市場調查報告書
商品編碼
1447724
生物技術合約製造市場評估:按平台類型、產品類型、應用、治療領域和地區劃分的機會和預測(2017-2031)Biotechnology Contract Manufacturing Market Assessment, By Platform Type, By Product Type, By Application Type, By Therapeutic Area Type, By Region, Opportunities and Forecast, 2017-2031F |
全球生物技術合約製造市場規模將從2023年的176.9億美元增長到2031年的339.7億美元,在2024年至2031年的預測期內複合年增長率為8.5%。預計將增長到美元。
受生物製藥需求增加以及細胞和基因治療技術進步等驅動因素的影響,生物技術合約製造市場預計將成長。 生物製藥性質複雜,需要專門的生產設備,這為製藥公司帶來了管理難度。 在此背景下,製藥公司聘請具有獨特專業知識和製造能力的合約製造組織來滿足市場需求。 不斷擴大的應用領域和對新型細胞和基因療法的需求也正在推動市場擴張。 此外,製造技術的進步以及製藥公司和生物製劑合約製造商之間的合作關係也是市場成長的關鍵驅動力。 然而,生物製品的複雜性以及對專業設施和設備不斷變化的需求對市場成長構成了重大挑戰。 此外,監管的複雜性和限制也限制了市場的成長。 儘管存在這些挑戰和限制因素,預計市場在未來幾年仍將呈指數級增長。
生物製藥的需求不斷增加
由於慢性病的流行、老年人口的增加以及人們對高效、便捷地獲取生物製藥的認識不斷增強,全球對生物製藥的需求正在迅速擴大。 此外,對治療各種疾病的先進生物製藥(例如基因為基礎的生物製藥)的需求不斷增長,也推動了市場的成長。 隨著市場對生物製藥的需求激增,生物技術合約製造的需求預計將進一步增加。 製造商不斷致力於發布新產品並擴大服務,以更好地響應市場需求。
製造技術的進步
製造技術正在改變生物技術合約製造,從而提高效率、增強客製化能力並增強溝通。 自動化、靈活性和增強的供應鏈管理使製造流程更加高效、經濟高效且可靠。 這些進步使合約製造商能夠大量生產高品質的產品並滿足不斷增長的市場需求。 個人化藥物和生物相似藥的進步也提供了進一步的市場吸引力。
基於哺乳動物的平台的優勢
基於哺乳動物細胞的生物技術可生產治療免疫疾病所必需的高品質蛋白質。 這些產品在疾病抗體治療的開發中發揮重要作用,並且比傳統方法具有優勢,例如更高的準確性和更少的副作用。
本報告調查了全球生物技術合約製造市場,提供了市場定義和概述、市場規模趨勢和預測、各個細分市場和地區的詳細分析、行業結構以及影響市場成長的因素、分析、案例研究、競爭格局、以及主要公司的簡介。
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.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.