Biologics CDMO Market Size (2024 - 2029)

The market size of the Biologics CDMO sector is expected to see significant growth due to the increasing trend of outsourcing services within the pharmaceutical industry. This expansion is driven by global economic growth, a rising and aging population, and the launch of new products. Despite the prominence of small molecules in the market, large molecules such as biologics, biosimilars, and cell and gene therapies are projected to experience the fastest growth. Cancer therapies are primary drivers of growth in the biologics market. However, the highly regulated manufacturing processes, complex technology transfers, and IP security concerns could potentially hinder the anticipated market growth. The COVID-19 pandemic has highlighted the potential of vaccine manufacturing and outsourcing as a sustainable revenue stream within the market.

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Market Size of Biologics CDMO Industry

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Biologics CDMO Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 15.32 Billion
Market Size (2029) USD 27.94 Billion
CAGR (2024 - 2029) 12.78 %
Fastest Growing Market Asia-Pacific
Largest Market North America

Major Players

Biologics CDMO Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Biologics Contract Development & Manufacturing Organization (CDMO) Market Analysis

The Biologics CDMO Market size is estimated at USD 15.32 billion in 2024, and is expected to reach USD 27.94 billion by 2029, growing at a CAGR of 12.78% during the forecast period (2024-2029).

With an increasing number of companies within the pharmaceutical sector considering outsourcing services, the demand for services from contract manufacturing and contract development manufacturing organizations will rise.

  • The pharmaceutical industry is growing exponentially, driven by global economic growth, a growing and aging population, and new product launches. Even though small molecules continue to command a prominent share of the market, large molecules, such as biologics, biosimilars, and cell and gene therapies, are expected to witness the fastest growth over the forecast period.
  • Even though volumes in large molecules tend to be smaller, the segment is growing faster. Absolute growth in the large molecules market, including originator biologics, biosimilars, and cell and gene therapies, is expected to propel the market to USD 133 billion by 2023. The market size for originator biologics is expected to reach USD 371 billion by 2023, according to Results Healthcare.
  • Cancer therapies are among the primary drivers for a large portion of the growth in the biologics market. Even with the faster growth forecast, small molecules outweigh biologics regarding drug approvals. For instance, the FDA's Center for Drug Evaluation and Research (CDER) approved 50 new drugs and biological products in 2021. Of the 50 approved new drugs and biological products, 33 were small molecule drugs, and 17 were monoclonal antibodies and other big molecule drugs. The number of biologic approvals has been increasing steadily over the past few years.
  • Companies need to invest additional amounts in complying with regulations imposed on the manufacturers. Instead, companies are willing to spend on R&D activities, which benefit the company overall. Hence, the highly regulated manufacturing processes, with complicated technology transfer and IP security concerns, impede the anticipated growth and adoption of the market in different regions.
  • The COVID-19 pandemic indicated the potential of vaccine manufacturing and outsourcing as a sustainable revenue stream for companies operating in the market studied. Following the COVID-19 vaccine, introducing boosters is expected to create a favorable landscape for growth for CDMO vendors. For instance, Catalent has worked on nearly 100 different compounds to investigate its potential to develop COVID-19 vaccines and therapies for more than 60 customers.

Biologics Contract Development & Manufacturing Organization (CDMO) Industry Segmentation

A contract development and manufacturing organization (CDMO) is an organization that aids the pharmaceutical industry and equips its clients with comprehensive services ranging from drug development to manufacturing. CDMOs provide essential services incorporating external third-party projects and offer their knowledge, development, and manufacturing capabilities.

The biologics contract development and manufacturing organization (CDMO) market is segmented by type (mammalian and non-mammalian (microbial)), product type (biologics (monoclonal, recombinant proteins, antisense and molecular therapy, vaccines, and other biologics) and biosimilars), and geography.

By Type
Mammalian
Non-mammalian (Microbial)
By Product Type
Biologics
Monoclonal (Diagnostic, Therapeutic, and Protein-based)
Recombinant Proteins
Antisense and Molecular Therapy
Vaccines
Other Biologics
Biosimilars
By Geography
North America
Europe
Asia-Pacific
Middle-East & Africa
Latin America

Biologics CDMO Market Size Summary

The Biologics Contract Development and Manufacturing Organization (CDMO) market is experiencing significant growth due to increasing outsourcing services from pharmaceutical companies. The market, which includes large molecules such as biologics, biosimilars, and cell and gene therapies, is expected to witness rapid expansion over the forecast period. The growth of the large molecules market, including originator biologics, biosimilars, and cell and gene therapies, is expected to propel the overall market. Additionally, the rise in cancer therapies is driving a large portion of the growth in the biologics market. However, the highly regulated manufacturing processes, with complicated technology transfer and IP security concerns, impede the anticipated growth and adoption of the market in different regions. CDMOs are gaining significant market traction through advanced technology and specialized expertise. The pressure to reduce the supply chain length and improve lead-time efficiency is forcing companies to take various measures, turning contract manufacturing into a major enabler in the supply chain. Biopharmaceutical CDMOs are most likely to succeed in this highly competitive industry, especially those willing to adopt cutting-edge technology and invest in building differentiated capabilities. The rising prevalence of infectious diseases and increased demand for novel therapies are driving collaborations with CDMOs, further driving the market's growth. North America is one of the major markets for the biologics CDMO industry, owing to the presence of major economies and a significant pharmaceutical industry.

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Biologics CDMO Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Access to New Technologies and Higher Speed of Execution Realized by CDMOs

      2. 1.2.2 Need for High Capital Investments to Develop Capabilities Has Led to Firms Choosing the Outsourcing Model

      3. 1.2.3 Lack of In-house Capacity among Emerging Drug Development Companies

    3. 1.3 Market Challenges

      1. 1.3.1 Transfer Complexities and Concerns over the Breach of IP and Patents

      2. 1.3.2 Capacity Issues Related to Large-molecule Drugs

    4. 1.4 Market Opportunities (Emergence of the Concept of Biosimilars Co-development and Designer Cell Lines)

    5. 1.5 Key Considerations Involved in the Selection of Biologics CDMO Vendors

    6. 1.6 Business Model Analysis - Value Added, Flexible Capacity Risk Sharing, and In-time Manufacturing

    7. 1.7 Detailed Assessment of the Impact of COVID-19 on Biologics CDMO (The Race for the Development of a New Vaccine and Impact on the Current Capacities)

    8. 1.8 Key Trends in Biopharmaceutical Industry

    9. 1.9 Coverage on the Current Use of Biologics for Different Types of Disease Treatment - Oncology, Infectious, Cardiovascular, etc.

  2. 2. MARKET SEGMENTATION

    1. 2.1 By Type

      1. 2.1.1 Mammalian

      2. 2.1.2 Non-mammalian (Microbial)

    2. 2.2 By Product Type

      1. 2.2.1 Biologics

        1. 2.2.1.1 Monoclonal (Diagnostic, Therapeutic, and Protein-based)

        2. 2.2.1.2 Recombinant Proteins

        3. 2.2.1.3 Antisense and Molecular Therapy

        4. 2.2.1.4 Vaccines

        5. 2.2.1.5 Other Biologics

      2. 2.2.2 Biosimilars

    3. 2.3 By Geography

      1. 2.3.1 North America

      2. 2.3.2 Europe

      3. 2.3.3 Asia-Pacific

      4. 2.3.4 Middle-East & Africa

      5. 2.3.5 Latin America

Biologics CDMO Market Size FAQs

The Biologics CDMO Market size is expected to reach USD 15.32 billion in 2024 and grow at a CAGR of 12.78% to reach USD 27.94 billion by 2029.

In 2024, the Biologics CDMO Market size is expected to reach USD 15.32 billion.

Biologics CDMO Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)