Biologics Contract Development and Manufacturing Organization (CDMO) - Global Market Outlook (2021 - 2028)

Biologics Contract Development and Manufacturing Organization (CDMO) - Global Market Outlook (2021 - 2028)

According to Stratistics MRC, the Global Biologics Contract Development and Manufacturing Organization (CDMO) Market is accounted for $11.01 billion in 2021 and is expected to reach $25.75 billion by 2028 growing at a CAGR of 12.9% during the forecast period. Biologics contract development and manufacturing organizations offer complete services from cell line development to long term commercial supply of biological products. The services include the development of cell lines, upstream and downstream processes, analytical and bioanalytical methods, formulations and quality assessment, and regulatory assistance.

Market Dynamics:

Driver:

Increasing prevalence of various diseases

The prevalence of diseases, such as cancer, neurological disorders, gynecological disorders, ophthalmic disorders, and cardiovascular disorders, is increasing every year. For instance, according to WHO, approximately 8.2 million people die each year due to cancer, accounting for 13.0% of deaths worldwide. Moreover, there will be an estimated 70.0% increase in new cancer cases over the next couple of decades. In such cases, healthcare CDMOs play a vital role in patient care, as many biopharma companies are focusing on the development of novel therapies or first in class products for the treatment of diseases.

Restraint:

In-house production of biologic drugs by top pharma companies

Top pharma companies' propensity toward producing biologic drugs in-house is hampering the growth, as these drugs are high value, high margin products, owing to which large companies are focused on the security of supply, ensuring quality, IP protection of proprietary cell strains, and manufacturing process.

Opportunity:

High consolidation activities by major players

Global biologics contract manufacturing demand will see more consolidation as key players look to inorganic growth strategies to offer integrated solutions to customers. Companies interested in global biologics contract manufacturing demand are seeking to consolidate their position through acquisitions, collaborations, and partnerships with small and medium manufacturers in the market, and expand their product reach. Consolidation activities significantly accelerate a company's strategy and build scale and depth in biologics contract manufacturing demand services.

Threat:

Technical difficulties

It is technically difficult to manufacture products, such as biologics, where tech transfer can be a lengthy and expensive process. A single supplier relationship has the potential to reduce the risk of supply issues. However, the relationship, in turn, helps the CDMO to sell more services to the same customer and lock in products at an earlier stage in their life cycle.

The mammalian segment is expected to be the largest during the forecast period

Using mammalian cells for protein expression can offer the major advantage of being able to produce mammalian proteins with all the correct post-translational modifications that provide a native structure. Mammalian cells like Chinese Hamster Ovary (CHO) cell lines have been among the most preferred and about 70.0% of the protein therapeutics is developed from CHO cells.

The biologics segment is expected to have the highest CAGR during the forecast period

The biologics segment consists of antisense and molecular therapy, recombinant proteins, vaccines, and monoclonal. The favorable safety profile of monoclonal antibodies associated with therapeutic use and high specificity constitutes it as the largest class of biologics in the biopharmaceuticals contract research, development, and manufacturing industry. Increasing demand for antibody-based therapeutics is expected to drive biologics contract manufacturing demand, followed by recombinant proteins, and vaccines. Advanced variants of monoclonal antibodies such as antibody fragment-based products and bispecific antibodies are also steadily gaining traction in the pharmaceutical industry.

Region with largest share:

North America is projected to hold the largest market share 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. In addition to this, global biologics CDMO vendors are increasing their investments and are expanding their presence in the region. For instance, in March 2020, Bora Pharmaceuticals expanded its footprint in North America. Over the coming years, CDMOs are expected to expand their presence in the region due to the growing health ailments and aging population.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR due to the various amendments made by regulatory organizations to change clinical trial evaluation standards according to global requirements and many major players are investing in the Asia Pacific. Countries in the Asia Pacific have a dense patient pool and the potential to have advanced medical expertise. The cost of conducting a clinical trial is very low here as compared to western countries. These aforementioned factors will assist the biologics contract development and manufacturing organization market within the region.

Key players in the market

Some of the key players profiled in the Biologics Contract Development and Manufacturing Organization (CDMO) Market include Samsung Biologics, Boehringer Ingelheim Group, Sandoz Biopharmaceuticals (Novartis AG), Parexel International Corporation, Fujifilm Diosynth Biotechnologies USA Inc., AbbVie Contract Manufacturing, Lonza Group, Binex Co. Limited, Rentschler Biotechnologies, Toyobo Co. Limited, AGC Biologics, PRA Health Sciences, Catalent Inc, Wuxi Biologics, and JRS Pharma.

Key developments:

In May 2021: Samsung Biologics announced its plans to add an mRNA vaccine production line at its facility in Songdo, 30 kilometers southwest of Seoul, by the first half of 2022. Messenger RNA (mRNA) vaccines are known for their safety and fast scalability in manufacturing, the company said in a statement, and have been among the first COVID-19 vaccines authorized for use in the United States.

In April 2021: Gene Biotherapeutics partnered with Fujifilm Diosynth Biotechnologies to manufacture Generx [ad5fgf-4] phase 3 angiogenic gene therapy product candidate for refractory angina. Manufacturing operations will be conducted at FDB’s facilities in College Station, TX, where FDB will perform technology transfer and process development activities for Phase 3 clinical and commercial-scale GMP manufacturing of Genereux.

In January 2021: Boehringer Ingelheim entered into a strategic collaboration and licensing agreement with Enara Bio to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen discovery platform. The collaboration combines Boehringer Ingelheim’s approach to tackling cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification.

Services Covered:
Contract Manufacturing Organization (CMO)
Contract Research Organization (CRO)

Types Covered:
Mammalian
Non-Mammalian (Microbial)

Products Covered:
Biosimilars
Biologics

Applications Covered:
Small Pharma
Big Pharma
Generic Pharma

Regions Covered:
North America
US
Canada
Mexico
Europe
Germany
UK
Italy
France
Spain
Rest of Europe
Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
South America
Argentina
Brazil
Chile
Rest of South America
Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
Company Profiling
Comprehensive profiling of additional market players (up to 3)
SWOT Analysis of key players (up to 3)
Regional Segmentation
Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances