Investigación de mercado de biosimilares

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Participar en una investigación exhaustiva del mercado de biosimilares ayuda a las empresas a comprender la dinámica del mercado, los cambios regulatorios y las preferencias de los consumidores, garantizando que puedan tomar decisiones estratégicas que impulsen el crecimiento y la innovación.

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.

¿Por qué las empresas necesitan investigaciones de mercado de biosimilares?

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.

Además, 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.

Además, 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.

Nuestra revisión del mercado actual y recomendaciones

En SIS International, consideramos que el mercado de biosimilares está experimentando un crecimiento significativo impulsado por la creciente demanda de tratamientos biológicos rentables, la expiración de patentes de los principales productos biológicos y entornos regulatorios favorables. Nuestra investigación indica que se espera que el mercado continúe expandiéndose, con un número creciente de productos biosimilares ingresando al mercado en diversas áreas terapéuticas.

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.

Recomendaciones para empresas

1. Aprovechar las oportunidades del mercado: Recomendamos que las empresas aprovechen la creciente demanda de biosimilares ampliando sus carteras de productos e ingresando a nuevas áreas terapéuticas. Al identificar mercados de alto potencial y necesidades no satisfechas, las empresas pueden desarrollar productos biosimilares que se dirijan a poblaciones de pacientes específicas y obtener una ventaja competitiva.
2. Fortalecer las estrategias regulatorias: Navegar por el panorama regulatorio es fundamental para lanzar y comercializar biosimilares con éxito. Creemos que las empresas deben invertir en el desarrollo de estrategias regulatorias sólidas que garanticen el cumplimiento de los requisitos regionales y faciliten las aprobaciones oportunas. 
3. Mejorar la participación de las partes interesadas: Generar confianza entre los proveedores de atención médica, los pagadores y los pacientes es esencial para la adopción generalizada de biosimilares. Consideramos importante que las empresas se centren en estrategias integrales de educación y comunicación que destaquen la seguridad, eficacia y rentabilidad de los biosimilares. 

Regional Variations in Biosimilar Adoption

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

En Europa, 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.

Actores líderes en la investigación de mercado de biosimilares

En el mercado de los biosimilares, varios actores líderes están impulsando la innovación, el desarrollo y la comercialización de productos biosimilares. Estas empresas aprovechan la investigación de mercado integral para navegar por los panoramas regulatorios, comprender la dinámica del mercado y posicionarse competitivamente. Estos son algunos de los principales actores en la investigación de mercado de biosimilares:

amgen

• Amgen es líder mundial en biotecnología y uno de los pioneros en el desarrollo de biosimilares. Con un fuerte enfoque en investigación y desarrollo, Amgen utiliza una extensa investigación de mercado para identificar oportunidades y optimizar su cartera de productos. 

Sandoz (una división de Novartis)

• Sandoz, una división de Novartis, es un actor líder en el mercado de biosimilares, con una amplia cartera de productos biosimilares. La empresa utiliza una investigación de mercado en profundidad para comprender las preferencias de los proveedores de atención médica, los requisitos regulatorios y los panoramas competitivos. 

Biocon

• Biocon es un líder emergente en el mercado de biosimilares conocido por su enfoque innovador y alcance global. La empresa aprovecha la investigación de mercado para ampliar su presencia en mercados clave y mejorar su posicionamiento competitivo. 

Pfizer

• Pfizer es un actor importante en el mercado de biosimilares y pone gran énfasis en la investigación y el desarrollo. La empresa utiliza una investigación de mercado exhaustiva para guiar sus estrategias de biosimilares, desde el desarrollo del producto hasta la comercialización. 

Celltrión

• Celltrion es una empresa biotecnológica especializada en el desarrollo y fabricación de biosimilares. La empresa lleva a cabo una extensa investigación de mercado para identificar las necesidades del mercado, los desafíos regulatorios y las oportunidades competitivas. 

Bioepis Samsung

• Samsung Bioepis es una empresa conjunta entre Samsung Biologics y Biogen, dedicada al desarrollo de biosimilares de alta calidad. La empresa aprovecha la investigación de mercado para navegar por panoramas regulatorios complejos y comprender la dinámica del mercado. 

Farmacéutica Teva

• Teva Pharmaceuticals es líder mundial en medicamentos genéricos y especializados, incluidos los biosimilares. La empresa utiliza la investigación de mercado para guiar sus estrategias de desarrollo y comercialización de biosimilares. El enfoque de Teva en el acceso de los pacientes y la contención de costos impulsa sus esfuerzos para llevar al mercado biosimilares de alta calidad, ofreciendo opciones de tratamiento más asequibles a pacientes de todo el mundo.

Merck & Co. (MSD)

• Merck & Co., conocida como MSD fuera de Estados Unidos y Canadá, es un actor importante en el mercado de biosimilares. La empresa lleva a cabo una extensa investigación de mercado para comprender las preferencias de los proveedores de atención médica, los desafíos regulatorios y las oportunidades de mercado. El compromiso de Merck con la innovación y la calidad garantiza que sus productos biosimilares cumplan con los más altos estándares de seguridad y eficacia.

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.

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

Cómo la investigación de mercado de SIS International en el mercado de biosimilares ayuda a las empresas

Nuestra experiencia en investigación de mercado de biosimilares cubre varios aspectos de la dinámica del mercado, panoramas regulatorios y análisis competitivo, lo que permite a las empresas tomar decisiones informadas y alcanzar sus objetivos estratégicos. Así es como nuestra investigación de mercado en el mercado de biosimilares ayuda a las empresas:

Mayores ingresos

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

La reducción de riesgos

Proporcionamos a las empresas la información necesaria para identificar riesgos potenciales y desarrollar estrategias de mitigación. Nuestra investigación ayuda a las empresas a tomar decisiones informadas que reducen la probabilidad de cometer errores costosos y garantizan la resiliencia ante los desafíos.

Eficiencia de marketing mejorada

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

Crecimiento acelerado e innovación

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

Asociación a largo plazo

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. 

 

Preguntas frecuentes

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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Acerca de SIS Internacional

SIS Internacional ofrece investigación cuantitativa, cualitativa y estratégica. Proporcionamos datos, herramientas, estrategias, informes y conocimientos para la toma de decisiones. También realizamos entrevistas, encuestas, grupos focales y otros métodos y enfoques de investigación de mercado. Póngase en contacto con nosotros para su próximo proyecto de Investigación de Mercado.