pharmaceutical industry trends 2012 - w1.siemens.ch · expanding the global market . ... active...

Pharmaceutical Industry Trends 2012

Gert Moelgaard, VP, Strategic Development

NNE [email protected]

After the Patent Expiry Cliff

Dealing with Price Pressure

Expanding the Global Market

Changing Global Regulations

Facilities of the Future

Siemens Pharma Forum -

Gert Moelgaard NNE Pharmaplan

Challenges & Opportunities

Setting the Scene

Top 50 Pharma



Scrip

100 –

2012December 2011

Setting

the Scene: Top 10 Big Pharma sales and profitability

Scrip

100 –

2012December 2011



Setting

the Scene: Top 20 Pharma Products

Sales 2010

EvaluatePharmaMay 2011



Setting

the Scene: Top 10 Pharma Products

Sales 2016




Setting

the Scene: Small vs. Large Molecule

Pharmaceuticals




Setting

the Scene: Shifting

to smaller

product

sales



What

is the ”Patent Expiry

Cliff”?



OSD(”Small Molecules”)

Biotech(”Large Molecules”)

A brief introduction

to Small vs. Large molecule Pharmacetical

Products

ChemicalSynthesis

Drying orGranulating

Tableting Packaging

ChemicalActive Pharmaceutical Ingredient

(API)

“Tablets”Oral Solid Dosage Form

(OSD)

Formulation

Fermentation orCell CultureInteferon

moleculevs

Aspirin

Formulation AsepticFilling

Packaging

BiologicsActive Pharmaceutical Ingredient

(API)

“Injectables”Parenteral

Dosage Form(aka Sterile Products)

Small Molecules

Large Molecules

Since “1899”

Since “1982”



http://images.google.dk/imgres?imgurl=http://www.pharmaceutical-machinery-manufacturer.com/rimages/126/tablet-fluid-bed-dryer-B.jpg&imgrefurl=http://www.pharmaceutical-machinery-manufacturer.com/tablet/fluid-bed-dryer.htm&h=238&w=250&sz=19&hl=da&start=16&tbnid=sBvwA7uE80wL0M:&tbnh=106&tbnw=111&prev=/images?q=drying+pharmaceuticals&svnum=10&hl=da&lr=

http://images.google.dk/imgres?imgurl=http://www.hlyj.com/imgup/200511236497905.jpg&imgrefurl=http://www.hlyj.com/e_welcome.asp&h=156&w=200&sz=4&hl=da&start=3&tbnid=3UMTQ4R3A35KCM:&tbnh=81&tbnw=104&prev=/images?q=pharmaceutical+blister+packaging+machine&svnum=10&hl=da&lr=&sa=G

http://images.google.dk/imgres?imgurl=http://terrapharmacy.com/Images/gbx_terpharma_modA.jpg&imgrefurl=http://terrapharmacy.com/&h=170&w=180&sz=12&hl=da&start=27&tbnid=lKiwHlJDbRMY5M:&tbnh=95&tbnw=101&prev=/images?q=pharmaceutical+formulation&start=20&ndsp=20&svnum=10&hl=da&lr=&sa=N

http://images.google.dk/imgres?imgurl=http://www.hlyj.com/imgup/200511236497905.jpg&imgrefurl=http://www.hlyj.com/e_welcome.asp&h=156&w=200&sz=4&hl=da&start=3&tbnid=3UMTQ4R3A35KCM:&tbnh=81&tbnw=104&prev=/images?q=pharmaceutical+blister+packaging+machine&svnum=10&hl=da&lr=&sa=G

http://www.millipore.com/catalogue.nsf/docs/C8685

http://images.google.dk/imgres?imgurl=http://terrapharmacy.com/Images/hds_terisochamberB.jpg&imgrefurl=http://terrapharmacy.com/&h=170&w=180&sz=9&hl=da&start=28&tbnid=nU4dyLpr2Dzh0M:&tbnh=95&tbnw=101&prev=/images?q=pharmaceutical+formulation&start=20&ndsp=20&svnum=10&hl=da&lr=&sa=N

http://images.google.dk/imgres?imgurl=http://cvc-pharmaceutical-packaging.electronic.com.tw/rimages/161/liquid-filling-capping-06-B.jpg&imgrefurl=http://cvc-pharmaceutical-packaging.electronic.com.tw/liquid-filling-capping/06.htm&h=300&w=300&sz=17&hl=da&start=10&tbnid=4ZSrzBusT9gdLM:&tbnh=116&tbnw=116&prev=/images?q=pharmaceutical+filling+machine&svnum=10&hl=da&lr=

http://en.wikipedia.org/wiki/Image:Aspirin-skeletal.svg

10 companies compensation of patent losses



Scrip

100 –

2012December 2011

( >$2bn in 2010 -13)

Top 10 Pharma league

changes



Approvals

vs. Patent Expiry: Pharma Innovation Gap



USA. Cardiovascular diseases cause 40% of all deaths in the United States. This is more

than all forms of cancer combined.

DENMARK. Pronova

BioPharma

has inaugurated a new facility to produce the first omega-3

based prescription drug approved for treatment of cardiovascular diseases in the EU and USA.

Our company filmSiemens Pharma Forum -


2012-01-10 NNE Pharmaplan IM 2012

#1 Medical Expenses in USA: Heart Conditions -

$95.6 Billion

More than 80 million Americans have cardiovascular disease, which claims more than 860,000 lives a year.

Heart disease is the most expensive U.S. health condition, according to the U.S. Agency for Healthcare Research and Quality.

To reduce your risk of heart disease complications, maintain a healthy weight by eating right and getting regular exercise. Don't smoke. Be sure to follow your doctor's recommendations to control other risk factors, like high blood pressure and diabetes.

WebMD.com

Pfizer after

Lipitor



Daily Reporter 15-Jan-2011

The Wyeth deal ensures that Pfizer won't get caught in another Lipitor death grip: Kindler has vowed that henceforth, no one medicine will make up more than 10% of the revenue mix.

CNN Money August 18, 2009

“Big Pharma’s

traditional business model hinges on the ability to identify promising new molecules, test them in large clinical trials and promote them with an extensive marketing and sales presence…

By 2020, the strategy of singlehandedly placing big bets on a few molecules, marketing them heavily and turning them into blockbusters will not suffice…

It is a business model that will no longer meet the market’s needs”

PriceWaterhouseCooper:“Pharma 2020: Challenging business models -

Which path will you take?”, 2009



From few

blockbustes

to many

small sources

ParadigmShift

Old Pharma New Pharma



Sanofi

PasteurGSK Biologics

Novartis Vaccines

Centocor

ImClone

Wyeth

GenentechMedImmune

Schering-Plough

(Pfizer)

Scrip 2009 Top 100Pharma Analysis

The NEW pharmaceutical industry since 2009

New Big Pharma with

Biotech

etc…



New Pharmaceutical Mergers: From specialised

to diversified

business

All Big Pharma companies have diversified their business•Small molecule (APIs, OSD)•Generics•Biopharmaceuticals•Biosimilars•Vaccine•Diagnostics•Medical devices, •Orphan drugs, •OTC (Over the Counter)•Special care, •Personalised

medicine

•… and new focus on Emerging Economy Countries



Pharmaceutical products

gets

smaller

Dr. Jagschies, GE Healthcare Life SciencesFlexible

Manufacturing, 2008



From large specialised

facilities to small, scalable

and flexible

facilities

ParadigmShift

Old Pharma New Pharma

EquipmentPipingVesselsInstrumentsValvesVeldingsControls…

EquipmentPipingVesselsInstrumentsValvesVeldingsControls…

FlexibilityBags

TubesFittings

Data collectionSupervisionSterilizationContainment

…

Sartorius/Stedim

2009Siemens Pharma Forum -


Traditional

Big Pharma facilities

in Asia

...



US Health Reform Headlines



•

Broaden the population that receives health care

coverage through either public sector insurance

programs or privat

sector insurance companies

•

Expand the array of health care providers consumers may choose among

•

Improve the access to health care specialists

•

Improve the quality of health care

•

Give more care to citizens

•

Decrease the cost of health care



“Germany pays very high prices for drugs.

Drug spending has risen by two-thirds in the past decade. Dr Rösler

proposes a crackdown: an independent agency

will evaluate whether new drugs outperform existing ones.

If so, manufacturers will have to negotiate prices with insurers, and submit to mediation if they do not agree.

Dr Rösler

hopes to shave €2 billion ($2.6 billion) off the annual €32 billion drugs bill.

Drugmakers

denounce the idea as “poison”, but most others applaud it. “ The Economist

Apr

29th 2010

German

Health Reform

The Global Use of Medicines: Outlook Through 2015 IMS Health 2011



Life Expectancy vs. Healthcare Spending



OECD 2010 From Burrill

Biotech 2011

Cost of ChronicDiseaseIn USA

Shareholder Pressure



More effective pharmaceutical industry…



Need to learn from other industries

•

Pharmaceutical Lean and Six Sigma programs •

However, the net effect is far behind other industries

•

Needed to respond to the drug price cost pressure•

The GMPs

does not prevent re-thinking…

New regulation

supports ”Car

industry

thinking” Lean Six

Sigma, PAT, QbD...

Roche and Genentech: Avastin

as a thought

leader... US PhRMA

2008 Biotech

Report



Roche Half-year results 2009July 23, 2009 Basel, LondonSiemens Pharma Forum -


The Pharma Letter 31 October

2011



Roche Half-year results 2009July 23, 2009 Basel, London

Pharma &Diagnosis



Herceptin

HER 2 Diagnosis



The National Institute for Clinical Excellence (Nice) has been criticised

for ruling that Avastin

is not cost-

effective enough to be prescribed on the NHS. The Guardian, March 2011



“In the past, Western drugmakers

thrived on innovation while firms in emerging markets made cheap copies of their products.

Now they are invading each other’s turf.

Blockbuster drugs are losing their patents and, despite some bright spots, research has become more costly and less fruitful.

Big Western firms are now looking to emerging markets for growth, hoping to sell not just their patented drugs but generic ones, too.

Firms in emerging markets are expanding their footprint, ramping up sales in the West and investing in research. It is an energetic exchange, but a risky one.”



The EconomistJan 7th 2012



The Global Use of Medicines: Outlook Through 2015 IMS Health 2011

Biosimilars

in Asia: The second

Chinese

biosimilar

wave...

•

40% of China’s recombinant biologic product sales come from biosimilars, which have enjoyed a 25-30% annual growth rate over the past 10 years

•

As China’s healthcare market continues to expand …

it is plausible to expect China to become an important market for biosimilars.

•

Recombinant

biologics

reached approximately $1.5 billion in China in 2010, of which $670 million were biosimilars

(excluding peptides).



Scrip 2012 Report

The counterfeit issue...





The counterfeit

issue

requires

new technology

New counterfeit

technology

and regulations

is an important

part of the solution

Changed

regulations

–

More Harmonisation



Wall Street Journal front page announcement“The pharmaceutical industry has a little secret: Even as it invents futuristic new drugs, its manufacturing techniques lag far behind those of potato-chip and laundry-

soap makers.”

Wall Street JournalSeptember 3, 2003

“To the FDA, with its mission of protecting patient safety, it seemed more important to manufacture drugs precisely to specification, using tried-and-true systems, than to latch on to the latest in manufacturing trends”

“Now things are starting to change. The FDAhas concluded that the industry needs to adopt manufacturing innovations, partly to raise quality standards. The agency is overhauling its elaborate manufacturing regulations for the first time in 25 years.”



Harmonisation

of regulations

FDAPAT

ICHQ8

ICHQ9

ICHQ10

FDAProcess

Validation

“This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/ICH guidances

for industry, •Q8(R2) Pharmaceutical Development, •Q9

Quality Risk Management, •Q10

Pharmaceutical Quality System”

“This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/ICH guidances

for industry, •Q8(R2) Pharmaceutical Development, •Q9

Quality Risk Management, •Q10

Pharmaceutical Quality System”

FDA Process Validation GuideJan 2011



What

can

we

expect

in Europe?

ICHQ8

ICHQ9

ICHQ10

FDAPV

Guide2011

“Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.”

“Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.”

“The Quality Working Party recommends the revision of the Note for Guidance on Process Validation in order to include the concepts defined in ICH Q8, Q9 and Q10 including continuous validation and monitoring. “

“The Quality Working Party recommends the revision of the Note for Guidance on Process Validation in order to include the concepts defined in ICH Q8, Q9 and Q10 including continuous validation and monitoring. “

EMAPV

Concept2009




New Process Validation

Paradigm

Process Validation GuideMay, 1987 FDA CDER, CBER, CDRH

“Process validation is establishing documented evidence

which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-

determined specifications and quality characteristics”

“Process validation is the collection and evaluation of data, from the process design

stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”


Old NEW



FDA’s New Process Validation Life Cycle

ContinuedProcess

Verification

ContinuedProcess

VerificationProcessDesign

ProcessDesign

Development

ProcessQualification

ProcessQualification

Before Sale Commercialisation

1 2 3



Re-defining

Process Validation

Grace McNally, FDA, ”Process Validation: Lifecycle

Approach”, PDA Annual

Meeting April 2011Validation

Process Validation is now the whole Life Cycle of Process Validation

-“Classical”

validation is now PPQ

-IQ/OQ/PQ is now PQ

Process Validation is now the whole Life Cycle of Process Validation

-“Classical”

validation is now PPQ-IQ/OQ/PQ is now PQ



Understanding

Variability

is basis for Manufacturing

Control

•

“Manufacturers should •

understand the sources of variation,

•

detect the presence and measure degree of variation, •

understand its impact on the process and ultimately product attributes,

•

manage it in a manner commensurate with risk it represents to the process and product”

•

QbD: Mechanisms for managing variability is part of the control strategy •

e.g., may choose advanced manufacturing technologies that employ

detection, analysis and control feedback loops to react to input variability (PAT)

Variable Process Input

Consistent Process Output

AdjustableProcess

Variable Process Input

Variable Process Output

FixedProcess



URS

”PQ”

OQ

Good

Engineering Practice

Require-ments

Specifica-tion

and Design

Verifi-cation

Accept-ance

and Release

ProductKnowledge

ProcessKnowledge

RegulatoryRequirements

CorporateQualityReqs

Operation &ContinuousImprovement

Risk

Management

Design Review

Change

Management

User Requirement(i.e

What)

Functional Design(i.e. How as Schematic)

Detail Design

(i.e

How to make)

Operational

Qualification

Performance

QualificationPQ Test Plan

OQ Test Plan

IQ Test Plan

Implementation

(inc. PDI)

(inc. FAT)

Impact Assessment/Enhanced Design Review

Design Development

Installation Qualification

IQ

SAT

FAT

Peter Werner ChristensenNNE Pharmaplan

Steve Wisniewski, IPSISPE Webinar

2009



Product Quality Attribute C

QA

Prod

uctio

n B

iore

acto

r

Prot

ein

A

Low

pH

/VI

CEX

AEX

Nan

ofilt

ratio

n

UF/

DF

Com

poun

ding

Filtr

atio

n

Filli

ng, s

topp

er, c

ap

Test

ing

elem

ents

Aggregate Yes Form Remove Form Remove Remove Form Form LR

Deamidated isoforms No Form PM

Oligosaccharide Yes Form PM

CHO HCP Yes Form Remove Remove Remove Remove PM

DNA No Form Remove None

Protein A No Form Remove Remove None

Viral safety Yes Inact Clear Clear Biorx. IPC

Niels Guldager, NNE Pharmaplan

Quality

Risk

Management and Facility

Design

New Regulation

-

Stronger

Enforcement

Eye for PharmaWarning Letter Summary 4th Quarter 2010January 11, 2011

“We are in an unprecedented era in drug enforcement,”

Sturgeon explained.

“We have 300-400 active clients –

everything from one-person entrepreneurial firms all the way up to the largest pharma

companies.

Nobody is being spared the scrutiny of FDA.”

IPQ June 2010

PharmaTalk, September 15, 2009



A Paradigm

ShiftDocument

Driven Quality Data Driven Quality



Pharmaceutical Manufacturing

Innovation•

Patent expiry

pressure•

Health cost

pressure•

Global market

price

pressure•

Regulatory

pressure

•

Many

pharmaceutical

customers

are

now

ready

to re-think

their

facilities

•

New generation of pharmaceutical

facilities

with

very

advanced

manufacturing

technology

and systems

•

We

need

to follow

and share

the technology

trends

•

Understand the business of our customers...



The pharmaceutical

industry

is a newcomer

inManufacturing

InnovationCompared

to automotive, semiconductors, food

etc. etc.

Pharmaceutical Factory

of the Future Example



Sartorius

Stedim



Single Use

Biotech

Example

Continuous

Manufacturing

example



ConsiGma™A blue sky approach from powder to tablet

Continuous Tabletting: From Powder to Tablet in 20 Minutes A NEW GENERATION

A new generation of continuous production equipment overcomes these problems and ensures no –

or only minimal –

waste at start-up and shut-

down. GEA Pharma’s

ConsiGma™ continuous tableting

line was developed in concurrence with the FDA’s QbD

initiative and was designed to satisfy the industry’s need for continuous production

to provide improved quality, flexibility and consistency for pharmaceutical processes. The systems are designed in such a way that both R&D and production can use the same size of equipment, thus eliminating scale-up.

Modular

Pharmaceutical Facilities

examples



Bosch/Pharmatec2011

ModularPartners2011

Pharmadule

Morimatsu

AB2011

G-Con

2010



Deep Customer Understanding

New Pharma & Biotech

Know-how

New Technology

Opportunities

New Regulatory

insight

Global knowledge

and local

presence

GERMANY. Almost one million childrenand adolescents suffer from hay fever and will do so for the rest of their lives, unless treated

DENMARK. ALK started supplying GRAZAX®

-

the world’s first tablet-based grass pollen allergy vaccine-

out of their modernised facilities.



Engineering for a healthier world

Thank You!

pharmaceutical industry trends 2012 - w1.siemens.ch · expanding the global market . ... active...

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