Biologics Contract Manufacturing Market

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

-

Biologics Contract Manufacturing Market Overview

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.

Key Market Insights

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. 

Growing Demand for Biologics

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.  

Fundamental Advancements in the Biopharmaceutical Manufacturing Processes

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.  

Competitive Landscape of Biologics Contract Manufacturing Companies

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. 

Biologics Contract Manufacturing Market Size: North America to Hold the Largest Market Share 

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 is the Most Preferred Choice of Expression System Amongst Biologics Contract Manufacturing Players

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. 

Biologics CMO Made Considerable Investments to Build or Expand Manufacturing Facilities, With Some Global CMOs Re-evaluating Capacity Investments

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.  

Biologics Contract Manufacturing Market Trends Analysis: Increasing Partnerships and Collaborations to Foster Progress and Innovation

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.

Leading CMOs Engaged in Biologics Contract Manufacturing Market 

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.

Recent Developments in the Biologics Contract Manufacturing Market

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 

• In June 2023, Cell and Gene Therapy Catapult announced a technology licensing agreement with Albumedix, under which the latter company’s latest technology will be utilized for improving the manufacturing of viral vectors. 
• In June 2023, Wuxi Biologics, offering end-to-end solutions to discover, develop and manufacture biologics, announced the expansion of its capacity for drug substances and drug products at its facility in Wuppertal, Germany. 
• In March 2023, Samsung Biologics announced the construction of a fifth plant, at its facility in Incheon, South Korea, as part of its strategic expansion in response to increased market demand. Upon its completion, the plant is expected to hold a manufacturing capacity of 180,000 L and will expand the company’s total site capacity to 784,000 L by investing a sum of KRW 1.9 trillion.
• It is interesting to note that in February 2023, LOTTE BIOLOGICS announced the addition of three biomanufacturing plants in South Korea in order to produce a total of 360,000 L of antibody drugs. Such capacity additions are expected to drive biologics contract manufacturing market growth, during the forecast period.

Scope of the Report

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:

Market Segmentations

Report Attribute	Details
Historical Trend	2018 – 2022
Base Year	2022
Forecast Year	2023-2035
Market Size 2023	$19.9 billion
CAGR	~9%
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
Company Size	Small, Mid-sized, Large, Very Large
Key Geographical Regions	North America, Europe, Asia-Pacific, Middle East and North Africa, Latin America
Key Companies Profiled	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 (Full list of more than 305 companies captured is available in the market report)
Excel Data Packs (Complementary)	Market Landscape Analysis Regional Capability Analysis Big Pharma Initiatives Partnerships and Collaborations Mergers and Acquisitions Recent Expansions Capacity Analysis Demand Analysis  Total Cost of Ownership Market Forecast and Opportunity Analysis

 

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:

• A preface providing an introduction to the full market report, Biologics Contract Manufacturing Market, 2023-2035.
• An outline of the systematic research methodology adopted to conduct the study on the biologics contract manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
• An overview of economic factors that impact the overall biologics contract manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the key insights captured during our research, offering a high-level view on the current state of the biologics contract manufacturing market and its likely evolution in the short to mid-to-long term.
• A brief introduction to the biologics contract manufacturing market, highlighting general overview of biopharmaceuticals, biopharmaceutical manufacturing processes, and various expression systems used for the development of different types of biotherapeutic products. Further, it features a brief overview of biologics contract manufacturing, along with a detailed discussion on the need for outsourcing within the biopharmaceutical industry. It also provides information on the challenges faced by players currently engaged in this market. 
• An overview of the current market landscape of companies engaged in offering contract manufacturing services for biologics, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service offered (API and FDF manufacturing), type of biologic manufactured (antibody drug conjugates, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single-use and stainless steel) and mode of operation of bioreactor (batch, fed batch and continuous).
• An insightful analysis, highlighting the detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.
• Elaborate profiles of key biologics CMO based in North America that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, along with details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.
• Elaborate profiles of key biologics CMO based in Europe that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, along with details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.
• Elaborate profiles of key biologics CMO based in Asia-Pacific that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, along with details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.
• A detailed discussion on the key enablers in this industry, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market.
• A case study on the growing global biosimilars market, highlighting the associated opportunities for biologics CMOs and CDMOs.
• A case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
• A detailed discussion on the benefits and challenges associated with in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource the production operations.
• A qualitative analysis, highlighting various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a biologics CMO.
• A review of the various biopharmaceutical-focused manufacturing initiatives undertaken by top 12 big pharma players (shortlisted on the basis of 2022 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.
• An analysis of the recent collaborations within the biologics contract manufacturing market, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this industry, during the period 2018-2023 (till July). 
• A detailed analysis of the various mergers and acquisitions that have taken place within this industry, during the period 2018-2023 (till July), based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.
• A detailed review of expansion initiatives undertaken by biologics CMO, during the period 2016-2023 (till July), along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.
• An analysis of the recent developments within the biologics contract manufacturing market, highlighting information on the funding investments made during the period 2016-2022 (till July), along with information on the technology advancements related to biomanufacturing. 
• An estimate of the overall installed capacity for the manufacturing of biopharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized, and large and very large), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).
• An informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
• A company size-wise, detailed analysis of the total cost of ownership for biologics CMO, during the period 2023-2043.
• A discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT analysis, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT analysis on the overall biopharmaceutical industry.
• A case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.    
• An elaborate discussion on the future opportunities / trends within the biologics contract manufacturing market that are likely to influence the market growth of this industry over the forecast period.

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: 

• Chief Executive Officer, Mid-Sized Company, Scotland
• Chief Executive Officer and Co-Founder, Small Company, Slovenia
• Chief Technical Officer, Large Company, USA
• President and Chief Operating Officer, Mid-Sized Company, China
• Senior Director of Global Strategic Marketing, Large Company, USA
• Senior Director of Commercial Strategy and Market Insights, Large Company, USA
• Global Head of Sales and Marketing and Head of Business Development, Large Company, USA
• Business Development Manager, Small Company, Spain
• Manager Marketing and Sales, Mid-Sized Company, Germany

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.

Frequently Asked Questions

Question 1: What are biopharmaceuticals?

Answer: Biopharmaceuticals (also called as biologics), are complex pharmaceutical entities derived from living cells or microbes. They are primarily developed as precision treatments for various medical conditions.

Question 2: How big is the biologics contract manufacturing market?

Answer: The biologics contract manufacturing market size is estimated to be worth $19 billion in 2023.

Question 3: What is the projected market growth of the biologics contract manufacturing market?

Answer: The biologics contract manufacturing market is expected to grow at compounded annual growth rate (CAGR) of 9.6% during the forecast period 2022 - 2035.

Question 4: Who are the leading biologics CMO / CDMO in the biologics contract manufacturing market?

Answer: Examples of key CMO / CDMO engaged in biologics contract manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include AGC Biologics, Catalent (Catalent Pharma Solutions), Cytiva (GE Healthcare), FUJIFILM Diosynth Biotechnologies, KBI Biopharma, Patheon (acquired by Thermo Fisher Scientific) and Piramal Pharma Solutions.

Question 5: How many biologics CMO / CDMO are there globally?

Answer: Currently over 275 companies claim to be biologics CDMO / biologics CMO, in compliance with the regulatory standards.

Question 6: What are some recent market trends in the biologics contract manufacturing market?

Answer: The biologics CMO are entering into mergers & acquisitions, as well as partnerships to become one stop shops for biologics manufacturing.

Question 7: How many expansions have been undertaken in biologics contract manufacturing market?

Answer: Since 2018, over 195 expansions have taken place in the biologics contract manufacturing market, majority of these instances being new facilities.