Biologics Contract Development and Manufacturing Organization (CDMO) Market By Type (Mammalian, Non-mammalian), By Product Type (Biologics, Biosimilars) and By Region (North America, Europe, Asia-Pacific, Latin America, MEA) - Global Forecasts 2017 to 2027

Biologics Contract Development and Manufacturing Organization (CDMO) Market Definition:

Contract development and manufacturing organizations (CDMOs) are referred to those companies that serve pharmaceutical corporations on a contract basis, offering comprehensive drug development and manufacturing services. A few of them include pre-formulation, stability studies, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, scale-up along with development services.

The Global biologics contract development and manufacturing organization (CDMO) market size was US$9.07 Billion in 2019 and is expected to reach US$18.58 Billion by 2027; This converts into a compounded annual growth rate (CAGR) of 9.38% for the forecast period.

Biologics Contract Development and Manufacturing Organization (CDMO) Market Overview:

The pharmaceutical industry, driven by economic growth, growing population, new product launches, outbreaks such as the recent pandemic, etc., is growing at a significant rate. Although small molecules are dominating the industry, large molecules are anticipated to display a substantial growth rate on account of their benefits over small molecules. Restraints such as lack of facilities, equipment, funding, and so on can be addressed by outsourcing the development of drugs to CDMOs. The economic benefits, of this partnership, are bolstering the growth of the CDMO market. Even though the market was adversely affected during the pandemic, due to disruptions in the supply chain, the market is predicted to register an upward graph with ease in post-lockdown measures.

The Global Biologics Contract Development and Manufacturing Organization (CDMO) Market is segmented to include

By Type

• Mammalian
• Non-mammalian (Microbial)

By Product Type

• Biologics
• Monoclonal (Diagnostic, Therapeutic, and Protein-based)
• Recombinant Proteins
• Antisense and Molecular
• Therapy
• Vaccines
• Other Types
• Biosimilars

By Geography

Mammalian cell lines are largely used to produce large molecules due to their ability to add human-like post-translational modifications to complex protein therapeutics. The segment, therefore dominated the market accounting for more than 70% of the market. In terms of revenue, it garnered approximately USD 6.3 billion in 2019. The development of enhanced systems, improving monitoring solutions, automatic screening methods, cell line engineered tools, and more has led to efficient manufacturing using mammalian cells in recent times. As a result, the segment, during the forecast timeline, is projected to display a CAGR of close to 14%.

Biologics accounted for a little under 85% of the market in 2019. This converts to more than USD 7.5 billion in revenue. The high specificity of biologics, higher success rates as compared to other drug molecules, rising demand for biological therapeutics for patient care and the increasing number of conventional drug manufacturers seeking to enter the sector are a few factors that played an essential role in the segment’s dominance. Nevertheless, the steady surge in investments into biosimilars is estimated to expand the segment by a CAGR of more than 15% between 2020 to 2027.

Market Geography Overview: Based on geography market is segmented as below:

• North America
• Europe
• APAC
• Latin America (LATAM)
• Middle East & Africa (MEA)

The presence of two major economies, the U.S. and Canada, makes North America one of the major markets for CDMO. Furthermore, the United States accounts for nearly half of the R&D spending on pharmaceutical and biotechnology markets. Biologic CDMOs play a vital role in the growth of the biologics contract development and manufacturing organization (CDMO) market in the region. They invest in advanced technologies and facilities to cater to a range of outsourcers. The rising collaboration between biopharmaceutical entities with CDMOs is anticipated to support regional market growth.

Outsourcing to Asian countries is done largely due to cost-associated benefits such as lower labor cost, operating cost, comparatively lower initial capital, etc. Lack of adequate regulations for biosimilar approval and the high-volume production capacity are a few other factors that will expand the biologics contract development and manufacturing organization (CDMO) market in the region at the fastest rate.

Biologics Contract Development and Manufacturing Organization (CDMO) Market Dynamics

Drivers:

1. Access to new technologies and higher speed of execution realized by CDMOs.

Mergers, acquisitions, partnerships, etc. help CDMOs provide integrated bioprocessing services that make these organizations attractive and feasible for rapid product launch. Moreover, the heavy investments made by them in acquiring technologies and equipment ensure efficient drug production. These factors are encouraging pharmaceutical companies to outsource to CDMOs, thereby accelerating market progress.

2. Lack of in-house capacity among emerging drug development companies.

Small and mid-sized biopharmaceutical entities lack resources, funding, or both to establish facilities required for the development of biologics or biosimilars. These entities, therefore, merge or pool resources with CDMOs. Hence, the lack of in-house capacity among drug development companies will boost the market growth.

3. Need for high capital investments.

Tools and technologies such as screening methods, disposable devices, process monitoring solutions, etc. essential for the manufacturing of drugs are quite expensive to procure. Additionally, the conceptualization and development of drugs involve a huge amount of money. The alternative to reducing these costs is outsourcing the development and/or manufacturing which, in turn, propels the market forward.

Opportunity:

1. Emergence of the concept of biosimilars co-development.

The development of biosimilars with an objective to outperform safety, efficacy, cost and other parameters of in-class innovator drugs have led to increased investment into the product type. Due to its high-cost challenges, several companies are collaborating for its development and production. This is expected to raise the demand for CDMOs and thus create new opportunities for the market in the years to come.

Challenges:

1. Transfer complexities and concerns over the breach of IP and patents.

Contract negotiations between CDMOs and their customers are challenging due to the regulatory landscape and the complexity of service. Issues pertaining to IP rights, patents, warranty & liability, etc., and their protection could deter market growth.

The market is studied by analyzing all the key market participants across the ecosystem. The key players in the global biologics contract development and manufacturing organization (CDMO) market include, but not limited to:

• Boehringer Ingelheim Group
• Wuxi Biologics
• Samsung Biologics
• Lonza Group
• Fujifilm Diosynth Biotechnologies USA Inc.
• Toyobo Co. Limited
• Parexel International Corporation
• PRA Health Sciences
• Binex Co. Limited
• JRS Pharma

Recent News and Developments in the Biologics Contract Development and Manufacturing Organization (CDMO) Market:

• 1) Invetx entered a partnership with WuXi Biologics and AbCellera in February 2020. The company invested around USD 15 million for clinical entry and pre-clinical development of its broader pipeline of protein-based therapeutics for Animal Biopharmaceutical Development.
• 2) Worceester Business Development Corporation and WuXi Biologics signed a land deal for the expansion of the company’s clinical and commercial facility in Worcester in May 2020.
• 3) In August 2020, Lonza Group AG partnered with IsoPlexis to expand the manufacturing of cell therapies.

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