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The growing importance of outsourced innovation, R&D, and manufacturing

Twenty years ago, the market was dominated by large multinationals that were fully integrated companies with their own discovery, development, and manufacturing engines. Today, these companies rely heavily on outsourced services. They in-license or acquire most of their innovation and outsource clinical development and manufacturing.

An evolving
commercialization model

Twenty years ago, most blockbuster drugs were small molecules designed to address large therapeutics areas such as cardiovascular and CNS. Today, companies are developing biologics to address the needs of narrower patient populations. As a result, large sales forces have been replaced by highly skilled small groups of key account managers and medical science liaisons who can have more in-depth discussions with physicians.

Pricing and
reimbursement have become key success factors

Twenty years ago, market access was not such an important aspect. Companies would just leverage their massive sales force to make their products “top of mind” with physicians and win prescriptions. Today, having a comprehensive market access strategy including pharmacoeconomics is essential in successfully selling a pharmaceutical product.

The R&D globalization

Twenty years ago, the US, Europe, and Japan were the key markets where all innovation took place. Today, South Korea and China have built R&D capabilities and are having global success. Twenty years ago, local emerging markets companies sold their products as branded generics without having the need to perform bio-equivalence studies. Today, more and more regulatory authorities are requiring studies and driving bad actors out of the system.

Twenty Years Ago.

Vertically integrated companies with discovery, development, manufacturing, and commercial capabilities.

Seeking to develop blockbuster drugs that were small molecules designed to address large therapeutics areas.

Large sales forces driven by “Top of Mind” strategy.

Little focus on market access.

US, Europe, and Japan were the key markets where all innovation took place.

Local emerging markets companies sold their products as branded generics without having the need to perform bio-equivalence studies.

Small chemical-based molecules made up the bulk of new developments.

Today.

Highly decentralized companies that in-license or acquire most of their innovation.

Developing biologics to address the needs of narrower patient populations.

Highly skilled small groups of key account managers and medical science liaisons who can have more in-depth discussions with physicians.

Having a comprehensive market access strategy including pharmacoeconomics is essential in successfully selling a pharmaceutical product.

South Korea and China have built R&D capabilities and are having global success.

More and more regulatory authorities are requiring studies and driving bad actors out of the system.

Innovation is much more complex. We went from chemical-based compounds to reformulations, to biologics, to cell therapy, and now gene therapy.

What impact do these changes have on the pharmaceutical industry?

These changes are likely to have a significant impact on an industry that remains much too fragmented. Access to innovation is becoming costlier because technologies used to develop new drugs are becoming more and more complex. We went from developing small chemical-based molecules, to drug delivery technologies, to biologics, to cell therapy such as CAR-T and now gene therapy such as CRISPR.

In developed markets, the era of “me toos” is disappearing fast. Developing or acquiring new drugs will become more competitive and require additional financing, which could be obtained by securing non-dilutive global or regional licensing deals.

I was born and raised in Rwanda. In Kinyarwanda, the word “kuyobora” means “Guide.” I wanted to use this word because guiding our clients to success is at the core of KYBORA’s principles and values.

Alan Vanderborght

CEO Kybora

Pharma

Biotech

Medtech

The growing importance of outsourced innovation, R&D, and manufacturing

An evolving
commercialization model

Pricing and
reimbursement have become key success factors

The R&D globalization

Alan Vanderborght

Dr. Jean Chatellier

Pauline Salvaing

Vijay Murugan

TYPE & ENTER:

Pharma

The growing importance of outsourced innovation, R&D, and manufacturing

An evolving commercialization model

Pricing and reimbursement have become key success factors

The R&D globalization

TYPE & ENTER:

An evolving
commercialization model

Pricing and
reimbursement have become key success factors