Biologics Contract Development & Manufacturing Organization (CDMO) Market Size & Share, by Product Type (Biologics, Biosimilars); Cell Line Type (Microbial, Mammalian, Viral Vector & Other Modalities); Service Type (Clinical, Commercial) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2024-2036

  • Report ID: 5516
  • Published Date: Jan 08, 2024
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2024-2036

Biologics CDMO Market size is poised to cross USD 39 Billion by the end of 2036, growing at a CAGR of 12% during the forecast period, i.e., 2024-2036. In the year 2023, the industry size of biologics CDMO was around USD 18 Billion. The major factor to influence the growth of the market is the growing prevalence of chronic diseases such as diabetes. The number of diabetes patients is set to rise to about 642 million by 2030 up from a number of over 536 million in the year 2021. Further, by 2045 the number of patients is estimated to reach approximately 782 million. Hence, the demand for biologics CDMO is set to grow.

Additionally, there has been a surge in outsourcing of clinical services. While traditional underlying drivers such as the availability of specialized knowledge and technology (exacerbated by treatments being more complex), cost advantages, and a greater focus on marketing and innovation among big. Pharma remains strong, but significant recent developments have occurred that strengthen the need for outsourcing investment. Some of these recent developments include automation, the Internet of Things (IoT), software development, and other contemporary technologies. However, this technology needs to be updated recurrently which is why the demand for outsourcing is growing. Hence, the market revenue for biologics CDMO is poised to rise.


Biologics CDMO Market
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Biologics Contract Development & Manufacturing Organization (CDMO) Market: Key Insights

Base Year

2023

Forecast Year

2024-2036

CAGR

~12%

Base Year Market Size (2023)

~ USD 18 Billion

Forecast Year Market Size (2036)

~ USD 39 Billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Biologics CDMO Market: Growth Drivers and Challenges

Market-Growth-Drivers

Growth Drivers

  • Rising COVID-19 Cases - Worldwide coronavirus (COVID-19) cases were close to 767 million as of June 13, 2023. Hence, the demand for CDMO has been surging since the COVID-19 pandemic has brought attention to how essential it is to have a robust and reliable supply chain for the development and production of biologics. In addition, the increasing geopolitical tensions with China and other regions of the world have merely made it more important to have an efficient supply chain management system. This system is established to reduce any supply risks that could negatively impact the personnel, equipment, and raw material quantity and accessibility required for the manufacture of biologics.
  • Surge in Demand for Cell & Genetic Therapy - Cell and gene therapies (CGTs) are going to keep multiplying as long as CDMOs continue to expand the sector and leave their mark on human history. The greatest barrier to commercial success for cell and gene therapy (CGT) companies may be converting a medicine from a biological notion to a scalable and producible treatment. This is particularly challenging in the CGT industry since there lack many suitable individuals with expertise in both process engineering and biology. An early-stage CGT developer can get support from a CDMO in understanding the constraints of their source cells. Additionally, the CDMO may encourage the development of plans for tissue processing, cell bank creation, and cell line engineering.
  • Growth in Use of Biologics in Geriatric Population - Ageing is a challenging process that involves a multisystem functional decline, flaws in many homeostatic processes, and a dramatically diminished ability to adapt to stress. Furthermore, the pharmacokinetics of pharmaceuticals are modified in the elderly population, leading to elevated hazards associated with their usage. These modifications are associated with an increase in total body fat and reductions in lean body mass, total body water, serum albumin level, and renal and hepatic function. Consequently, there is a higher risk of myelosuppression, cardiotoxicity, renal insufficiency, and neurotoxicity in older individuals using drugs. There additionally exists a special impact of polypharmacy on the mental state of aging. Due to these factors, biologic medicines seem appropriate for usage in the geriatric population. These therapies have a largely unidentified metabolism that appears independent to hepatic metabolism or renal excretion. As a consequence, with the surge in demand for biologic product by geriatric po0pulation the need for CDMO is also projected to grow.

Challenges

  • Barrier in Communication - Within an organization as well as with other businesses, communication can occasionally breakdown. If company fail to make and follow a communication plan, business may find itself in the dark regarding what's happening during the packing, shipping, and production processes.
  • Lack in Complete Control on Profits - The total earnings will fall if business outsource the manufacturing needs to a third party. The product and the manufacturing procedure will determine the exact amount of the investment. The overall amount they pay will depend on a number of factors, including labour costs, raw materials, and the quantity of orders you require.
  • Strict FDA Regulations for CDMO 


Biologics CDMO Segmentation

Cell Line Type (Microbial, Mammalian, Viral Vector & Other Modalities)

The mammalian segment in the biologics contract development & manufacturing organization (CDMO) market is set to gather the highest share of about 50% during the forecast period. When producing biopharmaceuticals, mammalian cell lines are frequently employed due to their precision in replicating complicated proteins, which ensures high bioactivity and low post-translational changes. This sort of cell is particularly useful for generating monoclonal antibodies, which make up a significant amount of biological medications. Scalability, dependability, and comparability with the complex needs of therapeutic protein production are offered by mammalian cell cultures. The dominance of mammalian cell culture technology highlights its critical role in satisfying the expanding demand for sophisticated biopharmaceuticals on a global basis as the biologics CDMO industry continues to rise.   

Product Type (Biologics, Biosimilars)

Biologics CDMO market from the biologics segment is predicted to gather the largest share of over 60% during the forecast period. A vast range of goods, such as blood and blood components, vaccinations, somatic cells, tissues that trigger allergies, recombinant therapeutic proteins, and gene therapy, are classified as biological molecules. Nucleic acids, proteins, or a combination of these may be employed to create biologics. Certain cell receptors associated with the advancement of disease are occupied by biologics. Additionally, the increased incidence of various metabolic illnesses that can be managed by biologics further contributes to the expanding need for biologics. For instance, in the US, metabolic syndrome is prevalent. Adults with metabolic syndrome make up about one in three.

Our in-depth analysis of the global biologics CDMO market includes the following segments:

      Product Type

  • Biologics
  • Biosimilars

      Cell Line Type

  • Microbial
  • Mammalian
  • Viral Vector & Other Modalities

     Service Type

  • Clinical
  • Commercial

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Biologics CDMO Industry - Regional Synopsis

North American Market Forecasts

The North America biologics CDMO market is predicted to capture the highest share of over 35% in the coming years. The major factor to dominate the market share in this region is rising pharmaceutical companies. The USA holds a special distinction of being the world's largest manufacturer of pharmaceuticals. Due to the rapid technological breakthroughs occurring in the nation, some experts even rank it as the best country for the pharmaceutical business. Particularly, the United States of America tops the list of nations that import the most pharmaceuticals, underscoring its important position in the world pharmaceutical industry. Hence, the market for biologic CDMO is also surging in this region. Furthermore, this region is observing a huge rise in clinical trials which has further led to a shift from academic medical centers to community-based practices which is further predicted to dominate the market growth in this region.

APAC Market Analysis

The biologics CDMO market in Asia Pacific is projected to have significant growth during the forecast timeframe. This growth is set to be influenced by the rising population. 60 percent of the global population, which is approximately 4.3 billion people, live in the Asia and Pacific region, which happens to be home to China and India, the two most populous nations on earth. Furthermore, there has been a rise in government programs to spread awareness regarding the availability of biologics and influence the imports of various biologics. This is why the market for biologics CDMO is rising in this region.

Research Nester
Biologics CDMO Market Size
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Companies Dominating the Biologics CDMO Landscape

top-features-companies
    • AGC Biologics
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Biocon Biologics Ltd.
    • Catalent, Inc.
    • Emergent BioSolutions
    • JRS PHARMA LP
    • Lonza Group Ltd.
    • Binex Co., Ltd.
    • Thermo Fisher Scientific Inc.
    • Icon PLC
    • Parexel International Corporation

In-the-news

In The News

  • At its protein biologics manufacturing facility in Seattle, AGC Biologics, a preeminent worldwide Biopharmaceutical Contract Development and Manufacturing Organisation (CDMO), has announced the launch of a new commercial manufacturing project. Provention Bio, Inc., a biopharmaceutical firm dedicated to furthering the development of investigational medicines that may intercept and prevent debilitating and life-threatening immune-mediated disorders, is the source of TZIELD (teplizumab-mzwv), a novel medication for Type 1 Diabetes that the CDMO is creating.
  • Being the first provider of biosimilar insulins to endorse and support the International Diabetes Federation (IDF) and its Core Mission initiative, Biocon Biologics Ltd. is a fully integrated, "pure play" biosimilars firm and a subsidiary of Biocon Ltd. This significant collaboration with IDF advances Biocon Biologics' goal of providing diabetics with accessible, inexpensive insulins on a global scale and aligns with the beginning of the centenary celebrations of insulin invention.

Author Credits:  Radhika Gupta, Shivam Bhutani


  • Report ID: 5516
  • Published Date: Jan 08, 2024
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

The major factors driving the growth of the market are rising covid19 cases, surge in demand for cell & genetic therapy, and growth in use of biologics in geriatric population.

The market size of biologics CDMO is anticipated to attain a CAGR of 12%over the forecast period, i.e., 2024-2036.

The major players in the market are AGC Biologics, Biocon Biologics Ltd., Catalent, Inc., Emergent BioSolutions and others.

The biologics segment is anticipated to garner the largest market size by the end of 2036 and display significant growth opportunities.

The market in the North America region is projected to hold the largest market share by the end of 2036 and provide more business opportunities in the future.
Biologics CDMO Market Report Scope
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