Global Lyophilization Services for Biopharmaceuticals Market

Report ID : 1350 | Published : 2022-08-03 | Pages: | Format: PDF/EXCEL

The Global Lyophilization Services for Biopharmaceuticals Market size was valued at US$ 774.86 million in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 10.1% from 2022 to 2030. Lyophilization is a method that involves freezing a substance at extremely low temperatures and then extracting liquid via sublimation, thereby transforming solid water into gaseous water. A significant advantage of this process is that the extracted water goes directly from solid to gas without passing through the liquid phase. This process is exceptional at extending a product's shelf life and storage time while preserving its three-dimensional structure and integrity. It is a modern alternative to the cryopreservation technique, which was generally used for cell and tissue preservation. Lyophilizers freeze the material, then reduce the pressure and add heat to allow the frozen water in the material to sublimate. The lyophilized formulation has the advantage of better stability and provides easy handling, i.e. shipping and storage. To minimize detrimental effects, lyophilized products sensitive to oxidation can be stoppered and sealed within an inert atmosphere (i.e. nitrogen). This technique is useful in developing thermolabile and unstable drugs in an aqueous medium. The majority of lyophilized or freeze-dried products in the pharmaceutical industry are used for parenteral application.

Increasing investment, demand for easy drug packaging and transport, and the need for better preservation of heat-sensitive drugs will be responsible for the fast growth of the service industry. Technical advancement in lyophilization equipment and continuous research on process validation will support the development of the Lyophilization Services for Biopharmaceuticals market. In Nov 2021, Baxter Biopharma announced an approximately $100 million expansion of its sterile fill/finish manufacturing facility in Germany. This investment expands Baxter's manufacturing footprint and improves shelf life through Lyophilization. It is a long and cost-intensive process, and it requires sterile diluents for reconstitution. Lyophillization is mostly used when the product is unstable and heat-liable. The limited amount of vials processed in each process run restricts the overall production capacity. Alternatives for Lyophilization like spray drying, High cost of setup and maintenance of machines and methods, and strict regulatory guidelines will hinder the market growth to some extent.

The Asia Pacific and North America will hold the largest market share due to expansions of drug and biotechnology companies and extensive research on drug development. Companies are doing collaborations and strategic partnerships for rapid growth to achieve the production goals.

Global Lyophilization Services for Biopharmaceuticals Market is segmented into two main segments, Type of Biologic Lyophilized and Type of Primary Packaging System. The type of biologic lyophilized is again sub-segmented into four parts antibodies, cell and gene therapies in which living cells are preserved at room temperature for a prolonged period without loss of viability, vaccines and other biologics. The type of primary packaging system is divided into vials, syringes, cartridges, ampoules and others.

Major market key players are AB BioTechnologies, Inc., Albany Molecular Research (AMRI), ATTWILL Medical Solutions, Axcellerate Pharma LLC., Baxter BioPharma Solutions, Berkshire Sterile Manufacturing, Inc., Biofortuna Ltd, BioZed Engineering, CinnaGen, CordenPharma, Curia, Emergent BioSolutions, Jubilant HollisterStier LLC, LSNE Contract Manufacturing, Lyophilization Technology, Inc., MabPlex, Northway Biotech, ProJect Pharmaceutics, Samsung Biologics, Synerlab Group, Vetter Pharma, and WuXi Biologics

Companies Mentioned

  • AB BioTechnologies, Inc.
  • Albany Molecular Research (AMRI)
  • ATTWILL Medical Solutions
  • Axcellerate Pharma LLC.
  • Baxter BioPharma Solutions
  • Berkshire Sterile Manufacturing, Inc.
  • Biofortuna Ltd
  • BioZed Engineering
  • CinnaGen
  • CordenPharma
  • Curia
  • Emergent BioSolutions
  • Jubilant HollisterStier LLC
  • LSNE Contract Manufacturing
  • Lyophilization Technology, Inc.
  • MabPlex
  • Northway Biotech
  • ProJect Pharmaceutics
  • Samsung Biologics
  • Synerlab Group
  • Vetter Pharma
  • WuXi Biologics

Chapter 1. Methodology and Scope

1.1. Research Methodology

1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Lyophilization Services for Biopharmaceuticals Market Snapshot

Chapter 4. Global Lyophilization Services for Biopharmaceuticals Market Variables, Trends & Scope

4.1. Market Segmentation & Scope

4.2. Drivers

4.3. Challenges

4.4. Trends

4.5. Investment and Funding Analysis

4.6. Industry Analysis – Porter’s Five Forces Analysis

4.7. Competitive Landscape & Market Share Analysis

4.8. Impact of Covid-19 Analysis

Chapter 5. Market Segmentation 1: By Biologic Lyophilized Types Estimates & Trend Analysis

5.1. By Biologic Lyophilized Types & Market Share, 2020 & 2030

5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2030 for the following By Biologic Lyophilized Types:

5.2.1. Antibodies

5.2.2. Cell and Gene Therapies

5.2.3. Vaccines

5.2.4. Other Biologics

Chapter 6. Market Segmentation 2: By Primary Packaging System Estimates & Trend Analysis

6.1. By Primary Packaging System & Market Share, 2020& 2030

6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2020 to 2030 for the following By Primary Packaging System:

6.2.1. Vials

6.2.2. Syringes

6.2.3. Cartridges

6.2.4. Ampoules

6.2.5. Other Pakaging System

Chapter 7. Lyophilization Services for Biopharmaceuticals Market Segmentation 3: Regional Estimates & Trend Analysis

7.1. North America

7.1.1. North America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts By Biologic Lyophilized Types, 2019-2030

7.1.2. North America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts By Therapy, 2019-2030

7.1.3. North America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts by Primary Packaging System, 2019-2030

7.1.4. North America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts by country, 2019-2030

7.2. Europe

7.2.1. Europe Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Biologic Lyophilized Types, 2019-2030

7.2.2. Europe Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Therapy, 2019-2030

7.2.3. Europe Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts by Primary Packaging System, 2019-2030

7.2.4. Europe Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) by country, 2019-2030

7.3. Asia Pacific

7.3.1. Asia Pacific Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Biologic Lyophilized Types, 2019-2030

7.3.2. Asia Pacific Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Therapy, 2019-2030

7.3.3. Asia Pacific Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts by Primary Packaging System, 2019-2030

7.3.4. Asia Pacific Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) by country, 2019-2030

7.4. Latin America

7.4.1. Latin America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Biologic Lyophilized Types, 2019-2030

7.4.2. Latin America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Therapy, 2019-2030

7.4.3. Latin America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts by Primary Packaging System, 2019-2030

7.4.4. Latin America Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) by country, 2019-2030

7.5. Middle East & Africa

7.5.1. Middle East & Africa Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Biologic Lyophilized Types, 2019-2030

7.5.2. Middle East & Africa Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) By Therapy, 2019-2030

7.5.3. Middle East & Africa Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) estimates and forecasts by Primary Packaging System, 2019-2030

7.5.4. Middle East & Africa Lyophilization Services for Biopharmaceuticals Market revenue (US$ Million) by country, 2019-2030

Chapter 8. Competitive Landscape

8.1. Major Mergers and Acquisitions/Strategic Alliances

8.2. Company Profiles

8.2.1. Baxter BioPharma Solutions

8.2.2. Curia

8.2.3. Emergent BioSolutions

8.2.4. LSNE Contract Manufacturing

8.2.5. Lyophilization Technology, Inc.

8.2.6. CordenPharma

8.2.7. Coriolis Pharma

8.2.8. Northway Biotech

8.2.9. ProJect Pharmaceutics

8.2.10. Vetter Pharma

8.2.11. BioZed Engineering

8.2.12. CinnaGen

8.2.13. MabPlex

8.2.14. Samsung Biologics

8.2.15. WuXi Biologics

8.2.16. Other Prominent Players

Global Lyophilization Services for Biopharmaceuticals Market, by Type of Biologic Lyophilized, 2022-2030 (Value US$ Mn)

  • Antibodies
  • Cell and Gene Therapies
  • Vaccines
  • Other Biologics

Global Lyophilization Services for Biopharmaceuticals Market, by Type of Primary Packaging System, 2022-2030 (Value US$ Mn)

  • Vials
  • Syringes
  • Cartridges
  • Ampoules
  • Others

Global Lyophilization Services for Biopharmaceuticals Market, by Region, 2022-2030 (Value US$ Mn)

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

North America Lyophilization Services for Biopharmaceuticals Market, by Country, 2022-2030 (Value US$ Mn)

  • U.S.
  • Canada

Europe Lyophilization Services for Biopharmaceuticals Market, by Country, 2022-2030 (Value US$ Mn)

  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe

Asia Pacific Lyophilization Services for Biopharmaceuticals Market, by Country, 2022-2030 (Value US$ Mn)

  • India
  • China
  • Japan
  • South Korea
  • Australia & New Zealand

Latin America Lyophilization Services for Biopharmaceuticals Market, by Country, 2022-2030 (Value US$ Mn)

  • Brazil
  • Mexico
  • Rest of Latin America

Middle East & Africa Lyophilization Services for Biopharmaceuticals Market, by Country, 2022-2030 (Value US$ Mn)

  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Landscape

  • Company Overview
  • Financial Performance
  • Key Development
  • Latest Strategic Developments

InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.

Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.

Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.

Secondary research

The secondary research sources that are typically mentioned to include, but are not limited to:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista

Primary Research:

Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies

The contributors who typically take part in such a course include, but are not limited to: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

Data Modeling and Analysis:

In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.

The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.

To know more about the research methodology used for this study, kindly contact us/click here.

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US$ 774.86 million in 2021

The market is expected to grow at a compound annual growth rate (CAGR) of 9.17% from 2022 to 2030.

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