The essential

guide to drug

commercialization

A handbook for selecting solutions and partners

Successful commercialization

depends on

more than regulatory approval alone.

Decisions made across development,

launch planning, and post-launch

execution all influence whether a therapy

achieves meaningful uptake, access, and

long-term success.

Discover the key considerations biopharma

companies should address at each stage

of the commercialization journey — and how

the right partner can help unlock product

potential and make the most of

commercialization investments.

You have invested time, expertise, and financial resources

to develop a therapy that can improve patients’ lives.

After all that work, a critical question remains: how can

you ensure your product reaches the patients who need it?

Your Global Product

Launch Lead (GPLL)

For many biopharma companies,

working with Cencora feels like

having a dedicated guide. This

single point of coordination, the

GPLL, evaluates needs holistically,

helps plan the commercialization

strategy, and brings in the right

subject-matter experts at the right

time, so teams stay aligned and

focused on what matters most.

Table of contents

Cencora The Essential Guide to Drug Commercialization — page 3

Table of contents

This guide is organized into five sections

The commercialization process

Drug development checklist

Pre-launch checklist

Post-launch checklist

A model for success

How to use this guide

This guide provides a high-level view of

the commercialization lifecycle,

highlighting the strategic decisions

that shape product success. While

every product and organization is

different, common considerations

emerge across development stages,

markets, and therapeutic areas.

You’ll glean actionable insights from

experts who work alongside biopharma

companies to align planning, execution,

and decision-making, bringing

products to market with coordinated,

integrated approaches across the

commercialization lifecycle.

Connect with our team

Cencora The Essential Guide to Drug Commercialization — page 4

Clinical development and early planning

During clinical development, biopharma companies may

face challenges in patient recruitment, supply chain

planning, data collection, and global coordination. Early

decisions can carry long-term commercial implications

that are difficult to reverse later.

Key considerations include:

•

Recruiting eligible patient populations and supporting

trial participation

•

Building scalable logistics and distribution capabilities

•

Acquiring comparator drugs for testing

•

Planning for packaging, storage, and transportation

requirements

•

Aligning clinical evidence with future regulatory and

access expectations

With so many moving parts, a partner with integrated

capabilities can make a meaningful difference

— coordinating operational expertise, digital visibility, and

cross-functional alignment to support both development

needs and future launch readiness.

When to start planning

During early development, including patient

recruitment and decisions around packaging,

temperature control, and logistics, up to

24 months before launch

Bringing a new therapy to market can be a long,

complex, and expensive journey. Recent estimates

put the average cost of research and

development alone at about

$2.6 billion

, and the

process can take several years. Developing a

quality product and securing regulatory approval

are essential milestones, but they rarely guarantee

commercial success on their own.

A product’s success is shaped by a series of

interconnected decisions made from early

planning through launch and beyond. Increasingly,

commercialization planning begins earlier than it

once did. Choices around evidence generation,

target populations, operational readiness, and

market sequencing can all influence downstream

access, adoption, and performance. Taking a

holistic view across stages helps organizations

anticipate challenges and act with greater

confidence.

The commercialization

process

Key considerations for each stage of the process

Table of contents

Cencora The Essential Guide to Drug Commercialization — page 5

Pre-launch: Market access

and value planning

As products move closer to approval, market access

planning becomes increasingly interconnected with

evidence generation, pricing strategy, and launch

readiness.

At this stage, biopharma companies evaluate the

evidence they’ve gathered (and any remaining gaps)

and begin defining the product’s value proposition,

brand identity, and messaging — often across

multiple markets.

Key considerations include:

•

Establishing a clear value narrative supported

by evidence

•

Anticipating access and reimbursement requirements

•

Aligning internal teams around pricing, positioning,

and launch priorities

•

Incorporating early regulatory strategy and

engagement with health authorities to align on

evidence requirements, timelines, and approval

pathways

•

Using digital and data-driven insights to inform

scenario planning and decision-making

Early coordination will help avoid delays, rework,

and misalignment later in the process.

When to start planning

12-24 months prior to launch

Pre-launch: Patient access

and support

Ensuring patients can obtain and remain on therapy is

a critical component of commercialization. Planning

ahead helps organizations address affordability,

administrative complexity, and access barriers that

may arise once a product is available. Regulatory

approval is a critical milestone, but increasingly, it

marks the starting point for demonstrating value to

payers, providers, and health systems.

Key considerations include:

•

Defining the role of patient support services

•

Anticipating out‑of‑pocket costs and access

challenges

•

Designing programs that align with patient and

provider needs

Digital tools, automation, and analytics can help

streamline access pathways and support timely

initiation of therapy, while preserving a human-

centered experience.

When to start planning

12-18 months prior to product launch

Table of contents

The commercialization process (continued)

Cencora The Essential Guide to Drug Commercialization — page 6

Pre-launch: Distribution and logistics

Distribution and channel strategy decisions shape how

products reach providers and patients. Whether

organizations manage logistics internally or work with a

third-party partner, early planning is essential.

Key considerations include:

•

How will the product be distributed across markets

and sites of care

•

Quality, compliance, and licensing requirements

•

How logistics will scale as demand evolves

The right partner thinks beyond distribution

alone — delivering coordinated, efficient solutions

across the supply chain that support long-term growth.

When to start planning

18-24 months prior to launch

When it comes to optimizing the commercialization

process, technology plays an important enabling role.

The right partner combines broad expertise across the

commercialization lifecycle with digital capabilities that

help teams work more efficiently and make informed

decisions.

Used thoughtfully, these tools can support key

moments along the journey — facilitating alignment

around messaging and brand strategy, informing

investment decisions such as patient support

programs, and helping streamline access pathways so

patients can start therapy sooner.

Post-launch needs

Launch is not the endpoint. It is the start of continual

optimization.

Once a product is in market, organizations must raise

awareness among providers and payers, communicate

product information compliantly, and continue refining

access strategies. Patient support, reimbursement

education, and coordinated field engagement all play

ongoing roles.

As products mature, companies must monitor

performance, respond to changing conditions, and

refine their strategies over time. Real-time insights into

uptake, adherence, and access help identify issues

early and support continuous improvement.

A trusted commercialization partner can help manage

this evolving landscape — supporting activities such as

lifecycle planning, safety monitoring, maintaining and

expanding reimbursement coverage, and navigating

payer relationships as market dynamics evolve.

When to start planning

Up to 12 months pre-launch for field services;

24-36 months for regulatory and market

access needs

What integration really means

The most effective commercialization partners

go beyond assembling individual services. True

partnership, and true integration, connect

evidence, access, operations, and insights;

helping organizations respond to change,

reduce complexity, and stay focused on

patients. They’re rooted in seeking solutions for

today’s healthcare challenges and making

investments where gaps exist.

When responsibilities are fragmented, risk

increases. A single, integrated point of

coordination helps align strategy and execution

across the commercialization lifecycle.

Table of contents

The commercialization process (continued)

Cencora The Essential Guide to Drug Commercialization — page 7

Long before launch, foundational

decisions influence future

outcomes.

With the right commercialization

partner involved from the start,

biopharma companies can feel

more confident that the drug

development process establishes

the best possible foundation for

market entry — even when that

may be months or years away.

It’s never too early to find the

right partner. Start your search

by looking for someone who

covers these critical needs:

Drug development

checklist

Seven success factors during development

Time-sensitive, temperature-

controlled logistics for

clinical trials

Look for near-perfect

execution of storage and

transport solutions.

Reaching eligible patient

populations for clinical trial

participation

The right partner will offer

direct-to-patient solutions for

in-home trials and access to

specialty provider networks for

hard-to-reach patient

populations.

Data collection and clinical

journey insights

Seek out a robust, scalable

logistics platform with

powerful inventory

management, ordering, and

tracking tools.

Ability to move treatments

across borders

The ideal partner will offer

global reach with local

expertise on customs and

credentials.

Table of contents

Cencora The Essential Guide to Drug Commercialization — page 8

Comparator sourcing

Look for efficient access to

comparator products and

reliable transportation

support.

Navigating the

regulatory process

You’ll need to leverage

expertise in regulatory

strategy, dossier authoring,

submission preparation, and

lifecycle management

integrated with expert

publishing and quality

assurance solutions.

Ensuring drug safety and

compliance with continually

evolving regulatory

requirements across

various markets

Make sure you have access

to comprehensive

pharmacovigilance (PV) and

medical information services.

You need an expansive

partner with expertise in the

unique needs of each global

market and their local

compliance or regulatory

requirements.

Table of contents

Drug development checklist (continued)

Cencora The Essential Guide to Drug Commercialization — page 9

The pre-launch phase of the drug commercialization journey is a mission-

critical period that shapes both product and patient outcomes. During this

time, organizations align on the building blocks of a successful therapeutic

debut, finalizing value propositions, aligning distribution strategies, and

designing patient support programs.

Position yourself for optimal market access — and start your search for a

commercialization partner — by asking these questions:

How can evidence gaps be

addressed?

Even after preclinical and

clinical phases, evidence gaps

can persist — particularly in

specialty and complex

therapies. Look for partners

who recommend practical

approaches, such as real-

world evidence studies, to

strengthen the evidence base.

Increasingly, data-driven

insights support scenario

planning, evidence

generation, and access

strategy decisions across the

commercialization lifecycle.

How can health economics

and outcomes research

(HEOR) support a compelling

value story?

HEOR plays an important role

in articulating a therapy’s

broader value and supporting

payer decision-making.

Partners who apply HEOR

insights effectively can help

demonstrate economic

impact, justify access

decisions, and strengthen the

overall value narrative.

Have I set up a PV model

appropriately in each market?

A strong PV framework is

essential across markets. The

right partner helps navigate

local safety reporting

requirements, regulatory

expectations, and ongoing

compliance obligations,

supporting risk management

planning and consistent safety

oversight throughout the

product lifecycle.

Pre-launch checklist

Eleven questions to ask yourself and your partner

Table of contents

Cencora The Essential Guide to Drug Commercialization — page 10

How do I set up third-party

logistics and quality systems

to ensure regulatory

compliance across markets?

Establishing quality and

logistics strategies that meet

local regulatory requirements

is critical to launch success.

This includes considerations

such as licensing, audits,

importation rules, quality

systems, packaging, labeling,

and channel strategy —

tailored by market to support

compliant and reliable

product distribution.

How can I increase visibility

into the ordering process?

Even when order management

is outsourced, visibility remains

critical. Look for partners that

provide transparent, web-

enabled reporting — allowing

real-time insight into inventory

levels, distribution activity, and

financial performance.

How can I gain internal

consensus on my product’s

value message?

As teams become more

geographically dispersed,

gathering pre-launch input

from internal stakeholders can

be challenging. The right

partner helps facilitate

alignment — using structured

approaches and digital

collaboration tools to

streamline feedback and

ensure clarity around the

product’s value story.

How can I deliver information

to payers when and where

they need it?

Supporting payer decision-

making requires timely,

accessible, and tailored

information. Traditional hard-

copy dossiers are often

insufficient on their own. An

effective partner supports

coordinated engagement —

enabling productive dialogue

between commercial teams,

medical affairs, and payers

through secure digital

platforms.

What are my business process

and order infrastructure

needs?

Not all biopharma companies

are positioned — or choose — to

build internal processes and

logistics infrastructure.

Effective partners offer

scalable solutions across

areas such as storage,

staffing, customer service, and

payment processing, helping

transform logistics into a

predictable and manageable

component of operations.

How can I help provider

offices overcome

reimbursement and access

hurdles?

Even with strong value

propositions and formulary

placement, therapies may

underperform if providers lack

practical access information.

Partners offering field

reimbursement and access

support help bridge these

gaps by providing guidance

on prior authorizations, claims

processes, and reimbursement

pathways.

Table of contents

Pre-launch checklist (continued)

Cencora The Essential Guide to Drug Commercialization — page 11

How can I address access,

adherence, and affordability

barriers more effectively?

Helping patients start and

stay on therapy requires both

human support and

technology. The right partner

helps balance the two —

combining nurse educators

and social workers with

data-driven insights to identify

adherence risks early and

intervene when support is

most needed.

How can I ensure my product

is available wherever patients

receive care?

Patients receive care across a

wide range of settings — from

hospitals and community

practices to specialty and

retail pharmacies. Partners

with broad distribution

networks and strong provider

reach help ensure consistent

availability. When evaluating

partners, consider the scale of

their network and alignment

with key group purchasing

organizations.

Table of contents

Pre-launch checklist (continued)

Cencora The Essential Guide to Drug Commercialization — page 12

You’ve seen your new therapy through to its official launch, but the work

doesn’t end there. Once in-market, product logistics and patient needs

fluctuate in real-time, requiring a post-launch strategy that can pivot.

What should your commercialization partner focus on post-launch? Effective

partners optimize programs and solutions as needed to remove access and

adherence barriers and ensure products reach their full potential.

Look for a partner who leads the way in these key post-launch areas:

Post-launch checklist

Five success factors for sustained success

Education and support for

providers and patients

The right partner offers

targeted education and

engagement to address

reimbursement, coverage, and

affordability questions, along

with patient education on

administration, side-effect

management, and

adherence — delivered by

qualified clinical professionals.

An action plan for

removing access barriers

The right partner supports

ongoing payer engagement

for formulary expansion,

strengthens access pathways,

and adapts strategies to

address evolving

reimbursement and coverage

dynamics.

Ongoing global

distribution excellence

The right partner brings strong

distribution infrastructure and

network reach, with regular

touchpoints to optimize

channel strategy — accounting

for inventory needs, resolving

shipping issues, and planning

for future demand.

Table of contents

Cencora The Essential Guide to Drug Commercialization — page 13

Real-time insights

and analytics

The right partner uses timely

insights into uptake and

patient engagement to

measure performance against

key indicators and recommend

adjustments that strengthen

patient support and

reimbursement strategies.

Ongoing strategic

analysis

The right partner helps

anticipate how market

conditions may change as

products mature, offering

perspective and guidance to

adapt strategies and support

evolving commercial priorities.

Table of contents

Post-launch checklist (continued)

Cencora The Essential Guide to Drug Commercialization — page 14

To understand the real impact of

integrated commercialization, the

Cencora Insights team spoke with

one of our biopharma partners

about their experience working

with a single partner — and what’s

often missing when services are

fragmented.

What do you find most valuable about

working with Cencora?

Working with Cencora is like having a dedicated tour

guide to help plan and execute our commercialization

strategy. That guide looks across our commercial needs

holistically and brings the right solutions and subject

matter experts into the conversation at the right time.

This ability to align evidence, access, and operational

decisions across the commercialization lifecycle is what

truly differentiates Cencora.

Whether the need is related to safety, regulatory affairs,

market access, logistics, HEOR, or beyond, there is a

single point of accountability who can quickly connect us

to the right expertise — helping keep momentum and

alignment across teams.

Did you need to course-correct at any

point, and what were the outcomes?

When our initial launch did not achieve the payer

coverage we anticipated, Cencora’s expertise and agility

helped us reassess the situation and adjust our strategy.

Their willingness to revisit assumptions and bring the right

solutions together at the right time was essential to

expanding access to the product.

A model for success

The hidden value of integrated commercialization services:

A biopharma company’s perspective

Table of contents

Cencora The Essential Guide to Drug Commercialization — page 15

What’s at risk without a single

point of coordination?

Without a central point person managing integrated

commercialization services, companies often find

themselves working across multiple vendors, contracts,

and partners. In these situations, communication

becomes fragmented, accountability is unclear, and

important details can fall through the cracks.

Beyond the operational complexity, fragmentation can

lead to higher costs, inconsistent data, and missed

opportunities to leverage scale across the

organization. Managing multiple specialty pharmacies,

hubs, or group purchasing organizations — each

reporting data differently — creates added burden and

risk for internal teams. In the worst case scenario, a

critical breakdown can delay therapy access for

patients who need it most.

What do you want others to

understand about Cencora’s

commercialization approach?

When it comes to bringing a new therapy to market,

Cencora supports nearly every aspect of the process.

The team brings together integrated commercialization

services, tailors solutions to the unique needs of both

the product and the organization, and simplifies what

is often a highly complex journey.

It’s the difference between working with a consultant

who offers direction and leaves execution up to you,

and working with a commercialization partner with the

experience, scale, and capability to execute — and help

biopharma companies reach their destination.

Table of contents

A model for success (continued)

Cencora The Essential Guide to Drug Commercialization — page 16

Continue the conversation

Commercialization success depends on more than launch

readiness. It requires coordinated planning, informed

decision-making, and the right expertise across development,

access, distribution, and post-launch execution. See how

Cencora can help you navigate complexity with an integrated

approach that supports product potential at every stage.

Explore our Commercialization Solutions and connect with our team

Cencora The Essential Guide to Drug Commercialization

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