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CMO/CDMO Biotechnology Market

Increasing Demand for Biologics and Personalized Medicine Drives Growth in CMO/CDMO Biotechnology Market

CMO/CDMO Biotechnology Market Segmented By Standalone Services and Integrated Development for CMO/CDMO Biotechnology Service in Monoclonal Antibodies, Antibody Fragments, Recombinant Proteins, Vaccines Product

CMO/CDMO Biotechnology Market Outlook (2023-2033)

Global revenue from the CMO/CDMO biotechnology market stands at US$ 10.2 Bn in 2022, with the worldwide market estimated to surge ahead at a CAGR growth value of 11.6% to reach a valuation of around US$ 34.1 Bn by the end of 2033.

Attribute

Details

CMO/CDMO Biotechnology Market Size (2022)

US$ 10.2 Bn

Projected Market Value (2033)

US$ 34.1 Bn

Global Market Growth Rate (2023-2033)

11.6% CAGR

Market Share of Top 5 Countries

69.2%

According to Persistence Market Research, the stand-alone services segment of the CMO/CDMO biotechnology market based on the services secured a market value of US$ 5.9 Bn in 2022. Demand for stand-alone services will remain the maximum through the course of the forecast period. Throughout the forecast period, the demand for stand-alone services will continue to be at its highest level.

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Sales Analysis of CMO/CDMO Biotechnology Market from 2016 to 2022 Vs Market Outlook for 2022 to 2032

The market value of the CMO/CDMO biotechnology was approximately 18.3% of the overall ~US$ 55.7 Bn of the global CMO/CDMO market in 2022. The global market for CMO/CDMO biotechnology recorded a historic CAGR of 9.4% in the last 6 years from 2016 to 2022.

Contract development and manufacturing organization (CDMO) offers biotechnology and biopharmaceutical firms, development and manufacturing services. Pharmaceutical, biopharmaceutical, and biotechnology firms collaborate with CDMOs to contract out both drug development and production.

The biotechnology CDMO/CMO offers a variety of services, including bio-manufacturing services, analytical testing, development services, clinical supply services, fill finishing, packaging and many others.

With a share of 62.2% in the market, the stand-alone services category will dominate by service over the forecast period. The higher proportion of this market is mostly attributable to the biopharmaceuticals and biotechnology businesses' expanding cell-line development services.

The top worldwide CDMOs are concentrating on increasing their manufacturing capacity while maintaining high operational speed and flexibility. The companies are able to reduce batch manufacturing and cleaning time from seven days to one day because of the advantages offered by cutting-edge single-use technologies. In terms of high capacity, low cost, convenience, and operational efficacy, this is anticipated to give the companies a competitive edge.

For instance, in order to facilitate the scaling up of the production of recombinant proteins, Lonza in June 2020, created a brand-new, cutting-edge platform technology called New GSv9 TM media and feeds that maximize yield and batch-to-batch consistency. This offers a reliable platform for the culture that can consistently produce high-quality, stable proteins.

Leading CDMOs are concentrating on the expansion of their integrated capabilities from molecule to final product in light of improvements in contract solutions offerings. The increase is noteworthy because biopharmaceutical and biologics developers are finding it more and more important to accelerate development and speed up to the market. This is quite advantageous for the growth of this market.

The global CMO/CDMO biotechnology market is thus likely to show significant growth over the coming years with a CAGR value of 11.6%, and reach a global market size of around US$ 34.1 Bn by 2033.

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How can Market for CMO/CDMO Biotechnology Grow?

Novel Biologic and Biosimilar Manufacturing Present Strong Growth Opportunities

The manufacturing of novel biologics and biosimilars offers significant growth potential to the growth of the CMO/CDMO biotechnology market. Additionally, chances for technologically enhanced CDMOs with prospective capacities are growing as a result of scientific developments in the field of biopharmaceuticals.

For instance, AGC Biologics acquired Molecular Medicine S.p.A., a cutting-edge cell and gene therapy business in Italy, in July 2020 to expand its end-to-end cell and gene therapy services and plasmid production capacity.

Additionally, the adoption of CDMO and CMO business models in terms of product offerings and a decrease in operational costs is probably going to present the possibility for the growth of this market. Operational efficiency could be improved by concentrating on lowering operating expenses through outsourcing R&D and commercialization of biopharmaceuticals to CMOs/CDMOs. Through the selection and engagement of a strategic partner, outsourcing at later phases of clinical development could increase efficiency throughout the entire value chain. Differentiation strategies for the long-term profitability of CMOs are being driven by the emerging CDMO business model which points to the changes in the pharmaceutical ecosystem, innovative drug development and manufacturing technologies, and significant growth opportunities in high potency and biopharmaceutical manufacturing. This would help in creating lucrative opportunities for this market.

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Are There Any Barriers That Can Affect the Growth of the CMO/CDMO Biotechnology Market in Any Way?

High Costs Associated With the Investment in CMO

High costs associated with the investment in contract manufacturing, are expected to hamper the growth of this market. For instance, No matter where they are produced, biopharmaceutical production capacity is limited. In only the last five years, biopharma businesses have spent more than $50 Bn worldwide on the construction of new facilities and the purchase of machinery. A large portion of that has occurred in emerging markets and tax havens like Singapore and Ireland. The majority of the initiatives have been in the U.S. Simply said, there are not enough facilities, and the ones that exist are not up to date with contemporary medications. A new plant must be designed, constructed, and certified in almost four years. A large plant may cost between $1 billion and $2 billion.

Other than this, the lack of highly qualified and experienced professionals is another factor that can restrain the growth of the CMO/CDMO biotechnology market. The expanding region needs competent professionals to grow its economy. There is a significant talent gap between the current labor and the trained experts, according to several companies’ reports. Inadequate funding, poor planning and a shortage of experienced individuals have hampered the growth of the industry in most emerging countries.

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Country-wise Insights

Why is the U.S. Market Booming?

“High Number of Acquisitions and Mergers by the U.S. Companies”

The U.S. accounted for around 89.4% market share in the North American market in 2022, and a similar trend is expected over the forecast period.

The expansion of the industry in the region is greatly aided by merger and acquisition activity among American manufacturers, which will present opportunities throughout the forecast period. Additionally, the preference for single-use (disposable) bioreactors will rise in the region's biopharmaceutical CDMOs market as a result of the growing tendency toward multi-drug manufacturing facilities that produce a variety of biopharmaceutical treatments. This points to the growth of the CMO/CDMO biotechnology market in this country.

For instance, Thermo Fisher Scientific stated in October 2018 that it would expand a CDMO plant in St. Louis, Missouri, U.S., for US$ 50 Mn by adding 16,000 L of single-use capacity, in response to a rapidly increasing demand for commercial biologic manufacture. According to the company, this facility will be the biggest single-use biologics outsourcing location in North America.

Will U.K. be a Lucrative Market for CMO/CDMO?

“Wide Services Being Offered by the Manufacturers in this Region”

The U.K. held around 26.7% market share of the Europe market in 2022 and was valued at US$ 795.3 Mn in 2022.

Due to expanding applications for gene and cell therapy, the market in the U.K. is expected to experience an increase in demand. Additionally, manufacturers provide the pharmaceutical and biotechnology industries with top-notch biopharmaceuticals contract development and manufacturing services by focusing on strategic worldwide presence, specialist knowledge, and exclusive technological capabilities.

For instance, Lonza and Ankyra Therapeutics agreed to develop and produce a cytokine fusion protein in May 2021. According to this arrangement, Lonza will provide Ankyra with its services for developing cell lines, medicinal substances, and products.

How is South Korea Emerging as a Prominent Market for CMO/CDMO?

“Extensive Range of Development Services in this Region”

South Korea held the largest market share of about 70.6% in the East Asia market in 2022. It exhibits the growth of 15.2% by the end of 2033.

Due to its extensive range of developmental services, including cell line creation, process development, and formulation analysis methodology, South Korea is anticipated to be the most lucrative country in the East Asian market.

For instance, in August 2020, Samsung Biologics, introduced its patented cell line technology – S-CHOice to advance the cell line development process. Such launches are expected to strengthen the company’s existing portfolio.

Category-wise Insights

Which Service is Driving Growth of the Global Market?

“Expansion of Cell-Line Development Services”

The stand-alone services segment held around 57.5% share of the total market in 2022. The higher market share of this sector is mostly attributable to the biopharmaceutical and biotechnology companies' expanding cell-line development services which in turn is quite fruitful to the various pharmaceutical and biopharmaceutical companies.

Which Product is Driving Growth of the Global Market?

“Rise in the Development and Approval of the Monoclonal Antibodies”

The monoclonal antibodies segment held around 41.9% share of the total market in 2022. This segment is expected to surge at a CAGR of 13.2% over the period of 2023 to 2033. This is owing to a significant success rate of development and approvals of monoclonal antibody therapeutics and the launch of biosimilars in the U. S. and Europe market.

A contract for the large-scale production of the SARS-COV-2 monoclonal antibody (mAb) for prospective COVID-19 treatment was signed in April 2020 by Samsung Biologics and Vir Biotechnology, a clinical-stage immunology business based in the United States. Manufacturing for Samsung Biologics' commercial batches is was reported to start at Plant 3 in South Korea in 2021.

Which Expression System is Driving Growth of the Global Market?

“High Efficacy and Maximum Expression Potential of the Mammalian Expression System”

The mammalian segment held the largest share of 84.4% share of the total market in 2022 based on the expression system category. It is due to the high efficacy, and maximum expression potential of the mammalian platform along with low process cost and minimum impurities. Moreover, high-level strengthening by manufacturers to develop novel technologies for mammalian bioreactors tends to augment the market.

For instance, in November 2019, AGC Biologics invested US$18 million in facilities in Seattle and Denmark to increase their global footprint. The Seattle investment included a 500 L mammalian cell bioreactor and improved service from the clinical to commercial phases.

Which Company Size Accounted for the Highest Share in the Global Market?

“Extensive Range of Services Offered by Mid-Sized CMOs/CDMOs”

Mid-sized contract development manufacturers accounted for more than 46.0% share in 2022 of the global manufacturing space. Due to the extensive range of services provided, including analytical services, fill finish services, development & biomanufacturing, and cell-line development, the market share is larger.

Which Segment is Leading by Scale of Operations?

“Rising Approvals of New Biotherapeutics and their Commercialization”

The commercial scale of operations held the largest share of more than half of the global market in 2022. The commercial segment in this market is also expected to surge at a CAGR of 12.7% over the period of 2023 to 2033. The rising approvals of new biotherapeutics and their commercialization make commercial the dominant segment in the scale of operations category. To treat serious, life-threatening disorders, top industry companies are concentrating on the creation and introduction of next-generation biotherapeutics.

Competitive Landscape

Key players are concentrating on expansion in emerging regions and new revised product manufacturing. Market participants are also working to strengthen their expansion, new product launches, and improved distribution channels such as online sources of advertisement.

For instance:

  • For instance, Iovance Biotherapeutics chose Avid Bioservices in August 2020 to spearhead process development through cGMP manufacture of IOV-3001, an innovative anti-cancer medication candidate and new IL-2 analogue.
  • Fujifilm Diosynth Biotechnologies in April 2021, announced the establishment of its new Microbial production facility in the U.K. The aim of this expansion was to triple the existing microbial production. This new production facility was equipped with 2*2000L of fermenters and modular purification suits.

CMO/CDMO Biotechnology Market Scope

Attribute

Details

Forecast Period

2023-2033

Historical Data Available for

2016-2022

Market Analysis

USD Million for Value

Key Countries Covered

  • U.S.
  • Canada
  • Brazil
  • Mexico
  • Argentina
  • Germany
  • Italy
  • France
  • U.K.
  • Spain
  • Russia
  • BENELUX
  • India
  • Indonesia
  • Malaysia
  • Thailand
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • GCC Countries
  • Turkey
  • South Africa

Key Market Segments Covered

  • Services
  • Product
  • Expression System
  • Company Size
  • Scale of Operations
  • Region

Key Companies Profiled

  • Patheon N.V.
  • Catalent
  • Samsung Biologics Co., Ltd
  • Lonza.
  • Boehringer Ingelheim
  • Samsung BioLogics
  • AGC Biologics, Inc.
  • WuXi Biologics
  • AbbVie Inc
  • Avid Bioservices, Inc.
  • Fujifilm Diosynth Biotechnologies
  • Xpress Biologic
  • Rentschler Biopharma SE
  • KBI Biopharma (JSR Corporation)
  • Cytovance Biologics

Report Coverage

  • Market Forecast
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Segments Covered in CMO/CDMO Biotechnology Industry Research

By Service:

  • Stand-Alone Services
    • Cell-line development
    • Development and Bio manufacturing
    • Analytical Services
    • Fill Finish
    • Packaging
    • Clinical Supply Services
  • Integrated

By Product:

  • Monoclonal Antibodies
  • Antibody Fragments
  • Recombinant Therapeutic Proteins
  • Viral Vector
  • Cell and Gene Therapy
  • Vaccine

By Expression System:

  • Mammalian
  • Microbial
    • Bacteria
    • Yeast

By Company Size:

  • Small
  • Mid-Sized
  • Large
  • Very Large

By Scale of Operations:

  • Pre-clinical
  • Clinical
  • Commercial

By Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa (MEA)

- Companies Covered in This Report -

  • Patheon N.V.
  • Catalent
  • Samsung Biologics Co., Ltd
  • Lonza.
  • Boehringer Ingelheim
  • Samsung BioLogics
  • AGC Biologics, Inc.
  • WuXi Biologics
  • AbbVie Inc
  • Avid Bioservices, Inc.
  • Fujifilm Diosynth Biotechnologies
  • Xpress Biologic
  • Rentschler Biopharma SE
  • KBI Biopharma (JSR Corporation)
  • Cytovance Biologics

- Frequently Asked Questions -

The global market is currently valued at around US$ 10.2 Bn in 2022.

Sales of the CMO/CDMO biotechnology market are set to witness a high growth rate of 11.6% and be valued at US$ 34.1 Bn by 2033.

Demand for CMO/CDMO biotechnology increased at a 9.4% CAGR from 2016 to 2022.

The U.S., South Korea, U.K., Germany and China account for the highest share within the global market, currently holding a 69.2% market share.

The U.S. accounts for around 89.4% share of the North American market in 2022.

Canada accounted for around 10.6% share of the North American market in 2022.

Europe market is predicted to expand at 9.3% CAGR over the forecast period.

South Korea market held a share of about 70.6% in the East Asia market in 2022.

The current value of the South Asia market is US$ 492.8 Mn for the year, 2022.

UK held around 26.7% market share of the Europe market in 2022 and was valued at US$ 795.3 Mn in 2022.

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