Biopharmaceutical CMO Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2034

A biopharmaceutical contact manufacturing organization (CMO), is defined as an organization which offers manufacturing solutions to biopharmaceutical businesses, under an agreement for a fee. These CMOs engage in the development of most stages of drug production ranging from early development to commercial production. It has a key role in the layout of pharmaceutical supply chain since the contract manufacturing helps biotechnological companies, particularly those that are still starting and growing, get the best manufacturing facilities without having to invest large of amounts of money. The use of biopharmaceutical CMOs is therefore highly dependent on the rise in divisiveness of bio-therapeutic products and heightened outsourcing trends in the pharmaceutical value chain.

Technologically advanced, outsourcing saves companies cost and time required to fabricate products while enabling them to concentrate on developing new therapies, marketing and research. The global biopharmaceutical CMO market has experienced significant growth in recent years, driven by advancements in biotechnology and the increasing demand for biopharmaceuticals. This market plays a crucial role in outsourcing services for biopharmaceutical companies, offering manufacturing expertise, scalability, and cost-effective solutions. The rapid development of complex biologics, such as monoclonal antibodies, vaccines, and gene therapies, has propelled the demand for biopharmaceutical CMOs.

The biopharmaceutical CMO market is anticipated to reach USD XXX.X million by 2034 from USD XXX.X million in 2023, at a CAGR of XX.X% during the forecast period 2024-2034.

The global biopharmaceutical pipeline is expanding rapidly, with a growing number of biologics and biosimilars in clinical trials. This increase in the pipeline is creating a higher demand for contract manufacturing services, particularly for small and mid-sized biopharmaceutical companies that rely heavily on CMOs for production capabilities, which is expected to further boost the biopharmaceutical CMO market during the forecast period 2024-2034.

Growth Drivers:

The global biopharmaceutical CMO market is on a rapid growth trajectory, which can be attributed to the increasing need for biologic and biosimilar products. Biologics, which consist of recombinant proteins, monoclonal antibodies, and vaccines, have risen to be the standard of care for numerous chronic conditions, such as cancer, autoimmune diseases, and diabetes. Another type that is also picking up a lot of ground is biosimilars, these are biologic drugs that are a replica of the approved biologics which normally come with lower prices. The recent loss of exclusivity for huge biologic molecules such as Humira and Avastin has set the tone for the generation of biosimilars, which has led to significant business prospects for CMOs involved in the production of biologic drugs.

Another factor that has contributed to the expansion of the biopharmaceutical CMO industry is the tendency for more pharmaceutical firms to outsource production. Manufacturing biologic drugs is a complex process that demands precise equipment, aseptic environments, scientific personnel, and strict adherence to rules and regulations, which is costly for many companies to equip their factories, hence they outsource. Therefore, it is evident that various small and big pharmaceutical companies heavily depend on CMOs for managing the various issues involved in manufacturing, regulatory issues, and scalability. This trend is especially evident in the biopharmaceutical industry where the capital expenditure required to set up a bio-manufacturing plant may cost between USD 200 million and USD 500 million.

An increase in the overall expenditure by pharmaceutical and biotech firms on research and development is also a key factor that has been driving the biopharmaceutical CMO market. For instance, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the research-based biopharmaceutical industry is estimated to have spent USD 196 billion globally on biopharmaceutical R&D in 2023. The shift towards biologic drugs is the major driving force behind biopharmaceutical CMO’s growth as most such companies often seek for third-party manufacturers and clinical trial providers during the initial stages of production.

Biopharmaceutical CMO Segmentation:

By Product:

·         Biologics

o   Vaccines

o   Recombinant Proteins

o   Antisense RNAi, & Molecular Therapies

o   Gene Therapies

o   Monoclonal Antibodies (MABs)

o   Others

·         Biosimilars

By Source:

·         Mammalian

·         Non-Mammalian

By Service:

·         Manufacturing

o   Upstream Processing

o   Downstream Processing

·         Fill & Finish Operations

·         Packaging

·         Analytical & AC Studies

·         Others

By Region:

·         North America

·         Europe

·         Asia Pacific

·         Latin America

·         Middle East and Africa

Biopharmaceutical CMO Market by product Review:

Based on the product, the biopharmaceutical CMO market is segmented into two segments including biologics, which is further sub-segmented into vaccines, recombinant proteins, antisense RNAi, & molecular therapies, gene therapies, monoclonal antibodies (MABs), and others, and biosimilars. On the basis of product, the bilogics segment is expected to dominate the market in terms of market share, while the biosimilars segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Biopharmaceutical CMO Market by Source Review:

Based on the source, the market is segmented into mammalian, and non-mammalian. On the basis of source, the mammalian segment is expected to be the largest in terms of market share, while the non-mammalian segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Biopharmaceutical CMO Market by Service Review:

Based on the service, the market is segmented into manufacturing, which is further sub-segmented into upstream processing, and downstream processing, fill & finish operations, packaging, analytical & ac studies, and others. On the basis of service, the manufacturing segment is expected to be the largest in terms of market share, while the fill & finish operations segment is predicted to grow at the highest rate in terms of CAGR during the forecast period.

Regional Outlook:

The biopharmaceutical CMO market research report offers detailed analysis and forecasts for five major regions i.e., North America, Europe, Asia Pacific, Latin America, and Middle East and Africa.

The North America region is forecasted to maintain its dominant position in the global biopharmaceutical CMO market, accounting for a projected market share of XX.X% in 2023. The major driving forces for the regional biopharmaceutical CMO market include the growth in the biopharmaceutical R&D, well-developed regulatory environment, and key players of the biopharmaceutical CMOs and manufacturers. However, the major focus of the North American CMO market is the United States as it is the global leader in the biopharmaceutical industry in terms of research and development, manufacturing and outsourcing. Moreover, the increase in the cost of in-house production along with the challenges in biologics manufacturing make many companies dependent on CMOs for their production requirement, which is predicted to further drive the biopharmaceutical CMO market in the North America region during the forecast period 2024-2034.

North American countries, specifically the United States and Canada, owns a large share in the global biopharmaceutical CMO market. The region has a well-developed pharmaceutical and biotechnology industry with large-scale pharma companies engaging contract manufacturing organizations (CMOs) to improve efficiency, control costs and shorten the time to market of new therapies.

Biologics have been adopted as a standard form of treatment in North American countries in managing chronic conditions including cancer, auto-immune diseases, and cardiovascular diseases. With Biologics development picking up pace, it is observed that pharma giants have shifted their focus to outsourcing development with CMOs that house these facilities. In addition, there are many CMOs in North America that are actively engaged in increasing their manufacturing capabilities. For instance, in 2021, Lonza announced a USD 1 billion expansion of its biologics manufacturing facilities in Portsmouth, New Hampshire. Moreover, the high cost associated with the development of biologic drugs, as well as the need to manufacture such drugs at a large scale is forcing companies to turn to outsourcing and is likely to boost the overall market in the region in the forecast period 2024-2034.

The Asia Pacific region is projected to grow at the highest CAGR in the biopharmaceutical CMO market over the forecast period due to countries such as China, India, South Korea, and Japan. The Asia Pacific region has great growth potential due to the growing healthcare expenditures, government support, and the demand for biological products. Secondly, the Asia-Pacific region is much cheaper to operate in terms of wages, materials, and overhead costs. India and China are among the preferred locations for contract manufacturing due to competitive cost structure, which is expected to further boost the market growth in the region during the forecast period 2024-2034.

Key Companies in Biopharmaceutical CMO Market:

The research report offers a competitive analysis of prominent companies operating in the global biopharmaceutical CMO market. Some of the leading players profiled in the market research report include:

·         Thermo Fisher Scientific, Inc.

·         Lonza

·         Samsung Biologics

·         Catalent, Inc.

·         Cambrex Corporation

·         Recipharm AB

·         WuXi Biologics

·         FUJIFILM Diosynth Biotechnologies

·         Siegfried Holding AG

·         Laboratory Corporation of America® Holdings

·         Other Player’s