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タンパク質治療市場レポート:製品、治療領域、機能、地域別、2024~2032年Protein Therapeutics Market Report by Product (Monoclonal Antibodies, Human Insulin, Erythropoietin, Clotting Factors, Fusion Protein, and Others), Therapy Area, Function, and Region 2024-2032 |
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タンパク質治療市場レポート:製品、治療領域、機能、地域別、2024~2032年 |
出版日: 2024年08月10日
発行: IMARC
ページ情報: 英文 136 Pages
納期: 2~3営業日
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世界のタンパク質治療市場規模は2023年に3,456億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに6,035億米ドルに達し、2024~2032年の間に6.2%の成長率(CAGR)を示すと予測しています。がん、糖尿病、心血管疾患、自己免疫疾患などの慢性疾患の有病率の増加、タンパク質工学の急速な技術進歩、バイオ医薬品産業の拡大、多様な治療領域における製品の広範な応用は、市場を推進しているいくつかの要因です。
タンパク質治療は、病気の予防、管理、治療のためにタンパク質やペプチドを利用する治療法の一種です。これらの治療は、体内の特定の分子や経路を標的とするように設計されており、高度に的を絞った治療アプローチを記載しています。がん、自己免疫疾患、遺伝病など、幅広い疾患に対する革新的な解決策を記載しています。治療用蛋白質は天然由来のものから、あるいは組み換えDNA技術によって製造されたものまであり、非常に特異的で強力な治療法の開発を可能にしています。これらの治療用タンパク質は、モノクローナル抗体、成長因子、酵素、サイトカインなど様々な形態をとることができます。それらは体内の特定のレセプターや分子と相互作用し、細胞プロセスを調節したり、免疫反応を抑制・刺激したり、病気の原因物質を直接標的にしたりします。タンパク質治療の利点は、その高い特異性、効力、低毒性にあります。従来の低分子医薬品に比べ、有効性が向上し、副作用が少ないことが多いです。タンパク質治療は、様々な疾患において新たな治療選択肢を提供し、患者の転帰を改善することで、医療セグメントを大きく発展させてきました。
世界市場を大きく牽引しているのは、個別化医療への注目の高まりです。これに伴い、研究開発活動の活発化と医療インフラの拡大が市場に大きく寄与しています。さらに、製造プロセスの進歩が市場を活性化すると予想されます。これとは別に、遺伝子工学、タンパク質合成、生産技術における画期的な進歩は、タンパク質治療の効率性と有効性を高め、市場にプラスの影響を与えています。さらに、がん、糖尿病、心血管障害、自己免疫疾患などの慢性疾患の有病率の増加が市場を活性化しています。さらに、腫瘍学におけるタンパク質治療の広範な応用が市場を刺激しています。さらに、ドラッグデリバリーシステムの急速な技術革新により、タンパク質治療の送達が改善され、その有効性と患者のコンプライアンスが向上しています。徐放性製剤、ナノ粒子、標的ドラッグデリバリーシステムなどの新しいデリバリー方法は、タンパク質医薬品の治療可能性を高めることで市場の成長を促進しています。
バイオ医薬品研究開発投資の拡大
バイオ医薬品企業や研究機関は、その特異性、有効性、標的性の高さから、タンパク質ベースの医薬品開発にますます注力するようになっています。バイオ医薬品セクターにおける研究開発投資の増加は、タンパク質治療の進歩に拍車をかけています。これらの投資は、タンパク質工学、創薬、製剤最適化に関する研究活動を支援し、新規かつ改良されたタンパク質治療の開発につながります。さらに、研究開発に充てられる多額の資金により、研究者は新たな治療標的を探索し、活性を高めるためにタンパク質構造を最適化し、大規模な前臨床試験や臨床試験を実施することができます。こうした努力は、様々な疾患に対する革新的な治療を導入することで市場の拡大に貢献しています。さらに、研究開発投資の拡大により、タンパク質治療の生産プロセスのスケールアップが促進され、より利用しやすく費用対効果の高いものとなっています。これにより、タンパク質ベースの医薬品の商業化と市場浸透が進みます。
バイオシミラーの拡大
バイオシミラー市場の拡大は市場に大きく貢献しています。バイオシミラーとは、承認された参照タンパク質治療と類似性の高い生物製剤のことです。いくつかの大ヒット生物製剤の特許が切れるにつれて、バイオシミラー市場は急速に拡大しています。バイオシミラーが利用可能になると、高価なタンパク質治療に代わる費用対効果の高い代替品が提供され、患者や医療システムにとってより利用しやすくなります。この手頃な価格の増加は、必要な治療への患者のアクセスを向上させ、市場の成長を促進します。さらに、バイオシミラーの採用は市場競争を促進します。競争は価格の引き下げにつながり、市場の拡大を促すとともに、バイオシミラーメーカーや参照蛋白質治療メーカーに製品の革新と改良の機会をもたらします。さらに、バイオシミラーに関する規制の枠組みやガイドラインが確立され、合理化されたことで、バイオシミラーの開発と承認に明確な道筋が示されるようになりました。その結果、医療関係者の信頼が高まり、バイオシミラーの採用が増加しています。バイオシミラー市場が拡大するにつれ、タンパク質治療の研究開発努力がさらに刺激されます。メーカーはより高度で差別化されたバイオシミラーの開発に努め、市場に明るい展望をもたらしています。
高齢化人口の増加
高齢化人口の増加は、市場にプラスの影響を与えています。世界人口の高齢化に伴い、アルツハイマー病、パーキンソン病、黄斑変性症、骨粗鬆症など、加齢に関連する疾患や症状の有病率が高くなっています。タンパク質治療は、高齢化社会が直面するこれらの特定の健康課題に対処するために開発・利用されています。さらに、タンパク質治療は、加齢に関連した疾患に対する標的治療の選択肢を提供し、従来の治療法に比べて有効性の向上と副作用の軽減を実現します。特定の分子経路を標的とし、これらの疾患の根本的なメカニズムに対処することで、患者の転帰と生活の質を改善することができます。さらに、高齢化社会における製品需要の増加が、市場成長の原動力となっています。製薬会社や研究機関は、この層の特定のニーズを満たすため、新規タンパク質治療の開発に投資しています。さらに、高齢化人口の増加はタンパク質治療の市場を拡大させ、メーカーに製品ポートフォリオの拡大と増産を促しています。その結果、タンパク質治療の入手可能性が広がり、市場の成長がさらに促進されることになります。
The global protein therapeutics market size reached US$ 345.6 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 603.5 Billion by 2032, exhibiting a growth rate (CAGR) of 6.2% during 2024-2032. The increasing prevalence of chronic diseases such as cancer, diabetes, cardiovascular diseases, and autoimmune disorders, the rapid technological advancements in protein engineering, the expanding biopharmaceutical industry, and the widespread product applications in diverse therapeutic areas are some factors propelling the market.
Protein therapeutics is a class of medical treatments utilizing proteins or peptides to prevent, manage, or cure diseases. These therapeutics are designed to target specific molecules or pathways within the body, providing a highly targeted approach to treatment. They offer innovative solutions for a wide range of conditions, including cancer, autoimmune disorders, genetic diseases, and more. They can be derived from natural sources or produced through recombinant DNA technology, allowing for the development of highly specific and potent therapies. These therapeutic proteins can take various forms, including monoclonal antibodies, growth factors, enzymes, and cytokines. They interact with specific receptors or molecules in the body, modulating cellular processes, inhibiting or stimulating immune responses, or directly targeting disease-causing agents. The advantages of protein therapeutics lie in their high specificity, potency, and low toxicity. They often offer improved efficacy and fewer side effects than traditional small-molecule drugs. They have significantly advanced the field of medicine, providing novel treatment options and improving patient outcomes across various diseases.
The global market is majorly driven by the increasing focus on personalized medicine. In line with this, the rising research and development activities and the expanding healthcare infrastructure are significantly contributing to the market. Furthermore, the advancements in manufacturing processes are expected to fuel the market. Apart from this, the breakthroughs in genetic engineering, protein synthesis, and production technologies have enhanced the efficiency and effectiveness of protein therapeutics, positively influencing the market. Moreover, the growing prevalence of chronic diseases such as cancer, diabetes, cardiovascular disorders, and autoimmune diseases is catalyzing the market. Besides, the widespread applications of protein therapeutics in oncology are stimulating the market. Additionally, the rapid innovations in drug delivery systems have improved the delivery of protein therapeutics, enhancing their efficacy and patient compliance. Novel delivery methods such as sustained-release formulations, nanoparticles, and targeted drug delivery systems are driving the market growth by increasing the therapeutic potential of protein drugs.
Growing biopharmaceutical research and development investments
Biopharmaceutical companies and research institutions are increasingly focusing on the development of protein-based drugs due to their high specificity, efficacy, and targetability. The rise in R&D investments in the biopharmaceutical sector is fueling advancements in protein therapeutics. These investments support research activities related to protein engineering, drug discovery, and formulation optimization, leading to the development of novel and improved protein therapeutics. Furthermore, the substantial funds allocated to R&D enable researchers to explore new therapeutic targets, optimize protein structures for enhanced activity, and conduct extensive preclinical and clinical trials. These efforts contribute to the expansion of the market by introducing innovative treatments for various diseases. Moreover, the growing R&D investments facilitate the scaling-up of production processes for protein therapeutics, making them more accessible and cost-effective. This enables increased commercialization and market penetration of protein-based drugs.
Expansion of biosimilars
The expansion of the biosimilars market is significantly contributing to the market. Biosimilars are biologic drugs that are highly similar to approved reference protein therapeutics. As patents for several blockbuster biologics expire, the market for biosimilars is expanding rapidly. The availability of biosimilars provides cost-effective alternatives to expensive protein therapeutics, making them more accessible to patients and healthcare systems. This increased affordability enhances patient access to necessary treatments, driving market growth. Furthermore, the introduction of biosimilars fosters competition in the market. Competition leads to price reductions, encouraging market expansion and creating opportunities for biosimilar manufacturers and reference protein therapeutics companies to innovate and improve their products. Moreover, the regulatory frameworks and guidelines for biosimilars have become more established and streamlined, providing a clear pathway for their development and approval. This has instilled confidence in the healthcare community and resulted in increased biosimilar adoption. As the biosimilars market expands, it stimulates further research and development efforts in protein therapeutics. Manufacturers strive to develop more advanced and differentiated biosimilars, creating a positive outlook for the market.
Rising aging population
The rising aging population is positively influencing the market. As the global population ages, there is a higher prevalence of age-related diseases and conditions such as Alzheimer's disease, Parkinson's disease, macular degeneration, and osteoporosis. Protein therapeutics are being developed and utilized to address these specific health challenges the aging population faces. Furthermore, protein therapeutics offer targeted treatment options for age-related diseases, providing improved efficacy and reduced side effects as compared to traditional therapies. They can target specific molecular pathways and address the underlying mechanisms of these diseases, thereby improving patient outcomes and quality of life. Moreover, the increasing product demand among the aging population is driving market growth. Pharmaceutical companies and research institutions are investing in the development of novel protein therapeutics to meet the specific needs of this demographic. Additionally, the growing aging population creates a larger market for protein therapeutics, prompting manufacturers to expand their product portfolios and increase production. This, in turn, leads to a wider availability of protein therapeutics and further drives market growth.
IMARC Group provides an analysis of the key trends in each segment of the global protein therapeutics market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on product, therapy area, and function.
Monoclonal Antibodies (mAbs)
Human Insulin
Erythropoietin
Clotting Factors
Fusion Protein
Others
Monoclonal Antibodies (mAbs) dominates the market
The report has provided a detailed breakup and analysis of the market based on product. This includes monoclonal antibodies (mAbs), human insulin, erythropoietin, clotting factors, fusion protein, and others. According to the report, monoclonal antibodies (mAbs) represented the largest segment.
Monoclonal antibodies (mAbs) are extensively used to treat cancer, autoimmune disorders, and inflammatory diseases. The increasing prevalence of these conditions, coupled with advancements in antibody engineering and production technologies, drives the demand for mAbs and contributes to the market growth.
On the other hand, human insulin is a vital protein therapeutic for managing diabetes. With the rising incidence of diabetes worldwide, the demand for insulin and insulin analogs is increasing, leading to market growth in this segment. Moreover, erythropoietin (EPO) is another important therapeutic protein stimulating red blood cell production. It is used to treat anemia, particularly in patients with chronic kidney disease and cancer undergoing chemotherapy. The expanding patient pool requiring EPO therapy is driving the growth of this segment.
Besides this, the clotting factors are proteins essential for blood clotting. They are used to manage bleeding disorders such as hemophilia. The growing awareness, diagnosis, and treatment of hemophilia fuel the demand for clotting factors and contribute to the market. In addition, fusion proteins, which combine two or more functional protein domains, have gained significant attention in the development of innovative therapeutics. They offer unique treatment approaches for various diseases, including cancer and autoimmune disorders, thus driving the market in this segment.
Metabolic Disorders
Immunological Disorders
Hematological Disorders
Cancer
Hormonal Disorders
Genetic Disorders
Others
Metabolic Disorders holds the largest share of the market
A detailed breakup and analysis of the market based on the therapy area have also been provided in the report. This includes metabolic disorders, immunological disorders, hematological disorders, cancer, hormonal disorders, genetic disorders, and others. According to the report, metabolic disorders accounted for the largest market share.
Metabolic disorders encompass conditions such as diabetes, obesity, and hypercholesterolemia. Protein therapeutics, such as insulin for diabetes management, are crucial in treating and controlling these disorders. The rising prevalence of metabolic disorders, coupled with the increasing demand for targeted and effective treatments, is driving the growth of the market in this segment.
On the contrary, immunological disorders, including autoimmune diseases and inflammatory conditions, represent another significant therapy area for protein therapeutics. Monoclonal antibodies and other protein-based drugs modulate the immune system and target specific disease pathways. The growing incidence of immunological disorders and the expanding range of approved protein therapeutics for these conditions are driving the market.
In addition, cancer remains one of the primary drivers of the market. Protein-based therapies, including monoclonal antibodies, antibody-drug conjugates, and immune checkpoint inhibitors, have revolutionized cancer treatment. The increasing incidence of cancer globally, coupled with the development of targeted therapies and immunotherapies, is propelling the growth of the market in oncology.
Enzymatic and Regulatory Activity
Special Targeting Activity
Vaccines
Protein Diagnostics
A detailed breakup and analysis of the market based on the function have also been provided in the report. This includes enzymatic and regulatory activity, special targeting activity, vaccines, and protein diagnostics.
Protein therapeutics with enzymatic and regulatory activity are vital in modulating biological processes and metabolic pathways. These proteins act as enzymes, receptors, or signaling molecules, offering therapeutic benefits in various diseases. The development of novel protein therapeutics with specific enzymatic or regulatory functions drives market growth in this segment.
Furthermore, special targeting activity refers to protein therapeutics targeting certain cells, tissues, or molecular targets. Monoclonal antibodies and antibody-drug conjugates are examples of protein therapeutics with special targeting activity. They can precisely recognize and bind to specific molecules or cells, providing highly targeted therapies. The increasing demand for targeted treatments in conditions such as cancer and autoimmune diseases fuels the growth of protein therapeutics in this segment.
Moreover, vaccines are another significant segment in the market. Protein-based vaccines utilize specific proteins or peptides to stimulate an immune response and confer immunity against infectious diseases. The global focus on vaccination programs, the emergence of new infectious diseases, and the need for improved vaccine technologies drive market growth in this segment.
Besides, protein diagnostics involves using proteins or protein-based assays for diagnostic purposes. These diagnostics can detect specific proteins or biomarkers associated with diseases, aiding in early detection, disease monitoring, and personalized treatment. The growing demand for accurate and reliable diagnostic tools fuels the growth of protein diagnostics and contributes to the overall 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 protein therapeutics 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); 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.
North America, particularly the United States, holds a significant market share. The region benefits from advanced healthcare infrastructure, a strong presence of biopharmaceutical companies, and robust research and development activities. The presence of key players and extensive investments in protein therapeutics research contribute to market growth in North America. Additionally, the high prevalence of chronic diseases, a large aging population, and favorable reimbursement policies further drive the market in the region.
On the other hand, Asia Pacific is emerging as a rapidly growing market. The region has a large population base, increasing healthcare expenditure, and a rising prevalence of chronic diseases. Countries such as China, Japan, and India are witnessing substantial growth in the biopharmaceutical industry and investing in research and development. Moreover, the increasing awareness of personalized medicine and growing demand for cost-effective treatment options are driving the adoption of protein therapeutics in Asia Pacific.
Top companies are investing heavily in scientific research to identify new therapeutic targets and develop protein-based drugs with enhanced efficacy and safety profiles. They leverage their protein engineering, molecular biology, and biotechnology expertise to design and optimize therapeutic proteins. Furthermore, these companies establish strategic collaborations with academic institutions, research organizations, and other pharmaceutical companies to access new technologies, expand their pipelines, and accelerate development. Collaborations enable the exchange of knowledge, resources, and expertise, fostering innovation and driving the market. Moreover, successful commercialization strategies play a vital role in driving market growth. These companies employ robust marketing and sales efforts to promote and distribute their products to healthcare providers and patients worldwide. They conduct extensive clinical trials, generate compelling clinical data, and obtain regulatory approvals to ensure market access. Additionally, the top companies continuously invest in manufacturing capabilities and quality control systems to meet the growing demand and ensure a consistent supply of their products. This commitment to manufacturing excellence helps them meet the needs of patients, healthcare providers, and payers, further driving the market growth.
Amgen Inc.
Abbott Laboratories
Abbvie Inc.
Baxter International Inc.
Biogen Inc.
Csl Behring L.L.C. (CSL Limited)
Eli Lilly and Company
F. Hoffmann-La Roche AG (Roche Holding AG)
Johnson & Johnson
Merck & Co. Inc.
Novo Nordisk A/S (Novo Holdings A/S)
Pfizer Inc.
In 2020, Amgen Inc. entered into a collaboration with Adaptive Biotechnologies to develop and commercialize fully human-neutralizing antibodies targeting SARS-CoV-2, the virus that causes COVID-19.
In 2021, Abbott Laboratories received FDA clearance for their Tendyne Transcatheter Mitral Valve Replacement (TMVR) system, a minimally invasive therapy for patients with severe mitral regurgitation.
In 2020, AbbVie Inc. acquired Allergan, a pharmaceutical company known for its portfolio of aesthetic and therapeutic products, including Botox.