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市場調査レポート
商品コード
1806143
バイオシミラー市場:製品タイプ、適応症、投与経路、エンドユーザー別-2025-2030年の世界予測Biosimilars Market by Product Type, Indication, Administration Route, End User - Global Forecast 2025-2030 |
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バイオシミラー市場:製品タイプ、適応症、投与経路、エンドユーザー別-2025-2030年の世界予測 |
出版日: 2025年08月28日
発行: 360iResearch
ページ情報: 英文 199 Pages
納期: 即日から翌営業日
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バイオシミラー市場は、2024年には318億3,000万米ドルとなり、2025年には352億7,000万米ドル、CAGR11.32%で成長し、2030年には606億米ドルに達すると予測されています。
主な市場の統計 | |
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基準年2024 | 318億3,000万米ドル |
推定年2025 | 352億7,000万米ドル |
予測年2030 | 606億米ドル |
CAGR(%) | 11.32% |
バイオシミラー医薬品は、世界の生物学的製剤市場を再構築する重要な力として浮上しています。当初はブロックバスター生物製剤の特許切れによって牽引されたこの市場は、現在ではコスト圧力、患者の需要、製造における技術革新の収束を反映しています。世界中のヘルスケアシステムが予算増と闘う中、バイオシミラー医薬品は質を落とすことなくアクセスを拡大する道を提供しています。欧州医薬品庁(EEA)や米国食品医薬品局(FDA)などの主要機関が確立した規制上のパスウェイは、バイオシミラーを実証するための明確な枠組みを提供し、これらの製品が市場に投入されるペースを加速させています。
バイオシミラーの領域は、規制の改善、技術革新、戦略的提携に後押しされ、変革の時期を迎えています。主要市場の規制当局は、互換性指定や承認経路の合理化を順次導入し、ヘルスケアプロバイダーや支払者の信頼を高めています。その結果、スポンサーは上市時の市場シェアを確保するため、ライフサイクルマネジメントや特許訴訟戦略に再び力を入れるようになっています。
2025年に米国の関税が改定されたことで、バイオシミラーのサプライチェーンに多面的な圧力がかかり、メーカーは調達戦略やコスト構造の見直しを迫られています。世界の主要拠点から輸入される原材料や特殊な試薬は関税引き上げの対象となり、製造コストの増加や在庫バッファーの増加を招いています。これに対応するため、利害関係者はサプライヤー基盤の多様化を追求し、エクスポージャーを軽減して供給の継続性を確保するためにニアショアリングの選択肢を模索しています。
詳細なセグメンテーション分析により、製品の優先順位付けや市場参入戦略に役立つ明確な採用パターンが明らかになりました。製品タイプ別に見ると、エリスロポエチン、フォリトロピン、顆粒球コロニー刺激因子(G-CSF)、ヒト成長ホルモン、インスリン、インターフェロン、モノクローナル抗体で違いが見られます。インスリンやG-CSFのような大量生産されるカテゴリーのバイオシミラー医薬品は、慢性期医療における予算削減の圧力から急速に普及したが、モノクローナル抗体はより複雑な開発経路と微妙な競合力学を有しています。
地域力学はバイオシミラーの軌道を形成する上で極めて重要であり、規制理念、ヘルスケアインフラ、市場の成熟度の相違を反映しています。南北アメリカでは、特に米国とカナダにおいて、強固な償還ガイドラインと確立された製造能力が、バイオシミラーの早期上市と競争力のある価格設定を促進しています。利害関係者は、明確な互換性条項と医師の高い認知度から利益を得ており、公的・私的双方の支払者セグメントでの採用が加速しています。
大手開発企業は、バイオシミラー領域における競争優位性を確保するため、多様な戦略を展開しています。既存企業は、高価値のモノクローナル抗体やペプチドベースの治療薬に焦点を当て、社内研究や戦略的買収を通じて製品パイプラインを積極的に拡充しています。同時に、中小のバイオテクノロジー革新企業は、専門知識を活用し、効率的に生産規模を拡大するために、開発・製造受託機関と協力関係を結んでいます。
進化する市場環境に対応するため、業界リーダーは連続処理やシングルユースシステムなどの高度な製造技術への投資を優先すべきです。これらのプラットフォームはコスト効率を高めるだけでなく、需要の変動に対応した迅速なスケールアップを可能にします。さらに、共同科学的助言プログラムを通じて規制当局と積極的に関わることで、承認プロセスを合理化し、コンプライアンス上の課題を先取りすることができます。
本分析は、一次情報と二次情報の両方を統合した厳密な調査手法に基づいています。1次調査では、主要地域の上級幹部、規制の専門家、製造の専門家、主要オピニオンリーダーとの詳細な面談を行いました。これらの会話から、戦略的優先事項、採用の障壁、新たな機会に関する定性的洞察が得られました。
結論として、バイオシミラーの状況は規制の革新、技術の進歩、貿易政策の変化の影響を受けて急速に進化しています。セグメンテーション分析では、製品タイプ、適応症、投与方法、エンドユーザー設定によって異なる採用パターンが浮き彫りになっています。地域力学は、規制の成熟度、ヘルスケアインフラ、地域市場の優先順位によって大きく異なります。
The Biosimilars Market was valued at USD 31.83 billion in 2024 and is projected to grow to USD 35.27 billion in 2025, with a CAGR of 11.32%, reaching USD 60.60 billion by 2030.
KEY MARKET STATISTICS | |
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Base Year [2024] | USD 31.83 billion |
Estimated Year [2025] | USD 35.27 billion |
Forecast Year [2030] | USD 60.60 billion |
CAGR (%) | 11.32% |
The biosimilars sector has emerged as a pivotal force reshaping the global biologic therapeutics landscape. Driven initially by patent expirations on blockbuster biologics, this market now reflects a convergence of cost pressure, patient demand, and innovation in manufacturing. As healthcare systems worldwide grapple with rising budgets, biosimilars offer an avenue to expand access without compromising quality. Subsequent regulatory pathways established by leading agencies such as the European Medicines Agency and the U.S. Food and Drug Administration have provided well-defined frameworks for demonstrating biosimilarity, accelerating the pace at which these products enter the market.
Moreover, the interplay between large pharmaceutical firms and specialized biotech companies has fostered a collaborative ecosystem. Partnerships spanning development, manufacturing, and distribution are enabling scale efficiencies and risk sharing. In addition, technological advances in cell line engineering and analytical characterization have enhanced the confidence of payers and prescribers, underpinning growing acceptance. As a result, the biosimilars sphere has transitioned from a nascent alternative to a mainstream option, exerting downward pressure on overall biologic costs while expanding treatment possibilities.
Initially focused on foundational products, market participants are now exploring next-generation biosimilars with improved delivery systems and formulation stability. This evolution underscores the dynamic nature of the landscape and highlights the need for strategic agility as new entrants challenge established norms and legacy stakeholders refine their competitive approaches
The biosimilars arena is undergoing transformative shifts propelled by regulatory refinements, technological innovation, and strategic alliances. Regulatory bodies in major markets have progressively introduced interchangeability designations and streamlined approval pathways, fostering greater confidence among healthcare providers and payers. Consequently, sponsors are refocusing efforts on life-cycle management and patent litigation strategies to secure market share upon launch.
In parallel, recent breakthroughs in digital bioprocessing and single-use manufacturing are enabling more flexible and cost-efficient production. These advances reduce capital expenditures and accelerate time to market, giving nimble entrants a competitive edge. Furthermore, high-throughput analytical platforms are enhancing comparability assessments, minimizing the risk of post-approval surprises and reinforcing stakeholder trust.
Additionally, the rise of value-oriented partnerships between established pharmaceutical companies and agile biotechs is redefining go-to-market models. Collaborative frameworks now often span joint development agreements, licensing deals, and co-marketing arrangements, enabling shared expertise and expanded geographical reach. As a result, the ecosystem is characterized by a balance of competition and collaboration, where innovation extends beyond molecules to encompass integrated service offerings and patient-centric solutions
The implementation of revised United States tariffs in 2025 has exerted multifaceted pressure on biosimilar supply chains, compelling manufacturers to reassess sourcing strategies and cost structures. Raw materials and specialized reagents imported from key global hubs have become subject to heightened duties, resulting in incremental production costs and elevated inventory buffers. In response, stakeholders have pursued diversification of supplier bases and explored nearshoring options to mitigate exposure and ensure continuity of supply.
Moreover, increased tariffs have influenced pricing negotiations with healthcare systems and distributors, prompting manufacturers to refine their value propositions. Some have introduced tiered pricing models or contractual rebates to offset duty-induced cost uplifts, while others have leveraged vertical integration to retain margin control. Concurrently, contract manufacturing organizations have faced margin compression, driving consolidation among smaller operators and reinforcing partnerships with larger, vertically integrated producers.
This trade policy shift has also highlighted the strategic importance of logistics and inventory management. Companies have invested in digital tracking and demand forecasting tools to optimize order quantities and reduce holding costs. In the longer term, these adaptations are expected to bolster resilience against future policy shifts and global disruptions, while enhancing overall operational agility and cost transparency
A detailed segmentation analysis reveals distinct adoption patterns that inform product prioritization and market entry strategies. When examined by product type, differences emerge across erythropoietin, follitropin, granulocyte-colony stimulating factor (G-CSF), human growth hormone, insulin, interferons, and monoclonal antibodies. Biosimilar versions of high-volume categories such as insulin and G-CSF have garnered rapid uptake due to budgetary pressures in chronic care, whereas monoclonal antibodies present more complex development pathways and nuanced competitive dynamics.
Turning to indication, the adoption trajectory spans autoimmune diseases, blood disorders, diabetes, growth hormone deficiency, infectious diseases, and oncology. Chronic conditions with predictable treatment protocols have facilitated payer acceptance and formulary inclusion, whereas niche oncology segments are advancing more gradually as real-world evidence accumulates. Growing epidemiological burdens and evolving reimbursement frameworks are shaping the pace of adoption across these therapeutic areas.
Administration route further differentiates end-user preferences and infrastructure requirements, with intramuscular, intravenous, and subcutaneous pathways each presenting unique logistics and training considerations. Finally, the market's end users-clinics, homecare providers, and hospitals-exhibit varying procurement cycles and patient support needs. Homecare models are gaining traction as they align with value-based care initiatives, whereas hospital settings continue to dominate high-acuity therapies
Regional dynamics are critical in shaping the biosimilars trajectory, reflecting divergent regulatory philosophies, healthcare infrastructure, and market maturity. In the Americas, robust reimbursement guidelines and established manufacturing capabilities have fostered early biosimilar launches and competitive pricing, particularly in the United States and Canada. Stakeholders benefit from clear interchangeability clauses and substantial physician awareness, accelerating adoption in both public and private payer segments.
In Europe, the Middle East & Africa, well-established regulatory frameworks in the European Union have set global precedents for demonstration of comparability, underpinning widespread biosimilar acceptance. Meanwhile, markets in the Middle East and Africa are rapidly developing capacity and adapting regulatory guidelines, creating incremental opportunities for partnerships focused on technology transfer and capacity building.
Asia-Pacific exhibits a heterogeneous landscape. Mature markets such as Australia and Japan are advancing biosimilar frameworks through pilot interchangeability programs and clinician education initiatives. Simultaneously, emerging economies in China and India are expanding local production networks and prioritizing biosimilars to alleviate healthcare spending. These regions present high growth potential, driven by large patient populations and government incentives for domestic manufacturing
Leading developers are deploying diverse strategies to secure competitive advantage in the biosimilars space. Established players have aggressively expanded product pipelines through internal research and strategic acquisitions, focusing on high-value monoclonal antibodies and peptide-based therapies. At the same time, smaller biotech innovators are forging collaborative alliances with contract development and manufacturing organizations to leverage specialized expertise and scale production efficiently.
Notably, several market incumbents have entered value-added service models, bundling patient support programs and digital adherence tools with pharmaceutical offerings. This holistic approach addresses payer concerns around treatment continuity and enhances patient engagement. In parallel, cross-border partnerships are facilitating access to emerging markets, with licensing agreements tailored to local regulatory and commercial frameworks.
Some organizations have invested in modular biomanufacturing facilities, enabling rapid capacity expansion and flexible deployment across multiple products. Such infrastructure also supports decentralized manufacturing strategies, reducing lead times and transportation costs. These varied initiatives illustrate how top biosimilar developers balance innovation, operational efficiency, and market access to navigate an increasingly complex competitive landscape
To capitalize on evolving market conditions, industry leaders should prioritize investments in advanced manufacturing technologies such as continuous processing and single-use systems. These platforms not only drive cost efficiencies but also enable rapid scale-up in response to demand fluctuations. Furthermore, engaging proactively with regulatory agencies through joint scientific advice programs can streamline approval processes and preempt compliance challenges.
Building robust alliances across the value chain-from raw material suppliers to distributors-will enhance supply chain resilience and mitigate the impact of policy shifts. Diversification of sourcing locations and nearshoring initiatives can reduce exposure to tariff volatility and geopolitical tensions. Meanwhile, adopting digital supply chain management tools will improve transparency and optimize inventory levels.
Market differentiation can be achieved by integrating patient support services, digital adherence solutions, and real-world evidence generation. Collaborations with healthcare providers and payers to demonstrate total cost of care benefits will strengthen the value proposition. Finally, expanding into high-growth regional markets requires tailored commercial strategies that account for local regulatory frameworks, pricing environments, and healthcare infrastructure
This analysis is grounded in a rigorous research methodology that integrates both primary and secondary data sources. Primary research involved in-depth interviews with senior executives, regulatory specialists, manufacturing experts, and key opinion leaders across major geographies. These conversations provided qualitative insights into strategic priorities, adoption barriers, and emerging opportunities.
Secondary research encompassed a comprehensive review of regulatory filings, scientific publications, industry white papers, and public policy documents. Data from authoritative databases and government reports were synthesized to validate trends and benchmark best practices. Triangulation of qualitative findings with quantitative data ensured consistency and accuracy.
Throughout the project, a multi-stage validation process was employed. Initial hypotheses were tested against real-world evidence, and draft conclusions were refined based on feedback from an advisory panel of industry stakeholders. Quality assurance protocols, including data reconciliation and logical consistency checks, were applied to all analytical outputs, ensuring that the final report offers a reliable foundation for strategic decision making
In conclusion, the biosimilars landscape is rapidly evolving under the influence of regulatory innovation, technological advancements, and shifting trade policies. Segmentation analysis highlights nuanced adoption patterns across product types, indications, delivery methods, and end-user settings. Regional dynamics vary significantly, driven by regulatory maturity, healthcare infrastructure, and local market priorities.
Competitive forces are intensifying as major developers and emerging biotechs deploy diverse strategies spanning pipeline expansion, manufacturing optimization, and service integration. To navigate this complexity, stakeholders must embrace agile manufacturing approaches, proactive regulatory engagement, and differentiated value offerings anchored in patient support and cost-effectiveness.
Ultimately, the ability to adapt to policy changes, build resilient supply chains, and tailor approaches to regional nuances will determine success in the global biosimilars arena. By aligning strategic investments with evolving market realities, organizations can unlock sustainable growth and expand patient access to high-quality biologic therapies