동결건조 주사제 시장 조사 – 규모, 점유율, 개발 및 미래 범위 2031

  • Report Code : TIPRE00004411
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 200
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동결건조 주사제 시장은 2021년 27억 1942만 달러에서 2028년 40억 127만 달러에 이를 것으로 예상된다. 2022년부터 2028년까지 CAGR 5.8%로 성장할 것으로 예상됩니다.



시장을 주도하는 주요 요인은 계약 연구 제조 서비스에 대한 수요 증가, 의약품 승인 증가, 생물 제제에 대한 수요 증가입니다. 그러나 제품 리콜로 인해 시장 성장이 제한됩니다.



동결 건조 주사제는 운송 중에 안정적인 동결 건조 약물입니다. 일회용 바이알, 현장 진료 재구성 및 특수 포장에 장기간 보관됩니다. 사용 시 희석제를 사용하여 필요한 양의 약물을 재구성할 수 있습니다. 동결건조 주사제는 동결건조 주사제라고도 하는데, 이는 용액을 진공하에서 동결 및 증발시켜 용매로부터 고체 물질을 분리하는 기술인 동결건조 공정으로 제조되기 때문입니다. 동결 건조 주사는 종종 경구용 고형 제형에 대한 최상의 대안으로 간주됩니다. 많은 사례 연구에서 주사는 누워만 있는 환자에게 엄청난 혜택을 주었습니다. 또한 동결건조 주사제는 다른 제형보다 유통기한이 더 길기 때문에 여러 질병을 앓고 있는 환자의 최대 생체이용률과 안정성을 얻기 위해 처방됩니다.



전략적 통찰력



글로벌을 위한 수익성 있는 지역 동결건조 주사제 시장



시장 통찰력



의약품 승인 증가로 시장 성장 촉진



입원 치료에 사용되는 새로운 동결건조 치료제의 안전성과 효능에 대한 지속적인 연구가 나타나고 있습니다. COVID-19 진단을 받은 성인 환자. 전 세계 동결 건조 주사제 시장의 제조업체는 심각한 COVID-19 증상으로 고통받는 환자를 치료하기 위한 이러한 혁신의 긴급 사용 승인(EUA)에 대해 미국 FDA로부터 승인을 받고 있습니다.



COVID-19 대유행 이후, 전 세계 동결 건조 주사제 시장의 참여자들은 인도에서 제한된 긴급 사용에 대해 인도 의약품 통제국(Drug Controller General of India, DCGI)과 같은 규제 기관의 승인을 얻기 위한 노력을 강화하고 있습니다. Remdesivir와 같은 의약품에 대한 승인이 증가함에 따라 결국 동결 건조 주사제에 대한 수요가 높아졌습니다. 다음은 FDA 및 기타 규제 기관에서 승인한 의약품의 몇 가지 예입니다.



  • 2020년 2월 Mylan은 COVID-19에서 제한된 긴급 사용을 위해 인도에서 Remdesivir 동결 건조 분말에 대해 DCGI로부터 규제 승인을 받았습니다.

  • 2020년 6월 Cipla는 Remdesivir 동결건조 주사용 분말인 Cipremi를 출시했습니다. 또한 미국 FDA는 입원한 COVID-19 환자를 치료하기 위해 렘데시비르를 긴급 사용하기 위해 Gilead Sciences Inc.에 긴급 사용 승인(EUA)을 발행했습니다. COVID-19 감염이 의심되거나 실험실에서 확인된 성인 및 소아 환자를 위한 유일한 FDA 승인 EUA 치료법입니다. 따라서 5월에 Gilead Sciences Inc.는 CIPREMI라고 하는 Cipla의 레메디스비르 제네릭 버전을 제조 및 판매하기 위해 Cipla에 대한 자발적인 비독점 라이선스를 확장했습니다.

  • 2020년 7월, Jubilant Life는 인도에서 중증 질환 치료를 위해 제한된 응급 사용을 위해 렘데시비르를 100mg/바이알(동결 건조 주사제)로 제조 및 판매할 수 있도록 인도 의약품감독청(DCGI)으로부터 승인을 받았습니다. COVID-19.

  • 2020년 8월, Novartis AG의 일회용 바이알에 담긴 Cosentyx 동결 건조 분말이 EU 승인을 받았습니다. 승인된 약물은 피부 증상을 빠르게 개선하고 건선으로 고통받는 환자의 삶의 질을 향상시키는 데 매우 생산적이었습니다.


따라서 전 세계적으로 증가하는 승인은 동결 건조 주사제 시장의 성장을 촉진합니다.



패키징 유형 기반 통찰력



글로벌 포장 유형에 따라 동결 건조 주사제 시장은 일회용 바이알, 현장 진료 재구성 및 특수 포장으로 분류됩니다. 2021년에는 일회용 바이알 부문이 가장 큰 시장 점유율을 차지한 반면 특수 포장 부문은 예측 기간 동안 가장 높은 CAGR 6.7%를 기록할 것으로 예상됩니다.



전달 유형 - 기반 인사이트< /h3>

전달 유형에 따라 전 세계 동결 건조 주사 가능 시장은 미리 채워진 희석제 주사기, 독점 재구성 장치, 단일 단계 장치 및 다단계 장치로 분류됩니다. 미리 채워진 희석제 주사기 부문은 2021년에 가장 큰 시장 점유율을 차지했으며 예측 기간 동안 가장 높은 CAGR 6.3%를 기록할 것으로 예상됩니다.



지시 기반 통찰력



지시 기반, 전 세계 동결건조 주사제 시장은 대사 및 종양 상태, 전염병, 자가면역 질환 및 기타 적응증으로 분류됩니다. 대사 및 종양 질환 부문은 2021년에 가장 큰 시장 점유율을 차지했으며 예측 기간 동안 가장 높은 CAGR 6.2%를 기록할 것으로 예상됩니다.



최종 사용자 기반 통찰력



기준 최종 사용자, 세계 동결 건조 주사 가능 시장은 병원, 외래 수술 센터, 전문 클리닉 등으로 분류됩니다. 병원 부문은 2021년에 가장 큰 시장 점유율을 차지했습니다. 그러나 전문 클리닉 부문은 예측 기간 동안 시장에서 가장 높은 CAGR 6.3%를 기록할 것으로 추정됩니다.



유형별 글로벌 동결건조 주사제 시장 패키징 - 2021년 및 2028년



글로벌 동결건조 주사제 시장에서 활동하는 회사는 전 세계적으로 진화하는 고객 요구를 충족하기 위해 제품 혁신 전략을 채택하고 이를 통해 글로벌 시장에서 브랜드 이름을 유지할 수 있습니다. 예를 들어, 2022년 4월 Recipharm은 첨단 치료제 CDMO Arranta Bio와 바이로테라피 CDMO Vibalogics를 인수했습니다. 이번 인수를 통해 Recipharm은 매사추세츠주 Boxborough에 시설을 갖추고 미국에 강력한 기반을 구축하고 새로운 생물 제제 방식에서 역량을 구축할 수 있는 플랫폼을 제공할 수 있었습니다.



세계 동결건조 주사제 시장 - 지역별



지리적으로 전 세계 동결건조 주사제 시장은 북미(미국, 캐나다 및 멕시코), 유럽(독일, 영국, 프랑스, 이탈리아, 스페인 및 기타 유럽), 아시아로 구분됩니다. 태평양(중국, 인도, 일본, 한국, 호주 및 기타 APAC), 중동 및 아프리카(남아프리카, 사우디아라비아, UAE 및 기타 MEA), 중남미(브라질, 아르헨티나) , 나머지 중남미).



회사 프로필



  • Baxter

  • Nipro

  • Curia Global, Inc .

  • Recipharm AB

  • Vetter Pharma

  • Jubilant HollisterStier LLC(Jubilant Pharma Limited)

  • Aristopharma Ltd.

  • CordenPharma International

  • Credence MedSystems, Inc.

  • SG Biopharm Pvt. 회사


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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