바이오테크놀러지 수탁제조 시장 평가 : 플랫폼 유형, 제품 유형, 용도, 치료 분야, 지역별 기회 및 예측(2017-2031년)

Global biotechnology contract manufacturing market is projected to witness a CAGR of 8.5% during the forecast period 2024-2031, growing from USD 17.69 billion in 2023 to USD 33.97 billion in 2031. The biotechnology contract manufacturing market is expected to thrive under the influence of driving factors like growing demand for biopharmaceuticals and technical advancements in cell and gene therapies. Biopharmaceutical products are complex in nature and require a specialized manufacturing setup, which is not easy to manage for pharmaceutical firms. In such situations, pharmaceutical companies hire contract manufacturing organizations with exclusive expertise and manufacturing capabilities to cater to the market requirements. The growing application areas and demand for novel cell and gene therapy have significantly induced market expansion. Advancements in manufacturing technologies and collaborations between pharmaceutical companies and biologics contract manufacturers are some other major driving forces for market growth. However, the complexities in the biologics and constantly evolving needs of specialized facilities and equipment are the major growth challenges for the market. Additionally, regulatory complications and restrictions pose restraints on market growth. With regularly evolving technology, the contract manufacturers need to stay updated, which hinders the expansion of key players. Despite all the challenges and restraints, the market is expected to grow exponentially in the future.

In October 2023, with the introduction of Expert'Biome CDMO by Lallemand, the company is bolstering its strategic position in the microbiome space through contract development and production operations. By providing extensive services in the healthcare sector, Lallemand Health Solutions hopes to assist partners in the creation of next-generation strains through Expert'Biome. These services include medicine manufacturing, bioprocess scaling, strain research and development, and other production procedures.

Growing Demand for Biopharmaceuticals

The global demand for biopharmaceuticals is growing rapidly due to the increasing prevalence of chronic diseases, a rising elderly population, and the growing awareness of efficiency and easy access to biopharmaceuticals. The increasing demand for advanced biologic drugs, such as gene-based biopharmaceuticals, to treat various diseases is also fueling market growth. As the market witnesses the surge in demand for biopharmaceuticals, the biotechnology contract manufacturing requirements will rise further, in turn, expanding the market growth. Manufacturers are constantly working on new launches and service expansions to better cater to the market needs.

For instance, in July 2023, Kincell Bio, a CDMO specializing in cell therapies, was officially launched with USD 36 million in funding led by Kineticos Ventures. Kincell is a spinoff of Inceptor Bio's CMC, manufacturing, and quality organizations. With its new funding, Kincell plans to accelerate innovative research and clinical trials. The company has acquired a facility and a team in Gainesville, Florida, and intends to expand in other key markets such as Research Triangle Park, Boston, and other customer locations.

Advancements in Manufacturing Technologies

Manufacturing technologies are driving changes in biotech contract manufacturing, leading to improved efficiency, increased customization, and enhanced communication. Automation, flexibility, and supply chain management enhancements have made the manufacturing process more efficient, cost-effective, and reliable. These advancements enable contract manufacturers to produce high-quality products in large quantities, meeting the growing market demand. The growing advancements in personalized medicines and biosimilars further enhance the market traction. For instance, in November 2023, SwiftPharma, a Belgian biotech company specializing in molecular farming, and PlantForm Corporation, a Canadian biopharmaceutical company, entered into a contract manufacturing agreement. Under this agreement, SwiftPharma will manufacture antibodies and proteins for PlantForm's product pipeline. Notably, PlantForm will have non-exclusive access to SwiftPharma's manufacturing expertise, enabling the production of biosimilar pembrolizumab utilizing PlantForm's unique systems and materials.

Dominance of Mammalian-based Platforms

Mammalian cell-based biotechnology creates high-quality proteins that are essential in treating immunological disorders. These products are key in developing antibody treatments for diseases and offer advantages over older methods, such as increased precision and fewer adverse effects. There is a regulatory shift towards replacing animal components in cell growth media used for mammal-derived biotech products. For instance, in May 2023, with an EMA and FDA-compliant, state-of-the-art cGMP manufacturing site in Vilnius, Lithuania, Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), announced the completion of its expansion project for cGMP manufacturing facilities in Waltham, Massachusetts. This noteworthy achievement enhances Northway Biotech's reputation as a major force in the field of biopharmaceuticals. The successful 2020 opening of Northway Biotech's process and analytical development laboratories in Waltham, Massachusetts, is the reason for this latest expansion. Modern cGMP suites are now part of the new facility, which is a major turning point in the company's history.

Monoclonal Antibodies Segment Dominates the Market

The demand for monoclonal antibodies has increased significantly, especially during the COVID-19 pandemic, leading to challenges in manufacturing capacity and global shortages of raw materials. To meet this demand, biopharmaceutical companies had to innovate by forming strategic partnerships with contract manufacturing organizations, securing raw materials in advance and collaborating closely with health authorities and government agencies. The demand for these antibodies continues to rise, leading to innovations in manufacturing practices to meet global needs. For instance, in September 2023, KBI Biopharma, a subsidiary of JSR Life Sciences, introduced SUREmAb. This optimized solution uses the SUREtechnology Platform to produce monoclonal antibodies (mAbs) more efficiently and cost-effectively. By utilizing SUREmAb, biopharmaceutical manufacturers can expedite their development timelines. It enables the creation of a research cell bank (RCB) in nine weeks. Additionally, customers can swiftly transition from DNA to GMP drug substance in as little as eleven months. SUREmAb is designed to attain titers of up to 10 g/L, resulting in lower-cost workflow, enhanced operational efficiency, and improved return on investment.

North America to be the Dominating Region

North America leads the biotechnology contract manufacturing due to several factors. The region has a strong pharmaceutical and biotech industry and the presence of highly advanced manufacturing technologies, making it an attractive market for contract manufacturing. Additionally, the rising demand for biologics and biosimilars, increasing outsourcing of biologics manufacturing among biopharmaceutical companies, growing focus on personalized medicines, increasing collaborations between pharmaceutical companies and biologics contract manufacturers, and advancements in manufacturing technologies are driving the growth of the biotechnology contract manufacturing market in North America.

For instance, in January 2024, Enzene Biosciences established its first fabrication facility in the United States, positioned in Hopewell, New Jersey. Scheduled for completion in June 2024, the site has already gained interest from customers, who have started reserving capacities for constant production. The facility, developed to incorporate Enzene Biosciences' patented EnzeneX persistent production technology, is located within the Princeton West Innovation Campus, a strategic area surrounded by biotech and pharmaceutical companies. This location is ideal, enabling Enzene Biosciences to cater to budding US biotechnology firms seeking expertise in continuous manufacturing.

Future Market Scenario

The biopharmaceutical industry has already adjusted its partnerships with suppliers and contract development and manufacturing organizations (CDMOs) to satisfy humanitarian requirements, and this pattern is anticipated to grow. There will be more collaborations between CMOs, biotech startups, and pharmaceutical giants, which will create a strong ecosystem that can speed up the delivery of life-saving treatments to patients worldwide. Additionally, the future of contract manufacturing in the pharmaceutical industry will likely see pharmaceutical companies and CDMOs working more closely together, sharing expertise, resources, and risks to come up with more innovative and effective solutions.

In October 2023, Advent International and Warburg Pincus, prominent global investors, finalized the previously announced acquisition of Baxter International Inc.'s BioPharma Solutions (BPS) business. Operating as an independent contract development and manufacturing organization (CDMO) under the name Simtra BioPharma Solutions, the business will maintain its current range of solutions and capabilities to ensure the continued supply of essential pharmaceutical products worldwide. According to the definitive agreement, Baxter received USD 4.25 billion in cash after factoring in closing adjustments.

Key Players Landscape and Outlook

Catalent Inc., Lonza Group Ag, Patheon N.V. (Thermo Fisher Scientific Inc.), Abzena Plc., Sandoz International GmbH (Novartis AG), Fujifilm Diosynth Biotechnologies (FUJIFILM Holdings), and Baxter Pharmaceutical Solutions LLC are some of the renowned players in the biotechnology contract manufacturing market. These companies play a crucial role in offering specialized services for the manufacturing of biological drugs, particularly biologics, drug substance, and drug product, catering to the needs of pharmaceutical and biotechnological companies globally.

In February 2024, Novo Holdings, a subsidiary of Novo Nordisk, plans to purchase Catalent, a well-established contract manufacturing organization, for USD 16.5 billion. The acquisition will involve Novo Holdings paying USD 63.50 in cash for each outstanding share of Catalent, reflecting a 16.5% increase above the current market value. The transaction is projected to be finalized around the end of 2024.

Table of Contents

1.Research Methodology

2.Project Scope & Definitions

3.Executive Summary

4.Global Biotechnology Contract Manufacturing Market Outlook, 2017-2031F

• 4.1.Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2.By Platform Type
  • 4.2.1.Mammalian-based
  • 4.2.2.Microbial-based
• 4.3.By Product Type
  • 4.3.1.Monoclonal Antibodies
  • 4.3.2.Recombinant Protein
  • 4.3.3.Vaccine
  • 4.3.4.Insulin
  • 4.3.5.Growth factor
  • 4.3.6.Interferons
  • 4.3.7.Others
• 4.4.By Application Type
  • 4.4.1.Clinical
  • 4.4.2.Commercial
• 4.5.By Therapeutic Area Type
  • 4.5.1.Autoimmune Diseases
  • 4.5.2.Oncology
  • 4.5.3.Metabolic Diseases
  • 4.5.4.Ophthalmology
  • 4.5.5.Cardiovascular Diseases
  • 4.5.6.Infectious Diseases
  • 4.5.7.Neurology
  • 4.5.8.Respiratory Disorders
  • 4.5.9.Others
• 4.6.By Region
  • 4.6.1.North America
  • 4.6.2.Europe
  • 4.6.3.Asia-Pacific
  • 4.6.4.South America
  • 4.6.5.Middle East and Africa
• 4.7.By Company Market Share (%), 2023

5.Global Biotechnology Contract Manufacturing Market Outlook, By Region, 2017-2031F

• 5.1.North America*
  • 5.1.1.Market Size & Forecast
    • 5.1.1.1.By Value
    • 5.1.1.2.By Volume
  • 5.1.2.By Platform Type
    • 5.1.2.1.Mammalian-based
    • 5.1.2.2.Microbial-based
  • 5.1.3.By Product Type
    • 5.1.3.1.Monoclonal Antibodies
    • 5.1.3.2.Recombinant Protein
    • 5.1.3.3.Vaccine
    • 5.1.3.4.Insulin
    • 5.1.3.5.Growth factor
    • 5.1.3.6.Interferons
    • 5.1.3.7.Others
  • 5.1.4.By Application Type
    • 5.1.4.1.Clinical
    • 5.1.4.2.Commercial
  • 5.1.5.By Therapeutic Area Type
    • 5.1.5.1.Autoimmune Diseases
    • 5.1.5.2.Oncology
    • 5.1.5.3.Metabolic Diseases
    • 5.1.5.4.Ophthalmology
    • 5.1.5.5.Cardiovascular Diseases
    • 5.1.5.6.Infectious Diseases
    • 5.1.5.7.Neurology
    • 5.1.5.8.Respiratory Disorders
    • 5.1.5.9.Others
  • 5.1.6.United States*
    • 5.1.6.1.Market Size & Forecast
    • 5.1.6.1.1.By Value
    • 5.1.6.1.2.By Volume
    • 5.1.6.2.By Platform Type
    • 5.1.6.2.1.Mammalian-based
    • 5.1.6.2.2.Microbial-based
    • 5.1.6.3.By Product Type
    • 5.1.6.3.1.Monoclonal Antibodies
    • 5.1.6.3.2.Recombinant Protein
    • 5.1.6.3.3.Vaccine
    • 5.1.6.3.4.Insulin
    • 5.1.6.3.5.Growth factor
    • 5.1.6.3.6.Interferons
    • 5.1.6.3.7.Others
    • 5.1.6.4.By Application Type
    • 5.1.6.4.1.Clinical
    • 5.1.6.4.2.Commercial
    • 5.1.6.5.By Therapeutic Area Type
    • 5.1.6.5.1.Autoimmune Diseases
    • 5.1.6.5.2.Oncology
    • 5.1.6.5.3.Metabolic Diseases
    • 5.1.6.5.4.Ophthalmology
    • 5.1.6.5.5.Cardiovascular Diseases
    • 5.1.6.5.6.Infectious Diseases
    • 5.1.6.5.7.Neurology
    • 5.1.6.5.8.Respiratory Disorders
    • 5.1.6.5.9.Others
  • 5.1.7.Canada
  • 5.1.8.Mexico

All segments will be provided for all regions and countries covered

• 5.2.Europe
  • 5.2.1.Germany
  • 5.2.2.France
  • 5.2.3.Italy
  • 5.2.4.United Kingdom
  • 5.2.5.Russia
  • 5.2.6.Netherlands
  • 5.2.7.Spain
  • 5.2.8.Turkey
  • 5.2.9.Poland
• 5.3.Asia-Pacific
  • 5.3.1.India
  • 5.3.2.China
  • 5.3.3.Japan
  • 5.3.4.Australia
  • 5.3.5.Vietnam
  • 5.3.6.South Korea
  • 5.3.7.Indonesia
  • 5.3.8.Philippines
• 5.4.South America
  • 5.4.1.Brazil
  • 5.4.2.Argentina
• 5.5.Middle East & Africa
  • 5.5.1.Saudi Arabia
  • 5.5.2.UAE
  • 5.5.3.South Africa

6.Market Mapping, 2023

• 6.1.By Platform Type
• 6.2.By Product Type
• 6.3.By Application Type
• 6.4.By Therapeutic Area Type
• 6.5.By Region

7.Macro Environment and Industry Structure

• 7.1.Demand Supply Analysis
• 7.2.Import Export Analysis
• 7.3.Value Chain Analysis
• 7.4.PESTEL Analysis
  • 7.4.1.Political Factors
  • 7.4.2.Economic System
  • 7.4.3.Social Implications
  • 7.4.4.Technological Advancements
  • 7.4.5.Environmental Impacts
  • 7.4.6.Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5.Porter's Five Forces Analysis
  • 7.5.1.Supplier Power
  • 7.5.2.Buyer Power
  • 7.5.3.Substitution Threat
  • 7.5.4.Threat from New Entrant
  • 7.5.5.Competitive Rivalry

8.Market Dynamics

• 8.1.Growth Drivers
• 8.2.Growth Inhibitors (Challenges and Restraints)

9.Regulatory Framework and Innovation

• 9.1.Patent Landscape
• 9.2.Innovations/Emerging Technologies

10.Key Players Landscape

• 10.1.Competition Matrix of Top Five Market Leaders
• 10.2.Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3.Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4.SWOT Analysis (For Five Market Players)

11.Pricing Analysis

12.Case Studies

13.Key Players Outlook

• 13.1.Catalent Inc.
  • 13.1.1.Company Details
  • 13.1.2.Key Management Personnel
  • 13.1.3.Products & Services
  • 13.1.4.Financials (As reported)
  • 13.1.5.Key Market Focus & Geographical Presence
  • 13.1.6.Recent Developments
• 13.2.Lonza Group Ag
• 13.3.Patheon N.V. (Thermo Fisher Scientific Inc.)
• 13.4.Abzena Plc.
• 13.5.Sandoz International GmbH (Novartis AG)
• 13.6.Fujifilm Diosynth Biotechnologies (FUJIFILM Holdings)
• 13.7.Baxter Pharmaceutical Solutions LLC (Baxter Inc.)
• 13.8.AbbVie Contract Manufacturing (AbbVie Inc.)
• 13.9.Samsung Biologics Co. Ltd.
• 13.10.Pfizer Centre Source Ltd (Pfizer Inc.)

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14.Strategic Recommendations

15.About Us & Disclaimer