Regenerative Medicine

Part
01
of six
Part
01

Regenerative Medicine: Northeast U.S.

Massachusetts is undoubtedly becoming the capital of regenerative medicine investment, innovation and collaboration. There are several actors present in this region and it is considered a global region in this field of medicine. Additionally, findings suggest strong growth is to be expected in this field.

Overview of Regenerative Medicine

  • There are significant investments into cell and gene therapy particularly in Massachusetts where a private-public partnership involving MIT, Harvard and the Massachusetts Life Sciences Strategy Group will see to hospitals, corporations and state officials combine in a $50 million project to create a center for advanced biological innovation and manufacturing. This project will give researchers and companies in the state an advantage by adding cell manufacturing capacity at reduced costs while fostering innovation and collaboration.
  • Further, Astellas Pharma Inc plans to invest a further $13 million in addition to the over $1 billion invested in the greater Boston area life sciences community.
  • The pharmaceutical giant, Bayer AG, is also heavily invested in the region. BlueRock Therapeutics, which is developed the CELL+GENE platform was established in with initial funding of $225 million. It was fully acquired by Bayer, evaluating the company at approximately $1 billion. The company, like Nikon's bioimaging lab, is based in Cambridge, Massachusetts.
  • Another key player operating in Cambridge, Massachusetts is ElevateBio, which is actively "creating and operating a portfolio of cell and gene therapy companies through partnerships with the world’s most innovative scientists and inventors".
  • The Massachusetts community hosts over 200 professionals in regenerative medicine and other related fields. The region is thus regarded as a global leader in this branch of medicine according to the Harvard Gazette.
  • Organogenesis Holdings Inc. (Massachusetts) and Osiris Therapeutics, Inc (Maryland) are among the larger companies active in the North-Eastern states of the US. They are particularly active in the advanced wound care section of regenerative medicine.
  • In the United States, less than 5% of the 3.3 million patients with wounds ineffectively treated by traditional therapies utilise skin substitutes. This presents a large market.
  • However, as it stands, a significant number of government and private health insurers do not provide coverage for regenerative medicine procedures. On the background of the fact that these products cost more than traditional ones, this could represent significant hurdles for high market penetration.
  • Within the advanced wound care (AWC) market, the biggest treatments by number are advanced wound dressing (54%), negative wound pressure (20%), and wound biologics (17%). Despite being one of the smaller segments of the overall AWC market, the wound biologics market was estimated to be worth $1.5 billion in 2018 and is the fastest-growing segment of the market.
  • Skin substitutes are the largest (64%) and fastest-growing segment of the wound biologics market and it grew from $725 million in 2016 to $965 million in 2018. This is at an estimated annual growth rate of 15%.
  • BIS Research, the global Advanced Wound Care market was estimated to be approximately $8.9 billion in 2018 and is expected to grow at a compound annual growth rate, or CAGR, of 3.6% through 2024.

Research Strategy

This overview of regenerative medicine specifically focused on developments in and around Massachusetts, which is undoubtedly the most influential region in the United States and possibly the world in regard to regenerative medicine. Details were derived from official sources, news releases and organizational annual reports.
Part
02
of six
Part
02

Regenerative Medicine: Trends

Two of the trends in the regenerative medicine market are the growth of the oncology segment and the dominant share of orthopedic treatments.

Growth of the Oncology Segment

  • Among all segments of the US regenerative medicine market, oncology is forecast to register the highest CAGR until 2025.
  • At the same time, it will be the fastest-growing segment in the North American stem cell market. The US has a 77.4% share of this market.
  • The forecast CAGR for the North American cancer stem cell market between 2019 and 2026 is 8.9%.
  • The main driver behind the trend is the high prevalence of cancer. In 2018, the National Cancer Institute estimated 1,735,350 new cases and 609,640 deaths.
  • Also, many government and non-government organizations, as well as companies, are investing in developing regenerative treatments for cancer.
  • Within the oncology segment, Chimeric Antigen Receptor (CAR) T cell therapy is growing particularly fast. It "comprises reengineering cancer patient's white blood cells (WBC) to fight the malignant cells by recognizing them."
  • While the figures for the US are behind a paywall, it has a dominant share in the $482.2 million global market, which is expected to have a CAGR of 34.5% until 2026.
  • Also, the US was first to approve two CAR-T treatments in 2017, which are Kymriah produced by Novartis and Yescarta by Gilead/Kite Pharma. By 2018, they had 33 and 28 certified treatment centers, respectively.
  • Additionally, Celgene announced it would file for FDA approvals for treatments for CAR-T treatments for lymphoma and myeloma in 2020.
  • Other developments in the CAR-T market in the US are described in detail in this article.

Company at the Forefront

  • A company at the forefront of this trend is Juno Therapeutics, which is a major player in the CAR-T sector.
  • It develops regenerative cancer treatments using "genetically altered T cell technology from Fred Hutch, Seattle Children’s Research Institute and others."
  • It is worth to note that Juno Therapeutics is a Celgene company. It was acquired by the large biotech for $9 billion in 2018. Then, in 2019, Celgene was acquired by Bristol-Myers Squibb.

Dominance of Orthopedics

  • Musculoskeletal disorders are expected to be the largest segment of the US regenerative medicine market due to the growth in orthopedic diseases among the elderly population.
  • Additional factors include an increase in sports and road injuries, as well as the increasing burden of obesity.
  • Furthermore, increased use of regenerative medicine in osteoarthritis and sports medicine is the major growth driver in orthobiologics, as patients demand non-invasive therapies such as bone grafting and growth factor treatment.
  • Some analysts predict double-digit annual growth for orthobiologics in the next five years.
  • Orthopedic companies are responding to the growth in this sector by moving into regenerative medicine. There is also more research and development activity in the space.
  • The major available orthopedic regenerative medicine treatments are platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), adipose-derived mesenchymal stem cells, and human amniotic membrane (AM)-derived tissues.

Companies at the Forefront

  • Michigan-based Stryker, a key player in the regenerative medicine market, is also regarded as one of the major companies in the global orthobiologics space.
  • Some of its orthopedic regenerative medicine products are BIO Viable Bone Matrix and Vitoss Synthetic Bone Graft. Both solutions have bone healing properties.
  • Among less established companies that are recognized for developing promising solutions, Cellular Biomedics Group is working on two therapies for knee arthritis.
Part
03
of six
Part
03

Microscopy Imaging Customers

Biotech startups and companies, hospitals and medical centers, and pharma companies and medicine-research organizations (like those conducting clinical trials on drugs related to neurodegenerative diseases or on regenerative medicines) have been identified as the main types of businesses that would be likely to use contract microscopy imaging services. These business-types were identified through a detailed search of the types of organizations that utilize (or might utilize) microscopy services; those that appeared as the most-frequent users (or most-likely users) of these types of services were selected and detailed below.

Biotech Startups & Companies

  • Biotech startups (or established companies) are businesses that might utilize contract microscopy imaging services, depending on their scope of business. Focusing on those that have been in business for at least a year (so they have enough funding or revenue to pay for the services), and those that may be looking to change the contract services they’re currently using (or engage new services) is most recommended.
  • The Angel List shows 4,423 Biotechnology startups valued at $5.2 M, and is a great place to identify the perfect candidate-companies for these services. It would be necessary to weed out those that provide similar services to drill down the list further. Angel Kings ranks the top Biotech startups in the US on this list, which could provide some outstanding potential candidates (once they’ve been pared down to remove those offering similar or related services).
  • On the Angel List, Biotechnology companies fall under the parent category of Life Sciences, with sibling categories of: Medical, Neuroscience, Pharmaceuticals, Synthetic Biology, and Therapeutics, and with child categories of: Bioinformatics and Genomics. Any of these would also be viable avenues to pursue for potential customers for contract microscopy imaging services.
  • Additionally, XTalks lists “six biotech companies carving the path for Parkinson’s disease research” each of which might be potential client-candidates. MedicalStartups lists the top 27 startups focusing on stem cell research, any of which may be viable candidates (excluding those with in-house microscopy services).
  • Avoiding the largest Pharmaceutical, Medical Device, and Biotech hub-cities in America is a strong recommendation. These areas are likely to be saturated already with companies offering similar services, so it would be harder to break into the markets. This list provides the “top 10 pharmaceutical and medical device industry hubs in the USA,” and should identify areas to avoid.
  • The Balance notes that Boston and San Francisco are the largest biotech hubs in the US, so these areas should also be avoided. An additional eight US biotech hub-cities are noted here, so it’s wise to avoid these, as well.

Hospitals & Medical Centers

  • Hospitals and/or medical centers that need microscopic imaging for diagnostics (or other medical functions) are also businesses that might utilize contract microscopy imaging services. Additionally, medical centers conducting clinical trials are also top candidates. Notably, some medical centers (and especially those conducting clinical trials) are affiliated with universities or major medical companies, and often have their own sources (internal and/or external) for microscopic imaging, so identifying which of these might be interested would require detailed consideration of multiple aspects.
  • Becker’s Hospital Review lists “100 of the largest hospitals and health systems in America” for 2019, and some of these might qualify as top candidates for contract microscopy imaging services. The health systems are considered largest based on the number of hospitals they have in their network, and the large hospitals were identified based on bed count.
  • Hospital and medical centers conducting research are also key candidates. Nature Index provides a list of the “top 5 healthcare institutions for scientific research” which may be useful. Notably, avoid research university medical centers, as they would not likely be interested in contract services, considering they are liable to have the equipment and personnel to do the jobs themselves. This list offers the top-ranked universities for research so it can help eliminate potentials.
  • Although it requires a free registration login, Medscape provides a list of the top-ranked hospitals for neurology and neurosurgery; since these are among the top functions for Nikon’s services, they might be top candidates to become clients. Alzheimer’s Disease research centers are another type of organization that are likely candidates for these services. The National Institute on Aging provides a list of these centers broken down by state.
  • Another option is to look at this list of hospital rankings by state to discover which states have the worst hospitals. From there, further exploring which particular hospitals rank the lowest in each state in microscopy imaging (or related services) should provide a potential list of client that may be looking to change services (or upgrade their current services).
  • NIH-funded hospitals and medical centers might be another viable avenue, as they would most definitely utilize these types of services; additionally, government-funded institutions typically have ample funding for all necessary services. This list from Genetic Engineering & Biotechnology News includes the “top 50 NIH-Funded Institutions of 2018,” and would be helpful in identifying which organizations to approach.

Pharma Companies & Medicine-Research Organizations

  • Pharmaceutical companies and medicine-research organizations dedicated to researching regenerative medicines and neurodegenerative issues are also primary candidates for the use of microscopy imaging services. The largest organizations often have their own internal teams, though some outsourcing is done; determining which companies outsource and which may be looking to switch contractors would be the key to success for this group.
  • GlobeNewsWire notes the following as the biggest pharma companies conducting research into neurodegenerative diseases: Pfizer (though they may no longer be doing this according to other sources), H. Lundbeck A/S, Sanofi, Teva Pharmaceutical Industries, Orion Pharma, Merck & Co, Inc, UCB S.A, Mitsubishi Tanabe Pharma Corporation, and ACADIA Pharmaceuticals.
  • BioPharmGuy lists 297 “stem cell and cellular therapy companies” all over the globe that may be interested in utilizing contract microscopy services. This list would have to be pared down to exclude companies with in-house services to better identify which companies would be the best fit for potential client-candidates.
  • Companies focusing on regenerative medicines are strong candidates for using these services. Venture Radar outlines the top companies working on regenerative medicine therapies in the US, which may provide a list of potential client candidates.
  • Additionally, medical centers performing clinical trials would also be top candidates for these types of services. SPGlobal notes that, in 2018, there were over 1000 regenerative medicine-based clinical trials going on through the 906 regenerative medicine companies all over the world. Any of the organizations conducting the trials might be in need of these services.
  • Looking into companies presenting at or attending seminars, workshops, and conferences related to these functions (regenerative medicines, degenerative diseases, stem cell therapies, etc) would be likely to yield lists of potential client candidates who may have interest or need for contract microscopy imaging services, or with whom Nikon could partner. One example conference is the 2018 Cell & Gene Meeting on the Mesa held by the Alliance for Regenerative Medicine (ARM); they released a list of the companies that presented at the conference, which can be found here.
  • The organizations that host these conferences, like the Alliance for Regenerative Medicine, may also be gold mines of potential client candidates. Although they would not be likely to need these services themselves, organizations on their member lists might!
Part
04
of six
Part
04

Microscopy Imaging Customers: Regenerative Medicine

Microscopy Imaging Customers: Regenerative Medicine

Bioimaging is a dominant form of analyzing molecules, cells and tissue. Nikon's newly established lab provides a platform which applies bioimaging in a range of ways. In the previous research "Microscopy Imaging Customers", three types of businesses identified include biotech startups and companies, hospitals and medical centers and, pharmaceutical companies and medical research centers. For each of these, Nikon's bioimaging technology would serve a different purpose and trends in their market suggest that these demand for these services will be regular and likely to rise.

Biotechnology Companies

  • Biotechnology differs from pharmaceutical companies in the sense that, while both produce medicines, the former utilises compounds derived from living organisms, including enzymes. Pharmaceuticals primarily derive medicines from chemicals developed or synthesized from non-living material. As such, their requirements may vary significantly.
  • The Nikon Lab provide services which enable researchers in biotechnology to study the impact of small molecules, peptides and antibodies in cells on a molecular level.
  • Biotechnology is expanding in Massachusetts. Harvard, the Massachusetts Institute of Technology (MIT), and Massachusetts Life Sciences Strategy Group are partnering with hospitals, corporations, public entities and some of the over 200 professionals in and around the state to collaborate in the regenerative medicine field.
  • This expansion of biotechnology in Massachusetts is likely to require the use of Nikon's product demonstration platform. Nikon has advanced imaging systems for biotech researchers interested in incorporating live-cell imaging technology in their processes.

Hospitals and Medical Centers

  • Non-healing or chronic wounds are a significant issue in the United States. In its annual report, the Massachusetts-based regenerative medicine company, Organogenesis Holdings Inc., estimates that only 5% of the 3.3 million patients who require advanced wound care in the United States receive it.
  • The market for regenerative medicine is growing; patients in the surrounding hospitals and other medical centers will require advanced wound therapy services. It is unsurprising, then, that more regenerative medicine companies are establishing in the area. In fact, organizations like ElevateBio, who are creating a portfolio of cell and gene therapy companies, will aim to address the same market. However, not every organization in this market will have the resources required for quality control for cell and gene therapy.
  • Nikon's bioimaging lab is equipped with identity testing, lot releasing and batch monitoring, quantitative imaging essential for quality control in the cell and gene therapy market. With a growing market size, demand for these services will rise.

Pharmaceutical Companies and Medicine Research Organizations

  • Assays which Nikon's bioimaging technology is capable of producing will accelerate the discovery and development processes of new drugs through providing mechanistic insights earlier in the process.
  • Typically, the drug discovery and development processes take 10 years, with the discovery contributing 3 years to the total time. In both cases, bioimaging will be a necessary service.
  • However, the advancements of stem cell technology not only mean that researchers can grow and observe cells in a non-invasive manner, but it also created an opportunity for them to observe directly the effects of certain drugs outside of a living host.
  • Nikon's live-cell imaging technology allows researchers to observe the impact of drugs on a cellular level. Nikon capabilities include High Content Screening (HCS), which is used to measure early cytotoxicity — essentially cell health, and this significantly reduces the drug discovery process.
  • Advantages of the HSC technique include the ability to test multiple compounds, its ability to benefit from automation and minimal prior knowledge of the target requirement.
  • However, the process is significantly costly when the resources required are contrasted with the active compounds discovered. As such, pharmaceutical companies and other organizations looking to discover and develop new active compounds would require the services provided by Nikon.

Research Strategy

The first approach for this research was to understand the various application of bioimaging in the identified markets. This was followed by an analysis of Massachusetts and surrounding markets to establish whether the activities in the respective market suggest frequent use of the technologies available in Nikon's lab.
Part
05
of six
Part
05

Case Studies: Imaging/Bioimaging Services

Elucid Bioimaging and Expansion Technologies are 2 bioimaging companies headquartered in Boston and Cambridge, Massachusetts. Their marketing strategy overviews are provided below.

Elucid Bioimaging

  • Elucid Bioimaging is a medical technology company headquartered in Boston, Massachusetts.
  • The company leverages machine intelligence to improve accuracy, patient experience and cost-effectiveness in cardiovascular diagnostic imaging.
  • Elucid's flagship product is vascuCAP, the first FDA-approved software for assessing plaque vulnerability from a single CTA to determine risk of heart attack or stroke.
  • The company also provides contract quantitative image analysis services.

Marketing


Expansion Technologies

Marketing

Part
06
of six
Part
06

Regenerative Medicine Contract Imaging Services

After scouring news and media publications across media data bases and advanced search strategies, it was determined that only one article has been published by the approved media sources in the past three months that mentions both bioimaging services/microscopy imaging and regenerative/neurodegenerative medicine. All articles found, including those published by global media sources, have been provided below.

Articles That Mention Bioimaging Services/Microscopy Imaging And Regenerative/Neurodegenerative Medicine

  • Body-on-chip technology: resolving current limitations in drug discovery:
    • The article was published on 1/30/2020 by Drug Trade Review, a United States healthcare publication.
    • The article discusses the introduction of new body-on-chip technology that can avoid animal testing through digital demonstration of pharmacokinetics and pharmacodynamics. The article discusses how this technology uses microscopy imaging and can be used to test the effects of an oral drug for neurodegenerative and inflammatory bowl disease.

Articles That Mention Bioimaging Services/Microscopy Imaging And Regenerative/Neurodegenerative Medicine NOT Published By Approved Sources In The Last 3 Months

Sources
Sources

From Part 03
From Part 05
Quotes
  • "FDA-cleared and CE-marked cardiovascular diagnostic image analysis software"
  • "Users Cardiologists​ + Neurologists​ + Radiologists + Vascular Surgeons​ +"
  • "Clinical Edition FDA-cleared & CE-marked arterial analysis software for clinical use Research Edition Arterial analysis software with innovative additional features for research and studies Enterprise Radiological image and annotation database/knowledge base system"
Quotes
  • "Elucid Bioimaging is a medical technology company leveraging machine intelligence to improve the accuracy, experience, and cost-effectiveness of vascular diagnostic imaging. Its groundbreaking product, vascuCAP®, is the first FDA-cleared & CE-marked, histology-validated, non-invasive image analysis software for evaluating CTAs to provide multi-dimensional visualization, structural measurements, & plaque composition to inform risk of event (heart attack or stroke) and personalized treatment selection. "
  • "vascuCAP® is in use by cardiologists, vascular surgeons, radiologists, and neurologists across the US and EU at health systems, clinics, and research institutes. vascuCAP® has applications for coronary, carotid, and peripheral arteries, and it is offered as an on-site deployed software or remotely conducted analysis."
  • "In addition, Elucid also offers quantifying imaging services to evaluate the severity of vascular disease, in particular, atherosclerosis, and assess longitudinal therapeutic response to investigative therapeutic agents to vascular disease."
Quotes
  • "Precision Medicine Empowered by Precision Imaging"
  • "At Expansion Technologies, we are revolutionizing the early detection of diseases through our novel super-resolution imaging method that physically expands samples, coupled with cutting-edge multiplexed in situ analysis methods and machine learning"
Quotes
  • "Expansion Technologies pioneers the use of the expansion microscopy bioimaging tool for biology, medicine, and beyond. Cambridge, Massachusetts, United States"
  • "Expansion Technologies pioneers the development of the expansion microscopy bioimaging tool to bring simple scalable nanoimaging to biology and medicine."
Quotes
  • "Expansion Microscopy: Principles and Uses in Biological Research Asmamaw T. Wassie, Yongxin Zhao and Edward S. Boyden; Nature Methods, 2019, 16, 33–41"
  • "Expansion Microscopy: Protocols for Imaging Proteins and RNA in Cells and Tissues Shoh M. Asano Ruixuan Gao Asmamaw T. Wassie Paul W. Tillberg Fei Chen Edward S. Boyden; Current Protocols in Cell Biology, 2018, "
  • "Q&A: Expansion microscopy Ruixuan Gao, Shoh M. Asano, and Edward S. Boyden; BMC Biology, 2017, 15:50."
  • "Tools for Mapping and Repairing Brain Prof. Ed Boyden presents advanced super-resolution imaging platform at 2017 - Future of Genomic Medicine. "
  • "A new way to study the brain's invisible secrets Prof. Ed Boyden TED talk on how responsive polymers inspired a revolution in super-resolution imaging. "
  • "Expansion microscopy Fei Chen, Paul W. Tillberg, Edward S. Boyden; Science, 2015, 347 (6221), 543-548."