Summary

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.

Key Highlights

• 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) Market Trends

CDMOs’ Access to New Technologies and Higher Speed of Execution Driving Market Growth

• Pressure to reduce the supply chain length and improve lead-time efficiency is forcing companies to take various measures to meet the demand, turning contract manufacturing into a major enabler in the supply chain to reduce the speed of execution.
• Often, contract manufacturing is followed by contract packaging for some pharmaceutical drugs. As a result, pharmaceutical companies seek vendors who provide contract manufacturing and contract packaging, along with quality testing. In addition, third-party logistic providers, like DHL, are extending their service capability to include contract packaging services.
• CDMOs are gaining significant market traction through advanced technology and specialized expertise. Keeping up with the latest technology trends is particularly important for niche CDMOs specializing in one compound or dosage form.
• Biopharmaceutical CDMOs are most likely to succeed in a highly competitive industry. They are willing to adopt cutting-edge technology and invest the necessary time and capital to build differentiated capabilities. The best CDMOs will move quickly to increase capacity while remaining flexible and agile.
• With the rising prevalence of infectious diseases and increased demand for novel therapies, pharma and biotech companies requiring higher capital investments for advanced technologies are forming collaborations with CDMOs, further driving the market's growth.

North America to Hold Prominent Market Share

• North America is one of the major markets for the biologics CDMO industry, owing to the presence of two major economies, namely, 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 market revenue.
• According to a study by the IQVIA Institute for Human Data Science, global medicine spending will reach USD 1.8 trillion in 2026, including COVID-19 vaccines. In addition, the region also holds a prominent share of the CDMO market. According to Results Healthcare, the region accounts for about 37% of the CDMO market share and is expected to witness growth in mid-single-digit percentage points over the coming years.
• The high prevalence of chronic diseases, the aging of the population, and the increased need for evidencebased practice are factors that have bolstered the high demand for clinical trials in the United States. In recent years, a growing number of clinical trials have shifted from academic medical centers to communitybased practices to global sites in different countries.
• Moreover, CROs have a strong foothold in the region, contributing to the market's growth. These include QVIA Holdings Inc., Pharmaceutical Product Development LLC, PRA Health Sciences Inc., and Laboratory Corporation of America Holdings. Companies such as Biovectra are also focusing on offering contract development and manufacturing capacity for intermediates and active pharmaceutical ingredients (APIs) at four cGMP facilities in North America. The Chinese contract development and manufacturing organization (CDMO) recently signed a 10-year lease deal for a clinical manufacturing facility in the United States, further helping the biologics CDMO market grow.
• Emergent BioSolutions also announced various CDMO deals with COVID-19 vaccine developers, including Vaxart, Novavax, J&J, and AstraZeneca. The company's experience in commercializing anti-infectious disease vaccines, including FDA-approved vaccines BioThrax (Anthrax Vaccine Adsorbed) and Vaxchora (Cholera Vaccine, Live, Oral), and its pandemic-ready manufacturing network are major factors in winning these deals for the COVID-19 vaccine. The company's Bayview drug substance facility in Baltimore, Maryland, was designed and built in partnership with the US government to respond to the pandemic. The new Center for Innovation in Advanced Development and Manufacturing (CIADM) has single-use bioreactor systems of up to 4,000 L.

Biologics Contract Development & Manufacturing Organization (CDMO) Industry Overview

The biologics contract development and manufacturing organization (CDMO) market is highly concentrated, with close to half of the market being dominated by a few players. In 2021, major players, such as Catalent, Boehringer Ingelheim Group, Lonza Group, and Samsung Biologics, together accounted for more than 30.1% of the market studied.

• May 2022 - Euroapi is a CDMO specializing in small-molecule active pharmaceutical ingredients (APIs). In May 2022, the company's stock began trading on the Euronext Paris stock exchange. Sanofi is extending its support for the CDMO by establishing a long-term customer relationship with Euroapi. It has agreed to hold a minority stake of approximately 30% in the CDMO for a two-year lock-up period. Furthermore, EPIC Bpifrance, a French public investment bank owned by the French government, has agreed to buy 12% of EuroAPI's shares from Sanofi.
• April 2022 - ChimeronBio announced that it had signed a manufacturing agreement with FUJIFILM DiosynthBiotechnologies (FDB) to advance its Oncology portfolio to include clinics. ChimeronBio opted for FUJIFILM DiosynthBiotechnologies as its partner for transferring and scaling its drug substance manufacturing process.
• January 2022 - Samsung Biologics signed an agreement with Biogen to acquire Biogen's 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to USD 2.3 billion. The complete buyout of Biogen's stake by Samsung Biologics is anticipated to strengthen Samsung Bioepis' biosimilar development capabilities and future performance in new drug development.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY
2.1 Research Framework
2.2 Secondary Research
2.3 Primary Research
2.4 Primary Research Approach and Key Respondents
2.5 Data Triangulation and Insight Generation

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 Has Led to Firms Choosing the Outsourcing Model
4.2.3 Lack of In-house Capacity among Emerging Drug Development Companies
4.3 Market Challenges
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 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)
4.8 Key Trends in Biopharmaceutical Industry
4.9 Coverage on the Current Use of Biologics for Different Types of Disease Treatment - Oncology, Infectious, Cardiovascular, etc.

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-Pacific
5.3.4 Middle-East & Africa
5.3.5 Latin America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Boehringer Ingelheim Group
6.1.2 Wuxi Biologics
6.1.3 Samsung Biologics
6.1.4 Lonza Group
6.1.5 Fujifilm Diosynth Biotechnologies USA Inc.
6.1.6 Toyobo Co. Limited
6.1.7 Parexel International Corporation
6.1.8 Icon PLC
6.1.9 Binex Co. Limited
6.1.10 JRS Pharma
6.1.11 Rentschler Biotechnologies
6.1.12 AGC Biologics
6.1.13 Sandoz Biopharmaceuticals (Novartis AG)
6.1.14 Catalent Inc.
6.1.15 AbbVie Contract Manufacturing

7 VENDOR MARKET SHARE

8 INVESTMENT ANALYSIS

9 FUTURE OUTLOOK OF THE MARKET