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市場調查報告書
商品編碼
1451397
2024-2032 年按來源、產品、疾病、製造和地區分類的生物製品市場報告Biologics Market Report by Source, Product, Disease, Manufacturing, and Region 2024-2032 |
2023年全球生物製品市場規模達3,496億美元。展望未來, IMARC Group預計到2032年市場規模將達到6,995億美元,2024-2032年複合年成長率(CAGR)為7.8%。慢性病盛行率不斷上升,需要更有效的治療方案,不斷的技術進步促進了越來越有針對性的療法的開發,以及先進的藥物傳輸系統的出現,這些都是推動市場發展的一些因素。
生物製劑是源自活細胞的複雜分子,用於診斷、治療和預防疾病。這些分子與小分子藥物有著根本的不同,不僅在尺寸上,而且在結構的複雜性上。這些藥物解決方案具有高度特異性的特點,經過專門設計,可與人體內的特定成分(例如細胞和蛋白質)相互作用。這一獨特的屬性使它們能夠更精確地針對疾病途徑,提供更高的療效潛力,同時最大限度地減少副作用。其工作機制通常涉及透過阻斷或增強天然分子的活性來調節生物途徑,以恢復生理功能或消除病理因子。
這些複雜分子的全球市場主要是由慢性病盛行率上升所推動的,這需要更有效的治療選擇。與此一致的是,不斷的技術進步促進了越來越有針對性的療法的開發,這反過來又為市場提供了動力。此外,不斷擴大的醫療保健預算導致對先進治療方案的持續需求,成為重要的成長誘導因素。除此之外,向個人化醫療的轉變導致客製化療法的採用率更高,從而進一步擴大了市場。促進市場成長的其他一些因素包括知情且受過教育的患者基礎、人工智慧在藥物發現中的最佳化作用、生物製藥實體之間的策略合作,以及隨著非專利版本變得更容易被更大的人使用而出現的生物相似藥的出現。人口。
標靶治療持續創新
複雜分子市場的一個重要驅動力是標靶治療的持續創新。這些療法旨在專門作用於某些導致疾病的細胞或分子,從而提高治療效果,同時最大限度地減少副作用。鑑於癌症和自體免疫疾病等疾病的嚴重性,標靶治療提供了一種新穎有效的治療途徑。廣泛的科學研究使人們能夠在分子層面上了解疾病機制,為比傳統方法更有效、毒性更小的專門治療方法鋪平了道路。隨著研發投資的增加,加上對個人化醫療的高度關注,這些標靶療法有望成為主流。它們的推出和隨後的成功可以大大提高對複雜分子的需求,從而成為市場的關鍵驅動力。
先進藥物輸送系統的出現
藥物輸送系統在醫療保健中發揮越來越重要的作用,通常決定複雜分子治療的有效性和患者依從性。該領域的創新有多種形式,從控釋機製到基於奈米技術的輸送系統。這些進步使患者更容易堅持治療方案,進而改善臨床結果。例如,較新的輸送系統可能會以每週甚至每月劑量取代每日注射,大大提高患者的便利性和繼續治療的意願。大量投資正在流入這些技術的研究和開發,目的是最大限度地提高複雜分子的治療效果。藥物輸送系統的這些進步極大地增強了市場的彈性和成長潛力,滿足了對更有效和對患者友好的治療選擇的需求。
監管變化和協調
長期以來,對於醫療保健產業的公司來說,穿越迷宮般的監管環境一直是一項艱鉅的挑戰。然而,當前監管協調的趨勢正在簡化這一複雜的情況。透過不同國家統一或相互認可的核准流程,市場准入障礙大大降低。這意味著新產品和現有產品可以比以前更快地覆蓋更廣泛的患者群體。其影響是多方面的:不僅加快了向患者提供這些創新療法的速度,而且這些產品的地理覆蓋範圍也顯著擴大。透過加速核准和擴大市場准入,這種有利的監管實踐協調正在推動複雜生物分子全球市場的大幅持續成長。
The global biologics market size reached US$ 349.6 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 699.5 Billion by 2032, exhibiting a growth rate (CAGR) of 7.8% during 2024-2032. The rising prevalence of chronic diseases that necessitate more effective treatment options, continual technological advancements facilitating the development of increasingly targeted therapies, and the emergence of advanced drug delivery systems represent some of the factors that are propelling the market.
Biologics are complex molecules derived from living cells, which are used to diagnose, treat, and prevent diseases. These molecules are fundamentally different from small-molecule drugs, not only in terms of size but also in the intricacy of their structure. Characterized by a high degree of specificity, these medicinal solutions are tailored to interact with specific components within the human body, such as cells and proteins. This unique attribute enables them to target disease pathways more precisely, offering a higher potential for efficacy while minimizing side effects. The working mechanism often involves the modulation of biological pathways, either by blocking or enhancing the activity of naturally occurring molecules, to restore physiological function or eliminate pathological agents.
The global market for these complex molecules is primarily driven by the rising prevalence of chronic diseases that necessitate more effective treatment options. In line with this, continual technological advancements facilitating the development of increasingly targeted therapies, which in turn is providing an impetus to the market. Moreover, expanding healthcare budgets are resulting in a sustained demand for advanced therapeutic options, acting as a significant growth-inducing factor. In addition to this, the shift toward personalized medicine is leading to higher adoption rates of tailored therapies, thus expanding the market further. Some of the other factors contributing to the market's growth include an informed and educated patient base, the optimizing role of artificial intelligence in drug discovery, strategic collaborations between biopharmaceutical entities, and the emergence of biosimilars as off-patent versions become more accessible to a larger population.
Continual innovations in targeted therapies
A significant driver in the market for complex molecules is the continuous innovation in targeted therapies. These are therapies designed to specifically act on certain cells or molecules responsible for disease, thus increasing treatment effectiveness while minimizing side effects. Given the critical nature of diseases like cancer and autoimmune disorders, targeted therapies offer a novel and effective avenue for treatment. Extensive scientific research has enabled the understanding of disease mechanisms at the molecular level, paving the way for specialized treatments that are more effective and less toxic than traditional approaches. With increasing investments in research and development, coupled with a heightened focus on personalized medicine, these targeted therapies are poised to become mainstream. Their introduction and subsequent success can substantially elevate the demand for complex molecules, thus serving as a pivotal driver for the market.
The emergence of advanced drug delivery systems
Drug delivery systems play an increasingly crucial role in healthcare, often determining the effectiveness and patient compliance for complex molecular treatments. Innovation in this sector comes in various forms, from controlled-release mechanisms to nanotechnology-based delivery systems. Such advancements make it easier for patients to adhere to their treatment regimens, thereby improving clinical outcomes. For instance, newer delivery systems might replace daily injections with weekly or even monthly doses, substantially enhancing patient convenience and willingness to continue treatment. Significant investments are flowing into the research and development of these technologies, with the aim to maximize the therapeutic effectiveness of complex molecules. These advances in drug delivery systems are contributing immensely to the market's resilience and growth potential, fulfilling a demand for more efficient and patient-friendly therapeutic options.
Regulatory changes and harmonization
Navigating through the labyrinthine regulatory environments has long been a daunting challenge for companies in the healthcare sector. However, the current trend toward regulatory harmonization is simplifying this complex landscape. With unified or mutually recognized approval processes across different countries, market entry barriers are substantially reduced. This means that new and existing products can reach a wider patient base much faster than before. The implications are manifold: not only is there an accelerated pace at which these innovative therapies are made available to patients, but there is also a significant expansion in the geographic reach of these products. This favorable alignment of regulatory practices, by expediting approvals and broadening market access, is driving substantial and sustained growth in the global market for complex biologics molecules.
IMARC Group provides an analysis of the key trends in each segment of the global biologics market report, along with forecasts at the global, regional and country levels for 2024-2032. Our report has categorized the market based on source, product, disease, and manufacturing.
Microbial
Mammalian
Others
Microbial accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the source. This includes microbial, mammalian, and others. According to the report, microbial represented the largest segment.
The microbial segment in the global market is mainly driven by its cost-effectiveness and shorter production times compared to mammalian cell cultures. The ability of microbial systems to produce large quantities of proteins makes them an attractive option for the mass production of vaccines and insulin. Moreover, advancements in microbial fermentation technologies are making it easier to produce complex proteins. Furthermore, a wide range of approved microbial-based products and a robust pipeline of microbial-based therapies are contributing to the growth of this segment.
On the other hand, the mammalian cell culture segment is particularly suited for the production of complex biologics that require post-translational modifications. Though costlier and more time-consuming than microbial systems, mammalian cell culture remains critical for certain high-value biologics, like monoclonal antibodies. Advances in cell line development and culture methods are contributing to increased yields and efficiency. Given the specific advantages, the mammalian segment continues to maintain a substantial share in the market.
Monoclonal Antibodies
Vaccines
Recombinant Proteins
Antisense, RNAi and Molecular Therapy
Others
Monoclonal antibodies represents the largest market segment
The report has provided a detailed breakup and analysis of the market based on the product. This includes monoclonal antibodies, vaccines, recombinant proteins, antisense, RNAi and molecular therapy, and others. According to the report, monoclonal antibodies represented the largest segment.
The monoclonal antibodies (mAbs) segment is increasingly prominent due to their specificity in targeting a wide array of diseases including cancers, autoimmune disorders, and infections. Technological advancements in antibody engineering and hybridoma technologies have allowed for the development of highly specific and potent mAbs. Additionally, the growing number of FDA approvals for monoclonal antibodies further fuels this segment. The capacity for personalized treatment options using monoclonal antibodies also adds to its robust market potential.
On the other hand, the segments comprising vaccines, recombinant proteins, antisense RNAi, and molecular therapy, is primarily fueled by advances in genetic engineering and biotechnology. These approaches offer new avenues for treating a variety of diseases that are not adequately addressed by existing therapies. Investments in R&D are contributing to the growth of this segment, along with a growing understanding of the mechanisms behind these therapies. A robust pipeline of products in clinical trials indicates promising future prospects for these segments.
Oncology
Immunological Disorders
Cardiovascular Disorders
Hematological Disorders
Others
Oncology accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the disease. This includes oncology, immunological disorders, cardiovascular disorders, hematological disorders, and others. According to the report, oncology represented the largest segment.
The oncology segment in the global market is driven by the high prevalence of cancer worldwide and an aging population more susceptible to this disease. Advancements in genomics have facilitated the development of targeted therapies for various types of cancer. The growing awareness about personalized medicine and targeted therapy in cancer treatment is also propelling this segment forward. Moreover, a strong pipeline of oncology biologics in clinical trials indicates future market growth.
On the other hand, the minor segments consisting of immunological, cardiovascular, and hematological disorders is driven by increasing incidence rates and a lack of effective treatments in some cases. Emerging biologics offer novel methods for treating these conditions, including monoclonal antibodies and recombinant proteins. The growing awareness of these innovative treatments among healthcare professionals and patients is also contributing to these segments. A strong pipeline of therapies targeting these disorders is indicative of potential growth.
Outsourced
In-House
In-house represents the largest market segment
The report has provided a detailed breakup and analysis of the market based on the manufacturing. This includes outsourced and in-house. According to the report, in-house represented the largest segment.
The in-house segment benefits from complete control over the research, development, and manufacturing processes. Organizations are increasingly preferring in-house production to protect intellectual property rights and proprietary technologies. In-house facilities also allow for quicker adaptations to market changes and more effective implementation of quality controls. The capacity for more integrated and streamlined operations contributes to the growth of the in-house segment in the global biologics market.
On the other hand, outsourcing is an increasingly common practice due to the high costs and complexities associated with biologics production. Organizations are utilizing contract manufacturing organizations (CMOs) to lower operational costs and accelerate time-to-market. Outsourcing also allows companies to focus on core competencies like R&D while leaving production to specialized firms. Thus, the outsourced segment is seeing consistent growth in the biologics market.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest biologics market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America dominates the global biologics market, primarily due to the presence of a well-established healthcare infrastructure and significant investments in biopharmaceutical research. The region is home to numerous leading biopharmaceutical companies and research institutions that drive innovation, which is creating a positive outlook for the market.
In addition to this, favorable regulatory support in the form of fast-track approvals for biologics and various financial incentives for extensive research and development (R&D) activities are also contributing to the market growth. Moreover, rising patient awareness and willingness to adopt new therapies are further fueling the demand for biologics in North America.
Furthermore, the U.S. is the largest market within the region, which is majorly buoyed by high healthcare spending, broad insurance coverage, and an increase in chronic and lifestyle-related diseases.
Key players in the global biologics market are aggressively focusing on innovation and research & development (R&D) activities. They are continually expanding their product pipelines to include advanced therapies in oncology, immunology, and other therapeutic areas. To meet stringent regulatory requirements, companies are investing significantly in state-of-the-art manufacturing facilities that adhere to good manufacturing practices. Collaborative agreements with academic institutions are being initiated for acquiring novel technologies. Through mergers and acquisitions, these organizations are consolidating their market presence. Strategic partnerships with smaller biotech companies are enabling the leveraging of unique skill sets and technologies. Furthermore, market leaders are engaging in patient access programs to facilitate the affordability of biologics.
AbbVie Inc.
Amgen Inc.
AstraZeneca plc
F. Hoffmann-La Roche Ltd
GlaxoSmithKline plc
Johnson & Johnson
Merck KGaA
Novartis AG
Pfizer Inc.
Sanofi
In August 2023, AbbVie Inc. announced that the European Commission has approved AQUIPTA (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. The approval makes AQUIPTA the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment in the European Union for the preventive treatment of both chronic and episodic migraine.
In September 2023, Amgen announced that it has reached a consent order agreement with the Federal Trade Commission, resolving a pending lawsuit and paving the way for its acquisition of Horizon Therapeutics. The companies anticipate finalizing the acquisition in early Q4 2023, focusing on serving patients with rare diseases.
In August 2023, AstraZeneca plc announced that Japan's Ministry of Health, Labour and Welfare has approved the expanded use of Soliris (eculizumab) for treating pediatric patients with generalized myasthenia gravis who are resistant to other therapies. The approval follows positive outcomes from a Phase III trial, making Soliris the first targeted therapy for this condition in children and adolescents in Japan.