合約生技藥品開發和受託製造廠商的成長機會，2024-2029

下一代生技藥品的風險共用經營模式將推動生物/CDMO 的成長並激發未來的可能性

到2023年，生技藥品將佔治療產品線的44%，其中抗體和重組蛋白是主要類別。然而，這些領域的進展已經放緩，大部分擴展在異種細胞療法、合成核酸和病毒方面。全球生技藥品管道可能轉向更複雜的治療方法，包括細胞和基因療法（CGT）、核酸療法、ADC和雙特異性抗體。專注於這些治療的生物製藥公司可能會透過縮短臨床開發時間和降低銷貨成本（COGS）來更加重視生產具有成本效益的藥物。生技藥品合約開發和受託製造廠商(Bio-CDMO) 正在積極制定其製造和供應鏈策略，特別專注於與服務供應商合作以最佳化製造流程。

美國通貨膨脹減少法案 (IRA) 和 BIOSECURE 法案可能會減緩對製藥創新和 CDMO 服務的需求，導致全球外包動態和 CDMO 策略發生根本性變化。創業投資透過內部重組和增加現金儲備來支持其醫藥投資組合。對 CDMO 的需求持續下降，尤其是在開發的早期階段。然而，2023年下半年至2024年，併購交易增加，生技資金籌措和估值具備有利條件，通膨和利率趨於穩定。到 2024 年，我們預計需求將會復甦，尤其是新興生物製藥和早期開發階段的需求。

該分析提供了全球生物/CDMO 市場的詳細收益預測。預測按市場和細分市場分類，提供有價值的行業見解。我們的分析重點是透過考慮趨勢、經營模式和創新策略來強調參與企業的潛在成長機會。市場區隔涵蓋產品類型、細胞表現類型、模式和區域等各個方面。考慮到 COVID-19 大流行的結束和當前的全球地緣政治問題，外包需求正在放緩。 CDMO 的需求正在減少，尤其是來自規模較小的新興生物製藥公司和早期公司的需求。該分析全面檢驗了2024 年至 2029 年的未來趨勢。還包括有關產能擴張、併購、收購和服務擴展的見解。我們也分析生物/CDMO 策略挑戰、成長促進因素、阻礙因素、收益佔有率預測和商機的影響。

目錄

成長環境：生物/CDMO領域的轉型

• 為什麼成長如此困難？
• The Strategic Imperative 8（TM）
• 生物/CDMO產業三大戰略重點的影響

成長環境：Bio/CDMO生態系統

• 生技藥品產業-展望
• 生技藥品產業－重點治療領域展望
• 生技藥品管道 - 按方式、按階段
• 生技藥品產業 - 按方式分類的市場規模和成長率預測
• 影響生物/CDMO產業的全球趨勢
• 影響生物/CDMO產業的產業趨勢
• 經營模式－從按服務收費轉向以價值為基礎的風險分擔
• 基於價值的風險分擔經營模式
• 分析範圍
• 分割
• 分割
• 競爭環境
• 主要競爭對手

成長要素

• 成長指標
• 生長促進因子
• 成長抑制因素
• 預測考慮因素
• 預測架構 - 生物/CDMO 市場規模
• 預測方法-Bio/CDMO市場
• 收益預測
• 收益預測：依產品類型
• 收益預測：按細胞培養類型
• 收益預測：按地區
• 收益預測：依方式分類
• 收益分析
• 收益分析：按地區
• 收益佔有率
• 收益佔有率分析

生長機會分析：細胞/基因治療

• 成長指標
• 收益預測
• 預測分析

成長機會分析：疫苗

• 成長指標
• 收益預測
• 預測分析

成長機會分析：抗體療法

• 成長指標
• 收益預測
• 預測分析

成長機會分析：蛋白質/胜肽

• 成長指標
• 收益預測
• 預測分析

生物/CDMO 領域的成長機會

• 成長機會 1 – 擴大製藥能力以支持抗肥胖藥物
• 成長機會2－提供端對端mRNA服務
• 成長機會3－印度國內企業加強生技藥品能力

生物/CDMO 最佳實踐的認可

生物/CDMO 領域的FROST RADAR

下一步

Risk-sharing Business Models for Next-generation Biologics Will Drive Bio-CDMO Growth and Spur Future Potential

By 2023, biologics constituted 44% of the therapeutic pipeline, with antibodies and recombinant proteins as leading categories. Nevertheless, advancements in these fields decelerated, with most of the expansion happening in heterologous cell treatments, synthetic nucleic acids, and viruses. The global biologics pipeline will shift toward more complex treatment modalities, including cell and gene therapy (CGT), nucleic acid therapy, ADC, and bispecific antibodies. Biopharmaceutical companies that focus on these treatments will strive for reduced durations for clinical development and a greater focus on cost-effectively producing drugs with lower costs of goods sold (COGS). Biologics contract development and manufacturing organizations (Bio-CDMOs) are actively framing manufacturing and supply chain strategies, with a specific emphasis on partnering with service providers to optimize the production process.

The US Inflation Reduction Act (IRA) and the BIOSECURE Act have the potential to slow down drug innovation and the demand for CDMO services, leading to radical transformations in global outsourcing dynamics and CDMO strategies. Venture capitalists are assisting their pharmaceutical portfolios by internally restructuring and extending their cash reserves. CDMOs have experienced a consistent decrease in demand, especially for the initial phases of development. However, in late 2023 and 2024, there was a rise in M&A transactions, favorable conditions for biotech financing and valuation, and a stabilization of inflation and interest rates. Demand will resurge, particularly from emerging biopharma and early-stage development, by 2024.

This Frost & Sullivan analysis provides detailed revenue forecasts for the global market of bio-CDMOs. The forecasts are categorized by market and segment, offering valuable insights into the industry. The analysis focuses on highlighting the potential growth opportunities for participants by considering trends, business models, and innovative strategies. The market segments cover various aspects, such as product type, cell expression type, modality, and geographic region. Considering the end of the COVID-19 pandemic and the current global geopolitical issues, demand for outsourcing has decelerated. CDMOs are experiencing a decline in demand, particularly from small and emerging biopharmaceutical companies and those in the early stages of development. This analysis provides a comprehensive examination of future trends, covering the period between 2024 and 2029. It includes insights on capacity expansions, mergers, acquisitions, and the expansion of service offerings. The analysis also investigates the impact of strategic imperatives, growth drivers, restraints, revenue share estimates, and opportunities for bio-CDMOs.

Table of Contents

Growth Environment- Transformation in theBio-CDMO Sector

• Why is it Increasingly Difficult to Grow?
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Bio-CDMO Industry

Growth Environment- Ecosystem in Bio-CDMO

• Biologics Industry-Outlook
• Biologics Industry-Key Therapeutic Area Outlook
• Biologics Pipeline by Modality and Phase
• Biologics Industry-Market size and Growth Rate Forecast by Modality
• Global Trends Impacting the Bio-CDMO Industry
• Industry Trends Impacting the Bio-CDMO Industry
• Business Model-Shift from Fee-for-service to Value-based Risk-sharing
• Value-based Risk-sharing Business Model
• Scope of Analysis
• Segmentation
• Segmentation
• Competitive Environment
• Key Competitors

Growth Generator

• Growth Metrics
• Growth Drivers
• Growth Restraints
• Forecast Considerations
• Forecast Framework-Bio-CDMO Market Sizing
• Forecast Methodology-Bio-CDMO Market
• Revenue Forecast
• Revenue Forecast by Product Type
• Revenue Forecast by Cell-culture Type
• Revenue Forecast by Region
• Revenue Forecast by Modality
• Revenue Forecast Analysis
• Revenue Forecast Analysis by Region
• Revenue Share
• Revenue Share Analysis

Growth Generator Analysis-Growth GeneratorCell and Gene Therapy

• Growth Metrics
• Revenue Forecast
• Forecast Analysis

Growth Opportunity Analysis-Growth Generator Vaccines

• Growth Metrics
• Revenue Forecast
• Forecast Analysis

Growth Opportunity Analysis-Growth Generator Antibody Therapeutics

• Growth Metrics
• Revenue Forecast
• Forecast Analysis

Growth Opportunity Analysis-Growth Generator Proteins and Peptides

• Growth Metrics
• Revenue Forecast
• Forecast Analysis

Growth Opportunity Universe in Bio-CDMO

• Growth Opportunity 1-Expanding Drug Product Capabilites to Support Anti-obesity Drugs
• Growth Opportunity 2-Providing End-to-end mRNA Services
• Growth Opportunity 3-Indian Domestic Players Enhance Biologics Capabilities

Best Practice Recognition in Bio-CDMO

• Best Practice Recognition

Frost Radar in Bio-CDMO

• Frost Radar

Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• Take the Next Step
• List of Exhibits
• Legal Disclaimer