経口固形剤受託製造の米国市場規模、シェア、動向分析レポート：製品タイプ別、メカニズム別、最終用途別、セグメント予測、2023年-2030年

米国の経口固形剤受託製造市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、米国の経口固形剤受託製造市場規模は、2023年から2030年にかけてCAGR 6.1%で拡大し、2030年には164億2,000万米ドルに達すると推定されます。

同市場の成長は、国内における医薬品アウトソーシングの増加や技術の進歩などの要因によるものです。患者中心の剤形に対する需要は時代とともに増加しており、服薬アドヒアランスを高めることから、医療分野における極めて重要な動向となっています。その結果、メーカーは飲み込みやすさを優先した経口剤形を製造しています。

固形の経口薬をより使いやすくするため、医薬品スポンサーは革新的に薬をマイクロ錠やミニ錠、スプリンクルカプセルに変えています。この製剤アプローチは、特に小児や老人の間で人気を集めています。慢性疾患や感染症の流行が拡大していることも、新規治療薬に対する需要が高まっている主な要因のひとつです。さらに、老年人口の増加が慢性疾患の罹患率上昇に寄与しており、新規治療プロセスへの需要をさらに後押ししています。

既存の薬剤に対する副作用も、新規治療法の需要に寄与しています。例えば、2022年7月にリバプール大学が発表した調査によると、副作用関連の入院は2004年の6.5％から2019年には16.5％に増加しました。既存の治療薬に対する副作用を伴う症例数の増加は、将来的に新たな治療薬の需要を押し上げると予想されます。

多くのバイオ医薬品企業にとって、イノベーションと臨床へのスピードという要素は極めて重要です。小規模企業や特殊なバイオ医薬品企業は、業界内でこれらの重要な要件を実現することにますます依存するようになっています。多くのCROやCDMOは、自らをワンストップ・ショップ企業として宣伝しています。ワン・ストップ・ショップ・サービス・モデルとは、CROが原薬から剤形、初期開発から商業化までのすべてを扱うというものです。このようなサービスを提供するためには、CDMOは特定の問題提起に対応するための幅広い実現技術や専門的な対応能力を有している必要があります。

さらに、主要企業による戦略的イニシアチブの取り組みが増加していることも、米国の経口固形製剤（OSD）受託製造市場の成長を後押しすると予想されます。例えば、2023年1月、キャタレント社とEthicann社は、キャタレント社の口腔内崩壊錠（ODT）技術「Zydis」を使用してEthicann社の臨床医薬品パイプラインを開発するために提携しました。もう一つの例として、2023年3月、ロンザ社は、ヴィスプ拠点における新しい臨床・商業用医薬品製造ラインが本格稼動したことを発表しました。この拡張により、同社の医薬品サービス（DPS）が強化される見込みです。

米国の経口固形剤受託製造市場レポート・ハイライト

• 製品タイプ別では、錠剤部門が2022年に最も高い市場シェアを獲得しました。これは、錠剤の普及、製造の容易さ、患者受容率の高さに起因します。
• カプセルは今後数年で大きな市場成長が見込まれます。様々な放出特性を持つ複数の薬理学的成分をカプセルに配合することが可能であるため、その需要が促進されます。
• メカニズム別では、放出制御型が2022年の市場を独占しました。放出制御機構は、有効性と安全性の向上、投与回数の削減、安定した血中濃度など、複数の利点を提供します。
• 最終用途別では、大企業セグメントが2022年の市場を独占しました。受託製造業者は一般に、要件の変動に基づいて生産量を増減する能力を有しています。このような柔軟性は、OSD製品の需要が変動する大手製薬企業にとって有利となります。
• 今後数年間は、中堅・中小企業が大きな成長率で前進すると予想されます。中堅・中小企業にとって、財源は限られていることが多いです。自社で製造設備を建設・運営するにはコストがかかりすぎるかもしれないです。受託生産であれば、多額の初期投資をすることなく、最先端の生産能力を得ることができます。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国の経口固形剤受託製造市場：変数、動向、範囲

• 市場系統の見通し
• 米国の経口固形製剤の契約製造のダイナミクス
• 市場力学
• 米国の経口固形剤受託製造市場：分析ツール
• 新型コロナウイルス感染症（COVID-19）の影響
• 米国における経口固形製剤の包装タイプに関するブリスターとボトル別の分析（容量%シェア、2022年）
• 規制状況

第4章 米国の経口固形剤受託製造市場：製品タイプ分析

• 米国の経口固形剤受託製造市場の製品タイプセグメント別：重要なポイント
• 米国の経口固形剤受託製造市場：製品タイプの変動分析
• 製品タイプ別

第5章 米国の経口固形剤受託製造市場：メカニズム分析

• 米国の経口固形剤受託製造市場のメカニズムセグメント別：重要なポイント
• 米国の経口固形剤受託製造市場：メカニズムの変動分析
• メカニズム別

第6章 米国の経口固形剤受託製造市場：エンドユーザー分析

• 米国の経口固形剤受託製造市場のエンドユーザーセグメント別：重要なポイント
• 米国の経口固形剤受託製造市場：エンドユーザーの変動分析
• 最終用途別

第7章 国の推定・動向分析、2018～2030年

• 米国
  • 主要な国の動向
  • 競合シナリオ

第8章 競合情勢

• 企業の分類
• サービスヒートマップ分析
• 米国の経口固形剤受託製造企業の市場シェア分析、2022年
• 企業プロファイル
  • Catalent, Inc.
  • Lonza
  • AbbVie Inc.
  • Aenova Group
  • Adare Pharma Solutions
  • Boehringer Ingelheim International GmbH
  • Jubilant Pharmova Limited
  • Patheon Pharma Services
  • Recipharm AB.
  • Corden Pharma International
  • Siegfried Holding AG

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 U.S. Oral Solid Dosage Contract Manufacturing Market by Product Type, 2018 - 2030 (USD Million)
• Table 4 U.S. Oral Solid Dosage Contract Manufacturing Market by Mechanism, 2018 - 2030 (USD Million)
• Table 5 U.S. Oral Solid Dosage Contract Manufacturing Market by End User, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 U.S. oral solid dosage contract manufacturing market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Data Analysis Models
• Fig. 6 Market Formulation and Validation
• Fig. 7 Data Validating & Publishing
• Fig. 8 Parent market analysis
• Fig. 9 Service/Commodity Flow Analysis
• Fig. 10 Value-Chain-Based Sizing & Forecasting
• Fig. 11 QFD model sizing & forecasting
• Fig. 12 Market formulation & validation
• Fig. 13 Market snapshot
• Fig. 14 Segment snapshot
• Fig. 15 Segment snapshot
• Fig. 16 Competitive landscape snapshot
• Fig. 17 Parent market outlook, 2022 (USD Million)
• Fig. 18 Ancillary market outlook, 2022 (USD Million)
• Fig. 19 U.S. oral solid dosage contract manufacturing market dynamics
• Fig. 20 Biosimilar approval in the U.S. and EU per year (2016 - 2021)
• Fig. 21 Porter's five forces analysis
• Fig. 22 U.S. oral solid dosage contract manufacturing market: PESTEL analysis
• Fig. 23 Oral solid dosage packaging types in the U.S., 2022 (volume percentage share %)
• Fig. 24 Oral solid dosage blister packaging types in the U.S., 2022 (volume percentage share %)
• Fig. 25 Regulatory Landscape
• Fig. 26 U.S. oral solid dosage contract manufacturing market: Product type outlook and key takeaways
• Fig. 27 U.S. oral solid dosage contract manufacturing market: Product type movement analysis
• Fig. 28 U.S. tablets contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 29 U. S. capsules contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 30 U. S. powders contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 31 U.S. granules contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 32 U. S. others contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 33 U.S. oral solid dosage contract manufacturing market: mechanism outlook and key takeaways
• Fig. 34 U.S. oral solid dosage contract manufacturing market: mechanism movement analysis
• Fig. 35 U.S. immediate release contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 36 U.S. delayed release contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 37 U.S. controlled release contract manufacturing market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 38 U.S. oral solid dosage contract manufacturing market: end-user outlook and key takeaways
• Fig. 39 U.S. oral solid dosage contract manufacturing market: End-user movement analysis
• Fig. 40 Large-Size Companies market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 41 Medium & small size companies market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 42 Others market estimates and forecast, 2018 - 2030 (USD Million)
• Fig. 43 Key country dynamics
• Fig. 44 U.S. oral solid dosage contract manufacturing market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 45 Key company categorization
• Fig. 46 Service heat map analysis
• Fig. 47 U.S. oral solid dosage contract manufacturing market share analysis, 2022

U.S. Oral Solid Dosage Contract Manufacturing Market Growth & Trends:

The U.S. oral solid dosage contract manufacturing market size is estimated to reach USD 16.42 billion by 2030, expanding at a CAGR of 6.1% from 2023 to 2030, according to a new report by Grand View Research, Inc.. The growth of the market is attributed to factors such as the increasing pharmaceutical outsourcing and technological advancements in the country. The demand for patient-centric dosage forms has been increasing with time, making it a pivotal trend in the medical field, as it enhances medication adherence. Consequently, manufacturers are producing oral dosage forms that prioritize ease of swallowing.

To render solid oral drugs more user-friendly, drug sponsors are innovatively transforming drugs into micro or mini tablets and sprinkle capsules. This formulation approach is gaining popularity, especially among the pediatric and geriatric populations. The growing prevalence of chronic and infectious diseases is one of the major factors responsible for the rising demand for novel therapies. Furthermore, the growing geriatric population is contributing to the rising incidence of chronic diseases, further supporting the demand for novel treatment processes.

Adverse drug reactions to existing drugs are also contributing to the demand for novel treatment options. For instance, in July 2022, research published by the University of Liverpool stated that adverse drug reaction-related hospital admissions increased from 6.5% in 2004 to 16.5% in 2019. A rise in the number of cases involving adverse drug reactions to existing therapies is expected to boost the demand for new therapies in the future.

For many biopharmaceutical companies, innovations and speed-to-clinic factors are of critical importance. Small companies and specialty biopharmaceutical players increasingly rely upon delivering these important requirements within the industry. Many CROs and CDMOs promote themselves as one-stop-shop companies. The one-stop-shop service model is where a CRO handles everything from API to dosage form and early development to commercialization. To provide these services, a CDMO must have a wide range of enabling technologies and specialized handling capabilities to address specific problem statements.

Furthermore, increasing undertaking of strategic initiatives by key players is also expected to drive U.S. oral solid dosage (OSD) contract manufacturing market growth. For instance, in January 2023, Catalent and Ethicann collaborated to develop Ethicann's clinical drug pipeline using Catalent's orally disintegrating tablet (ODT) technology 'Zydis'. In another instance, in March 2023, Lonza announced that its new clinical and commercial drug product manufacturing line at its Visp site had become fully operational. The expansion is expected to strengthen the company's Drug Product Services (DPS) offering.

U.S. Oral Solid Dosage Contract Manufacturing Market Report Highlights:

• Based on product type, the tablets segment captured the highest market share in 2022.This is attributed to their widespread use, ease of manufacturing, and strong patient acceptance rate
• The capsule segment is expected to show significant market growth in the coming years. Multiple pharmacological ingredients with various release characteristics can be combined in capsules, thus driving their demand
• Based on the mechanism, the controlled release segment dominated the market in 2022. The controlled release mechanism offers multiple advantages, such as improved efficacy and safety, reduced dosage frequency, and steady blood levels
• Based on the end-user, the large companies segment dominated the market in 2022. Contract manufacturers generally have the capacity to scale production up or down based on requirement fluctuation. This flexibility can be advantageous for large pharma companies that experience varying levels of demand for their OSD products
• Medium- and small-sized companies are expected to advance at a significant growth rate in the coming years. Financial resources are frequently limited for small- and medium-sized companies. Their own manufacturing facilities might be too expensive to build and operate. They can gain cutting-edge production capabilities through contract manufacturing without making a large initial investment

Table of Contents

Chapter 1 Methodology And Scope

• 1.1 Market Segmentation And Scope
  • 1.1.1 Regional Scope
  • 1.1.2 Estimates And Forecast Timeline.
• 1.2 Research Methodology
• 1.3 Information Procurement
  • 1.3.1 Purchased Database
  • 1.3.2 GVR's Internal Database
  • 1.3.3 Secondary Sources
  • 1.3.4 Primary Research
• 1.4 Information/data Analysis
  • 1.4.1 Information Analysis
• 1.5 Market Formulation & Visualization
• 1.6 Data Validation & Publishing
• 1.7 Market Definitions/scope
• 1.8 Model Details
  • 1.8.1 Approach 1: Parent Market Analysis
  • 1.8.2 Approach 2: Service/ Commodity Flow Analysis
  • 1.8.3 Approach 3: Value-chain-based Sizing & Forecasting
  • 1.8.4 Approach 4: Qfd Model Sizing & Forecasting
• 1.9 Market Formulation & Validation
• 1.10 List Of Secondary Sources
• 1.11 List Of Primary Sources

Chapter 2 Executive Summary

• 2.1 Market Snapshot
• 2.2 Segment Snapshot
• 2.3 Segment Snapshot
• 2.4 Competitive Landscape Snapshot

Chapter 3 U.S. Oral Solid Dosage Contract Manufacturing Market: Variables, Trends, & Scope

• 3.1 Market Lineage Outlook
  • 3.1.1 Parent Market Outlook
  • 3.1.2 Ancillary Market Outlook
• 3.2 U.S. Oral Solid Dosage Contract Manufacturing Dynamics
• 3.3 Market Dynamics
  • 3.3.1 Market Driver Impact Analysis
  • 3.3.2 Market Restraint Analysis
• 3.4 U.S. Oral Solid Dosage Contract Manufacturing Market: Analysis Tools
  • 3.4.1 Porter's Five Forces Analysis
  • 3.4.2 PESTEL Analysis
• 3.5 COVID-19 Impact
  • 3.5.1 Activities by Market Players
  • 3.5.2 Long-Term Changes in The Pharmaceutical Contract Manufacturing Market
• 3.6 Analysis Pertaining to Oral Solid Dosage Packaging Types in the U.S. by Blisters vs. Bottles (Volume % Share, 2022)
  • 3.6.1 Blister Packaging
  • 3.6.2 Bottle Packaging
  • 3.6.3 Types of Blister Packaging
    • 3.6.3.1 Blister Packaging
• 3.7 Regulatory Landscape
  • 3.7.1 U.S.
  • 3.7.2 Europe
  • 3.7.3 Rest Of The World

Chapter 4 U.S. Oral Solid Dosage Contract Manufacturing Market: Product Type Analysis

• 4.1 U.S. Oral Solid Dosage Contract Manufacturing Market by Product Type Segment: Key Takeaways
• 4.2 U.S. Oral Solid Dosage Contract Manufacturing Market: Product Type Movement Analysis
• 4.3 U.S. Oral Solid Dosage Contract Manufacturing Market Estimates & Forecast by Product Type (USD Million)
  • 4.3.1 Tablets
    • 4.3.1.1 Tablets Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 4.3.2 Capsules
    • 4.3.2.1 Capsules Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 4.3.3 Powders
    • 4.3.3.1 Powders Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 4.3.4 Granules
    • 4.3.4.1 Granules Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 4.3.5 Others
    • 4.3.5.1 Others Contract Manufacturing Market, 2018 - 2030 (USD Million)

Chapter 5 U.S. Oral Solid Dosage Contract Manufacturing Market: Mechanism Analysis

• 5.1 U.S. Oral Solid Dosage Contract Manufacturing Market by Mechanism Segment: Key Takeaways
• 5.2 U.S. Oral Solid Dosage Contract Manufacturing Market: Mechanism Movement Analysis
• 5.3 U.S. Oral Solid Dosage Contract Manufacturing Market Estimates & Forecast by Mechanism (USD Million)
  • 5.3.1 Immediate Release
    • 5.3.1.1 Immediate Release Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 5.3.2 Delayed Release
    • 5.3.2.1 Delayed Release Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 5.3.3 Controlled Release
    • 5.3.3.1 Controlled Release Contract Manufacturing Market, 2018 - 2030 (USD Million)

Chapter 6 U.S. Oral Solid Dosage Contract Manufacturing Market: End-user Analysis

• 6.1 U.S. Oral Solid Dosage Contract Manufacturing Market by End-user Segment: Key Takeaways
• 6.2 U.S. Oral Solid Dosage Contract Manufacturing Market: End-user Movement Analysis
• 6.3 U.S. Oral Solid Dosage Contract Manufacturing Market Estimates & Forecast by End User (USD Million)
  • 6.3.1 Large-Size Companies
    • 6.3.1.1 Large-Size Companies Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 6.3.2 Medium & Small-Size Companies
    • 6.3.2.1 Medium & Small Size Companies Contract Manufacturing Market, 2018 - 2030 (USD Million)
  • 6.3.3 Others
    • 6.3.3.1 Others Contract Manufacturing Market, 2018 - 2030 (USD Million)

Chapter 7 Country Estimates & Trend Analysis, 2018 - 2030 (USD Million)

• 7.1 U.S.
  • 7.1.1 Key Country Dynamics
  • 7.1.2 Competitive Scenario
    • 7.1.2.1 U.S. Oral Solid Dosage Contract Manufacturing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8 Competitive Landscape

• 8.1 Company Categorization
• 8.2 Service Heat Map Analysis
• 8.3 U.S. Oral Solid Dosage Contract Manufacturing Company Market Share Analysis, 2022
• 8.4 Company Profiles
  • 8.4.1 Catalent, Inc.
    • 8.4.1.1 Participants' Overview
    • 8.4.1.2 Financial Performance
    • 8.4.1.3 Product/Service Benchmarking
    • 8.4.1.4 Strategy Initiatives
  • 8.4.2 Lonza
    • 8.4.2.1 Participants' Overview
    • 8.4.2.2 Financial Performance
    • 8.4.2.3 Product/Service Benchmarking
    • 8.4.2.4 Strategy Initiatives
  • 8.4.3 AbbVie Inc.
    • 8.4.3.1 Participants' Overview
    • 8.4.3.2 Financial Performance
    • 8.4.3.3 Product/Service Benchmarking
    • 8.4.3.4 Strategy Initiatives
  • 8.4.4 Aenova Group
    • 8.4.4.1 Participants' Overview
    • 8.4.4.2 Financial Performance
    • 8.4.4.3 Product/Service Benchmarking
    • 8.4.4.4 Strategy Initiatives
  • 8.4.5 Adare Pharma Solutions
  • 8.4.6 Boehringer Ingelheim International GmbH
  • 8.4.7 Jubilant Pharmova Limited
  • 8.4.8 Patheon Pharma Services
  • 8.4.9 Recipharm AB.
  • 8.4.10 Corden Pharma International
  • 8.4.11 Siegfried Holding AG