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市場調査レポート
商品コード
1417589
生物学的製剤の世界市場の評価:製品別、用途別、医薬品分類別、購入方式別、流通チャネル別、地域別、機会、予測(2017年~2031年)Biologics Market Assessment, By Product By Application By Drug Classification, By Mode of Purchase By Distribution Channel By Region, Opportunities and Forecast, 2017-2031F |
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カスタマイズ可能
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生物学的製剤の世界市場の評価:製品別、用途別、医薬品分類別、購入方式別、流通チャネル別、地域別、機会、予測(2017年~2031年) |
出版日: 2024年01月29日
発行: Market Xcel - Markets and Data
ページ情報: 英文 242 Pages
納期: 3~5営業日
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世界の生物学的製剤の市場規模は、2023年に4,013億4,000万米ドル、2031年に6,957億9,000万米ドルに達し、2024年~2031年の予測期間にCAGRで7.12%の成長が見込まれています。慢性疾患の罹患率と診断の増加は、先進の診断と治療薬に対する大きな需要を生み出し、結果として世界の生物学的製剤市場を後押ししています。このような特殊な医薬品は、炎症を引き起こす免疫系の特定の成分を標的とするように遺伝子改変されています。COVID-19疾患の登場に伴い、世界各国の政府は医療産業を強化し、生物学的製剤の利用可能性を確保するための対策を講じています。
同時に、科学者や研究者は生物学的製剤の効率を高めるために、さまざまな生物種や発現系を模索しています。さらに、多くの製薬企業が関節炎の経口薬の効果を高めることを目的とした研究開発に取り組んでいます。低分子医薬品の研究開発における生産性が低下していることから、生物学的製剤市場の大幅な躍進が今後数年に予測されます。これらの製薬企業は、市場での優位性を維持するために、さまざまな生物学的製剤の開発を積極的に進めています。クローン病や関節リウマチのような疾患向けの経口薬がより効果的になるにつれて、より多くの中等症患者が新たにブランド化された治療薬に移行すると予測されます。さらに、これらの新たな化合物は、従来の治療に抵抗を示していた患者に代替の治療法を提供し、多くの場合、優れた安全性と有効性を示します。
世界の生物学的製剤市場は、慢性疾患の高い有病率によって大きな影響を受けています。がん、糖尿病、自己免疫疾患、心血管疾患などの慢性疾患は、世界的にますます流行しています。生物由来の医薬品である生物学的製剤は、これらの疾患の多くに対する重要な治療オプションとして浮上しています。これらの複雑な分子は標的療法を提供し、多くの場合、従来の医薬品よりも副作用が少なく、有効性が高いです。
例えば、世界保健機関(WHO)が2023年9月に発表したレポートによると、非感染性疾患(NCDs)で命を落とす人は年間約4,100万人で、これは世界の総死亡者数の74%に相当します。毎年、およそ1,700万人が70歳になる前にNCDsで命を落としており、これらの早すぎる死亡の86%は世界規模で発生しています。世界では毎年4,100万人以上が慢性疾患で命を落としています。なかでも、心血管疾患が年間1,790万人の死亡をもたらし、次いでがん、糖尿病、呼吸器疾患となっています。これら4つのカテゴリを合わせると、慢性疾患による死亡者数の80%を占めます。慢性疾患の流行が、診断と治療の進歩に拍車をかけています。
市場の拡大は、研究開発活動の重視の高まりによって推進されており、生物学的製剤市場の成長に有利な見通しをもたらすと予測されています。さらに、科学者や研究者は生物学的製剤の生産性を高めるため、さまざまな生物種や発現系を探索しています。いくつかの製薬企業は、関節リウマチやクローン病などの症状に対する経口薬の有効性を改善することを目的とした研究開発活動に従事しています。さらに、医薬品の承認や導入の加速も、市場の成長軌道を後押ししています。
例えば、2023年1月、レカネマブは米国FDAの早期承認経路を介してアルツハイマー病治療薬として承認されました。2022年6月にはAlnylamが、遺伝性トランスサイレチンを介するアミロイドーシスに伴う多発性神経障害の治療を目的としたRNAi治療薬アムヴトラのFDA承認を取得しました。
世界の生物学的製剤市場は主要企業による投資の急増が続いており、これはこの部門の成長と可能性を示しています。主要製薬企業、バイオテクノロジー企業、研究機関は、生物学的製剤の研究開発と製造に多額の投資を行っています。こうした資金投入の目的は、イノベーションの強化、製品ポートフォリオの拡充、製造技術の向上であり、最終的に先進の個別化医療ソリューションへの需要の高まりに応えるものです。
競合情勢は急速に進化しており、各社はがん、自己免疫疾患、感染症など多様な治療領域に焦点を当て、新たな生物学的製剤の導入を計画しています。投資動向の拡大は、世界の医療課題に対する画期的な進歩や治療オプションの向上を促進し、市場の有望な将来性に対する業界の自信を示すものです。
当レポートでは、世界の生物学的製剤市場について調査分析し、市場規模と予測、市場力学、主要企業情勢と見通しなどを提供しています。
Global biologics market size was valued at USD 401.34 billion in 2023, and is expected to reach USD 695.79 billion in 2031, with a CAGR of 7.12% for the forecast period between 2024 and 2031F. The increasing incidence and diagnosis of chronic diseases have created a significant demand for advanced diagnostics and treatment medications, consequently propelling the global biologics market. These specialized drugs have been genetically altered to target specific components of the immune system that trigger inflammation. With the emergence of coronavirus diseases, governments worldwide are taking measures to fortify the healthcare industry and ensure the availability of biologics.
Simultaneously, scientists and researchers are exploring different species and expression systems to enhance the efficiency of biological products. Moreover, numerous pharmaceutical companies are engaged in research and development efforts aimed at enhancing the effectiveness of oral medications for arthritis. Given the decline in productivity in small molecule medication research and development, a substantial surge in the biologics market is anticipated in the coming years. These pharmaceutical firms are actively pursuing the development of various biologic medications to sustain their market dominance. As oral medications for conditions like Crohn's disease and rheumatoid arthritis become more effective, it is predicted that a larger number of moderately affected patients will transition towards newly branded therapies. Additionally, these new compounds provide therapeutic alternatives for patients who have previously shown resistance to traditional treatments, often displaying superior safety and efficacy.
The global biologics market is witnessing a significant impact due to the high prevalence of chronic diseases. Chronic conditions like cancer, diabetes, autoimmune disorders, and cardiovascular diseases are increasingly becoming prevalent globally. Biologics, which are medicinal products derived from living organisms, have emerged as a critical treatment option for many of these conditions. These complex molecules offer targeted therapies, often with fewer side effects and greater efficacy than traditional pharmaceuticals.
For instance, as per the World Health Organization's report in September 2023, approximately 41 million individuals succumb annually to non-communicable diseases (NCD), representing 74% of the total global deaths. Each year, roughly 17 million people perish from NCDs before reaching the age of 70, with 86% of these untimely fatalities occurring on a global scale. Over 41 million individuals globally succumb to chronic diseases annually. Among these, cardiovascular disease leads, causing 17.9 million deaths per year, followed by cancer, diabetes, and respiratory disorders. Together, these four categories account for 80% of all fatalities attributed to chronic diseases. The prevalence of chronic diseases has spurred the advancement of diagnostics and treatments. Biologics, genetically engineered medications, and target specific components of the immune system are responsible for inflammation.
The expansion of the market is being driven by the increasing emphasis on research and development activities, which is expected to create advantageous prospects for biologics market growth. Moreover, scientists and researchers are exploring various species and expression systems to enhance the productivity of biological products. Several pharmaceutical companies are engaged in research and development activities aimed at improving the effectiveness of oral medications for conditions like rheumatoid arthritis and Crohn's disease. Furthermore, the escalating rate of drug approvals and introductions will continue to accelerate the growth trajectory of the market.
For instance, as an example, in January 2023, Lecanemab received approval from the U.S. FDA via its accelerated approval pathway, specifically intended for addressing Alzheimer's Disease. In June 2022, Alnylam Pharmaceuticals, Inc. obtained FDA approval for its RNAi therapeutic, AMVUTTRA, designed for treating the Polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.
The global biologics market continues to witness a surge in investments by key players, indicative of the sector's growth and potential. Major pharmaceutical companies, biotech firms, and research institutions are channeling substantial investments into research, development, and manufacturing of biologics. The financial commitment aims to bolster innovation, expand product portfolios, and enhance manufacturing technologies, ultimately meeting the rising demand for advanced and personalized healthcare solutions.
The competitive landscape is evolving rapidly as companies are planning to introduce novel biologics, focusing on diverse therapeutic areas like oncology, autoimmune diseases, and infectious diseases. The growing investment trend signifies the industry's confidence in the market's promising future, fostering groundbreaking advancements and improved treatment options for global healthcare challenges. For Instance, in March 2023, Novartis announced the intention of its division, Sandoz to allocate roughly USD 400 million towards establishing a biologics manufacturing plant situated in Slovenia. During March 2023, Eli Lilly disclosed its proposal to invest USD 500 million into expanding its current 500,000 sq. ft. biologics manufacturing site in Limerick.
The global biologics market has witnessed remarkable technological advancements, revolutionizing the landscape of medicine and healthcare. Innovations in biotechnology, particularly in areas like genetic engineering, monoclonal antibodies, and recombinant DNA technology, have significantly enhanced the development and production of biologics industry.
Advanced techniques in cell culture systems, gene editing (like CRISPR), and bioprocessing have streamlined the manufacturing of complex biological molecules. Furthermore, the emergence of personalized medicine has driven a shift towards more tailored and effective treatments, utilizing biologics designed to target specific patient populations. The progress has led to the development of novel biologics, including therapeutic proteins, vaccines, and monoclonal antibodies, fostering breakthroughs in treating various diseases like cancer, autoimmune disorders, and infectious diseases.
For Instance, in February 2022 CARVYKTI, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson obtained approval from the US Food and Drug Administration (FDA) for sale. The biologic medication is designated for individuals with relapsed or refractory multiple myeloma (RRMM) who have undergone four prior lines of therapy, which may include proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody treatments.
The COVID-19 pandemic had a significant impact on the global biologics market. Biologics are complex, large-molecule drugs used to treat a variety of diseases, including autoimmune disorders, cancer, and infectious diseases. The pandemic disrupted supply chains and manufacturing processes, leading to production delays and shortages of some biologics. Additionally, the increased focus on vaccine development and monoclonal antibody therapies to combat the virus diverted resources and attention from other biologic drug development efforts.
On the contrary, the pandemic has highlighted the importance of biotechnology and accelerated innovation in the field. The rapid development of mRNA vaccines, such as the Pfizer-BioNTech and Moderna vaccines, showcased the potential of biologics in responding to infectious diseases. Furthermore, the pandemic has driven investment in research and development of biologics, leading to advancements in bioprocessing and manufacturing technologies. During April 2022, GSK, a British multinational pharmaceutical and biotechnology company, together with SK bioscience, presented a biologics license application for SKYCovione, a COVID-19 vaccine candidate based on recombinant proteins, to the Korean Ministry of Food and Drug Safety (KMFDS).
Prominent industry stakeholders are allocating significant funds to research and development endeavors, aiming to diversify their product portfolios, thereby stimulating the expansion of the global biologics market. The market participants are implementing various strategic measures to enhance their global presence, including pivotal actions such as launching new products, engaging in mergers and acquisitions, forming contractual agreements, amplifying investments, and fostering collaborations with other organizations. In the competitive landscape of the biologics sector, companies must provide cost-effective offerings to broaden their scope and endure in an intensifying, competitive, and burgeoning market environment.
For Instance, the FDA granted approval to Leqembi (lecanemab-irmb) through the Accelerated Approval pathway in January 2023 for addressing Alzheimer's disease. The medication diminishes amyloid-B plaques and moderately retards mild cognitive decline in individuals with early-stage Alzheimer's disease.
All segments will be provided for all regions and countries covered:
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.