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市場調查報告書
商品編碼
2045941
生物相似藥測試和開發服務市場-全球產業規模、佔有率、趨勢、機會和預測:按服務類型、分子類型、治療領域、最終用戶、地區和競爭格局分類,2021-2031年Biosimilar Testing and Development Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type, By Molecule Type, By Therapeutic Area, By End User, By Region & Competition, 2021-2031F |
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全球生物相似藥測試和開發服務市場預計將經歷顯著成長,從 2025 年的 37.3 億美元成長到 2031 年的 75.3 億美元,複合年成長率高達 12.42%。
這些服務包括製藥公司外包的專業分析、生物學分析和臨床活動,旨在檢驗生物相似藥與參考生物製藥的安全性、有效性和結構相似性。推動這一擴張的主要因素是眾多重磅生物製藥的專利即將到期,這導致全球醫療保健系統對經濟高效的替代療法的需求日益成長。這種「專利懸崖」迫使生物製藥開發商積極推動生物相似藥的研發,以獲得市場佔有率,而這需要進行全面的分析表徵和廣泛的臨床試驗,以滿足複雜的監管要求。美國食品藥物管理局 (FDA) 在 2024 年核准的 18 種生物相似藥,就充分證明了這一點。此外,生物相似藥研發外包的日益成長的趨勢使製藥公司能夠策略性地利用合約研究組織/合約生產組織 (CRO/CMO) 的外部專業知識,並在無需大量資本投入的情況下獲得先進的基礎設施。這種方法不僅可以降低風險、簡化研發流程,還可以讓公司將內部資源集中在商業化上。這體現在一家大型 CDMO 的非 COVID 後期和商業化生產銷售額成長了 11.7%,以及Adalimumab生物類似藥在美國獲得的顯著市場佔有率。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 37.3億美元 |
| 市場規模:2031年 | 75.3億美元 |
| 複合年成長率:2026-2031年 | 12.42% |
| 成長最快的細分市場 | 自體免疫疾病 |
| 最大的市場 | 北美洲 |
重磅生技藥品專利到期是推動全球生物相似藥檢測和開發服務市場擴張的根本動力。隨著高利潤生物製藥的獨家權利到期,生物製藥開發公司正積極開發生物相似藥以搶佔市場佔有率,這需要進行全面的分析表徵和臨床試驗來證明其生物相似性。這種「專利懸崖」導致對專業檢測服務的需求激增,以滿足新核准的監管要求,因為開發公司必須證明其分子與參考產品高度相似。根據美國食品藥物管理局(FDA)於2025年1月發布的《2024年新藥認證年度報告》,FDA在2024年核准了18種生物相似藥。這是有史以來最高的數字,凸顯了需要嚴格檢驗和開發支持的分子數量激增。生物相似藥開發業務外包的增加進一步推高了市場收入,使製藥公司能夠利用外部專業知識來滿足複雜的分析和臨床需求。生物製藥公司擴大與合約研究組織 (CRO) 和合約開發與生產組織 (CDMO) 合作,以獲取先進的基礎設施,而無需承擔擴建內部設施所需的大量資本投資。這種策略轉變降低了風險,使內部資源能夠專注於商業化,而外部合作夥伴則負責管理複雜的生物分析和測試階段。藥明生物於 2024 年 8 月發布的《2024 年中期報告》顯示,在新冠疫情之外,後期研發和商業化生產的收入成長了 11.7%,這反映出該行業對外部開發合作夥伴的持續依賴。這種外包模式的成功體現在經過嚴格測試的產品的市場滲透率。三星 Bioepis 於 2024 年 10 月發布的《2024 年第四季美國生物相似藥市場報告》顯示,截至 2024 年 8 月,Adalimumab單抗生物相似藥在美國的市佔率為 22%。
不同司法管轄區嚴格且差異顯著的監管標準是全球生物相似藥測試和開發服務市場擴張的主要障礙。製藥公司將開發工作外包給專家以推進核准流程,但由於全球法規缺乏統一性,為了滿足不同地區的要求,因此必須進行大量且重疊的分析和臨床比較試驗。這種監管碎片化迫使合約研究組織 (CRO) 和開發公司對同一分子重複進行測試,顯著增加了開發成本並延長了開發週期。這些財務和營運負擔起到了阻礙力,使製藥公司對啟動新的生物相似藥專案猶豫不決,並直接減少了進入外包流程的專案數量。這些監管障礙的直接影響是開發平臺的萎縮,從而有效地限制了測試和開發服務的潛在收入來源。由於進入門檻高,許多潛在的生物相似藥甚至無法進入臨床階段,導致對生物分析支持的需求停滯不前。根據可及藥品協會(Association for Accessible Medicines)統計,截至2024年,超過80%的競爭品牌生技藥品在開發平臺中沒有生物相似藥候選產品。這項數據凸顯了監管的複雜性以及由此產生的大量資源投入如何直接抑制市場活動,並限制了對外包服務的需求,儘管該行業理論上潛力巨大。
採用動態物標記豁免生物相似藥的療效比較試驗,標誌著監管範式的根本性轉變,旨在降低生物相似藥研發的高額資金門檻。監管機構透過先進的分析表徵和藥物動力學/動態(PK/PD) 數據檢驗生物類似性,而非透過大規模的III核准臨床試驗,從而實現更有效率、更經濟的核准流程。這項轉變將使研發公司能夠將資源從重複的臨床試驗中重新分配到生產和產品組合擴展,從而顯著降低市場進入門檻。根據 MedPath 於 2025 年 9 月發表的報導《FDA核准單株抗體生物相似藥首次豁免臨床療效試驗》,FDA 豁免這些臨床療效要求的決定預計將使生物相似藥的研發成本降低 90% 以上。人工智慧 (AI) 和機器學習在比較試驗中的應用,透過提高結構表徵的準確性和速度,正在改變生物類似藥研發的分析階段。人工智慧演算法正被擴大用於預測分子行為、最佳化細胞株開發以及分析海量資料集,從而以前所未有的精度展現與參考生技藥品的結構相似性。這項技術的整合不僅加速了關鍵品質屬性的識別,而且透過提高早期對比評估的準確性,降低了後期研發階段失敗的風險。根據 Pharmaphorum 2025 年 1 月發表的一篇報導《人工智慧在生物製藥產業的崛起:2025 年是實用化階段,而非炒作階段》,67% 的領先生物製藥公司正在採用人工智慧和機器學習技術來提高營運效率並加速藥物研發進程。
The Global Biosimilar Testing and Development Services Market is poised for substantial growth, projected to increase from USD 3.73 Billion in 2025 to USD 7.53 Billion by 2031, demonstrating a robust 12.42% Compound Annual Growth Rate. These services involve specialized analytical, bioanalytical, and clinical activities outsourced by pharmaceutical companies to verify the safety, efficacy, and structural similarity of biosimilars compared to their reference biologics. A primary catalyst for this expansion is the impending patent expiration of numerous blockbuster biologics, which fuels an escalating demand for cost-effective therapeutic alternatives within global healthcare systems. This "patent cliff" compels biopharmaceutical developers to aggressively pursue biosimilar creation to capture market share, necessitating comprehensive analytical characterization and extensive clinical trials to meet complex regulatory requirements, as evidenced by the FDA's approval of a record 18 biosimilars in 2024. Furthermore, the increasing trend of outsourcing biosimilar development activities allows pharmaceutical firms to strategically leverage external expertise from contract research and manufacturing organizations, accessing advanced infrastructure without incurring heavy capital costs. This approach not only mitigates risks and streamlines development but also allows companies to focus internal resources on commercialization, as reflected by an 11.7% revenue growth in non-COVID late-phase and commercial manufacturing for a major CDMO and the significant market share achieved by adalimumab biosimilars in the U.S.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 3.73 Billion |
| Market Size 2031 | USD 7.53 Billion |
| CAGR 2026-2031 | 12.42% |
| Fastest Growing Segment | Autoimmune Diseases |
| Largest Market | North America |
Market Driver
Expiration of patents for major blockbuster biologics serves as the fundamental catalyst expanding the Global Biosimilar Testing and Development Services Market. As exclusive rights for high-revenue biologics conclude, biopharmaceutical developers aggressively pursue the creation of biosimilar alternatives to capture market share, necessitating comprehensive analytical characterization and clinical trials to demonstrate biosimilarity. This "patent cliff" creates an immediate surge in demand for specialized testing services to navigate regulatory requirements for new approvals, as developers must prove their molecules are highly similar to the reference product. According to the U.S. Food and Drug Administration, January 2025, in the '2024 New Drug Therapy Approvals Annual Report', the agency approved 18 biosimilars in 2024, a record number that underscores the intensifying volume of molecules requiring rigorous validation and development support. Growth in outsourcing of biosimilar development activities allows pharmaceutical companies to leverage external expertise for complex analytical and clinical requirements, further driving market revenue. Biopharmaceutical firms are increasingly partnering with contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) to access advanced infrastructure without incurring the heavy capital costs associated with internal facility expansion. This strategic shift mitigates risks and focuses internal resources on commercialization while external partners manage the intricate bioanalytical testing phases. According to WuXi Biologics, August 2024, in the 'Interim Report 2024', revenue from non-COVID late-phase and commercial manufacturing grew by 11.7%, reflecting this sustained industry reliance on external development partners. The success of this outsourced model is evident in the commercial uptake of these rigorously tested products; according to Samsung Bioepis, October 2024, in the 'Fourth Quarter 2024 US Biosimilar Market Report', the market share for adalimumab biosimilars reached 22% in the U.S. by August 2024.
Market Challenge
Rigorous and divergent regulatory standards across different jurisdictions constitute a formidable barrier restricting the scalability of the Global Biosimilar Testing and Development Services Market. While pharmaceutical developers outsource to experts to navigate approval pathways, the lack of global harmonization necessitates extensive and duplicative analytical and clinical comparative studies to satisfy differing regional requirements. This regulatory fragmentation forces contract research organizations and developers to execute redundant testing protocols for the same molecule, significantly inflating development costs and extending timelines. These financial and operational burdens act as a deterrent, discouraging pharmaceutical companies from initiating new biosimilar programs and directly reducing the volume of projects entering the outsourcing pipeline. The direct impact of these regulatory hurdles is a constricted development funnel, which effectively caps the potential revenue stream for testing and development services. High entry barriers prevent many potential biosimilars from ever reaching the clinical phase, thereby stalling demand for bioanalytical support. According to the Association for Accessible Medicines, in 2024, more than 80 percent of brand biologics that are eligible for competition did not have a biosimilar candidate in the development pipeline. This statistic underscores how regulatory complexity and the associated resource intensity directly suppress market activity, limiting the demand for outsourced services despite the broader sector's theoretical potential.
Market Trends
The Adoption of Pharmacodynamic Biomarkers to Waive Comparative Efficacy Trials represents a fundamental regulatory paradigm shift designed to reduce the high capital barriers associated with biosimilar development. By validating biosimilarity through advanced analytical characterization and pharmacokinetic/pharmacodynamic (PK/PD) data rather than large-scale Phase 3 studies, regulatory bodies are enabling a more streamlined and cost-efficient approval process. This shift allows developers to reallocate resources from redundant clinical testing to manufacturing and portfolio expansion, significantly lowering the threshold for market entry. According to MedPath, September 2025, in the article 'FDA Grants First-Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilars', the FDA's decision to waive these clinical efficacy requirements is expected to reduce the cost of developing biosimilars by more than 90%. Integration of Artificial Intelligence and Machine Learning in Comparability Studies is transforming the analytical phase of biosimilar development by enhancing the precision and speed of structural characterization. AI algorithms are increasingly employed to predict molecular behavior, optimize cell line development, and analyze vast datasets to demonstrate structural similarity to reference biologics with unprecedented accuracy. This technological integration not only accelerates the identification of critical quality attributes but also mitigates the risk of failure in later development stages by ensuring higher fidelity in early comparability assessments. According to Pharmaphorum, January 2025, in the article 'Biopharma's AI rally: Readiness not hype in 2025', 67% of large biopharma companies have adopted artificial intelligence and machine learning technologies to drive operational efficiency and accelerate discovery pipelines.
Report Scope
In this report, the Global Biosimilar Testing and Development Services 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 Biosimilar Testing and Development Services Market.
Global Biosimilar Testing and Development Services 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: