How Regional CDMOs Break Into Global Markets? 5 Practical Strategies for Global Expansion

Strategy 1: Focus and Deepen in a Specific Niche Market

With limited resources, small to mid-sized CDMOs should prioritize specialization so that the market can clearly recognize their core capabilities. Instead of trying to offer “everything to everyone”, focus your resources on a domain where your team has unique expertise. This prevents resource dispersion that leads to being “jack of all trades, master of none.”

How to choose your niche:

1.Technology-driven focus:

Each of the following drug types requires specialized techniques and corresponding production equipment:

• Specific small-molecule drugs
• Biologics (e.g., monoclonal antibodies)
• Peptide or oligonucleotide drugs
• APIs or specific dosage forms
• Cell and gene therapy vectors
• High-complexity products like ADCs

2.Market-driven focus:

Assess current and potential blockbuster drug areas, positioning yourself ahead of market trends

Organic growth path Recommendation:

• Phase 1: Build professional reputation based on your team’s core technical expertise
• Phase 2: Expand vertically—extend services upstream or downstream along your core technology.
• Phase 3: Once your business stabilizes, consider expanding into other technical domains.

Regarding M&A Development:

If financially supported, acquisitions can be a rapid expansion option—Taiwan’s Bora Pharmaceuticals is a good example.

Strategy 2: Obtain and Maintain International Certifications

The pharmaceutical industry differs fundamentally from IT: while semiconductor products meeting ISO standards can be sold globally, drug manufacturing requires country-by-country certification. The actual operational model works as follows:

• If a drug is to be sold in countries A, B, C, D, E, F, and G
• Applications must be submitted separately to each country’s regulatory authority
• Each authority reviews drug documentation and conducts on-site inspections
• Only after approval, granting drug licenses and GMP certificate, the drug can be sold in those markets

Note: Depending on drug type, EU member states can use EMA centralized approval for distribution across member nations.

The importance of global GMP certification:

• Basic requirement: Beyond domestic GMP certification, certifications from mainstream markets like the US, EU, and Japan are essential tickets for global business.
• Maintenance: Both drug licenses and GMP certificates have expiration dates. Therefore, maintaining high compliance standards and transparency in subsequent routine inspections is important to hold valuable GMP certificates.
• Trust factor: When a manufacturing facility obtains certifications from multiple major markets, it demonstrates that production quality is recognized by mainstream countries, naturally making it more attractive to global clients.

In some countries, local regulatory authorities lacking sufficient pharmaceutical review capabilities and manpower may accept drugs already approved in the US, EU (and sometimes Japan), simplifying the review process for these drugs.

Therefore, most clients prioritize CDMOs that can assist with US, EU, and Japanese certification. Obtaining GMP certification from mainstream pharmaceutical markets greatly supports CDMOs to break into global markets.

Strategy 3: Pursue Strategic Collaborations and Partnerships

Strategic cooperation with appropriate partners accelerates global expansion.

1.Collaborating with CDMOs in target market

If your goal is to enter the US, EU, or Japan market , consider partnering with local CDMOs that already have strong market presence and client relationships.

Strategic alliance model:

• Based on complementary cooperation (such as technical complementarity)
• Provide one-stop service to clients, eliminating the need to contact multiple CDMOs
• Early exposure, reputation building, and face challenges together

M&A model:

• Identify suitable acquisition targets in the target country’s market
• Complete ownership of the company and inherit existing clients and orders
• When executed properly, can rapidly enter those market sectors

2.Collaborating with startups in target market

Focusing on promising drug development companies or biotech startups in target markets can accumulate specific domain expertise and experience.

If collaboration goes well, the CDMO can grow alongside the startup.

Considering that startups typically have tighter budgets,

CDMOs can consider splitting contracts into multiple milestones for payment, easing the startup’s cash burn rate:

• Split payments into multiple milestones to slow cash consumption
• As development and manufacturing progress, startups pay corresponding fees
• This model is more startup-friendly and increases cooperation willingness

If startups offer equity in lieu of partial manufacturing fees, it can slow their cash burn rate. Additionally, when the startup succeeds, the CDMO benefits from stock appreciation. Sharing interests through equity strengthens mutual motivation.

However, if a CDMO holds startup equity, the following risks should be considered:

• Holding partial equity in a startup may create competitive relationships with other companies developing similar drugs, reducing cooperation opportunities with those companies
• CDMOs have their own operational expenses. Equity monetization takes time and carries failure risk, increasing cash flow pressure on the CDMO

Strategy 4: Customer and Regional Strategy for Business Development

1.Starting with clinical trial drug manufacturing

• Initial Strategy: Target companies planning Phase I or Phase II clinical trials for collaboration discussions.
• Rationale: Clinical trial drug manufacturing requires GMP compliance. For CDMOs that haven’t yet obtained complete international GMP certificates, this is an entry-level cooperation opportunity.

2.Leverage PIC/S mutual recognition advantages

As a member of the PIC/S GMP alliance, member country enjoys mutual recognition advantages with other member countries.

Certain countries recognize GMP certificates from other PIC/S member countries

• It simplifies audit and review processes, which simplifies facility audits or converts them to document-based reviews
• Significantly shortens the time for partners to obtain certification in that country

Practical Impact: Generally, arranging inspections (including personnel arrangement, scheduling, on-site audits, deficiency corrections, and completion of certification) takes about a year. If inspections can be simplified or be waived, it will greatly help faster drug launch in those markets.

Opportunities for PIC/S member CDMOs: For countries that mutually recognize PIC/S GMP certification, CDMOs have clear advantages in contract manufacturing cooperation.

Strategy 5: Build an Industry Network Systematically

Networking isn’t just about who you know, but what value you create for each other.

At this point, I must emphasize the importance of network building. But I want to stress that it’s not simply about “knowing who’s who,” but rather cultivating your professional value. Core principles for cultivating professional value include:

• What are you good at?
• How can you help others?
• When both parties have areas of expertise, genuine cooperation opportunities emerge

Technical capability gets you to the table. Trust gets you the contract.

Trust is the keystone in business cooperation.

I once witnessed a case: an Asian regional CDMO founder and a US startup founder were former colleagues who knew each other well and understood each other’s work styles. When the US startup prepared Phase I clinical trial drug manufacturing, they unhesitatingly commissioned this Asian regional CDMO.

Just like that? Why?

Because of the trust between the founders. They knew that difficulties would inevitably arise during drug development and manufacturing, but both parties knew these challenges would be faced honestly and solved proactively, rather than concealed.

This kind of trust is the most valuable asset in business cooperation.

The world is large, but circles are small—so please care your reputation.

How to systematically build your network:

• Attend major industry conferences: BIO International Convention, CPHI, JPM Healthcare Conference, etc.
• Join professional organizations: National biotech associations, CDMO industry alliances, etc.
• Build your personal brand: Share professional insights through articles, videos, and presentations to help others
• Maintain long-term engagement: Regularly stay in touch with industry partners

Action Checklist

If you’re considering globalization strategies for your regional CDMOs, consider this checklist:

• Identify your core technical strengths and niche market positioning
• Assess your timeline and budget for your international GMP certification
• Search potential strategic partners (CDMOs, startups, clients)
• Study target-market GMP mutual recognition and regulatory requirements
• Develop a networking plan (conferences, organizations, personal branding)
• Set your goals and milestones for globalization

Conclusion

The globalization path for regional CDMOs is full of challenges, but opportunities exist. Through niche positioning, compliance-first approach, strategic cooperation, precise market development, and building trust relationships, small to mid-sized CDMOs can find their place on the globalization stage.

Globalization isn’t achieved overnight—it requires long-term cultivation. Choose the right strategy, insist on quality, build trust, and your CDMO can become a trusted partner for global clients.

Extended Reading:

Why Asian CDMOs Struggle with Globalization: 5 Key Structural Barriers Explained

Why Asian CDMOs Struggle with Globalization? 5 Key Structural Barriers Explained

Despite solid technology and competitive pricing, many Asian CDMOs struggle to win global clients. Here explores 5 deep-rooted structural barriers — regulatory hurdles, reputation building, geopolitical risks, communication challenges — prevent Asian CDMOs from achieving true globalization.

ChivantaShaoChi CHENG

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