Plasma Fractionation: Benchmarking, Analysis & Trends 2023

 

The plasma industry is at a crossroads, with rising input costs but with revenues that struggle to cover them. While plasma acquisition costs play a large role in the overall expenditure incurred to produce plasma derived therapies, the manufacturing cost also plays a critical role, as billions are invested in fractionation and purification projects to expand and modernize plasma manufacturing plants around the world. Still, there is continued interest from veteran and new players alike in expanding the industry with new facilities, especially in countries which import all their products but wish to have their own domestic industry.

 This report is a comprehensive resource of information which provides a clear and broad understanding of the plasma manufacturing industry. It includes a detailed description of the plasma manufacturing process along with relevant data/benchmarking on immunoglobulin (IgG) production yields, key equipment pricing, and on the major vendors that support the industry.

 OBJECTIVES

 Companies are faced with important questions in relation to their position in this competitive industry, including:

  • How and why have plasma fractionation costs risen and what components have mostly contributed to that change?
  • How can companies respond to increasing customer demand while maintaining or even reducing manufacturing costs?
  • How do companies compare on their efficiency in producing IgG from a liter of plasma, and what can they do to improve their performance?
  • Which suppliers can help them improve process efficiency, reduce costs or increase automation?
  • How much does key equipment, materials and certain services cost for new products or process development?
  • What novel fractionation or production methods are in development that could affect the incumbent industry?

 This report answers these questions and many others, using multiple data, analysis and trends to help companies understand where they stand in the present and future competitive environment  and the key operational risks they face in this space. It also provides key benchmarks on yields that are of major importance for all organizations active in the plasma industry and suggests some general steps companies can take to improve their yields going forward. It is a first-of-its-kind report covering many aspects that have never been explored in this format and level of detail. Overall, this report is a key resource with a lot of insight across a wide range of aspects of the manufacturing of plasma proteins. It will be highly valuable to all stakeholders in involved in the plasma industry, or planning to invest in it.

METHODOLOGY

Experts Interviews. Over 60 interviews were conducted with industry experts experienced in every of the multiple aspect of plasma fractionations, as well as with engineering companies, suppliers of the equipment, supplies, services of fractionation facility.

MRB database: The Marketing Research Bureau has an extensive database covering over forty years of plasma fractionation industry operations. Some of the invaluable data and information have been included in this report, ensuring that it is not confidential and available to the general public.

REPORT CONTENTS (185 PAGES IN TOTAL)

The report begins with a broad background and history of plasma fractionation, including the key steps in the fractionation process, and how it influences the present environment. The current challenge of rising costs, especially since the beginning of the Covid19 pandemic are detailed, giving an impetus to the companies to make difficult and focused changes so as to improve their efficiency and maintain viability.

 IgG is the most important plasma protein and the focus of many companies at present. The report discusses how different processes and techniques used within the fractionation industry affect the IgG production yields. It also provides the estimated yields of all the major IgG brands, and the reasons of their differentiation.

Historical and current costs of key equipment used in plasma fractionation are provided, along with an analysis on the reason for inflation-adjusted changes. Other inputs, such as various energy costs are also explored, which are significant contributors to overall costs in this industry.

 The report also delves into trends in packaging, single-use systems, supply chain management, regulatory actions against plasma companies, automation trends and sustainability trends. Special attention is paid on how the Covid19 pandemic has affected, and continues to affect these areas of plasma products manufacturing. Key suppliers to the industry – engineering companies and others – are profiled, with descriptions of the ways they can bring plasma fractionation companies to higher levels of efficiency and rationality.

 This report will support companies in their understanding of their positioning across a broad range of manufacturing activities and serve as an essential comparison and cross-check tool for those which are currently active in the plasma fractionation space. It will help them understand some of the competitive strengths or weaknesses in this dynamic, but challenging industry. It will also highlight the capabilities of the main vendors to the plasma fractionation field, facilitate their assessment in regard to the customers’ requirements, and help them identify potential suppliers who may best contribute to efficiency enhancement or facility improvements in the future.

PLASMA FRACTIONATION: BENCHMARKING, ANALYSIS AND TRENDS 2023

TABLE OF CONTENTS of the Current Report

EXECUTIVE SUMMARY  (page 7)

  1. INTRODUCTION TO THE PLASMA FRACTIONATION INDUSTRY (page 12)

Where is the Plasma Fractionation Industry Headed after post-Covid19 Pandemic?

Cost Components to Product Plasma Proteins

Cost of Goods Sold (COGS) Grows Faster than Revenue since Pandemic Started

Top Biomanufacturing Trends

  1. PLASMA FRACTIONATION STEPS (page 21)

Precipitation

Ethanol Precipitation

Cold or Cryo Precipitation

Caprylate Precipitation

Citrate Precipitation

Centrifugation and Depth Filtration

Chromatography

Viral Reduction

Pasteurization

Solvent Detergent

Low pH Hold

Ethanol Precipitation as Viral Step

Caprylate Precipitation as Viral Step

Nanofiltration

Chromatography as Viral Step

Fractionation Construction & Support Supplies

  1. IMMUNOGLOBULIN (IgG) PRODUCTION YIELDS BY COMPANY (page 44)

Factors that affect IgG Yield

Optimized Upstream Process (Bulk Plasma Fractionation)

Large Batch Sizes

Downstream (Purification) Process Step Optimization

Regulatory Limitations on Improving IgG Yield

Overall IG Production Yields by Company

CSL Behring’s Privigen and Hizentra

Grifols’ Gamunex-C and GammaKed

Grifols’ Xembify

Grifols’ Flebogamma 5% and 10%

Takeda’s Gammagard Liquid, Kiovig and Hyqvia

Takeda’s Cuvitru

Octapharma’s Octagam 5% and 10%

Octapharma’s Panzyga

BPL’s Gammaplex 10%

Kedrion’s IG Vena

Biotest’s Intratect

LFB’s IQYmune (10%)/Clairyg (5%)

  1. NOVEL PLASMA FRACTIONATION PLATFORMS (page 58)

Evolve Biologics – Expanded Bed Chromatography Platform

Aegros HaemaFrac® Platform

Prometic BioProduction PPPS Process “Plasma Protein Purification System”

Novel Immunoglobulin Production Methods

GigaGen: Recombinant Hyperimmune products

SAb Biotherapeutics- Humanized Cows

Future Impact of Novel Technologies

  1. PLASMA FRACTIONATION PROCESSING EQUIPMENT PRICING & TRENDS (page 68)

Background on Fractionation Equipment

Filling Equipment – Background & Trends

Fractionation Process Equipment Pricing – 2014 and 2022

Process Equipment Pandemic Challenges

Selected Fractionation Plant Investments 2010 to Present

  1. PLASMA FRACTIONATION SUPPLIES/RAW MATERIALS UNIT PRICING (page 83)

Methodology

Unit Pricing Results

Process Chemicals

Process Filters

Analysis of the pricing effects

  1. ETHANOL & ENERGY PRICING TRENDS (page 89)

Industrial Ethanol

Natural Gas

Crude Oil

Electricity Rates in the United States

  1. LABORATORY SUPPORT SERVICES COST & TRENDS (page 99)

Viral Clearance Study Costs

Methods Validation Service Costs

  1. CONTRACT MANUFACTURING & CONTROLS (CMC) OUTSOURCING (page 102)

Example of Plasma-Focused Services Provided (Previ Pharma)

  1. PACKAGING (page 105)

Product Container Trends

Glass containers

Closures (Stoppers)

Overall Trends for Product Containers

Drug Product Packaging (Leaflets)

Overall Packaging Trends in the Pharmaceutical Industry

Serialization and track-and-trace

Innovations in packaging machinery/automation

IoMT (Internet of Medical Things)

  1. SINGLE USE SYSTEMS/TECHNOLOGIES (SUS/SUT) (page 118)

What are they and why use SUS?

How the pandemic affected SUS

How Suppliers Responded to Supply Challenges – Case Study

Cytiva on SUS Documentation of its Suppliers

  1. SUPPLY CHAIN MANAGEMENT (page 123)

Major Suppliers

Cost of Poor Quality (COPQ)

Reducing Total Cost of Ownership for Chemical Materials

Assessing the True Cost of a cGMP Chemical Supply Chain

Supply Chain Partnerships Value and Case Study

Supplier Audit Programs

Digitization of end-to-end Supply Chain

  1. PROCUREMENT CONTRACTS PRICING TRENDS (page 144)

Current Procurement Strategies

Potential Procurement Alliances

Competitive Pricing

  1. REGULATORY TRENDS & RECENT FDA ENFORECEMENT ACTIONS ON PLASMA COMPANIES (page 147)

Putting the “c” in cGMP (Regulatory Service Provider Redica)

Plasma Fractionation Site Enforcement Actions 2019-2022

FDA Guidance since the Covid19 Pandemic started

FDA Guidance on Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency Guidance for Industry

  1. INCREASING AUTOMATION, INTEGRATION AND DIGITIZATION (page 158)

Unit Operations Automation

Plant Floor to Business System Integration

Manufacturing Execution Systems (MES)

Advantages of an MES system

Laboratory Information Management Systems (LIMS)

Quality Management Systems (QMS)

Examples of Quality Management Systems

Enterprise Resource Planning Systems (ERP)

Cloud-based ERP System Components

Large-scale Data Repositories

Expectations for the Future of Software Platforms

  1. SUSTAINABILITY PROGRAMS & SUGGESTIONS (page 174)

Reduction Project Suggestions

Electrification Project Suggestions

Plasma Fractionation Companies Sustainability Programs