microbiome growth opportunities...microbiome growth opportunities dec, 8th 2020 2 electric vehicle...

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Sudeep Basu, Ph.D. Global Pract ice Leader, Innovat ion Services sbasu@frost .com

The Growth Pipeline™ Company Powering clients to a future shaped by growth

Microbiome Growth Opportunities

Dec, 8th 2020

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ELECTRIC VEHICLE (XEV)

Functional Expertise

• Leading the Innovation Services practice to present an integrated IP-Tech-Market perspective

- Managing Strategic Projects on a Global Level

- Advising Corporate R&D, Governments, Universities, and Government R&D institutions on Technology

Innovation & Intellectual Property Strategy, Energy Policy, R&D policy.

- Technology Roadmap Development and Implementation of Technology Transfer Programs

Industry Expertise

Global Consulting and project management experience across various industries

Expert in Technology Strategy, R&D Strategy and Intellectual Property Business Intelligence

Invited speaker, author, panelist, reviewer and conference-chair. Advisor to office’s of heads of state.

Career Highlights

Honorary Guest Faculty & Guest Lecturer at Rutgers University and Stanford University, USA

Reviewer: NIH, National Science Foundation (NSF) and Federal Laboratory Consortium (FLC)

Advisor: Coulter Translational Partnership Program, University of Pittsburgh Feb 2013-

Co-Chair IP & Technology Transfer: VAIL Europe Conference, Wroclaw, Poland, July 2013-

Asst Vice President for Global Partnerships: AUTM International Feb 2014-2016 term

Bio-Engineering Advisory Council Member: University of Missouri, 2014-

RMTM for Cell therapy & Regen Med: Member Standards Development Committee- June 2018-

Voting Member of U.S. TAG for ISO/TC276: BIOTECHNOLOGY : NIST

Education

Ph.D., Brown Cancer Research Center, (USA), American Heart (AHA) Fellow, IPIBS Fellow

Indian Institute of Technology (IIT-Bombay), Mumbai, India, TATA Scholar, CSIR Scholar

University of Mumbai, India,

Sudeep Basu, Ph.D.,

Practice Leader

Innovation Services

Frost & Sullivan, USA

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MICROBIOME GROWTH TRENDS

Microbiome Patent Publications, Global, 2012-2017

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Key Takeaway: There has been a growing interest in microbiome patent landscape, with 2017 being the most prominent year marked by 3178 patent publications.

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Microbiome Venture Funding, Global, 2015-2017

Key Takeaway: Despite the setback faced by Seres due to SER-109’s Phase II failure, recent VC funding activity has been encouraging across the global microbiome landscape. Synlogic has gained significant attention by developing recombinant microorganisms for disease treatment and raising $116 million through venture funding (2014-2017).

Source: lens.org, Frost & Sullivan

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SKIN MICROBIOME PATENT FAMILIES DISTRIBUTION BY ENTITY TYPE

Source: Patseer and Frost & Sullivan

Patent Distribution by Company Name, Global, 1996 - 2015 Total 168 patent families relevant to Skin microbiome space were identified for January 1st Jan 2017 to 31st May 2018 timeframe.

The entire patent portfolio was reviewed and clustered by entity type. 60% of the total patents were filed by corporate entities.

Patent families Distribution by Entity Type

101, 60%

24, 14%

23, 14%

20, 12%

Corporate

Individual Inventor

Startup

23

19

18

12

8

6

5

2 2 2

1 1 1 1 Cosmetics

Personal Care

Chinese SMEs

Biopharma

Ingredients Supplier

Supplements/cosmetics

NPE / Patent Trolls

Agribiotech/ Cosmetics

Electronics

Others

diagnostics

Financial Institution

Large Pharma

Technology Transfer company

Distribution of 101 Corporate patents by Sector

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KEY PLAYERS (BASED ON PATENTING ACTIVITY)

Corporates

1. L'Oréal

2. Elwha LLC (A Patent Troll)

3. GOJO Industries

4. Natura Cosmeticos

5. Procter & Gamble

6. Amorepacific

7. Cell Biotech

8. Coreana Cosmetics

9. Henkel

10. Unilever

Research Institutes

1. Harvard University

2. Ohio State University

3. University of California

4. Korea Institute of Science and Technology

5. New York University

6. Hiroshima University

7. Konkuk University

8. Sunchon National University

9. Jeju National University

10. Jiangnan University

Start-ups

1. AObiome

2. Ubiome

3. S-Biomedic

4. Skin Biotherapeutics

5. Yun NV

6. Naked Biome

7. Xycrobe Therapeutics

8. 4D Pharma

9. Tak Circulator

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PATENT OFFICE-WISE DISTRIBUTION OF SKIN MICROBIOME PATENT PORTFOLIO, 2017-2018*

USA ChinaSouthKorea

WIPO EPO Australia France Japan Brazil Germany

Patent Count 46 31 28 26 12 3 3 3 2 2

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Patent Distribution by Company Name, Global, 1996 - 2015 The exhibit below shows distribution of Skin Microbiome patent portfolio by patent offices. The USPTO has witnessed the highest

patenting activity. It is followed by patent offices in patent office in China and South Korea.

Skin Microbiome Patent Portfolio Distribution by Patent Offices, Global, 2017-2018*

Source: Patseer

*2018 is current year of the study so data for 2018 was covered till 31st May 2018.

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SNAPSHOT OF EMERGING RESEARCH TRENDS

Skin 35%

Hair or Scalp 2%

Oral 62%

Home 1%

Microbiome Industry: Percent Distribution of Research Studies across Skin, Hair or

Scalp, Oral and Home Health Applications, Global, 2014-2018 Oral and skin care applications are the key research focus areas. As there is extensive scientific knowledge that’s available for these applications. An FMCG/ CPG player could gain a major competitive advantage as a leading consumer care brand by acquiring or developing a differentiated skin or oral care offering us technologies.

Hair & scalp care applications are also an emerging research interest for microbiome technologies, although there’s a need for additional research to evaluate the impact of incorporating microbial platforms across hair care products.

Home care applications are a relatively niche space for microbiome technologies and may gain research traction in the next few years. Being an early mover in this space might give great head start for microbiome consumer product innovations.

Key Takeaways:

Source: NCBI PubMed, Frost and Sullivan

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SNAPSHOT OF EMERGING RESEARCH TRENDS

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Hair & Scalp Microbiome Industry: Research Studies, Global, 2014-2018

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Oral Microbiome Industry: Research Studies, Global, 2014-2018

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Home Microbiome Industry: Research Studies, Global, 2014-2018

Source: NCBI PubMed, Frost and Sullivan

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Skin Microbiome Industry: Research Studies, Global, 2014-2018

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KEY FINDINGS FOR THE GLOBAL MICROBIOME LANDSCAPE

While OTC probiotics have been long established as a important contributor

to human health in general, novel microbiome-based therapies for

gastrointestinal disorders may emerge in the next few years.

This is an area of growing industry interest as large FMCH companies are

looking towards improving F&B products by introducing probiotic, prebiotic

and in some cases, even non-live probiotic ingredients for targeted health

applications.

The personal care and cosmetic industries have witnessed the launch of

several new companies that are solely focused on offering microbiome-based

skincare products. Not surprisingly, leading cosmetic brands are also interested

in developing new products that incorporate microbiome technologies.

Another interesting area that is starting to get impacted by microbiome

technologies is the heating, ventilation and air conditioning (HVAC) industry.

Re-introduction of probiotics in indoor air environment is the newest trend that

is likely to witness significant traction the coming years.

Source: Frost & Sullivan

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MICROBIOME TECHNOLOGIES TRANSFORMING SKIN CARE

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SUMMARY OF KEY DRIVERS

Rapid Advances in Microbiome Research Rapid advances across biomarker, bioinformatics and microbiome research platforms have provided actionable insights across the microbiome which can be directly related to human health and disease.

Rising Microbiome Collaborations There has been a lot of collaborative activity for microbiome technologies in the recent past. Some the recent examples include Probi-Symrise collaboration in February 2019 and Lonza-Chr Hansen venture in April 2019.

Increasing Demand for “free from” Ingredients As the consumer focuses towards the use of “free-from” ingredients such as paraben-free and sulfate-free formulations for cosmetic applications, the use of nature-derived prebiotic and prebiotic ingredients help meet the consumer needs.

Increasing Consumer Awareness The modern day consumer is increasingly aware of the health benefits of microbial platforms is consciously investing in health and wellness products across all avenues.

Growing Demand for Personalization There is rising need to personalize consumer care products, hence there is a growing focus on diagnostics.


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Key Takeaway: Microbiome technologies are here to stay and will have a growing impact on several industry sectors. The personal care and cosmetic industries have witnessed the launch of several new companies that are solely focused on offering microbiome-based skincare products. Not surprisingly, leading cosmetic brands are also interested in developing new products that incorporate microbiome technologies. Within the consumer care segment, skin and oral care applications take the larger share of the microbiome pie, while home care and indoor air quality are the newest entrants in this space. Moreover, there is likely to be a growing focus on diagnostic applications to personalize microbiome-enabled consumer care products and services.

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SUMMARY OF KEY CHALLENGES

Clinical Validation of Microbiome Research The biggest challenge for probiotic and other microbiome-enabled technologies is having the right science (high quality, strain-specific, human clinical evidence) to support the health benefits of the organism.

Limited Availability of Shelf Stable Probiotic Strains Frost & Sullivan believes that incorporation of live probiotic strains is restricted by the limited availability of shelf stable probiotic strains. There is a need for the discovery and development of such strains.

Defining Global Regulatory Guidelines Probiotic and microbiome regulations for consumer health vary significantly across the globe and it has been difficult to harmonize health benefits claims regulations across countries.

Achieving Optimal Scalability For live probiotic products, manufacturing and scalability will be a challenge. However, advances in biomanufacturing and biomonitoring platforms will help address that difficulty in the mid-term future.

Restraining Production Costs Probiotic skincare products are likely to be expensive initially. However, as manufacturing is optimized enable time, resource and cost savings, consumer products will become more cost-effective in the future.


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Key Takeaway: Strain-specific clinical documentation of health benefits will be the key rate-limiting factor for developing new consumer products across the global probiotic landscape. Low shelf-stability and viability of probiotic strains will also restrict their incorporation in consumer care products. However, rapid research advances are likely to address these challenges in the mid-term future. While there is growing dialogue to define the use of probiotic and associated health claims in F&B and supplement applications, there is need to accelerate regulatory frameworks for use in cosmetic and home hygiene applications.

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MICROBIOME TECHNOLOGIES FOR SKINCARE AND HEALTHY AGING

Microbiome

technologies

for skin care

and anti-aging

applications

Probiotics

Companies such as AOBiome are looking to introduce live probiotic bacteria

on human skin to alleviate inflammatory skin conditions. It’s a niche

application area with very few participants in the space.

Probiotic-derived Products

Probiotic lysates or supernatants have been scientifically documented to

provide anti-aging benefits. Such probiotic-derived ingredients can be useful

to creating topical formulations for personal care applications. For example.

Ganeden offers Bonicel, a supernatant derived from its probiotic, BC30, for

application in cosmetic, anti-aging formulations.

Prebiotics

Prebiotic ingredients are being actively researched for use in personal care

products. Ingredients such as inulin, β-glucan and algae are being actively

researched for applications in skin care formulations. Companies working in

this space include Gallinée and Oskia Skincare.

Targeted Antimicrobials

Antimicrobial products that specifically target pathogenic bacteria are likely

to have a growing market potential. Antimicrobial topical formulations will

have a growing adoption for skin ailments such as acne, eczema and other

inflammatory conditions. For instance, Micreos offers antimicrobial acne

gel.

Microbiome-friendly Ingredients

There is a growing focus towards the use of skin-friendly and pH-balanced

ingredients in skin care formulations so that the natural skin microbiome is not

adversely affected by use of cosmetic products. Companies like Yun are

offering skin-friendly products in this space


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S-BIOMEDIC, BELGIUM

(FOUNDED WITH HORIZON 2020 PROGRAM FUNDING IN EU)

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PROBIOTIC FORMULATIONS FOR SKINCARE

Skin care formulations are poised to transform skincare routine with the advent of microbiome-based innovations. Probiotic technologies that use live microbiota in their unique formulations are likely to lead this transformation. Big pharma companies, such as Johnson & Johnson, are helping biotech start-ups such as S-Biomedic, to advance probiotic formulations for therapeutic and cosmetic applications. The key application areas for live probiotic topical formulations are reduction of skin sensitivity, acne and skin spots.

• The company’s initial target area is acne vulgaris, a key reason for the distortion of the skin microbiome.

• The company’s unique skin care formulations are focused towards restoring skin’s natural homeostasis

• Additionally, the products are also focused towards accelerating skin regression towards a healthy sate.

• Other areas of interest include ageing and dandruff treatment

S-Biomedic is currently working to develop a probiotic technology that modulates the skin microbiome.

Innovation Attributes: Technology Description

The company has developed and advanced technological platform that leverages natural strains from the skin microbiome to enhance and restore skin health.

Related Patents

• WO2008002063A1 • US2018142202A1 • WO2018073651A1 • EP3285872A1

TechVision Analysis: Probiotic product for skin care

applications is a technologically challenging space. It is

important for companies claiming topical benefits for probiotic

products to show that live probiotics are viable on skin

surface and can lead to significant benefits to the host.

The company is looking to develop therapeutic and cosmetic formulations for topical application on skin. S-Biomedic selects beneficial bacteria to generate products that can rebalance the skin microflora.

The company leverages the beneficial interactions between skin and commensal flora to develop novel probiotic formulations

Overview Application Area


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S-BIOMEDIC’S LEAD INNOVATION FOCUSED TOWARDS ACNE

Ageing

Acne

Dandruff

Concept In Vitro Clinical Prototype Partner

Indication

Developmental Status

Innovation Pipeline Summary, S-Biomedic, 2018

The lead program is focused towards acne vulgaris and clinical studies are likely to be completed in 2019

Initial clinical studies for acne vulgaris are in line with in vitro findings

Early concept studies for ageing and dandruff are in development

Acne >$5B

Ageing >$170

Dandruff >$4B

Global Market Value, 2017


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OVERVIEW OF THE PARTNERSHIP LANDSCAPE

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03

02

04

CG Health Ventures

This strategic partner

helps S-Biomedic with

advice, collaborations and

capital

JLINX

JLINX helps to identify and nurture early-stage start-ups in Europe

Sachsen-Anhalt ESI Fund

This funding helps technology-focused organizations

JLABS & DSM

A resident of the J&J labs program and counts DSM as a key investor/ partner.

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ANALYSIS OF RESEARCH PARTNERSHIP

Flanders Bio

Cluster Organization

S-Biomedic is a member of Flanders Bio

which is a cluster organization that

enables network economy in a life

sciences driven environment

Regulatory Affairs

The European Non-profit organization, PRI, is focused towards the regulatory landscape for the microbiome space.

The PRI


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OVERVIEW OF THE REGIONAL COMPETITIVE LANDSCAPE

Australia

• The Beauty Chef

• Blackmores

• WelleCo

• China & Hong Kong

• DSM (China)

• BioGaia (China)

• Esse Probiotic Skin Care (Hong Kong)

Japan

• Kosé

• Yakult

Korea

• Able C&C

• Goodal (Soko Glam)

• Skin Food

Malaysia

• BLACK PAINT Microbiome Skincare

• GD Manufacturing Sdn Bhd.

Singapore

• BioGaia

• Givaudan

• BetterAir

• Gallinee

Microbiome

Industry: List of

Key Regional

Innovators, Asia

Pacific (APAC),

2019

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IMPACT OF ETHNIC AND RACIAL INFLUENCES

Source: doi:10.1371/journal.pone.0151990.g001, Frost & Sullivan Analysis

Cutaneous microbial diversity in 645 samples from 110 subjects, based on skin location and beta diversity analysis over time, by ethnic group.

Key Takeaways:

Research has revealed that skin microbiome samples from different ethnic groups were similar to each other when grouped based on the skin site

Despite the microbial conservation unique to skin site, there was distinct clustering observed for population groups such as Caucasian, African Americans, etc.

Ecological zone of the skin is the primary factor that relates to cutaneous microbiota composition

Ethnicity also impacts microbial composition, but is only secondary to the impact of ecological site

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ADVANCES IN PROBIOTIC TECHNOLOGIES FOR SKINCARE

Overview

Skin care formulations are poised to transform skincare

routine with the advent of microbiome-based innovations.

Probiotic technologies that use live microbiota in their unique

formulations are likely to lead this transformation. Big pharma

companies, such as Johnson & Johnson, are helping biotech

start-ups such as S-Biomedic, to advance probiotic

formulations for therapeutic and cosmetic applications. There

are a few companies, such as Esse and AOBiome, that claim

to introduce live probiotic bacteria topically to provide

skincare benefits. Some companies, such as Azitra, are

looking to develop recombinant microbes that can express

filaggrin to treat skin ailments such as eczema.

Technology Capability

Application Landscape Key Companies

Probiotic product for skin care applications is a

technologically challenging space. It is important for

companies claiming topical benefits for probiotic products to

show that live probiotics are viable on skin surface and can

lead to significant benefits to the host. Additionally, most skin

care formulations are not conducive for bacterial growth.

Hence, skin care formulations in the probiotic space need to

show the growth of skin-friendly microbial species, and also

need to inhibit the growth of pathogenic microorganisms

without using very harsh chemical preservatives. As a result,,

very few companies have been able to successfully claim the

use of live probiotic products in formulations.

The key application areas for live probiotic topical

formulations are reduction of skin sensitivity, acne, and skin

spots. The products are also beingg used for slowing ageing

process. Yun offers a live probiotic spray for foot care

applications. AOBiome, a very innovative probiotic company,

, offers a water-based mist formulation having ammonia-

oxidizing bacteria that can be used regularly instead of a

shower, to prevent destruction of the healthy skin microbiota after a bath. Another company, Azitra, is looking to developing recombinant microbes for topical applications

AOBiome Esse Gallinée

Yun Azitra

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THE GROWING USE OF PROBIOTIC-DERIVED FORMULATIONS FOR ENHANCING SKINCARE

Overview

There are several cosmetic companiess that use probiotic-

derived ingredients for skincare applications. Some of the

typical ingredients in this space include Lactobacillus extract,

Lactococcus ferment lysate and post-biotic products such as

lactic acid. Companies also use probiotic ferment filtrate or

broth derived from microbial fermentation for enhanced skin

health. Possibly one of the foremost technology in this space

is that offered by Estée Lauder, the Miracle Broth formulation

derived from sea kelp fermentation and used in the

company’s signature Crème de la Mer product. There are

several start-up companies that are also looking to delve in to

this space of probiotic-derived cosmetics.



From a technology standpoint, it’s relatively easier to

introduce probiotic-derived ingredients in skincare

formulations. Most probiotic-derived cosmetics do not require

refrigeration as they do not use live microorganisms in the

products. Furthermore, such ingredients do not require major

changes in preservative process and do not affect the

product shelf-life. A growing emphasis on wellness in

skincare products is likely to fuel the use of such ingredients

in topical formulations, especially when it comes to alleviating

skin sensitivity, redness and irritation. Probiotic-derived

ingredients are likely to transform the cosmetic industry by

restoring the skin microbiome balance.

Most of the applications for topical probiotic-derived

formulations help to reduce skin sensitivity, redness, irritation,

rosacea, acne and aging. While aiding the restoration of

skin’s natural barrier functions, most formulations containing

collagen also help to restore skin’s natural firmness and

prevent sagging. Companies such as Ganeden, offer

probiotic-derived ingredients for skin care and anti-aging

applications. The company’s anti-aging ingredient, Bonicel, is

a supernatant derived from their proprietary BC30 probiotic

line and is primarily used in various cosmetic products.

Clinique Glowbiotics MD Estée Lauder

Tula Aurelia Skincare

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NOVEL SKIN-FRIENDLY FORMULATIONS FUELING THE ADOPTION OF INNOVATIVE PREBIOTIC INGREDIENTS

Overview

Several cosmetic companies are developing novel

formulations that contain ingredients that serve as food for

the beneficial microorganisms on the skin surface. Such

ingredients, or ‘prebiotics’ typically comprise plant sugars and

oligosaccharides such as alpha-glucan oligosaccharide, beta-

glucan or carbohydrates derived from microalgal origins.

Certain cosmetic brands offer a combination of prebiotic and

probiotic ingredients to enable a more holistic skincare

regime. Some of the key companies in this space include

Gallinée, Glowbiotics MD and Novexpert. The prebiotic

ingredient space is likely to be a growing focus area for

cosmetic industries in the near future.



Prebiotic ingredients are shelf-stable and relatively easier to

incorporate within cosmetic formulations. There is a growing

focus towards the incorporations of such plant sugars into

topical formulations. One of the key differentiators of such

topical formulations will be the availability of scientific data

that back the benefit claims of the skin care products

organically-sourced prebiotic ingredients are likely to be a

part of luxury cosmetic brands initially,. However, this trend

may change as more products start incorporating a shift

towards the use of naturally-derived prebiotics in the near to

mid-term future.

Prebiotic ingredients are mostly derived from plant sources

and are consumed by beneficial skin microorganisms. When

combined with probiotic and probiotic-derived for a wide

range of skin conditions such as acne, redness, irritation,

sensitivity, rosacea and eczema. Such products may also be

useful to reduce visible sings of skin aging such as wrinkles

and fine lines. Furthermore, as prebiotics are derived from

natural sources they are less likely to have adverse effects on

human skin.

Gallinée Glowbiotics MD Novexpert

Vantage Specialty

Ingredients Greenaltech

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NOVEL TARGETED ANTIMICROBIAL FORMULATIONS

Overview

In 2016,the US FDA issued a rule that prohibited the use of

antibacterial ingredients such as triclosan in topical

antibacterial washes as they were not shown to have long

term benefits when compared to regular washes.

Furthermore, studies have revealed that triclosan, being a

broad spectrum bactericidal agent, can adversely effect the

beneficial skin microflora and cause drug resistance in

pathogenic bacteria. Such non-specific antimicrobials can

also reduce the levels of histone deacetylaces (HDACs) in

skin cells which is needed for maintaining an optimal balance

of the skin’s commensal bacteria. Thus, there is a need for

developing targeted antimicrobial ingredients.



As there is growing consumer awareness of the harmful

effects of long term use of topical broad-spectrum

antimicrobial agents, more users are looking towards natural

and gentle skincare formulations that do not harm the

beneficial skin microflora. Hence, companies such as Nerd

Skincare, US, are offering targeted antimicrobial formulations

that help the growth of the beneficial microflora to restore the

skin’s natural balance and enable enhanced immunity against

pathogenic bacteria. Another company, Micreos, offers the

Staphefekt SA.100 enzyme ingredient in topical formulation

that is specifically targeted against Staphylococcus aureus,

(including MRSA).

Targeted antimicrobial ingredients are being used for several

cosmetic skin care applications, especially for the treatment

of acne, eczema, rosacea and skin irritation. Ingredients that

help the growth of the skin’s natural microflora or specifically

inhibit the growth of pathogenic bacteria are likely to garner

increased acceptance moving forward, especially across a

wide range of innovative skincare formulations.

Nerd Skincare Micreos

Naked Biome

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INNOVATIVE MICROBIOME-FRIENDLY FORMULATIONS

Overview

Several companies that offer probiotic skin formulations also

offer several products that are pH balanced and skin-biome

friendly. Most products in this space use ingredients that do

not alter the microflora of the skin, although they may not

have any active probiotic formulations.

Key Companies


This technology platforms is likely to garner growing focus as

it offers biome-friendly formulations that may not necessarily

use any active probiotic ingredient. Hence, they do not face

the typical technological hurdles associated with the

development of a skincare formulation that contain live

probiotic microorganisms or probiotic-derived metabolites.

Application Landscape

Most products in this space offer solutions for skin dryness,

irritation. Unlike other probiotic products that are targeted for

specific skin conditions, microbiome-friendly formulations

help to improve skin health, without harming the skin

microbiome in any way.

Yun AOBiome

Esse

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MARKET SEGMENTATION PREDICTIONS– DISEASE

1%

17%

38% 15%

10%

3%

7%

2% 2% 5%

Disease Segments

Cancer Type II Diabetes

Gastrointestinal Disorders Infection Disease

Oral health Women's health

Skin Disorders Respiratory Disorders

Liver Disorders Obesity & Metabolic Disorders

13%

8%

26%

16%

7%

6%

6%

8%

7% 3%

Disease Segments

Cancer Type II Diabetes

Gastrointestinal Disorders Infection Disease

Oral health Women's health

Skin Disorders Respiratory Disorders

Liver Disorders Obesity

~2020 ~2025

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Sudeep Basu Global Practice Leader

[email protected]

CONTACTS

Bernard Weber Director Commercial Solutions

[email protected]

microbiome growth opportunities...microbiome growth opportunities dec, 8th 2020 2 electric vehicle...

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