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市場調查報告書
商品編碼
1818079
2032 年生技藥品和生物相似藥市場預測:按產品類型、治療領域、製造商、分銷管道、最終用戶和地區進行的全球分析Biologics & Biosimilars Market Forecasts to 2032 - Global Analysis By Product Type, Therapeutic Area, Manufacturing Source, Distribution Channel, End User, and By Geography |
根據 Stratistics MRC 的數據,全球生技藥品和生物相似藥市場預計在 2025 年達到 5,382 億美元,到 2032 年將達到 1,2198.6 億美元,預測期內複合年成長率為 12.4%。
生技藥品是指利用活細胞或生物體製造的創新療法,例如單株抗體、蛋白質和疫苗,用於治療慢性和嚴重。生物相似藥是在生技藥品專利保護到期後研發的,其安全性、有效性和品質與生物製劑相似,從而確保相同的治療效果。這些經濟高效的選擇擴大了患者獲得重要療法的管道。生技藥品和生物相似藥協同作用,透過推進醫療解決方案、降低治療成本和改善整體臨床療效,提升醫療保健水準。
慢性病增多
在全球範圍內,癌症、糖尿病和自體免疫疾病等慢性疾病的發生率不斷上升,推動了對生技藥品和生物相似藥的需求。醫療保健系統優先考慮能夠提高療效、減少副作用的長期治療方案。具有標靶作用機制的生技藥品正成為疾病管理策略的核心。隨著患者群體老化和診斷能力的提高,對生技藥品的需求持續成長。生物相似藥作為一種經濟高效的替代方案,正日益受到青睞,尤其是在醫療保健預算緊張的市場。這種日益成長的需求正在加速整個生物製藥產業的創新和投資。
開發和製造成本高
生技藥品和生物相似藥的開發涉及從細胞株工程到純化和驗證的複雜流程。嚴格的監管要求和漫長的臨床試驗時間進一步加劇了高成本。生產設施必須滿足嚴格的品質標準,並且通常需要專業的基礎設施和熟練的人員。低溫運輸物流和污染控制的需求進一步增加了營運成本。規模較小的公司面臨進入壁壘,限制了競爭,並減緩了市場擴張。因此,定價仍然是一個挑戰,尤其是在新興國家。
研發和製造領域的技術進步
先進的分析技術和人工智慧驅動的建模技術正在加速藥物研發並縮短開發週期。細胞培養基和表達系統的創新正在提高產量和產品一致性。自動化數位雙胞胎正被用於最佳化設施營運並減少人為錯誤。這些進步正在降低成本,並實現複雜生技藥品的可擴展生產。隨著技術的成熟,提供具有競爭力的生物相似藥產品的公司得以進入市場。
激烈的競爭和價格壓力
專利到期導致多家製藥公司進入該領域,加劇了價格競爭。法規雖然不斷發展,但仍是阻礙市場進入和增加合規成本的障礙。付款人和醫療保健提供者要求降低價格,從而擠壓了整個價值鏈的利潤率。品牌忠誠度和醫生對生物相似藥的猶豫也影響了採用率。如果沒有差異化和策略定位,企業將在日益商品化的環境中面臨失去市場佔有率的風險。
COVID-19的影響
疫情擾亂了生技藥品和生物相似藥的臨床試驗、供應鏈和生產流程。封鎖措施以及疫苗和緊急治療資源的重新分配,推遲了與新冠疫情無關的產品上市。然而,這場危機凸顯了生技藥品在管理感染疾病和免疫反應的重要性。生物製藥公司加速數位轉型,並採用遠端監控和分散式檢測模式。各國政府和監管機構引入了靈活的框架,以維持藥物研發的連續性。疫情後的策略越來越強調生技藥品生產的韌性、敏捷性和全球協作。
生技藥品領域預計將成為預測期內最大的細分市場
由於療效卓越且適應症不斷擴展,生技藥品領域預計將在預測期內佔據最大市場佔有率。單株抗體、重組蛋白和基因療法正在獲得廣泛的臨床認可。複雜疾病的日益普及推動了對生物目標療法的需求。在可靠的臨床數據和患者接受度的支持下,監管核准正在加速。生技藥品的研發投入持續超過其他領域,鞏固了其市場領先地位。隨著生技藥品的普及,其在全球生技藥品支出中的佔有率預計將穩步上升。
生物製藥公司部門預計在預測期內以最高複合年成長率成長
在積極創新和產品線不斷拓展的推動下,生物製藥公司預計將在預測期內實現最高成長率。這些公司利用先進的平台進行生技藥品的合成、配製和遞送。戰略聯盟和許可協議使其能夠更快地進入市場並擴大地域覆蓋範圍。生物製藥公司也正在投資生物相似藥組合,以抓住專利到期後的機會。他們的敏捷性和對利基療法的專注使其在持續成長方面佔據有利地位。在個人化醫療需求日益成長的背景下,生物製藥公司在生技藥品開發方面處於主導。
受醫療保健支出成長和患者人數不斷增加的推動,預計亞太地區將在預測期內佔據最大的市場佔有率。中國、印度和韓國等國家正在大力投資,以更新生技藥品基礎設施和法規。國內製造商正在擴大生產規模,以滿足國內和出口需求。政府舉措正在推動生物相似藥的推廣應用,以降低治療成本。臨床試驗活動蓬勃發展,亞太地區正逐漸成為生技藥品研究的中心。該地區的人口和經濟動態是該行業的關鍵成長引擎。
在技術領先地位和強勁的生物製藥投資的推動下,北美預計將在預測期內實現最高的複合年成長率。美國和加拿大正在透過產學研合作和聯邦資金推動生技藥品創新。監管機構正在簡化生物相似藥的核准途徑,鼓勵市場競爭。精準醫療和生技藥品的應用正在各個治療領域加速發展。數位健康整合和人工智慧主導的藥物開發正在提高效率和療效。
According to Stratistics MRC, the Global Biologics & Biosimilars Market is accounted for $538.20 billion in 2025 and is expected to reach $1219.86 billion by 2032 growing at a CAGR of 12.4% during the forecast period. Biologics are innovative therapies produced using living cells or organisms, such as monoclonal antibodies, proteins, and vaccines, that target chronic and severe diseases. Biosimilars, created after biologics lose patent protection, are close replicas in terms of safety, efficacy, and quality, ensuring similar therapeutic effects. These cost-effective options expand patient access to critical treatments. Together, biologics and biosimilars enhance healthcare by advancing medical solutions, reducing treatment costs, and improving overall clinical outcomes.
Rising prevalence of chronic diseases
The increasing global burden of chronic illnesses such as cancer, diabetes, and autoimmune disorders is fuelling demand for biologics and biosimilars. Healthcare systems are prioritizing long-term treatment solutions that offer improved efficacy and reduced side effects. Biologics, with their targeted mechanisms, are becoming central to disease management strategies. As patient population's age and diagnostic capabilities improve, the need for biologic therapies continues to rise. Biosimilars are gaining traction as cost-effective alternatives, especially in markets with strained healthcare budgets. This growing demand is accelerating innovation and investment across the biopharmaceutical landscape.
High development and manufacturing costs
Developing biologics and biosimilars involves complex processes, from cell line engineering to purification and validation. These high costs are compounded by stringent regulatory requirements and extended clinical trial timelines. Manufacturing facilities must meet rigorous quality standards, often requiring specialized infrastructure and skilled personnel. The need for cold chain logistics and contamination control further increases operational expenses. Smaller firms face barriers to entry, limiting competition and slowing market expansion. As a result, pricing remains a challenge, especially in emerging economies.
Technological advancements in R&D and manufacturing
Advanced analytics and AI-driven modelling are enhancing drug discovery and reducing development timelines. Innovations in cell culture media and expression systems are improving yield and product consistency. Automation and digital twins are being adopted to optimize facility operations and reduce human error. These advancements are lowering costs and enabling scalable production of complex biologics. As technology matures, more players can enter the market with competitive biosimilar offerings.
Intense competition and pricing pressure
Patent expirations are opening the door to multiple entrants, intensifying pricing battles. Regulatory pathways, while evolving, still pose hurdles that delay market access and increase compliance costs. Payers and healthcare providers are demanding lower prices, squeezing margins across the value chain. Brand loyalty and physician hesitancy toward biosimilars also impact adoption rates. Without differentiation and strategic positioning, companies risk losing market share in an increasingly commoditized landscape.
Covid-19 Impact
The pandemic disrupted clinical trials, supply chains, and manufacturing schedules for biologics and biosimilars. Lockdowns and resource reallocation toward vaccines and emergency treatments delayed non-COVID product launches. However, the crisis also highlighted the importance of biologics in managing infectious diseases and immune responses. Biopharma companies accelerated digital transformation, adopting remote monitoring and decentralized trial models. Governments and regulators introduced flexible frameworks to maintain continuity in drug development. Post-pandemic strategies now emphasize resilience, agility, and global collaboration in biologics manufacturing.
The biologics segment is expected to be the largest during the forecast period
The biologics segment is expected to account for the largest market share during the forecast period, its superior therapeutic outcomes and expanding indications. Monoclonal antibodies, recombinant proteins, and gene therapies are gaining widespread clinical acceptance. Increasing prevalence of complex diseases is driving demand for targeted biologic treatments. Regulatory approvals are accelerating, supported by robust clinical data and patient advocacy. Investment in biologics R&D continues to outpace other segments, reinforcing its market leadership. As biologics become more accessible, their share in global pharmaceutical spending is expected to rise steadily.
The biopharma companies segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the biopharma companies segment is predicted to witness the highest growth rate, driven by aggressive innovation and pipeline expansion. These firms are leveraging advanced platforms for biologic synthesis, formulation, and delivery. Strategic collaborations and licensing agreements are enabling faster market entry and broader geographic reach. Biopharma players are also investing in biosimilar portfolios to capture post-patent opportunities. Their agility and focus on niche therapies position them well for sustained growth. As demand for personalized medicine increases, biopharma companies are leading the charge in biologics development.
During the forecast period, the Asia Pacific region is expected to hold the largest market share supported by rising healthcare expenditure and expanding patient populations. Countries like China, India, and South Korea are investing heavily in biologics infrastructure and regulatory modernization. Local manufacturers are scaling up production to meet domestic and export demand. Government initiatives are promoting biosimilar adoption to reduce treatment costs. Clinical trial activity is surging, with Asia Pacific emerging as a hub for biologics research. The region's demographic and economic dynamics make it a key growth engine for the industry.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, furled by technological leadership and robust biopharma investment. The U.S. and Canada are advancing biologics innovation through academic-industry partnerships and federal funding. Regulatory agencies are streamlining approval pathways for biosimilars, encouraging market competition. Adoption of precision medicine and biologic therapies is accelerating across therapeutic areas. Digital health integration and AI-driven drug development are enhancing efficiency and outcomes.
Key players in the market
Some of the key players profiled in the Biologics & Biosimilars Market include Amgen, Sanofi, Pfizer, Eli Lilly, Novartis, Viatris, Biocon Biologics, AbbVie, Samsung Bioepis, Teva Pharmaceuticals, Celltrion, Fresenius Kabi, Roche, Boehringer Ingelheim, and Merck KGaA.
In September 2025, Novartis AG has reached an agreement to purchase the New York-based firm, Tourmaline Bio Inc., in a deal valued at a staggering $1.4 billion. This move is aimed at reducing systemic inflammation, which is termed a major driver of cardiovascular disease. Novartis has been on the lookout for deals that would amplify its sales beyond 2025.
In August 2025, Sanofi announces the completion of its acquisition of Vigil Neuroscience, Inc. This acquisition strengthens Sanofi's early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist, which will be evaluated in a phase 2 clinical study in patients with Alzheimer's disease. In addition, the acquisition of Vigil's preclinical pipeline will further strengthen Sanofi's research in various neurodegenerative diseases.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.