Biologics Contract Manufacturing Market Size Worth over USD 55 Billion in 2035 | Roots Analysis

Global Biologics Contract Manufacturing Market Overview

The biologics contract manufacturing market, valued at USD 21.2 billion in 2024, is projected to grow to USD 23.8 billion in 2025 and USD 55.0 billion by 2035, representing a CAGR of 8.8% during the forecast period.

Various challenges associated with the development process of biologics, such as complex stages of manufacturing, limitations of analytical sciences, lack of incentives and the current statutory and regulatory framework, have contributed heavily to the demand for consistent evolution of product development and biomanufacturing processes. Furthermore, it is very difficult for the drug / therapy developers to keep up with the latest manufacturing trends and technologies. These aforementioned difficulties faced by developers are likely to translate into lucrative business opportunities for contract service providers.

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Key Report Takeaways
1. Presently, over 305 contract manufacturing organizations (CMOs) are engaged in the production of biologics; more than 90% of such players provide FDF manufacturing services
2. Around 70% of the stakeholders operate at all scales of operation to cater to the diverse needs of clients; notably, mammalian cell-based expression systems have emerged as a popular choice among CMOs
3. The competition among service providers that claim to be focused on the niche and upcoming drug classes is fierce; it is primarily influenced by the success of several therapies in the recent past
4. In the past decade, a shift in trend has been observed in the biologics contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific
5. A comprehensive set of company profiles of prominent / emerging players offers valuable insights into their current strategic focus and future initiatives, empowering stakeholders with essential information
6. Over the last five years, more than 695 deals have been inked by biologics CMOs; most of the partnerships were inked for the manufacturing of vaccines, antibodies and cell therapies
7. In order to maintain a competitive edge and establish themselves as one-stop-shops, players are expanding their existing capabilities and service portfolios; the domain has witnessed over 135 mergers and acquisitions
8. Considering the enormous opportunities associated with biologics contract manufacturing, investors have actively extended funds, amounting to USD 7.5 billion, across more than 90 funding instances in the past eight years
9. Driven by the growing demand, CMOs have made elaborate investments to expand their existing capacities and capabilities, primarily for niche biologics; this trend is most pronounced in the US and China
10. In the past five years, more than 215 initiatives have been undertaken by big pharma players; more than 80% of such initiatives were focused on partnerships and expansions
11. The anticipated demand for biologics is rising at an annualized rate of 7% over the next decade; ADC therapeutics and cell therapies will continue to be the key pockets of growth
12. The global installed biologics contract manufacturing capacity is spread across various geographies; notably, large players account for 80% of the total capacity
13. Though existing installed capacity is sufficient to meet the current annual demand for biologics, we anticipate that CMOs are likely to invest in installing incremental capacity to meet the long-term demand
14. Our proprietary total cost of ownership model offers an informed estimate of both capital and operational expenses associated with the establishment and maintenance of a contract manufacturing facility, over a span of 20 years
15. With the growing pipeline of the biologics and the increased preference for outsourcing, the biopharmaceutical contract manufacturing services market is anticipated to witness a steady growth in the foreseen future
16. As more developers outsource various aspects of their respective manufacturing operations, we expect the biologics CMOs market to grow at an annualized rate of over 9% in the coming decade
17. The anticipated future opportunity, in terms of annual service revenues, is expected to be well distributed across segments, such as scale of operation, company size, leading players and key geographical regions

Competitive Landscape of Biologics Contract Manufacturing Market

The biologics contract manufacturing companies landscape features over 305 companies offering a range of biologics contract manufacturing services, including API manufacturing and FDF manufacturing. Overall, the biologics contract manufacturing market is highly fragmented, featuring the presence of established companies, as well as emerging start-ups and mid-sized companies. It is interesting to highlight that most of the biopharmaceutical contract service providers are based in North America (35%), followed by those headquartered in Europe (33%); prominent manufacturing hubs in Asia Pacific include China and South Korea. In addition to this, majority (22%) of the CMOs are currently utilizing all types of expression systems for the manufacturing of biologics, namely mammalian, microbial and others.

Biologics Contract Manufacturing Market Regional Outlook

Based on the key geographical regions, the biologics contract manufacturing market can be segmented into five major regions, North America, Europe, Asia Pacific, Latin America, and Middle East & North Africa. Led by the US, North America is anticipated to capture the majority share of the biologics contract manufacturing market in 2023. Key industry players such as Lonza, Catalent Biologics, Samsung BioLogics, and Wuxi Biologics are pivotal in shaping the market dynamics in this region. Additionally, the integration of scalable platforms is likely to be the reason to improve the manufacturing and development of biologics in the region.

Asia Pacific is likely to exhibit lucrative opportunities owing to the ecosystem for manufacturing and restraining the cost of goods associated with manufacturing in Asia-Pacific is highly favorable in terms of producing high-quality products for global markets. Additionally, the promising growth is not only in the emerging economies of Asia Pacific, but also in Latin America and the Middle East and Africa.

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Biologics Contract Manufacturing Market Key Players
Examples of key companies engaged in biologics contract manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include:

1. AcuraBio
2. AGC Biologics
3. Boehringer Ingelheim
4. Catalent
5. Cell Therapies
6. Celltrion
7. Cytiva
8. Charles River Laboratories
9. FUJIFILM Diosynth Biotechnologies
10. KBI Biopharma
11. Kemwell Biopharma
12. Lonza
13. Miltenyi Biotec
14. Minaris Regenerative Medicine
15. Novasep
16. Olon
17. Patheon
18. Piramal Pharma Solutions
19. Samsung Biologics
20. Sandoz
21. Takara Bio
22. Vetter Pharma
23. Wuxi Biologics

It is interesting to note that in August 2023, Exothera entered into an agreement with National Institutes of Health (NIH) to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I / II trial in Africa and the US. Such types of agreements are expected to drive the demand for biologics across the globe, resulting in substantial market growth during the forecast period.

To get market data, market insights, financial statements and a comprehensive analysis of the Biologics Contract Manufacturing Market, please contact sales@rootsanalysis.com

Biologics Contract Manufacturing Market Segments

Based on the research, Roots Analysis has segmented the Biologics Contract Manufacturing Market into Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, Geography and Leading Players.

Biologics Contract Manufacturing Market, by Type of Service Offered
1. API Manufacturing
2. FDF Manufacturing

Biologics Contract Manufacturing Market, by Type of Biologic Manufactured
1. Antibodies
2. Cell Therapies
3. Vaccines
4. Other Biologics

Biologics Contract Manufacturing Market, by Type of Expression System Used
1. Mammalian Expression Systems
2. Microbial Expression Systems
3. Other Expression Systems

Biologics Contract Manufacturing Market, by Scale of Operation
1. Preclinical / Clinical
2. Commercial

Biologics Contract Manufacturing Market, by Company Size
1. Small
2. Mid-sized
3. Large and Very Large

Biologics Contract Manufacturing Market, by Key Geographical Regions
1. North America
2. Europe
3. Asia-Pacific
4. Latin America
5. Middle East and North Africa

Biologics Contract Manufacturing Market, by Leading Players
1. BioXcellence
2. Catalent Biologics
3. FUJIFILM Diosynth Biotechnologies
4. Lonza
5. Samsung BioLogics
6. WuXi Biologics

Browse Full Report Description + Research Methodology + Table of Content + Infographics here:
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Contact Details
Gaurav Chaudhary
Email: Gaurav.chaudhary@rootsanalysis.com or sales@rootsanalysis.com
Website: https://www.rootsanalysis.com

About Roots Analysis

Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.

This release was published on openPR.