Biologics Contract Development & Manufacturing Organization (CDMO) Market Size
| 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-Market-ML.webp)
*Disclaimer: Major Players sorted in no particular order |
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) Market Trends
Mammalian Type Segment is Expected to Hold Significant Market Share
- Biopharmaceuticals or biologics has been a growing sector, with cultured mammalian cells gaining momentum across expression systems for production due to their ability to complete the posttranslational modifications required for drug safety and efficacy.
- Mammalian cells are widely used to produce vaccines through viral infection and therapeutic proteins through genetic engineering. The allied mammalian expression systems present expansive advantages for certain types of proteins, such as trans-membrane, membrane-bound, and glycoproteins.
- Also, the Chinese hamster ovary (CHO) cells have been instrumental in manufacturing recombinant proteins with complex structures. Approximately 60% of biopharmaceuticals in clinical trials or approved by the US FDA across the last few years are therapeutic proteins, especially antibodies for treating cancers and autoimmune diseases, produced using mammalian cells. The applications of mammalian cells, thus, make it a pervasive and mass-adopted method across biologics.
- According to ClinicalTrials.gov, Clinical studies are essential to drug development globally. The number of registered clinical trials has increased significantly in recent years. As of January 17, 2024, nearly 479 thousand clinical studies were registered globally. The number of clinical studies has increased dramatically. There were just 2,119 registered in 2000. Clinical trials have grown more complex in recent years and remain vital for researching and developing new drugs and products.
- Mammalian biologics have evolved as the preferred production technology due to pipeline increases and improvements in manufacturing technology in both volumetric and specific productivities. Also, the primary driver of consumption has been the growing incidence rate of oncology and immunological disorders.
- As biologics production by mammalian cells continues to increase, the biopharmaceutical industry is expected to continue developing next-generation-based efficient cell culture processes. Therefore, market leaders have witnessed increasing mammalian-based production capacities on the manufacturing front.
- In February 2024, leading biopharmaceutical CDMO Avid Bioservices collaborated with CRB on the design to increase the production capacity at its current Myford site in Tustin, California. To meet the market's growing demand for mammalian cell culture production of clinical and commercial biologics, Myford expanded its drug substance line (DS 2) to augment it. This reaffirmed the client's commitment to being a reliable partner for delivering innovative and high-quality biopharmaceuticals.
North America to Hold Major Market Share
- North America is one of the major markets for the biologics CDMO industry, owing to the presence of two major economies, such as the United States and Canada. The United States is home to one of the major pharmaceutical industries in the world and commands a significant share of the industry revenue.
- According to the study by the IQVIA Institute for Human Data Science, global medicine spending will reach USD1.8 trillion in 2026, including spending on COVID-19 vaccines. In addition to this, the region holds a prominent share of the CDMO market as well. According to Results Healthcare, the region holds about 37% of the CDMO market share and is expected to witness growth in mid-single-digit percentage points over the coming years.
- The pharmaceutical industry is one of the most innovative sectors in Canada. Pharmaceuticals, a key sector of the Canadian economy, is supported by the Canadian government, which provides a business-friendly environment for pharmaceutical companies and can leverage assets for short- and long-term business strategies.
- In the wake of the patent cliff, pharmaceutical companies in this region are reorganizing and looking for new business models built on third-party partnerships and external networks. This business model mostly relies on outsourcing most of the operations, including manufacturing, and providing growth opportunities for CDMOs in this region. Canada also holds the advantage of having a skilled workforce.
- Although Canada is going to face intense competition from emerging Asian countries, the complex manufacturing processes required for certain drugs, which need skilled personnel, a stable political environment, and the proximity to the end market of the United States and Canada, are expected to drive the growth of the biologics CDMO market in this region.
- Contract Service Providers (CSPs) in Canada are better replacements due to complex manufacturing processes for certain products, as well as the proximity to the end market in Canada and the United States. With intensifying international competition, CSPs based in Canada will seek to differentiate themselves in terms of quality and advantages of scale in their services to appeal to the demands of global leaders in pharmacy. Moreover, the growing expansions are further boosting the market growth rate in the region.
Biologics Contract Development & Manufacturing Organization (CDMO) Industry Overview
The biologics contract development and manufacturing organization (CDMO) market is highly fragmented due to the presence of both global players and small and medium-sized enterprises. Some of the major players in the market are Boehringer Ingelheim Group, Wuxi Biologics (Cayman) Inc., Samsung Biologics, Lonza Group Ltd, and Fujifilm Diosynth Biotechnologies USA Inc. Players in the market are adopting strategies such as partnerships and acquisitions to enhance their product offerings and gain sustainable competitive advantage.
In March 2024, WuXi Biologics, a global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that it had broken ground on its 13.5-hectare CRDMO center in Tuas Biomedical Park in Singapore. The center will provide integrated biologics research and development along with manufacturing services. The CRDMO site also includes an additional 120,000L manufacturing capacity to WuXi Biologics’ global network.
In January 2024, Boehringer Ingelheim, the research-driven biopharmaceutical company, announced an expansion and upgrade of its plant in Koropi, Greece. The company announced an increase in the manufacturing capacity of new and existing medications that are in late-stage development, with an investment of EUR 120 million (USD 129.99 million).
Biologics Contract Development & Manufacturing Organization (CDMO) Market Leaders
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Boehringer Ingelheim Group
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Wuxi Biologics (Cayman) Inc.
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Samsung Biologics
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Lonza Group Ltd
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Fujifilm Diosynth Biotechnologies USA Inc.
*Disclaimer: Major Players sorted in no particular order
-Market-Conc.webp)
Biologics Contract Development & Manufacturing Organization (CDMO) Market News
- In March 2024, FUJIFILM Diosynth Biotechnologies announced an expansion of its manufacturing agreement with Argenx to provide drug products and services for efgartigimod, a monoclonal antibody (mAb) fragment to target the neonatal Fc receptor (FcRn), in patients with severe autoimmune disease.
- In February 2024, Samsung Biologics partnered with LegoChem Biosciences, a biotech company, to research and develop antibody-drug conjugate (ADC) programs. As part of the partnership, Samsung Biologics will provide antibody development and drug substance manufacturing services to treat solid tumors as a part of LegoChem Biosciences’ ADC program.
Biologics CDMO Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Access to New Technologies and Higher Speed of Execution Realized By CDMOs
4.2.2 Need for High Capital Investments to Develop Capabilities Led to the Demand for the Outsourcing Model
4.2.3 Lack of In-house Capacity among Emerging Drug Development Companies
4.3 Market Challenges/ Restraints
4.3.1 Transfer Complexities and Concerns over the Breach of IP and Patents
4.3.2 Capacity Issues Related to Large-molecule Drugs
4.4 Market Opportunities (Emergence of the Concept of Biosimilars Co-development and Designer Cell Lines)
4.5 Key Considerations Involved in the Selection of Biologics CDMO Vendors
4.6 Business Model Analysis - Value Added, Flexible Capacity Risk Sharing, and In-time Manufacturing
4.7 Key Trends in Biopharmaceutical Industry
4.8 Coverage on the Current Use of Biologics for Different Types of Disease Treatment
5. MARKET SEGMENTATION
5.1 By Type
5.1.1 Mammalian
5.1.2 Non-mammalian (Microbial)
5.2 By Product Type
5.2.1 Biologics
5.2.1.1 Monoclonal (Diagnostic, Therapeutic, and Protein-based)
5.2.1.2 Recombinant Proteins
5.2.1.3 Antisense and Molecular Therapy
5.2.1.4 Vaccines
5.2.1.5 Other Biologics
5.2.2 Biosimilars
5.3 By Geography***
5.3.1 North America
5.3.2 Europe
5.3.3 Asia
5.3.4 Australia and New Zealand
5.3.5 Latin America
5.3.6 Middle East and Africa
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles*
6.1.1 Boehringer Ingelheim Group
6.1.2 Wuxi Biologics (Cayman) Inc.
6.1.3 Samsung Biologics
6.1.4 Lonza Group Ltd
6.1.5 Fujifilm Diosynth Biotechnologies USA Inc.
6.1.6 Toyobo Co. Ltd
6.1.7 Parexel International Corp.
6.1.8 Icon PLC
6.1.9 Binex Co. Ltd
6.1.10 Celonic Group (JRS Pharma Group)
6.1.11 Rentschler Biopharma SE
6.1.12 AGC Biologics (AGC Inc.)
6.1.13 Sandoz AG
6.1.14 Catalent Inc.
6.1.15 AbbVie Inc.
7. VENDOR MARKET SHARE
8. INVESTMENT ANALYSIS
9. FUTURE OUTLOOK OF THE MARKET
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 | |||||||
| |||||||
| Biosimilars |
| By Geography*** | |
| North America | |
| Europe | |
| Asia | |
| Australia and New Zealand | |
| Latin America | |
| Middle East and Africa |
Biologics CDMO Market Research Faqs
How big is the Biologics CDMO Market?
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.
What is the current Biologics CDMO Market size?
In 2024, the Biologics CDMO Market size is expected to reach USD 18.17 billion.
Who are the key players in Biologics CDMO Market?
Boehringer Ingelheim Group, Wuxi Biologics (Cayman) Inc., Samsung Biologics, Lonza Group Ltd and Fujifilm Diosynth Biotechnologies USA Inc. are the major companies operating in the Biologics CDMO Market.
Which is the fastest growing region in Biologics CDMO Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Biologics CDMO Market?
In 2024, the North America accounts for the largest market share in Biologics CDMO Market.
What years does this Biologics CDMO Market cover, and what was the market size in 2023?
In 2023, the Biologics CDMO Market size was estimated at USD 16.19 billion. The report covers the Biologics CDMO Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Biologics CDMO Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What future trends are expected in the Biologics CDMO market?
Major trends in the Biologics CDMO Market are a) Increased adoption of single-use technologies b) Focus on personalized medicine c) Expansion in emerging markets
Biologics CDMO Industry Report
The Biologics CDMO Market Report is segmented by type, product type, and geography. The market size is expanding, driven by the growing demand for outsourcing services in the biopharmaceutical industry. This market overview highlights the significance of biologics CDMOs, which offer specialized expertise, advanced technologies, and cost-effective solutions essential for developing and manufacturing biologic drugs. The industry analysis indicates that companies are increasingly relying on CDMOs for their comprehensive solutions, thereby enhancing the capacity, flexibility, and efficiency of drug development processes.
The market growth is supported by the rising demand for biologics such as monoclonal antibodies, recombinant proteins, and gene therapies. The industry trends show a diverse range of CDMOs catering to different segments of the biopharmaceutical landscape. This market forecast suggests that the global market for biologics CDMOs will continue to expand, driven by the need for innovative biologics. The market segmentation includes detailed statistics on market share, size, and revenue growth rate, providing a comprehensive market analysis.
The industry outlook is positive, with market leaders offering solutions across the development and manufacturing spectrum. The market value is expected to increase as the demand for biologics grows. The market predictions and market review indicate a strong future for the biologics CDMO market. The industry reports available from Mordor Intelligence™ provide detailed market data, including historical overviews and future forecasts.
For those interested in further details, the report pdf is available for download, offering a deeper dive into the market research. This report example serves as a valuable resource for understanding the dynamics of the biologics CDMO market, including industry sales, industry size, and industry statistics. Research companies and industry researchers will find this report particularly useful for gaining insights into the market outlook and market trends.
