바이오시밀러 시장조사

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철저한 바이오시밀러 시장 조사에 참여하면 기업은 시장 역학, 규제 변화, 소비자 선호도를 이해하고 성장과 혁신을 주도하는 전략적 결정을 내릴 수 있습니다.

The truth about biosimilars? They’re not just cheaper alternatives—they’re healthcare game-changers that most executives still don’t fully understand. I’ve sat across from pharmaceutical CEOs who dismissed them, only to watch their market share erode months later.

Having led SIS International through decades of market evolution, I can assure you that few sectors offer the complexity and opportunity that biosimilars present today. Our specialists have uncovered patterns that separate market leaders from those struggling to adapt—and the differences might surprise you.

기업에 바이오시밀러 시장 조사가 필요한 이유는 무엇입니까?

Biosimilar market research is crucial for developing effective market entry and growth strategies. It identifies the market size, growth potential, and key drivers of demand. Companies can tailor their products and marketing strategies to meet the specific needs of different market segments by analyzing trends in patient adoption, healthcare provider preferences, and regional market variations.

게다가, the biosimilar market is heavily regulated, with stringent requirements for approval and ongoing compliance. Therefore, biosimilar market research enables businesses to stay updated on regulatory changes, understand the approval processes in different regions, and anticipate potential regulatory hurdles. This knowledge helps companies develop regulatory strategies that ensure timely approval and compliance, reducing the risk of delays and additional costs.

추가적으로, market research provides detailed competitive analysis, helping businesses understand their competitors’ strategies, strengths, and weaknesses. It is essential to identify market gaps, develop unique value propositions, and effectively position biosimilar products to gain a competitive advantage.

The Evolving Landscape of Biosimilars

The truth about biosimilars? They’re not just cheaper alternatives—they’re healthcare game-changers that most executives still don’t fully understand.

Market disruption is the daily reality reshaping pharmaceutical economics worldwide. The biosimilar market research we’ve conducted over the past five years reveals a startling truth: manufacturers who initially scoffed at biosimilar competition now scramble to develop their portfolios. You’re witnessing a fundamental shift in how biological therapies reach patients, with ripple effects touching everything from pricing strategies to R&D priorities.

… And what’s driving this transformation? It’s not just cost savings, though they’re substantial. Our latest biosimilar market research indicates that successful market entrants are those who understand the complex interplay between regulatory pathways, physician acceptance, and patient education. The barriers to entry remain high—developing a biosimilar isn’t like producing a simple generic pill—but the rewards for getting it right have never been greater.

The most successful organizations we’ve worked with approach biosimilar market research as an ongoing commitment rather than a one-time investment. They’re constantly testing assumptions, tracking evolving prescriber behaviors, and adjusting their commercialization strategies based on real-world evidence.

현재 시장 검토 및 권장 사항

SIS International에서는 비용 효과적인 생물학적 치료제에 대한 수요 증가, 주요 생물학적 제제의 특허 만료, 우호적인 규제 환경에 힘입어 바이오시밀러 시장이 크게 성장하고 있다고 생각합니다. 우리 연구에 따르면 다양한 치료 분야에 걸쳐 시장에 진입하는 바이오시밀러 제품의 수가 증가함에 따라 시장은 계속 확대될 것으로 예상됩니다.

Additionally, healthcare providers’ and patients’ acceptance and adoption of biosimilars are on the rise, supported by increased education and awareness efforts. However, challenges such as regulatory complexities, competitive pressures, and the need for robust pharmacovigilance remain.

기업을 위한 권장 사항

1. 시장 기회 활용: 우리는 기업들이 제품 포트폴리오를 확장하고 새로운 치료 분야에 진출하여 증가하는 바이오시밀러 수요를 활용할 것을 권장합니다. 잠재력이 높은 시장과 충족되지 않은 요구 사항을 파악함으로써 기업은 특정 환자 집단을 대상으로 하는 바이오시밀러 제품을 개발하고 경쟁 우위를 확보할 수 있습니다.
2. 규제 전략 강화: 바이오시밀러를 성공적으로 출시하고 상용화하려면 규제 환경을 탐색하는 것이 중요합니다. 우리는 기업이 지역 요구 사항을 준수하고 시기적절한 승인을 촉진하는 강력한 규제 전략을 개발하는 데 투자해야 한다고 믿습니다. 
3. 이해관계자 참여 강화: 바이오시밀러의 광범위한 채택을 위해서는 의료 서비스 제공자, 지불자 및 환자 간의 신뢰와 확신을 구축하는 것이 필수적입니다. 우리는 기업이 바이오시밀러의 안전성, 효능 및 비용 효율성을 강조하는 포괄적인 교육 및 커뮤니케이션 전략에 집중하는 것이 중요하다고 생각합니다. 

Regional Variations in Biosimilar Adoption

Geographic differences in biosimilar uptake tell a fascinating story about healthcare systems and cultural attitudes toward innovation.

~ 안에 유럽, where biosimilar market research shows impressive adoption rates, centralized purchasing decisions and physician incentives have created a flourishing ecosystem. Meanwhile, the U.S. market presents a more fragmented picture, with biosimilar market research revealing pockets of rapid adoption alongside areas of persistent resistance.

I’ve walked hospital corridors in Germany, where biosimilar utilization exceeds 90% for certain molecules, and contrasted this with facilities in parts of the U.S. where that figure struggles to reach 20%. Our biosimilar market research teams have identified key inflection points that predict when and how quickly adoption accelerates in different regions. It’s not simply about price—though that matters enormously—but about confidence in the regulatory framework and educational outreach.

Asian markets present perhaps the most dynamic picture of all. Our biosimilar market research in South Korea, India, and China reveals aggressive government policies promoting domestic development alongside unique physician education needs. We’ve helped multinational clients navigate these complexities, identifying partnership opportunities that leverage local knowledge while maintaining global quality standards.

바이오시밀러 시장 조사의 주요 플레이어

바이오시밀러 시장에서는 몇몇 주요 업체들이 바이오시밀러 제품의 혁신, 개발 및 상용화를 주도하고 있습니다. 이들 회사는 포괄적인 시장 조사를 활용하여 규제 환경을 탐색하고, 시장 역학을 이해하고, 경쟁력 있는 입지를 구축합니다. 바이오시밀러 시장 조사의 주요 업체는 다음과 같습니다.

암젠

• Amgen은 생명공학 분야의 글로벌 리더이자 바이오시밀러 개발의 선구자 중 하나입니다. 연구 개발에 중점을 두고 있는 Amgen은 광범위한 시장 조사를 활용하여 기회를 파악하고 제품 파이프라인을 최적화합니다. 

산도스(노바티스 사업부)

• 노바티스의 계열사인 산도스는 광범위한 바이오시밀러 제품 포트폴리오를 갖춘 바이오시밀러 시장의 선두주자입니다. 이 회사는 심층적인 시장 조사를 통해 의료 서비스 제공업체의 선호도, 규제 요구 사항 및 경쟁 환경을 이해합니다. 

바이오콘

• Biocon은 혁신적인 접근 방식과 글로벌 도달 범위로 잘 알려진 신흥 바이오시밀러 시장 리더입니다. 회사는 시장 조사를 활용하여 주요 시장에서의 입지를 확장하고 경쟁력 있는 위치를 강화합니다. 

화이자

• 화이자(Pfizer)는 바이오시밀러 시장의 주요 기업으로 연구개발에 중점을 두고 있습니다. 회사는 포괄적인 시장 조사를 통해 제품 개발부터 상업화까지 바이오시밀러 전략을 안내합니다. 

셀트리온

• 셀트리온은 바이오시밀러 개발 및 제조를 전문으로 하는 생명공학 기업입니다. 회사는 시장 요구 사항, 규제 문제 및 경쟁 기회를 파악하기 위해 광범위한 시장 조사를 수행합니다. 

삼성바이오에피스

• 삼성바이오에피스는 고품질 바이오시밀러 개발에 전념하는 삼성바이오로직스와 바이오젠의 합작사다. 회사는 시장 조사를 활용하여 복잡한 규제 환경을 탐색하고 시장 역학을 이해합니다. 

테바제약

• Teva Pharmaceuticals는 바이오시밀러를 포함한 제네릭 및 특수 의약품 분야의 글로벌 리더입니다. 회사는 시장 조사를 통해 바이오시밀러 개발 및 상업화 전략을 안내합니다. Teva는 환자 접근성과 비용 절감에 초점을 맞춰 고품질 바이오시밀러를 시장에 출시하고 전 세계 환자에게 보다 저렴한 치료 옵션을 제공하려는 노력을 기울이고 있습니다.

머크 앤 컴퍼니(MSD)

• 미국과 캐나다 이외의 지역에서는 MSD로 알려진 Merck & Co.는 바이오시밀러 시장의 주요 업체입니다. 이 회사는 의료 서비스 제공자의 선호도, 규제 문제 및 시장 기회를 이해하기 위해 광범위한 시장 조사를 수행합니다. 혁신과 품질에 대한 머크의 노력은 바이오시밀러 제품이 최고의 안전성과 효능 기준을 충족하도록 보장합니다.

Future Trends in Biosimilar Development

The next wave of biosimilars will transform therapeutic areas that have remained relatively untouched by this revolution. Our biosimilar market research forecasts indicate that ophthalmology, dermatology, and neurology will experience the kind of competitive reshaping that oncology and immunology have already undergone. You’re looking at a market that will nearly triple in value over the next decade, with particularly aggressive growth in emerging economies.

What makes this next phase different?

Biosimilar market research points to several key factors. Manufacturing technologies have advanced dramatically, lowering development costs. Regulatory pathways have become more predictable in major markets. And perhaps most importantly, the first generation of biosimilars has built credibility among clinicians who were initially skeptical but now have years of real-world experience with these products.

“The pioneers in biosimilar development faced headwinds that the next generation of products won’t encounter to the same degree—but they’ll face new challenges that require equally sophisticated market intelligence,” as one of our senior analysts recently noted in our global biosimilar market research report.

I’ve advised clients to pay particular attention to how digital health technologies reshape patient monitoring capabilities. Our biosimilar market research indicates that biosimilar manufacturers who can offer compelling value-added services—not just competitive pricing—will increasingly differentiate themselves in crowded therapeutic categories. We’re already seeing this play out in diabetes and growth hormone therapies, where device integration and patient support programs have become competitive battlegrounds.

Competitive Analysis in the Biosimilar Space

When we conduct biosimilar market research focused on competitive positioning, we often uncover development programs that aren’t widely publicized but could fundamentally alter market entry timing decisions. You’re operating in an environment where being third-to-market with the right strategy often outperforms being first with the wrong one.

Our biosimilar market research methodology combines traditional pharmaceutical intelligence gathering with specialized approaches developed specifically for this unique market. We track not just which molecules are in development, but also manufacturing capacity investments, clinical trial site selections, and patent litigation strategies that signal competitors’ intentions and capabilities.

What distinguishes high-value biosimilar market research is the ability to forecast product approvals and adoption curves across different customer segments. We’ve developed sophisticated models incorporating stakeholder research, analog analysis, and payer dynamics to help clients realistic volume projections at launch and throughout the product lifecycle as competitive intensity increases.

Biosimilar Market Research – Key Insights

- Market Disruption: Biosimilars are fundamentally reshaping pharmaceutical economics, with even skeptical manufacturers now developing their biosimilar portfolios.

- Success Factors: Leading companies in the biosimilar space excel through deep stakeholder insights rather than just competitive pricing, understanding the interplay between regulatory pathways, physician acceptance, and patient education.

- Regional Variations: Significant differences exist in adoption rates across regions, with Europe showing adoption rates up to 90% for certain molecules while some U.S. regions struggle to reach 20%.

- Asian Markets: Countries like South Korea, India, and China present unique opportunities with aggressive government policies promoting domestic development alongside specific education needs.

- Stakeholder Complexity: Successful biosimilar launches require orchestrating messages across multiple audiences simultaneously, including payers, hospital administrators, patient groups, and regulatory authorities.

- Value Thresholds: Different stakeholders require different cost savings to find biosimilar value propositions compelling—hospital pharmacists may demand 30% savings. In comparison, integrated health systems might change formularies at just 15% if supply reliability is high.

- Emerging Therapeutic Areas: The next wave of biosimilars will transform ophthalmology, dermatology, and neurology, with market value expected to nearly triple over the next decade.

- Regulatory Navigation: Significant differences in approval requirements across regions necessitate sophisticated intelligence to design efficient development programs meeting diverse expectations.

- Competitive Positioning: Being third-to-market with the right strategy often outperforms being first with the wrong approach—successful companies track molecules in development, manufacturing investments, and patent litigation strategies.

- 디지털 통합: Forward-thinking biosimilar manufacturers differentiate themselves through value-added services like device integration and patient support programs, particularly in diabetes and growth hormone therapies.

SIS International의 바이오시밀러 시장 조사가 기업에 어떻게 도움이 됩니까?

바이오시밀러 시장 조사에 대한 우리의 전문 지식은 시장 역학, 규제 환경 및 경쟁 분석의 다양한 측면을 다루며 기업이 정보에 입각한 결정을 내리고 전략적 목표를 달성할 수 있도록 지원합니다. 바이오시밀러 시장에 대한 당사의 시장 조사가 기업에 어떻게 도움이 되는지 살펴보겠습니다.

수익 증가

Our research helps companies understand which products or services resonate most with healthcare providers and patients, enabling them to focus on high-potential areas. 

위험 감소

우리는 잠재적인 위험을 식별하고 완화 전략을 개발하기 위한 통찰력을 기업에 제공합니다. 우리의 연구는 기업이 비용이 많이 드는 실수의 가능성을 줄이고 문제에 직면했을 때 회복력을 보장하는 정보에 입각한 결정을 내리는 데 도움이 됩니다.

마케팅 효율성 향상

SIS 국제 market research services help businesses identify the most effective marketing channels, messages, and strategies to reach their target audience. 

가속화된 성장과 혁신

Our research services provide businesses with the insights to identify emerging trends and consumer needs, fueling innovation and growth. 

장기적인 파트너십

We believe in building long-term partnerships with our clients. SIS International provides ongoing support and consultation to help businesses adapt to market changes and continuously refine their strategies. Our commitment to client success ensures you have a trusted partner to rely on as you navigate the biosimilar market. 

 

자주 묻는 질문

1. What makes biosimilar market research different from traditional pharmaceutical research?

Biosimilar market research requires a more comprehensive stakeholder approach than traditional pharmaceutical research. While traditional research often focuses heavily on prescriber preferences, biosimilar research must include payers, hospital administrators, patient advocacy groups, and regulatory authorities—all of whom significantly influence adoption. Additionally, biosimilar research must account for unique considerations like interchangeability, switching studies, and reference product selection that don’t exist in other pharmaceutical categories.

2. How long do biosimilars typically take to gain significant market share after launch?

Market share acquisition varies dramatically by region, therapeutic area, and molecule. In Europe, where centralized purchasing decisions and physician incentives support adoption, biosimilars can capture 50-80% market share within 12-24 months for well-established molecules. In the U.S., adoption has historically been slower, though this is changing with improved stakeholder education and evolving payer policies. Our research shows that oncology biosimilars typically gain traction faster than those in immunology, and hospital-administered products generally see quicker uptake than self-administered ones.

3. What are the most common barriers to biosimilar market entry for entrepreneurs?

The primary barriers include:
1) High development costs and technical complexity, requiring sophisticated manufacturing capabilities;
2) Patent thickets created by reference product manufacturers;
3) Regulatory uncertainty in some regions;
4) Physician and patient education needs; 5) Reference product manufacturer defensive strategies including contracting tactics and product improvements;
6) Limited differentiation opportunities beyond price; and
7) Challenges in building credibility with key stakeholders as a new entrant. Successful entrepreneurs typically address these through strategic partnerships, focused therapeutic area selection, and innovative go-to-market approaches.

4. How important is interchangeability designation for biosimilar commercial success?

While interchangeability designation can be valuable in certain market segments, particularly retail pharmacy-dispensed products, our research shows it’s not universally necessary for commercial success. Building prescriber confidence through strong clinical data and education often proves more important than interchangeability designation in hospital and clinic settings where physicians actively prescribe products. The significance of interchangeability varies substantially by therapeutic area, product administration setting, and regional pharmacy substitution laws.

5. What role do value-added services play in biosimilar competition?

As more biosimilars enter the same therapeutic spaces, value-added services are becoming increasingly important differentiators. Our research indicates that services like patient support programs, simplified reimbursement assistance, injection training, and digital monitoring tools can significantly influence adoption decisions when multiple biosimilars offer similar pricing. For entrepreneurs entering the space, strategically designed service offerings that address specific stakeholder pain points can create competitive advantage without requiring the massive investments to compete solely on price.

6. How are biosimilar pricing strategies evolving as markets mature?

Early biosimilar entrants typically launched with modest discounts (15-30%) to reference products, but pricing strategies have become more sophisticated as competition intensifies. In mature biosimilar markets like Europe, we now see average discounts of 30-70% depending on the therapeutic area and competitive intensity. Contract structures have also evolved beyond simple percentage discounts to include volume-based tiering, outcomes guarantees, and portfolio-based contracting. Entrepreneurs should be prepared for aggressive pricing competition in established biosimilar categories while potentially finding more pricing flexibility in newly-opening therapeutic areas.

7. What capabilities are most critical for new entrants to develop when entering the biosimilar space?

Beyond the obvious technical and regulatory capabilities required for development, successful new entrants must excel at:

1) Stakeholder mapping and engagement across the entire ecosystem;
2) Health economic modeling that quantifies value beyond simple acquisition cost;
3) Educational content development tailored to different stakeholder concerns;
4) Supply chain reliability and scalability;
5) Competitive intelligence gathering;
6) Nimble commercial operations that can adapt to rapidly changing market conditions; and
7) Strategic partnership development to complement internal capabilities. Our research consistently shows that companies underinvesting in these areas struggle even with technically excellent products.

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