This report represents a current and important business tool to evaluate technologies, trends, products and market participants in the outsourcing sector for drug and medical device development. The geographic scope of this study covers the U.S. and companies worldwide.
Drug development and commercialization is an expensive, lengthy and risky process.
Bringing a new drug/therapy to the market requires three main steps: discovery, development and commercialization. Each of these steps consist of number of stages that can lead to successful product on the market.
Outsourcing has become one of the main strategies to reduce the cost and time of drug or device development. For example, there are contract research organizations (CROs) that specialize in the drug discovery stage, offering solutions for target screening, validation and lead optimization. Other companies focus on animal studies, pharmacokinetics or assay development.
Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) are also essential parts of the drug development process. These companies supply manufacturing services for different stages of preclinical and clinical research. Formulation development and bioanalytical testing are also outsourced to variety of vendors.
To conduct clinical trials, many medium-size and small biotech companies outsource specific activities such as study design, patient recruitment and other associated services. Medical device development represents a unique sector due to its specific design, regulatory and manufacturing needs. Overall, the outsourcing market can be viewed and analyzed by different stage of drug/device development process.
Importantly, pharma companies have different outsourcing needs than smaller biotech and start-ups. In sum, each development activity can be outsourced to vendors with the required experience and knowledge.
This report will describe current trends, products, evolving technologies and new services in the outsourcing industry for drug and medical device development. It will evaluate current situation and forecast possible outcomes of this market for the next five years.
The report includes:
- 22 data tables and 25 additional tables
- An overview of the global outsourcing market for drug and medical device development and discussion on their services and technologies
- Analyses of global market trends, with data from 2018, 2019, estimates for 2020, and projections of compound annual growth rates (CAGRs) through 2025
- Identification of key challenges and opportunities in the drug and medical device development market and coverage of products and services related to different sectors of the industry
- Information on ISO, GLP, cGMP regulatory aspects in drug development and discussion on their importance related to certification of specific facilities
- A look at the ongoing activities in drug and device development process, their budget, timeline, resources and processes
- Insights into regulatory framework, investment analysis, growth indicators and key decision supporting factors and evaluation of current market size, market forecast, and market share analysis of the leading players of the industry
- Comprehensive profiles of major players in the industry, including Sterling Medical Devices, Evotec SE, Ajinomoto Althea, Eurofins Scientific, Charles River Laboratories Inc and DeviceLab
Market Projections
- The global outsourcing services market for drug and medical device development is expected to grow from 130.5 billion pounds in 2020 to 205.6 billion pounds by 2025 with a compound annual growth rate (CAGR) of 9.5% for the period of 2020-2025.
- The global outsourcing services market for preclinical stage is expected to grow from 67.5 billion pounds in 2020 to 106 billion pounds by 2025 with a compound annual growth rate (CAGR) of 9.4% for the period of 2020-2025.
- The global outsourcing services for medical device development market is expected to grow from 30 billion pounds in 2020 to 50 billion pounds by 2025 with a compound annual growth rate (CAGR) of 10.8% for the period of 2020-2025.
Table of Contents
Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of Report
- Information Sources and Methodology
- Intended Audience
- Market Breakdown
- Analyst's Credentials
- Custom Research
- Related Reports
Chapter 2 Summary and Highlights
Chapter 3 Market Background
- Overall Drug Development Process Overview: From Discovery to Commercialization
- Drug Development Outsourcing Market Overview
Chapter 4 Drug Discovery Outsourcing
- Drug Discovery Process Overview
- Target Identification and Validation
- Target Identification and Validation Market Overview and Estimate
- Biaffin
- Biognosys
- Creative Biolabs
- Evotec
- Pelago Bioscience
- REPROCELL
- Market Summary
- Hit Generation and Selection
- Animal Immunization and Hybridoma Generation.
- Microbial/Phage Display
- Eukaryotic Ribosome Display
- Single B Cell
- Hit Generation and Selection Drug Discovery Services Market Overview and Estimate
- GenScript Biotech Corp.
- I-MAb
- NovAlix
- SARomics Biostructures
- Taros
- Lead Optimization
- Lead Optimization Drug Discovery Services Market Overview and Estimate
- AMRI (Albany Molecular Research Inc.)
- BioDuro
- Charles River Laboratories
- IRBM
- Medicilon
- NJ Biopharmaceuticals
- Provid Pharmaceuticals
- Drug Discovery Stage Outsourcing Services Market Estimates
Chapter 5 Preclinical Drug Development Outsourcing Market
- Preclinical Process Overview and Outsourcing
- Drug Substance/Active Pharmaceutical Ingredient (API) Manufacturing Market for Drug Development
- Almac Group
- AmbioPharm
- Avara Pharmaceutical Services
- Bachem
- Biopeptek Pharmaceuticals
- Cambrex Corp.
- PCI Synthesis (Novacap)
- PolyPeptide Group
- Lonza
- Luina Bio
- WuXi Biologics
- VxP Biologics
- Cognate BioServices
- Market Estimate for Outsourcing API Manufacturing for Drug Development
- Formulation and Dosage Design Outsourcing Services Market
- Ascendia Pharmaceuticals
- Evonik Health Care
- Metrics Contract Services/Mayne Pharma
- PYRAMID Laboratories
- Recipharm Laboratories
- UPM Pharmaceuticals
- Market Overview and Estimates for Outsourcing of Formulation Development
- Analytical/Bioanalytical Methods Development, Validation and Testing
- Analytical Methods Development
- Analytical Methods Validation, Verification and Qualification
- Analytical Testing Method Development and Validation Market Landscape and Estimates
- Alcami Corp.
- Avomeen Analytical Services
- Charles River Laboratories
- Eurofins Scientific
- Recro Gainesville
- Metabolism, Pharmacokinetics and Toxicology Outsourcing
- Absorption Systems
- Alliance Pharma
- Covance
- Noble Life Sciences
- Pacific BioLabs
- Metabolism, Pharmacokinetics and Toxicology Outsourcing Services Market Estimates
- Clinical Trial Material Manufacturing and Testing
- Ajinomoto Althea
- Avid BioServices
- Bioserv Corp.
- Emergent BioSolutions
- IRISYS
- Patheon
- Release and Stability Testing
- ACTA Laboratories
- Nelson Labs
- R.D. Laboratories
- STERIS
- Clinical Trial Material Manufacturing and Testing Outsourcing Market Estimates
- Preclinical Stage Outsourcing Services Market Estimates
Chapter 6 Clinical Stage in the Drug Development Outsourcing Market
- Clinical Stage Process Overview and Outsourcing
- Clinical Stage Outsourcing Services Market Landscape and Estimates
- Clinipace
- IQVIA
- Quanticate
- Parexel International
- PRA Health Sciences
- Premier Research
- Synteract
Chapter 7 Medical Device Development Outsourcing Market
- Medical Device Development Overview
- Outsourcing of Medical Device Development Process
- Medical Device Development Outsourcing Market Participants
- Boston Engineering
- Cirtec Medical
- DeviceLab
- Freudenberg Medical
- Omnica Corp.
- Plexus
- Sterling Medical Devices
- Viant Medical
- Centaur Clinical
- Emergo by UL
- Medpace
- Pacific Bridge Medical
- Qserve CRO
- Medical Device Development Outsourcing Market Estimates
Chapter 8 Consulting Services Outsourcing Market
- Overview of Consulting Services for Drug and Medical Device Development
- Market Landscape and Estimates for Consulting Services for Drug and Medical Device Development
- CMC Pharmaceuticals
- Pacific-Link Regulatory Consulting
- Syner-G Pharma Consulting
Chapter 9 Patent Review for Drug and Medical Device Development Outsourcing Market
Chapter 10 Market Summary
- Overview
- Market Participants
- Market Estimates
Chapter 11 Company Profiles
- Absorption Systems
- Ajinomoto Althea
- Almac Group
- Avomeen Analytical Services
- Bioserv Corp.
- Charles River Laboratories
- Covance
- DeviceLab
- Evotec SE
- Eurofins Scientific
- Genscript Biotech Corp.
- Lonza
- Pacific Biolabs
- PRA Health Sciences
- Sterling Medical Devices
List of Tables
Summary Table: Global Outsourcing Services Market for Drug and Medical Device Development, Through 2025
Table 1: Average Cost of Different Drug Development Stages
Table 2: Distribution of First-in-Class Drugs Across Target Families
Table 3: Main Drug Discovery Stages and Their Description
Table 4: Examples of Target Deconvolution or Target Discovery Techniques
Table 5: Examples of Companies Providing Target Identification and Validation Services
Table 6: Global Outsourcing Services Market for Target Identification and Validation in Drug Discovery, Through 2025
Table 7: Screening Strategies for Small Molecule Hit Selection
Table 8: Examples of Companies Providing Hit Generation Services for Drug Discovery
Table 9: Global Outsourcing Services Market for Hit Generation and Selection in Drug Discovery, Through 2025
Table 10: Examples of Companies Providing Lead Optimization Services in Drug Discovery
Table 11: Global Outsourcing Services Market for Lead Optimization in Drug Discovery, Through 2025
Table 12: Examples of Collaboration Between CROS and Nonprofit Organizations
Table 13: Global Outsourcing Services Market for Drug Discovery Stage of Pharmaceuticals, Through 2025
Table 14: Example of Companies in API Manufacturing Sector and Their Average Annual Revenue
Table 15: Global Outsourcing Services Market for API Manufacturing in Drug Development, Through 2025
Table 16: Examples of Companies Providing Formulation and Dosage Design Services for Drug Development
Table 17: Distribution of Companies by Revenue Range in the CDMO Sector
Table 18: Global Outsourcing Services Market for Formulation Development and Related Services in Drug Development, Through 2025
Table 19: Examples of Companies Providing Analytical Testing Method Development and Validation Services for Drug Development
Table 20: Global Outsourcing Services Market for Analytical Methods Development and Validation in Drug Development, Through 2025
Table 21: Average Cost of Preclinical Activities in Drug Development
Table 22: Examples of Companies Providing Drug Metabolism and Toxicology Services for Preclinical Drug Development
Table 23: Global Outsourcing Services Market for Metabolism, Pharmacokinetics and Toxicology in Drug Development, Through 2025
Table 24: Examples of CMOs for Clinical Material Manufacturing
Table 25: Examples of Typical Release Testing Assays for Clinical Trial Material
Table 26: Examples of Companies Providing Release and Stability Testing Services for Clinical Trial Material
Table 27: Global Market Shares of CMOS Manufacturing Clinical Trial Materials, by Region, 2020
Table 28: Global Outsourcing Services Market for Clinical Trial Material Manufacturing and Testing, Through 2025
Table 29: Global Outsourcing Services Market for Preclinical Stage in Drug Development, Through 2025
Table 30: Cost Range of Clinical Trials in the U.S., 2020
Table 31: Average Cost of Enrolling One Patient in Clinical Trials in the U.S., 2020
Table 32: Clinical Trials Cost, by Countries in Comparison to the U.S., 2020
Table 33: Examples of Companies Providing Services for Clinical Trials Management
Table 34: Global Clinical CRO Market Share, by Region, 2020
Table 35: Global Outsourcing Services Market for Clinical Research in Drug Development, Through 2025
Table 36: Examples of Companies Providing Services for Medical Device Development
Table 37: Number of Clinical Trials Started in Medical Device Development, 2013-2019
Table 38: Examples of Companies Providing Services for Clinical Trials Management for Medical Device Companies
Table 39: Global Outsourcing Services Market for Medical Device Development, Through 2025
Table 40: Examples of Companies Providing Consulting Services for Drug and Medical Device Development Companies
Table 41: Global Outsourcing Consulting Services Market for Drug and Medical Device Development, Through 2025
Table 42: Number of Patents and Patent Applications, by Company
Table 43: Examples of Patents and Patent Applications Filed, by Outsourcing Market Participants
Table 44: Examples of Companies Providing Outsourcing Services in Drug and Medical Device Development
Table 45: Shares of Each Outsourcing Sector in Drug and Medical Device Development Market, 2020
Table 46: Global Outsourcing Services Market for Drug Development and Medical Devices, Through 2025
List of Figures
Summary Figure: Global Outsourcing Services Market for Drug and Medical Device Development, 2018-2025
Figure 1: Drug Development Process: From Research to Market
Figure 2: Outsourcing for Drug Development Market Overview
Figure 3: Target Identification to Validation Process Overview
Figure 4: Global Outsourcing Services Market for Target Identification and Validation in Drug Discovery, 2018-2025
Figure 5: Global Outsourcing Services Market for Hit Generation and Selection in Drug Discovery, 2018-2025
Figure 6: Global Outsourcing Services Market for Lead Optimization in Drug Discovery, 2018-2025
Figure 7: Global Outsourcing Services Market for Drug Discovery Stage of Pharmaceuticals, 2018-2025
Figure 8: Global Outsourcing Services Market for API Manufacturing in Drug Development, 2018-2025
Figure 9: Global Outsourcing Services Market for Formulation Development and Related Services in Drug Development, 2018-2025
Figure 10: Global Outsourcing Services Market for Analytical Methods Development and Validation in Drug Development, 2018-2025
Figure 11: Global Outsourcing Services Market for Metabolism, Pharmacokinetics and Toxicology in Drug Development, 2018-2025
Figure 12: Global Market Shares of CMOS Manufacturing Clinical Trial Materials, by Region, 2020
Figure 13: Global Outsourcing Services Market for Clinical Trial Material Manufacturing and Testing, 2018-2025
Figure 14: Global Outsourcing Services Market for Preclinical Stage in Drug Development, 2018-2025
Figure 15: Global Outsourcing Services Market for Clinical Research in Drug Development, 2018-2025
Figure 16: Medical Device Development Process Overview in the USA
Figure 17: Number of Clinical Trials Started in Medical Device Development, 2013-2019
Figure 18: Global Outsourcing Services Market for Medical Device Development, 2018-2025
Figure 19: Global Outsourcing Consulting Services Market for Drug and Medical Device Development, 2018-2025
Figure 20: Shares of Each Outsourcing Sector in Drug and Medical Device Development Market, 2020
Figure 21: Global Outsourcing Services Market for Drug Development and Medical Devices, 2018-2025
Samples
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Companies Mentioned
- Absorption Systems
- ACTA Laboratories
- Ajinomoto Althea
- Alcami Corp.
- Alliance Pharma
- Almac Group
- AmbioPharm
- AMRI (Albany Molecular Research Inc.)
- Ascendia Pharmaceuticals
- Avara Pharmaceutical Services
- Avid BioServices
- Avomeen Analytical Services
- Bachem
- Biaffin
- BioDuro
- Biognosys
- Biopeptek Pharmaceuticals
- Bioserv Corp.
- Boston Engineering
- Cambrex Corp.
- Centaur Clinical
- Charles River Laboratories
- Cirtec Medical
- Clinipace
- CMC Pharmaceuticals
- Cognate BioServices
- Covance
- Creative Biolabs
- DeviceLab
- Emergent BioSolutions
- Emergo by UL
- Eurofins Scientific
- Evonik Health Care
- Evotec
- Evotec SE
- Freudenberg Medical
- Genscript Biotech Corp.
- I-MAb
- IQVIA
- IRBM
- IRISYS
- Lonza
- Luina Bio
- Medicilon
- Medpace
- Metrics Contract Services/Mayne Pharma
- Nelson Labs
- NJ Biopharmaceuticals
- Noble Life Sciences
- NovAlix
- Omnica Corp.
- Pacific Biolabs
- Pacific Bridge Medical
- Pacific-Link Regulatory Consulting
- Parexel International
- Patheon
- PCI Synthesis (Novacap)
- Pelago Bioscience
- Plexus
- PolyPeptide Group
- PRA Health Sciences
- Premier Research
- Provid Pharmaceuticals
- PYRAMID Laboratories
- Qserve CRO
- Quanticate
- R.D. Laboratories
- Recipharm Laboratories
- Recro Gainesville
- Release and Stability Testing
- REPROCELL
- SARomics Biostructures
- STERIS
- Sterling Medical Devices
- Syner-G Pharma Consulting
- Synteract
- Taros
- UPM Pharmaceuticals
- Viant Medical
- VxP Biologics
- WuXi Biologics
