors, purification, and quality control are some of the very complex and resource-intensive processes involved in producing antibodies, especially monoclonal antibodies.
• Such processes are more expensive to produce due to the specialized equipment, skilled labourers, and strict adherence to regulations. The funds are further amplified by the high-end bioprocessing facilities and technologies, including GMP. It will be challenging for smaller biotechnology companies or start-ups to reserve enough inputs to make large-scale productions of antibodies because of these costs. This will consequently make many businesses limit or delay their research and development, which in turn will minimize their ability to introduce new treatments into the market because of budget constraints.
• Moreover, manufacturing costs can also deteriorate by the shifting raw material prices, the cost of complying with regulations, and the possibility of process-related problems. Here, smaller companies may face difficulties in effective competition, despite more significant pharmaceutical corporations having a financial opportunity to cover these expenses. For that reason, high production costs of antibodies remain a tremendous barrier preventing the availability and expansion of antibody-based treatments in the biopharmaceutical industry.

Segmentation Analysis

The market scope is segmented because of by Product, by Source, by End-User.

By Product

Based on the Product of the market is segmented into Monoclonal Antibodies, Polyclonal Antibodies, Others.

Monoclonal antibodies are the highest in-demand product segment in the antibody contract manufacturing market as they are developed for a multitude of therapeutic purposes and account for a large market share. Monoclonal antibodies are targeted to bind at specific antigens; thus, they have the potential to treat extensively varied illnesses, ranging from infectious diseases and autoimmune diseases to malignancies. Unlike polyclonal antibodies, drawn from many sources, which can sometimes act more erratically, therapeutic effectiveness is enhanced by their ability to be engineered for specificity and precision.

The demand for monoclonal antibodies is booming with the surge in chronic diseases and also with the increase in costs for research and development. Personalized treatment, which aims at tailoring therapy according to a specific patient profile, often relies on these biologics, and it was this that led to their employment in the clinic. On the other hand, their commercial position has been strengthened by the acceptance of novel monoclonal antibodies and developments in antibody engineering, such as specific antibodies and antibody-drug conjugates.

Regulatory support and the increasing adoption of monoclonal antibodies by health care providers have also contributed to their market leadership. Contract manufacturing companies are increasingly calibrating their capacities in response to the industry-specific requirements that pharmaceutical companies are focusing on while developing monoclonal antibodies or mAbs. Calibration supports scale requirements for successfully launching such critical medicines into the marketplace in addition to ensuring compliance with regulatory norms.

By Source

Based on the Source of the market is segmented into Mammalian, Microbial.

Mammalian cell systems are the leader in the source divisions of the antibodies contract manufacturing market due to their ability to produce complex, properly folded proteins and are therefore far better at fulfilling the requirements needed for effective therapeutic antibodies. Mammalian cell systems—more specifically, Chinese hamster ovary (CHO) cells—is preferred for monoclonal antibodies due to the fact that they can perform post-translational changes, such as glycosylation, which are essential for biologic product stability and activity. The alterations allow these products to achieve the desired pharmacokinetics and pharmacodynamics, ensuring that the antibodies behave as they do in the human body.

The ever-increasing need for monoclonal antibodies in treatments of autoimmune and cancer diseases underscore the greater importance of mammalian systems. As pharmaceutical companies focus attention on producing new and highly targeted drugs, mammalian cell systems become vital in the production of high-quality antibodies with proper structural integrity. Additionally, because goods formulated from mammalian systems more closely mirror human biological processes, regulation bodies often favour them, raising their market attractiveness.

Microbial systems, such as yeast and E. coli, are other examples that have the capability to produce antibodies much faster and at a relatively lower cost, however, they lack the ability to produce complex proteins and post-translational changes that many therapeutic antibodies require. Given this limitation in their ability to be applied, especially to more sophisticated antibody formats, mammal cell systems have remained leaders in the industry of contract manufacture of antibodies.

Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. North America remains the global market leader for the contract manufacture of antibodies because of its strong biopharmaceutical industry, large R&D expenditure, and concentration of big biotechnology and pharmaceutical businesses. Specifically, the United States leads globally in the production of monoclonal antibodies, with the help of sophisticated manufacturing techniques, strong regulatory frameworks, and a highly qualified labour force. The region's focus on innovation in creating new treatments along with its growing focus on personalized medicine is fuelling the requirement for better antibody production. As chronic diseases such as cancer and autoimmune diseases spread, the need for effective therapeutic options promotes North America's market position.

Still, the Asia-Pacific area is poised to grow at the fastest pace. All these are fuelled by growing outsourcing of production from Western companies seeking cheaper alternatives, a fast-growing health care sector and increased investment in biotechnology infrastructure. Pharmaceutical multinationals are establishing production units in the latter two countries that are gaining significant ground in building their manufacturing capabilities. Demand for biologics, specifically monoclonal antibodies in Asia-Pacific countries, is expected to increase because of better access to healthcare and rising populations. For this reason, this region will be important going forward for market expansion.

List of Companies Profiled

• Lonza
• Samsung Biologics
• WuXi Biologics.
• Charles River Laboratories
• FUJIFILM Holdings Corporation
• Boehringer Ingelheim Biopharmaceuticals GmbH.
• AGC Biologics
• Cytovance Biologics, Inc.
• EMERGENT
• Thermo Fisher Scientific
• Labcorp Drug Development
• Catalent, Inc.

Key Industry Developments

• In June 2023, Lonza, a manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, today announced that it has acquired Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage technology platform for the development of ADCs.
• In October 2022, Thermo Fisher Scientific Inc. The world leader serving science announced that it has completed its acquisition of The Binding Site Group ("The Binding Site"), a global leader in specialty diagnostics, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.3 billion, or $2.8 billion at current exchange rates. Thermo Fisher announced the agreement to acquire.
• In 21 September 2021, Boehringer Ingelheim announced an agreement to acquire Abexxa Biologics Inc., a biopharmaceutical company pioneering in immuno-oncology and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments.

Report Coverage

The report will cover the qualitative and quantitative data on the global Antibodies Contract Manufacturing Market. The qualitative data includes latest trends, market players’ analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Antibodies Contract Manufacturing market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Antibodies Contract Manufacturing. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Antibodies Contract Manufacturing companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Antibodies Contract Manufacturing Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Antibodies Contract Manufacturing Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions

• How much the global Antibodies Contract Manufacturing Market valued?
• Which region has the largest share in 2024 for the global Antibodies Contract Manufacturing Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of Antibodies Contract Manufacturing Market

• Historic year: 2019-2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Billion

Antibodies Contract Manufacturing Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: