市場調査レポート

商品コード

1771305

薬物・機械器具コンビネーション製品市場：業界動向と世界の予測 - 機器タイプ別、サービス重点分野別、企業規模別、主要地域別

Drug Device Combination Products Market: Industry Trends and Global Forecasts - Distribution by Type of Device, Service Focus Area, Company Size, and Key Geographical Regions

出版日: 2025年07月15日
発行: Roots Analysis
ページ情報: 英文 212 Pages
納期: 即日から翌営業日

カスタマイズ可能

価格

PDF (Single User License)

USD 4,799 712,507円

レポートPDFを1名のみがご利用頂けるライセンスです。PDF内のテキスト等のコピー＆ペーストは可能です。PDFの印刷も可能です。印刷したもののご利用はPDFのご利用範囲に準拠します。

PDF (One-Location Site License)

USD 6,999 1,039,141円

レポートPDFを同一所在地における特定事業ユニットに属する全ての方にてご利用頂けるライセンスです。PDF内のテキスト等のコピー＆ペーストは可能です。PDFの印刷は可能です。印刷したもののご利用はPDFのご利用範囲に準拠します。

PDF (Department License)

USD 10,599 1,573,633円

レポートPDFを部署単位で12名様までご利用いただけるライセンスです。同一部署内であれば、地理的に同じ地点に存在する必要はありません。PDF内のテキスト等のコピー＆ペーストは可能です。PDFの印刷も可能です。印刷したもののご利用はPDFのご利用範囲に準拠します。

PDF (Enterprise License)

USD 17,999 2,672,311円

レポートPDFを同社の国内外拠点における全ての方にてご利用頂けるライセンスです。PDF内のテキスト等のコピー＆ペーストは可能です。PDFの印刷も可能です。印刷したもののご利用はPDFのご利用範囲に準拠します。

価格表記: USDを日本円(税抜)に換算

本日の銀行送金レート: 1USD=148.47円

全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

世界の薬物・機械器具コンビネーション製品市場：成長と動向

処方された薬物療法へのノンアドヒアランス（服薬不遵守）は、患者の健康に悪影響を及ぼすだけでなく、製薬業界全体の負担を増大させる重大な問題です。Contract Pharmaが最近報告したように、服薬不遵守は医薬品開発企業にとって毎年2,500億米ドル以上のコストになると推定されています。さらに、原薬（API）を標的送達部位で徐放または制御放出するための効果的なソリューションがないことは、ドラッグデリバリーにおける大きな課題として残っています。実際、APIの放出制御が不十分だと、血漿中の薬物濃度が変動し、さまざまな副作用を引き起こす可能性があります。このため、患者のための効果的なドラッグデリバリー治療オプションに対する需要が高まっています。

Drug Device Combination Products Market-IMG1

特筆すべきは、ここ最近、コンビネーション製品の開発が製薬会社から大きな関心を集めていることです。これらの製品は、FDAが規制する2つ以上の成分を統合し、原薬の制御放出を可能にするものです。しかし、医薬品と医療機器の組み合わせ製品を開発するのは、革新的な技術、多額の投資、専門的な知識を必要とする複雑で時間のかかるプロセスです。さらなる課題としては、薬剤とデバイスの適合性の確保、ユーザーの要求事項への対応、放出試験の実施、製造・包装基準の遵守などが挙げられます。こうしたハードルに対処し、患者の転帰を改善するため、多くの開発企業は現在、コンビネーション製品の試験・検証サービスを提供する専門企業に主な業務をアウトソーシングしています。

世界の薬物・機械器具コンビネーション製品市場：主要インサイト

当レポートでは、世界の薬物・機械器具コンビネーション製品市場の現状を調査し、潜在的な成長機会を特定しています。主な調査結果は以下の通りです。

現在、世界中で25社以上の企業が、様々な医薬品と医療機器の組み合わせ製品の開発・試験サービスを提供しています。
サービスプロバイダーは、様々なタイプの組み合わせ製品に幅広いサービスを提供するために必要な専門知識を持っていると主張しています。
ドラッグデリバリーデバイス/システムの開発と試験をサポートする企業の大半（85％以上）は北米に本社を置いています。
45%以上のサービスプロバイダーが、組み合わせ製品の性能試験と製品開発を支援しており、そのうち40%は大手/超大手です。
コンビネーション製品のサービスプロバイダーの約75%は、プロセス開発とバリデーションを実施しており、BS、EKG Labs、Exponent、Surpassなどがその例です。

Drug Device Combination Products Market-IMG2

この競争の激しい業界で優位に立つため、サービスプロバイダーは、既存のサービス内容をアップグレードする取り組みを継続的に行っています。
増大する需要に対応するため、多くの企業がサービス・ポートフォリオを強化するため、新規施設の設立（～40％）や既存能力の拡大（～50％）といった拡大策を実施しています。
拡張イニシアチブの大半は、米国を拠点とするコンビネーション製品サービスプロバイダー別実施されたもので、DDL、NAMSA、Nelson Labsなどがその例です。
大半の拡張は、コンビネーション製品に関連する検査サービスに対する需要の増加に対応するために実施されました。
報告された拡張のほとんどは、地元での取り組みでしたが、米国を拠点とするいくつかの企業は、国際的な拡張の取り組みも行っています。
現在、210を超えるコンビネーション製品が様々な臨床症状の治療用に開発されており、また現在開発中です。これらのコンビネーション製品は非経口および非経口ドラッグデリバリーの両方に使用できます。
パイプラインには、様々な治療領域向けに開発された／開発中の様々なコンビネーション製品があり、その大半は生物製剤の投与用に評価されています。
現在開発中の大容量WIコンビネーション製品の大部分（約80％）は、基礎用量を提供するために開発されています。
大容量WIコンビネーション製品のかなりの割合（33％）が神経疾患の治療用に開発されており、例としてD-mine（R）Pump、ND0701が挙げられます。
プレフィルドシリンジコンビネーション製品の90％以上が生物製剤の投与用に開発されており、現在開発中です。
コンビネーション製品開発企業は、独自のコンビネーション製品の開発と試験のために、サービスプロバイダーと戦略的提携を結ぶと予想されます。
当社は、知的資本を基に、開発者が製造を外注するか自社で行うかを決定できる独自のフレームワークを提案しています。

Drug Device Combination Products Market-IMG3

コンビネーション製品の需要の高まりに伴い、サービスプロバイダーの関連市場は今後10年間、年率換算で安定した成長が見込まれます。

薬物・機械器具コンビネーション製品市場における参入企業例

EKG LABS
Eurofins Medical Device Testing
Exponent
Kymanox
Medical Engineering Technologies
Pace Analytical Services
Suttons Creek
West Pharmaceutical Services

当レポートでは、世界の薬物・機械器具コンビネーション製品市場について調査し、市場の概要とともに、機器タイプ別、サービス重点分野別、企業規模別動向、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

章の概要
コンビネーション製品のイントロダクション
コンビネーション製品の開発に伴う課題
アウトソーシングされたコンビネーション製品業務/サービス
コンビネーション製品のアウトソーシング業務のメリット
CDMOを選択する際に考慮すべき重要な点
将来の展望

第4章コンビネーション製品サービスプロバイダー：市場情勢

章の概要
コンビネーション製品サービスプロバイダー：市場情勢

第5章企業競争力分析

章の概要
前提/主要パラメータ
調査手法
コンビネーション製品サービスプロバイダー：企業競争力分析

第6章コンビネーション製品サービスプロバイダー：企業プロファイル

章の概要
EKG LABS
Eurofins Medical Device Testing
Exponent
Kymanox
Medical Engineering Technologies
Pace Analytical Services
Suttons Creek
West Pharmaceutical Services
結論：業界参入企業が実施する取り組み

第7章最近の拡張

第8章ケーススタディ：大容量ウェアラブルインジェクターとプレフィルドシリンジのコンビネーション製品

章の概要
大容量ウェアラブルインジェクターコンビネーション製品
プレフィルドシリンジコンビネーション製品

第9章可能性のあるパートナーの分析

章の概要
大容量ウェアラブルインジェクターコンビネーション製品
プレフィルドシリンジコンビネーション製品

第10章アウトソーシング：GO/NO-GOフレームワーク

章の概要
アウトソーシング：Go/No-Goフレームワーク
プレフィルドシリンジコンビネーション製品開発者：Go/No-Goフレームワーク

第11章市場予測

章の概要
主要な前提と予測調査手法
世界のコンビネーション製品サービスプロバイダー市場（2035年まで）
- 世界のコンビネーション製品サービスプロバイダー市場：機器タイプ別
- 世界のコンビネーション製品サービスプロバイダー市場：サービス重点分野別
- 世界のコンビネーション製品サービスプロバイダー市場：企業規模別
- コンビネーション製品サービスプロバイダー市場：地域別

第12章結論

第13章エグゼクティブ洞察

第14章付録1：表形式データ

第15章付録2：企業・団体一覧

図表

List of Tables

Table 4.1 Combination Products Service Providers: Information on Year of Establishment, Company Size and Location of Headquarters
Table 4.2 Combination Products Service Providers: Information on Type of Combination Product
Table 4.3 Combination Products Service Providers: Information on Type of Device
Table 4.4 Combination Products Service Providers: Information on Service Focus Area(s)
Table 4.5 Combination Products Service Providers: Information on Type of Service(s) Offered
Table 4.6 Combination Products Service Providers: Information on Location of Facility(s)
Table 6.1 Combination Products Service Providers: List of Companies Profiled
Table 6.2 EKG LABS: Company Overview
Table 6.3 Eurofins Medical Device Testing: Company Overview
Table 6.4 Eurofins Medical Device Testing: Recent Developments and Future Outlook
Table 6.5 Exponent: Company Overview
Table 6.6 Exponent: Recent Developments and Future Outlook
Table 6.7 Kymanox: Company Overview
Table 6.8 Kymanox: Recent Developments and Future Outlook
Table 6.9 Medical Engineering Technologies: Company Overview
Table 6.10 Medical Engineering Technologies: Recent Developments and Future Outlook
Table 6.11 Pace Analytical Services: Company Overview
Table 6.12 Pace Analytical Services: Recent Developments and Future Outlook
Table 6.13 Suttons Creek: Company Overview
Table 6.14 Suttons Creek: Recent Developments and Future Outlook
Table 6.15 West Pharmaceutical Services: Company Overview
Table 6.16 West Pharmaceutical Services: Recent Developments and Future Outlook
Table 7.1 Combination Products Service Providers: List of Expansions, Since 2017
Table 8.1 Large Volume Drug Device Combinations: Information on Phase of Development and Device Features
Table 8.2 Large Volume Drug Device Combinations: Information on Drug Administration Related Parameters
Table 8.3 Large Volume Wearable Injectors for Drug Device Combinations: Information on Developers
Table 8.4 Prefilled Syringes Combination Products: List of Approved Drugs, Since 2013
Table 8.5 Prefilled Syringes Combination Products: Information on Approval Year, Since 2013
Table 8.6 Prefilled Syringes Combination Products: Information on Target Indication(s) and Dosage Strength
Table 8.7 Prefilled Syringes Combination Products: List of Other Drug Delivery Solutions, Since 2013
Table 8.8 Prefilled Syringes Combination Products: List of Clinical Stage Drugs
Table 8.9 Prefilled Syringes Combination Products: List of Developers
Table 9.1 Most Likely Partners
Table 9.2 Likely Partners
Table 9.3 Least Likely Partners
Table 14.1 Combination Products Service Providers: Cumulative Distribution by Year of Establishment
Table 14.2 Combination Products Service Providers: Distribution by Company Size
Table 14.3 Combination Products Service Providers: Distribution by Location of Headquarters
Table 14.4 Combination Products Service Providers: Distribution by Company Size and Location of Headquarters
Table 14.5 Combination Products Service Providers: Distribution by Type of Combination Product
Table 14.6 Combination Products Service Providers: Distribution by Company Size and Type of Combination Product
Table 14.7 Combination Products Service Providers: Distribution by Type of Device
Table 14.8 Combination Product Service Providers: Distribution by Service Focus Area(s)
Table 14.9 Combination Product Service Providers: Distribution by Type of Service(s) Offered
Table 14.10 Combination Product Service Providers: Distribution by Location of Facility (Region-wise)
Table 14.11 Combination Product Service Providers: Distribution by Location of Facility (Country-wise)
Table 14.12 Leading Combination Product Service Providers: Distribution by Number of Key Service(s) Offered
Table 14.13 4D Bubble Analysis: Distribution by Company Size, Company Headquarters (Region), Number of Service Focus Area(s) and Number of
Table 14.14 Mekko Representation: Distribution by Company Size and Service Focus Area(s)
Table 14.15 Recent Expansions: Cumulative Year-wise Trend, Since 2017
Table 14.16 Recent Expansions: Distribution by Type of Expansion
Table 14.17 Recent Expansions: Distribution by Year of Expansion and Type of Expansion
Table 14.18 Recent Expansions: Distribution by Location of Expanded Facility
Table 14.19 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
Table 14.20 Recent Expansions: Distribution by Type of Expansion (Country-wise)
Table 14.21 Recent Expansions: Distribution by Location of Expanded Facility and Type of Expansion (Country-wise)
Table 14.22 Most Active Players: Distribution by Number of Recent Expansions
Table 14.23 Large Volume Drug Device Combinations: Distribution by Phase of Development
Table 14.24 Large Volume Drug Device Combinations: Distribution by Type of Device
Table 14.25 Large Volume Drug Device Combinations: Distribution by Mechanism of Action
Table 14.26 Large Volume Drug Device Combinations: Distribution by Type of Technology Used
Table 14.27 Large Volume Drug Device Combinations: Distribution by Route of Administration
Table 14.28 Large Volume Drug Device Combinations: Distribution by Method of Administration
Table 14.29 Large Volume Drug Device Combinations: Distribution by Therapeutic Area
Table 14.30 Large Volume Drug Device Combinations: Distribution by Type of Dosage
Table 14.31 Large Volume Drug Device Combinations: Distribution by Storage Volume / Capacity (in mL)
Table 14.32 Large Volume Drug Device Combinations: Distribution by Usability
Table 14.33 Large Volume Drug Device Combinations: Distribution by Drug Compatibility
Table 14.34 Large Volume Drug Device Combinations: Distribution by Drug Container
Table 14.35 Large Volume Wearable Injectors for Drug Device Combinations: Distribution of Developers by Year of Establishment
Table 14.36 Large Volume Wearable Injectors for Drug Device Combinations: Distribution of Developers by Company Size
Table 14.37 Large Volume Wearable Injectors for Drug Device Combinations: Distribution of Developers by Location of Headquarters
Table 14.38 Leading Players: Distribution by Number of Products
Table 14.39 Approved Prefilled Syringes Combination Products: Distribution by Type of Drug Molecule
Table 14.40 Approved Prefilled Syringes Combination Products: Distribution by Approval Year
Table 14.41 Approved Prefilled Syringe Combination Products: Distribution by Geography
Table 14.42 Approved Prefilled Syringe Combination Products: Distribution by Route of Administration
Table 14.43 Approved Prefilled Syringe Combination Products: Distribution by Therapeutic Area
Table 14.44 Approved Prefilled Syringe Combination Products: Distribution by Other Dosage Forms
Table 14.45 Clinical Stage Prefilled Syringes Combination Products: Distribution by Type of Drug Molecule
Table 14.46 Clinical Stage Prefilled Syringes Combination Products: Distribution by Phase of Development
Table 14.47 Clinical Stage Prefilled Syringes Combination Products: Distribution by Route of Administration
Table 14.48 Clinical Stage Prefilled Syringes Combination Products: Distribution by Therapeutic Area
Table 14.49 Prefilled Syringe Combination Product Developers: Distribution by Year of Establishment
Table 14.50 Prefilled Syringe Combination Product Developers: Distribution by Company Size
Table 14.51 Prefilled Syringe Combination Product Developers: Distribution by Location of Headquarters
Table 14.52 Global Combination Products Service Providers Market, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.53 Global Combination Products Service Providers Market: Distribution by Type of Device
Table 14.54 Combination Products Service Providers Market for Large Volume Wearable Injectors, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.55 Combination Products Service Providers Market for Autoinjectors, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.56 Combination Products Service Providers Market for Prefilled Syringes, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.57 Combination Products Service Providers Market for Other Types of Combination Products, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.58 Global Combination Products Service Providers Market: Distribution by Service Focus Area
Table 14.59 Combination Products Service Providers Market for Particle Testing, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.60 Combination Products Service Providers Market for Performance Testing Till, 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.61 Combination Products Service Providers Market for Product Development, Till 2035 (USD Million), Conservative, Base and
Table 14.62 Global Combination Products Service Providers Market: Distribution by Company Size
Table 14.63 Combination Products Service Providers Market for Very Small Companies, Till 2035 (USD Million), Conservative, Base and
Table 14.64 Combination Products Service Providers Market for Small Companies, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.65 Combination Products Service Providers Market for Mid-sized Companies, Till 2035 (USD Million), Conservative, Base and Optimistic
Table 14.66 Combination Products Service Providers Market for Large Companies, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.67 Combination Products Service Providers Market for Very Large Companies, Till 2035 (USD Million), Conservative, Base and Optimistic
Table 14.68 Global Combination Products Service Providers Market: Distribution by Region
Table 14.69 Combination Products Service Providers Market in North America, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.70 Combination Products Service Providers Market in Europe, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.71 Combination Products Service Providers Market in Asia, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios
Table 14.72 Combination Products Service Providers Market in Rest of the World, Till 2035 (USD Million), Conservative, Base and Optimistic Scenarios

List of Figures

Figure 2.1 Executive Summary: Combination Products Service Providers Market Landscape
Figure 2.2 Executive Summary: Recent Expansions
Figure 2.3 Executive Summary: Case Study on Large Volume Wearable Injectors and Prefilled Syringes Combination Products
Figure 2.4 Executive Summary: Market Forecast
Figure 3.1 Types of Combination Products
Figure 3.2 Recently Approved Combination Products
Figure 3.3 Challenges Associated with Development of Combination Products
Figure 3.4 Key Outsourced Combination Product Operations / Services
Figure 4.1 Combination Products Service Providers: Distribution by Year of Establishment
Figure 4.2 Combination Products Service Providers: Distribution by Company Size
Figure 4.3 Combination Products Service Providers: Distribution by Location of Headquarters
Figure 4.4 Combination Products Service Providers: Distribution by Company Size and Location of Headquarters
Figure 4.5 Combination Products Service Providers: Distribution by Type of Combination Product
Figure 4.6 Combination Products Service Providers: Distribution by Company Size and Type of Combination Product
Figure 4.7 Combination Products Service Providers: Distribution by Type of Device
Figure 4.8 Combination Product Service Providers: Distribution by Service Focus Area(s)
Figure 4.9 Combination Product Service Providers: Distribution by Type of Service(s) Offered
Figure 4.10 Combination Product Service Providers: Distribution by Location of Facility (Region-wise)
Figure 4.11 Combination Product Service Providers: Distribution by Location of Facility (Country-wise)
Figure 4.12 Leading Combination Products Service Providers: Distribution by Number of Service(s) Offered
Figure 4.13 4D Bubble Representation: Distribution by Company Size, Location of Headquarters (Region), Number of Service Focus Area(s) and Number of Service(s) Offered
Figure 4.14 Mekko Representation: Distribution by Company Size and Service Focus Area(s)
Figure 5.1 Company Competitiveness Analysis: Players based in North America
Figure 5.2 Company Competitiveness Analysis: Players based in Europe and Asia
Figure 6.1 Company Profiles: Initiatives Undertaken by Industry Players
Figure 7.1 Recent Expansions: Cumulative Year-wise Trend, Since 2017
Figure 7.2 Recent Expansions: Distribution by Type of Expansion
Figure 7.3 Recent Expansions: Distribution by Year of Expansion and Type of Expansion
Figure 7.4 Recent Expansions: Distribution by Location of Expanded Facility
Figure 7.5 Recent Expansions: Distribution by Type of Expansion (Country-wise)
Figure 7.6 Recent Expansions: Distribution by Location of Expanded Facility and Type of Expansion (Country-wise)
Figure 7.7 Most Active Players: Distribution by Number of Expansions
Figure 9.1 Large Volume Drug Device Combination Products: Distribution by Phase of Development
Figure 9.2 Large Volume Drug Device Combination Products: Distribution by Type of Device
Figure 9.3 Large Volume Drug Device Combination Products: Distribution by Mechanism of Action
Figure 9.4 Large Volume Drug Device Combination Products: Distribution by Type of Technology Used
Figure 9.5 Large Volume Drug Device Combination Products: Distribution by Route of Administration
Figure 9.6 Large Volume Drug Device Combination Products: Distribution by Method of Administration
Figure 9.7 Large Volume Drug Device Combination Products: Distribution by Therapeutic Area
Figure 9.8 Large Volume Drug Device Combination Products: Distribution by Type of Dosage
Figure 9.9 Large Volume Drug Device Combination Products: Distribution by Storage Volume / Capacity (in mL)
Figure 9.10 Large Volume Drug Device Combination Products: Distribution by Usability
Figure 9.11 Large Volume Drug Device Combination Products: Distribution by Drug compatibility
Figure 9.12 Large Volume Drug Device Combination Products: Distribution by Drug Container
Figure 9.13 Large Volume Drug Device Combination Products Developers: Distribution by Year of Establishment
Figure 9.14 Large Volume Drug Device Combination Products Developers: Distribution by Company Size
Figure 9.15 Large Volume Drug Device Combination Products: Distribution by Location of Headquarters
Figure 9.16 Most Active Players: Distribution by Number of Products Manufactured
Figure 9.17 Approved Prefilled Syringes Combination Products: Distribution by Type of Drug Molecule
Figure 9.18 Approved Prefilled Syringes Combination Products: Distribution by Approval Year
Figure 9.19 Approved Prefilled Syringes Combination Products: Distribution by Geography
Figure 9.20 Approved Prefilled Syringes Combination Products: Distribution by Route of Administration
Figure 9.21 Approved Prefilled Syringes Combination Products: Distribution by Therapeutic Area
Figure 9.22 Approved Prefilled Syringes Combination Products: Distribution by Other Dosage Forms
Figure 9.23 Clinical Stage Prefilled Syringes Combination Products: Distribution by Type of Drug Molecule
Figure 9.24 Clinical Stage Prefilled Syringes Combination Products: Distribution by Phase of Development
Figure 9.25 Clinical Stage Prefilled Syringes Combination Products: Distribution by Route of Administration
Figure 9.26 Clinical Stage Prefilled Syringes Combination Products: Distribution by Therapeutic Area
Figure 9.27 Prefilled Syringes Combination Product Developers: Distribution by Year of Establishment
Figure 9.28 Prefilled Syringes Combination Product Developers: Distribution by Company Size
Figure 9.29 Prefilled Syringes Combination Product Developers: Distribution by Location of Headquarters
Figure 10.1 Outsourcing: Go / No-Go Framework
Figure 10.2 Outsourcing: Go / No-Go Framework for Prefilled Syringes Combination Product Developers
Figure 10.3 Prefilled Syringes Combination Products Developers: Benchmarking of Very Small / Small Companies
Figure 10.4 Prefilled Syringes Combination Products Developers: Benchmarking of Mid-sized Companies
Figure 10.5 Prefilled Syringes Combination Products Developers: Benchmarking of Large Companies
Figure 11.1 Global Combination Products Service Providers Market, Till 2035 (USD Million)
Figure 11.2 Global Combination Products Service Providers Market: Distribution by Type of Device (USD Million)
Figure 11.3 Combination Products Service Providers Market for Large Volume Wearable Injectors, Till 2035 (USD Million)
Figure 11.4 Combination Products Service Providers Market for Autoinjector, Till 2035 (USD Million)
Figure 11.5 Combination Products Service Providers Market for Prefilled Syringes, Till 2035 (USD Million)
Figure 11.6 Combination Products Service Providers Market for Other Types of Combination Products, Till 2035 (USD Million)
Figure 11.7 Global Combination Products Service Providers Market: Distribution by Service Focus Area (USD Million)
Figure 11.8 Combination Products Service Providers Market for Particle Testing, Till 2035 (USD Million)
Figure 11.9 Combination Products Service Providers Market for Performance Testing, Till 2035 (USD Million)
Figure 11.10 Combination Products Service Providers Market for Product Development, Till 2035 (USD Million)
Figure 11.11 Global Combination Products Service Providers Market: Distribution by Company Size (USD Million)
Figure 11.12 Combination Products Service Providers Market for Very Small Companies, Till 2035 (USD Million)
Figure 11.13 Combination Products Service Providers Market for Small Companies, Till 2035 (USD Million)
Figure 11.14 Combination Products Service Providers Market for Mid-sized Companies, Till 2035 (USD Million)
Figure 11.15 Combination Products Service Providers Market for Large Companies, Till 2035 (USD Million)
Figure 11.16 Combination Products Service Providers Market for Very Large Companies, Till 2035 (USD Million)
Figure 11.17 Global Combination Products Service Providers Market: Distribution by Region (USD Million)
Figure 11.18 Combination Products Service Providers Market in North America, Till 2035 (USD Million)
Figure 11.19 Combination Products Service Providers Market in Europe, Till 2035 (USD Million)
Figure 11.20 Combination Products Service Providers Market in Asia, Till 2035 (USD Million)
Figure 11.21 Combination Products Service Providers Market in Rest of the World, Till 2035 (USD Million)
Figure 12.1 Conclusion: Combination Products Service Providers Market Landscape
Figure 12.2 Conclusion: Company Competitiveness Analysis
Figure 12.3 Conclusion: Recent Expansions
Figure 12.4 Conclusion: Combination Products Case Study on Large Volume Wearable Injectors and Prefilled Syringes
Figure 12.5 Conclusion: Likely Partner Analysis
Figure 12.6 Conclusion: Outsourcing Go / No-Go Framework
Figure 12.7 Conclusion: Market Forecast

Product Code: RA100375

GLOBAL DRUG DEVICE COMBINATION PRODUCTS MARKET: GROWTH AND TRENDS

Non-adherence to prescribed medication regimens is a significant issue that not only negatively impacts patient health but also increases the overall burden on the pharmaceutical industry. As recently reported by Contract Pharma, medication non-adherence is estimated to cost drug developers over USD 250 billion each year. Additionally, the lack of effective solutions for sustained or controlled release of active pharmaceutical ingredients (APIs) at targeted delivery sites remains a major challenge in drug delivery. In fact, inadequate control over API release can lead to fluctuations in plasma drug levels, which may result in various side effects. This has led to a rise in the demand for effective drug delivery treatment options for patients.

Notably, in the recent past the development of combination products has attracted significant interest from pharmaceutical companies. These products integrate two or more FDA-regulated components to enable controlled release of APIs. However, creating drug-device combination products is a complex and lengthy process that demands innovative technologies, substantial investment, and specialized expertise. Additional challenges include ensuring drug-device compatibility, addressing user requirements, conducting release testing, and meeting production and packaging standards. To address these hurdles and improve patient outcomes, many developers are now outsourcing key operations to specialized companies that provide testing and validation services for combination products.

GLOBAL DRUG DEVICE COMBINATION PRODUCTS MARKET: KEY INSIGHTS

The report delves into the current state of global drug device combination products market and identifies potential growth opportunities within industry. Some key findings from the report include:

At present, more than 25 companies across the globe offer services for the development and testing of various drug-device combination products.
Service providers claim to have the necessary expertise to provide a wide range of services for different types of combination products; majority (~20%) of these services are focused on performance testing.
Majority of the players (over 85%) that support development and testing of drug delivery devices / systems are headquartered in North America.
Over 45% of the service providers assist the performance testing and product development of combination products; of these, 40% are large / very large players.
Around 75% of the combination product service providers perform the process development and validation; examples include BS, EKG Labs, Exponent and Surpass.

In order to gain an edge in this competitive industry, service providers are continuously undertaking initiatives to upgrade their existing service offerings.
To keep pace with the growing demand, many companies have undertaken expansion initiatives, such as establishing new facilities (~40%) or expanding their existing capabilities (~50%), to strengthen their service portfolio.
Majority of the expansion initiatives were undertaken by combination product service providers based in the US; examples include DDL, NAMSA, and Nelson Labs.
Majority expansions were undertaken in order to meet the increasing demand for testing services related to combination products.
Most of the expansions reported were local initiatives; some companies based in the US have undertaken international expansions initiatives as well.
Presently, over 210 combination products have been / are being developed for the treatment of various clinical conditions; these can be used for both parenteral as well as non-parenteral drug delivery.
The pipeline features a variety of combination products that have been / are being developed for various therapeutic areas; majority of the products are being evaluated for the administration of biologics.
Majority of the large volume WI combination products (~80%) that are currently under development are being developed to provide basal dose.
A sizeable proportion of large volume WI combination products are being developed for the treatment of neurological disorders (33%); examples include D-mine(R) Pump, and ND0701.
Over 90% of the prefilled syringe combination products have been / are being developed to administer biologics; of these, majority are antibody-based molecules (48%).
Combination product developers are anticipated to forge strategic alliances with service providers for the development and testing of their proprietary combination products.
Built on our intellectual capital, we have proposed a proprietary framework to allow developers to decide whether to outsource manufacturing or keep it in-house; we expect majority of the small firms to outsource such operations.

With the rising demand for combination products, the affiliated market for service providers is expected to grow at a steady annualized rate over the coming decade.

Example Players in the Drug Device Combination Products Market

EKG LABS
Eurofins Medical Device Testing
Exponent
Kymanox
Medical Engineering Technologies
Pace Analytical Services
Suttons Creek
West Pharmaceutical Services

GLOBAL DRUG DEVICE COMBINATION PRODUCTS MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global drug device combination products market, focusing on key market segments, including [A] type of device, [B] service focus area, [C] company size and [D] key geographical regions.
Market Landscape: A comprehensive evaluation of combination product service providers, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] type of combination product(s), [E] type of device(s), [F] service focus area(s), [G] type of service(s) offered, [H] location of facility and [I] leading players (in terms of number of services offered).
Company Competitiveness Analysis: A comprehensive competitive analysis of combination product service providers, examining factors, such as [A] supplier power and [B] service portfolio strength.
Company Profiles: In-depth profiles of companies that offer services for development and testing of combination products, focusing on [A] company overviews and [B] recent developments and an informed future outlook.
Recent Expansions: An insightful analysis of recent expansions undertaken by various combination product service providers, based on various relevant parameters, such as [A] year of expansion, [B] type of expansion, [C] location of expanded facility, [D] most active players (in terms of number of recent expansions) and [E] geographical distribution.
Case Study: A detailed discussion on the most advanced and popular combination products, including large volume wearable injectors and prefilled syringes combination products, providing information on their developer(s) and combination product specific features.
Likely Partner Analysis: A comprehensive analysis of more than 90 combination product developers that are likely to partner with combination product service providers. These players analyzed based on various parameters, such as [A] pipeline strength, [B] developer strength and [C] product strength.
Go or No-Go Framework Analysis: In-depth analysis highlighting the various factors that need to be considered by combination product developers while deciding whether to develop their respective products in-house or engage the services of a service provider.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?
Which are the leading companies in this market?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

ADDITIONAL BENEFITS

Complimentary PPT Insights Packs
Complimentary Excel Data Packs for all Analytical Modules in the Report
15% Free Content Customization
Detailed Report Walkthrough Session with Research Team
Free Updated report if the report is 6-12 months old or older

1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
- 1.2.1. Research Assumptions
- 1.2.2. Project Methodology
- 1.2.3. Forecast Methodology
- 1.2.4. Robust Quality Control
- 1.2.5. Key Considerations
  - 1.2.5.1. Demographics
  - 1.2.5.2. Economic Factors
  - 1.2.5.3. Government Regulations
  - 1.2.5.4. Supply Chain
  - 1.2.5.5. COVID Impact / Related Factors
  - 1.2.5.6. Market Access
  - 1.2.5.7. Healthcare Policies
  - 1.2.5.8. Industry Consolidation
1.3 Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Introduction to Combination Products
3.3. Challenges Associated with Development of Combination Products
3.4. Outsourced Combination Products Operations / Services
3.5. Advantages of Outsourcing Operations for Combination Products
3.6. Key Considerations while Selecting a CDMO
3.7. Future Perspectives

4. COMBINATION PRODUCTS SERVICE PROVIDERS: MARKET LANDSCAPE

4.1. Chapter Overview
4.2. Combination Products Service Providers: Overall Market Landscape
- 4.2.1. Analysis by Year of Establishment
- 4.2.2. Analysis by Company Size
- 4.2.3. Analysis by Location of Headquarters
- 4.2.4. Analysis by Type of Combination Product
- 4.2.5. Analysis by Type of Device
- 4.2.6. Analysis by Service Focus Area(s)
- 4.2.7. Analysis by Type of Service(s) Offered
- 4.2.8. Analysis by Location of Facility
- 4.2.9. Leading Combination Products Service Providers: Analysis by Number of Service(s) Offered
- 4.2.10. 4D Bubble Representation: Analysis by Company Size, Location of Headquarters (Region), Number of Service Focus Area(s) and Number of Service(s) Offered
- 4.2.11. Mekko Representation: Analysis by Company Size and Number of Service Focus Area(s)

5. COMPANY COMPETITIVENESS ANALYSIS

5.1. Chapter Overview
5.2. Assumptions / Key Parameters
5.3. Methodology
5.4. Combination Products Service Providers: Company Competitiveness Analysis
- 5.4.1. Combination Products Service Providers based in North America
- 5.4.2. Combination Products Service Providers based in Europe and Asia

6. COMBINATION PRODUCTS SERVICE PROVIDERS: COMPANY PROFILES

6.1. Chapter Overview
6.2. EKG LABS
- 6.2.1. Company Overview
- 6.2.2. Recent Developments and Future Outlook
6.3. Eurofins Medical Device Testing
- 6.3.1. Company Overview
- 6.3.2. Recent Developments and Future Outlook
6.4. Exponent
- 6.4.1. Company Overview
- 6.4.2. Recent Developments and Future Outlook
6.5. Kymanox
- 6.5.1. Company Overview
- 6.5.2. Recent Developments and Future Outlook
6.6. Medical Engineering Technologies
- 6.6.1. Company Overview
- 6.6.2. Recent Developments and Future Outlook
6.7. Pace Analytical Services
- 6.7.1. Company Overview
- 6.7.2. Recent Developments and Future Outlook
6.8. Suttons Creek
- 6.8.1. Company Overview
- 6.8.2. Recent Developments and Future Outlook
6.9. West Pharmaceutical Services
- 6.9.1. Company Overview
- 6.9.2. Recent Developments and Future Outlook
6.10. Concluding Remarks: Initiatives Undertaken by Industry Players

7. RECENT EXPANSIONS

7.1. Chapter Overview
7.2. Combination Products Service Providers: List of Recent Expansions
- 7.2.1. Analysis by Year of Expansion
- 7.2.2. Analysis by Type of Expansion
- 7.2.3. Analysis by Location of Expanded Facility
- 7.2.4. Analysis by Type of Expansion (Country-wise)
- 7.2.5. Most Active Players: Analysis by Number of Expansions
- 7.2.6. Geographical Analysis

8. CASE STUDY: LARGE VOLUME WEARABLE INJECTORS AND PREFILLED SYRINGES COMBINATION PRODUCTS

8.1. Chapter Overview
8.2. Large Volume Wearable Injector Combination Products
- 8.2.1. Large Volume Drug Device Combination Products: Market Landscape
  - 8.2.1.1. Analysis by Phase of Development
  - 8.2.1.2. Analysis by Type of Device
  - 8.2.1.3. Analysis by Drug Compatibility
  - 8.2.1.4. Analysis by Type of Dosage
  - 8.2.1.5. Analysis by Route of Administration
  - 8.2.1.6. Analysis by Method of Administration
  - 8.2.1.7. Analysis by Therapeutic Area
  - 8.2.1.8. Analysis by Storage Volume / Capacity
  - 8.2.1.9. Analysis by Usability
  - 8.2.1.10. Analysis by Technology Used
  - 8.2.1.11. Analysis by Mechanism of Action
  - 8.2.1.12. Analysis by Type of Drug Container
- 8.2.2. Large Volume Drug Device Combination Products: Developer Landscape
  - 8.2.2.1. Analysis by Year of Establishment
  - 8.2.2.2. Analysis by Company Size
  - 8.2.2.3. Analysis by Location of Headquarters
  - 8.2.2.4. Most Active Players: Analysis by Number of Products Manufactured
8.3. Prefilled Syringes Combination Products
- 8.3.1. Prefilled Syringe Combination Products: List of Approved Drugs
  - 8.3.1.1. Analysis by Type of Drug Molecule
  - 8.3.1.2. Analysis by Approval Year
  - 8.3.1.3. Analysis by Geography
  - 8.3.1.4. Analysis by Route of Administration
  - 8.3.1.5. Analysis by Therapeutic Area
  - 8.3.1.6. Analysis by Dosage Strength
  - 8.3.1.7. Analysis by Other Approved Dosage Forms
- 8.3.2. Prefilled Syringe Combination Products: List of Clinical Stage Drugs
  - 8.3.2.1. Analysis by Type of Drug Molecule
  - 8.3.2.2. Analysis by Phase of Development
  - 8.3.2.3. Analysis by Route of Administration
  - 8.3.2.4. Analysis by Therapeutic Area
- 8.3.3. Prefilled Syringes Combination Products: Information on Developers
  - 8.3.3.1. Analysis by Year of Establishment
  - 8.3.3.2. Analysis by Company Size
  - 8.3.3.3. Analysis by Location of Headquarters

9. LIKELY PARTNER ANALYSIS

9.1. Chapter Overview
9.2. Large Volume Wearable Injectors Combination Products
- 9.2.1. Scoring Criteria and Key Assumptions
- 9.2.2. Scope and Methodology
- 9.2.3. Potential Strategic Partners
  - 9.2.3.1. Most Likely Partners
  - 9.2.3.2. Likely Partners
  - 9.2.3.3. Less Likely Partners
9.3. Prefilled Syringes Combination Products
- 9.3.1. Scoring Criteria and Key Assumptions
- 9.3.2. Scope and Methodology
- 9.3.3. Potential Strategic Partners
  - 9.3.3.1. Most Likely Partners
  - 9.3.3.2. Likely Partners
  - 9.3.3.3. Less Likely Partners

10. OUTSOURCING: GO / NO-GO FRAMEWORK

10.1. Chapter Overview
10.2. Outsourcing: Go / No-Go Framework
10.3. Prefilled Syringes Combination Products Developers: Go / No-Go Framework
- 10.3.1. Assumptions and Key Parameters
- 10.3.2. Methodology
- 10.3.3. Results and Interpretations
  - 10.3.3.1. Outsourcing: Go / No-Go Framework for Very Small and Small Companies
  - 10.3.3.2. Outsourcing: Go / No-Go Framework for Mid-sized Companies
  - 10.3.3.3. Outsourcing: Go / No-Go Framework for Large Companies

11. MARKET FORECAST

11.1. Chapter Overview
11.2. Key Assumptions and Forecast Methodology
11.3. Global Combination Products Service Providers Market, Till 2035
- 11.3.1. Global Combination Products Service Providers Market: Distribution by Type of Device
  - 11.3.1.1. Combination Products Service Providers Market for Large Volume Wearable Injectors
  - 11.3.1.2. Combination Products Service Providers Market for Autoinjector Combination Products
  - 11.3.1.3. Combination Products Service Providers Market for Prefilled Syringe
  - 11.3.1.4. Combination Products Service Providers Market for Other Types of Combination Products
- 11.3.2. Global Combination Products Service Providers Market: Distribution by Service Focus Area
  - 11.3.2.1. Combination Products Service Providers Market for Particle Testing
  - 11.3.2.2. Combination Products Service Providers Market for Performance Testing
  - 11.3.2.3. Combination Products Service Providers Market for Product Development
- 11.3.3. Global Combination Products Service Providers Market: Distribution by Company Size
  - 11.3.3.1. Combination Products Service Providers Market for Very Small Companies
  - 11.3.3.2. Combination Products Service Providers Market for Small Companies
  - 11.3.3.3. Combination Products Service Providers Market for Mid-sized Companies
  - 11.3.3.4. Combination Products Service Providers Market for Large Companies
  - 11.3.3.5. Combination Products Service Providers Market for Very Large Companies
- 11.3.4 Combination Products Service Providers Market: Distribution by Region
  - 11.3.4.1. Combination Products Service Providers Market in North America, Till 2035
  - 11.3.4.2. Combination Products Service Providers Market in Europe, Till 2035
  - 11.3.4.3. Combination Products Service Providers Market in Asia, Till 2035
  - 11.3.4.4. Combination Products Service Providers in Rest of the World, Till 2035

薬物・機械器具コンビネーション製品市場：業界動向と世界の予測 - 機器タイプ別、サービス重点分野別、企業規模別、主要地域別

Drug Device Combination Products Market: Industry Trends and Global Forecasts - Distribution by Type of Device, Service Focus Area, Company Size, and Key Geographical Regions

世界の薬物・機械器具コンビネーション製品市場：成長と動向

世界の薬物・機械器具コンビネーション製品市場：主要インサイト

薬物・機械器具コンビネーション製品市場における参入企業例

目次

第1章 序文

第2章 エグゼクティブサマリー

第3章 イントロダクション

第4章 コンビネーション製品サービスプロバイダー：市場情勢

第5章 企業競争力分析

第6章 コンビネーション製品サービスプロバイダー：企業プロファイル

第7章 最近の拡張

第8章 ケーススタディ：大容量ウェアラブルインジェクターとプレフィルドシリンジのコンビネーション製品

第9章 可能性のあるパートナーの分析

第10章 アウトソーシング：GO/NO-GOフレームワーク

第11章 市場予測

第12章 結論

第13章 エグゼクティブ洞察

第14章 付録1：表形式データ

第15章 付録2：企業・団体一覧