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市場調查報告書
商品編碼
1656912
生技藥品原料藥製造的全球市場:洞察,競爭情形,市場預測:2032年Biologics Drug Substance Manufacturing - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
到 2024 年,生物製藥活性藥物成分製造的市場規模預計將達到 4,363.6 億美元。預計預測期內(2025-2032 年),市場複合年增長率為 10.59%,到 2032 年將達到 9.6832 億美元。生物製劑 API 製造市場正在經歷顯著成長,這主要是由於慢性病的增加推動了對生物製劑開發和製造的需求。這一積極成長背後的關鍵因素包括生物製劑製造技術的進步、研發活動的增加以及行業主要公司推出的產品激增。此外,生物製劑的日益普及也有助於市場擴張。預計這些因素將在 2025 年至 2032 年期間生物製藥活性藥物成分製造市場的成長中發揮關鍵作用。
慢性病盛行率的上升預計將推動市場成長。根據GLOBOCAN在2023年提供的最新數據,預計2022年全球新發癌症病例數為2,000萬,預計到2045年將增加至3,260萬。
此外,英國癌症協會2023年最新數據顯示,英國每年報告的癌症新病例超過385,000例。這令人震驚的統計數據凸顯了對有效治療方案的迫切需求。生物製劑被認為是一種對抗各種癌症的有前景的創新方法,這極大地促進了生物製劑需求的成長。
根據國際糖尿病聯盟 2023 年的數據,2021 年約有 5.37 億 20 至 79 歲的成年人患有糖尿病。預計到 2030 年這一數字將上升至 6.43 億,到 2045 年將上升至 7.83 億。
根據世界肥胖聯盟2022年的數據,預測到2023年,全球約有10億人(五分之一的女性和七分之一的男性)將患有肥胖症。肥胖的增加與需要長期持續治療的慢性病的增加密切相關。這促使對生物製劑的需求穩定,從而極大地推動了市場成長。
生物製劑(尤其是疫苗)的日益普及預計將顯著推動市場成長。根據世界衛生組織(WHO)2024年7月的數據,2023年,全球約有84%的嬰幼兒,約1.08億人,接種了三劑白喉-破傷風-百日咳(DTP3)疫苗,成為預防傳染病的重要形式。此類疫苗的日益普及和接受度正在推動對生物製劑 API 製造的需求,從而促進市場擴張。
市場的主要參與者正專注於創新技術以增強生物製劑的生產。例如,2024 年 10 月,Forge Biologics 宣布推出其 FUEL(TM) 製造平台。該平台旨在為 AAV 基因治療開發商提供更有效率、更靈活的製造基礎,幫助他們推進新的計畫並針對更廣泛的疾病。
本報告提供全球生技藥品原料藥製造市場相關調查,提供按市場概要,以及生技藥品各類型,製造,各製造原料,各地區趨勢,及加入此市場的主要企業簡介等資訊。
Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence chronic diseases and technological advancements in biologics manufacturing
The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032. The market for biologics drug substance manufacturing is experiencing significant growth, primarily driven by the increasing prevalence of chronic diseases, which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.
Biologics Drug Substance Manufacturing Market Dynamics:
The growing prevalence of chronic disease is expected to drive the market growth. According to recent data provided by GLOBOCAN in 2023, the estimated new number of cancer cases was 20 million in 2022, and the projection is estimated to increase to 32.6 million by 2045 around the world.
Furthermore, according to recent data from Cancer Research UK in 2023, over 385,000 new cancer cases are reported annually in the United Kingdom. This alarming statistic underscores the urgent need for effective treatment options. Biologics are recognized as a promising and innovative approach for addressing various cancer types, significantly contributing to the growing demand for biologic drugs.
The data from the International Diabetes Federation in 2023, indicates that approximately 537 million adults aged 20 to 79 were living with diabetes in 2021. This figure is projected to escalate to 643 million by 2030 and 783 million by 2045 globally.
According to the data from World Obesity Federation in 2022, it was projected that, approximately 1 billion people, representing 1 in 5 women and 1 in 7 men, will be living with obesity by 2023 across the globe. This rise in obesity is closely linked to the increasing incidence of chronic diseases, which require long-term and continuous treatment. As a result, there is a consistent demand for biologic drugs, significantly driving market growth.
The growing adoption of biologics, particularly vaccines, is expected to significantly propel market growth. According to the data from the World Health Organization in July 2024, approximately 84% of infants worldwide; around 108 million received three doses of the diphtheria-tetanus-pertussis (DTP3) vaccine in 2023, providing crucial protection against infectious diseases. This increasing utilization and acceptance of vaccines is driving demand for biologics drug substance manufacturing, thereby fostering market expansion.
Key players in the market are focusing on innovative technologies to enhance biologics manufacturing. For instance, in October 2024, Forge Biologics announced the launch of its FUEL(TM) manufacturing platform, designed to offer AAV gene therapy developers a more efficient and accelerated foundation for production as they advance new programs and target a broader range of diseases.
Additionally, major players are expanding their capabilities in biologics manufacturing through strategic mergers and acquisitions. For instance, in October 2024, Lonza completed its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, California, from Roche for USD 1.2 billion. This acquisition significantly enhances Lonza's capacity for mammalian manufacturing in the United States. Such strategic moves by key players are expected to further stimulate market growth.
However, the high development and production costs of biologics and stringent regulatory requirements, among others are some of the key constraints that may limit the growth of the biologics drug substance manufacturing market.
Biologics Drug Substance Manufacturing Market Segment Analysis:
Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the biologics type segment of the biologics drug substance manufacturing market, the monoclonal antibodies category is estimated to account for the largest market share in the biologics drug substance manufacturing market in 2024. This can be attributed to the growing prevalence of cancer and infectious diseases, among other factors. According to recent data from the Global Burden of Disease (2023), approximately 1 in 20 people globally suffer from chronic respiratory diseases. Furthermore, data from GLOBOCAN indicates that in 2022, there were an estimated 2.48 million new cases of trachea, bronchus, and lung cancer worldwide, with projections expected to rise to 4.25 million by 2045. Monoclonal antibodies are increasingly utilized in targeted cancer therapy, making the rising prevalence of cancer a significant driver of demand for these biologics. Consequently, this heightened demand is propelling the capabilities of biologics drug substance manufacturing, leading to robust market growth.
Major players in the market are increasingly focusing on the development of innovative technologies to enhance their monoclonal antibody manufacturing capabilities. For instance, in April 2024, Evotec Biologics launched the J.CHO(TM) high expression system, designed for the continuous manufacturing of antibodies. As part of Evotec Biologics' advanced continuous bioprocessing platform, J.CHO(TM) optimizes both clinical and commercial biologics production processes by delivering higher productivity and ensuring the high quality of complex antibody formats, including candidate antibodies, Fc-fusions, and bispecific antibodies. This innovation is expected to significantly contribute to the efficiency and effectiveness of monoclonal antibody manufacturing, thereby promoting market growth.
North America is expected to dominate the overall biologics drug substance manufacturing market:
North America is projected to account for leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.
According to the American Cancer Society's Cancer Facts & Figures in 2024, nearly 2 million new cancer cases were expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023.
According to the data from the GLOBOCAN in 2024, North America saw an estimated number of 2,673,174 million new cases of cancer in 2022, with forecasts indicating a rise to 3,828,805 million by 2045. Chronic conditions such as cancer and autoimmune diseases can be treated with biologics and specialty drugs, which are complex molecules and require advanced manufacturing processes. Therefore, the increasing prevalence of cancer is driving the market growth.
Also, according to data from the American Diabetes Association (2023), approximately 38.4 million people, or 11.6% of the population, were living with diabetes in 2021 in the United States. Among these individuals, 29.7 million had received a diagnosis, while an estimated 8.7 million were undiagnosed. The rising prevalence of such conditions has driven demand for more effective treatments. Biologics are increasingly used in these areas due to their specificity and lower toxicity compared to small-molecule drugs.
The growing number of chronic diseases such as cancer requires the development of novel biological drugs for effective treatment, which leads to increased biological drug substance manufacturing, thereby driving the market growth.
Key players in the region are actively establishing biological manufacturing facilities to strengthen their market position. For instance, in July 2024, BeiGene Ltd. announced the opening of its flagship U.S. facility in Hopewell, N.J., located at the Princeton West Innovation Campus. This facility boasts state-of-the-art biologics manufacturing capabilities, alongside a clinical research and development center that enhances the company's reputation as an oncology innovator. The site features approximately 400,000 square feet dedicated to commercial-stage biologic pharmaceutical manufacturing, with the capacity for future expansion. Such activities are expected to drive the market growth in the region.
Therefore, the above-mentioned factors will contribute to the growth of the biologics drug substance manufacturing market in North America.
Biologics Drug Substance Manufacturing Market Key Players:
Some of the key market players operating in the biologics drug substance manufacturing market include Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, and others.
Recent Developmental Activities in the Biologics Drug Substance Manufacturing Market:
Key Takeaways from the Biologics Drug Substance Manufacturing Market Report Study
Target Audience who can be benefited from this Biologics Drug Substance Manufacturing Market Report Study
Frequently Asked Questions for the Biologics Drug Substance Manufacturing Market: