Global Lyophilized Injectable Drugs Market

Global Lyophilized Injectable Drugs Market Size, Share, Growth Analysis, By Drug(Anti-infective, Anti-neoplastic), By Indication(Autoimmune diseases, Respiratory diseases) - Industry Forecast 2023-2030


Report ID: SQMIG35B2145 | Region: Global | Published Date: February, 2024 | Pages: 157 | Tables: 71 | Figures: 75

Global Lyophilized Injectable Drugs Market Insights

The Global Lyophilized Injectable Drugs Market Size was valued at USD 2.9 billion in 2021 and is poised to grow from USD 3.09 billion in 2022 to USD 5.11 billion by 2030, growing at a CAGR of 6.5% in the forecast period (2023-2030).

The global lyophilized injectable drugs market provides global economies with pharmaceutical products that have been freeze-dried to produce stable, powder-like formulations that can be altered for injection. This process elongates shelf life of medications by removing water content, which also helps convenient storage and transportation. As a result of its benefits in reducing the risk of contamination and preserving drug efficacy, the market has seen exponential growth.

Lyophilized injectable drugs can be applied in multiple therapeutic areas, including infectious diseases, oncology, and autoimmune disorders, and more. The process of creating these products goes like this: first, manufacturers freeze the drug solution, which is then followed by the sublimation of the iced outcome under vacuum that finally leaves them with a dry powder which can be altered into liquid form with a suitable solvent before administration.

The necessity for more stable formulations, particularly for biologics and intricate molecules that are more prone to degradation is one of the major market drivers. Healthcare providers find these drugs extremely inviting as they have a longer shelf life which reduces wastage. Moreover, lyophilized drugs offer an advantageous position in emergency situations and also in environments where refrigeration might be unavailable due to limited resources.

However, the need for specialized equipment and higher production costs can pose a major challenge for the growth of the lyophilized injectable drugs market. Any errors in the reconstitution of lyophilized drugs can impact medication effectiveness and patient safety, and thus the process needs proper training, leading to a waste of time and resources. Despite these challenges, advancements in lyophilization techniques, increasing research into novel therapeutic areas, and ongoing efforts to improve drug stability are expected to sustain the growth of this market.

Market snapshot - 2023-2030

Global Market Size

USD 2.9 billion

Largest Segment

Anti-infective

Fastest Growth

Anti-infective

Growth Rate

6.5% CAGR

Global Lyophilized injectable drugs market ($ Bn)
Country Share for North America Region (%)
Global Lyophilized injectable drugs market By Drug ($ Bn)
Global Lyophilized injectable drugs market By Drug (%)

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Global Lyophilized Injectable Drugs Market Segmental Analysis

The global lyophilized injectable drugs market is segmented by Drug, Indication, Delivery, Packaging, Distribution Channel, and Region. Based on Drug the market is segmented as, Anti-infective, Anti-neoplastic, Anticoagulant, Hormones, Antiarrhythmic, Others. Based on Indication the market is segmented as, autoimmune diseases, Respiratory diseases, gastrointestinal disorders, Oncology, Cardiovascular diseases, Infectious diseases, Metabolic disorders, others. Based on Delivery the market is segmented as, Prefilled diluent syringes, Multi-step devices. Based on Packaging the market is segmented as, Vials, Cartridges, and Prefilled devices. Based on Distribution Channel the market is segmented as, Hospital pharmacy, Retail pharmacy, and online pharmacy. Regional the market is segmented as, North America, Asia Pacific, Latin America, and Middle East & Africa (MEA).

Analysis By Drug

The “Anti-infective” segment has historically dominated the lyophilized injectable drugs market. This dominance can be attributed to the persistent global demand for antibiotics and other antimicrobial agents to combat infections. The stability advantages offered by lyophilization are particularly valuable for preserving the efficacy of anti-infective drugs, ensuring their potency and reducing the risk of contamination during storage and transportation.

On the other hand, the “Anti-neoplastic” segment has emerged as the fastest-growing segment in the market. With the increasing prevalence of cancer and the development of targeted therapies, there has been a surge in demand for lyophilized injectable anti-cancer drugs. These drugs often have complex formulations and require precise dosing, making lyophilization an advantageous technique for maintaining their stability and enhancing their therapeutic efficacy.

Analysis By Indication

“Oncology” has been a dominating segment within the lyophilized injectable drugs market. The demand for stable and potent formulations for chemotherapeutic agents and targeted therapies has driven the prominence of this segment. The ability of lyophilized drugs to maintain the integrity of complex molecules, often used in cancer treatments, has contributed to its strong presence.

The fastest-growing segment in the market has been “Autoimmune diseases”. The prevalence of autoimmune disorders is increasing globally, prompting the need for effective treatments. Lyophilized injectable drugs offer an advantage by ensuring the stability of biologics and peptides used to manage autoimmune conditions, such as rheumatoid arthritis, multiple sclerosis, and lupus. This segment's growth is further accelerated by the advancement of novel biologics and therapies targeting specific autoimmune pathways..

Global Lyophilized injectable drugs market By Drug , 2021 (%)

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Global Lyophilized Injectable Drugs Market Regional Insights

The lyophilized injectable drugs market’s largest region is North America, with the United States and Canada, in particular, playing pivotal roles in achieving substantial market growth due to their advanced healthcare infrastructure, well-established pharmaceutical industries, and continual R&D activities. The demand for lyophilized injectable drugs in this region grew only further with the prevalence of chronic diseases, coupled with a focus on drug innovation and biotechnology.

Following closely behind North America, Europe comes in as the second-largest region in the lyophilized injectable drugs market. Countries like the UK, France, and Germanyhave been the greatest contributors to market growth in this region. Europe's position in the market is owed to its focus on biopharmaceutical advancements, specialized medicine, and strong regulatory frameworks for drug development. Moreover, the need for stable and efficient formulations was further highlighted as a result of a growing elderly population and increasing incidence of chronic diseases, thus driving the market demand for lyophilized injectable drugs.

Global Lyophilized injectable drugs market By Geography, 2023-2030
  • Largest
  • Fastest

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Global Lyophilized Injectable Drugs Market Dynamics

Drivers

Biologics and Complex Molecules:

  • The demand for lyophilized injectable drugs can be credited to the increased usage of peptides, biologics, and other complex molecules in therapies. In order to maintain their efficacy, these drugs often require stable formulations due to their fragile nature.

Extended Shelf Life:

  • Lyophilization extends the shelf life of therapeutic drugs by removing water content and enhancing the stability of drugs. Healthcare providers and pharmaceutical manufacturers that are looking for products with longer storage periods are especially attracted to this beneficial feature.

Restraints

Production Complexities:

  • The lyophilization process can be costly due to its complex nature and process which requires specialized equipment and expertise, resulting in larger production costs, which can be problematic when manufacturing wants to scale up.

Patient Training and Convenience:

  • Healthcare professionals and patients may need training for the reconstitution process before administration which can have a negative impact on treatment convenience and patient adherence.

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Global Lyophilized Injectable Drugs Market Competitive Landscape

The competitive landscape of the lyophilized injectable drugs market is marked by intense rivalry among pharmaceutical companies striving to establish a prominent presence in this specialized sector. Key players in the industry focus on research and development to create innovative lyophilized formulations that enhance drug stability and patient outcomes. This landscape is dominated by established pharmaceutical giants with the capability to invest in advanced manufacturing technologies and meet stringent regulatory requirements.

Top Player’s Company Profile

  • Pfizer Inc.
  • Novartis AG
  • Roche Holding AG
  • Johnson & Johnson
  • Sanofi S.A.
  • Amgen Inc.
  • AbbVie Inc.
  • Eli Lilly and Company
  • AstraZeneca PLC
  • Bristol Myers Squibb Company
  • GlaxoSmithKline plc
  • Gilead Sciences, Inc.
  • Biogen Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Celgene Corporation
  • Vertex Pharmaceuticals Incorporated
  • Takeda Pharmaceutical Company Limited

Recent Developments

  • In January 2023, the FDA signed over its approval for the first lyophilized injectable drug that can be administered in the treatment of atopic dermatitis in children that are 6 months and older.
  • In February 2023, a new technology for continuous lyophilization was strategized and developed which is aimed at improving the efficiency and the quality of the overall process.
  • In March 2023, a pharmaceutical company reported that it was expanding its manufacturing capacity for lyophilized injectable drugs so that the market can meet the growing demand.

Global Lyophilized Injectable Drugs Key Market Trends

  • Rise in Biologics and Complex Molecules: The development and utilization of peptides, biologics, and other complex molecules for various therapeutic areas was an increasing development in the market. Lyophilization guarantees the efficacy upon reconstitution by preserving the stability of these delicate molecules, which is essential in the industry.
  • Advancements in Drug Delivery: Improvements in drug delivery systems for lyophilized injectables were furthered by technological innovations. This also included the production of user-friendly devices and reconstitution mechanisms, which in turn enhances patient convenience.

Global Lyophilized Injectable Drugs Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Component types team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.

According to our global lyophilized injectable drugs market analysis; the lyophilized injectable drugs market involves the production and distribution of freeze-dried medications, which offer extended shelf life and stability. This market is categorized into various therapeutic segments, including oncology, autoimmune diseases, infectious diseases, and more. As of my last update in September 2021, North America and Europe were dominant regions due to their advanced pharmaceutical industries and healthcare infrastructure. Key drivers included the rise of biologics and complex molecules, the need for stable drug formulations, and the increasing prevalence of chronic diseases. Technological advancements, personalized medicine, and environmental sustainability were shaping the industry, driving innovations in drug delivery systems and greener practices. However, the intricacies of production, regulatory compliance, and patient safety remained challenges in this evolving landscape.

Report Metric Details
Market size value in 2021 USD 2.9 billion
Market size value in 2030 USD 5.11 billion
Growth Rate 6.5%
Base year 2021
Forecast period 2023-2030
Forecast Unit (Value) USD Billion
Segments covered
  • Drug
    • Anti-infective, Anti-neoplastic, Anticoagulant, Hormones, Antiarrhythmic, Others
  • Indication
    • Autoimmune diseases, Respiratory diseases, Gastrointestinal disorders, Oncology, Cardiovascular diseases, Infectious diseases, Metabolic disorders, and Others
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Pfizer Inc.
  • Novartis AG
  • Roche Holding AG
  • Johnson & Johnson
  • Sanofi S.A.
  • Amgen Inc.
  • AbbVie Inc.
  • Eli Lilly and Company
  • AstraZeneca PLC
  • Bristol Myers Squibb Company
  • GlaxoSmithKline plc
  • Gilead Sciences, Inc.
  • Biogen Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Celgene Corporation
  • Vertex Pharmaceuticals Incorporated
  • Takeda Pharmaceutical Company Limited
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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Global Lyophilized Injectable Drugs Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Global Lyophilized Injectable Drugs Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Global Lyophilized Injectable Drugs Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global Lyophilized Injectable Drugs Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Global Lyophilized Injectable Drugs Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Global Lyophilized Injectable Drugs Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQ's

The Global Lyophilized Injectable Drugs Market Size was valued at USD 2.9 billion in 2021 and is poised to grow from USD 3.09 billion in 2022 to USD 5.11 billion by 2030, growing at a CAGR of 6.5% in the forecast period (2023-2030).

The competitive landscape of the lyophilized injectable drugs market is marked by intense rivalry among pharmaceutical companies striving to establish a prominent presence in this specialized sector. Key players in the industry focus on research and development to create innovative lyophilized formulations that enhance drug stability and patient outcomes. This landscape is dominated by established pharmaceutical giants with the capability to invest in advanced manufacturing technologies and meet stringent regulatory requirements. 'Pfizer Inc.', 'Novartis AG', 'Roche Holding AG', 'Johnson & Johnson', 'Sanofi S.A.', 'Amgen Inc.', 'AbbVie Inc.', 'Merck & Co., Inc.', 'Eli Lilly and Company', 'AstraZeneca PLC', 'Bristol Myers Squibb Company', 'GlaxoSmithKline plc', 'Gilead Sciences, Inc.', 'Biogen Inc.', 'Teva Pharmaceutical Industries Ltd.', 'Mylan N.V.', 'Celgene Corporation', 'Novo Nordisk A/S', 'Vertex Pharmaceuticals Incorporated', 'Takeda Pharmaceutical Company Limited'

The demand for lyophilized injectable drugs can be credited to the increased usage of peptides, biologics, and other complex molecules in therapies. In order to maintain their efficacy, these drugs often require stable formulations due to their fragile nature.

Rise in Biologics and Complex Molecules: The development and utilization of peptides, biologics, and other complex molecules for various therapeutic areas was an increasing development in the market. Lyophilization guarantees the efficacy upon reconstitution by preserving the stability of these delicate molecules, which is essential in the industry.

The lyophilized injectable drugs market’s largest region is North America, with the United States and Canada, in particular, playing pivotal roles in achieving substantial market growth due to their advanced healthcare infrastructure, well-established pharmaceutical industries, and continual R&D activities. The demand for lyophilized injectable drugs in this region grew only further with the prevalence of chronic diseases, coupled with a focus on drug innovation and biotechnology.

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