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The development pipelines of big biopharma companies are extensive and it is difficult for such players to carry out manufacturing operations using in house capacities. As a result, such companies often opt to outsource certain aspects of their production processes, predominantly drug substance manufacturing and aseptic filling. Therefore, there is a high demand for contract services from the aforementioned companies
The global biologics contract manufacturing market is estimated to reach over $19 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of ~9% during the forecast period. The biologics contract manufacturing market, also known as the biopharmaceutical CMO market, is a dynamic and rapidly growing sector with a large number of players investing in research and development activities for developing new modalities, such as antibody drug conjugates, biosimilars, and cell and gene therapies. With the increased interest and gradual shift of investment from small molecule drugs to biologics, over the years, more than 250 biologic therapies and vaccines have been developed globally. Notably, biologics have higher success rates than conventional small-molecule drugs owing to lesser off-target toxicity of biologics, which is one of the key reasons of failures in small molecule drugs development. Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics.
In fact, biopharmaceuticals are anticipated to play a significant role in shaping the pharmaceutical industry and will eventually serve as an integral part of traditional medicines. Moreover, the exuberant development of biologics has revolutionized the treatment of a range of therapeutic conditions, which has further contributed to the exponential growth in the current demand for biologic therapies. It is worth highlighting that numerous biologics manufacturers, including biologics CMOs, have adopted digital technologies in order to enhance their productivity and reliability of existing biologics related processes and facilities. In March 2023, Bristol Myers Squibb sent a selection of its protein-based medicines to the International Space Station with the aim to refine their production processes and improve the biomanufacturing of potent medicines.
However, the complexity of biologics, as well as the integration of emerging technologies, offer challenges for current good manufacturing practices (cGMP) for biologics. Some of the key concerns of contemporary innovators include rate of attrition of pipeline drugs / therapies, long development timelines, current facility limitations, regulatory and compliance-related issues, and inconsistencies related to the quality attributes of the final product. As a result, an increasing number of biopharmaceutical drug developers are relying on contract manufacturers that are well-equipped with expertise and advanced technologies for their GMP-based manufacturing requirements. These service providers offer end-to-end solutions, including bioprocess development and optimization, to shorten operational timelines and reduce the high costs associated with the production of complex biologic drugs. In addition, there are some manufacturers that particularly outsource various operations to tap into sophisticated facilities and know-how, particularly if contract manufacturing firms are utilizing cutting-edge technologies, such as software-driven robotics, to enhance manufacturing processes and mitigate the risks and constraints associated with manual methods. With outsourcing becoming increasingly accepted as a viable and beneficial business model within this field, the global market for biologics contract manufacturing is expected to witness remarkable growth during the forecast period.
The Biologics Contract Manufacturing Market by Type of Service Offered (API Manufacturing, FDF Manufacturing), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities associated with the biologics contract manufacturing market, during the given forecast period. Further, the market report highlights the efforts of various stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the biologics contract manufacturing market are briefly discussed below.
Biologics are the essential structural analogs of various biomolecules found in the human body. They are highly specific and have fewer side effects as compared to conventional pharmacological molecules. Thus, biologics exhibit enormous potential to target and eradicate the cause of a disease at the genetic level, which has resulted in the increased interest of various stakeholders in the pharmaceutical and biotechnology industry. Additionally, novel modalities, including recombinant proteins, vaccines, cell and gene therapies, are growing faster than any other segment of medicine. This has led the biologics to be on the verge of surpassing small molecules in terms of revenues.
Conventional methods of biopharmaceutical manufacturing have been revolutionized by single-use technologies and its adoption is rapidly increasing for the production of biologics, including monoclonal antibodies, antibody drug conjugates, vaccines, cell and gene therapies. These disruptive innovations have also played a crucial role during the COVID-19 pandemic, facilitating rapid process development for manufacturing monoclonal antibodies-based drugs and vaccines. Closed plug-and-play solutions offered by single-use systems enable process intensification and continuous manufacturing, thereby becoming a preferred choice from developmental phases to commercial production of biologics.
The current landscape features the presence of over 305 biologics CMO offering contract manufacturing services for biologics. It is worth mentioning that there has been a substantial rise in the number of biologics manufacturing companies over the past decade, indicating a growing demand for capacities for manufacturing both novel and conventional drugs. Further, a significant proportion of the companies (30%) offer services for contract manufacturing of APIs and FDFs to biologic developers; notable examples include 3P Biopharmaceuticals, Afton Scientific, Baccinex, Celltrion, Eubiologics, Genovior, Hybio Pharmaceutical, Kanda BioTech, Lonza and Lubrizol Life Sciences.
The global market for biologics contract manufacturing is estimated to be more than USD 19 billion in 2023. North America currently holds the largest share (34%) of the market, owing to the increasing R&D investments and number of clinical studies pertaining to the development of large molecules. Further, the biologics contract manufacturing market in Asia-Pacific is expected to grow at a relatively high CAGR of 11% during the forecast period. In terms of type of biologic manufactured, cell therapies capture around 40% share of the biologics contract manufacturing market by 2035.
Mammalian cell cultures have become the predominant expression system for the production of biopharmaceuticals, owing to their ability to effectively complete the post-translational modifications required for drug safety and efficacy. Over the past decade, the productivity of mammalian cell culture processes has grown dramatically due to improvements in cell line development.
The biologics CMO are actively adding new facilities in order to accommodate the growing biologics demand. These players are vigorously advancing their capabilities to serve as a fully integrated one-stop-shop by offering a range of biologic services, such as plasmid and viral vector development, fill-finish capabilities and gene delivery solutions. In order to expand the capabilities, expansion and investment in manufacturing facilities is essential. In June 2023, Enzene Biosciences announced the opening of its new state-of-the-art manufacturing facility in Pune, India with an aim to extend their drug development and manufacturing capabilities. In another announcement in March 2023, Biose expanded its live biotherapeutic product (LBP) process development and production capabilities with the opening of a new manufacturing facility in Massachusetts, US.
Post COVID-19 and considering the changes in macro-economic factors, some global biologics CMOs have recently re-evaluated their capacity expansions. In March 2023, Boehringer Ingelheim announced its plans to open a second biologics manufacturing facility in Austria is currently on hold.
Stakeholders in the biopharmaceutical manufacturing industry have forged several partnerships in order to enhance their service portfolios. The growing preference for outsourcing bioprocessing operations is evident from the rise in partnership activity. It is worth highlighting that more than 61% of deals were inked in the last three years. Additionally, this segment of the global contract manufacturing market is growing rapidly and consistently after the COVID-19 pandemic. Notably, majority of the deals are focused on manufacturing and development of biologics, followed by mergers and acquisitions. This can be attributed to the incessant efforts of biologics CMO to further advance the development of their product offerings, across different phases. In May 2023, 3P Biopharmaceuticals signed an agreement with Zhittya Genesis Medicine to manufacture the latter company’s therapeutic candidate, for the treatment of neurodegenerative diseases (Parkinson’s disease). Further, in February 2023, AGC Biologics entered into an agreement with Genenta to manufacture cell therapy lentivirus-based product.
Examples of key biologics CMO (which have also been profiled in this market report) offering manufacturing services include (in alphabetical order) AGC Biologics, Boehringer Ingelheim, Catalent, Cell Therapies, Charles River Laboratories, FUJIFILM Diosynth Biotechnologies, KBI Biopharma, Kemwell Biopharma, Lonza, Miltenyi Biotec, Minaris Regenerative Medicine, Samsung Biologics, Sandoz, Vetter Pharma, WuXi Biologics. This market report includes an easily searchable excel database of all the biologics CMO and details on their manufacturing facilities worldwide.
Several recent developments have taken place in the global biologics contract manufacturing market. Some of these recent initiatives have been mentioned below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we have outlined in our analysis
The study presents an in-depth analysis of the various firms / organizations that are engaged in the biologics contract manufacturing market, across different segments, as defined in the below table:
2018 – 2022
Market Size 2023
Type of Service Offered
|API Manufacturing, FDF Manufacturing
|Type of Biologic Manufactured
|Antibodies, Cell Therapies, Vaccines and other Biologics
|Scale of Operation
|Preclinical / Clinical, Commercial
|Small, Mid-sized, Large, Very Large
|Key Geographical Regions
|North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America
Key Companies Profiled
(Full list of more than 305 companies captured is available in the market report)
|Excel Data Packs (Complementary)
The market report presents an in-depth analysis, highlighting the capabilities of various biologics CMO engaged in this industry, across different geographies. Amongst other elements, the market research report features:
One of the key objectives of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for biopharmaceutical contract manufacturers over the next decade. Based on several parameters, likely adoption trends and through primary validation, we have provided an informed estimate on the market evolution during the forecast period 2023-2035. The market report also features the likely distribution of the current and forecasted opportunity within the biologics contract manufacturing market based on various relevant parameters, such as type of service offered (API Manufacturing, FDF Manufacturing), type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), type of expression system used (mammalian, microbial and others), scale of operation (preclinical / clinical and commercial), company size (small, mid-sized, and large and very large), key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America) and leading players. In order to account for future uncertainties with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s evolution.
The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.