市場調查報告書
商品編碼
1403507
2030 年生技藥品製品外包市場預測:按產品類型、來源、服務、應用、最終用戶和地區進行的全球分析Biologics Outsourcing Market Forecasts to 2030 - Global Analysis By Product (Antibodies, Vaccines, Recombinant Proteins and Other Products), Type (Instruments and Kits & Reagents), Source, Service, Application, End User and By Geography |
根據Stratistics MRC的數據,2023年全球生技藥品外包市場規模為237.8億美元,預計2030年將達到622億美元,預測期內複合年成長率為16.0%。
生技藥品外包是指將生技藥品產業在生物製品的開發、生產、研究各個階段向CRO(合約藥物委外研發機構)、CMO(業務生產組織)等外部方提供專業化服務。委託給合作夥伴。目標是簡化業務、降低成本、加快時間表、獲取專業資源並擴大市場上可用的生物製藥產品組合。
據世界衛生組織(WHO)稱,2019年冠狀病毒感染疾病(COVID-19)是由嚴重急性呼吸症候群冠狀病毒2(SARS-CoV-2)引起的一種高度感染疾病。截至 2023 年 2 月 15 日,全球約有 756,291,327 人受到影響。
製藥公司越來越注重開發治療多種疾病的生物製藥,包括癌症和自體免疫疾病。隨著這種發展的增加,需要專業知識和基礎設施,並且委託研發和製造外包給 CRO(合約藥物委外研發機構)和 CMO(業務藥品製造組織)的趨勢正在加速。此外,外包可以利用外部能力,加快藥物開發時間表,並獲取專業資源,從而促進創新並擴大可用的生物療法的種類。
確保不同的外包合作夥伴保持一致且嚴格的品質標準是一項挑戰。特別是對於生產要求複雜的生物製藥,很難協調品管措施並保持生產過程的一致性。不同合作夥伴之間品質保證實踐的差異可能會影響生技藥品的可靠性和一致性,引發對產品功效和安全性的擔憂。
生物加工技術的快速進步,包括一次性系統、連續製造和基因編輯工具,為外包合作夥伴提供了採用尖端創新並將其整合到其服務產品中的機會。透過整合這些進步,外包公司可以提高其在生技藥品開發、生產和品管方面的能力。此外,透過投資和利用這些最尖端科技,外包合作夥伴可以吸引尋求最尖端科技的客戶,並開發獨特的競爭優勢,為不斷變化的生技藥品開發和製造市場提供一定的成長。
對外部專業知識的依賴是生技藥品製劑外包市場的主要威脅。在研究、開發和製造等關鍵職能方面過度依賴外包合作夥伴可能會限制我們對生技藥品製造流程的內部知識和控制。過度依賴外部專業知識可能會導致缺乏彈性、增加破壞的脆弱性以及降低迴應動態市場需求的敏捷性。
COVID-19大流行對生技藥品外包市場產生了重大影響。這場流行病的主要影響是對生技藥品的需求增加以及由此產生的對外包服務的需求。由於迫切需要開發針對病毒的有效疫苗和治療方法,許多製藥公司將業務外包給專門的受託製造廠商(CDMO)來滿足生技藥品製造和開發需求。為了確保生技藥品的穩定供應,這種中斷導致許多製藥公司尋找其他外包的可能性。
預計抗體領域將佔最大佔有率。抗體被用作針對引起疾病的特定分子的治療劑,並可用於治療各種疾病,例如感染疾病、自體免疫疾病和癌症。抗體廣泛應用於藥物研發、藥物開發和許多其他領域的標檢驗、蛋白質表徵和定量。此外,外包抗體可以確保公司的監管合規性並降低監管風險,使他們能夠專注於自己的核心優勢,例如藥物研發、臨床前和臨床研究以及其他可以做的研究業務。
預計腫瘤學領域在預測期內將出現良好的成長。生物製藥為癌症治療提供了有針對性的個體化方法,使其能夠非常有效地對抗不同類型的惡性。委外研發機構(CRO) 和業務組織 (CMO) 為癌症相關生技藥品提供專門支持,包括單株抗體、免疫療法和標靶治療。此外,隨著越來越多的製藥公司專注於癌症領域的藥物開發,該領域的外包服務需求預計將迅速增加。
在估計期間,亞太地區佔據最大的市場佔有率。該地區不斷發展的生物製藥行業、有利的法規結構以及不斷增加的研發投資正在推動市場擴張。此外,由於成本效率、創新和接觸多樣化患者群體等競爭優勢,生技藥品製劑外包(包括研發和受託製造服務)在亞太地區蓬勃發展。該地區繼續在全球生技藥品外包形勢發揮關鍵作用,推動產業成長和創新。
由於其強大的醫療基礎設施、最先進的研發設施以及對技術創新的重視,預計北美在預測期內將實現盈利成長。此外,對疫苗、細胞治療藥物和單株抗體等生技藥品的需求不斷成長,正促使製藥和生物技術公司外包生技藥品的製造過程,因為內部製造成本昂貴。北美因其優越的地理位置和豐富的熟練勞動力而成為生技藥品外包的熱門目的地。
According to Stratistics MRC, the Global Biologics Outsourcing Market is accounted for $23.78 billion in 2023 and is expected to reach $62.20 billion by 2030 growing at a CAGR of 16.0% during the forecast period. Biologics Outsourcing refers to the practice of contracting specialized services in the biopharmaceutical industry to external partners, such as contract research organizations (CROs) and contract manufacturing organizations (CMOs), for various stages of biologic drug development, manufacturing, or research. It aims to streamline operations, reduce costs, accelerate timelines, access specialized resources, and expand the portfolio of biologic therapies available in the market.
According to the World Health Organisation (WHO), coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As of February 15, 2023, about 756,291,327 people are affected worldwide.
Pharmaceutical companies increasingly focus on biologic drug development for various ailments, like cancer and autoimmune disorders. This heightened development necessitates specialised expertise and infrastructure, driving the outsourcing of research, development, and manufacturing to contract research organisations (CROs) and contract manufacturing organisations (CMOs). Moreover, outsourcing allows for leveraging external capabilities, accelerating drug development timelines, and accessing specialised resources, thereby fostering innovation and expanding the array of available biologic therapies.
Ensuring consistent and stringent quality standards across diverse outsourcing partners poses challenges. Harmonising quality control measures and maintaining uniformity in production processes, especially for biologic drugs with complex manufacturing requirements, can be demanding. Variability in quality assurance practices among different partners might impact the reliability and consistency of biologics, raising concerns about product efficacy and safety.
The rapid evolution of bioprocessing technologies, such as single-use systems, continuous manufacturing, and gene editing tools, offers outsourcing partners the chance to adopt and integrate cutting-edge innovations into their service offerings. By embracing these advancements, outsourcing firms can enhance their capabilities in biologics development, production, and quality control. Furthermore, investing in and utilising these cutting-edge technologies allows outsourcing partners to provide unique and competitive services that draw in clients looking for cutting-edge technologies and provide growth prospects in the ever-changing biologics development and manufacturing market.
Dependency on external expertise poses a significant threat in the Biologics Outsourcing market. Relying extensively on outsourcing partners for critical functions like research, development, and manufacturing might limit in-house knowledge and control over the biologics production process. Overreliance on external expertise could potentially result in a lack of flexibility, increased vulnerability to disruptions, and reduced agility in responding to dynamic market needs.
The COVID-19 pandemic had a significant impact on the biologics outsourcing market. The pandemic's primary impact has been a rise in the demand for biologics and the ensuing requirement for outsourcing services. Many pharmaceutical companies are outsourcing to specialised contract development and manufacturing organisations (CDMOs) to handle their biologics manufacturing and development needs due to the emerge to develop effective vaccines and therapies against the virus. In order to guarantee a steady supply of biologics products, this disruption compelled numerous pharmaceutical corporations to search for other outsourcing possibilities.
The antibodies segment is estimated to hold the largest share. Antibodies are used as therapeutic agents to target particular molecules that cause disease, assisting with the treatment of a variety of diseases such as infectious diseases, autoimmune diseases, and cancer. Antibodies are extensively employed in drug discovery, development, and many other fields for target validation, protein characterization, and quantification. In addition, outsourcing antibodies ensures regulatory compliance and lowers regulatory risks for the companies, allowing them to concentrate on their core strengths, which include drug discovery, pre-clinical and clinical research, and other R&D operations.
The oncology segment is anticipated to have lucrative growth during the forecast period. Biologics offer targeted and personalised approaches to cancer treatment, making them highly effective in combating various types of malignancies. Contract research organisations (CROs) and contract manufacturing organisations (CMOs) offer specialised support for oncology-related biologics, including monoclonal antibodies, immunotherapies, and targeted therapies. Moreover, with an increasing number of pharmaceutical companies focusing on oncology drug development, the need for outsourcing services in this segment is expected to surge.
Asia Pacific commanded the largest market share during the extrapolated period. The region's growing biopharmaceutical industry, favourable regulatory frameworks, and increasing investments in research and development fuel the market's expansion. Furthermore, outsourcing biologics production, including contract research, development, and manufacturing services, thrives in Asia-Pacific due to its competitive advantages in cost-efficiency, innovation, and access to a diverse patient pool. This region continues to play a pivotal role in the global biologics outsourcing landscape, fostering growth and innovation within the industry.
North America is expected to witness profitable growth over the projection period due to robust healthcare infrastructure, cutting-edge research and development facilities, and a strong emphasis on innovation. Furthermore, the growing need for biologics, such as vaccines, cell treatments, and monoclonal antibodies, has encouraged pharmaceutical and biotechnology companies to outsource their biologic production processes due to the high expense of internal manufacture. North America has become a popular destination for biologics outsourcing due to its advantageous geographic position and plenty of highly skilled labour.
Some of the key players in the Biologics Outsourcing Market include Thermo Fisher Scientific Inc, Adimab LLC, Abzena Ltd., KBI Biopharma, Curia Global, Inc., EirGenix, Inc., Bionova Scientific, Inc., Boehringer Ingelheim International GmbH., Abbvie Inc., STC Biologics, Avid Bioservices, Inc., Catalent Inc., Genentech, Inc., Eurofins Scientific, Genscript Biotech Corporation, Lonza, JSR Corporation, Merck KGaA, Rentschler Biopharma SE and Emergent.
In December 2022, AbbVie partnered with AbCellera Biologics Inc. The partnership leverage AbCellera's antibody discovery and development engine to deliver optimized development candidates for up to five targets selected by AbbVie across multiple indications. This helped the company to enhance its service offerings.
In December 2022, Thermo Fisher expanded its biologics and steriles manufacturing capabilities in China. The facility offers integrated clinical and commercial drug substance and drug product capabilities. This includes process development, cell line development, biologics drug substance manufacturing, and sterile fill-finish. This helped the company expand its geographic presence.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.