The North America Pharmaceutical Contract Development and Manufacturing Market is expected to reach $105.42 billion by 2030 at a CAGR of 7.1% from 2023 to 2030. Pharmaceutical contract development and manufacturing organizations (CDMOs) partner with pharmaceutical companies and offer contract-based manufacturing and drug development services. CDMOs handle everything from pre-formulation and formulation development to clinical trials and manufacturing. Pharmaceutical companies opt for CDMOs because of the benefits such as reduced labor, cost, high product quality, faster time, and resource savings.
The growth of the North America pharmaceutical contract development and manufacturing market is attributed to the complex manufacturing requirements of the pharmaceutical industry, manufacturers’ growing inclination towards the use of cutting-edge technologies, patent expiration, increasing investments in pharmaceutical R&D, and the rising demand for generic medicines & biologics. However, the lack of skilled professionals is challenging the growth of this market. In addition, growing consolidation among CDMO market players and virtual business models are the industry trends in the market.
Next-generation medicines, such as cell and gene therapy, provide significant opportunities for growth in CRO and CDMO marketplaces. Gene therapy alters the genes to cure disease or improve the body's ability to fight disease. Also, cell therapy is a therapy in which viable cells are injected, grafted, or implanted into a patient to effectuate a medicinal effect. Potential applications of cell therapies include treating cancers, autoimmune diseases, urinary problems, and infectious diseases, rebuilding damaged cartilage in joints, repairing spinal cord injuries, improving a weakened immune system, and helping patients with neurological disorders.
As of 2023, there are 32 cell or gene therapy products approved in the U.S. for cancer, eye diseases, and rare hereditary diseases. Also, many therapies are in pre-clinical stages and are expected to enter the clinical trials pipeline. Gene therapies under development are designed to address defects in the genetic code, which cause a wide range of diseases.
A shortage of manufacturing capacity poses a massive hurdle to growth in the cell and gene therapy marketplace; therefore, major firms outsource their cell or gene therapy process development, providing lucrative opportunities for the growth of the pharmaceutical contract development and manufacturing market.
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The pharmaceutical industry is largely driven by scientific discovery, development, and toxicological and clinical experience. Pharmaceutical manufacturing operations may be categorized as primary production of bulk drug substances (APIs) and manufacturing of dosage form products (formulations).
In addition to the complexity of the pharmaceutical manufacturing process, many countries globally have specific legal protections for proprietary drugs and manufacturing processes, known as intellectual property rights. When legal protections are limited or nonexistent, some companies specialize in manufacturing and marketing generic drugs. The pharmaceutical industry requires large capital investments due to the high expenses associated with R&D, regulatory approvals, manufacturing, quality assurance & control, marketing, and sales.
U.S. and Canada have extensive government regulations affecting the development and approval of drugs for commercial sale. These countries have strict requirements for good manufacturing practices to ensure the integrity of drug manufacturing operations and pharmaceutical products' quality, safety, and efficacy. These challenges have led pharmaceutical companies to partner with contract manufacturing and development organizations to develop and manufacture pharmaceuticals and biologics, driving the growth of the pharmaceutical contract development and manufacturing market.
Based on type, the North America pharmaceutical contract development and manufacturing market is segmented into pharmaceutical manufacturing services, drug development services, and biologics manufacturing services. In 2023, the pharmaceutical manufacturing services segment is expected to account for the largest share of the market. The large of this segment is attributed to factors such as the growing need to reduce manufacturing costs in the pharmaceutical industry, the requirement for high-quality bulk manufacturing, and the growing demand for generic drugs. According to the U.S. FDA, as of 2022, it is estimated that 91% of all prescriptions in the United States are filled as generic drugs, with more than 32,000 generic drugs approved.
Based on end user, the North America pharmaceutical contract development and manufacturing market is segmented into large pharmaceutical companies, small & mid-size pharmaceutical companies, and generic pharmaceutical companies. In 2023, the large pharmaceutical companies segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the increasing demand from businesses worldwide, the increasing need for state-of-the-art processes and production technologies, and the continued efforts of pharmaceutical companies to reduce production costs. Additionally, with the increasing burden of diseases, the demand for drugs is increasing. Thus, to tackle the high demand, pharmaceutical companies are collaborating or partnering with CDMOs. For instance: In May 2021, Siegfried Holdings AG (Switzerland) signed an agreement with Novavax, Inc. (U.S.) to manufacture and supply Novavax's protein-based COVID-19 Vaccine. Under this agreement, Siegfried served as a non-exclusive supplier for the aseptic fill and finish of Novavax's COVID-19 vaccine NVX-CoV2373.
The U.S. is expected to register the highest CAGR during the forecast period. Factors such as drug shortages due to the emergence of the COVID-19 pandemic, the presence of large pharmaceutical and biotechnology manufacturers, biopharmaceutical R&D funding, and rising demand for cell and gene therapies in the U.S. drive the pharmaceutical contract development and manufacturing market. Growing demand for biopharmaceuticals and supportive initiatives for their adoption resulted in expanding biopharmaceutical manufacturing facilities in the U.S. For instance, in April 2022, FUJIFILM Diosynth Biotechnologies (U.S.) announced to build BioProcess Innovation Center in Research Triangle Park (U.S.). The facility will have analytical instrumentation, high throughput bioprocessing equipment, and automation technologies. Also, in March 2022, Amgen, Inc. (U.S.) announced the establishment of a biomanufacturing facility in North Carolina (U.S.). The facility is expected to be operational by 2025.
The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over the years. The key players operating in the North America pharmaceutical contract development and manufacturing market are Thermo Fisher Scientific Inc. (U.S.), Catalent, Inc. (U.S.), C.H. Boehringer Sohn AG & CO. KG. (Germany), Synoes Health, Inc. (U.S.), Curia Global, Inc. (U.S.), Cambrex Corporation (U.S.), FUJIFILM Diosynth Biotechnology (U.S.), Samsung Biologics (South Korea), Siegfried Holding AG (Switzerland), Aenova Group (Germany), WuXi Biologics (China), and Vetter Pharma International GmbH (Germany).
Report Summary:
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Particular |
Details |
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Number of Pages |
~150 |
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Format |
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Forecast Period |
2023-2030 |
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Base Year |
2022 |
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CAGR |
7.1% |
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Estimated Market Size (Value) |
$105.42 billion by 2030 |
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Segments Covered |
by Type
by End User
by Country
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Countries Covered |
North America (U.S., Canada) |
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Key Companies |
Thermo Fisher Scientific Inc. (U.S.), Catalent, Inc. (U.S.), C.H. Boehringer Sohn AG & CO. KG. (Germany), Synoes Health, Inc. (U.S.), Curia Global, Inc. (U.S.), Cambrex Corporation (U.S.), FUJIFILM Diosynth Biotechnology (U.S.), Samsung Biologics (South Korea), Siegfried Holding AG (Switzerland), Aenova Group (Germany), WuXi Biologics (China), and Vetter Pharma International GmbH (Germany). |
Key questions answered in the report:
What is the focus of the North America pharmaceutical contract development and manufacturing market?
The North America pharmaceutical contract development and manufacturing market studies different types of services, such as pharmaceutical manufacturing services, drug development services, and biologics manufacturing services used by end users. The North America pharmaceutical contract development and manufacturing market studied in this report involve the analysis of various segments at country levels.
The North America pharmaceutical contract development and manufacturing market is projected to reach $ 105.42 billion by 2030 at a CAGR of 7.1% from 2023 to 2030.
Among all the types studied in the report, the pharmaceutical manufacturing services segment is expected to account for the largest share of the market in 2023. The large share of the segment is attributed to the growing need to reduce manufacturing costs, bring a new drug to the market quickly at the lowest possible cost, the requirement for high-quality bulk manufacturing, and the growing demand for generic drugs.
The growth of this market is driven by the complex manufacturing requirements of the pharmaceutical industry, manufacturers' growing inclination toward the use of cutting-edge technologies, patent expiration, increasing investments in pharmaceutical R&D, and the rising demand for generic medicines & biologics. In addition, the growing demand for cell and gene therapies and personalized medicine and growth in high potency active pharmaceutical ingredients (HPAPI) and antibody-drug conjugates (ADC) markets are expected to offer significant opportunities for the growth of the pharmaceutical contract development and manufacturing market.
The key players operating in the North America pharmaceutical contract development and manufacturing market are Thermo Fisher Scientific Inc. (U.S.), Catalent, Inc. (U.S.), C.H. Boehringer Sohn AG & CO. KG. (Germany), Synoes Health, Inc. (U.S.), Curia Global, Inc. (U.S.), Cambrex Corporation (U.S.), FUJIFILM Diosynth Biotechnology (U.S.), Samsung Biologics (South Korea), Siegfried Holding AG (Switzerland), Aenova Group (Germany), WuXi Biologics (China), and Vetter Pharma International GmbH (Germany).
The U.S. is expected to offer significant growth opportunities owing to the government initiatives to create favorable pharmaceutical drug approval programs, increase investment from existing pharmaceutical manufacturers in the country for infrastructure development, and growing investments towards biosimilar manufacturing.
This report provides pre & post COVID-19 market estimates.
1. Introduction
1.1. Market Definition & Scope
1.2. Market Ecosystem
1.3. Currency & Limitations
1.4. Key Stakeholders
2. Research Methodology
2.1. Research Approach
2.2. Process of Data Collection and Validation
2.2.1. Secondary Research
2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
2.3. Market Sizing and Forecast
2.3.1. Market Size Estimation Approach
2.3.2. Growth Forecast Approach
2.4. Assumptions for the Study
3. Executive Summary
4. Market Insights
4.1. Overview
4.2. Drivers
4.2.1. Complex Manufacturing Requirements of the Pharmaceutical Industry
4.2.2. Manufacturers' Growing Inclination Toward the Use of Cutting-edge Technologies
4.2.3. Rising Demand for Generic Medicines and Biologics
4.2.4. Patent Expiration
4.2.5. Increasing Investments in Pharmaceutical R&D
4.3. Restraints
4.3.1. Stringent Regulatory Requirements
4.4. Opportunities
4.4.1. Growing Demand for Cell Therapies, Gene Therapies, and Personalized Medicines
4.4.2. Growth in High Potency Active Pharmaceutical Ingredients (HPAPI) and Antibody-drug Conjugates (ADC) Markets
4.5. Challenge
4.5.1. Shortage of Skilled Professionals
4.6. Factor Analysis
4.7. Trends
4.7.1. Virtual Business Models
4.7.2. Growing Consolidation Among CDMO Market Players
4.8. Regulatory Analysis
4.9. Porter’s 5 Force Analysis
5. North America Pharmaceutical Contract Development and Manufacturing Market Assessment— by Type
5.1. Overview
5.2. Pharmaceutical Manufacturing Services
5.2.1. Active Pharmaceutical Ingredient (API) Manufacturing Services
5.2.2. Finished Dosage Forms (FDF) Manufacturing Services
5.2.2.1. Parenteral/Injectable Manufacturing Services
5.2.2.2. Tablet Manufacturing Services
5.2.2.3. Capsule Manufacturing Services
5.2.2.4. Oral Liquid Manufacturing Services
5.2.2.5. Other Formulations
5.3. Drug Development Services
5.4. Biologics Manufacturing Services
5.4.1. Active Pharmaceutical Manufacturing Services (API) Manufacturing Services
5.4.2. Finished Dosage Form Manufacturing (FDF) Services
6. North America Pharmaceutical Contract Development and Manufacturing Market Assessment—by End User
6.1. Overview
6.2. Large Pharmaceutical Companies
6.3. Small & Mid-Size Pharmaceutical Companies
6.4. Generic Pharmaceutical Companies
7. North America Pharmaceutical Contract Development and Manufacturing Market Assessment–by Geography
7.1. Overview
7.2. U.S.
7.3. Canada
8. Competition Analysis
8.1. Overview
8.2. Key Growth Strategies
8.3. Competitive Benchmarking
8.4. Competitive Dashboard
8.4.1. Industry Leaders
8.4.2. Market Differentiators
8.4.3. Vanguards
8.4.4. Emerging Companies
8.5. Market Share Analysis, by the Key Player/Market Ranking, 2022
9. Company Profiles (Company Overview, Financial Snapshot, Product Portfolio, and Strategic Developments, SWOT Analysis)
9.1. Thermo Fisher Scientific Inc.
9.2. Catalent, Inc.
9.3. C.H. Boehringer Sohn AG & CO. KG.
9.4. Synoes Health, Inc.
9.5. Curia Global, Inc.
9.6. Cambrex Corporation
9.7. FUJIFILM Diosynth Biotechnology
9.8. Samsung Biologics
9.9. Siegfried Holding AG
9.10. Aenova Group
9.11. WuXi Biologics
9.12. Vetter Pharma International GmbH
(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)
10. Appendix
10.1. Available Customization
10.2. Related Reports
List of Tables
Table 1 North America Pharmaceutical Contract Development and Manufacturing Market, by Type, 2021-2030 (USD Million)
Table 2 North America Pharmaceutical Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 3 North America Pharmaceutical Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 4 North America Active Pharmaceutical Ingredient (API) Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 5 North America Finished Dosage Forms (FDF) Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 6 North America Finished Dosage Forms (FDF) Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 7 North America Parenteral/Injectable Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 8 North America Tablet Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 9 North America Capsule Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 10 North America Oral Liquid Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 11 North America Other Formulations Market, by Country/Region, 2021–2030 (USD Million)
Table 12 North America Drug Development Services Market, by Country/Region, 2021–2030 (USD Million)
Table 13 North America Biologics Manufacturing Services, by Type, 2021–2030 (USD Million)
Table 14 North America Biologics Manufacturing Services, by Country/Region, 2021–2030 (USD Million)
Table 15 North America Active Pharmaceutical Manufacturing Services (API) Manufacturing Services Market, by Country/Region, 2021–2030 (USD Million)
Table 16 North America Finished Dosage Form Manufacturing (FDF) Services Market, by Country/Region, 2021–2030 (USD Million)
Table 17 North America Pharmaceutical Contract Development and Manufacturing Market, by End User, 2021–2030 (USD Million)
Table 18 North America Pharmaceutical Contract Development and Manufacturing Market for Large Pharmaceutical Companies, by Country/Region, 2021–2030 (USD Million)
Table 19 North America Pharmaceutical Contract Development and Manufacturing Market for Small & Mid-Size Pharmaceutical Companies, by Country/Region, 2021–2030 (USD Million)
Table 20 North America Pharmaceutical Contract Development and Manufacturing Market for Generic Pharmaceutical Companies, by Country/Region, 2021–2030 (USD Million)
Table 21 North America Pharmaceutical Contract Development and Manufacturing Market, by Country/Region., 2021-2030 (USD Million)
Table 22 North America: Pharmaceutical Contract Development and Manufacturing Market, by Type, 2021–2030 (USD Million)
Table 23 North America: Pharmaceutical Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 24 North America: Finished Dosage Forms (FDF) Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 25 North America: Biologics Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 26 North America: Pharmaceutical Contract Development and Manufacturing Market, by End User, 2021–2030 (USD Million)
Table 27 U.S.: Pharmaceutical Contract Development and Manufacturing Market, by Type, 2021–2030 (USD Million)
Table 28 U.S.: Pharmaceutical Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 29 U.S.: Finished Dosage Forms (FDF) Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 30 U.S.: Biologics Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 31 U.S.: Pharmaceutical Contract Development and Manufacturing Market, by End User, 2021–2030 (USD Million)
Table 32 Canada: Pharmaceutical Contract Development and Manufacturing Market, by Type, 2021–2030 (USD Million)
Table 33 Canada: Pharmaceutical Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 34 Canada: Finished Dosage Forms (FDF) Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 35 Canada: Biologics Manufacturing Services Market, by Type, 2021–2030 (USD Million)
Table 36 Canada: Pharmaceutical Contract Development and Manufacturing Market, by End User, 2021–2030 (USD Million)
Table 37 Recent Developments, by Company, 2020—2023
List of Figures
Figure 1 Research Process
Figure 2 Key Secondary Sources
Figure 3 Primary Research Techniques
Figure 4 Key Executives Interviewed
Figure 5 Breakdown of Primary Interviews (Supply Side & Demand Side)
Figure 6 Market Size Estimation
Figure 7 North America Pharmaceutical Contract Development and Manufacturing Market, by Type, 2023 VS. 2030 (USD Million)
Figure 8 North America Pharmaceutical Contract Development and Manufacturing Market, by End User, 2023 VS. 2030 (USD Million)
Figure 9 Factors Affecting Market Growth
Figure 10 North America Pharmaceutical Contract Development and Manufacturing Market, by Type, 2023 VS. 2030 (USD Million)
Figure 11 North America Pharmaceutical Contract Development and Manufacturing Market, by End User, 2023 VS. 2030 (USD Million)
Figure 12 North America Pharmaceutical Contract Development and Manufacturing Market, by Country, 2023 VS. 2030 (USD Million)
Figure 13 North America: Pharmaceutical Contract Development and Manufacturing Market Snapshot
Figure 14 Key Growth Strategies Adopted by Leading Players, 2020—2023
Figure 15 North America Pharmaceutical Contract Development and Manufacturing Market: Competitive Dashboard
Figure 16 North America Pharmaceutical Contract Development and Manufacturing Market: Competitive Benchmarking, by Type
Figure 17 North America Pharmaceutical Contract Development and Manufacturing Market: Market Share Analysis (2022)
Figure 18 Thermo Fisher Scientific Inc.: Financial Snapshot (2022)
Figure 19 Catalent, Inc.: Financial Snapshot (2022)
Figure 20 C.H. Boehringer Sohn AG & CO. KG.: Financial Snapshot (2022)
Figure 21 Catalent, Inc.: Financial Snapshot (2022)
Figure 22 FUJIFILM Diosynth Biotechnology: Financial Snapshot (2022)
Figure 23 Samsung Biologics: Financial Snapshot (2022)
Figure 24 Siegfried Holding AG: Financial Snapshot (2022)
Figure 25 Aenova Gropu: Financial Snapshot (2022)
Figure 26 WuXi Biologics: Financial Snapshot (2022)
Figure 27 Vetter Pharma International GmbH: Financial Snapshot (2022)
This report provides pre & post COVID-19 market estimates.
This report provides pre & post COVID-19 market estimates.
Published Date: Jul-2023
