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バイオ医薬品市場レポート:適応症別、クラス別、地域別、2024-2032Biopharmaceutical Market Report by Indication (Autoimmune Diseases, Oncology, Metabolic Disorders, and Others), Class (Recombinant Proteins, Monoclonal Antibodies, Purified Proteins), and Region 2024-2032 |
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バイオ医薬品市場レポート:適応症別、クラス別、地域別、2024-2032 |
出版日: 2024年03月02日
発行: IMARC
ページ情報: 英文 135 Pages
納期: 2~3営業日
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世界のバイオ医薬品市場規模は2023年に3,005億米ドルに達しました。今後、IMARC Groupは、2024年から2032年にかけて8.6%の成長率(CAGR)を示し、2032年までに6,439億米ドルに達すると予測しています。個別化医薬品に対する需要の高まり、慢性疾患や生活習慣病の蔓延、遺伝子工学や組み換えDNA技術を含むバイオテクノロジーの急速な進歩などが、市場成長を促す主な要因となっています。
生物製剤とも呼ばれるバイオ医薬品は、生物由来の医薬品です。バイオ医薬品は、細菌、酵母、哺乳類細胞などの生体を用いて、バイオテクノロジーを駆使して製造されます。化学的に合成される従来の低分子医薬品とは異なり、バイオ医薬品は大きく複雑な分子であり、体内の生物学的標的と極めて特異的な相互作用を示します。バイオ医薬品には、従来の医薬品にはない利点がいくつかあります。バイオ医薬品の作用は特異性が高く、特定の受容体や分子を標的とすることが多いため、有効性が高まり、副作用が軽減されます。さらに、バイオ医薬品は、従来の医薬品では対処が困難であった疾患を治療できる可能性を秘めています。
個別化医療に対する需要の高まりにより、バイオ医薬品市場は大きな成長を遂げています。さらに、がん、糖尿病、乾癬、関節リウマチの治療にバイオ医薬品の利用が増加していることも、成長を促す大きな要因となっています。さらに、バイオ医薬品の有効性と入手可能性に関する大衆の意識の高まりも、成長を促す大きな要因となっています。さらに、希少疾患やオーファンドラッグへの注目の高まりも市場の成長を後押ししています。これらの希少疾患は、患者数が少ないという特徴を持つことが多く、アンメット・メディカル・ニーズが大きいです。このほか、世界各国の政府や規制当局は、これらの疾患に対する治療法の開発を奨励するため、インセンティブを導入し、規制プロセスを合理化しています。さらに、バイオ医薬品企業は希少疾病をターゲットとするオーファンドラッグを開発するための研究開発に投資しており、これにより重要な医療ニーズに対応し、市場拡大の機会を創出しています。
個別化医療への需要の高まり
個別化医療により、バイオ医薬品市場は標的治療や精密医療へのアプローチへとシフトしています。バイオ医薬品企業は、疾患に関連する特定の遺伝子変異、バイオマーカー、分子経路を標的とする治療法の開発にますます注力するようになっています。さらに、個別化医療は、個人の遺伝的体質が薬物反応にどのように影響するかを研究する薬理ゲノミクスの進歩につながっています。薬物の代謝、有効性、安全性に影響を与える遺伝的変異を理解することで、副作用のリスクがある患者や、特定の治療法に良好な反応を示す可能性が高い患者を特定することができます。この知識により、バイオ医薬品企業は個々の患者に合わせた標的療法や投与レジメンを開発し、治療効果を高め、有害事象のリスクを低減することができます。
慢性疾患と生活習慣病の蔓延
心血管疾患、糖尿病、がん、呼吸器疾患、自己免疫疾患などの慢性疾患は、世界の健康上の大きな課題となっています。これらの疾患は多くの場合、複雑な基礎メカニズムを有しており、標的を絞った個別化治療アプローチが必要とされます。モノクローナル抗体、組換え蛋白質、遺伝子治療などのバイオ医薬品は、正確な標的を定め、オーダーメイドの治療オプションを提供します。これらの治療法は、慢性疾患に関連する特定の分子経路、受容体、細胞を標的とすることができ、その結果、有効性が向上し、副作用が軽減されます。さらに、慢性疾患や生活習慣病による負担の増加により、対症療法から疾患の改善や予防に焦点が移りつつあり、これも市場の成長を後押ししています。
バイオテクノロジーにおける様々な進歩
バイオテクノロジーは創薬・開発プロセスを大幅に加速させています。ハイスループットスクリーニング、コンビナトリアルケミストリー、計算モデリングなどの高度な技術により、短期間で多数の薬剤候補を同定し、試験することが可能になった。これにより、創薬の効率とスピードが向上し、バイオ医薬品企業は新しい治療法をより迅速に市場に投入できるようになった。その上、個人の遺伝的体質を分析し、疾患マーカーを特定し、分子経路を理解する能力は、特定の患者集団に合わせた標的療法の開発を可能にしています。ゲノミクス、次世代シーケンシング、遺伝子編集技術などのバイオテクノロジー・ツールは、疾病メカニズムの理解に革命をもたらし、特定の遺伝的変異や分子標的に対処する治療法の開発を可能にしたため、市場を牽引しています。
The global biopharmaceutical market size reached US$ 300.5 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 643.9 Billion by 2032, exhibiting a growth rate (CAGR) of 8.6% during 2024-2032. The escalating demand for personalized medicines, the growing prevalence of chronic and lifestyle-related diseases, and rapid advancements in biotechnology, including genetic engineering and recombinant DNA technology, are among the key factors driving the market growth.
Biopharmaceuticals, also known as biologics, are a class of pharmaceutical drugs derived from biological sources. They are produced using living organisms, such as bacteria, yeast, or mammalian cells, through biotechnological processes. Unlike traditional small-molecule drugs, which are chemically synthesized, biopharmaceuticals are large, complex molecules that exhibit highly specific interactions with biological targets in the body. They offer several advantages over traditional pharmaceuticals. They tend to be highly specific in their action, often targeting specific receptors or molecules, resulting in increased efficacy and reduced side effects. Additionally, biopharmaceuticals have the potential to treat diseases that were previously challenging to address using conventional drugs.
The market is experiencing significant growth due to the escalating demand for personalized medicine. In addition, the increasing utilization of biopharmaceuticals to treat cancer, diabetes, psoriasis, and rheumatoid arthritis represents another major growth-inducing factor. Besides, the growing awareness among the masses regarding the effectiveness and availability of biopharmaceuticals represents another major growth-inducing factor. Moreover, the rising focus on rare diseases and orphan drugs is driving the growth of the market. These rare diseases, often characterized by small patient populations, present significant unmet medical needs. Other than this, governments and regulatory agencies worldwide have introduced incentives and streamlined regulatory processes to encourage the development of therapies for these conditions. Moreover, biopharmaceutical companies are investing in R&D to develop orphan drugs, which target rare diseases, thereby addressing critical medical needs and creating opportunities for market expansion.
The escalating demand for personalized medicine
Personalized medicine has led to a shift toward targeted therapies and precision medicine approaches in the biopharmaceutical market. Biopharmaceutical companies are increasingly focusing on the development of therapies that target specific genetic mutations, biomarkers, or molecular pathways associated with diseases. Moreover, personalized medicine has led to advancements in pharmacogenomics, which is the study of how an individual's genetic makeup influences their response to drugs. Understanding the genetic variations that impact drug metabolism, efficacy, and safety allows for the identification of patients who may be at risk of adverse reactions or those who are more likely to respond favorably to a specific treatment. This knowledge enables biopharmaceutical companies to develop targeted therapies and dosage regimens tailored to individual patients, enhancing treatment effectiveness and reducing the risk of adverse events.
The growing prevalence of chronic and lifestyle-related diseases
Chronic diseases, including cardiovascular disorders, diabetes, cancer, respiratory diseases, and autoimmune conditions, have become major global health challenges. These diseases often have complex underlying mechanisms, requiring targeted and personalized treatment approaches. Biopharmaceuticals, such as monoclonal antibodies, recombinant proteins, and gene therapies, offer precise targeting and tailored treatment options. These therapies can target specific molecular pathways, receptors, or cells associated with chronic diseases, resulting in enhanced efficacy and reduced side effects. Moreover, the increasing burden of chronic and lifestyle-related diseases has shifted the focus from symptomatic relief to disease modification and prevention, which is also propelling the market growth.
Various advancements in biotechnology
Biotechnology has greatly accelerated the drug discovery and development process. Advanced techniques, such as high-throughput screening, combinatorial chemistry, and computational modeling, enable the identification and testing of a large number of drug candidates in a shorter time frame. This has led to an increase in the efficiency and speed of drug discovery, allowing biopharmaceutical companies to bring new therapies to market more rapidly. Besides, the ability to analyze an individual's genetic makeup, identify disease markers, and understand molecular pathways has enabled the development of targeted therapies tailored to specific patient populations. Biotechnology tools, such as genomics, next-generation sequencing, and gene editing techniques, have revolutionized the understanding of disease mechanisms and enabled the development of therapies that address specific genetic variations and molecular targets, thus propelling the market.
IMARC Group provides an analysis of the key trends in each segment of the global biopharmaceutical market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on indication and class.
Autoimmune Diseases
Oncology
Metabolic Disorders
Others
Autoimmune diseases represent the leading segment
The report has provided a detailed breakup and analysis of the market based on the indication. This includes autoimmune diseases, oncology, metabolic disorders, and others. According to the report, autoimmune diseases represented the largest segment.
Autoimmune diseases are often chronic and complex conditions that require long-term management and treatment. These diseases can affect multiple organs and systems in the body, leading to a wide range of symptoms and complications. Biopharmaceutical therapies have shown promising results in managing and controlling autoimmune diseases, providing relief from symptoms, slowing disease progression, and improving quality of life for patients. Therapies, including monoclonal antibodies and other biologics, have emerged as a vital treatment option for autoimmune diseases. They target specific molecules, cells, or pathways involved in the autoimmune response, providing more precise and effective therapeutic interventions.
Recombinant Proteins
Monoclonal Antibodies
Purified Proteins
Monoclonal antibodies exhibit a clear dominance in the market
A detailed breakup and analysis of the market based on the class has also been provided in the report. This includes recombinant proteins, monoclonal antibodies, and purified proteins. According to the report, monoclonal antibodies accounted for the largest market share.
Monoclonal antibodies are highly specific in targeting disease-specific antigens or cells. They are designed to bind to a specific target with precision, minimizing off-target effects and reducing the risk of adverse reactions. This specificity contributes to their efficacy in treating various diseases, including autoimmune disorders, cancer, inflammatory conditions, and infectious diseases. They also have a wide range of therapeutic applications across different disease areas. They can be used as therapeutic agents on their own or in combination with other treatments. Monoclonal antibodies have been successful in neutralizing pathogens, blocking cell receptors, modulating immune responses, and delivering therapeutic payloads, making them versatile tools for disease management.
North America
United States
Canada
Latin America
Mexico
Brazil
Argentina
Europe
Germany
France
Italy
Spain
United Kingdom
Russia
Turkey
Asia Pacific
Japan
China
Australia
South Korea
India
Indonesia
North America accounts for the majority of market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Latin America (Mexico, Brazil, and Argentina); Europe (Germany, France, Italy, Spain, the United Kingdom, Russia, and Turkey); and Asia Pacific (Japan, China, Australia, South Korea, India, and Indonesia). According to the report, North America was the largest market for biopharmaceuticals.
North America, particularly the United States, boasts a highly developed healthcare infrastructure, including robust research and development capabilities, advanced clinical facilities, and a strong regulatory framework. The region is home to renowned academic institutions, pharmaceutical companies, and research organizations that drive innovation in the biopharmaceutical industry. The presence of these institutions and infrastructure facilitates the development, manufacturing, and commercialization of biopharmaceutical products. The region has a well-established ecosystem that supports biopharmaceutical innovation, including government funding initiatives, research grants, venture capital investments, and collaborations between academia, industry, and research institutes.
The competitive landscape of the biopharmaceutical market is highly dynamic and competitive, with numerous global and regional players vying for market share. Nowadays, leading biopharmaceutical companies are heavily investing in R&D to discover and develop innovative therapies. They are conducting preclinical and clinical trials, and advance promising candidates through the regulatory approval process. These investments aim to expand their product pipelines, address unmet medical needs, and stay ahead of competitors in terms of therapeutic advancements. They are also forming strategic partnerships and collaborations with academic institutions, research organizations, and other industry players. These alliances enable them to access new technologies, scientific expertise, and complementary resources.
AbbVie Inc.
Amgen Inc
Biogen Inc.
Eli Lilly and Company
F. Hoffmann-La Roche AG
Johnson & Johnson
Merck & Co. Inc.
Novo Nordisk A/S
Pfizer Inc.
Sanofi S.A
Pfizer and BioNTech developed and distributed their mRNA-based COVID-19 vaccine, Comirnaty (BNT162b2). The vaccine received emergency use authorizations and has been widely deployed globally, playing a crucial role in combating the COVID-19 pandemic.
Amgen Inc. recently received FDA approval for Lumakras (sotorasib), a targeted therapy for non-small cell lung cancer (NSCLC) with specific genetic mutations.
AbbVie Inc. has made significant advancements in immunology, particularly with its flagship product, Humira (adalimumab). Humira is one of the world's best-selling biologic drugs used to treat autoimmune conditions, including rheumatoid arthritis, psoriasis, and Crohn's disease.