Healthcare related sectors

1. 1
The Growth Pipeline™ Company
Powering clients to a future shaped by growth
Growth opportunities, value chain
and regulatory landscape
capabilities
HEALTHCARE
RELATED SECTORS
August 27th 2020

2. 2
HEALTHCARE RELATED
SECTORS: GROWTH
OPPORTUNITIES

3. 3
GROWTH OPPORTUNITIES
IN THE INGREDIENTS AND MATERIALS MARKETS FOR HEALTH, BEAUTY AND PACKAGING
Source: Frost & Sullivan
Multifunctional ingredients optimize multifunctional personal care formulations,
while fulfilling both consumer and manufacturing needs
MULTIFUNCTIONAL INGREDIENTS
AND EXCIPIENTS
• Today’s well-informed and time-strapped consumers are seeking personal care and cosmetic products that offer combined and value-added benefits, while
saving time and money. It is not uncommon for consumers to expect moisturizers with UV protection and anti-microbial action, or shaving creams with
lathering, soothing, and healing actions, as well as ingredients that serve hair, skin, and body care formulations.
• Brand owners are trending towards making multifunctional products in a way that helps them expand their product range with new functional categories, as
well as converting their mass brands to prestigious niche products. While formulators are developing quality ingredients with multifunctional benefits and
added value, that are optimized for volume, and have a number of active ingredients and excipients, ingredient suppliers are researching ways to make
ingredients attractive to formulators by providing processing (excipient) benefits e.g. thickening with emulsification properties and preservative action with
fragrance.
• Multifunctional ingredients can help formulators reduce material inventories and warehousing costs, simplify and optimize formulations, and facilitate easier
manufacturing systems. Leading ingredient suppliers are leveraging this trend for researching and patenting multifunctional ingredients that they are
eventually branded for the market.

4. 4
GROWTH OPPORTUNITIES
IN THE INGREDIENTS AND MATERIALS MARKETS FOR HEALTH, BEAUTY AND PACKAGING
Source: Frost & Sullivan
• It is said that words are powerful and this is especially true in the battle of “synthetic” over “natural” in the ingredients industry. “Synthetic” has been
demonized for decades by makers of so-called “natural” and “organic” products. This has lead to confusion in the consumer’s mind with increased challenges
and barriers to entry for suppliers of bioequivalent synthetic ingredients. Most of the realistic and balanced definitions of natural and synthetic products fall
into grey areas when discussing efficacy, safety and dosing. The chemical industry has synthesized some of the world’s greatest and most sustainable
ingredients for personal care, cosmetic, medical and pharmaceutical industries for instance aspirin, synthetic vitamins, antibiotics, and polymers.
• Many of the synthetic ingredients are inspired by the botanical world, and aim at keeping or improving the efficacy and reducing toxicity and side effects
(increasing safety) by molecular selection or modification. However, safety and efficacy of a natural product depends upon the mix of biochemicals it contains
based on the sources (species, sub-species, soil, climate, fertilizers and pesticides used, etc.).
• The industry trend in the next decade would be in establishing “synthetic” or “chemical” ingredients as sustainable, safe, humane, and bioequivalent to
competing natural ingredients. Rather than establishing an ingredient as “better” in black and white terms, the future will see more groups of synthetic and
natural ingredients being compared as equals, provided efficacy, safety and dosing are adequately researched by end applications.
Many synthetic ingredients are inspired by the botanical world, improving the
efficacy while reducing toxicity and side effects by molecular selection
SYNTHETICS AS SUSTAINABLE

5. 5
GROWTH OPPORTUNITIES
IN THE INGREDIENTS AND MATERIALS MARKETS FOR HEALTH, BEAUTY AND PACKAGING
Source: Frost & Sullivan
• There is a strong demand for natural and organic cosmetic and personal care products (about $12-13 billion globally, and growing with a CAGR of 9-10%) that
is stimulating the ingredients industry into closely reviewing and innovating their technologies and lines. Skin care, hair care and color cosmetics are the major
segments driving revenues in the natural and organic cosmetics and personal care ingredients market.
• Natural and organic ingredients for cosmetics and personal care products are manufactured from various botanical parts such as leaves, bark, roots, stems,
flowers, fruits, seeds, resins and saps, and other parts known to contain high levels of beneficial biochemicals and substances. If labeled organic, they are
certified to be grown organically without the use of chemical fertilizers or pesticides, however natural methods of plant nutrition (e.g. biofertilizers and manure)
and weed and pest control (e.g. biopesticides and inoculants) are permitted.
• Consumers across the globe are showing a growing interest in chemical-free products for health, safety and environmental reasons, with awareness that
many ingredients sourced from plants are likely to be more effective and safe for long term use on the face, skin and hair.
• The rise in disposable income of young couples and also single men and women, and rising standards of living in developing economies is expanding the
demand for natural and organic products that are perceived to provide gentle health benefits over a long term with the least risks.
Natural ingredients are perceived to be holistic, effective, and safe over long-
term contact
BACK-TO-NATURE

6. 6
GROWTH OPPORTUNITIES
IN THE INGREDIENTS AND MATERIALS MARKETS FOR HEALTH, BEAUTY AND PACKAGING
Source: Frost & Sullivan
• Traditionally, men’s grooming did not go beyond soap bars, body washes, shampoos, shaving creams, and deodorants. Some pampering was acceptable at
the barber shop with hair gel and occasional coloring of hair to look younger. Today, it is common to see variety in the pampering that males are getting used
to – not only at the barber shop, but also in their own bathroom shelves. These products specially researched and designed for male self-care include
moisturizers, sunscreens, anti-perspirants, facial cleansers, eye serums, bronzers, concealers, anti-agers ,and mud masks. With innovative products for
males targeted to trendy barber-shops and male-centric salons that provide personalized services. The global male grooming market is estimated to be more
than $20 billion in 2018 growing with a CAGR of about 10%.
• More men are investing in their looks to boost their self-confidence, marketability and successes in the competitive worlds of career and society. With an
appreciation of gender equality and feminism, men are beginning to focus on personal care and cosmetic products that are designed for men. For instance,
differences in acne patterns of growing male adults or hair color preferences in active aging men, shaving products for different stubble types, moisturizers for
diverse skin types.
• Skin care and shaving are the fastest growing male grooming products followed by hair care, with a number of new brands entering both the retail and
professional grooming (salons and barbershops) markets. The signs are clear – ingredient suppliers must be able to keep pace with the brand owners and
support the formulators and developers of men’s grooming products.
More men are investing in their looks to boost their self-confidence,
marketability, and success in the competitive worlds of career and society
MEN’S GROOMING

7. 7
GROWTH OPPORTUNITIES
IN THE INGREDIENTS AND MATERIALS MARKETS FOR HEALTH, BEAUTY AND PACKAGING
Source: Frost & Sullivan
• During the past years the pharmaceutical (drugs and medicinal) and medical device market has seeing significant growth opportunities and convergence with
the development of innovative drug-in-device systems that enable the administering of drugs to patients in a time-controlled fashion. For instance, specialized
designs of inhalers, diabetic pens, pre-filled syringes, ostomy wound care, and devices that use self-regulated and nano-technology systems help in
administering a drug accurately, safely and effectively to the patient with the least inconvenience.
• The medical applications for biosimilars and biologics have been rapidly increasing with both pharmaceutical and medical device manufacturers aiming to
leverage the opportunities to design more user-friendly, even if complex, delivery systems. With a surge in competition in both industries, suppliers are
seeking to develop products to differentiate their brand, and to diversify product portfolios with pharma-device fusion.
• Among the major challenges that medical device and pharmaceutical suppliers would need to face in order to be successful, is to effectively navigate through
the convergence areas. While the individual areas were already complex to begin with, the convergence of the two industries make the scenarios of clinical
trials and testing, FDA regulations, medical insurance, and marketing to the medical community, all the more complicated.
Fusion of medical device with drug helps diversify product portfolios
PHARMACEUTICAL AND MEDICAL DEVICE
CONVERGENCE

8. 8
GROWTH OPPORTUNITIES
IN THE INGREDIENTS AND MATERIALS MARKETS FOR HEALTH, BEAUTY AND PACKAGING
Source: Frost & Sullivan
• Over the past 5-6 years, 55-60 merger and acquisition (M&A) deals have occurred in the global personal care and cosmetic ingredients industry. The total
value of these deals is estimated to be over $2.5 billion. About 45% and 24% of these deals were from Europe and North America respectively, with the
remaining being mainly in Asia-Pacific, Middle East, and Africa.
• Key trends driving growth and M&A activities include:
• Customers looking for ingredients and formulation solutions from a single supplier as a one-stop shop providers
• Acquirers seeking targets that are likely to help them grow faster than routine organic growth;
• Acquisition ripe for targets with niche natural, botanical, or marine ingredients and those that are multifunctional or functional in specific areas;
• Companies in the personal care and cosmetic ingredients industry expanding their control in raw material sourcing and procurement, and customer
base and client lists through acquisitions that are more localized; and
• M&A’s high on the priority list of leading personal care and cosmetic ingredient companies as a sure source of planned cost synergies (R&D,
logistics, distribution, facilities, and capacities).
Consolidation in the personal care and cosmetic ingredients industry sustains
market growth
INDUSTRY CONSOLIDATION

9. 9
HEALTHCARE RELATED
SECTORS: INDUSTRY VALUE
CHAINS

10. 10
Specialty Materials for Medical Device Industry
Coatings Manufacturers: Acrymed, Inc.,
Cupron, Inc., Ecology Coatings, Surmodics,
Inc., Sono-Tek, Micell Tech. Accord
Biomaterials, DSM, Biocoat, Agion,
Akcoatings, AST Products
Resin & Synthetic
Material Suppliers
Naturally Derived
Material Suppliers
Compounders &
Blenders
Coatings
Manufacturers
Device Adhesives
Manufacturers
Molders, Extruders &
Component Manufacturers
Contract Manufacturers
Medical Device OEM’s
Medical & Dental
Adhesive Manufacturers
Hospitals, Clinics Pharmacies
Raw Materials
Value-Added
Materials
Parts and
Components
Medical Devices & Products
Medical Device Cos.:
NuCryst, Boston Scientific,
Abbott, C.R. Bard, Lombard
Medical, Smith Nephew
Medical & Dental Adhesive Manufacturers:
Aesculap, Advanced Medical Solutions plc /
Medlogic Global, B.Braun Melsungen AG, Cohera
Medical Inc., Covidien, Ethicon (J&J), Baxter
Biosurgery, Omrix Biopharmaceuticals, CryoLife
Inc., Henkel AG & Co. KGaA, 3M, Davol Inc.
Device Adhesives Manufacturers: Henkel Corp. (Loctite), Dymax,
Ellsworth, 3M Medical Tapes and Adhesives, Master Bond Inc., Adhesive
Systems, Inc.
Distributors
Material suppliers: DSM, DuPont,
ExxonMobil, Evonik, Innovene,
LyondellBassel, Sabic, Solvay, Dow Chemical,
Kraton, BASF, Polyone, Dow Cellulose Ethers
Distributors
Medical
Device End-
users
The value chain is complex for medical devices due to the high degree of value-addition and intermediate products before
making the finished devices for use in different healthcare settings.
Source: Frost & Sullivan

11. 11
Value Chain Analysis—In Vitro Diagnostics (IVD) Market
Point of care (POC) molecular diagnostics (MDx) will be the fastest growing segment in the IVD space, providing growth opportunities for
manufacturing firms, and consequently for material science firms. It will target non-traditional laboratory testing in scenarios, where quick medical
decisions are needed, e.g., infectious disease surveillance, life-threatening diseases that require immediate treatment, genetic testing, etc.
The IVD industry value chain
encompasses several stages—
concept development to market
access.
Contract Manufacturing
Organizations
play a significant role at every
step in ensuring product success.
The global IVD CMO market is
expected to grow from $8.58
billion in 2019 to $14.21 billion in
2025, at a CAGR of 8.8%.
Source: Frost & Sullivan

12. 12
Life Sciences and Biotechnology Value Chain
---------
Material
Sciences
Companies
---------
Source: Frost & Sullivan; Mastrangeli, M., Millet, S. and van den Eijnden-van Raaij, J., 2019. Organ-on-chip in development: towards a roadmap for organs-on-chip.

13. 13
Organ on Chips Devices in Life Sciences and Biotechnology
The healthcare challenge and the OoC roadmap
The Horizon 2020 FET-Open project Organ-on-Chip In Development (ORCHID) started in 2017 with the goal of creating a roadmap for
OoC technology and of building a network of academic, research, industrial, and regulatory institutions to move OoCs from
laboratories into general use to benefit the citizens of Europe and beyond.
Source: Frost & Sullivan; Mastrangeli, M., Millet, S. and van den Eijnden-van Raaij, J., 2019. Organ-on-chip in development: towards a roadmap for organs-on-chip.

14. 14
Microfluidics in Life Sciences and Biotechnology
Increasing R&D focusing on adhesives for microfluidics facilitates new product developments in life sciences and biotechnology.
Microfluidic devices have found most applications in the
life sciences and both clinical and point of care
diagnostics. adhesive bonding being a significant and low
cost alternatives. To bond microfluidic devices, a large
number of adhesive materials are used and newer ones
have been developed. Silicone adhesives are popular and
will continue to expand new horizons in the next few
years.
In the last few years microfluidics have shown significant interest
towards improving diagnostics and biology research. Currently as
the technology moves towards refining wafer packaging and
bonding technologies, pharmaceutical, drug delivery, diagnostics,
assays, and optics are some of the highly emerging wings of
microfluidics. Certain properties of microfluidic technologies,
such as rapid sample processing and the precise control of fluids
in an assay, are expected to develop and replace traditional
experimental approaches.
Source: Frost & Sullivan

15. 15
PDMS vs Thermoplastic Polymers in Microfluidics Manufacturing
Source: Frost & Sullivan; Tsao, C.W., 2016. Polymer microfluidics: Simple, low-cost fabrication process bridging academic lab research to commercialized production. Micromachines, 7(12), p.225.

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Value Chain Interactive Model for (Bio)pharma Manufacturing
Technical Process Research Process Development/Pilot Production Scale-Up/Process Optimization
Large
Biopharmaceutical
Companies
Investigational New Drug (IND) Application Submitted
Upstream Manufacturing
Microbiological processes optimization systems, bioreactors arrays,
automation systems, liquid handling, and in-line monitoring process analysis
instruments, etc.
Downstream Manufacturing
Purification processes, filtration systems, column chromatography,
tangential flow filtration (TFF) systems, etc.
Production Support and Fill/Finish Operations
Media/buffer preparation, equipment and component preparation, chemical dispensing, equipment and environmental cleaning, and in-line monitoring
process testing.
Final formulated product, glass vials containers, prefilled syringes or intravenous (IV) bags, etc.
Lab Process
Scale-
Up
Clinical
Trials
Pre-
Clinical
Drug
Discovery
Pre-
Discovery
Post-
Marketing
FDA
Review
New Drug Application (NDA) Submitted
Scalable Process Technical Process Commercial Process
cGMP Manufacture for Clinical Trials and Commercial Use: Entire Value Chain Coverage
Key Approaches: Silicones for (Bio)pharmaceutical Development & Manufacturing
Tubing Systems
(Coatings & Molding)
Labeled Packaging
(Films & Sheets)
On-site Testing
(Films & Sheets)
Smart Closures
(Coatings & Molding))
Active Ingredients &
Excipients
Cross
Industry
Participants
Source: Frost & Sullivan

17. 17
Value Chain Analysis for Pharmaceutical Ingredients Market
Direct business/sales from APIs and specialty excipients supplier to end-product pharmaceuticals manufacturer or brand
owners, and contract manufacturers, is common for branded products. Distributors are especially needed for generic active
ingredients and many of the excipients
Manufacturers of Active Pharmaceutical
Ingredients (APIs) and Excipients:
APIs: Teva, Dr.Reddy's, Aurobindo Pharma,
Novartis AG, GlaxoSmithKline, Sanofi, Pfizer,
Bristol-Myers Squibb, Boehringer Ingelheim
Excipients: BASF, Evonik, Ashland, Dow, Merck,
Croda, ADM, SEPPIC, Innophos, Lubrizol, Wacker-
Chemie, NuSil, Momentive, FMC, CP Kelco/ JM
Huber, Eastman, Cabot Corp, DSM, AkzoNobel
Distributors and Wholesalers of APIs, excipients
and other materials: Distributors are likely to deal
with bulk and established and/or commoditized
ingredients
Pharmaceutical Product Manufacturers (Brand Owners): Johnson & Johnson, Roche, Pfizer,
Novartis, Sanofi, GSK, Merck, AbbVie, Abbott, Gilead, Bayer, AstraZeneca
Retail Pharmacies, Hospitals,
Clinics
Pharmaceutical Contract Manufacturers:
Patheon, Catalent, Dr, Reddy’s, Baxter, Pfizer
CenterOne, Recipharm, Famar
There is a strong convergence of cosmetic
ingredients with pharmaceutical excipients
especially in formulations such as
ointments, creams, lotions, gels, and
solutions. Thus many of the suppliers are
common for both markets, as also
formulators and contract manufacturers.
Formulators & Blenders for Pharmaceuticals:
Formulators and blenders play an active role in
the cosmetics manufacturing value chain
APIs & Excipients Value Chain
Wholesalers,
Distributors &
Group Purchase
Organizations
Source: Frost & Sullivan

18. 18
Ingredients and Excipients for Pharmaceuticals
Active Pharmaceutical Ingredients (APIs) & Excipients
Ingredients and excipients for pharmaceuticals is a dynamic market area of active (chemical and biological)
ingredients, and functional and multi-functional excipients.
Active Pharmaceutical Ingredients
(APIs)
Biotech APIs, High Potency APIs
(HPAPIs), Generic/Branded
Excipients for Formulating
Dosage Forms
Solid Dosage Forms, Liquid
Dosage Forms, Semisolid and
Topical Products, Parenteral &
Transdermal Products
Patients in Therapeutic Groups being
treated
Central Nervous, Cardiovascular,
Respiratory, Oncology, Diabetes/
Endocrinology, Gastrointestinal, others
Technologies Supporting
Dosage Forms
Empty capsules, softgel capsule
materials, microencapsulation,
nanotechnology
Drug Delivery Systems, Drug-Device Combinations
Ingredients and excipients are regulated for quality and efficacy as
raw materials that go into making of the pharmaceutical
formulations. Pharmaceutical regulatory oversight focused on
health and safety is done by dedicated bodies in each country.
Pharmaceutical primary and secondary packaging
Ingredients and excipients need to primarily comply with the
specifications and testing under pharmacopoeias established by the
national regulatory bodies e.g. United States Pharmacopoeia/
National Formulary, British Pharmacopoeia etc.
Source: Frost & Sullivan

19. 19
Ingredients and Excipients for Pharmaceuticals
Active Ingredients and Excipients by Pharmaceutical Dosage Forms
The life sciences chemicals and materials market is driven by growth of the regulated pharmaceutical industry, and
technological development in healthcare (diagnosis, prevention and treatment of acute and chronic illnesses).
Solids
(Tablets, Capsules, Softgels),
Diluents, binders, lubricants,
glidants, disintegrants, colors,
flavors, sweeteners, sorbents,
coating materials, sustained release
materials, plasticizers
Parenterals
(Injections, Transdermal, IV Fluids,
Inhalers, Ophthalmic) Solvents & co-
solvents, buffers, antimicrobial
preservatives, antioxidants,
antifoaming agents, chelating agents
Liquids
(Syrups, Drops, Solutions)
Solvents & co-solvents, buffers,
antimicrobial preservatives,
antioxidants, wetting agents,
antifoaming agents, thickeners,
humectants, chelating agents,
emulsifiers, colors, flavors
Semi-solids
(Ointments, Creams, Gels,
Suppositories)
Structure-forming & gel-forming
agents, colors, preservatives,
antioxidants, solubilizers,
emollients, suppository bases
Active
Ingredients
and Excipients
Source: Frost & Sullivan

20. 20
HEALTHCARE RELATED
SECTORS: REGULATORY
LANDSCAPES

21. 21
Very diverse customer segment
Higher regulation and testing/
validation requirements; need
to meet ISO standards
Higher risk—device failure,
patient complications, etc.
Strong organic market growth
Biocompatibility issues
Require high degree of technical
support and customer service
Small industry – high impact of
internal word of mouth
Strong domestic manufacturing
base
What makes medical device manufacturers
unique as a customer segment of specialty
materials suppliers?
Medical Device
Industry
Unique Profile of Medical Device Manufacturers
Source: Frost & Sullivan

22. 22
Medical Devices are classified using any of the following classification. No particular method of classification is standard
and complete in itself, as there is always some overlap in the below mentioned parameters.
FDA Related Segmentation Parameters
Disposable or Limited
Capital or Long-Term Use
Invasive
Non-Invasive
Class I, II, III Medical Device
Factors
Design
Treatment
Clinical
Application
Number/
Duration of
Uses
End Users/
Patient or
Therapy Areas
Cost
Degree of
Control for
Safety
Facilities Used
In
Source: Frost & Sullivan

23. 23
Medical Devices Coatings and Materials
Medical Device Coatings and Materials
The regulated biomedical technologies and medical devices market (including in vitro diagnostics- IVD) drives the need
for safe and high performance, specialty polymers and materials, including multi-functional ingredients.
Adhesives, coatings, textiles & biotextiles, films, foams, membranes,
plastics & polymers, silicones, cellulosics, metals, plastic additives,
adhesives & sealants, antimicrobials, natural ingredients
Regulatory Classification (in terms of risk from lowest to highest)
Examples:
Class I: Medical instruments, crutches, wheel chairs, surgical beds,
bandaging
Class IIA: Dental filler, diagnostic ultrasonic devices, hearing aids,
contact lenses, tooth crowns, muscle and nerve stimulators
Class IIB: Anaesthetic devices, respiratory devices, X-ray, blood bags,
defibrillators, dialysis devices & tubing, condoms, moist wound
dressings, dental implants
Class III: Heart catheter, endoprothesis, coronary stents, ortho
implants, absorbable surgical sutures, breast implants, heart-valves.
Biomedical Technologies
& Medical Devices
Devices Instruments
Apparatus Machines
Equipment Tools
Top Groups:
(1) In-Vitro Diagnostic Substances* (2) Electro-medical and Electrotherapeutic Apparatus (3) Irradiation Apparatus (4) Surgical and Medical Instrument (5) Surgical
Appliances and Supplies (6) Dental Equipment and Supplies (7) Ophthalmic Goods
* The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866. Source: Frost & Sullivan

24. 24
Regulatory Requirements for Plastics and Polymers in Medical Device
Materials, Coatings and Adhesives
Biocompatibility
Guidelines
Highlights
USP Class VI Tests • Consists of generating extracts of the material in various media and then carrying out the tests
• Tests are mainly acute systemic injection, intra-cutaneous injection, and muscle implantation tests in animals such as mice or
rabbits
• Rating does not imply product approval by FDA, but only that the product exhibits a low level of toxicity under test conditions
ISO Standard 10993 • Consists of 16 parts – each part describes specific tests that include a variety of toxicity tests
• More extensive than the USP Class VI tests
• Standard of choice for globally operating companies
• Widely recognized by North American, European and Asian companies
• Acute systemic injection tests for evaluating potential toxic effects as a result of a single dose systemic injection
• Intra-cutaneous injection tests for evaluating the irritation potential
• Cytotoxicity tests to determine the biological reactivity of monolayer cell cultures to the material
• In vitro hemocompatibility tests to evaluate the hemolytic potential of the material with rabbit blood – implies lack of adverse
effects on blood cells
Regulatory Requirements—Medical Device Materials
USP Class VI tests and ISO Standard 10993 are the major regulatory requirements of U.S. companies.
Similar regulations exist in other countries.
Source: Frost & Sullivan

25. 25
Medical Device Class (By FDA Specifications)
Device Class FDA Class Examples
Non-
Invasive
Class I
Urine collection bottles; compression hosiery; non-invasive electrodes, hospital beds, administration sets for gravity infusion; syringes
without needles.
Non-
Invasive
Class II
Syringes and administration sets for infusion pumps; anesthesia breathing circuits, connectors, tubes used for blood transfusion
Non-
Invasive
Class III
Haemodialyzers; devices to remove white blood cells from whole blood, devices to warm or cool blood; devices to remove carbon
dioxide; particulate filters in an extracorporeal circulation system
Invasive Class I
Probes and tubes going into body orifices (not surgical) in ENT, ophthalmology, dentistry, proctology, urology and gynecology,
transient use devices - dental impression materials; examination gloves; enema devices, Manually operated surgical drill bits and saws
Invasive Class II
Short-term use devices - contact lenses, urinary catheters, catheters, tracheal tubes, tracheal tubes connected to a ventilator; suction
catheters for stomach drainage; dental aspirator tips, surgical devices even if for transient use - syringe needles; lancets, surgical
instruments (e.g. single-use scalpels; surgical staplers; surgical gloves; single-use aortic punch) and various types of catheter /sucker
etc., infusion devices, or are catheters of various types, clamps; infusion cannulae; surgical adhesive, brachy-therapy device,
neurological catheter, absorbable suture; biological adhesive, cardiovascular catheters; temporary pacemaker leads; carotid artery
shunts
Invasive Class III
Angioplasty balloon catheters and related guide wires; dedicated disposable cardiovascular surgical instruments will be upgraded to
Class IV from III if - intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system
through direct contact with these parts of the body, implantable devices, and long-term surgically invasive devices - orthopedic,
dental, ophthalmic and cardiovascular; maxilla-facial implants; prosthetic joint replacements; bone cement; non-absorbable internal
sutures; posts to secure teeth to the mandibular bone (without a bioactive coating); prosthetic heart valves; spinal and vascular
stents; pacemakers, their electrodes and their leads; implantable defibrillators
Source: Frost & Sullivan

26. 26
Medical Device Class (By FDA Specifications)
Device Class FDA Class Examples
Active Devices
Therapeutic
Class I or II or III
Muscle stimulators; TENS devices; powered dental hand pieces; hearing aids; neonatal phototherapy equipment;
ultrasound equipment for physiotherapy, lung ventilators; baby incubators; electrosurgical generators; external
pacemakers and defibrillators; surgical lasers; lithotriptors; therapeutic X-ray and other sources of ionizing radiation,
external feedback systems for active therapeutic devices, magnetic resonance equipment; diagnostic ultrasound in non-
critical applications; evoked response stimulators, electronic thermometers, stethoscopes and blood pressure monitors;
electrocardiographs, monitors/alarms for intensive care; biological sensors; oxygen saturation monitors; apnea
monitors, ultrasound equipment for use in interventional cardiac procedures, diagnostic X-ray source; devices for the
control, monitoring or influencing of the emission of ionizing radiation, feeding pumps; jet injectors, infusion pumps;
anesthesia equipment; dialysis equipment; hyperbaric chambers, examination lamps; surgical microscopes; powered
hospital beds & wheelchairs; powered equipment for the recording, processing, viewing of diagnostic images; dental
curing lights
Device Class Examples
Disposables Syringes, catheters, oxygenators, tubes, connectors, probes, leads, aspirators, cannulae, shunts
Reusables Surgical instruments, diagnostic equipment, probes, cannulae, pumps
Implantables Pacemakers, prostheses, sutures, clips, screws, staplers, balloons
Sterile Reusables Endoscopes, laparoscopes
Medical Device Class (By Reusability/Disposability)
Source: Frost & Sullivan

27. 27
Key Certifications Needed by Active Pharmaceutical Ingredients (API)
Certifications lead to faster product registration, ensuring speed to market of pharmaceutical ingredients – key certification
include US Drug Master Files (US DMFs) and Certificates of Suitability (CEPs). Good Manufacturing Practices (GMP) and ISO
certifications may also apply.
US Drug Master Files (US DMFS): DMFs provide regulatory authorities with the relevant details of the manufacturing facilities,
processes and quality of an API. They support the drug product marketing authorization applications. These certifications may be
applicable to Type II DMFs (for Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug
Product) especially for the US market.
Worldwide DMFS: Globally other documentation may be required to enable registrations worldwide. For instance, Japanese DMFs
that allow the registration of products in Japan, or Import Drug Licenses (IDLs) to support entry into the Chinese market, or other
country or regional documentation to meet varying registration requirements globally.
CEPS: These certifications are widely recognized across Europe, as well as countries such as Australia and Canada. CEPs are granted
by the European Directorate for the Quality of Medicines (EDQM). They are designed to provide a streamlined approach during
the assessments of product marketing authorization applications.
Good Manufacturing Practices (GMP) and ISO certifications
Source: Frost & Sullivan

28. 28
Key Certifications Needed by Active Pharmaceutical Excipients
“The EXCiPACT Certification Scheme, launched in 2013, was designed to fulfill these conditions. EXCiPACT GMP and GDP Standards
were developed from the IPEC-PQG GMP and IPEC GDP Guides and first published in 2012 based on ISO 9001:2008. A revised
version was published in 2017 based on ISO 9001:2015. They were designed to be applied by manufacturers and distributors who
already have ISO 9001 certification.
The EXCiPACT Standards allow for objective and consistent auditing. These Standards are the key components of the EXCiPACT
GMP/GDP Certification Scheme for pharmaceutical excipients provided since 2013 by independent, registered, third party
certification bodies employing registered auditors and in conformance to the ISO 17021-1:2015 standard.”
“The U.S. Food Drug & Cosmetics Act specifies that drugs must be manufactured, processed, packed, and held in accordance with
current good manufacturing practice (cGMP), or they are deemed to be adulterated. In 2012, the FDA Safety and Innovation Act
(FDASIA) Title VII became law, expanding the FDA’s authority to safeguard public health by, inter alia, enhancing the safety of the
increasingly global drug supply chains. This requires drug manufacturers to include as part of a drug listing, the name, address, and
unique facility identifiers of associated excipient manufacturers.”
- Article “PHARMACEUTICAL EXCIPIENT REGULATIONS: HOW THE EXCIPACT CERTIFICATION SCHEME CAN REDUCE THE AUDIT
BURDEN FOR BOTH SUPPLIERS AND USERS” in INDUSTRIAL PHARMACY April 2018
- Issue 57. Source: www.industrialpharmacy.eu
Source: Frost & Sullivan

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The Growth Pipeline™ Company
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B.Pharm., MBA--Marketing
Program Director—Chemicals,
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Email: raghu.tantry@frost.com
Raghu Tantry