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ペプチド合成サービス市場:事業規模別(前臨床/臨床、商業)、使用合成法の種類別(化学合成法、非化学合成法)、企業規模別(中小規模、大規模)、主要地域別(北米、欧州、アジア太平洋、その他の地域):業界動向と世界予測、2022-2035年


Peptide Synthesis Service Market by Scale of Operation (Preclinical / Clinical and Commercial), Type of Synthesis Method Used (Chemical Synthesis Method and Non-Chemical Synthesis Method), Company Size (Small, Mid-sized and Large), and Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035

世界のペプチド合成サービス市場は、2022年には17億ドルに達し、2022年から2035年の予測期間中に13.6%のCAGRで成長すると予測されている。 生物製剤の注目度が高まるにつれて、製薬企業はペプチド治療薬などの... もっと見る

 

 

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Roots Analysis
ルーツアナリシス
2023年9月1日 US$4,799
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サマリー

世界のペプチド合成サービス市場は、2022年には17億ドルに達し、2022年から2035年の予測期間中に13.6%のCAGRで成長すると予測されている。

生物製剤の注目度が高まるにつれて、製薬企業はペプチド治療薬などのより洗練された治療法へと軸足を移している。インスリンの発見以来、ペプチドベースの医薬品市場は繁栄し、癌、糖尿病、HIVを含む病気のスペクトルを標的とする80以上の薬を包含している。2017年以降、FDAは2021年にLupkynisTMとZegalogue®を、2020年にImcivreeTM、Victoza®、LUPRON DEPOT®を含む10以上のペプチド医薬品を承認した。現在、1,000を超える膨大な数の臨床試験が、新規ペプチドの治療可能性を研究している。
これらの薬剤に対する需要の急増は、その特異性、薬物相互作用の少なさ、多様な生物学的作用、半減期の延長、確立された薬理学的有効性、安全性プロファイルから生じている。しかし、ペプチドの合成と精製には、収量と純度の両方に影響を与える課題がある。これに対抗するため、ペプチド合成に携わる数多くの事業体が、製造受託を選択している。現在、60を超える受託製造機関(CMO)と受託開発・製造機関(CDMO)が、ペプチドの開発、製造、精製を包括するサービスを提供しており、開発者のための包括的なソリューションとして確固たる地位を築いている。
継続的な技術革新、精製技術の進歩、パイプラインの拡大により、ペプチド市場は持続的な成長が見込まれている。COVID-19以降、製薬会社がフル稼働を再開するにつれて、ペプチド治療薬の大規模製造に対する需要の増加が予測される。特に、ペプチドベースのCOVID-19ワクチンの開発により、承認後の製造規模を拡大し、世界的な需要に対応する製造サービスプロバイダーのニーズがさらに高まるだろう。

レポート範囲
 ペプチド受託製造市場に関する調査から得られた主要な洞察。ペプチドの現状と短期、中期、長期的に予想される進化のハイレベルな概要を提供する。
 ペプチドの紹介。様々なクラス、合成方法、修飾、精製戦略、用途、ペプチド製造業務をアウトソーシングする根拠について論じている。
 米国、欧州、オーストラリア、中国、インド、日本、韓国など様々な地域におけるペプチド受託製造業者の規制状況についての詳細な洞察。
 ペプチド受託製造サービスを提供する企業の概要で、設立年、企業規模、地理的位置、合成方法、精製技術、規制認証などのパラメータを強調。
 サービス力、製造能力、施設数、合成、精製方法、ペプチド修飾に基づく、著名なペプチド受託製造企業の競争力の分析。
 ペプチド受託製造領域における主要企業の詳細プロフィール。会社概要、設立年、従業員数、本社、提供サービス、最近の動向、将来の展望を掲載。
 2016年から2021年にかけての提携、共同研究、施設拡張など、ペプチド受託製造業界における最近の動向を分析。
 ペプチド治療薬に関する完了済み、進行中、計画中の臨床試験を、試験パラメータ、業界プレイヤー、試験フォーカス、地理的地域に焦点を当てて詳細に分析。
 CMO数、臨床サイト、試験、登録患者、製品タイプ、需要など様々なパラメータに基づく、様々な地域におけるペプチド受託製造サービスプロバイダーの能力の分析。
患者集団、投与頻度、強度に基づくペプチド治療薬の商業的および臨床的需要の分析。
 さまざまな規模の企業、事業規模(臨床と商業)、地理的地域にわたる全体的なペプチド製造能力の分析。
 パイプラインの強さ、成熟度、設立年、企業規模に基づき、ペプチド治療薬開発企業との協力のために特定された潜在的戦略的パートナー。
 ペプチド医薬品開発企業が、自社製造かCMOサービスのどちらを利用するかを決定する際に考慮すべき要素を概説する定性的分析。
 ペプチド受託製造サービスプロバイダーの10年間の総所有コストについて、直接経費と間接経費を考慮した詳細な分析。
 2035年までのペプチド受託製造市場の成長を予測する市場予測分析。事業規模、合成方法、企業規模、地域別に区分。
 COVID-19パンデミックがペプチド受託製造市場にどのような影響を与えるか、またパンデミックに起因する課題に対処するためにサービスプロバイダーがどのような取り組みを行っているかについての洞察に満ちた考察。
 業界動向、促進要因、課題、SWOT分析に関する詳細な考察を行い、ペプチド受託製造分野の進化に与える影響を評価。
 主要な要点、ペプチドCMO市場に関する独自の見解、市場成長に影響を与える今後の動向、調査・分析から得られた洞察を紹介したレポート全体の要約。
 ペプチド治療薬受託製造市場の複数の利害関係者が参加した包括的な調査からの洞察。

主要市場企業
 アンビオファーム
 CPCサイエンティフィック
 Creative Peptides
 CSBio
 バケム
 BCN Peptide
 コーデンファーマ
 ポリペプチド
 ゼンケミカルズ
 Auspep
 チャイニーズペプチド
 ハイバイオ製薬
 ペプチド研究所
 サイノファーマ

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目次

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
2.1. Chapter Overview
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Peptides
3.2.1. Structural Analysis of Peptides
3.2.2. Classification of Peptides
3.2.3. Peptide Synthesis
3.2.4. Type of Peptide Modification
3.2.4.1. N-terminal Modification
3.2.4.2. Internal Modification
3.2.4.3. C-terminal Modification
3.2.4.4. Other Modifications
3.2.5. Peptide Purification
3.2.5.1. Key Guidelines for Peptide Purity
3.3. Overview of Contract Manufacturing
3.3.1. Need for Outsourcing Peptide Manufacturing Operations
3.3.2. Key Considerations for Selecting a CMO Partner
3.3.3. Advantages of Outsourcing Manufacturing Services
3.3.4. Risks and Challenges Associated with Outsourcing Peptide Manufacturing Operations
3.4. Future Perspectives
4. REGULATORY LANDSCAPE
4.1. Chapter Overview
4.2. Regulatory Scenario: North America
4.2.1. The US Scenario
4.2.1.1. Overview
4.2.1.2. General Guidelines
4.3. Regulatory Scenario: Europe
4.3.1. The European Scenario
4.3.1.1. Overview
4.3.1.2. General Guidelines
4.4. Regulatory Scenario: Asia Pacific
4.4.1. Overview
4.4.2. Australian Scenario
4.4.2.1. General Guidelines
4.4.3. Chinese Scenario
4.4.3.1. General Guidelines
4.4.4. Indian Scenario
4.4.4.1. General Guidelines
4.4.5. Japanese Scenario
4.4.5.1. General Guidelines
4.4.6. South Korean Scenario
4.4.6.1. General Guidelines
4.5. Key Challenges Associated with Peptide Manufacturing
5. COMPETITIVE LANDSCAPE
5.1 Chapter Overview
5.2 Contract Peptide API Manufacturers: Overall Market Landscape
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Company Size
5.2.3. Analysis by Location of Headquarters
5.2.4. Analysis by Location of Manufacturing Facility (Continent-wise)
5.2.5. Analysis by Location of Manufacturing Facility (Country-wise)
5.2.6. Analysis by Type of Product
5.2.7. Analysis by Type of Service(s) Offered
5.2.8. Analysis by Scale of Operation
5.2.9. Analysis by Type of Peptide Synthesis Method Used
5.2.10. Analysis by Type of Peptide Modification Services Offered
5.2.11. Analysis by Type of Purification Technology Used
5.2.12. Analysis by Regulatory Accreditations / Certifications Received
5.3. List of Custom Peptide Manufacturers
6. COMPANY COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Key Parameters
6.3. Methodology
6.4. Company Competitiveness Analysis: Peptide Therapeutics Contract API Manufacturers
6.4.1 Company Competitiveness: Small Companies
6.4.2 Company Competitiveness: Mid-sized Companies
6.4.3. Company Competitiveness: Large Companies
7. COMPANY PROFILES
7.1 Chapter Overview
7.2. Contract Peptide API Manufacturers Based in North America
7.2.1. AmbioPharm
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.3. Manufacturing Facilities and Capabilities
7.2.1.4. Recent Development and Future Outlook
7.2.2. CPC Scientific
7.2.2.1. Company Overview
7.2.2.2. Service Portfolio
7.2.2.3. Manufacturing Facilities and Capabilities
7.2.2.4. Recent Developments and Future Outlook
7.2.3. Creative Peptides
7.2.3.1. Company Overview
7.2.3.2. Service Portfolio
7.2.3.3. Manufacturing Facilities and Capabilities
7.2.3.4. Recent Developments and Future Outlook
7.2.4. CSBio
7.2.4.1. Company Overview
7.2.4.2. Service Portfolio
7.2.4.3. Manufacturing Facilities and Capabilities
7.2.4.4. Recent Developments and Future Outlook
7.3. Contract Peptide API Manufacturers Based in Europe
7.3.1. Bachem
7.3.1.1. Recent Developments and Company Overview
7.3.1.2. Service Portfolio
7.3.1.3. Manufacturing Facilities and Capabilities
7.3.1.4. Recent Developments and Future Outlook
7.3.2. BCN Peptide
7.3.2.1. Company Overview
7.3.2.2. Service Portfolio
7.3.2.3. Manufacturing Facilities and Capabilities
7.3.2.4. Recent Developments and Future Outlook
7.3.3. Corden Pharma
7.3.3.1. Company Overview
7.3.3.2. Service Portfolio
7.3.3.3. Manufacturing Facilities and Capabilities
7.3.3.4. Recent Developments and Future Outlook
7.3.4. PolyPeptide
7.3.4.1. Company Overview
7.3.4.2. Service Portfolio
7.3.4.3. Manufacturing Facilities and Capabilities
7.3.4.4. Recent Developments and Future Outlook
7.3.5. Senn Chemicals
7.3.5.1. Company Overview
7.3.5.2. Service Portfolio
7.3.5.3. Manufacturing Facilities and Capabilities
7.3.5.4. Recent Developments and Future Outlook
7.4. Contract Peptide API Manufacturers Based in Asia Pacific
7.4.1. Auspep
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.3. Manufacturing Facilities and Capabilities
7.4.1.4. Recent Developments and Future Outlook
7.4.2. Chinese Peptide
7.4.2.1. Company Overview
7.4.2.2. Service Portfolio
7.4.2.3. Manufacturing Facilities and Capabilities
7.4.2.4. Recent Developments and Future Outlook
7.4.3. Hybio Pharmaceutical
7.4.3.1. Company Overview
7.4.3.2. Service Portfolio
7.4.3.3. Manufacturing Facilities and Capabilities
7.4.3.4. Recent Developments and Future Outlook
7.4.4. Peptide Institute
7.4.4.1. Company Overview
7.4.4.2. Service Portfolio
7.4.4.3. Manufacturing Facilities and Capabilities
7.4.4.4. Recent Developments and Future Outlook
7.4.5. ScinoPharm
7.4.5.1. Company Overview
7.4.5.2. Service Portfolio
7.4.5.3. Manufacturing Facilities and Capabilities
7.4.5.4. Recent Developments and Future Outlook
8. RECENT DEVELOPMENTS
8.1. Chapter Overview
8.2. Partnerships Models
8.3. Peptide Therapeutics Contract API Manufacturers: List of Partnerships and Collaborations
8.3.1. Analysis by Year of Partnership
8.3.2. Analysis by Type of Partnership
8.3.3. Analysis by Scale of Operation
8.3.4. Analysis by Region (Continent-wise)
8.3.4.1. Analysis by Region (Country-wise)
8.3.4.2. Intercontinental and Intracontinental Distribution
8.4. Expansion Models
8.5. List of Recent Expansions
8.5.1. Analysis by Year of Expansion
8.5.2. Analysis by Type of Expansion
8.5.3. Analysis by Location of Expansion (Continent-wise)
8.5.4. Analysis by Location of Expansion (Country-wise)
8.6. Emerging Peptide Synthesis Technologies
8.6.1. Chemo-Enzymatic Peptide Synthesis Technology
8.6.2. Continuous Flow Technology
8.6.3. Green Chemistry
9. CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Peptide Therapeutics: List of Clinical Trials
9.3.1. Analysis by Trial Status
9.3.2. Analysis by Trial Registration Year
9.3.3. Analysis by Type of Masking
9.3.4. Analysis by Type of Intervention Model
9.3.5. Analysis by Study Design
9.3.6. Analysis by Phase of Development
9.3.7. Analysis by Type of Sponsor
9.3.8. Most Active Players: Analysis by Number of Trials Registered
9.3.9. Analysis by Trial Registration Year and Trial Status
9.3.10. Analysis by Trial Registration Year and Geography
9.3.11. Analysis by Number of Trials, Trial Status and Geography
9.3.12. Analysis by Number of Trials, Trial Registration Year and Geography
9.4. Analysis of Enrolled Patient Population
9.4.1. Analysis of Enrolled Patient Population by Geography
9.4.2. Analysis by Number of Patients Enrolled, Trial Status and Geography
9.4.3. Analysis by Phase of Development, Trial Registration Year and Number of Patients Enrolled
9.4.4. Analysis of Number of Clinical Trials by Geography
10. REGIONAL CAPABILITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Overall Landscape of Contract Peptide API Manufacturers
10.4. Contract Peptide API Manufacturers in North America
10.5. Contract Peptide API Manufacturers in Europe
10.6. Contract Peptide API Manufacturing in Asia Pacific
11. DEMAND ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Methodology
11.3. Peptide API Manufacturing: Overall Annual Demand
11.3.1. Analysis by Geography
12. CAPACITY ANALYSIS
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Peptide API Manufacturing: Installed Global Capacity
12.3.1. Analysis by Company Size
12.3.2. Analysis by Scale of Operation
12.3.3. Analysis by Location of Manufacturing Facility
12.3.4. Analysis by Company Size and Location of Manufacturing Facility
12.3.5. Analysis by Scape of Operation and Location of Manufacturing Facility
12.4. Concluding Remarks
13. LIKELY PARTNERS FOR PEPTIDE THERAPEUTICS CONTRACT API MANUFACTURING SERVICE PROVIDERS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Potential Strategic Partners for Peptide Contract Manufacturers
14. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
14.1. Chapter Overview
14.2. Assumptions and Parameter Definitions
14.2.1. Scenario 1
14.2.2. Scenario 2
14.2.3. Scenario 3
14.2.4. Scenario 4
14.3. Concluding Remarks
15. TOTAL COST OF OWNERSHIP IN PEPTIDE CONTRACT MANUFACTURING ORGANIZATION
15.1. Chapter Overview
15.2. Expenditures Incurred by a Peptide Contract Manufacturing Organization
15.2.1. Capital Expenditures (CAPEX)
15.2.2. Operational Expenditures (OPEX)
15.3. Assumptions and Methodology
15.4. Total Cost of Ownership of Peptide Contract Manufacturing Organization, 2021-2030
15.5. Total Cost of Ownership of Peptide Contract Manufacturing Organization: Distribution by CAPEX and OPEX, 2021-2030
15.5.1. Total Cost of Ownership of Peptide Contract Manufacturing Organization: Distribution by CAPEX, 2021-2030
15.5.2. Total Cost of Ownership of Peptide Contract Manufacturing Organization: Distribution by OPEX, 2021-2030
15.6. Concluding Remarks
16. MARKET SIZING AND OPPORTUNITY ANALYSIS
16.1. Chapter Overview
16.2. Assumptions and Forecast Methodology
16.3. Overall Peptide Therapeutics Contract Manufacturing Market, 2022-2035
16.3.1. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035
16.3.2. Peptide Therapeutics Contract FDF Manufacturing Market, 2022-2035
16.4. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Scale of Operation
16.5. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Type of Peptide Synthesis Method Used
16.5.1. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Type of Chemical Synthesis Method Used
16.6. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Company Size
16.7. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Key Geographical Regions
16.7.1. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035
16.7.1.1. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Small Companies
16.7.1.2. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Mid-sized Companies
16.7.1.3. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Large Companies
16.7.1.4. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Preclinical / Clinical Scale Operations
16.7.1.5. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Commercial Scale Operations
16.7.1.6. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Chemical Synthesis Methods
16.7.1.8. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Non-Chemical Synthesis Methods
16.7.2. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035
16.7.2.1. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Small Companies
16.7.2.2. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Mid-sized Companies
16.7.2.3. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Large Companies
16.7.2.4. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Preclinical / Clinical Scale Operations
16.7.2.5. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Commercial Scale Operations
16.7.2.6. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Chemical Synthesis Methods
16.7.2.8. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Non-Chemical Synthesis Methods
16.7.3. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035
16.7.3.1. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Small Companies
16.7.3.2. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Mid-sized Companies
16.7.3.3. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Large Companies
16.7.3.4. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Preclinical / Clinical Scale Operations
16.7.3.5. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Commercial Scale Operations
16.7.3.6. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Chemical Synthesis Methods
16.7.3.7. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Non-Chemical Synthesis Methods
17. IMPACT OF THE COVID-19 PANDEMIC ON THE PEPTIDE API CONTRACT MANUFACTURING MARKET
17.1. Chapter Overview
17.2. Current Options and Recuperative Initiatives of Key Players
17.2.1. Bachem
17.2.2. CPC Scientific
17.2.3. Corden Pharma
17.2.4. PolyPeptide
17.2.5. Wuxi AppTec
17.3. Impact on Peptide API Contract Manufacturing Market
18. SWOT ANALYSIS
18.1. Chapter Overview
18.2. Strengths
18.3. Weaknesses
18.4. Opportunities
18.5. Threats
18.6. Comparison of SWOT Factors
18.7. Concluding Remark
19. CONCLUSION
19.1. Chapter Overview
20. SURVEY TRANSCRIPT(S)
21. APPENDIX 1: TABULATED DATA
22. APPENDIX 2: LIST OF COMPANIES AND ORGANISTIONS

 

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Summary

The global peptide synthesis service market is expected to reach USD 1.7 billion in 2022 anticipated to grow at a CAGR of 13.6% during the forecast period 2022-2035.

The increasing prominence of biologics has spurred a notable pivot among pharmaceutical enterprises towards more sophisticated interventions such as peptide therapeutics. Since the discovery of insulin, the market for peptide-based drugs has flourished, encompassing over 80 medications that target a spectrum of ailments including cancer, diabetes, and HIV. Since 2017, the FDA has approved over 10 peptide drugs, including LupkynisTM and Zegalogue® in 2021, and ImcivreeTM, Victoza®, and LUPRON DEPOT® in 2020. A vast array of clinical trials, exceeding 1,000, is currently investigating the therapeutic potential of novel peptides.
The surging demand for these drugs emanates from their specificity, minimal drug interactions, diverse biological actions, prolonged half-lives, established pharmacological efficacy, and safety profiles. However, the synthesis and purification of peptides present challenges that impact both yield and purity. To counter this, numerous entities involved in peptide synthesis opt to engage contract manufacturers. Presently, more than 60 Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) offer services encompassing peptide development, manufacturing, and purification, consolidating themselves as comprehensive solutions for developers.
With continuous technological innovations, advancements in purification techniques, and an expanding pipeline, the peptide market is anticipated to undergo sustained growth. As pharmaceutical companies resume full operational capacities post-COVID-19, there is a projected uptick in demand for large-scale manufacturing of peptide therapeutics. Notably, the development of peptide-based COVID-19 vaccines will further amplify the need for manufacturing service providers to scale up production post-approval, addressing global demands.

Report Coverage
 The key insights from our research on the peptide contract manufacturing market, offering a high-level overview of its current status and expected evolution in the short, mid, and long term
 Introduction to peptides, discussing different classes, synthesis methods, modifications, purification strategies, applications, and the rationale behind outsourcing peptide manufacturing operations.
 Detailed insights into the regulatory landscape of peptide contract manufacturers across various regions like the US, Europe, Australia, China, India, Japan, and South Korea, including challenges faced due to regulatory scrutiny.
 An overview of companies providing peptide contract manufacturing services, highlighting parameters such as establishment year, company size, geographical locations, synthesis methods, purification techniques, and regulatory certifications.
 An analysis of prominent peptide contract manufacturers' competitiveness based on service strength, manufacturing capabilities, facility numbers, synthesis, purification methods, and peptide modification
 Detailed profiles of key players in the peptide contract manufacturing domain, featuring company overviews, establishment years, employee count, headquarters, services offered, recent developments, and future outlooks.
 An analysis of recent developments in the peptide contract manufacturing industry, including partnerships, collaborations, and facility expansions between 2016 and 2021.
 In-depth analysis of completed, ongoing, and planned clinical studies on peptide therapeutics, focusing on trial parameters, industry players, study focus, and geographical regions.
 Analysis of peptide contract manufacturing service providers' capabilities across different regions based on various parameters like CMO numbers, clinical sites, trials, patients enrolled, product types, and demand.
An analysis of the commercial and clinical demand for peptide therapeutics based on patient population, dosing frequency, and strength.
 Analysis of the overall peptide manufacturing capacity across different-sized companies, operational scales (clinical vs. commercial), and geographical regions.
 Potential strategic partners identified for collaboration with peptide therapeutics developers based on pipeline strength, maturity, establishment year, and company size.
 Qualitative analysis outlining factors for peptide drug developers to consider while deciding between in-house manufacturing or engaging a CMO's services.
 Detailed analysis of the total cost of ownership for a peptide contract manufacturing service provider over ten years, considering direct and indirect expenses.
 Market forecast analysis projecting the peptide contract manufacturing market's growth till 2035, segmented by operational scale, synthesis methods, company size, and geographical regions.
 Insightful discussion on how the COVID-19 pandemic might impact the peptide contract manufacturing market and initiatives taken by service providers to address pandemic-induced challenges.
 In-depth discussion on industry trends, drivers, challenges, and SWOT analysis, evaluating their impact on the evolution of the peptide contract manufacturing field.
 A summary of the entire report, presenting key takeaways, independent opinions on the peptide CMO market, upcoming trends influencing market growth, and insights from the research and analysis.
 Insights from a comprehensive survey involving multiple stakeholders in the peptide therapeutics contract manufacturing market.

Key Market Companies
 AmbioPharm
 CPC Scientific
 Creative Peptides
 CSBio
 Bachem
 BCN Peptide
 Corden Pharma
 PolyPeptide
 Senn Chemicals
 Auspep
 Chinese Peptide
 Hybio Pharmaceutical
 Peptide Institute
 ScinoPharm



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Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
2.1. Chapter Overview
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Peptides
3.2.1. Structural Analysis of Peptides
3.2.2. Classification of Peptides
3.2.3. Peptide Synthesis
3.2.4. Type of Peptide Modification
3.2.4.1. N-terminal Modification
3.2.4.2. Internal Modification
3.2.4.3. C-terminal Modification
3.2.4.4. Other Modifications
3.2.5. Peptide Purification
3.2.5.1. Key Guidelines for Peptide Purity
3.3. Overview of Contract Manufacturing
3.3.1. Need for Outsourcing Peptide Manufacturing Operations
3.3.2. Key Considerations for Selecting a CMO Partner
3.3.3. Advantages of Outsourcing Manufacturing Services
3.3.4. Risks and Challenges Associated with Outsourcing Peptide Manufacturing Operations
3.4. Future Perspectives
4. REGULATORY LANDSCAPE
4.1. Chapter Overview
4.2. Regulatory Scenario: North America
4.2.1. The US Scenario
4.2.1.1. Overview
4.2.1.2. General Guidelines
4.3. Regulatory Scenario: Europe
4.3.1. The European Scenario
4.3.1.1. Overview
4.3.1.2. General Guidelines
4.4. Regulatory Scenario: Asia Pacific
4.4.1. Overview
4.4.2. Australian Scenario
4.4.2.1. General Guidelines
4.4.3. Chinese Scenario
4.4.3.1. General Guidelines
4.4.4. Indian Scenario
4.4.4.1. General Guidelines
4.4.5. Japanese Scenario
4.4.5.1. General Guidelines
4.4.6. South Korean Scenario
4.4.6.1. General Guidelines
4.5. Key Challenges Associated with Peptide Manufacturing
5. COMPETITIVE LANDSCAPE
5.1 Chapter Overview
5.2 Contract Peptide API Manufacturers: Overall Market Landscape
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Company Size
5.2.3. Analysis by Location of Headquarters
5.2.4. Analysis by Location of Manufacturing Facility (Continent-wise)
5.2.5. Analysis by Location of Manufacturing Facility (Country-wise)
5.2.6. Analysis by Type of Product
5.2.7. Analysis by Type of Service(s) Offered
5.2.8. Analysis by Scale of Operation
5.2.9. Analysis by Type of Peptide Synthesis Method Used
5.2.10. Analysis by Type of Peptide Modification Services Offered
5.2.11. Analysis by Type of Purification Technology Used
5.2.12. Analysis by Regulatory Accreditations / Certifications Received
5.3. List of Custom Peptide Manufacturers
6. COMPANY COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Key Parameters
6.3. Methodology
6.4. Company Competitiveness Analysis: Peptide Therapeutics Contract API Manufacturers
6.4.1 Company Competitiveness: Small Companies
6.4.2 Company Competitiveness: Mid-sized Companies
6.4.3. Company Competitiveness: Large Companies
7. COMPANY PROFILES
7.1 Chapter Overview
7.2. Contract Peptide API Manufacturers Based in North America
7.2.1. AmbioPharm
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.3. Manufacturing Facilities and Capabilities
7.2.1.4. Recent Development and Future Outlook
7.2.2. CPC Scientific
7.2.2.1. Company Overview
7.2.2.2. Service Portfolio
7.2.2.3. Manufacturing Facilities and Capabilities
7.2.2.4. Recent Developments and Future Outlook
7.2.3. Creative Peptides
7.2.3.1. Company Overview
7.2.3.2. Service Portfolio
7.2.3.3. Manufacturing Facilities and Capabilities
7.2.3.4. Recent Developments and Future Outlook
7.2.4. CSBio
7.2.4.1. Company Overview
7.2.4.2. Service Portfolio
7.2.4.3. Manufacturing Facilities and Capabilities
7.2.4.4. Recent Developments and Future Outlook
7.3. Contract Peptide API Manufacturers Based in Europe
7.3.1. Bachem
7.3.1.1. Recent Developments and Company Overview
7.3.1.2. Service Portfolio
7.3.1.3. Manufacturing Facilities and Capabilities
7.3.1.4. Recent Developments and Future Outlook
7.3.2. BCN Peptide
7.3.2.1. Company Overview
7.3.2.2. Service Portfolio
7.3.2.3. Manufacturing Facilities and Capabilities
7.3.2.4. Recent Developments and Future Outlook
7.3.3. Corden Pharma
7.3.3.1. Company Overview
7.3.3.2. Service Portfolio
7.3.3.3. Manufacturing Facilities and Capabilities
7.3.3.4. Recent Developments and Future Outlook
7.3.4. PolyPeptide
7.3.4.1. Company Overview
7.3.4.2. Service Portfolio
7.3.4.3. Manufacturing Facilities and Capabilities
7.3.4.4. Recent Developments and Future Outlook
7.3.5. Senn Chemicals
7.3.5.1. Company Overview
7.3.5.2. Service Portfolio
7.3.5.3. Manufacturing Facilities and Capabilities
7.3.5.4. Recent Developments and Future Outlook
7.4. Contract Peptide API Manufacturers Based in Asia Pacific
7.4.1. Auspep
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.3. Manufacturing Facilities and Capabilities
7.4.1.4. Recent Developments and Future Outlook
7.4.2. Chinese Peptide
7.4.2.1. Company Overview
7.4.2.2. Service Portfolio
7.4.2.3. Manufacturing Facilities and Capabilities
7.4.2.4. Recent Developments and Future Outlook
7.4.3. Hybio Pharmaceutical
7.4.3.1. Company Overview
7.4.3.2. Service Portfolio
7.4.3.3. Manufacturing Facilities and Capabilities
7.4.3.4. Recent Developments and Future Outlook
7.4.4. Peptide Institute
7.4.4.1. Company Overview
7.4.4.2. Service Portfolio
7.4.4.3. Manufacturing Facilities and Capabilities
7.4.4.4. Recent Developments and Future Outlook
7.4.5. ScinoPharm
7.4.5.1. Company Overview
7.4.5.2. Service Portfolio
7.4.5.3. Manufacturing Facilities and Capabilities
7.4.5.4. Recent Developments and Future Outlook
8. RECENT DEVELOPMENTS
8.1. Chapter Overview
8.2. Partnerships Models
8.3. Peptide Therapeutics Contract API Manufacturers: List of Partnerships and Collaborations
8.3.1. Analysis by Year of Partnership
8.3.2. Analysis by Type of Partnership
8.3.3. Analysis by Scale of Operation
8.3.4. Analysis by Region (Continent-wise)
8.3.4.1. Analysis by Region (Country-wise)
8.3.4.2. Intercontinental and Intracontinental Distribution
8.4. Expansion Models
8.5. List of Recent Expansions
8.5.1. Analysis by Year of Expansion
8.5.2. Analysis by Type of Expansion
8.5.3. Analysis by Location of Expansion (Continent-wise)
8.5.4. Analysis by Location of Expansion (Country-wise)
8.6. Emerging Peptide Synthesis Technologies
8.6.1. Chemo-Enzymatic Peptide Synthesis Technology
8.6.2. Continuous Flow Technology
8.6.3. Green Chemistry
9. CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Peptide Therapeutics: List of Clinical Trials
9.3.1. Analysis by Trial Status
9.3.2. Analysis by Trial Registration Year
9.3.3. Analysis by Type of Masking
9.3.4. Analysis by Type of Intervention Model
9.3.5. Analysis by Study Design
9.3.6. Analysis by Phase of Development
9.3.7. Analysis by Type of Sponsor
9.3.8. Most Active Players: Analysis by Number of Trials Registered
9.3.9. Analysis by Trial Registration Year and Trial Status
9.3.10. Analysis by Trial Registration Year and Geography
9.3.11. Analysis by Number of Trials, Trial Status and Geography
9.3.12. Analysis by Number of Trials, Trial Registration Year and Geography
9.4. Analysis of Enrolled Patient Population
9.4.1. Analysis of Enrolled Patient Population by Geography
9.4.2. Analysis by Number of Patients Enrolled, Trial Status and Geography
9.4.3. Analysis by Phase of Development, Trial Registration Year and Number of Patients Enrolled
9.4.4. Analysis of Number of Clinical Trials by Geography
10. REGIONAL CAPABILITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Overall Landscape of Contract Peptide API Manufacturers
10.4. Contract Peptide API Manufacturers in North America
10.5. Contract Peptide API Manufacturers in Europe
10.6. Contract Peptide API Manufacturing in Asia Pacific
11. DEMAND ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Methodology
11.3. Peptide API Manufacturing: Overall Annual Demand
11.3.1. Analysis by Geography
12. CAPACITY ANALYSIS
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Peptide API Manufacturing: Installed Global Capacity
12.3.1. Analysis by Company Size
12.3.2. Analysis by Scale of Operation
12.3.3. Analysis by Location of Manufacturing Facility
12.3.4. Analysis by Company Size and Location of Manufacturing Facility
12.3.5. Analysis by Scape of Operation and Location of Manufacturing Facility
12.4. Concluding Remarks
13. LIKELY PARTNERS FOR PEPTIDE THERAPEUTICS CONTRACT API MANUFACTURING SERVICE PROVIDERS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Potential Strategic Partners for Peptide Contract Manufacturers
14. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
14.1. Chapter Overview
14.2. Assumptions and Parameter Definitions
14.2.1. Scenario 1
14.2.2. Scenario 2
14.2.3. Scenario 3
14.2.4. Scenario 4
14.3. Concluding Remarks
15. TOTAL COST OF OWNERSHIP IN PEPTIDE CONTRACT MANUFACTURING ORGANIZATION
15.1. Chapter Overview
15.2. Expenditures Incurred by a Peptide Contract Manufacturing Organization
15.2.1. Capital Expenditures (CAPEX)
15.2.2. Operational Expenditures (OPEX)
15.3. Assumptions and Methodology
15.4. Total Cost of Ownership of Peptide Contract Manufacturing Organization, 2021-2030
15.5. Total Cost of Ownership of Peptide Contract Manufacturing Organization: Distribution by CAPEX and OPEX, 2021-2030
15.5.1. Total Cost of Ownership of Peptide Contract Manufacturing Organization: Distribution by CAPEX, 2021-2030
15.5.2. Total Cost of Ownership of Peptide Contract Manufacturing Organization: Distribution by OPEX, 2021-2030
15.6. Concluding Remarks
16. MARKET SIZING AND OPPORTUNITY ANALYSIS
16.1. Chapter Overview
16.2. Assumptions and Forecast Methodology
16.3. Overall Peptide Therapeutics Contract Manufacturing Market, 2022-2035
16.3.1. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035
16.3.2. Peptide Therapeutics Contract FDF Manufacturing Market, 2022-2035
16.4. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Scale of Operation
16.5. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Type of Peptide Synthesis Method Used
16.5.1. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Type of Chemical Synthesis Method Used
16.6. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Company Size
16.7. Peptide Therapeutics Contract API Manufacturing Market, 2022-2035: Distribution by Key Geographical Regions
16.7.1. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035
16.7.1.1. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Small Companies
16.7.1.2. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Mid-sized Companies
16.7.1.3. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Large Companies
16.7.1.4. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Preclinical / Clinical Scale Operations
16.7.1.5. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Commercial Scale Operations
16.7.1.6. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Chemical Synthesis Methods
16.7.1.8. Peptide Therapeutics Contract API Manufacturing Market in North America, 2022-2035: Share of Non-Chemical Synthesis Methods
16.7.2. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035
16.7.2.1. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Small Companies
16.7.2.2. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Mid-sized Companies
16.7.2.3. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Large Companies
16.7.2.4. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Preclinical / Clinical Scale Operations
16.7.2.5. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Commercial Scale Operations
16.7.2.6. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Chemical Synthesis Methods
16.7.2.8. Peptide Therapeutics Contract API Manufacturing Market in Europe, 2022-2035: Share of Non-Chemical Synthesis Methods
16.7.3. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035
16.7.3.1. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Small Companies
16.7.3.2. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Mid-sized Companies
16.7.3.3. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Large Companies
16.7.3.4. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Preclinical / Clinical Scale Operations
16.7.3.5. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Commercial Scale Operations
16.7.3.6. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Chemical Synthesis Methods
16.7.3.7. Peptide Therapeutics Contract API Manufacturing Market in Asia Pacific, 2022-2035: Share of Non-Chemical Synthesis Methods
17. IMPACT OF THE COVID-19 PANDEMIC ON THE PEPTIDE API CONTRACT MANUFACTURING MARKET
17.1. Chapter Overview
17.2. Current Options and Recuperative Initiatives of Key Players
17.2.1. Bachem
17.2.2. CPC Scientific
17.2.3. Corden Pharma
17.2.4. PolyPeptide
17.2.5. Wuxi AppTec
17.3. Impact on Peptide API Contract Manufacturing Market
18. SWOT ANALYSIS
18.1. Chapter Overview
18.2. Strengths
18.3. Weaknesses
18.4. Opportunities
18.5. Threats
18.6. Comparison of SWOT Factors
18.7. Concluding Remark
19. CONCLUSION
19.1. Chapter Overview
20. SURVEY TRANSCRIPT(S)
21. APPENDIX 1: TABULATED DATA
22. APPENDIX 2: LIST OF COMPANIES AND ORGANISTIONS

 

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