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市場調査レポート
商品コード
1451397
バイオロジクス市場レポート:由来、製品、疾患、製造、地域別、2024-2032Biologics Market Report by Source, Product, Disease, Manufacturing, and Region 2024-2032 |
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カスタマイズ可能
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バイオロジクス市場レポート:由来、製品、疾患、製造、地域別、2024-2032 |
出版日: 2024年03月02日
発行: IMARC
ページ情報: 英文 138 Pages
納期: 2~3営業日
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世界のバイオロジクス市場規模は2023年に3,496億米ドルに達しました。今後、IMARC Groupは、2024年から2032年にかけて7.8%の成長率(CAGR)を示し、2032年には6,995億米ドルに達すると予測しています。より効果的な治療オプションが必要とされる慢性疾患の有病率の上昇、よりターゲットを絞った治療法の開発を促進する継続的な技術進歩、先進的ドラッグデリバリーシステムの出現は、市場を推進する要因のいくつかを表しています。
バイオロジクスは生きた細胞に由来する複雑な分子で、病気の診断、治療、予防に用いられます。これらの分子は、サイズだけでなくその構造の複雑さにおいても、低分子医薬品とは根本的に異なっています。高度な特異性を特徴とするこれらの医薬品は、細胞やタンパク質など、人体内の特定の成分と相互作用するように調整されています。このユニークな特性により、より正確に疾患経路をターゲットにすることができ、副作用を最小限に抑えながら、より高い有効性が期待できます。その作用機序は、生理的機能の回復や病的要因の除去のために、天然に存在する分子の活性を阻害または増強することにより、生物学的経路を調節することにあります。
このような複合分子の世界市場は、より効果的な治療法を必要とする慢性疾患の蔓延が主な要因となっています。これに伴い、継続的な技術の進歩により、標的を絞った治療法の市場開拓が促進され、市場に弾みがついています。さらに、ヘルスケア予算の拡大が先進的な治療オプションへの持続的な需要をもたらし、大きな成長促進要因となっています。これに加えて、個別化医療へのシフトがオーダーメイド治療の採用率向上につながり、市場をさらに拡大しています。市場の成長に寄与するその他の要因としては、情報に精通し教育された患者ベース、創薬における人工知能の最適化された役割、バイオ医薬品企業間の戦略的提携、特許切れ製剤がより多くの人々に利用されるようになったことによるバイオシミラーの出現などが挙げられます。
標的治療における絶え間ないイノベーション
複合分子市場の重要な促進要因は、標的治療の絶え間ない革新です。これは、特定の細胞や疾患の原因分子に特異的に作用するように設計された治療法で、副作用を最小限に抑えながら治療効果を高めることができます。がんや自己免疫疾患のような疾患の重大な性質を考えると、標的療法は治療のための新規で効果的な手段を提供します。広範な科学的調査により、分子レベルでの疾病メカニズムの解明が可能になり、従来のアプローチよりも効果的で毒性の低い特殊な治療法への道が開かれました。研究開発への投資が増加し、個別化医療への注目度が高まるにつれて、こうした標的療法は主流になりつつあります。これらのイントロダクションの導入とその後の成功は、複合分子の需要を大幅に高める可能性があり、市場の極めて重要な促進要因となっています。
先進ドラッグデリバリーシステムの出現
ドラッグデリバリーシステムは、ヘルスケアにおいてますます重要な役割を果たすようになり、複雑な分子治療薬の有効性や患者のコンプライアンスを左右することも少なくないです。この分野における技術革新は、放出制御機構からナノテクノロジーに基づく送達システムまで、さまざまな形で現れています。このような進歩により、患者は治療レジメンを守りやすくなり、臨床転帰が改善されます。例えば、新しいデリバリー・システムは、毎日の注射を週1回、あるいは月1回の投与に置き換えることで、患者の利便性と治療継続意欲を大幅に向上させる可能性があります。複雑な分子の治療効果を最大化する目的で、こうした技術の研究開発には多額の投資が行われています。ドラッグデリバリーシステムにおけるこうした進歩は、より効率的で患者に優しい治療オプションへの需要を満たし、市場の回復力と成長性に大きく寄与しています。
規制の変化と調和
迷路のような規制環境の中を進むことは、ヘルスケア分野の企業にとって長い間困難な課題でした。しかし、規制調和に向けた現在の動向は、この複雑な状況を単純化しつつあります。異なる国間で統一された、あるいは相互に認められた承認プロセスにより、市場参入の障壁は大幅に軽減されます。つまり、新製品も既存製品も、以前よりずっと早く、より多くの患者層に届けられるようになるのです。革新的な治療薬が患者に提供されるペースが加速されるだけでなく、これらの製品の地理的範囲も大幅に拡大されます。承認の迅速化と市場アクセスの拡大による規制当局のこのような有利な連携は、複雑なバイオロジクス分子の世界市場の実質的かつ持続的な成長を促しています。
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.