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Cell Therapy Bioprocessing Market

Cell Therapy Bioprocessing Market - Global Industry Analysis 2016 - 2020 and Opportunity Assessment 2021 - 2031

Cell Therapy Bioprocessing Market Segmented By product type such as Technology and Cell Type used for Cardiovascular Disease, Oncology, Wound Healing and Orthopedic Indication in Hospitals, Clinics, Dignostic centers, Regenerative Medicine Centers, Acedamic and Research Institute

Global Cell Therapy Bioprocessing Market: Market Outlook

Cell therapy bioprocessing is a discipline that bridges the fields of cell therapy and bioprocessing (i.e., biopharmaceutical manufacturing), and is a sub-field of bioprocess engineering. Cell therapy has become one of the fastest-growing segments in the life sciences. It involves the delivery of whole, living cells to a patient for the treatment of disease.

Typically, this category is divided into two main sections: autologous (meaning the cells are derived from the patient, modified [usually genetically], and re-administered back to the patient), or allogenic (meaning the cells are derived from another individual and show some match to the potential new host - similar to a blood transfusion).

Modern cellular and gene therapy therapeutics are easily on track to become multibillion-dollar markets within 10 years. Newer cell therapies are now viewed as biopharmaceutical products requiring standardization and regulatory approvals, rather than being largely unregulated, physician-prescribed medical procedures, such as red blood cells. Selling live cultured human cells as therapeutics is essentially a new manufacturing paradigm.

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What are the Key Trends Impacting Growth of the Cell Therapy Bioprocessing Market?

Disease like cardiovascular, oncology, have according to American Cancer association Estimated numbers of new cancer cases and deaths in 2020 (In 2020, there will be an estimated 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in the United States.) This drive the great opportunities for cell therapy market.

The development of precision medicine and advancements in Advanced Therapies Medicinal Products (ATMPS) in context to their efficiency and manufacturing are expected to be the major drivers for the market. In addition, automation in adult stem cell and cord blood processing and storage are the key technological advancements that have supported the growth of the market for cell therapy.

The biomanufacturing companies are working in collaboration with customers and other stakeholders to enhance the clinical development and commercial manufacturing of these therapies. Biomanufacturers and OEMs such as GE healthcare are providing end-to-end flexible technology solutions to accelerate the rapid launch of therapies in the market for cell therapy.

While worldwide R&D spending is expected to increase every year, the average annual proportion of R&D spending to pharmaceutical revenue actually is expected to increase. Major drug approvals in 2018 and 2019 have shone a spotlight on the CGT industry, and with all the attention has come an influx of cash.

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What are the Key Challenges that may Restrain Growth of the Cell Therapy Bioprocessing Market?

The lack of appropriate equipment and the use of manual techniques have led to manufacturing capacity bottlenecks at facilities, and as more therapies reach clinical and commercial scale, the current capacity crunch is likely to get worse. 

BioPlan studies and related publications report that ~90 percent of cellular/gene therapy developers would prefer to use contract manufacturing organizations (CMOs) for their product manufacturing needs, if sufficient CMO capacity and expertise were available.

But developers report that current wait times at CMOs to start new projects now average ≥18 months, with only a relatively small number of CMOs having the needed resources and expertise.

There are very few CMOs yet involved, and their cellular therapy bioprocessing capacity and expertise are limited. A large number of new process lines and facilities will increasingly be needed. There is reliance on the use of hoods and cleanrooms, rather than closed systems, to assure prevention of microbial and other contamination.  But, importantly, regulatory expectations will eventually require full(er) GMP compliance.

A reason for the current slow innovation cycle is that the market for cellular therapy bioprocessing is limited and is still mostly at research, and some clinical, scales.

Thus, the return on investment in the development of new technologies is not quite there yet. And many innovative suppliers are in a holding pattern until they determine which technologies will prevail and which direction cell therapy bioprocessing will take in the near term.

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Key Segments of Cell Therapy Bioprocessing Market Covered in the Report

Based on product type, the Cell Therapy Bioprocessing market has been segmented as

  • Technology
    • Bioreactor
    • Controlflow centrifugation
    • Ultrasonic Lysis
    • Lyophilization
    • Electrodspinning
    • Viral Vector Technology
    • Cell Immortalization Technology
    • Genome Editing Technology
  • Cell Type
    • Immune cell
    • Steam Cell
    • Human embryonic stem cells
    • Pluripotent stem cells stem cell
    • Hematopoetic stem cells

Based on Indication, the Cell Therapy Bioprocessing market has been segmented as

  • Cardiovascular Disease (CVD)
  • Oncology
  • Wound Healing
  • Orthopedic
  • Others

Based on end user, the Cell Therapy Bioprocessing market has been segmented as

  • Hospitals
  • Clinics
  • Dignostic centers
  • Regenerative Medicine Centers
  • Acedamic and Research Institute

Based on the region, the Cell Therapy Bioprocessing market has been segmented as

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa
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Competitive Landscape

Key players such as

  • Fresenius Medical Care AG & Co. KGAA
  • Omnica Corporation
  • Medtronic
  • Baxter International Inc
  • B. Braun
  • Nikkiso Co., Ltd
  • Asahi Kasei Medical Co., Ltd.
  • Infomed SA
  • Bellco S.R.L

others are actively involved in offering Cell Therapy Bioprocessing for different applications. 

What strategies are the Key Players adopting for Increasing their Market Share in the Cell Therapy Bioprocessing Market?

Key players in the market are focused on increasing their product features and portfolio to strengthen their position in the market. Key players are expanding their manufacturing facilities to serve the increasing demand for Cell Therapy Bioprocessing.

Key players are entering the market with novel and innovative Cell Therapy Bioprocessing machine with features, such as technological advancements for decentralizing manufacturing of this therapy is anticipated to significantly benefit the market.

  • Miltenyi Biotec is one of the companies that has contributed to the decentralization in manufacturing through its CliniMACS Prodigy device. The device is an all-in-one automated manufacturing system that exhibits the capability of manufacturing various cell types.
  • Several companies have marked their presence in the market by acquiring small and emerging therapy developers. For instance, in August 2019, Bayer acquired BlueRock Therapeutics to establish its position in the market for cell therapy.
  • BlueRock Therapeutics is a U.S. company that relies on a proprietary induced pluripotent stem cell (iPSC) platform for cell therapy development.

Some key companies operating in this market for cell therapy are:

  • Miltenyi Biotec
  • Bayer, Fibrocell Science Inc.
  • Thermo Fisher Scientific
  • Merck Group
  • Becton
  • Dickinson and Company
  • Bio-Rad Laboratories
  • Takara Bio Group
  • STEMCELL Technologies
  • Pharmicell
  • Osiris Therapeutics

are the key player in Cell therapy bioproessing market.

What are the Key Opportunities for Cell Therapy Bioprocessing Manufacturers?

The cell therapy market will show rapid growth due to the increasing prevalence of chronic conditions, rising adoption of regenerative medicine and rise in the number of clinical studies pertaining to the development of cellular therapies. Chronic diseases and conditions are on the rise worldwide.

According to the World Health Organization, chronic disease prevalence is had been rise by 57% by the year 2020. The emerging markets will be hardest hit, as population growth is anticipated be most significant in developing nations. Increased demand for healthcare systems due to chronic disease has thus become major concern.

Healthcare expenditures greatly increase, with each additional chronic condition with greater specialist physician access, emergency department presentations and hospital admissions.

Therefore the increasing prevalence of chronic conditions, government assistance and numerous companies investing heavily stimulate the industry growth of cell therapy bioprocessing market. The proven effectiveness of cell therapy products coupled with increasingly favorable guidelines pertaining to cell therapy research and manufacturing should positively impact industry growth.

Why the U.S. is a Big Market for Cell Therapy Bioprocessing?

Cell Therapy Bioprocessing machine manufacturer in U.S. is more. Some prominent players in Cell Therapy Bioprocessing such as Miltenyi Biotec, Bayer International Inc, B. Braun are present in U.S. which creates significant revenue. For instance, is one of the companies that has contributed to the decentralization in manufacturing through its CliniMACS Prodigy device.

For instance, in August 2019, Bayer acquired BlueRock Therapeutics to establish its position in the market for cell therapy. Blue Rock Therapeutics is a U.S. company that relies on a proprietary induced pluripotent stem cell (iPSC) platform for cell therapy development.

The presence of leading universities such as the Institute for Stem Cell Biology and Regenerative Medicine, Stanford University, and Yale Stem Cell Center that support research activities in U.S. is one of the key factors driving the market for cell therapy in North America.

Moreover, strong regulatory and financing support from the federal bodies for expansion of this arena in U.S. as well as Canada are driving the market. Additionally, adaption of Cell Therapy Bioprocessing is more in USA due to significant reimbursement for dialysis treatment.

What is the impact of the Pandemic on the Growth of the Cell Therapy Bioprocessing Market?

COVID-19 pandemic will show a negative impact on the Cell Therapy Bioprocessing market. Due to short term shut down of production facilities of medical device industries for first few months in 2020.

However, the pandemic has also resulted in a temporary pause of all non-essential and elective procedures. Hence, Cell Therapy Bioprocessing had significantly impacted, with companies reporting significant drops in revenue due to the cancellation of these production.

The report covers exhaust analysis on:

  • Market Segments
  • Market Dynamics
  • Market Size
  • Supply & Demand
  • Current Trends/Issues/Challenges
  • Competition & Companies involved
  • Technology
  • Value Chain

Regional analysis includes:

  • North America (U.S., Canada)
  • Latin America (Mexico, Brazil, Argentina, and Rest of Latin America)
  • Europe (Germany, Italy, U.K, Spain, France, Russia and Rest of Europe)
  • South Asia (India, Thailand, Indonesia, Malaysia, Rest of South Asia)
  • East Asia (China, South Korea, Japan)
  • Oceania (Australia, New Zealand)
  • Middle East and Africa (GCC, S. Africa, Turkey, and Rest Of MEA)

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain.

The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Report Highlights:

  • Detailed overview of parent market
  • Changing market dynamics in the industry
  • In-depth market segmentation
  • Historical, current, and projected market size in terms of volume and value
  • Recent industry trends and developments
  • Competitive landscape
  • Strategies of key players and products offered
  • Potential and niche segments, geographical regions exhibiting promising growth
  • A neutral perspective on market performance
  • Must-have information for market players to sustain and enhance their market footprint

- Companies Covered in This Report -

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