Regional analysis of the biomaterials market Nord-Pas · PDF fileRegional analysis of the...

Paris, November 28th 2011

Regional analysis of the biomaterials market

Nord-Pas-De-Calais and Pays De La Loire, FR –

South West Germany, GE – Limburg province,

NL – East Midlands, UK

15/09/2011 2 Final report – Biomat-IN

Abbreviation

ATMP Advanced Therapy Medicinal Products

CAGR Compound Annual Growth Rate

HA Hyaluronic Acid

IPR Intellectual Property Rights

IPS Induced Pluripotent Stem (Cells)

KSF Key success factors

NWE North West Europe

ORL Oto-Rhino-Laryngology

PEEK PEEK polymer is a colorless organic polymer thermoplastic

PLA Poly Lactic Acid

PLGA Copoly Lactic Acid/Glycolic Acid

SMEs Small and Middle Enterprises

PMMA PolyMethyl MethAcrylate

R&D Research and Development

TPE ThermoPlastic Elastomer


Table of contents

Context, objectives and methodology 5

Overview of the biomaterials market 12

Introduction 12

Market trends 16

Biomaterial segmentation 22

Key players and value chain 51

Synthesis 62


Context, objectives and methodology

Overview of the biomaterials market

Table of contents

Synthesis: opportunities




Context, objectives

and methodology



The Biomat-IN project gathers 5 European clusters willing to pool their resources in order to foster innovation in the

field of biomaterials through transnational cooperation.

Biomat-IN’s global objectives are to:

Provide SMEs from NWE regions (within the project) with key information on the European market;

Stimulate and facilitate transnational collaborations between all players of the biomaterial industry by

broadening the competence network of biomaterials SMEs to link them with technologies, facilities and know-

how providers from NWE;

Establish a long-lasting transnational support framework providing SMEs with the assistance they need to

assess at an early stage the feasibility of their transnational R&D project idea;

Disseminate the project results in other NWE regions and business support organizations working in the field of

biomaterials.

The project will manage to achieve this with partners representing 5 leading regional human health clusters,

(Eurasanté and Atlanpole Biotherapies in France, Bioregio Stern in Germany, MedilinkEM in UK and Liof in the

Netherlands). Together these clusters include over 250 biomaterials SMEs.

The Biomat-IN project is a European project gathering 5 clusters from France, UK, Germany and the Netherlands to foster innovation in the field of biomaterials.

Context Context, objectives

and methodology


Context, objectives

and methodology

In this context, Biomat-IN’s objective is to identify the areas of synergy, knowledge gaps, areas of unique technologies and areas of need between the involved regions in the specific field of Biomaterials

ALCIMED aims to help Biomat-IN to:

– Realize an overview of the European market for biomaterials with a focus on specificities and opportunities for each national markets(France, England, Germany and The Netherlands)

– Build SWOT analyses for each cluster in order to identify potential cross-regional synergies, knowledge gaps and specific needs of players

– Establish operational recommendations on potential cross-regional synergies

Alcimed aims to help Biomat-IN to reach its objectives by realizing an overview of the European biomaterial market, building a SWOT for each region and finding potential cross-regional synergies.

Objectives


The mission has been split into 3 steps, the objectives of the first step were to realize an overview of the European biomaterial market and to identify opportunities for the 5 clusters.

Step 1

European market and national trends analysis

SC : Steering committee

WS : Working session

Kick off

meeting

July 26th

Follow-up

meeting

Septembre 2nd

End of phase

one

Septembre 15th

Overview of the European biomaterial market and elements

of comparison between the 4 national markets to identify the

opportunities of development for the SMEs of the clusters

and the clusters.

Step 2

Regional SWOT analyses

Regional biomaterial Industry

Regional biomaterial research sector

Step 3

Recommendations on

cross-regional synergies

S

C

W

S

S

C

Specific objectives of phase 1

Context, objectives

and methodology

Objectives Focus phase 1


Context, objectives

and methodology

Databasse, Society websites, Research center websites, Pubmed, etc. :

- Public scientific publications

- Public sector reports

- Regulatory information

- etc.

Examples :

« LEEM, study on cell therapy - 2010 »

« Medical innovation on omnexus – Oct 2009 » European society of biomaterials

Ispor.org

INSERM website

Etc.

Literature review Phone interviews

The study is based on a literature review and the realization of 10 interviews with European opinion leaders in biomaterials.

10 interviews were realized with academic and

industrial key opinion leaders in France,

Germany, Netherlands and United Kingdom.

Methodology Focus phase 1


A specific definition as well as specific therapeutics areas have been considered for this study.

“Any substance (other than a drug) or combination of substances, synthetic or natural in origin, which can be used for any period of time, as a whole or as a part of a system which treats, augments, or replaces any tissue, organ, or function of the body” (National Institutes of Health)”. NB: Cells are considered as a biomaterial for this study

Biomaterial definition

chosen for the study

Therapeutic areas

considered in the

project

Endocrinology and

metabolic disease

Dermatology and

wound care Plastic surgery Oncology

Immunology and

infection

Physiotherapy /

Rehabilitation Neurology Ophthalmology

ORL (Oto-Rhino-

Laryngology)

Pulmonary /

Respiratory diseases Cardiovascular

Gastroenterology

Uro-gynecology

Orthopedics


Scope of the study


Advanced Therapy Medicinal Products (ATMP)


Definition

Advance Therapy Medicinal Products are medicinal products which are prepared industrially or manufactured by a method involving an industrial process. They are ‘innovative, regenerative therapies which combine aspects of medicine, cell biology, science and engineering for the purpose of regenerating, repairing or replacing damaged tissues or cells’. ATMPs fall into three categories; Gene Therapies, Somatic Cell Therapies and Tissue Engineered Products.

Gene therapy

Gene Therapies refers to products obtained through a set of manufacturing processes aimed at the transfer, to be performed either in vivo or ex vivo, of a prophylactic, diagnostic or therapeutic gene (i.e. a piece of nucleic acid), to human /animal cells and its subsequent expression in vivo. The gene transfer involves an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. The vector can also be included in a human or animal cell.

Somatic Cell

Therapies

Somatic Cell therapies include the use in humans of autologous (coming from the patient himself), allogeneic (coming from another human being) or xenogeneic (coming from animals) somatic living cells, the biological characteristics of which have been substantially altered as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect through metabolic, pharmacological and immunological means.

Tissue Engineered

Products

Tissue Engineered Products are products that contain or consist of engineered cells or tissues, and is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.

NB : For the ATMP products, only cell therapy will be developed in this report / Source: HTA – Human Tissue Authority


Context, objectives and

methodology

Overview of the biomaterials

market

Introduction


Market trends

Biomaterials segmentation

Key players and value chain

Introduction


Today the biomaterials market is very broad and requires the control of many sciences

Environment of biomaterials Introduction

Biomaterials is a complicated science at the interface of many other field such as biology, physics, chemistry, medicine, etc.

Biomaterials

Medicine

Biology

Chemistry

Tissue engineering

Electronic

Physics

Understand the

needs of

pathologies, etc.

Understand the

living organism, etc.

Anticipate possible

chemical reactions,

etc.

Study the resistance

materials, etc.

Implant a

pacemaker, etc.

Replace biological

functions, etc.


Evolution of biomaterials Introduction

In more than 50 years 3 generations of biomaterials have been used, and the last generation concerns cell and gene-activating materials.

The

Egyptians

were already

trying to

replace all or

part of failing

organs with

substitutes

such as iron,

copper, lead,

wood,

plaster, ...

Starting from the mid-20th century, the evolution of biomaterials advanced with the use of

polyester, plastics, metal alloys, ceramics, etc..

First generation

A key feature of these

biomaterials is their

biological inertness,

which minimises the

body's response to the

foreign body

Second generation

Development of

resorbable material, HA

bioactive glasses and

glass ceramics,

molecularly tailored

resorbable polymers, etc

50 implantable devices

with 40 different

materials were used

Third generation

Work currently being

undertaken on cell and

gene activating materials

…1960/1970 1980 Today Before JC…


Objectives of the use of biomaterials Introduction

Repair and replace

Emergence of

innovative biomaterial

products

Desire to increase the

use of minimally

invasive surgery (MIS)

Past and current issue

The new objective of the biomaterials market is to favor self-healing.

Biomaterials have been used for a long

time in the human body to improve body

functions and to replace damaged

tissues. The objective was to minimize

as much as possible the interaction with

the human body’s tissues to avoid

undesired reactions.

Develop the patient’s self-

healing

Current and future issue

The objective is to create a real

interaction between the artificial material

and the human tissues, mainly based on

self-healing.



methodology


market

Market trends


Market trends



Introduction


Biomaterials market size Market trends

The European biomaterials market was worth $8.5 billion in 2008, which represented 33% of the global market.

Global biomaterials

market

Total market in

2008

$25.6 billion

43

33

3

2 19

US

Europe

Asia-pacific

Brazil

Other

Total revenu in 2008 = $ 25,6 billion

The U.S. and Europe hold a major share of the global

biomaterials market; while emerging economies such as China,

India, Japan, Brazil, Russia, and Romania represent a high

growth rates.

Europe is the second largest segment with 33% of the market, which

represented $8.5 billion in 2008.

~20%

~20%

~5 /10 %

~10%

Germany France The Netherlands UK

European biomaterials

market

Source: Alcimed data, Eucomed medical technology, Global Biomaterial Market (2009-2014), Marketsandmarkets, 2009


Biomaterials expected growth Market trends

The size of the European market tends to be increasing very quickly with a CAGR of around 15% until 2014.

Global biomaterials

market

In 2008

$ 25.6 billion

In 2011

$ 37.6 billion

In 2015

$ 64.7 billion

In 2017

$ 83.9 billion

European biomaterials

market

Es

tim

ate

d

ma

rke

t

Es

tim

ate

d

ma

rke

t CAGR of

15% from

2010 to

2015

CAGR of

14,6% from

2009 to

2014

In 2008

$ 8.5 billion

In 2011

$17.7 billion

The market size of Asia is expected to increase with CAGR of 18,2% from 2009 to 2014

The Brazilian market for biomaterials is expected to reach $ 1.7 billion in 2015 from $550.2 million in 2008 with a

CAGR of 19.5% from 2010 to 2015

Source: Alcimed data, Eucomed medical technology, Global Biomaterial Market (2009-2014), Marketsandmarkets, 2009

http://images.google.fr/imgres?imgurl=http://www.proximust.com/images/croissance-fleche.png&imgrefurl=http://www.proximust.com/proximust.php&usg=__eM5PpEBzGrRqRH_JO8fBFqVmBVc=&h=263&w=350&sz=39&hl=fr&start=2&um=1&itbs=1&tbnid=FZbv6qSGGLZHTM:&tbnh=90&tbnw=120&prev=/images?q=en+croissancefl%C3%A8che&um=1&hl=fr&sa=N&ndsp=21&tbs=isch:1



Therapeutic areas

Market size Market trends

Orthopedic and cardiovascular markets represented more than 65% of the global market in 2007.

4669

4491

3085

1642

1475

1359

1122

812

318

313

120

65

38

$ 8,9 billion in 2007



$ 810 million in 2007

$ 500 million in 2007

Indicator of research

activity (published on

Pubmed)

Global Market in 2007

(Total in 2008 = $ 25,6 billions)

Orthopedics

Cardiovascular

Immunology and infection

Pulmonary / Respiratory diseases

Plastic surgery

Urology / Gynecology

Endocrinology and metabolic disease

Ophthalmology

Oncology

Dermatology and wound care

Gastroenterology

Neurology

ORL (Oto-Rhino-Laryngology)

Therapeutic areas

Source: Alcimeddata, Eucomed medical technology, Global Biomaterial Market (2009-2014), Marketsandmarkets, 2009


Therapeutic areas

Market growth Market trends

Despite a lower CAGR, orthopedics and cardiovascular areas will maintain their leadership on the market.

$ 19,9 billion

$ 20,7 billion

$ 5,9 billion

$ 2,7 billion

$ 1,2 billion

12,6%

14,5%

13,9%

19,1%

19,8%

Estimated market in

2014/2015 CAGR from 2009 to 2014

ma

rkets

rela

tive

ly

ma

ture

co

mp

are

d

to th

e o

the

rs

Orthopedics

Cardiovascular



Plastic surgery



Ophthalmology

Oncology


Gastroenterology

Neurology

Therapeutic areas


Source: Alcimed,data, Eucomed medical technology, Global Biomaterial Market (2009-2014), Marketsandmarkets, 2009



Market growth explanation Market trends

The improvement of technologies and quality of life, as well as an increase in patient’s expectations and communication efforts explain the market growth.

Increasing expectations of citizens

Ongoing innovation by domestically and

internationally based companies

Introduction of sophisticated technologies in the

biomaterials market

Improved technologies

As we are getting used to more and more

comfort and safety, the healthcare industry is

pushed to innovate and to create new highly

sophisticated devices

Increased demand for medical technologies and

services

Marketing efforts and communication

Increasing marketing efforts by manufacturers and

distributors to educate both physicians and

patients on the wide variety of biomaterials

available

Aging population and lifestyle changes

Aging population (the major consumers of

biomaterials products are the baby boomers born

between 1946 and 1964. More than 20% of the

global population is expected to be over 60 years in

2050)

Changes of lifestyle (smoking, lack of exercise, etc)

increased obesity and stress levels that increase

the number of cardiac patients, diabetes, etc. Biomaterials

market

growth



methodology


market



Market trends



Introduction


Two types of segmentation have been chosen for the study, the first one related to the composition of the biomaterials and the second one to the therapeutic areas.

There is many ways to segment the

biomaterials market.

For this study we chose two

perspectives in order to identify the

future opportunities for the SMEs, the

researchers and the clusters

concerned.

Perspective 1

Segmentation according to the

composition of the biomaterials

More related to the SMEs point of view

Perspective 2


therapeutic areas

More related to the distributors,

buyers and clusters point of view

Chosen segmentation Biomaterials

segmentation


Chosen segmentation Perspective 1 – composition of the biomaterial

Biomaterials

segmentation

There is many ways to segment the

biomaterials market.





concerned.

Perspective 1


composition of the biomaterial


Perspective 2


therapeutic areas




Biomaterials category Biomaterials

segmentation

The biomaterial market could be segmented in 4 categories: metals & alloys, ceramics, polymers and natural materials.

Metals & alloys Ceramics Polymers Natural materials

(except polymers)

Metal = chemical element that is

a good conductor of both

electricity and heat and forms

cations and ionic bonds with non-

metals

Alloy = homogenous mixture or

metallic solid solution composed

of two or more elements

Inorganic, nonmetallic

solid prepared by the

action of heat and

subsequent cooling

(with or without

crystalline structure)

Large molecule

(macromolecule)

composed of repeating

structural units

Any product or physical

matter that comes from

plants, animals, or

ground

Defi

nit

ion

Titanium, shape memory alloys

(nickel titanium), stainless steel,

magnesium alloys based,

precious metals, cobalt based

alloys, aluminum alloys, etc.

Aluminium oxyde,

zirconia, calcium

phosphate, pyrolytic

carbon, bioglass

hydroxyapatite, etc.

Polysacharid, latex,

polyphenol, polyester,

polyether, polyoléfine,

polyuréthane,

polyamine, polyamide,

etc.

Collagen, animal

based material,

isolagen, hyaluronic

acid, human cells, etc. Ex

am

ple

s

Ma

jor

typ

es

of

ap

plic

ati

on

s

Bone / joint replacement and

fixation, stent, heart valves, dental

restoration, etc.

Bone and joint

replacement, dental

implants, etc.

Sutures, vascular

prosthesis, drug delivery

systems, lenses , soft-

tissue replacement,

adhesive, etc.

Wound healing, suture,

graft, etc.

Source: Alcimed data, interviews


Biomaterials maturity Biomaterials

segmentation

On a scale of maturity cell therapy is at the beginning of its expansion whereas metals & alloys is the most mature market.

Initiation Expansion Maturity Decline

Cu

rre

nt

leve

l o

f m

atu

rity

Metals & alloys

Ceramics

Polymers

Natural materials

(except polymers)

Cell derived

material

Animal based

material Vegetal based

material



Ideal specifications of biomaterials

To be efficient for replacing, repairing or favoring the patient’s self-healing, biomaterials must satisfy many restrictive characteristics concerning biocompatibility, mechanical properties and manufacturing.

Manufacturing

Reduce production cost

Keep high quality of raw materials

Capability of the material to be

safely and efficiently sterilized

Ideal specifications of biomaterials

Compatilibility

Biocompatibility

o Non toxic

o Non allergenic

o Non throbogenic

o Non antigenic

o Non carcinogenic

Minimize debris generation

Inert biomaterial or tissue activating

material

Mechanical properties

Resistance to mechanical,

biochemical and chemical

constraints (degradation, corrosion

,resistance for metals or resistance

to biological degradation in

polymers)

Flexible biomaterial by acting on:

o Life of the product in the body

(permanent, biodegradable, ect)

o Porosity of the product

o Elasticity

o Etc.

Biomaterials

segmentation

Source: Alcimed data, interviews, « Rapport biomatériaux de Laurent SEDEL, Président de l'Intercommission n° 1 de l'INSERM - Faculté de Médecine »


Paths of development Biomaterials

segmentation

The biomaterials market follows two paths of development: improve and optimize the properties of basic materials or use innovative solutions as cell therapy.

Improve and optimize the properties of

basic materials

2 possible paths of development

o Reduce the overall cost

o Lighten materials while keeping good

mechanical properties

o Combine different types of basic materials

to optimize the mechanical, biological or

chemical characteristics

Use completely innovative solutions

as ATMP (cell therapy)

o Find synergies

o Reach the expected specification

o Create tailor made solutions

o Combine cell therapy and basic

biomaterials to improve self-healing

Ma

in o

bje

ctives

NB : A combination product is a product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic,

or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity


Biomaterials

segmentation

Improve and optimize the

properties of basic materials


o Lower the overall cost






Use completely innovative solutions

as ATMP (cell therapy)

o Find synergies





Ma

in o

bje

ctives


Technological issues


Metals and alloys

Biomaterials

segmentation

Among the main technological issues for metals & alloys is resistance to mechanical and biological constraints.

Electrochemical corrosion and durability

Properties of friction and problems of scraps

Non-electrochemical degradation mechanisms including protein interactions / metal

Immune reactions and hypersensitivity

Adaptation of the mechanical properties

Metals and alloys Ceramics Polymers Natural materials

(except polymers)



2 possible ways of development

o lower the overall cost

o lighten materials while keeping good


o combine different types of basic materials



Use completely innovative materials

as cell therapy

o find synergies

o reach the waited specification

o create tailor made solutions

o combine cell therapy and basic


Ma

in o

bje

ctives





Ceramics

Biomaterials

segmentation

Different technological issues have to be addressed according to the type of ceramics: non-resorbable and bioresorbable.


(except polymers)

Bioresorbable ceramics

Measurement and control bioresorption and its

effect on the local community

Calcification

Knowledge of the effects of enzymes on

degradation

Effects of sterilization on bioresorbability

Impact on wound healing and bone formation

Non-resorbable ceramics

Behavior at high melting temperature

Degradation mechanisms

Sustainability

Fracture toughness

Surface activity

Adhesion of proteins or cells on the surface











as cell therapy

o find synergies





Ma

in o

bje

ctives

Source: Alcimed data, interviews, « Rapport biomatériaux de Laurent SEDEL, Président de l'Intercommission n°1 de l'INSERM - Faculté de Médecine »




Polymers

Biomaterials

segmentation

As for ceramics, numerous issues have to be addressed concerning the non-resorbable and bioresorbable polymers.


(except polymers)

Bioresorbable polymers

Lack of measurements of degradation and

bioresorption

Effects of organic degradation products

Effects of enzymes on degradability

Surface erosion or erosion of the mass

Effects of sterilization on the biodegradability,

pharmacological agents incorporated into the polymer

Effects on wound healing

Replacement of natural fabrics

Interactions with living elements (macromolecules,

cells, organs, etc. ...)

Non-resorbable polymers

Biocompatibility with the tissue-material interface

Instability in gamma radiation

Responsiveness to certain drugs

Variability of each “batch“

Hydrolytic stability

Calcification

Risks arising from additives

Lack of databases and standards to evaluate the

surface properties, biocompatibility reactions,

etc..

NB: an environmental concern is beginning to drive medical polymer trends (biobased polymer, managing medical waste, etc.)











as cell therapy

o find synergies





Ma

in o

bje

ctives





Natural materials

Biomaterials

segmentation

The main technological issue of natural materials is to find a way to replace animal based materials.


(except polymers)

Natural based material except cells

Reduce the problem of immunogenicity

Reduce the cost

Improve the productivity of the material

Animal based material

The trends are to stop the use of animal based

materials because of possible disease contamination











as cell therapy

o find synergies





Ma

in o

bje

ctives



Biomaterials

segmentation

Each type of biomaterial is driven by a specific material such as titanium for metals & alloys, HAP for ceramics, hydrogels for polymers and HA or cells for natural materials.

Stainless steel

Titanium

Chromium cobalt

alloys

Ma

in m

ate

ria

l u

se

d

Ne

w t

ren

ds Shape memory alloys

(some

biocompatibility

problems)

Alumina

Zirconia

Calcium phosphate

hydroxypatite(HAP)

Tricalcium phosphate

(TCP)

Polypropylene

Polyester

Polyuréthane

PLG / PLGA

Silicone

PTE

PMMA

PEEK

Hydrogels

Marine natural

polymers

Materials for

controlled release of

active ingredients

Chondroitine sulfate

Collagen

Chitosan

HA (hyaluronic acid -

more and more used

to replace collagen)

Cells

Soya

Categories of biomaterials

Main material used and new trends

Metals & alloys Ceramics Polymers Natural materials

(except polymers)



Biomaterials

segmentation


basic materials


o Lower the overall cost






Use completely innovative

solution as ATMP (cell therapy)

o Find synergies





Ma

in o

bje

ctives


Focus on cell therapy

Pathologies concerned

Biomaterials

segmentation


Even if marketed products encompass mainly bones and skin, clinical trials are related to several other pathologies including cardiovascular, neurological, immunological, etc.

The classical therapeutic areas of cell therapy are

dermatology (skin) and bone and cartilage repair…

…But it can also be used for degenerative diseases

(Parkinson's, etc.), diseases involving destruction of

cells, tissues or organs (diabetes), hematopoietic

supportive care in oncology, immunotherapy, etc.

22 18

2 bone / cartilage

skin / wound

other

Numbers of products marketed by private

companies in the world in 2009

100% = 42 products

92

26

23

12

10

11 5 14

heart / cardiovascular disease

bone / cartilage

skin / wounds

gastrointestinal

neurology

blood / hematologic disease

immunology

other

Number of trials by therapeutic area worldwide

in 2009

100% = 193 trials

Source : Alcimed data, interviews, « LEEM, Bionest étude sur la thérapie cellulaire 2010 »


Biomaterials

segmentation

Worlwide, only a few products were commercialized in 2007 and few should arrive soon. Only

two cell therapy products were commercialized in 2007 o Vavelta® from Intercytex launched in the UK in 2008 as an aesthetic product (repair and rejuvenation of

the skin)

o Cryoskin® from CellTran

The low number of launches can be explained by the transition from the use of autologous cells

to allogenic cells allowing an easier access to industrialization and a use for more patients

Only 21 products are in phase III (clinical trial) and 7 in phase II/III in 2009


Commercialized products and clinical trials


…But only few products are expected to arrive soon on the market.

The classical therapeutic aeras of the cell therapy are

dermatology (skin) and Bone and cartilage repair…

…But it can also be used for degenerative diseases

(Parkinson's, etc.), diseases involving destruction of

cells, tissues or organs (diabetes), hematopoietic

supportive care in oncology, immunotherapy, etc

2218

2bone / cartilage

skin / wound

other

Numbers of products marketed by private

companies in the world in 2009

100% = 42 products

92

26

23

12

10

115 14

heart / cardiovascuar disease

bone / cartilage

skin / plaies

gastrointestinal

neurology

blood / hematologic disease

immunology

other

Number of trials by therapeutic area worldwide

in 2009

100% = 193 trials



Biomaterials

segmentation

The world market for

cell and tissue therapy

is estimated at $145

million in 2005 and is

expected to grow at a

rate of 28% annually to

reach $2.1 billion in

2015

Moreover, this market is expected to grow by 28%, well above the average growth for biomaterials.

Orthopedics

Cardiovascular



Plastic surgery



Ophthalmology

Oncology


Gastroenterology

Neurology


Pathologies for which biomaterials

used are mainly cell therapy

Clinical trial almost ready for clinical

application

Bones: research

Cartilage: AMM (only one in the market)



Market size

Source : Alcimed data, interviews, « LEEM, Bionest étude sur la thérapie cellulaire 2010 », MedMarketDiligence, LLC April 2005


Biomaterials

segmentation

IPs are the last type of cells currently studied in cell therapy, their potential is rising interest in the scientific community.

Precarious Emerging Growing Mature

iPS (these

applications should

be routinely

available in the long

term (ten years)

Embryonic stem

cells

Adult Stem Cells

Differentiated

adult cells

Hematopoietic

stem cells

Research has also made significant progress in

delivery devices for therapeutic cells with the

development of matrices or films to create a “soft

contact” between cells and the tissue to regenerate

Cell

th

era

py

Ma

trix


Type of cell maturity







Biomaterials

segmentation

As the use of cell derive materials is at the beginning of the maturity curve, it generates lots of technological issues.


(except polymers)

Cell therapy

Improve control and understanding of cell differentiation techniques

Improve the adequacy of surface properties, degradability of visco elasticity, stem cells that are found

in a three-dimensional environment (biochemical and/or mechanical in which they must adapt)

Improve the survival rate of implanted cells, in particular thanks to nanobiotechnology and more widely the techniques

of vectorization

Transform cells in culture in industrial objects with the aim of producing a standardized and controlled therapy

Promote systematic approach (through allogeneic cell for example)

Use biomaterials to create matrix for cell therapy

Improve the lack of cells, lack of industrialisation, etc.



basic materials








Use completely innovative

materials as cell therapy

o find synergies





Ma

in o

bje

ctives


Chosen segmentation Perspective 2

Biomaterials

segmentation

There exist many ways to segment

the biomaterials market.





concerned.

Perspective 1


composition of the biomaterial


Perspective 2


therapeutic areas




Cartography of therapeutic areas Biomaterials

segmentation

Pathologies linked to cardiovascular, orthopedics and cell therapy are the most dynamic markets.

Market size

(current and future)

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-

Low dynamic Middle dynamic High dynamic

Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care

Gastroenterology Neurology

Source : Alcimed data, interviews


Hot topics

Cardiovascular

Biomaterials

segmentation

Today the main areas of the cardiovascular biomaterials are :

• Stent (49% of the market)

• Cardiac pacemaker (expected to reach $1,060 million in 2014 )

• Global implantable cardioverter defibrillator biomaterial (expected to

reach $400 million by 2014)

Trends:

• The polymer valves developed as an effective replacement for

mechanical valves and tissue valves provide greater advantages for

the end user. The endovascular valve procedure that is being

developed will eliminate the need for open-heart surgery.

• Surgery for vessel implants is growing (synthetic vessels that are

structural scaffolds, usually made of collagen material or

biodegradable polymer biomaterials.)

In the cardiovascular field, the consumption trend is particularly driven by polymers.

Focus on Cardiovascular

Metals and alloys

Polymers

Cell therapy

Natural material

Consumption trends

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care

GastroenterologyNeurology

Source : Alcimed data, interviews, Medical innovation on omnexus – oct 2009, Handbook biomaterials - Overveiw of Biomaterials and their use in medical device





Biomaterials

segmentation

Two areas are very important in the area of orthopedics: spinal surgery

(cervical and lumbar procedures) and cartilage repair

Trends:

• Biofunctional coatings for inert materials such as ceramics and

metals

• Polymers with functional groups capable of interacting on osteoblasts

and / or fibroblasts

• Polyglycolic, polylactic and polymaleic, tribology improved products

for joint replacement

• HA viscosupplementation

• Porous apatite ceramics (one big issue is to develop porous

materials)

• Focus on dental: the main applications are bone graft substitutes, dental

membranes and tissue regeneration products

In the orthopedics field the use of polymers is tending to increase whereas metals and ceramics should stagnate.

Focus on Orthopedics

Consumption trends

Metals and alloys

Ceramics

Polymers

Combined products: Ceramics and cell therapy

Natural material

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care


Hot topics

Orthopedics





Biomaterials

segmentation

Matrix used for cell or tissue growth:

Ceramics, poly and hydroxyesters, polyanhydrides, polyimides,

Polyphosphatzenes, collagen, hyaluronic acid, chitosan, PGA, PLLA, PLGA,

alginate, polyethylene oxide, polyurethanes

Endocrynology:

• Artificial pancreas

• Portable and implantable pumps

• Controlled release systems for drugs

• Biosensors

Oncology :

• Glass based biomaterials (ferrimagnetic glass ceramics)

• Calcium phosphate

Focus on Immunology, Endocrinology, Ophtalmology, Dermatology and

Wound care

Consumption trends

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care


Cell therapy

The trend is to use allogenic cells

allowing an easier access to

industrialization and to more patients

Hot topics

Immunology, Endocrinology, Ophtalmology,

Dermatology and Wound care

The main driver of Immunology, Endocrinology, Ophtalmology, Dermatology and Wound care is cell therapy.




Biomaterials

segmentation

NB: Most surgeons are shifting from reconstructive surgery to plastic

surgery due to the insurance and reimbursement difficulties in the former

Main applications are :

• Facial implants (42%),

• Injectable fillers

• Breast implants

The plastic and surgery field is at the intersection of orthopedics and wound care market with a specific utilization of HA.

Focus on Plastic Surgery

Consumption trends

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care


HA (preferred to collagen for

dermal filler)

Septal cartilage

Hot topics

Plastic surgery

Plastic surgery is linked to the orthopedics and wound care

market


Polymers

Natural material




Biomaterials

segmentation

The main applications are :

• stents (68% in 2007 – stents are used in most urological procedures)

• catheters

• products for dialysis

Current trends:

• biodegradable materials to avoid problems like catheterization

• introduction of different types of scaffolds like epithelium implants

Stents represent 1/3 of the market of urology, and the main biomaterials used are polymers.

Focus on Urology

Consumption trends

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care


Biodegradable materials

such as elastin-fibrin

PTFE

Polyester

Silicone

Polyuréthane

Hot topics

Urology


Polymers



Biomaterials

segmentation

Ophtalmology :

The ophthalmic biomaterials arena is a rapidly growing area for advanced

biomaterials research with wide-spread clinical applications:

• Advanced biomaterials for functional replacements of ocular tissues

• Surface modification and protein adsorption of polymers used for

refractive devices

• Synthetic corneas

• Next-generation contact lenses

• Vitreous replacement fluids

• Retinal tamponades

• Glaucoma drainage devices for the regulation of intraocular pressure

Neurology :

• Tube for neurone regeneration

• Neuronal Cell Outgrowth with Polycaprolactone Microfibre Scaffolds

• Neural Cell Differentiation on a Collagen 3D

• Biomimetic Matrix

• Cell therapy

A new trend towards ophtalmology and neurology is driven by polymers and cell therapy.

Focus on Ophtalmology and Neurology

Consumption trends

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care


Hot topics

Ophtalmology and Neurology

Source : Alcimed data, interviews, society for biomaterials

Polymers

Cell derived

materials




Biomaterials

segmentation

ORL:

Ceramic phosphocalcique

Gastroenterology:

For prosthesis device

• Stainless steel

• Cobalt chromium

• Silicone

• polypropylene

The ORL and gastroenterology market should not evolve a lot in the coming years mainly because the market is not ready.

Focus on ORL, Gastroenterology

Consumption trends

The market should not evolve a

lot in the coming years mainly

because the market is not

attractive enough in terms of

money.

« These are interesting markets,

of course biomaterial use could be

very helpful but the market is not

ready so it is very difficult to get

funds. »

KOL, UK

Market size

Sector dynamic

(innovation,

research, know-

how, etc.)

Cardiovascular

+++

++

+

+/-


Immunology

Orthopedic

Endocrinology

Plastic surgery

Urology

ORL

Ophtalmology

Oncology

Dermatology

and wound

care


Hot topics

ORL, gastroenterology

Source : Alcimed data, interviews


Country specificities Biomaterials

segmentation

Main country specificities

The only difference identified between the 4 countries in the type of biomaterials used concerns cell therapy, where Germany and UK are in advance.

No differences have been identified during phase one concerning the perception of the

trends concerning the pathologies and the type of biomaterials used

NB : Germany and United Kingdom appear to be in advance concerning cell therapy

More than 350 companies already exists in the field of tissue/cell engineering. The majority (60%)

are located in the United States, nearly 200 compared to 80 in Europe. In Europe, countries with the

largest number of companies are the United Kingdom and Germany. France is third with about

twenty companies, positioned on cell therapies and, to a lesser extent, on tissue engineering.

Source: Alcimed data, interviews, Pharmaprojects, 2006, 2005 MedMarketDiligence



methodology


market



Market trends



Introduction


Value Chain

Metals, ceramics and polymers (1)

Key players and

value chain

Big companies are mainly suppliers of raw materials and SMEs are implied in R&D, production and distribution…

End customer

Big companies

SMEs Research and

development

and producer

Raw materials

supplier

SMEs

Distributor

SMEs

Clinician / Hospital

Value chain for metals, ceramics and polymers

Monopolystic situation

SMEs are selling their products to

clinicians and hospitals directly

SMEs are buying raw materials

from big companies or

biomaterials produced by another

SMEs to push development

further

In the field of polymers, SMEs are

more numerous than in the field

of metals & alloys and ceramics


Value Chain

Metals, ceramics and polymers (2)

Key players and

value chain

…but once SMEs have developed and commercialized a good product, big companies try to become distributors of the product or try to buy the SMEs and their know-how.

End customer

Big companies

SMEs Research and

development

and producer

Raw materials

supplier

Big companies

SMEs

Distributor

SMEs


Value chain for metals, ceramics and polymers

Once the SME has provided

evidence, big companies show

their interest. The evidence

needed is:

- clinical trial

- CE label

- proof of concept

- attractiveness of the market

with first sales

To show their interest big

companies do not hesitate to:

- buy the SMEs at a high

price

- become distributors of the

product

Big companies


Value Chain

Cell therapy

Key players and

value chain

Concerning cell therapy, SMEs are already vertically integrated on the whole value chain.

End customer

Ph

arm

aceutic

al c

om

pa

ny

Research and

development

and producer

Raw materials

supplier

Distributor


Value chain for cell therapy

In cell therapy SMEs are implied in

the whole value chain, from cell

development to distribution and

product sales

Big pharmas promote partnerships

with research laboratories and SMEs

in the field more than the creation of

internal departments specializing in

cell therapy

As for metals, ceramics and

polymers, big companies are ready to

buy SMEs once they have

demonstrated some interesting

perspectives

SMEs SMEs

SMEs


Value Chain

Environment

Key players and

value chain

Value chain

Academic

researchers

Health

regulatory

system

Funders

Academic research has a dual role in this value chain:

- Buy some biomaterials or raw materials to develop the research

and validate some characteristics of the product

- Provide patents and know-how for SMEs

This value chain is influenced by academic researchers, health regulatory system and funders.

Big companies

SMEs

Big companies

SMEs

SMEs


Big companies

Environment of

the value chain

Both private and public funders help SMEs and researchers to

develop and produce biomaterials

Health regulation concerning the biomaterials appears to be very

complicated and restrictive according all the experts:

- Regulatory process depends on the biomaterial composition and

on the future application of the product (even more difficult with

combination products)

- No harmonization between European countries (local decisions)

- Very long and expensive process

- ATMP regulation is more strict than for the other biomaterials


Value Chain

Environment – focus on cell therapy

Key players and

value chain

Value chain

Academic

researchers

Health

regulatory

system

Funders

For cell therapy the regulatory system happens to be very different across European countries but should be harmonized by the end of 2012.

Big companies

SMEs

Big companies

SMEs

SMEs


Big companies

Environment of

the value chain

Regulatory framework

(autologous and allogeneic)

No specific regulatory

framework x

Drugs X x

Medical device

Drugs or medical device

(case by case) X

Specific national regulation x X

The regulation at the European level concerning the “advanced

therapy medicinal product” was launched in 2008 with the

objective of harmonizing the laws of different countries by the end

of 2012 ( CE regulation number 1394/2007). The process will be

centralized by the EMA and no longer by the Members states.

Example of complication in the regulatory process that

should be harmonized by the EMA by the end of 2012: cell

therapy



Improvement needed

(1)

Key players and

value chain

The lack of communication between all the stakeholders of the value chain is a real barrier to the development of the sector.

Value chain and

environment

Big companies

SMEs

Big companies

SMEs

SMEs


Big companies

Academic

researchers

Health regulatory

system

Funders

Lack of

communication

Improvement

needed

Monopoly of the

raw materials

supplier

High risk market

Influence of the

KOL

Communication problems :

o Lack of communication between

• SMEs

• SMEs and big companies

• Research and industry

• Different research organisations (public and

private)

• The different therapeutic areas

o Difficulty to have a healthy communication between

the small entreprises and the big ones

« Communication is the main problem in the field, we are

all working on the same subject, we don’t know who can

help us, we don’t know how to find synergies together »

KOL, UK

« The gap between research and industry is huge »

KOL, France


Improvement needed

(2)

Key players and

value chain

The other improvments needed refer to the monopolistic situation of big companies, the implication of KOL and the risky market that lowers investments.

Value chain and

environment

Big companies

SMEs

Big companies

SMEs

SMEs


Big companies

Academic

researchers

Health regulatory

system

Funders

Lack of

communication

Monopoly of the

raw materials

supplier

High risk market

Influence of the

KOL

Expensive prices

Few materials available and impossibility to customize them

push the SMEs and researchers to buy their products in Asia

« Since there is only one supplier of raw materials, we can’t

ask for specificities on the product, we are forced to buy in

China but the quality is lower. It is a real problem » KOL, UK

Knowing that it is a risky market, it is difficult for investors to

anticipate the return on investment

o Difficulty for the SMEs to support development costs

(long term development and expensive clinical trials)

o Fear of being associated to a product that does not work

or may be harmful to a patient

« It is very difficult to find money, the big companies hesitate to

invest on biomaterial products unless the product is already

commercialized » KOL, GE

The development of innovative products is very dependent on

the willingness of end users (doctors) to use innovative

products

Improvement

needed


Country specificities

Industrialisation and private/public collaboration

Key players and

value chain


Source : Alcimed data, interviews, medtech, « Dispositif médicaux : diagnostic et potentialité de développement de la filière français dans la

concurrence internationale – PIPAME »

The level of industrial implantation and private/public collaboration is stronger in Germany and UK than in France and the Netherlands.

Level of

industrial

implantation

Few industries

94% of the

manufacturers of

medical devices are

SMEs (of which 45%

very small entreprises)

Almost 50% of

European industries

Almost 15% of

European industries Few industries

Level of

private /

public

collaboration

Medium

Strong

Strength of networks

and clusters foster the

emergence of

innovation in R & D

and collaborative public

/ private projects

Strong

Many funding

programs set up, but

almost exclusively for

consortia



France and Germany

Key players and

value chain


The most complicated regulatory system seems to be in France.

Regulatory

system

Difficulties for SMEs to

integrate the requirements

for clinical evaluations

upstream of CE regulations

The response time for a

decision to refund an

innovative medical device

and an act of scoring is

very long (several years)

The required clinical

evaluations are perceived

as more restrictive in

France than in other

countries

Response time for

reimbursement issued to

companies is considered

fast (about 3 months)

Transcript in German law

of the European Directive

2007/47/EC in May 2010

Almost 15% of European industries

The costs of the clinical trials and

development are very expensive,

therefore some researchers or SMEs

prefer to go abroad (as in Sweden for

example where it costs half less)

A true desire to simplify and speed up

the process in terms of regulatory

validation by creating "NICE pathway

evaluation program" which publishes

guidelines to help the NHS to make

decisions more efficiently and quickly.

But the actual regulatory system is still

difficult





France and Germany

Key players and

value chain


Finding funding in the field of biomaterials, seems to be a real problem for SMEs and researchers in the UK.

Funders

Lack of capital venture

to fund new innovative

SMEs

The UK is the second main country in « venture capital », but

investors are not interested in medical devices

End users

In the UK, clinicians are not very keen on innovation and they take

time to adopt a new product. This explain why many SMEs prefer to

be delocalized in the USA where innovation and risk is part of the

culture




Past and Current issue Synthesis:

opportunities

Past and Current issue = repair and replace

To repair and replace a tissue or a function of the body the main biomaterials used today are metals and ceramics but the trends is to use more and more polymers and composites.

Current and Future issue =

Develop the patient’s self-

healing

Lower the cost

Lighten materials while keeping

good mechanical properties

Combine different types of

basic materials to optimize

mechanical, biological or


(combination products)

Metals & alloys

Ceramics

Natural materials (except cell therapy)

Polymers

Composite

Current

importance of use

Main biomaterials used Main objective = optimize these

biomaterials

Predicted

development




Current and Future issues Synthesis:

opportunities

Past and Current issue =

repair and replace

With the new objective of patient’s self-healing, new opportunities appear as the development of cell therapy and the combination of cell therapy and biomaterials.

Current and Future issue = Develop the patient’s self-healing

Opportunities

Follow the trend of cell

therapy

Combine cell therapy

with another

biomaterial (matrix, etc)


Therapeutic areas Synthesis:

opportunities

Some therapeutic areas seem to offer more potential development in the coming years than others : the leader of the market, the therapeutic areas linked to cell therapy and the new trends.

Cardiology

Orthodepics

Another important market in

volume is plastic surgery

Focus on therapeutic areas

that drive the market

Opportunities: therapeutic areas

Immunology

Endocrinology

Ophthalmology

Dermatology and Wound

care

Focus on therapeutic areas

linked to cell therapy

Ophthalmology

Neurology

Follow the new trends


Who is ALCIMED ?

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Industrial leaders in life-sciences, health, food, chemistry, materials, energy

and biotechnology sectors / National Institutions / European Organizations

With over 160 qualified biologists and chemists, most of whom have further

training in marketing or business, the ALCIMED team has a wide-ranging

general expertise and high standards of education and training

Paris, Lyon, Toulouse, Madrid, Cologne, Lausanne

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Founded in 1993, ALCIMED is a consulting firm specialized

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