전 세계 바이오의약품 위탁생산 시장 규모는 2023년부터 2029년까지 16.51%의 CAGR로 성장할 것으로 예상됩니다.
2024년, 대형 CMO 중 하나인 사노피는 프랑스에서 의약품 생산능력을 강화하기 위해 프랑스에서 바이오 제조에 10억 달러 이상을 투자했습니다. 2023년, GTP Bioways는 프랑스에 두 개의 바이오의약품 제조 시설을 신설했습니다. 2024년, Lonza는 미국 Genentech의 제조 부문을 Roche로부터 12억 달러에 인수하기로 합의했습니다. 론자(Lonza)가 미국 제네텍(Genentech)의 제조 부문을 Roche로부터 12억 달러에 인수하기로 합의했다고 발표했습니다.
2024년 Thermo Fischer Scientific은 차세대 단백질체학 솔루션 개발의 선구자인 Olink Holding AB를 인수했습니다. 2023년 Wuxi Biologics는 독일 시설에서 제조 능력을 강화할 것이라고 발표했습니다. 2020년부터 회사는 독일 내 두 개의 새로운 시설 건설 및 적응에 투자했습니다. 2020년 이후, 회사는 독일 내 2 개의 새로운 시설 건설 및 적응에 투자했으며, 2023년 Merck는 mRNA 서비스의 선구자로서 독일에 2 개의 새로운 제조 공장을 개설했습니다. 또한 비용을 43% 절감하고 생물학적 안전성 테스트 시간을 66% 단축할 수 있는 유전자 안정성 플랫폼의 출시를 발표했습니다.
2023년 세계 최고의 CDMO인 ACG Biologics는 밀라노의 Cell & Gene Center of Excellence 생산기지의 제조공장 확장을 완료했습니다.
The Manufacturing Dive(2024)에 따르면, CMO들은 로봇, 자동화, 연속 생산 등 혁신적이고 진보된 제조 기술로 전환하고 있으며, 기록적인 의약품 부족과 복잡한 신약 수요에 대응하기 위해 제조 공정의 최적화를 모색하고 있다고 보도했습니다. 연속 제조 기술은 CMO들 사이에서 인기가 높아지고 있습니다. 이 기술에서 투입 재료는 연속적으로 생산에 투입되고, 변환되고, 처리된 출력 재료는 연속적으로 제거됩니다. 자동화는 CMO들 사이에서 빠르게 확산되고 있는 추세로, 일관성과 정확성을 높이고 인적 오류를 최소화하는 데 도움이 됩니다. 현재 자동화, 공정 제어 시스템, 첨단 로봇 공학은 바이오 공정의 지속적인 모니터링과 최적화를 가능하게 하고, 제품 품질을 개선하고, 더 높은 수율을 달성하기 위해 널리 보급되고 있습니다.
바이오제약 산업에서 연구개발, 임상, 임상시험, 제품 승인, 신제품 시장개척이 점점 더 복잡해지면서 바이오제약 기업들은 보다 다양하고 경험이 풍부한 전통 있는 위탁생산 업체를 찾고 있습니다. 그러나 최근에는 보다 틈새적이고 치료가 필요한 치료 영역에 대한 관심이 높아짐에 따라 바이오제약 기업들은 CMO에 보다 전문적인 서비스와 역량을 요구하고 있습니다. 바이오 제약 산업이 치열한 경쟁과 규제 당국의 도전에 직면한 가운데, 바이오 제약 기업들은 특정 또는 단일 분야의 전문가인 CMO를 찾고 있습니다. 이러한 요인은 바이오제약 기업의 고유한 요구사항을 충족시키기 위해 맞춤형 솔루션과 서비스를 제공할 수 있는 소규모의 신생 전문 CMO에게 기회를 창출하고 있습니다.
세계의 바이오의약품 위탁생산 시장에 대해 조사했으며, 시장 개요와 함께 제품별, 바이오의약품별, 발현 시스템별, 사업 규모별, 기업 규모별, 지역별 동향, 시장 진출 기업 프로파일 등의 정보를 전해드립니다.
The global biopharmaceutical contract manufacturing market is expected to grow at a CAGR of 16.51% from 2023 to 2029.
RECENT VENDORS ACTIVITIES
KEY TAKEAWAYS
MARKET TRENDS & DRIVERS
Attention Towards Technology Adoption
Contract Manufacturing Organizations (CMOs) are shifting towards innovative and more advanced manufacturing technologies, such as robotics, automation, and continuous manufacturing. The Manufacturing Dive article (2024) reported that contract manufacturers seek to optimize manufacturing processes to meet demand for combat record-high drug shortages and new and complex drugs. Where Continuous Manufacturing technology become more popular among CMOs. In this technology, input materials are continuously fed into production and transformed, and processed output materials are continuously removed. Automation is a rapidly growing trend among CMOs that delivers more consistency, and precision and minimizes human error. Currently, automation, process control systems, and advanced robotics, that becoming popular to enable continued monitoring and optimization of bioprocesses, to improve product quality and lead to higher yield.
Attention Towards Specialized Capabilities and Services
In the biopharmaceutical industry, research and development, clinical trials, product approvals, and new products in the market have become more and more complex, the biopharma companies seeking more diverse, experienced, and well-established contract manufacturers. However, in recent days, with the growing attention toward more niche and care-demanding therapeutic areas, now biopharma companies looking for more specialized services and capabilities in CMOs. As the biopharmaceutical industry experiences huge competition and challenges from regulatory bodies, biopharma companies looking for CMOs who are experts in specific or single areas. This factor creates opportunities for small and emerging specialized CMOs that can offer tailored solutions and services to meet the unique requirements of biopharma companies.
Increasing Drug Approvals by Emerging, Small & Medium-Sized Biopharma Companies
Small & Medium pharma biotech companies are the most potential clients for CMOs/CDMOs as these entities face several issues in the development and manufacturing of their drugs. New and often small-sized to mid-sized biotech companies are seeking contract manufacturing companies to introduce their products due to a lack of resources and associated capabilities to invest in manufacturing facilities of their own. In the past few years, small-sized biopharma companies have accelerated their R&D and launched around 30% to 40% of new drugs. There are more than 5,500 total small and mid-sized biopharma companies present across the world revealed by Contract Pharma news in 2023, and it is expected that in upcoming years (by 2026-2027) they will contribute more than 55% of new drugs launched.
Rapid Developments in Biopharma Contract Production Services with AI
With the growing competition across the biopharmaceutical contract manufacturing industry, vendors are advancing them with new approaches that drive their efficiency in contract manufacturing. The partnership with the right contract manufacturer is an emerging trend that led to rising advancements among the vendors to stay competitive in the market. The majority of CMOs/CDMOs are developing and expanding their services to keep pace with rapidly evolving the global market. These factors attract more and more biopharma companies towards contract manufacturing and drive market growth. CMOs are advancing their performance with artificial intelligence (AI) and electronic platforms to become more cost-effective and speed up production time.
INDUSTRY RESTRAINTS
High Cost of Biologics Contract Manufacturing
Biopharmaceuticals are medicines made from living cells that treat common and serious diseases, such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. These are highly targeted and effective, and they are increasingly important in the fight against these diseases. They are relatively complex molecules and are usually composed of proteins for transplantation, carbohydrates, nucleic acids, cells or tissues, or complex complexes of these substances. Their examples include hormones, vaccines, blood products, allergens, mAbs, recombinant therapeutic proteins, C>, growth factors, cytokines, and insulin. Unfortunately, most patients cannot afford biologics. Medical costs divide consumers into rich and poor categories. Both categories are stressed due to high biological costs, but the poor stress much more. Expensive biological products are not easily accessible to poor patients. This is more pronounced in low- and middle-income countries.
SEGMENTATION INSIGHTS
INSIGHTS BY PRODUCT
The global biopharmaceutical contract manufacturing market by product is segmented into finished dosage form (FDF) and active pharmaceutical ingredients (API). The finished dosage form (FDF) accounted for the largest market share in 2023. An FDF (Finished Dosage Form) is a drug product that has undergone all stages of production, including manufacturing, testing, and regulatory approval before being made available to the public. The FDF contains both active pharmaceutical ingredients (APIs), which are responsible for the therapeutic effects experienced by the user, and inactive ingredients (excipients), which serve as carriers to facilitate the function of the active ingredients. Producing finished dosage forms requires specialized equipment, advanced technologies, and expertise. As the biopharmaceutical industry continues to expand, many companies are partnering with contract manufacturers to meet global FDF demand and ensure compliance with regulatory standards.
By Product
INSIGHTS BY BIOLOGICS
The global biopharmaceutical contract manufacturing market by biologics is categorized into monoclonal antibodies, vaccines, and other biologics. The monoclonal antibodies segment holds the largest market share of over 46% in 2023. Monoclonal antibodies (mAbs) currently dominate the biopharmaceutical product category, primarily driven by the rising prevalence of complex and severe health conditions, such as cancer, and the increasing sophistication of treatment approaches. Furthermore, 53 Biologics, a leading CDMO (Contract Development and Manufacturing Organization), reported a significant rise in research and development activities for monoclonal antibodies following the COVID-19 pandemic. As the demand for highly specific and immune-supportive biopharmaceutical products grows, the need for monoclonal antibody contract manufacturing is rapidly increasing worldwide.
By Biologics
INSIGHTS BY EXPRESSION SYSTEMS
The global biopharmaceutical contract manufacturing market by expression systems is segmented into mammalian and non-mammalian. The mammalian segment shows significant growth, with the fastest-growing CAGR of 16.78% during the forecast period. The development of biopharmaceuticals using transgenic mammalian cell lines remains a cornerstone of the biotechnology and pharmaceutical industries, with the market experiencing exponential growth since the introduction of human tissue plasminogen activator in 1987 and erythropoietin in 1988. Mammalian cells are widely considered for expression systems in biologics manufacturing, particularly for producing monoclonal antibodies. Chinese Hamster Ovary (CHO) cells, for instance, are responsible for over 70% of recombinant pharmaceutical protein production. Their unique ability to perform post-translational modifications, which are critical for drug safety and efficacy, makes mammalian expression systems essential for producing therapeutic proteins, complex proteins, and monoclonal antibodies, further driving their widespread application in the industry.
By Expression Systems
INSIGHT BY SCALE OF OPERATION
Based on the scale of operation, the commercial segment dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The commercial-scale operation in biopharma, driven by the outsourcing of biologics production, is significantly contributing to the growth of the commercial segment. By leveraging contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), biopharma companies can achieve large-scale production efficiently, reducing costs and time-to-market for essential biologics like vaccines, monoclonal antibodies, and cell and gene therapies. This scalability allows companies to meet the rising global demand driven by infectious diseases, chronic illnesses, cancers, and autoimmune disorders. Moreover, outsourcing enables biopharma companies to focus on research and innovation while relying on expert manufacturers to handle production complexities. This model also facilitates faster regulatory compliance and access to advanced manufacturing technologies, enhancing productivity. As a result, the commercial segment benefits from expanded market reach, improved profitability, and the ability to address global health challenges effectively, further fueling its growth.
By Scale of Operation
INSIGHT BY COMPANY SIZE
Based on the company size, the large companies segment accounted for the largest global biopharmaceutical contract manufacturing market share. Following the COVID-19 pandemic, budget constraints have become a common issue for large biopharma companies, primarily due to the substantial financial burden of investments in vaccine and therapeutic development. As a result, many companies are shifting from in-house manufacturing to outsourcing, allowing them to focus on core competencies like innovation while taking advantage of cost-effective contract manufacturing services. This trend is driven by the need to reduce manufacturing costs while ensuring high-quality production. CMOs in developing countries, such as India, South Korea, and Switzerland, are emerging as key players in this shift, offering advanced manufacturing facilities, a familiar regulatory environment, and significant cost savings. This movement toward outsourcing to developing countries is helping large biopharma companies optimize production and remain competitive in the global market.
By Company Size
GEOGRAPHICAL ANALYSIS
North America dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The market dominance of these regions can be attributed to the high concentration of biopharma companies, the growing trend of outsourcing biopharma contract manufacturing due to cost and regulatory compliance considerations, and the presence of several leading market players. In North America, numerous biopharma companies are actively involved in developing novel biologics. Significant investments in research and development aimed at strengthening pipelines for chronic autoimmune diseases are expected to drive the launch of new therapeutics in the region. The increasing number of approvals for novel therapeutics is creating valuable opportunities for market growth in North America.
By Geography
COMPETITIVE LANDSCAPE
The global biopharmaceutical contract manufacturing market report consists of exclusive data on 45 vendors. The market is highly competitive. There are several leading, growing, and emerging market players are present across the global market. Some emerging players compete against large and small medium-sized market players. Boehringer Ingelheim, Lonza, Samsung Biologics, AbbVie, Catalent, Emergent BioSolution, FUJIFILM, Merck KGaA, Pfizer, and Wuxi Biologics are leading companies that accounted for major market share in the global biopharmaceutical contract manufacturing market. These vendors are continuously focusing on expanding their biopharmaceutical contract manufacturing services that meet clients' requirements, international regulations, and increase the efficiency of their product, strengthen their market position.
Key Vendors
Other Prominent Vendors
KEY QUESTIONS ANSWERED:
CHAPTER - 1: Competitive Landscape of Biopharmaceutical Contract Manufacturing Market Overview
CHAPTER - 2: Competitive Landscape of Biopharmaceutical Contract Manufacturing Market
CHAPTER - 3: Biopharmaceutical Contract Manufacturing Market Prospects & Opportunities
CHAPTER - 4: Biopharmaceutical Contract Manufacturing Market Segmentation Data
CHAPTER - 5: Key Regions Overview
CHAPTER - 6: Biopharmaceutical Contract Manufacturing Market Industry Overview
CHAPTER - 7: Appendix