의약품 개발 및 제조 수탁기관 시장 예측(-2030년) : 서비스 유형별, 분자 유형별, 제형별, 용도별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market is accounted for $243.29 billion in 2024 and is expected to reach $354.68 billion by 2030 growing at a CAGR of 8.4% during the forecast period. A Pharmaceutical Contract Development & Manufacturing Organization (CDMO) is a specialized corporation that provides comprehensive services to pharmaceutical and biotechnology companies. These services encompass the entire drug development and manufacturing process, from initial product concept to commercial production. CDMOs offer expertise in formulation development, analytical testing, process optimization, and regulatory compliance. They enable clients to outsource various aspects of drug development and production, allowing them to focus on core competencies while benefiting from the CDMO's specialized capabilities and infrastructure.

According to the National Health Commission (NHC), China has over 180 million elderly citizens suffering from chronic diseases, of which 75% have more than one.

Market Dynamics:

Driver:

Rising biopharmaceuticals market

The rising biopharmaceuticals market fuels demand for specialized expertise and infrastructure, driving the expansion of PCDMOs. These organizations offer tailored solutions for drug development, manufacturing, and testing, catering to the unique requirements of biopharmaceuticals. CDMOs streamline processes, reduce costs, and mitigate risks for pharmaceutical companies, fostering innovation and accelerating time-to-market for new therapies. As biopharmaceuticals continue to dominate the market, CDMOs play a pivotal role in supporting their development and commercialization efforts, fueling the growth trajectory of the sector.

Restraint:

Stringent regulatory requirements & compliance standards

Stringent regulatory requirements and compliance standards in CDMOs are essential to ensure product quality, safety, and efficacy. These standards can hamper market growth by increasing operational costs, lengthening development timelines, and creating barriers to entry for smaller companies. Compliance efforts often require substantial resources, leading to higher prices for services and products. Additionally, stringent regulations may deter innovation and limit flexibility in adapting to market demands, thus impeding overall market expansion and competitiveness.

Opportunity:

Growing demand for specialized expertise

As pharmaceutical companies seek to focus on core competencies while leveraging external expertise, CDMOs play a crucial role in providing specialized services such as formulation development, manufacturing, and packaging. This trend is fuelled by the complexities of modern drug development, stringent regulatory requirements, and the need for cost-effective strategies. CDMOs provide a range of services including formulation development, analytical testing, manufacturing, and packaging, allowing pharmaceutical companies to accelerate their product pipelines and bring innovative treatments to market efficiently, thereby propelling market expansion.

Threat:

Pricing pressures

Pricing pressures in CDMOs arise due to increased competition, regulatory changes, and rising costs of raw materials and labor. These pressures often lead to downward pricing trends, squeezing profit margins and hindering investment in innovation and expansion. Consequently, CDMOs may struggle to maintain profitability and may be unable to invest in advanced technologies or infrastructure upgrades. This cycle of constrained investment can impede the development of new drugs and limit the industry's ability to meet evolving healthcare needs.

Covid-19 Impact

The covid-19 pandemic has had mixed impacts on the pharmaceutical contract development & manufacturing organization (CDMO) market. While the demand for certain pharmaceutical products, such as vaccines and treatments, surged, leading to increased outsourcing to CDMOs for manufacturing support, the pandemic also disrupted supply chains and delayed clinical trials and regulatory processes. Overall, the pandemic emphasized the importance of agile and resilient manufacturing capabilities, driving investment in technology and infrastructure to mitigate future disruptions.

The development services segment is expected to be the largest during the forecast period

The development services segment is estimated to have a lucrative growth. A pharmaceutical contract development & manufacturing organization in development services provides comprehensive support from drug discovery to clinical trials. These services include formulation development, analytical method development, stability studies, and regulatory submissions. CDMOs enable pharmaceutical companies to accelerate development timelines, reduce costs, and access specialized expertise, ensuring efficient and compliant progression of drug candidates from concept to clinical evaluation.

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

The biotechnology companies segment is anticipated to witness the highest CAGR growth during the forecast period. CDMOs provide biotechnology companies with specialized services for drug development and production. They offer expertise in areas like formulation, clinical trial support, and large-scale manufacturing. By outsourcing these tasks, biotech firms can focus on innovation and reduce time-to-market for new therapies, benefiting from CDMOs' advanced technologies and regulatory compliance expertise.

Region with largest share:

Asia Pacific is projected to hold the largest market share during the forecast period. Rapidly expanding pharmaceutical and biotechnology industries, increasing outsourcing trends from Western companies seeking cost-effective solutions, and the availability of skilled labor at lower costs are key drivers. Additionally, favourable regulatory environments and government initiatives to promote the life sciences sector further boost market growth. With a burgeoning demand for generic drugs and biologics, the Asia Pacific region is becoming a strategic hub for CDMOs offering a wide range of development and manufacturing services.

Region with highest CAGR:

North America is projected to have the highest CAGR over the forecast period. With a focus on innovation, quality, and efficiency, North American CDMOs offer end-to-end solutions spanning drug development, manufacturing, packaging, and supply chain management. The region benefits from a strong regulatory framework, skilled workforce, and advanced infrastructure, attracting both domestic and international clients. Key players constantly invest in R&D and technological advancements to meet evolving industry demands, ensuring competitiveness and sustainability in the market.

Key players in the market

Some of the key players profiled in the Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market include Lonza Group, Catalent Inc., WuXi AppTec, Samsung Biologics, Boehringer Ingelheim BioXcellence, Parexel International, Thermo Fisher Scientific, Siegfried Holding AG, Fujifilm Diosynth Biotechnologies, Recipharm AB, Albany Molecular Research Inc. (AMRI), Piramal Pharma Solutions, Charles River Laboratories, Ajinomoto Bio-Pharma Services, Alcami Corporation, Cambrex Corporation, Hovione, Fareva, Sartorius Stedim BioOutsource, Micron Technologies.

Key Developments:

In June 2023, FUJIFILM Corporation launched a commercial office in Tokyo to provide enhanced sales support and customer service for Contract Development and Manufacturing services for Biologics and Advanced Therapies to Asia-based pharmaceutical and biotechnology companies.

In April 2023, Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, has an agreement with ABL Bio, a pioneering Korean biologics company with a focus on bispecific antibodies for immuno-oncology and neurodegenerative diseases. The collaboration agreement between Lonza and ABL Bio supports the development and manufacturing of ABL Bio's new bispecific antibody product.

Service Types Covered:

• Development Services
• Manufacturing Services
• Clinical Trial Material (CTM) Production
• Scale-Up Services
• Regulatory Support Services
• Other Service Types

Molecule Types Covered:

• Small Molecule Drugs
• Biologics
• Other Molecule Types

Dosage Forms Covered:

• Solid
• Liquid
• Injectable
• Inhalables
• Other Dosage Forms

Applications Covered:

• Oncology
• Cardiovascular Diseases
• Central Nervous System (CNS) Disorders
• Infectious Diseases
• Metabolic Disorders
• Respiratory Diseases
• Other Applications

End Users Covered:

• Pharmaceutical Companies
• Biotechnology Companies
• Generic Drug Companies
• Other End Users

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 2022, 2023, 2024, 2026, and 2030
• 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

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market, By Service Type

• 5.1 Introduction
• 5.2 Development Services
  • 5.2.1 Preformulation Services
  • 5.2.2 Formulation Development
  • 5.2.3 Process Development
  • 5.2.4 Analytical & Quality Control Services
• 5.3 Manufacturing Services
  • 5.3.1 Active Pharmaceutical Ingredients (API) Manufacturing
  • 5.3.2 Finished Dosage Form Manufacturing
  • 5.3.3 Packaging
  • 5.3.4 Commercial Manufacturing
• 5.4 Clinical Trial Material (CTM) Production
• 5.5 Scale-Up Services
• 5.6 Regulatory Support Services
• 5.7 Other Service Types

6 Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market, By Molecule Type

• 6.1 Introduction
• 6.2 Small Molecule Drugs
• 6.3 Biologics
  • 6.3.1 Monoclonal Antibodies
  • 6.3.2 Vaccines
  • 6.3.3 Recombinant Proteins
• 6.4 Other Molecule Types

7 Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market, By Dosage Form

• 7.1 Introduction
• 7.2 Solid
• 7.3 Liquid
• 7.4 Injectable
• 7.5 Inhalables
• 7.6 Other Dosage Forms

8 Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market, By Application

• 8.1 Introduction
• 8.2 Oncology
• 8.3 Cardiovascular Diseases
• 8.4 Central Nervous System (CNS) Disorders
• 8.5 Infectious Diseases
• 8.6 Metabolic Disorders
• 8.7 Respiratory Diseases
• 8.8 Other Applications

9 Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market, By End User

• 9.1 Introduction
• 9.2 Pharmaceutical Companies
• 9.3 Biotechnology Companies
• 9.4 Generic Drug Companies
• 9.5 Other End Users

10 Global Pharmaceutical Contract Development & Manufacturing Organization (CDMO) Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 Lonza Group
• 12.2 Catalent Inc.
• 12.3 WuXi AppTec
• 12.4 Samsung Biologics
• 12.5 Boehringer Ingelheim BioXcellence
• 12.6 Parexel International
• 12.7 Thermo Fisher Scientific
• 12.8 Siegfried Holding AG
• 12.9 Fujifilm Diosynth Biotechnologies
• 12.10 Recipharm AB
• 12.11 Albany Molecular Research Inc. (AMRI)
• 12.12 Piramal Pharma Solutions
• 12.13 Charles River Laboratories
• 12.14 Ajinomoto Bio-Pharma Services
• 12.15 Alcami Corporation
• 12.16 Cambrex Corporation
• 12.17 Hovione
• 12.18 Fareva
• 12.19 Sartorius Stedim BioOutsource
• 12.20 Micron Technologies