Biotechnology Contract Manufacturing Market by Service (Manufacturing, Fill Finish, Packaging), Type (Drug Substance, Drug Product), Scale, Source (Mammalian), Therapy Area (Oncology), Molecule Type (mAbs, ADC, CGT, Vaccines) - Global Forecast to 2028
The global biotechnology contract manufacturing market in terms of revenue was estimated to be worth $16.6 billion in 2023 and is poised to reach $24.8 billion by 2028, growing at a CAGR of 8.3% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The growth of this market is majorly driven by factors like increasing approvals of monoclonal antibodies and, in other targeted therapies, rising approvals of biosimilars. Increasing investments for the expansion of production capacities among the contract manufacturers will support the growth of the market in the future. Moreover, factors like increasing investments for research in novel therapeutics like cell and gene therapy and antibody drug conjugates are likely to support the market growth.
Attractive Opportunities in the Biotechnology Contract Manufacturing Markets
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Biotechnology Contract Manufacturing Market Dynamics
DRIVER: Increasing biologics manufacturing outsourcing trend among biopharmaceutical companies
The increasing popularity of biologics in medicine has led to a significant rise in outsourcing manufacturing. Biologics contract manufacturers have the know-how and setup to make these complex therapies effective while ensuring the meeting of strict quality rules and regulations. Such contract manufacturers have a deep understanding of protein chemistry, cell culture, downstream process, and the impact of process conditions on yield and protein structure while proceeding from lab to GMP scale. Therefore, biopharmaceutical companies prefer to opt for a highly efficient way to accelerate development and manufacturing by partnering with CDMOs, and CMOs have strong expertise in biologics, chemistry manufacturing control, and commercial manufacturing. Further, biopharmaceutical companies outsource clinical and commercial biomanufacturing to reduce the cost and associated risk with in-house development and manufacturing. This, in turn, supports the market growth.
RESTRAINT: Intellectual property rights issues
Intellectual property protection is the most vital part of contract manufacturing. An innovator company has to share the complete details of its patented drug with the contract manufacturer to allow it to manufacture the drug. It includes the risk of using the information in an unauthorized manner and duplicating the products and the risk associated with infringements. Recently, the outsourcing of basic manufacturing activities is emerged as an upcoming trend in the industry. For example, pharmaceutical firms are outsourcing the manufacturing of complex biologics as it requires the expertise and infrastructure to manufacture them in a manner that meets individual patient requirements. For this trend to continue in the market, it is necessary to maintain an honest relationship between the pharmaceutical companies and the CMOs to ensure the protection of intellectual property.
OPPORTUNITY: Rising demand for cell therapies and gene therapies
Cell and gene therapies are highly specific and have the potential to address unmet medical needs associated with treating untouched disorders by small molecule drugs and other biologics. Their promising therapeutic potential has led many pharmaceutical companies to focus on developing and commercializing these therapies. This has led to increased demand for cell and gene therapy development and manufacturing. As of April 2022, more than 20 cell & gene therapies have been approved by the US FDA. The growing number of cell and gene therapy candidates, along with their progression through the various phases of clinical development and their complex manufacturing process, has increased the demand for facilities that offer manufacturing services for these therapies. This is likely to provide growth opportunities for the contract manufacturing of these therapies.
CHALLENGE: Challenges to meet reformed regulations
FDA regulations outline that the manufacturer needs to strictly follow the guidelines defined by the respective regulatory authority. The CMOs face the task of seeking regulatory approvals from different regions for the same molecule, tailoring their submissions based on specific client requirements. This process becomes complex due to variations in regulations and submission criteria across different countries. Mistakes in this complex attempt can pose significant obstacles for innovators aiming to access regulated markets. This challenge is deepened by the need to align manufacturing practices with the latest regulatory reforms. Thus making it challenging for CMOs to consistently meet evolving standards across diverse regions and countries.
Biotechnology contract manufacturing market Ecosystem
The global market is a complex ecosystem involving various stakeholders, including the supply side, i.e., companies providing contract manufacturing services, and the demand side, i.e., pharmaceutical companies and biotechnology companies, among others.
Several key companies provide services for contract manufacturing. For example, Lonza (Switzerland) is a leading provider of contract manufacturing services for biologics, including cell and gene therapies, viral vectors, and plasmid DNA. Other service providers include Thermo Fisher Scientific, Inc. (US), AbbVie, Inc. (US), Catalent Inc. (US), Wuxi Biologics (China), and others.
The manufacturing segment dominated the biotechnology contract manufacturing industry by service.
The manufacturing segment held the largest share of the global biotechnology contract manufacturing market in 2022. The manufacturing of biopharmaceuticals includes processes like upstream manufacturing and downstream manufacturing. As the manufacturing of biologics involves complex processes, the process design, optimization, and deployment of enhanced protocols and procedures to obtain purity is still an ongoing challenge for biopharmaceutical companies. Biologic manufacturers can fulfill their production goals while staying ahead of ever-changing trends and technologies, supporting the trend for outsourced manufacturing.
The biologic drug substance manufacturing segment dominated the biotechnology contract manufacturing industry by type.
The biologic drug substance manufacturing segment held the largest share of the global biotechnology contract manufacturing market in 2022. The large share of drug substance manufacturing is attributed to the growing research in the field of novel therapies to treat chronic diseases. As the marketed drugs are moving toward the patent cliff, there is an increasing demand for newer targeted therapies like monoclonal antibodies, cell therapies, and gene therapies. Whereas the manufacturing of these complex drug substances requires highly sophisticated equipment and manufacturing technologies. The innovator companies prefer to outsource the manufacturing of these biological drug substances, in turn supporting the market growth.
Asia Pacific region of the biotechnology contract manufacturing industry is estimated to register the highest CAGR during the forecast period.
Asia Pacific offers lucrative growth potential for the biotechnology contract manufacturing market. This can be attributed to the increasing pharmaceutical R&D spending in the region, the growing trend of outsourcing manufacturing services, and increasing government initiatives for healthcare research. One significant growth driver for the market in the Asia Pacific region is the increasing investment in healthcare infrastructure and R&D activities. Further, the growing prevalence of chronic diseases and the large population in the region are also facilitating the demand for novel therapies for treatment, supporting the demand for biologic drugs and their outsourced manufacturing. Also, the favorable regulatory guidelines for drug approval in the region are expected to drive market growth.
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Key players in the biotechnology contract manufacturing market include Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Catalent, Inc. (US), Samsung Biologics (South Korea), WuXi Biologics (China), Boehringer Ingelheim International GmbH (Germany), FUJIFILM Holding Corporation (Japan), AbbVie, Inc. (US), Eurofins Scientific (Luxembourg), GenScript Biotech Corporation (US), AGC, Inc. (Japan), Merck KgaA (Germany), JSR Corporation (Japan), among others.
Scope of the Biotechnology Contract Manufacturing Industry:
|
Report Metric |
Details |
|
Market Revenue in 2023 |
$16.6 billion |
|
Estimated Value by 2028 |
$24.8 billion |
|
Revenue Rate |
Poised to grow at a CAGR of 8.3% |
|
Market Driver |
Increasing biologics manufacturing outsourcing trend among biopharmaceutical companies |
|
Market Opportunity |
Rising demand for cell therapies and gene therapies |
This report categorizes the Biotechnology contract manufacturing market to forecast revenue and analyze trends in each of the following submarkets:
By Service
- Manufacturing
- Formulation and Fill-Finish
- Packaging and Labeling
- Other services
By Type
- Biologic Drug Substance Manufacturing
- Biologic Drug Product Manufacturing
By Scale of Operation
- Commercial Operations
- Clinical Operations
By Source
- Mammalian Expression Systems
- Non-Mammalian Expression Systems
By Molecule
- Monoclonal Antibodies
- Cell Therapy & Gene Therapy
- Antibody-Drug Conjugates (ADCs)
- Vaccines
- Therapeutic Peptides & Proteins
- Other Molecule Types
By Therapeutic Area
- Oncology
- Autoimmune Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Infectious Diseases
- Neurology
- Other Therapeutic Areas
By Region
-
North America
- US
- Canada
-
Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe (RoE)
-
Asia Pacific (APAC)
- China
- Japan
- India
- South Korea
- Rest of Asia Pacific (RoAPAC)
-
Latin America (LATAM)
- Brazil
- Rest of Latin America
- Middle East and Africa (MEA)
Recent Developments of Biotechnology Contract Manufacturing Industry
- In January 2023, WuXi Biologics entered into a licensing agreement with GSK plc for using WuXi Biologics’ proprietary technology platforms. Under this, GSK was granted an exclusive global license for the research, development, manufacturing, and commercialization of bispecific antibodies in the WuXi Biologics plan.
- In October 2022, Samsung Biologics partnered with GSK plc for the manufacturing of GSK’s monoclonal antibody and products, including lupus treatments like Benlysta.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global biotechnology contract manufacturing market?
The global biotechnology contract manufacturing market boasts a total revenue value of $24.8 billion by 2028.
What is the estimated growth rate (CAGR) of the global biotechnology contract manufacturing market?
The global biotechnology contract manufacturing market has an estimated compound annual growth rate (CAGR) of 8.3% and a revenue size in the region of $16.6 billion in 2023.
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This research study involved the extensive use of secondary sources, directories, and databases to identify and collect valuable information for the analysis of the biotechnology contract manufacturing market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess the growth prospects of the market. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
The secondary sources referred to for this research study include publications from government sources, such as the Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Bioprocess and Biosystems Engineering, Bioprocess International, PLOS Biology, European Medicines Agency (EMA), Pharma & Biopharma Outsourcing Association (PBOA), Generics and Biosimilars Initiative (GaBI), Parenteral Drug Association (PDA), American Association of Pharmaceutical Scientists (AAPS), Global Cancer Observatory, American Chemical Society, National Center for Biotechnology Information (NCBI), Food and Drug Administration (FDA), Biotechnology and Biological Sciences Research Council (BBSRC), and World Journal of Pharmaceutical Sciences. Secondary sources also include corporate and regulatory filings, such as annual reports, SEC filings, investor presentations, and financial statements; business magazines & research journals; press releases; and trade, business, and professional associations. Secondary data was collected and analyzed to arrive at the overall size of the biotechnology contract manufacturing market, which was validated through primary research.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the biotechnology contract manufacturing market scenario through secondary research. Several primary interviews were conducted with market experts from the demand side, such as personnel from pharmaceutical and biopharmaceutical industries, academic & research institutes, and experts from the supply side, such as C-level and D-level executives, product managers, and marketing & sales managers of key service providers. These interviews were conducted across four major regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Approximately 70% and 30% of the primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
The following is a breakdown of the primary respondents:
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Market Size Estimation
The global size of the market was estimated through multiple approaches. A detailed market estimation approach was followed to estimate and validate the value of the biotechnology contract manufacturing market and other dependent submarkets. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
- The key players in the industry and market have been identified through extensive primary and secondary research.
- The revenues generated from the contract manufacturing business of leading players have been determined through primary and secondary research.
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Market Size Estimation Methodology-bottom-up approach
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Market Size Estimation Methodology-top-down approach
Data Triangulation
After arriving at the market size from the market size estimation process explained above, the total market was divided into several segments and subsegments. Data triangulation and market breakdown procedures were employed, wherever applicable, to complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments.
Market Definition
Biotechnology contract manufacturing involves outsourcing biological manufacturing services to specialized contract manufacturing organizations (CMOs). Biologics are complex pharmaceutical products derived from living organisms, such as proteins, peptides, nucleic acids, cells or tissues, and other biotechnologically produced molecules. The market study includes the assessment of various services, sources, types, scale of operation, molecules, and therapeutic areas in biotechnology contract manufacturing.
Key Stakeholders
- Pharmaceutical and Biotechnology Companies
- Research and Consulting Firms
- Academic Medical Centers
- Government Research Organizations
- Clinical Research Institutes
- Contract Research Organizations
- Pharmaceutical Distributors and Suppliers
- Corporate Entities
- Contract Development and Manufacturing Organizations
Report Objectives
- To define, describe, and forecast the biotechnology contract manufacturing market based on service, type, source, scale of operation, molecule type, therapeutic area, and region
- To provide detailed information regarding the major factors influencing the growth of the market (such as drivers, restraints, opportunities, and challenges)
- To strategically analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall market
- To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments with respect to five main regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa
- To profile the key players and comprehensively analyze their service portfolios, market positions, and core competencies
- To track and analyze competitive developments such as acquisitions, expansions, agreements, partnerships, and collaborations in the market
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report:
Geographical Analysis
- Further breakdown of the Rest of Europe biotechnology contract manufacturing market, by country
- Further breakdown of the Rest of Asia Pacific biotechnology contract manufacturing market, by country
- Further breakdown of the Latin America and Middle East & Africa biotechnology contract manufacturing market, by country
Company Information
- Detailed analysis and profiling of additional market players (up to five)
Segment Analysis
- Further breakdown of the Therapeutic Areas segment
Growth opportunities and latent adjacency in Biotechnology Contract Manufacturing Market