凍結乾燥注射剤市場 - 2031年の成長予測、統計および事実

  • Report Code : TIPRE00004411
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 200
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凍結乾燥注射剤市場は、2021 年の 27 億 1,942 万米ドルから 2028 年までに 40 億 127 万米ドルに達すると予測されています。 2022 年から 2028 年にかけて CAGR 5.8% で成長すると予想されます。



市場を牽引する主な要因は、受託研究製造サービスの需要の増加、医薬品の承認の増加、生物製剤の需要の増加です。ただし、製品のリコールは市場の成長を抑制します。



凍結乾燥注射剤は、輸送中に安定している凍結乾燥薬です。それらは、使い捨てバイアル、ポイントオブケア再構成、および特殊パッケージで長期間保存されます。使用時には、希釈剤を使用して必要な量の薬物を再構成することができます。凍結乾燥注射剤は、真空下で溶液を凍結および蒸発させることにより溶媒から固体物質を分離する技術である凍結乾燥プロセスによって製造されるため、凍結乾燥注射剤とも呼ばれます。凍結乾燥注射剤は、経口固形剤形の最良の代替品と見なされることがよくあります。多くのケーススタディで、注射は寝たきりの患者に多大な恩恵をもたらしました。凍結乾燥注射剤は、他の剤形よりも保存期間が長いため、複数の疾患に苦しむ患者のバイオアベイラビリティと安定性を最大化するためにも処方されています。凍結乾燥注射剤市場

市場の洞察



医薬品の承認の増加が市場の成長を促進



入院患者で使用される新しい凍結乾燥治療薬の安全性と有効性に関する進行中の研究が浮上していますCOVID-19 と診断された成人患者。世界の凍結乾燥注射剤市場のメーカーは、重度の COVID-19 症状に苦しむ患者を治療するために、このようなイノベーションの緊急使用許可 (EUA) について米国 FDA から承認を受けています。



COVID-19 のパンデミック以来、世界の凍結乾燥注射剤市場のプレーヤーは、インドでの制限された緊急使用について、インドの薬物管理局 (DCGI) などの規制機関による承認を得るための取り組みを強化しています。レムデシビルなどの医薬品の承認が進むにつれて、最終的に凍結乾燥注射剤の需要が高まります。以下は、FDA およびその他の規制機関によって承認された医薬品のいくつかの例です。



  • 2020 年 2 月、Mylan は、COVID-19 での制限された緊急使用のためにインドでレムデシビル凍結乾燥粉末の規制当局の承認を DCGI から取得しました。

  • 2020 年 6 月、シプラは注射用レムデシビル凍結乾燥粉末のシプレミを発売しました。また、米国 FDA は、入院中の COVID-19 患者を治療するためのレムデシビルの緊急使用について、Gilead Sciences Inc. に緊急使用許可 (EUA) を発行しました。これは、COVID-19 感染が疑われる、または検査で確認された成人および小児患者に対する FDA が承認した唯一の EUA 治療です。このように、5 月にギリアド サイエンシズ社は、CIPREMI と呼ばれる Cipla のジェネリック バージョンの remedisvir を製造および販売するための任意の非独占的ライセンスを Cipla に拡張しました。

  • 2020 年 7 月、Jubilant Life はインドの医薬品管理局 (DCGI) から、重度の患者の治療のためにインドで緊急使用が制限されている 100 mg/バイアル (凍結乾燥注射剤) のレムデシビルを製造および販売する承認を受けました。 COVID-19。

  • 2020 年 8 月、Novartis AG による使い捨てバイアルの Cosentyx 凍結乾燥粉末が EU の承認を受けました。承認された薬剤は、皮膚症状を急速に改善し、乾癬に苦しむ患者の生活の質を改善する上で非常に効果的でした.


このように、世界中で増加する承認は、凍結乾燥注射剤市場の成長を促進します。



包装の種類 - ベースの洞察



グローバル包装の種類に基づく凍結乾燥注射剤市場は、使い捨てバイアル、ポイントオブケア再構成、および特殊包装に分割されます。 2021 年には、使い捨てバイアル セグメントが最大の市場シェアを占めましたが、特殊パッケージング セグメントは、予測期間中に 6.7% という最高の CAGR を記録すると予想されます。



配送の種類 - ベースのインサイト< /h3>

配信の種類に基づいて、世界の凍結乾燥注射剤市場は、プレフィルド希釈シリンジ、独自の再構成デバイス、シングルステップ デバイス、およびマルチステップ デバイスに分割されます。プレフィルド希釈シリンジ セグメントは、2021 年に最大の市場シェアを保持し、予測期間中に 6.3% という最高の CAGR を記録すると予想されます。



適応症に基づく洞察



適応症に基づいて、世界の凍結乾燥注射剤市場は、代謝および腫瘍状態、感染症、自己免疫疾患、およびその他の適応症に分割されています。代謝および腫瘍疾患セグメントは、2021 年に最大の市場シェアを保持し、予測期間中に 6.2% という最高の CAGR を記録すると予想されます。



エンド ユーザー ベースの洞察



に基づくエンドユーザー、世界の凍結乾燥注射剤市場は、病院、外来手術センター、専門クリニックなどに分割されています。病院セグメントは、2021 年に最大の市場シェアを保持しました。ただし、専門クリニック セグメントは、予測期間中に市場で 6.3% という最高の CAGR を記録すると推定されています。



タイプ別の世界の凍結乾燥注射剤市場パッケージング - 2021 年と 2028 年



グローバルな凍結乾燥注射剤市場で事業を展開する企業は、世界中で進化する顧客の需要を満たすために製品革新戦略を採用しています。これにより、グローバル市場でブランド名を維持することもできます。たとえば、2022 年 4 月、Recipharm は先進療法の CDMO Arranta Bio とウイルス療法の CDMO Vibalogics を買収しました。また、この買収により、Recipharm はマサチューセッツ州ボックスボローに施設を備えた米国での強固な基盤を確立し、新しい生物製剤モダリティでその機能を構築するためのプラットフォームを提供できるようになりました。



世界の凍結乾燥注射剤市場 - 地理別



地理的に、世界の凍結乾燥注射剤市場は、北米 (米国、カナダ、メキシコ)、ヨーロッパ (ドイツ、英国、フランス、イタリア、スペイン、その他のヨーロッパ)、アジアに分割されています。太平洋 (中国、インド、日本、韓国、オーストラリア、およびその他の APAC)、中東およびアフリカ (南アフリカ、サウジアラビア、UAE、およびその他の MEA)、および中南米 (ブラジル、アルゼンチン)



会社概要



  • バクスター

  • Nipro

  • Curia Global, Inc .

  • Recipharm AB

  • Vetter Pharma

  • Jubilant HollisterStier LLC (Jubilant Pharma Limited)

  • Aristopharma Ltd.

  • >CordenPharma International

  • Credence MedSystems, Inc.

  • SG Biopharm Pvt.株式会社


Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is meant by the lyophilized injectable market?

Lyophilized injectables are freeze-dried drugs that are more stable and can be transported and stored for a longer period. At the time of use, the required quantity of drugs can be reconstituted with the help of diluents. Lyophilized injectable are also termed as freeze-dried injectable as they are produced by the lyophilization process which is the technique of isolating a solid material from a solvent by freezing and evaporating the solution under vacuum. The lyophilized injectable market is segmented into type of packaging, type of delivery, indication, end user, and geography.

What are the driving factors for the lyophilized injectable market across the globe?

Increasing demand of contract research manufacturing services and rising approvals of pharmaceuticals are the most significant factors responsible for the overall market growth.

Which type of packaging segment held the largest market share in the lyophilized injectable market?

Based on type of packaging, single-use vials segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Which type of delivery segment led the lyophilized injectable market?

Based on type of delivery, prefilled diluent syringes segment accounted for the largest share in 2021 in the worldwide market and is expected to continue to do so till the forecast period.

Which indication segment held the largest market share in the lyophilized injectable market?

The metabolic and oncology conditions segment dominated the indication segment in the global lyophilized injectable market and accounted for the largest market share of 46.05% in 2021.

Which end user segment led the lyophilized injectable market?

Based on end user, hospital segment took the forefront lead in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Who are the key players in the lyophilized injectable market?

Baxter, Nipro, Curia Global, Inc., Recipharm AB, Vetter Pharma, Jubilant HollisterStier (Jubilant Pharma Limited), Aristopharma Ltd., CordenPharma International, Credence MedSystems, Inc., and S. G. Biopharm Pvt. Ltd. are among the leading companies operating in the lyophilized injectable market.

What is the regional market scenario of the lyophilized injectable market?

Global lyophilized injectable market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for lyophilized injectable market. The growth of the market in North America is expected due to the factors such as increasing demand for lyophilized injectable for safer packaging and prolonged shelf life, growing pharmaceutical production due to pandemic, and rising research and development in the healthcare industry. Further, the growing research & development activities owing to the investments by biotechnology, pharmaceutical, and biopharmaceutical companies and the rise in the research & applications of the lyophilized injectable drug in various fields are the key factors responsible for the Asia-Pacific regional growth for lyophilized injectable accounting for the fastest growth of the region during the coming years.

The List of Companies - Lyophilized Injectable Drugs Market

  1. Baxter
  2. Nipro
  3. Curia Global, Inc.
  4. Recipharm AB
  5. Vetter Pharma
  6. Jubilant HollisterStier LLC (Jubilant Pharma Limited)
  7. Aristopharma Ltd.
  8. CordenPharma International
  9. Credence MedSystems, Inc.
  10. S. G. Biopharm Pvt. Ltd

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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