Antibodies Contract Manufacturing Market Segmented By Monoclonal Antibodies, Antibody Fragments, Polyclonal Antibodies Product in Mammalian, Microbial Expression System
Industry: Healthcare
Published Date: December-2022
Format: PPT*, PDF, EXCEL
Delivery Timelines: Contact Sales
Number of Pages: 250
Report ID: PMRREP32933
The global revenue from the antibody contract manufacturing market stands ar US$ 4.8 Bn in 2022, with the global market expected to grow at a CAGR of 12.5% to reach a valuation of approximately US$ 17.5 Bn by the end of 2033.
| Attributes | Key Insights |
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Market Size (2022) |
US$ 4.8 Bn |
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Projected Market Value (2033) |
US$ 17.5 Bn |
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Global Market Growth Rate (2023-2033) |
12.5% CAGR |
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Market Share of Top 5 Countries |
69.4% |
As assessed by Persistence Market Research, monoclonal antibodies are expected to hold a market value of around US$ 15.9 Bn by 2033. Overall, antibody contract manufacturing market sales account for approximately 30.5% revenue share in the global biopharmaceutical contract manufacturing market, which was valued at around US$ 15.7 Bn in 2022.
The global market recorded a historic CAGR of 9.6% in the last 6 years from 2016 to 2022.
Biologics or biopharmaceutical drugs are collective terms for drugs manufactured employing biotechnology. Biologics, as opposed to small-molecule medications, are complex substances like proteins or cells that are employed as pharmaceutical ingredients.
Protein therapies was a limited industry in the twentieth century, but with the development of antibody drugs in the 21st century, it has undergone a significant transformation. The pharmaceutical business eventually experienced a paradigm change as protein therapies took over the sales of new drugs.
The immune system uses an antibody, which is a protein, to recognise and destroy foreign substances known as antigens. Numerous antibody drugs have been designed and introduced to the market by using their capacity to bind different target molecules.
The majority of antibody medications are humanised antibodies, which are produced by integrating the complementarity-determining region of mice mAbs into human antibodies. This finding suggests that antibody drugs have nearly identical physical and chemical properties.
As a result, the manufacturing of antibody medicines can be standardised. Downstream and upstream processes make up an appropriate output of antibody drug production platforms. The downstream process consists of steps to separate the produced antibody components from culture media, inactivate the virus, and fill it as a pharmaceutical product. The upstream process consists of steps to produce a cell line and culture the cell line in a bioreactor.
At pharmaceutical manufacturing facilities, the majority of procedures are batch-style and are governed by good manufacturing practise (GMP) production protocols. The standardisation of the antibody manufacturing process leads to the standardisation of manufacturing tools, ancillary materials, and raw - materials processes. The standardised production of antibodies has made it simpler for biopharmaceutical businesses to contract manufacture their products with biopharmaceutical CDMOs.
Production technologies with same calibre as that offered by pharmaceutical corporations can be obtained from CDMOs for biopharmaceuticals. For biopharmaceutical CDMOs to compete with manufacturing facilities in presently established CDMO industries, they will need to develop and acquire unique production technologies.
The global market is thus likely to show high growth over the coming years at a CAGR of 12.5% and reach a global market size of US$ 17.5 Bn by 2033.
“Development of End-to-End Continuous Manufacturing Process”
Attention is being drawn to the end-to-end continuous manufacturing process as a promising biologics production system in the future. Recently, the continuous processes of viral inactivation, membrane chromatography refining, concentration/buffer exchange, and storage processes have been clarified. These processes include the manufacture of therapeutic antibodies using a perfusion bioreactor.
For each operation, the continuous process eliminates the need to extract products, which might cut down on manufacturing time, operator count, and contamination risk.
Additionally, real-time quality monitoring can be used to achieve very dependable quality assurance. Continuous production will reduce the cost of manufacturing of antibody drugs, per some cost simulations.
In 2017, Steinebach et al. reported on a full continuous production method of antibody drugs on a lab scale. In contrast to the batch approach, continuous culture was successfully carried out using this method for 18 days, and the quality of the product was adequate.
Furthermore, it appears that the implementation of continuous manufacturing is moving more slowly than expected.
This is mostly because continuous process development and implementation take a long time to pay off an initial investment. Due to the system's high level of complexity, use of the continuous manufacturing approach is likewise constrained.
Despite the advancement of digital technologies like supervisory control and data capture, there is room for advancement if end-to-end continuous manufacturing of biologics is to be accomplished in real-world settings.
These opportunities will provide the market with traction in terms of growth over the forecast period.
“High Cost of Manufacturing and Lack of Skilled Professionals”
The cost of manufactured product is significantly influenced by international regulatory requirements, cGMP, inspection regimen strengthening, and supply chain security concerns across rising countries, and R&D financing for some initiatives. Due to these considerations, new entrants who want to enter the biopharmaceutical contract manufacturing industry face financial difficulties.
Given that biopharma companies have invested more than US$ 50 Bn in new facilities and equipment just in the last five years, high investment costs related to contract manufacturing of antibodies are one of the main bottlenecks. A large portion of that has been in emerging markets and tax havens like Singapore and Ireland.
The majority of the projects have been outside of the U.S. Simply said, there are not enough facilities, and the ones that are available are not up to date with current pharmaceuticals. Designing, constructing, and qualifying a new plant takes close to four years. Costs for large-scale facilities might range from $1 billion to $2 billion.
Emerging regions need qualified professionals to grow their economies. There is a significant shortage of skilled workers in comparison to the current workforce, according to many companies. Although progress has been gradual, many governments wish to support the growth of a commercial biotechnology industry to replicate the American model.
The development of contract manufacturing for antibodies has been constrained in the majority of emerging nations by inadequate finance, poor planning, and a shortage of skilled personnel.
Why is the U.S. Antibody Contract Manufacturing Market Booming?
“Rising Number of Clinical Trials and Increasing Demand for Contract Manufacturing”
The U.S. accounted for around 89.4% market share in the North America market in 2022. The growing number of clinical trials, the existence of major market participants, the advanced healthcare system, the rise in demand for antibodies contract manufacturing, and the increased focus of governments on biologics are all contributing factors.
Additionally, a number of mAb candidates for the treatment of COVID-19, had reached human clinical trials, and were made more widely available to patients through fast-track approval or emergency use authorization in a matter of months.
The market in the nation has expanded as a result of these activities.
Will U.K. Be a Lucrative Market for Antibody Contract Manufacturing?
“Existing Recommendations and Guidelines for Treatment of Infectious Diseases by Medical Societies”
U.K. held around 26.7% market share of the Europe market in 2022. The burden of various infectious/neglected diseases and drug-resistant bacterial infections falls disproportionately on poor nations, and as a result, there is not a significant financial incentive for pharmaceutical corporations to fund this study.
Alternative funding strategies are therefore filling the deficit. Nearly two-thirds of the world's financing for research and development on neglected and infectious diseases came from the public sector in 2016, with the US, UK, and European Commission taking the top spot.
With such initiatives and rising regulations, the market in the U.K. is expected to expand at a lucrative pace over the forecasted years.
How is South Korea Emerging as a Prominent Market?
“Recognized CMO Activity for Biologics in the Country”
South Korea held a market share of about 70.6% of the East Asia market in 2022. Since 2014, IMAPAC, the company behind Biologics Manufacturing Korea, has held an academic conference at the end of every February with the participation of 400 experts from more than 100 governments, NGOs, industry-related companies, and academic institutions. At this conference, outstanding businesses are recognised and awarded in each category.
The conference covers a wide range of issues, from the development, manufacturing, and quality assurance of biologic drugs to GMP and CMO operations, and features significant participation from international biopharmaceutical companies, CMOs, academia, and regulatory agencies from each country.
The Korea Bioprocessing Excellence Award went to Merck at the October 21st Biologics Manufacturing Korea 2020 event.
Such recognitions propel South Korea as a profitable market around the globe for contract manufacturing of antibodies.
Which Product is Driving Demand within the Global Market?
“Rising Chronic and Terminal Diseases and Development of Process Control Strategies”
The monoclonal antibodies segment held around 89.1% share of the total market in 2022. The production of monoclonal antibody (mAb) treatments involves a templated method that calls for reliable, scalable solutions for each step, from cell line generation until final fill.
Enhanced process knowledge has resulted in improvements in mAb production, including efficiency in both downstream and upstream processing.
Due to the importance of mAbs in the treatment of chronic or terminal diseases, manufacturers are always working to keep up with the rising demand on a worldwide scale, while also keeping prices under control and retaining production flexibility for their growing clinical pipelines, through contract manufacturing.
Which Expression System is Largely Adopted in the Global Market?
“High Exclusivity with Human Cell Expression”
The mammalian expression system holds a share of about 84.4% in 2022. The most common platform for developing biopharmaceuticals is mammalian expression systems because these cell lines can generate large, complex proteins with post-translational modifications that are comparable to those produced in humans.
Additionally, most proteins in mammalian cell lines and animal cell lines in general can be secreted without the need for cell lysis to extract them followed by protein refolding. When compared to other mammalian expression systems, human cell lines have the capacity to produce proteins that are most like those that humans naturally synthesize.
With today's technological advancements, human cell lines can now be used more productively, and fibrosarcoma HT-1080 and human embryonic kidney 293 cell lines can now be used to generate approved recombinant bio therapeutic products.
Which Company Size Offers the Market a Profitable Outlook?
“Growth Potential in Mid-Size CDMOs”
Mid-sized companies hold a share of about 46.2% in the global market in 2022. Small and medium-sized pharmaceutical firms, which are increasingly responsible for the approval of novel drugs but frequently lack the manufacturing capability to do so, will present new market prospects for CDMOs. One real concern for these businesses is that CDMOs that also provide services to larger pharmaceutical businesses may view their initiatives as being of secondary value.
Therefore, paying attention to smaller clients and comprehending their unique needs can be a successful differentiating tactic for CDMOs, thus propelling the market value for this segment over the forecast period.
Which Scale of Operation Generally Promotes Market Growth?
“High Disease Incidence and Rising CMO Activities to Meet Demand”
The commercial scale of operation holds a share of about 54.4% in the global market in 2022. Growing prevalence of chronic and infectious diseases has propelled the introduction of novel biologics in the global market. Owed to the increasing adoption of contract manufacturing in Asia Pacific region, the commercial scale of operation of several biologics holds a greater share in the global market.
The market for the contract manufacturing of antibodies will continue to consolidate as major competitors pursue inorganic growth strategies to provide customers with comprehensive solutions. Furthermore, chances for contract manufacturing of antibodies with significant capabilities are growing as a result of scientific developments in biopharmaceuticals.
Differentiation strategies for long-term sustainability are being driven by the growing antibody contract manufacturing business strategy, innovation in the biopharmaceutical industry, disruptive drug discovery and manufacturing technologies, and significant growth potential in the production of high potency biopharmaceuticals.
Some key instances of development include:
Similarly, the team at Persistence Market Research has tracked recent developments related to companies in the antibody contract manufacturing market, which are available in the full report.
| Attribute | Details |
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Forecast Period |
2023-2033 |
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Historical Data Available for |
2016-2022 |
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Market Analysis |
USD Million for Value |
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Key Countries Covered |
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Key Market Segments Covered |
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Key Companies Covered |
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Report Coverage |
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Customization & Pricing |
Available upon Request |
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The global market is currently valued at around US$ 4.8 Bn in 2022.
Sales of the market are set to witness growth at a CAGR of 12.5% and be valued at around US$ 17.5 Bn by 2033.
Demand for the global market increased at a 9.6% CAGR from 2016 to 2022.
The U.S., South Korea, U.K., Germany, and China account for most demand within the market, currently holding around 69.4% market share.
The U.S. accounts for around 89.4% share of the North American market in 2022.
Latin America accounts for around 2.1% share of the global market in 2022.
South Korea held a market share of about 70.6% of the East Asia market in 2022.
U.K. held around 26.7% market share of the Europe market in 2022.
Brazil antibody contract manufacturing market is expected to grow at a 13.9% CAGR during the forecast period.
The antibody contract manufacturing market in India is set to expand at an 18.6% CAGR over the forecast period.
