Biologics CDMO Market Size (2024 - 2029)

The Biologics CDMO market is projected to experience significant growth over the forecast period, driven by the increasing trend of pharmaceutical companies outsourcing services. This expansion is particularly notable in the large molecules segment, which includes biologics, biosimilars, and cell and gene therapies, despite their smaller volume compared to small molecules. The market's growth is further supported by the rising demand for cancer therapies and the lessons learned from the COVID-19 pandemic regarding vaccine manufacturing and outsourcing. However, the market's expansion is challenged by the need for compliance with stringent regulations and the complexities of technology transfer and IP security.

Market Size of Biologics CDMO Industry

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Biologics CDMO Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 18.17 Billion
Market Size (2029) USD 30.45 Billion
CAGR (2024 - 2029) 10.87 %
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 and Manufacturing Organization (CDMO) Market Analysis

The Biologics CDMO Market size is estimated at USD 18.17 billion in 2024, and is expected to reach USD 30.45 billion by 2029, growing at a CAGR of 10.87% during the forecast period (2024-2029).

The global 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 the 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.

  • Cancer therapies are among the primary drivers for a large proportion of the growth in the biologics market. Even with the faster growth forecast, small molecules outweigh biologics in terms of drug approvals. For instance, the FDA's Center for Drug Evaluation and Research (CDER) approved many new drugs and biological products in recent years.
  • The advancements in tag technology and blockchain are mainly helping pharmaceutical companies with serialization requirements. Although blockchain technology cannot be used in the pharmaceutical industry to label actual drug products, digital ledger technology is significantly being implemented as a two-dimensional barcoding system. The technology is then utilized to authenticate containers throughout the supply chain.
  • Cost-of-goods for a biological API are far higher than those for a drug product because of the technically challenging and capital-intensive API development and manufacturing process. About three-quarters of the revenue from biologics and outsourcing comes from API production, and CDMOs invest heavily to expand capacity. Biologic drugs are high-value, high-margin products, so pharma companies are mainly focused on supply security rather than investing in manufacturing.
  • Capacity constraints are still a problem in the pharmaceutical industry, and almost 6 in 10 pharma manufacturers face minor constraints at some manufacturing stage. In the current market scenario, capacity utilization information is essential for planners and investors to determine whether capacity will be available to produce pipeline drugs nearing approval. While most breakthroughs in the future are expected from bio-pharma, mass production capacity constraint is driving costs.
  • The COVID-19 outbreak drives health costs and further strains federal and state government finances. It's possible that many Americans lost their employer-based private health plans due to job loss or sickness. The United States spends more on health care than any other country. For instance, the Centers for Medicare & Medicaid Services has predicted the total national health spending in the United States from 2021 to 2030. The United States is expected to spend USD 6.7 trillion on healthcare by 2030.

Biologics Contract Development & Manufacturing Organization (CDMO) Industry Segmentation

The biologics contract development and manufacturing organization (CDMO) market is segmented by type (Mammalian and Non-Mammalian (Microbial)), by product type (biologics [monoclonal, recombinant proteins, antisense, and molecular therapy, vaccines, and other biologics], and biosimilars), by geography (North America, Europe, Asia Pacific, Latin America, Middle East and Africa). The market sizes and forecasts are provided in terms of value in USD for all the above segments.

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
Australia and New Zealand
Latin America
Middle East and Africa
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Biologics CDMO Market Size Summary

The biologics CDMO market is poised for significant expansion, driven by the increasing trend of outsourcing within the pharmaceutical sector. As the industry experiences rapid growth due to factors such as global economic development, an aging population, and the introduction of new products, the demand for contract development and manufacturing organizations (CDMOs) is expected to rise. While small molecules have traditionally dominated the market, large molecules, including biologics, biosimilars, and cell and gene therapies, are anticipated to grow at a faster pace. This growth is largely fueled by the demand for cancer therapies and the increasing number of biologic approvals. However, the market faces challenges due to the highly regulated nature of manufacturing processes and the complexities of technology transfer and intellectual property security.

North America stands out as a major market for biologics CDMOs, with the United States and Canada playing pivotal roles due to their robust pharmaceutical industries. The region's market is bolstered by a high prevalence of chronic diseases, an aging population, and a strong presence of contract research organizations (CROs). The COVID-19 pandemic highlighted the potential of vaccine manufacturing and outsourcing as a sustainable revenue stream, further propelling market growth. The market is characterized by a few dominant players, with companies like Catalent, Boehringer Ingelheim Group, Lonza Group, and Samsung Biologics holding significant market shares. Strategic partnerships and acquisitions, such as those involving Samsung Biologics and Biogen, and FUJIFILM Diosynth Biotechnologies, are enhancing capabilities and expanding the market's reach.

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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 Led to the Demand for the Outsourcing Model

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

    3. 1.3 Market Challenges/ Restraints

      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 Key Trends in Biopharmaceutical Industry

    8. 1.8 Coverage on the Current Use of Biologics for Different Types of Disease Treatment

  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

      4. 2.3.4 Australia and New Zealand

      5. 2.3.5 Latin America

      6. 2.3.6 Middle East and Africa

Biologics CDMO Market Size FAQs

The Biologics CDMO Market size is expected to reach USD 18.17 billion in 2024 and grow at a CAGR of 10.87% to reach USD 30.45 billion by 2029.

In 2024, the Biologics CDMO Market size is expected to reach USD 18.17 billion.

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