세계의 백신 수탁제조 시장 : 분석 - 제품별, 유형별, 사업 규모별, 공정별, 용도별, 최종사용자별, 지역별 예측(-2030년)

According to Stratistics MRC, the Global Vaccine Contract Manufacturing Market is accounted for $3.51 billion in 2023 and is expected to reach $8.30 billion by 2030 growing at a CAGR of 13.1% during the forecast period. Vaccine contract manufacturing involves outsourcing the production of vaccines to third-party manufacturers. Pharmaceutical companies partner with contract manufacturing organizations (CMOs) to leverage their expertise, facilities, and resources for the efficient and scalable production of vaccines. This approach allows companies to focus on research, development, and marketing while ensuring timely and cost-effective manufacturing of vaccines. Contract manufacturers adhere to strict quality standards and regulatory requirements, providing assurance of safety and efficacy. This model enables flexibility in production capacity, accelerating the availability of vaccines to meet global demand, especially during pandemics or emergencies.

According to data published by the American Academy of Pediatrics in March 2022, more than 1 million people in the United States have long-term hepatitis B infections, and people who are infected with hepatitis B as a baby have a 90% chance of developing serious, chronic conditions like liver cancer in their lifetime.

Market Dynamics:

Driver:

Increasing demand for vaccines

The increasing demand for vaccines serves as a pivotal driver propelling the growth of the vaccine contract manufacturing market. As the global population continues to prioritize preventive healthcare measures, the need for efficient vaccine production escalates. Vaccine Contract Manufacturing offers pharmaceutical companies the flexibility to scale up production swiftly to meet this rising demand. Additionally, outsourcing manufacturing to specialized facilities enables companies to focus on research and development, accelerating vaccine innovation. Furthermore, partnerships with contract manufacturers streamline the production process, ensuring timely delivery of vaccines to the market.

Restraint:

Quality control challenges

Quality control challenges primarily stem from the need for strict adherence to regulatory standards, complex manufacturing processes, and the demand for high-volume production. Ensuring consistent product quality across various batches and facilities presents a significant hurdle. Additionally, the global distribution of manufacturing sites complicates standardization and oversight. Moreover, the urgency to meet production deadlines while maintaining stringent quality standards can lead to errors or oversights. Variability in raw materials and equipment further exacerbates these challenges.

Opportunity:

Global vaccine demand

The global vaccine contract manufacturing market presents a significant opportunity driven by the escalating demand for vaccines worldwide. With the advent of the COVID-19 pandemic and increased focus on vaccination, there's a pressing need for expanded production capacity. This market offers advantages such as flexibility, scalability, and cost-effectiveness, enabling swift responses to emerging infectious diseases and large-scale immunization campaigns. Outsourcing vaccine production mitigates the risks associated with in-house manufacturing, including regulatory compliance and resource allocation.

Threat:

Intellectual property issues

Many vaccines are protected by patents, trademarks, and trade secrets, limiting access to their production methods and technologies. This creates barriers for contract manufacturers seeking to enter the market or scale up production. Additionally, disputes over IP rights can lead to legal battles, delays, and increased costs for manufacturers. Lack of clarity or enforcement of IP laws can also discourage innovation and investment in new vaccine manufacturing technologies. Addressing these issues through clear licensing agreements and effective IP protection mechanisms is crucial for ensuring equitable access to vaccines and fostering a competitive contract manufacturing market.

Covid-19 Impact:

The COVID-19 pandemic significantly impacted the vaccine contract manufacturing market in several ways. Firstly, there was an unprecedented surge in demand for vaccine manufacturing services, leading to a strain on existing capacities and prompting the need for expansion and ramping up of production capabilities. Secondly, the urgency of vaccine development and distribution necessitated collaborations between pharmaceutical companies and contract manufacturers, driving growth in the contract manufacturing sector. Additionally, the focus on advanced technologies for vaccine production, such as mRNA technology, created new opportunities for contract manufacturers with specialized expertise.

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

The clinical segment in the vaccine contract manufacturing market is witnessing robust growth due to increasing investments in vaccine development and clinical trials are driving demand for contract manufacturing services. Additionally, the surge in infectious diseases and pandemics has accelerated vaccine research, leading to a higher demand for manufacturing capacity. Moreover, advancements in biotechnology and immunology have widened the scope of vaccine development, further fueling growth in this segment. The clinical segment caters to early-stage trials, where speed and flexibility in manufacturing are crucial, making contract manufacturers' indispensable partners for pharmaceutical companies.

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

The Biotech Companies segment is experiencing robust growth because biotech firms are increasingly outsourcing manufacturing to specialized contract manufacturing organizations (CMOs) to focus on research and development. The demand for vaccines, driven by infectious disease outbreaks and the ongoing COVID-19 pandemic, is driving the need for expanded manufacturing capacity. Advancements in biotechnology are enabling the development of more complex vaccines, necessitating specialized manufacturing expertise. Additionally, the flexibility and scalability offered by CMOs allow biotech companies to respond quickly to changing market demands and regulatory requirements.

Region with largest share:

North America has witnessed significant growth in the vaccine contract manufacturing market due to the region's boasting advanced biopharmaceutical infrastructure and expertise, attracting companies to outsource vaccine production. The COVID-19 pandemic has accelerated demand for vaccine manufacturing capabilities, prompting pharmaceutical firms to seek contract manufacturing services to meet global needs swiftly. Additionally, regulatory support and favourable government initiatives have fostered a conducive environment for vaccine manufacturing partnerships.

Region with highest CAGR:

The Asia-Pacific region has experienced significant growth due to the region manufacturing infrastructure coupled with a skilled workforce, making it an attractive destination for vaccine production outsourcing. Favourable government policies and incentives have encouraged multinational pharmaceutical companies to establish manufacturing facilities in the region. Moreover, the increasing demand for vaccines, driven by population growth and rising healthcare awareness, has further fueled market expansion. Furthermore, the COVID-19 pandemic has highlighted the importance of vaccine manufacturing capacity, prompting governments and companies to invest in expanding production capabilities in the Asia Pacific.

Key players in the market

Some of the key players in Vaccine Contract Manufacturing market include AGC Biologics, Ajinomoto Bio-Pharma Services, Catalent, Charles River Laboratories International Inc., CJ CheilJedang Corporation, CSL Seqirus, Curia Global, Emergent BioSolutions Inc., Fujifilm Holdings Corporation , Gedeon Richter (Richter-Helm BioLogics) , ICON PLC, IDT Biologika GmbH, KBI Biopharma, Lonza Group AG, Merck KGaA, Recipharm AB, Samsung Biologics and WuXi Biologics.

Key Developments:

In April 2024, Invenra Inc., an innovative leader in bispecific antibody technology, has announced a strategic collaboration with Catalent, a global Contract Development and Manufacturing Organization (CDMO) specializing in innovative drug development solutions. The collaboration will harness the combined expertise and proprietary technologies of Invenra and Catalent to co-discover novel bispecific antibody-drug conjugates.

In April 2024, Merck has launched the Aptegra CHO Genetic Stability Assay, which leverages whole-genome sequencing and bioinformatics to significantly accelerate customers' biopharmaceutical safety testing, thereby helping to accelerate customers' entry into commercial production.

Products Covered:

• Recombinant Vector Vaccines
• Inactivated Vaccines
• Toxoid-based Vaccines
• Synthetic Vaccines
• Conjugate Vaccines
• Attenuated Vaccines
• Subunit-based Vaccines
• DNA-based Vaccines
• Other Products

Types Covered:

Bacterial

Viral

Other Types

Scale of Operations Covered:

• Clinical
• Commercial
• Preclinical

Processes Covered:

• Downstream
• Upstream
• Separator
• Electrolyte
• Other Processes

Application Covered:

• Veterinary
• Human Use
• Other Applications

End Users Covered:

• Biotech Companies
• Research Institutes
• Pharmaceutical 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 2021, 2022, 2023, 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 Product Analysis
• 3.7 Application Analysis
• 3.8 End User Analysis
• 3.9 Emerging Markets
• 3.10 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 Vaccine Contract Manufacturing Market, By Product

• 5.1 Introduction
• 5.2 Recombinant Vector Vaccines
• 5.3 Inactivated Vaccines
• 5.4 Toxoid-based Vaccines
• 5.5 Synthetic Vaccines
• 5.6 Conjugate Vaccines
• 5.7 Attenuated Vaccines
• 5.8 Subunit-based Vaccines
• 5.9 DNA-based Vaccines
• 5.10 Other Products

6 Global Vaccine Contract Manufacturing Market, By Type

• 6.1 Introduction
• 6.2 Bacterial
• 6.3 Viral
• 6.4 Other Types

7 Global Vaccine Contract Manufacturing Market, By Scale of Operations

• 7.1 Introduction
• 7.2 Clinical
• 7.3 Commercial
• 7.4 Preclinical

8 Global Vaccine Contract Manufacturing Market, By Process

• 8.1 Introduction
• 8.2 Downstream
  • 8.2.1 Analytical and QC Studies
  • 8.2.2 Fill and Finish
  • 8.2.3 Packaging
  • 8.2.4 Other Downstream Processes
• 8.3 Upstream
  • 8.3.1 Bacterial Expression Systems
  • 8.3.2 Baculovirus/Insect Expression Systems
  • 8.3.3 Mammalian Expression Systems
  • 8.3.4 Yeast Expression Systems
  • 8.3.5 Other Upstream Processes
• 8.4 Separator
• 8.5 Electrolyte
• 8.6 Other Processes

9 Global Vaccine Contract Manufacturing Market, By Application

• 9.1 Introduction
• 9.2 Veterinary
• 9.3 Human Use
• 9.4 Other Applications

10 Global Vaccine Contract Manufacturing Market, By End User

• 10.1 Introduction
• 10.2 Biotech Companies
• 10.3 Research Institutes
• 10.4 Pharmaceutical Companies
• 10.5 Other End Users

11 Global Vaccine Contract Manufacturing Market, By Geography

• 11.1 Introduction
• 11.2 North America
  • 11.2.1 US
  • 11.2.2 Canada
  • 11.2.3 Mexico
• 11.3 Europe
  • 11.3.1 Germany
  • 11.3.2 UK
  • 11.3.3 Italy
  • 11.3.4 France
  • 11.3.5 Spain
  • 11.3.6 Rest of Europe
• 11.4 Asia Pacific
  • 11.4.1 Japan
  • 11.4.2 China
  • 11.4.3 India
  • 11.4.4 Australia
  • 11.4.5 New Zealand
  • 11.4.6 South Korea
  • 11.4.7 Rest of Asia Pacific
• 11.5 South America
  • 11.5.1 Argentina
  • 11.5.2 Brazil
  • 11.5.3 Chile
  • 11.5.4 Rest of South America
• 11.6 Middle East & Africa
  • 11.6.1 Saudi Arabia
  • 11.6.2 UAE
  • 11.6.3 Qatar
  • 11.6.4 South Africa
  • 11.6.5 Rest of Middle East & Africa

12 Key Developments

• 12.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 12.2 Acquisitions & Mergers
• 12.3 New Product Launch
• 12.4 Expansions
• 12.5 Other Key Strategies

13 Company Profiling

• 13.1 AGC Biologics
• 13.2 Ajinomoto Bio-Pharma Services
• 13.3 Catalent
• 13.4 Charles River Laboratories International Inc.
• 13.5 CJ CheilJedang Corporation
• 13.6 CSL Seqirus
• 13.7 Curia Global
• 13.8 Emergent BioSolutions Inc.
• 13.9 Fujifilm Holdings Corporation
• 13.10 Gedeon Richter (Richter-Helm BioLogics)
• 13.11 ICON PLC
• 13.12 IDT Biologika GmbH
• 13.13 KBI Biopharma
• 13.14 Lonza Group AG
• 13.15 Merck KGaA
• 13.16 Recipharm AB
• 13.17 Samsung Biologics
• 13.18 WuXi Biologics