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市場調査レポート
商品コード
1692196
スペシャリティジェネリック市場- 世界の産業規模、シェア、動向、機会、予測、投与経路別、適応症別、流通チャネル別、地域別、競合市場別、2020-2030FSpecialty Generics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Route of Administration, By Indication, By Distribution Channel, By Region & Competition, 2020-2030F |
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カスタマイズ可能
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スペシャリティジェネリック市場- 世界の産業規模、シェア、動向、機会、予測、投与経路別、適応症別、流通チャネル別、地域別、競合市場別、2020-2030F |
出版日: 2025年03月24日
発行: TechSci Research
ページ情報: 英文 180 Pages
納期: 2~3営業日
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スペシャリティジェネリックの世界市場規模は2024年に556億米ドルとなり、2030年までのCAGRは9.70%で、予測期間中に目覚ましい成長が見込まれています。
複合型ジェネリック医薬品としても知られるスペシャリティジェネリックは、従来のジェネリック医薬品とはいくつかの点で異なるジェネリック医薬品のカテゴリーです。これらの違いは、医薬品そのもの複雑さ、承認のための規制上の経路、対象とする治療領域に関連しています。複雑な低分子のスペシャリティジェネリックの場合、基準薬と比較して治療上の同等性や生物学的同等性を確立するために、規制当局が追加のデータや試験を要求することがあります。これには、より広範な臨床試験や分析的特性評価が含まれます。スペシャリティジェネリックは、がん、自己免疫疾患、リウマチ性疾患、神経疾患などの慢性疾患や複雑な疾患の治療薬として開発されることが多いです。
市場概要 | |
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予測期間 | 2026-2030 |
市場規模:2024年 | 556億米ドル |
市場規模:2030年 | 961億4,000万米ドル |
CAGR:2025年~2030年 | 9.70% |
急成長セグメント | 注射剤 |
最大市場 | 北米 |
これらの医薬品は、特定の疾患経路やメカニズムを標的としています。スペシャリティジェネリック、特にバイオシミラーは通常、安全性と有効性を実証するために大規模な臨床試験が行われます。これらの試験には、臨床エンドポイントだけでなく、薬物動態学的および薬力学的評価も含まれます。医療費の高騰により、医療制度や支払者は費用対効果の高い解決策を見出す必要に迫られています。バイオシミラーや複合型ジェネリック医薬品を含むスペシャリティジェネリックは、先発品と比較して大幅なコスト削減の可能性を提供します。例えば、Niti Aayogの2021年のデータによると、インドには60の治療カテゴリーにわたって60,000のジェネリック医薬品ブランドがあり、世界最大のジェネリック医薬品供給国として、世界のジェネリック医薬品輸出量の20%に貢献しています。
技術の進歩
知的財産と特許訴訟
専門治療への注力
Global Specialty Generics Market was valued at USD 55.60 billion in 2024 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 9.70% through 2030. Specialty generics, also known as complex generics, are a category of generic drugs that differ from traditional generic drugs in several ways. These differences relate to the complexity of the drugs themselves, the regulatory pathway for approval, and the therapeutic areas they target. For complex small-molecule specialty generics, regulatory agencies may require additional data and studies to establish therapeutic equivalence and bioequivalence when compared to the reference drug. This can involve more extensive clinical testing and analytical characterization. Specialty generics are often developed for the treatment of chronic and complex diseases, including cancer, autoimmune disorders, rheumatologic conditions, and neurological disorders.
Market Overview | |
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Forecast Period | 2026-2030 |
Market Size 2024 | USD 55.60 Billion |
Market Size 2030 | USD 96.14 Billion |
CAGR 2025-2030 | 9.70% |
Fastest Growing Segment | Injectables |
Largest Market | North America |
These drugs target specific disease pathways and mechanisms. Specialty generics, particularly biosimilars, typically undergo extensive clinical trials to demonstrate safety and efficacy. These trials involve pharmacokinetic and pharmacodynamic assessments, as well as clinical endpoints. Escalating healthcare costs have put pressure on healthcare systems and payers to find cost-effective solutions. Specialty generics, including biosimilars and complex generics, offer the potential for substantial cost savings compared to their branded counterparts. For instance, according to Niti Aayog's 2021 data, India has 60,000 generic brands across 60 therapeutic categories and is the world's largest generic medicine provider, contributing 20% of global generic drug exports by volume.
Key Market Drivers
Technological Advancements
Biotechnology has revolutionized the production of biologic drugs, including biosimilars. Improved cell culture techniques and bioreactors allow for the efficient growth of cells that produce therapeutic proteins, monoclonal antibodies, and other complex molecules. This has made it possible to create biosimilars that closely mimic the originator biologics. High-resolution analytical tools, such as mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, and high-performance liquid chromatography (HPLC), have advanced the characterization of complex generics and biosimilars. These tools help manufacturers ensure the quality, purity, and consistency of their products. Innovative process intensification technologies improve the yield and efficiency of pharmaceutical manufacturing. This is particularly important for specialty generics that involve complex and costly production processes. Single-use bioreactors are increasingly used in the production of biologics, including biosimilars.
They offer flexibility, reduce the risk of contamination, and accelerate manufacturing timelines. For instance, in April 2023, Endo International plc launched a generic version of Noxafil (posaconazole) oral suspension, expanding treatment options for oropharyngeal candidiasis and enhancing access to affordable antifungal medication. Continuous manufacturing processes, as opposed to batch processes, are being adopted in the production of certain specialty generics. Continuous manufacturing can increase productivity and reduce the time and resources required for production. Advances in gene editing techniques, such as CRISPR-Cas9, have improved the development of high-yield cell lines for biologic production. This results in higher efficiency and reduced production costs. Specialty generics may include novel drug delivery systems to enhance drug stability and patient compliance. Technologies like microneedles, nanoparticles, and liposomal formulations have been employed to improve drug delivery. 3D printing technology is being explored for the development of personalized dosage forms, including patient-specific formulations of specialty generics. This could lead to more precise dosing and improved patient outcomes.
AI and machine learning algorithms are used to analyze large datasets in drug discovery, development, and manufacturing. These technologies can accelerate research, predict manufacturing issues, and optimize production processes. Quality-by-Design (QbD) principles involve designing quality into pharmaceutical products from the start of the development process. This approach uses scientific understanding and risk assessment to ensure product quality and consistency.
Key Market Challenges
Intellectual Property and Patent Litigation
Innovator pharmaceutical companies secure patents for their new drugs, which grant them exclusive rights to manufacture, market, and sell these drugs for a specified period, typically 20 years from the date of filing. During this exclusivity period, other companies are prohibited from manufacturing and selling generic versions of the drug. When the patents on brand-name drugs expire, it creates opportunities for specialty generics, including biosimilars and complex generics, to enter the market. These products aim to offer more affordable alternatives to the originator drugs. Innovator companies often file patent infringement lawsuits against generic manufacturers that attempt to market specialty generics. These lawsuits can delay the entry of specialty generics into the market, as they can take years to resolve in court.
In the United States, the Hatch-Waxman Act provides a framework for the approval of generic drugs while respecting innovator patents. It includes provisions for patent litigation, known as Paragraph IV challenges, which can trigger patent disputes between innovators and generic manufacturers. Biosimilars, which are similar but not identical to biologic drugs, often face complex patent disputes. The biosimilar approval process may require exchanges of patent-related information between the biosimilar manufacturer and the innovator, potentially leading to litigation. Innovator pharmaceutical companies and generic manufacturers may reach settlement agreements that allow for the entry of generic or biosimilar drugs before the patent expires. Such agreements can have implications for market competition and pricing. Some innovator companies employ strategies to extend their drug exclusivity, such as obtaining additional patents for variations of the original drug or for specific formulations. This can delay generic market entry.
Key Market Trends
Focus on Specialty Therapies
The growing prevalence of chronic diseases, including cancer, autoimmune disorders, and rare diseases, has created a substantial need for specialty therapies. Specialty generics, including biosimilars and complex generics, are developed to provide more affordable options for patients with these conditions. Many specialty therapies are biologics or other complex drugs. As patents for these drugs expire, pharmaceutical companies are focusing on the development of specialty generics to capture a share of this lucrative market. Specialty generics typically offer significant cost savings compared to their branded counterparts. This is particularly appealing for patients, healthcare systems, and payers, who seek effective treatments while managing healthcare costs. Regulatory agencies, such as the U.S. FDA and the European Medicines Agency (EMA), have established clear pathways for the approval of biosimilars. This has accelerated the development and marketing of biosimilar specialty generics, especially for biologics used in oncology, rheumatology, and gastroenterology. Over time, healthcare providers, payers, and patients have become more accepting of biosimilars and other specialty generics.
In this report, the Global Specialty Generics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Specialty Generics Market.
Global Specialty Generics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: