市場調査レポート
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1447724
バイオテクノロジー受託製造市場の評価:プラットフォームタイプ・製品タイプ・用途・治療領域・地域別の機会および予測 (2017~2031年)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 |
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バイオテクノロジー受託製造市場の評価:プラットフォームタイプ・製品タイプ・用途・治療領域・地域別の機会および予測 (2017~2031年) |
出版日: 2024年03月11日
発行: Market Xcel - Markets and Data
ページ情報: 英文 238 Pages
納期: 3~5営業日
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世界のバイオテクノロジー受託製造の市場規模は、2023年の176億9,000万米ドルから、2024年から2031年の予測期間中は8.5%のCAGRで推移し、2031年には339億7,000万米ドルの規模に成長すると予測されています。
バイオテクノロジー受託製造の市場は、バイオ医薬品の需要拡大や細胞・遺伝子治療技術の進歩といった促進要因の影響を受けて成長すると予想されます。バイオ医薬品はその性質上複雑であり、専門的な製造設備が必要とされるため、製薬企業にとって管理は容易ではありません。このような状況で、製薬会社は市場の要求に応えるため、独自の専門知識と製造能力を持つ製造受託機関を雇っています。新規細胞・遺伝子治療の応用分野と需要が拡大していることも市場の拡大を大きく促しています。さらに製造技術の進歩や製薬会社と生物製剤受託製造業者間の協力関係も市場成長の主な原動力となっています。しかし一方で、生物製剤は複雑であり、専門的な施設や設備のニーズが絶えず進化していることが、市場成長の大きな課題となっています。また、規制の複雑さや制限が市場成長の抑制要因となっています。これらの課題と抑制要因にもかかわらず、市場は今後飛躍的に成長すると予想されています。
高まるバイオ医薬品需要
バイオ医薬品に対する世界の需要は、慢性疾患の蔓延、高齢者人口の増加、バイオ医薬品への効率的かつ容易なアクセスに対する意識の高まりにより、急速に拡大しています。また、遺伝子ベースのバイオ医薬品など、さまざまな疾患を治療するための先進的なバイオ医薬品に対する需要の高まりも、市場の成長を後押ししています。市場がバイオ医薬品需要の急増を目の当たりにする中で、バイオテクノロジー受託製造のニーズはさらに高まる見通しです。メーカー各社は、市場ニーズへの対応を強化するため、常に新しい製品の発売やサービスの拡充に取り組んでいます。
製造技術の進歩
製造技術はバイオテクノロジー受託製造に変化をもたらし、効率の改善、カスタマイズの拡大、コミュニケーションの強化につながっています。自動化、柔軟性、サプライチェーンマネジメントの強化により、製造工程はより効率的、コスト効率的、信頼性の高いものとなっています。こうした進歩により、受託製造業者は高品質の製品を大量に生産できるようになり、市場の需要拡大に対応できるようになっています。個別化医薬品とバイオシミラーの進展も市場の牽引力をさらに高めています。
哺乳動物ベースのプラットフォームの優位性
哺乳動物細胞ベースのバイオテクノロジーは、免疫疾患の治療に不可欠な高品質のタンパク質を作り出します。これらの製品は、疾患に対する抗体治療法の開発において主な役割を担っており、精度の向上や副作用の少なさなど、旧来の方法にはない利点があります。
当レポートでは、世界のバイオテクノロジー受託製造の市場を調査し、市場の定義と概要、市場規模の推移・予測、各種区分・地域別の詳細分析、産業構造、市場成長への影響因子の分析、ケーススタディ、競合情勢、主要企業のプロファイルなどをまとめています。
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.